Federal Register Vol. 80, No.127,

Background

The regulations in 9 CFR part 94 (referred to below as the regulations) prohibit or restrict the importation of certain animals and animal products into the United States to prevent the introduction of various animal diseases, including rinderpest, foot-and-mouth disease (FMD), African swine fever, classical swine fever, and swine vesicular disease. These are dangerous and destructive communicable diseases of ruminants and swine. Section 94.1 of the regulations contains criteria for recognition by the Animal and Plant Health Inspection Service (APHIS) of foreign regions as free of rinderpest or free of both rinderpest and FMD. Section 94.11 restricts the importation of ruminants and swine and their meat and certain other products from regions that are declared free of rinderpest and FMD but that nonetheless present a disease risk because of the regions' proximity to or trading relationships with regions affected with rinderpest or FMD. Regions APHIS has declared free of FMD and/or rinderpest, and regions declared free of FMD and rinderpest that are subject to the restrictions in § 94.11, are listed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.

On December 23, 2013, we published in the Federal Register (78 FR 77370-77376, Docket No. APHIS-2009-0017) a proposal 1 to allow, under certain conditions, the importation of fresh (chilled or frozen) beef from a region in Brazil (the States of Bahia, Distrito Federal, Espírito Santo, Goiás, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Paraná, Rio Grande do Sul, Rio de Janeiro, Rondônia, São Paulo, Sergipe, and Tocantins).

We solicited comments concerning our proposal for 60 days ending February 21, 2014. We reopened and extended the deadline for comments until April 22, 2014, in a document published in the Federal Register on February 27, 2014 (79 FR 10999, Docket No. APHIS-2009-0017). We received 870 comments by that date. They were from producers, trade associations, veterinarians, representatives of State and foreign governments, and individuals. They are discussed below by topic.

Many commenters, citing the highly contagious nature of FMD, expressed the view that we should not allow fresh beef to be imported from any country where the disease is present because regionalization is not likely to mitigate the risks associated with imports effectively. Commenters noted that the FMD virus can travel up to 60 miles on the wind. Commenters also cited bird fecal matter and people traveling between affected and non-affected areas as additional vectors for transmission of the virus.

As noted in the risk assessment accompanying the December 2013 proposed rule, we considered the epidemiological characteristics of FMD. Based on our assessment, we concluded that beef from the exporting region of Brazil could safely be imported into the United States, provided that FMD has not been diagnosed in that region within the past 12 months, that there is no commingling of bovines or beef from that region with animals or beef from other regions prior to export, and that certain additional FMD-mitigation requirements, which include removal of bones and certain tissue and chilling of the carcasses until they reach a pH level of under 6.0, are met. We evaluated information submitted by Brazil's Ministry of Agriculture, Livestock and Food Supply (MAPA) and verified the accuracy of that information by conducting site visits. We concluded that Brazil has the legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs, and emergency response capacity to prevent FMD outbreaks within the boundaries of the Brazilian export region and, in the unlikely event that one should occur, to detect, control, and eradicate the disease. Brazil's active and passive surveillance system would allow for rapid detection. In the event of an outbreak, in the exporting region, Brazil would promptly report findings to the World Organization for Animal Health (OIE), and the United States would stop importing beef from Brazil. Our findings regarding Brazil's disease-control capabilities give us confidence that the mitigation methods required under this rulemaking will safely permit the importation of fresh beef from Brazil.

Some commenters cited FMD's 14-day incubation period as an additional risk factor. It was suggested that infected cattle may not exhibit clinical signs of FMD during the incubation period. According to those commenters, such cattle could be slaughtered and enter the food chain, with the FMD-infected beef derived from them potentially being exported to the United States. Commenters advised us to adopt what they stated was the recommendation of the OIE for a 3-week quarantine of animals from which beef for export is to be derived and for the complete segregation of animals in the export zone from animals in adjacent infected zones.

APHIS disagrees with the commenters. The OIE guidelines do not require the quarantine of cattle whose beef is destined for exportation from FMD-free regions with vaccination. Article 8.7.24 of the OIE Terrestrial Animal Health Code states that veterinary authorities of countries importing fresh meat from countries or regions recognized by the OIE as FMD-free with vaccination should require the presentation of an international veterinary certificate attesting that the entire consignment of meat comes from animals which (1) have either been kept in the free-with-vaccination region or country or otherwise meet OIE requirements for live animal imports under Chapter 8.7 and (2) have been slaughtered in an approved abattoir and have been subjected to ante- and post-mortem inspections for FMD with favorable results. Similarly, under this rulemaking we require that the animals from which the meat is derived must have been born and raised in the exporting region. Because the animals would have lived only in the exporting region, they would be unlikely to have been exposed to the FMD virus, and, if exposed, would have been immunized against the particular FMD strains that are prevalent in the region. APHIS does recognize the possibility, however remote, that because cattle that are in the early stages of the FMD incubation period may not show clinical signs of FMD, an ante-mortem inspection could fail to detect the disease, and FMD-infected cattle could be presented for slaughter, processing, and export of meat. In our view, however, the additional mitigation measures contained in this rulemaking, which include requiring the maturation of the beef in a chiller until the pH level in the longissimus dorsi is less than 6.0 and the removal of bovine parts, such as the head, feet, and internal organs, that are associated with a higher FMD risk than muscle tissue will ensure that beef may be safely imported into the United States from Brazil.

Some of the comments expressed reservations about the efficacy of the maturation requirements contained in the proposed rule, which included chilling of the carcass after slaughter for a minimum of 24 and a maximum of 48 hours to ensure that the pH in the loin muscle will be below 6.0. One commenter stated that chilling beef may be inadequate for eliminating the FMD virus, since that virus can remain active in blood clots. Another commenter stated that the reduction of pH is not included as one of the recognized procedures for the inactivation of FMD virus in meat in the OIE Terrestrial Animal Health Code. It was suggested that, in order to effectively reduce the risk of FMD virus presence in meat, freezing should occur after maturation. According to one commenter, however, if freezing occurs too early after slaughter, any FMD virus that is present in the meat may survive for months.

Based on the existing scientific literature, it is generally accepted that FMD virus is inactivated at pH 6.0 or below after maturation at a temperature of 4 °C. Acidification of skeletal muscle that takes place during carcass maturation is normally sufficient to inactivate FMD virus in this tissue, even when cattle are killed at the height of viremia. Because it is known that the required level of acidification cannot be guaranteed under all circumstances, measuring of the pH level of the carcass muscle can be used to ensure that it has occurred.

APHIS agrees that chilling alone may not be adequate to eliminate the virus. Other tissues, organs, etc., that may harbor FMD virus, such as blood clots, heads, feet, viscera, bones, and major lymph nodes, do not undergo acidification, allowing the virus to survive the maturation process and subsequent low-temperature storage. Under this rulemaking, however, as noted previously, these tissues and organs must be removed from the carcasses prior to export to the United States.

Some commenters, though, also questioned the efficacy of those mitigation measures. It was stated that their effectiveness had not been demonstrated conclusively by the scientific literature. It was claimed that there is no agreed safe threshold level in the literature for FMD virus contamination for deboned beef. It was also claimed that scientific information is lacking on the amount of residual blood clot, lymph node, and bone tissue remaining after deboning, which is a concern because, as noted above, FMD virus can survive maturation in the lymph nodes and bone marrow. Information was also said to be lacking on the survivability of the FMD virus in deboned beef from carcasses where the normal acidification of skeletal muscle had not occurred and on FMD survival in fat tissues.

APHIS recognizes that blood clots and lymph nodes do not undergo acidification. As explained above, however, under this rulemaking, these tissues and organs must be removed from the carcasses prior to export to the United States. Carcasses in which normal acidification has not occurred would not be eligible for export to the United States. The rule allows the importation of muscle tissue, but not fat, into the United States. The demonstrated efficacy of maturation in inactivating the FMD virus in carcasses has already been noted. Even where marbling occurs, the maturation process is sufficient to inactivate the FMD virus.

A number of commenters expressed reservations about the effectiveness of vaccinating animals as a means of mitigating the risk of exposing U.S. livestock to FMD via imported beef. It was stated that vaccinated animals may become FMD carriers; that vaccinations are not foolproof due to variations in disease strain (FMD has seven distinct serotypes), mutations, and differences in susceptibility of organisms; and that wildlife cannot be vaccinated. The Government of Nicaragua, in comments submitted, claimed that the efficacy of immunization via vaccination with strains of attenuated virus remains a subject of scientific debate. Commenters further stated that FMD may spread by means of contaminated vaccines or the escape of the virus from vaccine production facilities. It was suggested that APHIS should stick to its previous policy of allowing imports only from regions free of a disease without vaccination.

APHIS acknowledges that vaccination of livestock has certain limitations as a risk-mitigation measure and for that reason, does not recognize a country that vaccinates for FMD as free of the disease. Vaccination of cattle against FMD introduces risks related to the immunological response within the vaccinated herd. While a large percentage of individual animals in the herd may fully respond to FMD vaccination, some animals may have a limited response, resulting in partial or no immunity. Still, the scientific literature and decades of epidemiological, surveillance, and trade data indicate that the combination of vaccination and the mitigation measures we require under this rulemaking, (e.g., inspection, removal of certain tissue from the carcasses, and maturation), are adequate to appropriately minimize the risk of introduction of FMD into the United States via the importation of fresh beef from countries that vaccinate for FMD. In 2003, APHIS authorized the importation of fresh beef under the same conditions that are found in this rule from Uruguay, a region that, like the exporting region of Brazil covered under this rule, is free of FMD with vaccination. The importation of such Uruguayan beef has not been associated with an increased risk of FMD. Further, as we described in the risk assessment and will discuss in greater detail later in this document, Brazil has an effective vaccination program. Quality control measures are in place to ensure that the FMD virus will not be spread by contaminated vaccines or insufficient biosecurity measures at vaccine production facilities. FMD vaccine production in Brazil complies with international guidelines.

Some commenters expressed reservations about APHIS' ability to prevent the introduction of FMD into the United States via beef imports from Brazil and to respond to an outbreak should one occur. It was stated that APHIS has neither the physical and financial resources to adequately inspect Brazilian beef production and processing sites or to control an outbreak in the United States. Additionally, some commenters stated that production and distribution of appropriate vaccines could prove challenging in the event of an outbreak in the United States.

We disagree with some of these comments. In carrying out our safeguarding mission, APHIS works to ensure the continued health and welfare of our nation's livestock and poultry. One important aspect of this work is making sure we can readily detect foreign animal diseases, such as FMD, and respond efficiently and effectively when faced with an outbreak. APHIS partners with other Federal, State, and local government agencies and private cooperators to expand the pool of available resources we can draw on in an emergency. We recognize that, depending on the size and scope of an outbreak, the production and distribution of vaccines could prove challenging. While we do have a resource in the North American Foot-and-Mouth Disease Vaccine Bank, which stores many types of inactivated FMD virus antigens, this resource might be overwhelmed in the face of a large and expanding outbreak. APHIS continues to discuss this issue and engage our stakeholders in planning and preparation for any response.

As discussed later in this document and in the risk assessment, we consider the feeding of FMD-contaminated waste to susceptible animals, particularly swine, to be the most likely pathway for the transmission of the disease. A commenter representing the pork industry questioned whether budget cuts to APHIS and State animal health staffs have had a negative effect on the ability to carry out the regulatory activities outlined in the Swine Health Protection Act (SHPA), and if so, whether the resulting reduction in regulatory activities had decreased the number of inspections and searches for unlicensed garbage-feeding operations to a level lower than that we found in a pathway analysis we conducted in 1995 to estimate the likelihood of exposing swine to infected waste.

Budget cuts to APHIS have necessitated a reordering of priorities in relation to SHPA-related activities. We have deemphasized or passed on to State partners or other cooperators lower-yield activities, such as visiting restaurants to inquire about garbage-disposal methods, in favor of allowing inspectors to spend more time interacting with and educating swine producers and conducting inspections. The regular presence of APHIS inspectors in U.S. garbage feeding facilities provides opportunities to educate operators on disease signs and reporting requirements and to conduct direct observation of animals for signs of illness. APHIS believes, therefore, that the presence of animal products infected with FMD or other reportable conditions entering the United States would be detected more quickly in these types of premises than in other, unregulated premises.

Many commenters opposed the December 2013 proposed rule on the grounds that, contrary to the conclusions of our risk assessment, Brazil's existing disease-control measures are inadequate to prevent producers in that country from exporting FMD-contaminated beef to the United States. Commenters expressed concerns about, among other things, Brazil's vaccination program, testing and disease reporting protocols, slaughter plant procedures, veterinary infrastructure, international border and internal movement controls, and the possibility of wildlife infecting the Brazilian cattle herd with FMD.

We have already noted that some commenters questioned the efficacy of vaccination as a means of combatting the spread of FMD. A number of commenters also expressed reservations specific to Brazil's vaccination procedures. It was stated that Brazil's reported 77 to 99 percent vaccination rate is inadequate for preventing the spread of FMD, that not all Brazilian States vaccinate, and that the lowest vaccination rate in the exporting region is in Mato Grosso, which has the country's highest cattle population. It was suggested, as noted above, that FMD could spread in Brazil through contaminated vaccines or escapes of the virus from vaccine production facilities. In addition, one commenter expressed concern about the qualifications of some individuals administering vaccinations in Brazil, noting that farmers may vaccinate their own animals or hire professionals who do not have to be registered with or accredited by the Brazilian Government to do the job for them.

In Brazil, vaccination is used to prevent the transmission of the FMD virus in the event that the disease were to be introduced in the region. Vaccination of cattle and buffalo is required in the exporting region. The aim of the vaccination program is to immunize at least 80 percent of bovines in a region in order to provide the protection and herd immunity needed to stop the spread of disease. While our risk assessment indicated that there was 76 percent coverage of bovines under 12 months of age in Mato Grosso, the much higher vaccination rates for bovines over that age, which represent most of the bovine population in the State, means that the overall vaccination rate there well exceeds 80 percent. More recent data described in a peer reviewed Journal, indicates that the vaccination coverage in Brazil as a whole exceeded 95 percent during the 2007-2011 (http://dx.doi.org/10.1098/rstb.2012.0381). All FMD vaccines produced or used in Brazil must follow OIE guidelines, including being tested for quality and safety by government officials. APHIS did not detect any evidence to suggest that unacceptable biologics or vaccines are being used in Brazil. Vaccination records are verified by local veterinary unit (LVU) personnel and may also be verified by field inspectors visiting individual premises. Despite the fact that Brazilian State or Federal personnel do not physically observe all vaccinations, records in LVU offices that were reviewed by APHIS indicated that vaccination coverage was quite complete, reaching almost 100 percent.

Many commenters expressed concern about Brazil's disease-testing and reporting standards, citing delays in reporting a 2010 case of bovine spongiform encephalopathy (BSE) and in conducting the required testing in the wake of the detection and sending the OIE lab samples. It was also noted that during the time between the discovery of the case and the reporting of it, Brazil continued shipping processed meat to the United States.

APHIS agrees that the delays in the testing and reporting of the atypical BSE case detected in Brazil were problematic. Representatives of APHIS and the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) visited Brazil in February 2013 to evaluate the BSE laboratory infrastructure, emergency response capabilities, and BSE-related mitigations at the slaughter level. In addition, as a result of the delays in testing and reporting of this case, MAPA conducted audits of the laboratories to identify areas for change and improvement and subsequently implemented several new procedures to assure the timely testing of samples and reporting of results. These included the addition of a second laboratory to conduct immunohistochemistry tests, the expansion of testing capabilities, and the development of an inter-laboratory data management system to issue reports, record improper samples, and flag delays in sample receipt, completion, and notification of test results.

To evaluate Brazil's FMD-related laboratory capabilities, APHIS' risk assessment included site visits to various diagnostic laboratories in Rio Grande do Sul, Pará, Recife, and Pernambuco in 2002, 2008, and 2013. Based on those visits, APHIS concluded that Brazil has the diagnostic capability to adequately test samples for the presence of the FMD virus. Staffing was sufficient at the facilities, and staff members were well-trained and motivated. Laboratory equipment was adequate for diagnosing FMD, and quality control activities included routine monitoring and calibrating of the equipment. The tests used to investigate evidence of viral activity were consistent with OIE guidelines. The laboratories also had effective and efficient recordkeeping systems for storage and retrieval of data, and were able to turn samples around quickly.

Some commenters claimed that Brazil has failed to report detections of FMD within its cattle population and, therefore, could not be relied upon to report such detections in the future.

We disagree with the commenters. During the FMD outbreaks in 2005 and 2006, MAPA demonstrated that it has the capability to detect disease quickly, limit its spread, and report promptly. FMD cases were quickly identified, the disease was contained, and international authorities were notified in a timely manner. Further, as stated in our risk assessment, we did not detect any evidence to suggest that active outbreaks of FMD exist in the export region. Despite occasional outbreaks of FMD in Brazil and in neighboring countries of South America, APHIS considers the disease to be under control in the export region.

It was also noted that the protocols in place for reporting disease within Brazil depend on self-reporting by producers, which some commenters view as an unreliable method.

While passive disease surveillance in Brazil relies on self-reporting, producers, veterinarians, and others are required by law to report clinical signs of FMD to veterinary authorities. Failure to comply with FMD reporting requirements may result in penalties or fines.

Many commenters, noted that the exporting zone in Brazil borders FMD-affected regions, including the affected zone in Brazil, as well as Paraguay, Bolivia, and Argentina, and is not separated from all those regions by physical or geographic barriers. Commenters pointed out that there has been a history of FMD incursions in Brazil from neighboring countries and that as long as FMD remains endemic in South America, the possibility of reintroduction from those neighboring countries exists. Concerns were expressed about the adequacy of Brazil's border control measures. Commenters stated, among other things, that Brazil's border with Peru is not fixed and secure, that Brazil does not effectively control cattle coming in from Paraguay, and that there have been eyewitness accounts of unmanned Brazilian border inspection posts. A commenter stated that there was a discrepancy between our risk assessment and our environmental assessment in the way we characterized the physical barriers between the exporting region and affected regions and the possibility of virus transmission across those barriers. It was stated in the environmental assessment that some areas that APHIS regards as barriers could actually be wildlife disease reservoirs, but that the risk assessment contained no such statement.

In the risk assessment, we discussed the disease status of regions adjacent to the export region, the separation of those regions from the export region, and border controls. As noted in both that document and the environmental assessment, the exporting region has many natural barriers, such as large rivers, mountains, forests, and semiarid areas, along its international and internal borders. Even in relatively remote frontier areas, where there may be less surveillance and monitoring than in more populous ones, those geographic barriers restrict animal movement and human traffic, thereby preventing the spread of disease. In addition, Brazil collaborates with neighboring countries to harmonize FMD-related programs and restrictions. Mechanisms have been established to provide for immediate notification between these countries if an outbreak occurs. High-risk surveillance areas have been established on Brazil's borders with Argentina and Paraguay. Additionally, as discussed in greater detail below, research has determined that wildlife has not played a significant role in the maintenance and transmission of FMD in South America. We have added a statement to that effect to the environmental assessment, under the heading “Regulatory Control of FMD.”

One commenter suggested that we add to the final rule a requirement for a geographic buffer zone, i.e., a disease-free area, surrounding the export region. The commenter did not specify whether such a zone should apply to adjacent areas in Brazil or neighboring countries, or both.

Some of the same natural barriers, described above, that separate Brazil from neighboring countries also are present along the boundaries between the export region and other Brazilian States. Brazil's national FMD program provides for surveillance and reporting in the exporting area as well as in the adjacent Brazilian States. Buffer zones are already employed under Brazil's FMD program in areas where no natural barriers exist, along with enhanced border patrols. In addition, APHIS's site-visit team did not find any laboratory evidence that FMD currently exists anywhere in Brazil.

Some commenters stated that uncontrolled or inadequately controlled movement of wildlife in South America generally, and countries bordering Brazil in particular, may pose a risk of spreading FMD into the exporting zone of Brazil.

Although several South American wild animal species are susceptible to FMD, research into FMD in South America has determined that wildlife populations, including feral swine, do not play a significant role in the maintenance and transmission of FMD. During outbreak situations, wildlife may become affected by FMD; however, the likelihood that they would become carriers under field conditions is rare. Therefore, it is unlikely that FMD would be introduced into the exporting region through movement of infected wildlife. Further, Brazil's biosecurity measures, surveillance activities, and response capabilities, which we evaluated in our risk assessment, would mitigate the already low risk of the FMD virus spreading from wildlife to livestock in the exporting region of Brazil.

One commenter stated that Brazil is OIE certified as FMD free in just 2 of 26 States and relaxed its vaccination regimen almost 2 years ago.

The OIE currently recognizes the Brazilian State of Santa Catarina as FMD-free without vaccination. In addition, however, the OIE recognizes States and zones within Brazil as FMD-free with vaccination. The area so recognized by the OIE, which largely coincides with part of the APHIS exporting region, may be viewed on the OIE Web site at http://www.oie.int/animal-health-in-the-world/official-disease-status/fmd/list-of-fmd-free-members/.

A commenter stated that beef from Brazil may not meet Canada's import requirements and therefore could not be commingled with U.S. beef being shipped to Canada. The commenter expressed concern that U.S. beef exporters wishing to export beef to Canada could be negatively affected as a result of this rule.

The commenter's statement is correct but is not germane to the current rulemaking. Brazil does not export beef to Canada. U.S. exporters wishing to export beef to Canada have a legal obligation to meet that country's requirements by not commingling beef that is eligible for export to Canada, with beef that is not.

Some commenters questioned the efficacy of Brazil's internal animal movement controls. Noting that greater market opportunities and the resulting higher prices offered in the export region might foster illegal animal movements into that region from affected regions in Brazil, commenters questioned whether there were sufficiently stringent procedures in place in Brazil to restrict such movements. It was further stated that a European Commission (EC) audit found deficiencies in those controls. Some commenters also stated that Brazil does not require animal identification and that its voluntary traceability program and applies only to cattle whose meat is intended for countries that require traceability from birth, which the United States does not. That group of commenters included the Government of Nicaragua, which suggested that Brazil's “unreliable” traceability system could hinder its response to an outbreak of FMD, potentially allowing the disease to spread to other countries. One commenter expressed some doubt as to whether Brazil's traceability system, even if relatively effective, could aid in combatting an FMD outbreak, since traceability was not documented as effective in combatting FMD outbreaks in the United Kingdom.

We do not agree with these comments. Based on our review of the veterinary infrastructure in Brazil, we determined that MAPA, which oversees animal movement within the country, has the legal authority, technical capabilities, and personnel to implement the FMD program within Brazil. Movement controls in Brazil are stringent. As described in the risk assessment, MAPA requires that all cattle owners identify their animals with a unique brand. Sheep and swine are identified by a brand in the ear. Each LVU keeps a registry of brands and a complete registry of the cattle holdings in the region, with animal populations listed by age group and sex. The registry of holdings is updated at least twice per year, during the vaccination period, or when the animals are moved to another place. The LVU must issue an animal movement permit (GTA), which is required whenever animals are moved. The staff of the LVU is responsible for verifying that the vehicle transporting the animals has been cleaned and disinfected as required by law. A copy of the GTA is sent to the destination. Any inspection associated with animal movement involves checking the documents and verifying the animal information, as well as clinical observation of animal health. The EC Food and Veterinary Office (FVO) audits conducted in 2012 and 2013 found that post-mortem inspection were carried out in line with the EU requirements, that FMD related mitigation were conducted appropriately, and that Hazard Analysis Critical Control Points plans including traceability and maturation were implemented and verified by the veterinary authority were found to be satisfactory. In its most recent audit, conducted in October 2014, the EC FVO reported that that FMD-related requirements were met, and that Brazilian officials were able to demonstrate full traceability to farms of origin.

Other commenters expressed broader concerns about Brazil's disease-control activities, highlighting occasions when, the commenters suggested, Brazil may have failed to comply with safety standards. It was stated that, in the past, Brazil has failed to maintain equivalent safety standards for cooked products exported to the United States, causing FSIS to suspend imports of such products, that FSIS has not allowed imports from Santa Catarina, which we recognize as FMD-free, on the grounds that Brazil's microbiological and residue testing programs are deficient, and that repeated audits by FSIS and the EC have shown a failure on Brazil's part to promptly institute and maintain corrective action for deficiencies noted in previous audits. Commenters suggested that the results of those audits indicate that Brazil lacks either the willingness or the infrastructure to execute the consistent management controls needed to sufficiently mitigate the risk of the introduction of FMD into the United States through the importation of fresh beef. One commenter suggested that there was a dearth of veterinarians in Brazil who had the necessary training and expertise to manage a national FMD program.

As discussed in the risk assessment, APHIS evaluated the veterinary infrastructure of Brazil and concluded that MAPA has a system of official veterinarians and support staff in place for carrying out field programs and implementing import controls and animal quarantine. Additionally, MAPA has sufficient legal authority to carry out official control, eradication, and quarantine activities. We also determined that Brazil's technical infrastructure was adequate for rapid detection of FMD and for carrying out surveillance and eradication programs and that advanced technologies are utilized in conducting several animal health programs. Import controls are sufficient to protect international borders at principal crossing points.

A number of commenters expressed misgivings about Brazil's slaughter-plant procedures. It was suggested that Brazilian slaughter plants may be deficient on both sanitary and humane grounds. One commenter expressed doubt that, given Brazil's previous compliance issues, APHIS can be certain that beef imported from Brazil would have the lymph nodes removed in all cases, as required under this rulemaking. One commenter stated that if a pH meter at a Brazilian slaughter plant is faulty, infected beef may be exported to United States.

The commenters did not present specific evidence regarding deficiencies on sanitary or humane grounds at Brazilian slaughter plants. APHIS evaluated Brazil's ability to carry out slaughter-related mitigation measures, including ante-mortem and postmortem inspections and deboning and removal of lymph nodes from beef carcasses. We concluded that MAPA will be able to enforce compliance with our inspection and slaughter-plant processing procedures. Our assessment of Brazil's veterinary system included an evaluation of the likelihood of compliance with the pH requirement. Brazilian authorities monitoring slaughter plants calibrate the pH meters frequently. Beef that does not reach the required pH is not allowed to be exported to the United States and is diverted to the Brazilian domestic market.

A few commenters expressed BSE-related concerns about importing fresh beef from Brazil. One commenter stated that some countries have banned or restricted beef imports from Brazil due to concerns about safety, particularly regarding BSE. Another commenter questioned whether Brazil tests for E. coli and BSE.

These comments are beyond the scope of the present rulemaking, which contains FMD-related import restrictions. The risk assessment supporting the rulemaking specifically examined the potential risk of introducing FMD into the U.S. cattle population by allowing imports of fresh beef from Brazil under certain conditions. We would note, however, that the OIE currently recognizes Brazil as a negligible-risk country for BSE, a designation APHIS concurred with in a notice 2 published in the Federal Register on October 1, 2014 (79 FR 59207-59208, Docket No. APHIS-2013-0064). Should circumstances arise that would dictate a change in Brazil's BSE classification to a less favorable one, APHIS would require BSE mitigations for imports of beef as appropriate to the adjusted risk classification.

Some commenters, citing what they characterized as Brazil's spotty record of compliance with safety standards, recommended that APHIS consider the development of an ongoing oversight protocol, beyond the usual port-of-entry testing, to monitor Brazil's compliance with our required risk mitigation measures. It was stated that APHIS has not adequately described how it will continue to provide oversight and/or monitor Brazil's animal health infrastructure indefinitely, to ensure that the country will maintain adequate controls to prevent the spread of FMD from other regions of Brazil or from neighboring countries to the exporting area.

The regulations in § 92.2 provide for such monitoring of regions after we recognize them for animal health status. We may require such a region to submit additional information pertaining to its animal health status and may also conduct additional site visits or other information collection activities in order to monitor the region's continued compliance with our requirements.

As discussed in greater detail below in the section pertaining to issues raised regarding our risk assessment, the findings from that assessment led us to conclude that the most likely pathway of exposure of domestic livestock to the FMD virus in beef was through feeding of contaminated food waste to swine. A commenter representing the pork industry questioned whether APHIS has current data regarding the level of biosecurity, security, veterinary care, routine health observations, and knowledge of disease reporting pathways in garbage-fed populations in Brazil. According to the commenter, such data are necessary to meet the goal of a foreign animal disease preparation and response plan. The commenter further enquired about the level of confidence APHIS has regarding the education provided to licensed garbage feeders and whether biosecurity and veterinary care protocols and disease reporting procedures are being followed in Brazil.

Licensed garbage feeders are generally provided with education by MAPA during routine inspections by Brazilian animal health regulatory staff on topics including the importance of proper cooking, signs of foreign animal diseases, appropriate biosecurity measures, etc. Mandatory inspections conducted by MAPA at least quarterly provide confidence in the ability of licensed garbage feeding operations to maintain biosecurity and reporting requirement protocols. Demonstration of adequate facilities and equipment is a requirement for obtaining and maintaining licensure.

One commenter cited the refusal of countries other than the United States whose producers are represented under the Five Nations Beef Alliance to accept Brazilian beef as a reason for not allowing it to be imported into the United States. The Five Nations Beef Alliance consists of the national beef cattle producers' organizations of Australia, Canada, Mexico, and New Zealand—our top livestock trading partners—as well as the United States. The commenter recommended that no Brazilian beef be imported into the United States until all the members of the Five Nations Beef Alliance decide that such imports are safe.

We do not agree with this comment. The Five Nations Beef Alliance is an industry association that lobbies on behalf of the beef industry in support of its economic interests. Our international trade agreements permit us to impose only those sanitary and phytosanitary measures necessary to protect human, animal, or plant life or health on the basis of scientific principles and evidence. We cannot take such actions for economic reasons alone or on the basis of the actions of industry associations.

Some commenters stated that any beef we import from Brazil should be labeled as such, thus enabling U.S. consumers to make informed decisions regarding their beef purchases.

Country of origin labeling is already required under the Agricultural Marketing Service regulations in 7 CFR part 65.

A commenter stated that there was a lack of information on disease serotypes and strains outside the export zone.

APHIS disagrees with the commenter. In our risk assessment, under Factor 3, “Disease Status of Adjacent Regions” (pp. 23 to 29), we describe FMD outbreaks that occurred in the countries and Brazilian States adjacent to the export area, including the serotypes involved in the outbreaks over the last 10 years.

A large number of commenters voiced reservations about both the methodology we used to conduct our risk assessment of the proposed exporting region of Brazil and the conclusions we reached in that document.

Some commenters noted that, in the past, APHIS has characterized other countries, (e.g., Argentina, Japan, and South Korea), as low-risk countries for FMD, and that, soon after we did so, outbreaks of the disease occurred in those countries.

Because disease situations are fluid and no country, not even the United States, can guarantee perpetual freedom from a disease, APHIS' risk analyses consider whether a country can quickly detect, respond, and report changes in disease situations. In our evaluation, conducted according to the factors identified in § 92.2, “Application for recognition of the animal health status of a region,” we concluded that the specified region of Brazil has the legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs, and emergency response systems necessary to detect, report, control, and manage FMD outbreaks.

As a member of OIE, Brazil is obligated to immediately notify the organization of any FMD outbreak or other important epidemiological event. The notification must include the reason for the notification, the name of the disease, the affected species, the geographical area affected, the control measures applied, and any laboratory tests carried out or in progress.

Upon notification of an FMD outbreak in the exporting region of Brazil, APHIS would implement critical prevention measures to respond to the outbreak, including alerting U.S. Customs and Border Protection inspectors at all ports of entry. Because § 94.29(b) requires that FMD must not have been diagnosed in the exporting region within the past 12 months, fresh beef from the region would no longer meet our requirements, and we would immediately stop importation.

Some commenters questioned the methodology we employed for the site visits to Brazil. It was claimed that there is no obvious evidence of any established protocol or methodology to allow for consistency and assurance in the quality of the APHIS site visit reviews and that documentation pertaining to the visits was lacking or unavailable for public review. According to one commenter, documents pertaining to the specific methodology and measurements used during the site visits to support the qualitative risk assessment should have been available for the public to review. It was stated that without sufficient documentation, there was no way to distinguish between data obtained from the site visits and data supplied by the Government of Brazil. It was recommended that APHIS develop a protocol, which it should make available to the public, to be used for site visits so that our assessments can be analyzed and summarized more objectively.

APHIS' site visits consist of an in-depth evaluation of the eight factors identified in § 92.2 (scope of the evaluation being requested, veterinary control and oversight, disease history and vaccination practices, livestock demographics and traceability, epidemiological separation from potential sources of infection, surveillance, diagnostic laboratory capabilities, and emergency preparedness and response) as factors to consider in assessing the risk of transmission of an animal disease to U.S. livestock via the importation of animals or animal products from a foreign region. Risk factors are identified from the information gathered on these topics, and applicable mitigations are discussed. The regulations in § 92.2 are publically available at: http://www.thefederalregister.org/fdsys/pkg/FR-2012-07-27/html/2012-18324.htm. Further information on site visits is available in a guidance document regarding APHIS' approach to implementing its regionalization process and the way in which APHIS applies risk analysis to the decisionmaking process for regionalization. This document is available to the public at: http://www.aphis.usda.gov/import_export/animals/downloads/regionalization_process.pdf.

Our five site visits to Brazil, conducted in 2002, 2003, 2006, 2008, and 2013, included visits to Federal, State, and local veterinary offices, farms, border control stations, and diagnostic laboratories. The findings from these visits are discussed thoroughly in the risk assessment document. As noted in that document, the scope of the 2002 site visit included verification of FMD outbreak controls, an overview of the surveillance program and laboratory capabilities, vaccination practices and eradication activities, and movement and border controls. The focus of the 2003 site visit was to collect data that APHIS used in its risk assessment. The focus of the 2006 site visit was to evaluate the FMD situation following the 2005-2006 outbreak in Paraná and Mato Grosso do Sul. The focus of the 2008 visit was to evaluate the Brazilian State of Santa Catarina for freedom from classical swine fever, FMD, African swine fever, and swine vesicular disease. Finally, the scope of the 2013 visit included the evaluation of the FMD diagnostic capabilities, FMD laboratories, and vesicular disease emergency response.

Another issue raised in regard to our site visits was that not all of the factors for animal health status were reviewed during each of the site visits by APHIS. It was stated that because each site visit had a different focus, some of the information our site-visit teams obtained may now be out of date. For example, one commenter claimed that some risk factors associated with the importation of beef from Brazil, such as movement and border controls, appeared not to have been verified through site visits since the 2002 visit.

Even though a site visit may have a particular focus, all factors are evaluated during each visit, with emphasis on changes implemented since the previous one. Any observed changes in risk are noted in the risk assessment. If no changes are noted, then no changes are made to that factor in the risk assessment, and the original date for which risk was described is maintained. In the example noted below, movement and border controls were verified in site visits subsequent to 2002. However, since no significant changes were noted in risk, the 2002 date was retained to indicate when the initial observation was made.

Some commenters viewed the documentation supporting our risk assessment as insufficient. It was further noted that some of those supporting documents were in Portuguese. As a result, according to the commenters, transparency was lacking regarding our research methodology and the manner in which we arrived at our conclusions. It was also claimed that the documents we did make available lacked consistency and evidence of verification of our findings.

All of the documents that were provided by the Government of Brazil have been shared with stakeholders who requested them. APHIS acknowledges that some of the documents used as references in the risk analysis were submitted to APHIS in Portuguese; however, APHIS personnel involved in the evaluation had sufficient language skills to read those documents without requiring that they be translated into English. In addition, in most instances, the same or related data were provided in other documents or verbally presented to APHIS during site visits. The information provided by Brazil and the conclusions reached are thoroughly described in the risk analysis that was made available for public review and comment.

Some commenters stated that APHIS should prepare a quantitative risk assessment for beef from Brazil and make it available for public review. Commenters took the position that the qualitative risk assessment methodology that we employed is too subjective because it fails to quantify objectively the probability of risk and adequately assess the magnitude of the consequences of a disease outbreak. Noting that APHIS prepared a quantitative risk assessment in 2002 in support of the rulemaking allowing the importation of fresh beef from Uruguay, commenters questioned why APHIS chose to prepare only a qualitative risk assessment for Brazil.

Most of APHIS' risk analyses for FMD have been, and continue to be, qualitative in nature. APHIS believes that, when coupled with site visit evaluations, qualitative risk analyses provide the necessary information to assess the risk of the introduction of FMD through importation of commodities such as fresh beef. Quantitative risk analysis models may not be the best tool to use to assess the risk of FMD posed by exports from a country, such as in cases where the types of data required by such models are either unavailable or suffer from a high level of parameter uncertainty. In these instances, APHIS' approach is to characterize the risk of outbreak qualitatively in order to determine what appropriate measures to implement in order to mitigate the risk posed to the United States in the event of an outbreak in the exporting country (e.g., maturation and pH of beef, no diagnosis of FMD in the previous 12 months).

Some commenters raised issues regarding the scope of our risk assessment. It was stated that the release assessment, exposure assessment, and consequence assessment appeared to be incomplete with regard to the necessary steps and requirements described in the OIE Terrestrial Animal Health Code.

We conducted the risk assessment guided by Chapter 2.1 of the OIE Terrestrial Animal Health Code, “Import Risk Analysis.” The Code recommends that risk assessments include four steps: An entry assessment, an exposure assessment, a consequence assessment, and an overall risk estimation based on the data compiled in the previous three steps. A description of each of those steps is included. In conducting our risk assessment of Brazil, we followed the steps listed in the OIE Terrestrial Animal Health Code. Where there are differences between APHIS' methodology and that described by the OIE, they have more to do with terminology than methodology. For example, we refer to what the OIE terms the entry assessment as a release assessment.

Some commenters did not view the eight factors listed § 92.2 as sufficiently comprehensive for conducting a risk assessment, suggesting that we should have relied on the OIE guidelines instead.

We did evaluate Brazil using the factors listed in § 92.2. These factors, however, are essentially the same as the factors listed in Chapter 1.6 of the OIE Terrestrial Animal Health Code. Both § 92.2 and the OIE Code provide for the evaluation of a region seeking recognition for a disease status on the basis of, among other things, the region's veterinary infrastructure, disease history, geographical separation from affected regions, diagnostic and surveillance capabilities, and emergency response planning. Both the OIE Code and § 92.2 require the requesting region to provide the same documentation.

In contrast to the comments discussed above, one commenter criticized our risk assessment methodology on the grounds that we granted too much deference to the OIE guidelines, thus violating our statutory mandate to protect U.S. livestock.

We do not agree with this comment. As noted above, the OIE evaluation criteria and those in § 92.2 essentially cover the same topics. In addition, the site visits we conduct as part of our risk assessment process enable us to verify the requesting country's disease status and its ability to maintain that status and to control outbreaks if they occur.

Commenters also took issue with the release assessment for suggesting that wildlife does not play a significant role in the transmission of FMD. It was claimed that the statement lacked support in the scientific literature.

The epidemiology of the disease in South America over time and the information provided in the surveillance section of the risk assessment clearly demonstrate that the role of wildlife in disease transmission in the area under consideration is insignificant. Many decades of experience with the disease have shown no consistent relationship between outbreaks in domestic animals and coexistence of susceptible wild animals in South America. In addition, results of repeated serological testing focusing on cattle as the most susceptible species do not reveal evidence of viral activity in domestic ruminants that are likely to contact wild animals. If wild animals were carriers or reservoirs of FMD, evidence of viral activity would be expected in domestic species coexisting in the same regions as infected wild animals.

Some commenters also claimed that the biological pathways for the release of pathogens were not described clearly in the release assessment.

We address biological pathways for the release of the FMD virus in the exposure assessment, which we discuss in greater detail below.

Commenters stated that our exposure assessment identified only a single exposure pathway: The feeding of FMD-contaminated beef to susceptible animals. It was stated that the exposure assessment included no discussion of any alternative exposure pathways for FMD, such as illegal imports and backyard pig feeding. It was further stated that the exposure assessment should have focused on the effects of plate waste or manufacturing waste processing for swine feeding on the survival of FMD virus.

There is a general scientific understanding on the main pathway of FMD exposure via the importation of fresh beef. This pathway is through the feeding of food waste to swine. The likelihood of exposure of FMD-susceptible species to FMD-infected beef was evaluated by reviewing previous studies we conducted. In 1995, we conducted a pathway analysis to estimate the likelihood of exposing swine to infected waste. With 95 percent confidence, we estimated that 0.023 percent or less of plate and manufacturing waste would be inadequately processed prior to feeding to swine. Based on this percentage, less than 1 part in 4,300 of imported beef fed to swine as plate or manufacturing waste is likely to be inadequately cooked. The findings of a 2001 APHIS survey, which showed a substantial reduction in waste-feeding operations, further indicated that the risk of FMD exposure via feeding of contaminated waste to swine was continuing to decline.

Some commenters stated that that the pork industry has undergone significant changes since we conducted the 1995 risk analysis and 2001 survey cited above. A commenter representing a national pork producers' association questioned the validity of our 1995 pathway analysis in particular, stating that the findings are outdated and incomplete. Other commenters also expressed skepticism that the 1995 analysis and the 2001 survey adequately reflect the current risk to the U.S. pork industry of the introduction of FMD into the United States through garbage feeding. It was suggested that APHIS needs to consider obtaining updated scientific data, independent of the 2001 APHIS waste-feeder survey, in order to better verify the exposure assessment for FMD presented in the risk analysis.

APHIS acknowledges that the pork industry in general has undergone significant changes since 1995; however, the garbage-feeding industry in particular, which we discuss in greater detail immediately below, has not. In that discussion, we elaborate on our reasons for our confidence that the 1995 risk analysis and 2001 survey adequately reflect the current risk to the U.S. pork industry from the feeding of contaminated food waste to swine.

One commenter stated that, according to APHIS reports to the U.S. Animal Health Association's Transmissible Diseases of Swine Committee, from 2009 to 2013, a number of unlicensed garbage feeders were found each year by State and Federal animal health authorities. The commenter asked if APHIS has any supporting information that estimates the number of unlicensed garbage-feeding facilities.

Procedures for the handling, processing, and feeding of food waste to swine in the United States are subject to our swine health protection regulations in 9 CFR part 166. Compliance with the regulations has improved in recent years, thereby reducing the probability of survival of FMD virus in the food waste. Searches for non-licensed garbage feeding facilities are regularly conducted using several different techniques as part of the duties of APHIS animal health staff, as well as State animal health and other State agency staff. When unlicensed garbage feeding facilities are identified, the unauthorized activity is documented, and the facility is brought into compliance. Depending on the State, all swine on such premises may be quarantined and tested for foreign animal diseases. Information on the number of inspections conducted to detect unlicensed garbage feeding facilities, the number of unlicensed facilities identified, and resolution of cases resulting from such identification are captured at the State level and evaluated by APHIS on a regular basis. Given the regular monitoring of these facilities and their relatively small number, we stand by the conclusions we reached in our 1995 risk analysis.

A commenter stated that our consequence assessment should have focused on the specific commodity to be imported, as outlined in the scope of the risk assessment.

The consequence assessment did examine at some length the possible economic consequences for the cattle industry, as well as other livestock industries, that could result from an outbreak of FMD in the United States.

Commenters took issue with the methodology we used for evaluating the efficacy of Brazil's movement and border controls. As noted in the risk assessment, APHIS assumes that, if the riskiest pathways are sufficiently mitigated, then the overall spectrum of risk issues should be acceptable. The commenters viewed that assumption as unwarranted.

We do not agree with this comment. APHIS tries to target the riskiest border crossings (and other areas) during site visits as examples of a type of “maximized risk scenario” in order to address similar, but theoretically lower, risks in the remainder of the export region. Using this assumption and visiting the areas of highest risk in the export region, APHIS concluded that movement control measures for live animals are effective at both domestic and international checkpoints. The commenters did not present any evidence to support their claim that this methodology is flawed.

A commenter objected to the terminology we used in characterizing the FMD risk associated with imports of beef from Brazil. It was stated that the characterization of the risk of FMD introduction as “low” was arbitrary and misleading. The commenter stated that the term “low” actually falls in the middle of the risk spectrum, meaning, in the view of the commenter, that the actual risk of FMD introduction from Brazil was unacceptably high. The same commenter also stated that there was a discrepancy between the risk assessment, which characterized the risk as “low” and the environmental assessment, which characterized the risk as “extremely unlikely.”

APHIS disagrees with the commenter. We employ the term “low” to characterize the risk associated with importing a particular commodity when we have determined, based on a risk assessment, that the commodity can be safely imported into the United States under certain conditions. We base such determinations on our assessment of the exporting region's disease-control capabilities, as evaluated in relation to the eight factors in § 92.2, and the known efficacy of the risk mitigation measures available to us. The statements in the risk assessment and the environmental assessment are not contradictory. The environmental assessment refers to the risk of introduction of FMD into the United States as extremely unlikely. The risk assessment characterizes the combined risks of introduction and dissemination of the disease as low.

Many commenters expressed concern about the potentially devastating economic effect an outbreak of FMD in the United States could have on U.S. cattle producers. It was stated that the potential economic risks greatly outweigh the benefits of this rulemaking, and that the economic analysis accompanying the December 2013 proposed rule failed to take into account those potential costs. Some commenters recommended that we revise the economic analysis to account for those potential costs. It was suggested that we should perform a comprehensive, up-to-date economic analysis to identify consequences for all U.S. commodity groups potentially affected by an FMD outbreak.

It is true that an outbreak of FMD in the United States, whatever its source, could have very serious effects on the U.S. cattle industry. In the economic analysis accompanying the December 2013 proposed rule, we analyzed expected benefits and costs of annual imports of fresh (chilled or frozen) beef from Brazil averaging 40,000 metric tons (MT), and found that the expected changes in U.S. beef production, consumption, and exports would not be significant. We did not report on potential impacts of an FMD outbreak for the U.S. economy in the economic analysis accompanying the December 2013 proposed rule because, in our view, the risk-mitigation measures required of Brazil, which include deboning, maturation for at least 24 hours, and pH measurements below 6.0 in the loin muscle, will provide for the safe importation of beef from Brazil. The revised economic analysis accompanying this final rule, however, does analyze those potential impacts. We would further note that in the consequence assessment section of our risk assessment, we examined the potential economic and other consequences of an FMD outbreak in the United States at some length.

Some commenters also pointed out that an FMD outbreak in the United States could result in the loss of export markets for U.S. beef. It was further claimed that our economic analysis understated the value of those export markets.

An FMD outbreak would likely result in the loss of U.S. beef export markets. However, APHIS is confident that the required sanitary safeguards will ensure the safe importation of beef from Brazil as a result of this rule. Regarding the value of U.S. beef export markets, it can be measured differently depending on the combination of bovine products and composite prices used. The value can also vary based on how shipping and other transactional expenses may be included in reported prices. Commenters may consider the reported value of U.S. beef exports to be understated because of differences in product and price definitions. Nevertheless, attributing a higher value to U.S. beef export markets would not change our conclusion that the rule's impact on beef exports, as well as other segments of the beef industry, will be minor.

A commenter stated that allowing imports of beef from Brazil may cause a loss of consumer confidence in beef, resulting in a loss of profits for U.S. producers.

This is a hypothetical statement for which the commenter presents no supporting evidence.

A commenter expressed the view that the rulemaking would depress markets for U.S. producers and affect export markets because allowing imports from Brazil would facilitate Brazil's access to other international markets.

The question of whether or not allowing Brazilian beef to be imported into the United States would facilitate Brazilian producers' access to other international markets is beyond the scope of our economic analysis. The commenter did not present data that would support the proposition that Brazil's beef exports are likely to increase so precipitously as a result of this rulemaking that U.S. exporters would experience negative effects.

A commenter expressed the concern that the rulemaking would have adverse effects not only on U.S. beef producers but on associated industries as well.

Based on how small the volume of beef we project will be exported from Brazil to the United States relative to U.S. beef production, we anticipate that both U.S. beef producers and associated industries will be affected little, if at all, by this rulemaking.

Commenters questioned our projections regarding the amount of beef likely to be imported from Brazil and also expressed doubts about our assumption that Brazilian beef imports will mainly displace other imports rather than increasing the total volume of beef imports. It was stated that because exporting beef to the United States may be profitable for Brazilian producers, they are likely to ship more than the 40,000 MT of beef to the United States that we estimated they would in an average year.

Our import projections are based on the data we obtain from industry and other sources and the use of published models. In the preamble to the December 2013 proposed rule, we noted that we did not have all of the data necessary for a comprehensive analysis of the effects of the proposed rule on small entities, and we solicited comments on the potential effects. Because the commenters did not supply information that contradicted the data upon which we relied, that called into question the model we used, or that supported in any way the suggestion that our projections were inaccurate, we did not have cause to revise our projections.

Another commenter, while agreeing with our projection that Brazilian beef imports would most likely displace imports from elsewhere, questioned why the rulemaking was necessary if those existing imports are not problematic and there is no increased demand for beef by U.S. consumers.

The United States and many other member countries are a part of the rules-based international trading system, which has benefitted Members through the maintenance of open international markets. Under our international trade agreements, we consider requests from countries and regions to import their animals and/or animal products. Before such requests are granted, we must first assess the risks to U.S. herds posed by imports by evaluating the requesting country or region's disease status and the efficacy of its risk-mitigation measures. The United States' and other WTO Members' international trade obligations ensure that decisions regarding market access are based on scientific principles and risk assessments. U.S. demand for these products is not a part of the consideration of such requests.

One commenter characterized the proposed rule as a misguided attempt to remedy short-term beef price increases. The commenter stated that the U.S. cattle herd needs to be rebuilt, but the rulemaking may discourage producers from restocking.

The commenter's statement is a hypothetical one and, as such, difficult to evaluate. We did not receive any data from this or other commenters that would suggest that the rulemaking would discourage U.S. cattle producers from restocking.

A commenter claimed that the rulemaking would result in a larger drop in steer prices than the 0.14 percent we projected in the economic analysis supporting the December 2013 proposed rule.

We arrived at that estimate using results from a published economic model.3 Had the commenter supplied a different set of substantiated data, we could have reevaluated our estimate.

Some commenters suggested that in the event of an FMD outbreak in the United States, APHIS should indemnify or otherwise support U.S. cattle producers.

APHIS' ability to pay indemnities is dependent upon the availability of funds. In the past, APHIS has indemnified producers whose livestock had to be depopulated as part of disease-eradication efforts.

Some commenters objected to the proposed rule because of what they perceived as economic favoritism. Commenters claimed that the rulemaking favored meat packers and processors at the expense of farmers. It was also asserted that the proposed rule favored Brazilian producers at the expense of U.S. producers because U.S. producers would not be able to compete on price with their Brazilian counterparts, and that, therefore, the rule would have the unintended effect of shrinking the U.S. cattle herd and expanding Brazil's.

We undertook this rulemaking at the request of Brazil and in accordance with our international trade agreements. We based this rulemaking on the findings of our risk assessment that fresh beef could safely be imported into the United States from Brazil under certain conditions. We do not believe this rule favors one sector or country over another, and the commenters did not provide evidence to support their claims.

In addition to the issues already discussed in this document, commenters raised a few others that did not fit neatly into any of the above categories.

One commenter recommended that we allow the importation of fetal bovine serum from Brazil.

That comment is beyond the scope of the present rulemaking, which concerns the FMD status of Brazil and the importation of Brazilian beef.

Other commenters suggested that the rulemaking may lead to deforestation and/or environmental degradation.

The commenters did not explain how the rulemaking would have those effects. USDA prepared an environmental assessment, but the focus of the environmental assessment is to evaluate the potential impacts of allowing for the importation of fresh, maturated, and deboned beef from a region in Brazil into the United States, and not on increased deforestation in Brazil.

One commenter stated that the rulemaking does not comply with our statutory obligation to develop rural America.

The commenter did not cite any particular statute to support the claim that we were not meeting our statutory obligations.

Commenters writing on behalf of an association representing Hispanic and Native American livestock producers claimed that the rulemaking violates the civil rights and fair trade rights of minority livestock producers.

As we noted in the economic analysis accompanying the December 2013 proposed rule, we do not anticipate that the rulemaking will have a significant economic effect on any livestock producers. In the absence of economic or competitive harm, we do not see this rule as violating the rights of any group.

We are making an editorial change to § 94.29(a) for the sake of clarity. In the December 2013 proposed rule, the paragraph read as follows: “The meat is beef or ovine meat from animals that have been born, raised, and slaughtered in the exporting region of Brazil or in Uruguay.” As written, that paragraph could be interpreted to indicate that not only beef but also ovine meat could be imported from the exporting region of Brazil. Since ovine meat may not be imported from Brazil under § 94.29, we have edited the paragraph in this final rule to read as follows: “The meat is: (1) Beef from Brazil derived from animals that have been born, raised, and slaughtered in the exporting region of Brazil; or (2) Beef or ovine meat from Uruguay derived from animals that have been born, raised, and slaughtered in Uruguay.”

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the change discussed in this document.

This final rule has been determined to be economically significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also provides a final regulatory flexibility analysis that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

This analysis examines potential economic impacts of a final rule that will allow fresh (chilled or frozen) beef from a designated region in Brazil to be imported into the United States provided certain conditions are met. Economic effects of the rule for both U.S. producers and consumers are expected to be small. Welfare gains for consumers will outweigh producer losses, resulting in a net benefit to the U.S. economy. APHIS has concluded that the risk of exposing U.S. livestock to FMD via fresh beef imports from Brazil is sufficiently low so that such imports are safe.

The United States is the largest beef producer in the world, and yet still imports a significant quantity. Annual U.S. beef import volumes from 1999 to 2013 averaged 0.9 million MT, equivalent to 11 percent of U.S. production. Much of the beef imported by the United States is from grass-fed cattle, and is processed with trimmings from U.S. grain-fed cattle to make ground beef. Australia, Canada, and New Zealand are the main foreign suppliers of beef to the United States.

Effects of the final rule are estimated using a partial equilibrium model of the U.S. agricultural sector. Economic impacts are estimated based on intra-sectoral linkages among the grain, livestock, and livestock product sectors. Annual imports of fresh (chilled or frozen) beef from Brazil are expected to range between 20,000 and 65,000 MT, with volumes averaging 40,000 MT. Quantity, price, and welfare changes are estimated for three import scenarios. The results are presented as average annual effects for the 4-year period, 2015-2018.

A portion of the beef imported from Brazil will displace beef that would otherwise be imported from other countries. The model indicates that the net annual increase in U.S. fresh beef imports will be 15,894 MT (79 percent of 20,000 MT) under the 20,000 MT scenario; 32,000 MT (80 percent of 40,000 MT) under the 40,000 MT scenario; and 52,654 (81 percent of 65,000 MT) under the 65,000 MT scenario.

If the United States imports 40,000 MT of beef from Brazil, total U.S. beef imports will increase by 2.8 percent. Due to the supply increase, the wholesale price of beef, the retail price of beef, and the price of cattle (steer) are estimated to decline by 0.65, 0.26, and 0.70 percent, respectively. U.S beef production will decline by 0.03 percent while U.S. beef consumption and exports will increase by 0.2 and 0.7 percent, respectively. The 20,000 MT and 65,000 MT scenarios show similar quantity and price effects.

The fall in beef prices and the resulting decline in U.S. beef production will translate into reduced returns to capital and management in the livestock and beef sectors. Under the 40,000 MT import scenario, beef processors will experience a decline in surplus of $28.85 million or 0.85 percent, while consumers will benefit from the decrease in price by an increase in their surplus by $387.50 million or 1.14 percent. Cattle producers will experience decline in welfare of $216.01 million or 8 percent. The overall impact will be a net welfare gain of $358.36 million or 1 percent for producers and consumers in the beef processing sector. For the combined beef and cattle sectors, there will be a $142 million net welfare gain (0.36 percent net benefit).

The 20,000 MT and 65,000 MT scenarios show similar welfare impacts, with net benefits increasing broadly in proportion to the quantity of beef imported. The largest impact will be for the beef sector, but consumers of pork and poultry meat sectors will benefit negligibly. While most of the establishments that will be affected by this rule are small entities, based on the results of this analysis, APHIS does not expect the impacts on small entities to be significant.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

An environmental assessment and finding of no significant impact have been prepared for this final rule. The environmental assessment provides a basis for the conclusion that the importation of fresh beef from a region in Brazil under the conditions specified in this rule will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

The environmental assessment and finding of no significant impact may be viewed on the Regulations.gov Web site.4 Copies of the environmental assessment and finding of no significant impact are also available for public inspection at USDA, Room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 799-7039 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0414, have been submitted for approval to the Office of Management and Budget (OMB). When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements.

Accordingly, we are amending 9 CFR part 94 as follows:

The regulations in 9 CFR part 94 (referred to below as the regulations) prohibit or restrict the importation of certain animals and animal products into the United States to prevent the introduction of various animal diseases, including rinderpest, foot-and-mouth disease (FMD), African swine fever, classical swine fever, and swine vesicular disease. These are dangerous and destructive communicable diseases of ruminants and swine. Section 94.1 of the regulations contains criteria for recognition by the Animal and Plant Health Inspection Service (APHIS) of foreign regions as free of rinderpest or free of both rinderpest and FMD. Section 94.11 restricts the importation of ruminants and swine and their meat and certain other products from regions that are declared free of rinderpest and FMD but that nonetheless present a disease risk because of the regions' proximity to or trading relationships with regions affected with rinderpest or FMD. Regions APHIS has declared free of FMD and/or rinderpest, and regions declared free of FMD and rinderpest that are subject to the restrictions in § 94.11, are listed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.

Because vaccination for FMD may not provide complete protection to livestock, and because it can be difficult to quickly detect FMD in animals vaccinated for FMD, APHIS does not recognize regions that vaccinate animals for FMD as free of the disease. Although there has not been a major outbreak of FMD in Argentina since 2001/2002, we do not consider Northern Argentina to be free of FMD because of Argentina's vaccination program in that region. With few exceptions, the regulations prohibit the importation of fresh (chilled or frozen) meat of ruminants or swine that originates in or transits a region where FMD is considered to exist. One such exception is beef and ovine meat 1 from Uruguay, which is allowed to be imported into the United States under certain conditions that mitigate the FMD risks associated with these products. The conditions are set out in § 94.29 of the regulations.

In a proposed rule 2 published in the Federal Register (79 FR 51508-51514, Docket No. APHIS-2014-0032) on August 29, 2014, we proposed to also allow the importation of fresh (chilled or frozen) beef from Northern Argentina under those conditions found in § 94.29 of the regulations. The proposed conditions were as follows:

• The beef is from animals born, raised, and slaughtered in Northern Argentina.

• FMD has not been diagnosed in Northern Argentina within the previous 12 months.

• The meat comes from bovines that originated from premises where FMD had not been present during the lifetime of any bovines slaughtered for the export of beef to the United States.

• The meat comes from bovines that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.

• The meat comes from bovines that received ante-mortem and post-mortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease.

• The meat consists only of bovine parts that are, by standard practice, part of the animal's carcass that is placed in a chiller for maturation after slaughter. The bovine parts that may not be imported include all parts of the head, feet, hump, hooves, and internal organs.

• All bone and visually identifiable blood clots and lymphoid tissue have been removed from the meat.

• The meat has not been in contact with meat from regions other than those listed in the regulations as free of rinderpest and FMD.

• The meat comes from carcasses that were allowed to maturate at 40 to 50 °F (4 to 10 °C) for a minimum of 24 hours after slaughter and that reached a pH of below 6.0 in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both longissimus dorsi muscles. Any carcass in which the pH does not reach less than 6.0 may be allowed to maturate an additional 24 hours and be retested, and, if the carcass still has not reached a pH of less than 6.0 after 48 hours, the meat from the carcass may not be exported to the United States.

• An authorized veterinary official of the Government of Argentina certifies on the foreign meat inspection certificate that the above conditions have been met.

• The establishment in which the bovines are slaughtered allows periodic on-site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS representative.

We solicited comments concerning our proposal for 60 days ending October 28, 2014. We reopened and extended the deadline for comments until December 29, 2014, in a document published in the Federal Register on October 31, 2014 (79 FR 64687-64688, Docket No. APHIS-2014-0032). We received 295 comments by that date. They were from producers, trade associations, veterinarians, representatives of State and foreign governments, and individuals. Of those, 62 comments were non-substantive in nature, with 44 supportive of APHIS' proposal and 18 opposed. Two commenters requested an extension of the comment period, which was granted as detailed above. The remaining comments are discussed below by topic.

In May 2007, the World Organization for Animal Health (OIE) recognized Northern Argentina as being an area free of FMD where vaccination is practiced. One commenter stated that OIE recognition of a certain status was not sufficient reason for U.S. recognition of that status.

As a member of the OIE, the United States recognizes OIE guidelines, including guidelines on regionalization. OIE's Terrestrial Animal Health Code provides internationally accepted guidelines to protect animal health by limiting the spread of animal diseases within and between countries without unnecessarily restricting international trade. APHIS evaluates all requests from countries or regions requesting recognition of disease freedom or to export a particular commodity consistent with OIE guidelines. In this particular case, the request was to export fresh (chilled or frozen) beef. APHIS' evaluation of this request was based on science and conducted according to the factors identified in 9 CFR 92.2. We did not automatically accept OIE recognition of Northern Argentina's disease status as the basis for changes to our regulations; rather, we conducted our own evaluation, which is detailed in the proposed rule and its accompanying risk analysis.

One commenter said that the definition of Northern Argentina as “North of Patagonia South and Patagonia North B” is vague. The commenter added that the proposed rule's subsequent claim that “Northern Argentina is bordered by the Atlantic Ocean and shares land borders with Bolivia, Brazil, Chile, Paraguay, Uruguay, and the Province of Río Negro, Argentina” is confusing as Patagonia is not bordered by Bolivia, Brazil, Paraguay, or Uruguay. The commenter suggested that the definition of the proposed region be more clearly designated by the use of degrees of latitude.

Figure 12, which is located on page 52 of the risk analysis, is a map showing the various regions in Argentina, including Northern Argentina. The region under consideration is located north of the Patagonia Region; the Patagonia Region includes the region located south of the 42nd parallel known as Patagonia South, and the region immediately north of the 42nd parallel known as Patagonia North B.3 The limits of the Patagonia North B region are as follows: In the west along the Andes Mountains (international border with the Republic of Chile) in the Province of Neuquén; in the north along the Barrancas River at the border with the Province of Mendoza; in the east, the border with the Province of Río Negro; and in the south, the 42nd parallel and the southern border with the Province of Chubut. The region within the country of Argentina, north of Patagonia North B as described above is known as Northern Argentina.

It is true that Patagonia is not bordered by Bolivia, Brazil, Paraguay, or Uruguay, as Patagonia is located in the south of Argentina. Northern Argentina, however, shares land borders with those countries as well as being north of the Patagonia Region.

One commenter stated that the Country of Origin Labeling (COOL) law should cover any imports of fresh (chilled or frozen) beef from Argentina.

Under COOL, which is administered by the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service, retailers, such as full-time grocery stores, supermarkets, and club warehouse stores, are required to notify their customers with information regarding the source of certain food, including muscle cut and ground meats. Any fresh (chilled or frozen) beef imported from Argentina would be subject to such requirements.

Another commenter said that the risks posed by possible unregulated beef potentially entering the country far outweigh any short-term solutions to consumer demand issues that would result from allowing any type fresh (chilled or frozen) beef to be imported from Argentina.

In accord with the Animal Health Protection Act (AHPA, 7 U.S.C. 8301 et seq.) and consistent with our international agreements, APHIS has analyzed the FMD risks associated with allowing for the importation of fresh (chilled or frozen) beef from Northern Argentina. APHIS is confident that the required sanitary safeguards will allow fresh (chilled or frozen) beef to be imported safely into the United States.

One commenter stated that APHIS must ensure that cattle from Northern Argentina are held to the same health standards as cattle from the United States.

We are confident in our assessment of the capabilities of the Argentine sanitary system in maintaining the health of herds in Northern Argentina to the standards set out in this rule. Argentina may be required either to provide or to allow APHIS to collect additional information in order to maintain its authorization to export fresh (chilled or frozen) beef if we have reason to believe that events in the region or in surrounding regions could affect the risk profile of the region under consideration. We also note that APHIS uses a wide variety of sources to conduct verification activities in Northern Argentina. These sources include the U.S. Embassy, multilateral relationships with trading partners, and the OIE.

We received a number of comments from Argentine beef trade organizations. One domestic commenter stated that comments from those organizations should not be given any consideration. The commenter further stated that American cattle associations should be given the power to approve or deny any trade agreements reached by the United States and other countries.

We disagree. Federal agencies must accept and respond to comments from all interested parties. The comment regarding international trade agreements falls outside the scope of this final rule, as APHIS is not entering into a trade agreement with Argentina.

One commenter said that the importation of fresh (chilled or frozen) beef from Northern Argentina was contrary to the recommendation put forward by the U.S. Dietary Guidelines Advisory Committee that Americans eat more plant-based foods.

The dietary guidelines released yearly by the U.S. Department of Health and Human Services' Office of Disease Prevention and Health Promotion and the USDA's Center for Nutrition Policy and Promotion are irrelevant to APHIS' mission to protect the nation's animal and plant health and to APHIS' determination regarding whether fresh (chilled or frozen) beef may be safely imported from Northern Argentina. These guidelines are intended for individual use on a voluntary basis; they are not broad policy statements or trade directives.

One commenter stated that they believe the motivation for the publication of the proposed rule and APHIS' ongoing privileging of Argentine interests is tied to Argentina's WTO complaint against the United States over our ban of Argentina's animal and meat exports. The commenter found it troubling APHIS would place trade considerations ahead of food safety and animal health. Another commenter postulated that the proposed action is intended to decrease the cost of beef for the American consumer at the risk of the United States livestock industry.

We undertook this rulemaking at the request of Argentina and in accordance with APHIS' regulations, the United States' obligations under its international trade agreements, and the findings of our risk analysis that fresh beef could safely be imported into the United States from Northern Argentina under certain conditions. Our decision was based on a scientific evaluation of the disease situation in Northern Argentina, which we conducted in accordance with § 92.2. We would not propose to allow for the importation of a commodity from any region unless our evaluation of the region's disease situation and sanitary capabilities supported it, consistent with our statutory responsibility under the AHPA.

Another commenter wanted to know if the importation of fresh (chilled or frozen) beef from Argentina would result in a benefit to another portion of the American economy via the export of products to Argentina.

We do not believe this rule favors one portion of the American economy over another and the commenter did not provide evidence suggesting that such an effect would occur.

Under the agreements reached in the GATT was a provision that, upon approval of the USDA, Argentina would be authorized to ship an additional 20,000 metric tons (MT) of fresh (chilled or frozen) beef to the United States under the U.S. import quota system. One commenter said that the quota reached during the Uruguay Round is insignificant when compared to the existing security and financial stability of the U.S. beef market as a whole and that security and stability should not be jeopardized via the importation of fresh (chilled or frozen) beef from Argentina.

The commenter's point regarding import quotas reached at the GATT is beyond the scope of the rulemaking. APHIS evaluates the sanitary or phytosanitary risk of importing a given commodity independent of considerations of existing import quotas.

One commenter cited Argentina's willingness to export meat to Russia as problematic since the United States and the European Union (EU) member nations currently have trade sanctions in place against that country. The commenter said that APHIS should not be allowing for trade with a country openly mitigating the effects of those food sanctions.

Another commenter postulated that the importation of fresh (chilled or frozen) beef represents a quid pro quo arrangement between the Democratic Party and its financial backers. The commenter stated that the rule would serve to benefit these parties monetarily and is not scientifically substantiated. The commenter concluded that scientific evidence contrary to the proposed action has been ignored by APHIS.

Under the AHPA and its predecessor statutes, APHIS' primary responsibility with regard to international import trade has always been to identify and manage the sanitary risks associated with importing commodities. When we determine that the risk associated with the importation of a commodity can be successfully mitigated, it is our obligation under the international trade agreements to which the United States is signatory to make provisions for the importation of that commodity. Under our international trade agreements, APHIS considers market access requests from countries and regions. Approval or denial of these requests, as mandated by the AHPA and consistent with our Nation's trade agreements, are not and cannot be made along political lines. They must be made as a result of sound science. A detailed discussion of the scientific basis for this rule may be found in the risk analysis and in this document. Additionally, the commenter provided no examples or evidence to support the claim that APHIS has ignored any contrary scientific findings regarding FMD in Northern Argentina.

Many commenters said that no trade is worth jeopardizing the safety of U.S. livestock and wildlife. The commenters pointed to the trade deficit as proof that the United States should not prioritize importation of commodities and concluded that APHIS should be investing in domestic rather than foreign agriculture.

As stated above, our principal task related to international trade is to identify and manage the risks associated with importing commodities. Moreover, under the international trade agreements to which the United States is signatory, APHIS' decisionmaking regarding the safe importation of commodities must be based on scientific sanitary considerations. APHIS has determined that the import of the commodity at issue does not jeopardize U.S. animal health.

Several commenters questioned why the rulemaking was necessary if those existing imports are not problematic and there is no increased demand for beef by U.S. consumers. Another commenter stated that APHIS should focus on domestic agriculture, national animal identification, and labeling of all food products instead of international trade.

Consistent with our international obligations, APHIS considers market access requests from countries and regions. U.S. demand for these products is not a part of the consideration of such requests. Before such requests are granted, we must first assess the animal disease risks to U.S. herds posed by imports by evaluating the requesting country's or region's disease status and the efficacy of its risk mitigation measures. The United States and many other member countries are a part of the rules-based international trading system, which has benefitted all those countries through the maintenance of open international markets. Regarding the comment that APHIS focus on domestic activities, APHIS and other Federal agencies currently operate programs in the areas of focus specified by the second commenter, namely domestic agriculture, national animal identification, and food product labeling.

One commenter characterized the proposed rule as an attempt by APHIS to remedy short-term beef price increases. The commenter stated that the U.S. cattle herd needs to be rebuilt, but the rulemaking may discourage producers from restocking.

As noted in our previous responses, APHIS' consideration of Argentina's market access request is a scientific inquiry into whether fresh (chilled or frozen) beef from Northern Argentina can be safely imported. APHIS does not consider the impact on short-term beef prices. The commenter's second statement is a hypothetical one based on an unsupported presumption and, as such, difficult to evaluate. We did not receive any data from this or other commenters that would suggest that the rulemaking would discourage U.S. cattle producers from restocking.

Another commenter said that American cattle are not fed animal proteins, which are prohibited in ruminant feeds.

Although bovine spongiform encephalopathy (BSE)-related concerns were not within the scope of the FMD risk-specific risk analysis completed regarding the importation of beef (chilled or frozen) from Northern Argentina, we do note that Argentina also bans the feeding of ruminant proteins to ruminants in line with OIE guidelines concerning BSE.

One commenter said that APHIS does not appear to have a mitigation plan in place if FMD were to be introduced into the United States as a result of this proposal or otherwise. Two other commenters stated that there is no FMD vaccine currently available in the United States.

In carrying out our safeguarding mission, APHIS works to ensure the continued health and welfare of our Nation's livestock and poultry. One important aspect of this work is making sure we can readily detect foreign animal diseases, such as FMD, and respond efficiently and effectively when faced with an outbreak. APHIS partners with other Federal, State, and local government agencies and private cooperators to expand the pool of available resources we can draw on in an emergency. Specifics of our FMD response plan may be found in a document entitled “USDA APHIS Foot-and-Mouth Disease (FMD) Response Plan: The Red Book” (September 2014), which is designed to provide strategic guidance on responding to an FMD outbreak. The plan gives direction to emergency responders at the local, State, Tribal, and Federal levels to facilitate FMD control and eradication efforts in domestic livestock in the United States and may be found on the Internet at http://www.aphis.usda.gov/animal_health/emergency_management/downloads/fmd_responseplan.pdf.

As to the commenters' point regarding availability of the FMD vaccine, we recognize that, depending on the size and scope of an FMD outbreak, the production and distribution of vaccines could prove challenging. While we do have a resource in the North American Foot-and-Mouth Disease Vaccine Bank (NAFMDVB), which stores many types of inactivated FMD virus antigens, this resource might be overwhelmed in the face of a large and expanding outbreak. APHIS continues to discuss this issue and engage our stakeholders in planning and preparation for any response. In the event that the United States experiences an FMD outbreak in which a specific strain is identified, the USDA will notify the NAFMDVB, which will request the manufacturing of finished vaccine from approved suppliers, based on the stockpiled antigens.

One commenter recommended that APHIS conduct annual audits of the Argentine system as we do domestically in order to continually verify split-state disease status and regional disease programs. Another commenter stated that the USDA's Food Safety and Inspection Service (FSIS) must determine Argentina's equivalency to U.S. food safety standards in order for specific processing facilities to be eligible to export fresh (chilled or frozen) beef to the United States; any imported beef must follow FSIS labeling regulations; and shipments of fresh (chilled or frozen) beef from Northern Argentina is subject to examination by U.S. inspectors before being allowed to enter the country.

Under the provisions of § 92.2(g), APHIS may require Argentina to submit additional information pertaining to animal health status or allow APHIS to conduct additional information collection activities in order to maintain its authorization to export to the United States. Specifically, we ask for additional information if they report suspect or known cases of disease to the OIE; if we receive public information about suspect or known cases of disease; if the region that was previously evaluated has been re-defined; if there are public reports stating changes in the veterinary authority, budgets, or controls in border areas; if we receive reports or evidence of smuggling from neighboring countries; if there are outbreaks or suspect cases in border regions; or if there are changes in any of the other factors we consider when preparing a risk analysis. We do not require submission of additional information on a regular schedule because we are concerned primarily with events that could potentially affect the risk status of the region under consideration.

FSIS makes determinations of equivalence by evaluating whether foreign food regulatory systems attain the appropriate level of protection provided by our domestic system. Thus, while foreign food regulatory systems need not be identical to the U.S. system, any imported meat is subject to the inspection, sanitary, quality, species identification, and residue standards applied to products produced domestically. FSIS evaluates foreign food regulatory systems for equivalence through document reviews and on-site audits. Imported meat is subject to reinspection at the port of first entry into the United States.

One commenter stated that we did not adequately address the significance of the Argentine Government's failure to provide prompt notification of its widespread FMD outbreaks in 2000. The commenter suggested that Argentine officials were not subject to any type of sanctions that would prevent the recurrence of a similar failure to notify APHIS of any future FMD outbreaks. Another commenter, citing what they characterized as Argentina's spotty record of compliance with safety standards, recommended that APHIS consider the development of an ongoing oversight protocol, beyond the usual port-of-entry testing, to monitor Argentina's compliance with our required risk mitigation measures. Two commenters further stated that APHIS has not adequately described how it will continue to provide oversight and/or monitor Argentina's animal health infrastructure indefinitely, to ensure that the country will maintain adequate controls to prevent the spread of FMD from other regions of Argentina or from neighboring countries to the exporting area.

The regulations in § 92.2 provide for monitoring of regions after APHIS authorizes imports from such regions. If we determine that necessary measures have not been fully implemented or maintained, we will take appropriate remedial action to ensure that the importation of fresh (chilled or frozen) beef from Northern Argentina does not result in the importation of FMD into the United States. Contrary to the commenter's assertion, the consequence of Argentina's failure to notify APHIS of the FMD outbreak in 2000/2001 was a provisional suspension of the beef trade with Argentina. In the future, indications of noncompliance may result in similar actions. Incidents would be evaluated by APHIS on a case-by-case basis.

Many commenters stated that Argentina has shown a trend of decreasing compliance in audits conducted by FSIS between 2005 and 2009. The commenters stated that Argentina's history of compliance issues could influence its ability to consistently and successfully enforce control measures within Northern Argentina in order to successfully mitigate the risk from the possible entry of FMD into this region from the surrounding higher-risk areas. The commenters asked if APHIS consulted with FSIS as part of its evaluation, and if so, what was FSIS' feedback. Several commenters asked that the comment period on the proposed rule be extended until FSIS posted its most recent audit report for review by stakeholders.

The purpose of APHIS' evaluation was to assess the FMD situation in Northern Argentina and to evaluate Argentina's ability to prevent, detect, control, report, and manage FMD within its borders. Based on its site visits and other documentation and information, APHIS concluded that Argentina's legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs, and emergency response capacity are sufficient to detect, prevent, control, and eradicate FMD outbreaks within the boundaries of Northern Argentina. Moreover, with respect to Northern Argentina, APHIS concluded that the Argentine veterinary authority is capable of complying with our requirements. Nevertheless, based on the comments, APHIS has reviewed the last six FSIS audits conducted in Argentina at the slaughter level, including the most recent audit, which was finalized in July 2014. The FSIS audits concluded that ante-mortem inspection processes, which are relevant to the detection of FMD during the slaughter process, were conducted satisfactorily. We did not extend the comment period pursuant to the release of any future FSIS audit reports. As stated previously, the initial 60-day public comment period was extended by 60 days, providing stakeholders with a total of 120 days to share information relevant to the rule. In addition, given the contents of the last six reports, APHIS has no reason to believe that additional reports would be inconsistent.

One commenter said that little is known about the Argentine beef industry, including such factors as animal care standards, antimicrobial use, and environmental protection issues. The commenter said that we may be unintentionally supporting practices in these areas that have been determined to be harmful.

Contrary to the commenter's assertion, we thoroughly examined the infrastructure and efficacy of the Argentine bovine production and export system and detailed all aspects in our risk analysis. We subsequently determined that it is robust and capable of meeting the standards for exportation set forth by APHIS. Results of the environmental assessment we conducted to evaluate the possible environmental impacts of the rulemaking did not suggest that the rule would lead to adverse environmental impacts and the commenter provided no evidence to the contrary. FSIS's last six audits of the Argentine system at the slaughter level, which include a review of food safety practices, animal care standards, and antimicrobial use, concluded that the system is satisfactory.

Another commenter expressed concern about the financial stability of Argentina, which the commenter proposed could compromise the Servicio Nacional de Sanidad y Calidad Agroalimentario's (SENASA) ability to provide adequate sanitary surveillance and support a rigorous food safety inspection system. The commenter said that recent news reports speculating as to whether Argentina will default on its international loans suggest that the Argentine Government may not be able to adequately fund its own operations.

As described in the risk analysis, SENASA reported that its 2013 budget was 1.3 billion pesos (approximately $200.7 million). SENASA officials described the system as self-sufficient because user fees are required for almost every service SENASA provides, including slaughter surveillance, issuances of certificates, and laboratory tests. The budget for the laboratory is 60 million pesos (approximately $12 million). APHIS finds no reason to believe that the funding will change, as stable funding for the FMD control and eradication programs in Argentina has been in place for over a decade.

One commenter said that it is unrealistic to expect that Argentine beef will be uniformly processed and inspected under ideal circumstances as required by the standards set out in the proposed rule. The commenter viewed it as unrealistic to expect that the APHIS-approved criteria for sanitary safety to be foolproof. Another commenter said that Argentina has participated in a regional plan to eradicate FMD in all of South America since 1987 and APHIS should encourage Northern Argentina and neighboring countries to continue in their efforts and commitment to eradication of the disease so that vaccination is no longer necessary. The commenter said that, after this milestone is reached, Argentina's request to export fresh (chilled or frozen) beef to the United States could then be considered. The commenter concluded that if trade is permitted from a country or area of higher risk (e.g., FMD free with vaccination) to a country or area of lower risk (e.g., FMD free without vaccination), then there is little incentive for the vaccinating country or area to take the extra effort required to truly eradicate the disease, and global eradication is likely to be delayed.

We have determined that the Argentine production and export system is robust and capable of meeting the standards for exportation set forth by APHIS. APHIS does not adopt a zero tolerance for risk for international trade in meat products. Our risk analysis process is designed to determine whether a product may be imported safely into the United States. If, based on our risk analysis, we conclude that the production system in the country in question is insufficient to provide an appropriate level of protection, then we will not authorize the importation of the particular commodity. As described in the risk analysis, APHIS concluded that the surveillance, prevention, and control measures implemented by Argentina are sufficient to minimize the risk of introducing FMD into the United States for the purpose of beef imports. Since 2002, Argentina has taken a targeted approach to eradicating FMD one region at a time and harmonizing FMD-related regulations with neighboring countries. We therefore disagree with the commenter's conclusion that there is little incentive to eradicate the disease, as Argentina gives us no reason to believe that this targeted approach will not continue in the future. Any risk of FMD introduction into the exporting region is mitigated by this approach due to local regulations, standardized vaccination schedules, and other harmonization measures involved in regionalization. Consistency of approach allows for effective surveillance and monitoring.

One commenter suggested that APHIS conduct further surveillance of the Argentine program prior to any consideration of allowing for the importation of fresh (chilled or frozen) beef from Argentina. The commenter stated that three site visits made to the region in question are inadequate to fully understand the Argentine production system.

APHIS evaluated the information provided by Argentina since the application was first submitted in 2003, and conducted site visits as part of the verification process. We do not make our determinations based solely on site visits but rather on all the information gathered during the evaluation process, which, in the case of Argentina, lasted over 10 years. We are confident in our conclusion that the system in Northern Argentina is robust and that fresh (chilled or frozen) beef produced under the conditions stipulated may safely be imported into the United States.

One commenter claimed that it would be a poor decision to allow beef to be imported from Northern Argentina into the United States due to the risk associated with FMD, rinderpest, African swine fever, classical swine fever, and swine vesicular disease. The commenter observed that these diseases can be transferred from infected animals or meats from Argentina to animals in the United States.

The commenter's categorization of APHIS' proposed action is incorrect insofar as we only proposed to import fresh (chilled or frozen) beef from Northern Argentina and not any species of live animal. Further, no South American country has ever reported an outbreak of rinderpest except Brazil, which had an outbreak in 1921 that was limited in scope and quickly eradicated. Furthermore, the global distribution of rinderpest has diminished significantly in recent years as a result of the Food and Agriculture Organization Global Rinderpest Eradication Program. The last known cases of rinderpest worldwide occurred in the southern part of the “Somali pastoral ecosystem” consisting of southern Somalia, eastern Kenya, and southern Ethiopia. In May 2011, the OIE announced its recognition of global rinderpest freedom. Finally, African swine fever, classical swine fever, and swine vesicular disease are diseases only associated with pigs and not transmissible to cattle or other bovine species. A detailed discussion of FMD in Argentina may be found in the risk analysis and in this final rule under the subheading “Comments on FMD Risk.”

Another commenter stated that the United States would put all cloven hoofed animals in the United States, both domestic and wild, at risk for diseases not controlled in Northern Argentina.

APHIS disagrees with the commenter. Our evaluation shows that Argentina, as discussed in the risk analysis, has taken the necessary action to address FMD issues and the commenter provided no evidence or specifics concerning any other diseases.

Many commenters, citing the highly contagious nature of FMD, expressed the view that we should not allow fresh beef to be imported from any country where the disease is present because regionalization is not likely to mitigate the risks associated with imports effectively.

One commenter noted that Argentina's last significant FMD outbreak, which caused the loss of its countrywide FMD free status in 2001, was linked specifically to the movement of cattle across its northern borders with Bolivia and Paraguay, which were not free of FMD. The commenter added that cattle from Bolivia and Paraguay were sold in Argentine markets at a discount due to their inability to be sold legally in Argentina and this practice allowed for the spread of FMD into the Argentine domestic cattle population. Another commenter said that the acknowledgement of a risk of reintroduction of FMD from exporting regions into the export area as mentioned in the risk analysis is cause for concern.

Our evaluation is centered on the safety of a particular commodity—fresh (chilled or frozen) beef, not live animals—in terms of potential introduction of FMD into the United States. However, most of the countries in South America have been recognized by the OIE as being FMD free with (Uruguay) or without vaccination (Chile and Guyana) or with free regions with vaccination (Argentina, Bolivia, Brazil, Colombia, and Peru) or without vaccination (Argentina, Bolivia, Brazil, Colombia, and Peru). No outbreaks have been reported in Brazil since 2006, Paraguay since 2012, or Bolivia since 2007. In that regard, the risk of introduction from neighboring countries is low. Any risk of introduction is mitigated by the coordinated regional approach to FMD eradication among those countries. In our risk analysis, we also detail the many enhancements enacted by SENASA in its border control activities along the northern borders with Bolivia, Paraguay, and Brazil.

As stated in the risk analysis accompanying the proposed rule, we considered the epidemiological characteristics of FMD that are relevant to the risk that may be associated with importing beef from the export region of Northern Argentina. Based on our assessment, we concluded that beef from Northern Argentina could safely be imported into the United States, subject to certain mitigation requirements, which include removal of bones and certain tissue as well as chilling of carcasses until they reach a pH level of under 6.0. We evaluated information submitted by SENASA and verified the accuracy of that information through site visits. As detailed in the risk analysis, SENASA underwent extensive reorganization in the wake of the FMD outbreak in 2001. The new structure was designed to increase the efficiency and effectiveness of the existing system. Based on our assessment of this system, we concluded that Argentina has the legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs, and emergency response capacity to prevent FMD outbreaks within the boundaries of the export region and, in the unlikely event that one should occur, to detect, control, and eradicate the disease. Argentina's active and passive surveillance system would allow for rapid detection. In the event of an outbreak, in the exporting region, Argentina would promptly report findings to the OIE, and the United States would stop importing beef from Northern Argentina. Our findings regarding Argentina's disease-control capabilities give us confidence that the mitigation methods required under this rulemaking will be effective in preventing the introduction of FMD into the United States via the importation of fresh beef from Northern Argentina.

Another commenter stated that the risk analysis does not provide detailed information about the level and efficacy of the FMD vaccination programs in Northern Argentina.

The vaccination rates in Northern Argentina reached over 99 percent between 2008 and 2012. In addition, the region of Northern Argentina has several overlapping controls to ensure compliance with vaccination calendars through matching vaccination records to movement permits and census data and through field inspections. As detailed in the risk analysis, vaccination of cattle is mandatory in the area north of the 42nd parallel with the exception of Patagonia North B (the area adjacent to Patagonia South, a region without vaccination) and recently, Patagonia North A and the summer pastures (zona veranadas) of Calingasta Valleys in the Province of San Juan. The technical requirements for the vaccination program are established by SENASA and vaccination can only be performed by authorized personnel who are trained, registered, and accredited/audited by SENASA. Vaccination coverage rates have been over 97 percent in the region above the 42nd parallel (with the exception of Patagonia North B, and most recently Patagonia North A, in which vaccination is not conducted) since 2001. In the unlikely event that unvaccinated susceptible animals are exposed to the FMD virus, these animals will develop clinical signs that will be easily detected in the field and during ante-mortem and postmortem inspection. This will trigger a response that includes epidemiological investigation, movement restrictions, and submission of samples for laboratory analysis. If the laboratory reports the case as positive for FMD, Argentina will notify the international authorities and its trading partners, and trade will cease.

One commenter claimed that the regionalization process has eroded the sanitary safety of the United States with regard to FMD. The commenter stated that a blanket prohibition on the importation of meat from countries that have experienced outbreaks of FMD is by far the more effective option. The commenter concluded that the change from APHIS' previous policy involving such a prohibition to our current regionalization approach was motivated by trade pressures.

Regionalization recognizes that pest and disease conditions may vary across a country as a result of ecological, environmental, and quarantine differences, and adapts import requirements to the health conditions of the specific area or region where a commodity originates. This final rule is predicated on a risk analysis document that provides a scientific basis for potential importation of chilled (fresh or frozen) beef from Northern Argentina. Without this document, APHIS would not have proposed this action. Political and economic interests may stimulate consideration of the expansion of trade of agricultural commodities between countries, but all APHIS decisionmaking concerning sanitary restrictions on trade is based on sound science, not on trade pressures.

Many commenters stated that the last FMD outbreak in Argentina was detected in February 2006 in an area near the border with Paraguay and that this area of Paraguay continues to have active virus present that can serve as a source of new outbreaks in cattle. According to officials in Argentina, illegal movement of animals from neighboring countries, as well as mechanical transmission of the virus, introduced the FMD virus into Argentina during the 2000/2001, 2003, and 2006 outbreaks. These officials acknowledge that even where there are barriers or checkpoints, people, cars, and animal products can cross both domestic and international borders illegally. The commenters concluded that the potential for the FMD virus to cross the border, particularly by passenger car or foot traffic, remains. Another commenter said that the risk analysis did not adequately describe the degree to which the region is separated from high risk regions by physical and other barriers.

In the risk analysis, we discussed the disease status of regions adjacent to the export region, the separation of those regions from the export region, and border controls. As noted in both the risk analysis and the environmental assessment, Northern Argentina has many natural barriers, such as large rivers, mountains, forests, and semiarid areas, along its international and internal borders. Even in relatively remote frontier areas, where there may be less surveillance and monitoring than in more populous ones, those geographic barriers restrict animal movement and human traffic, thereby preventing the spread of disease. In addition, Argentina collaborates with neighboring countries to harmonize FMD-related programs and restrictions. Mechanisms have been established to provide for immediate notification between these countries if an outbreak occurs. High-risk surveillance areas have been established on Argentina's borders with Bolivia, Paraguay, and Brazil. Border control and security in Northern Argentina are discussed in detail in the risk analysis. APHIS examined these issues during all of its site visits. Based on those visits and other documents and information that APHIS has obtained and made available with the risk analysis, APHIS is confident that Argentina's border controls with respect to Northern Argentina are sufficient to prevent the introduction of FMD into the region.

Some commenters questioned the efficacy of the Argentine system in controlling illegal entry of livestock and wildlife interactions, specifically citing potential transmission via feral swine populations in the northern border regions with Bolivia and Paraguay. Several commenters stated that reviews of European Commission Food and Veterinary Office (EC FVO) audits identified points of concern in the areas of border control, particularly those along the border with Bolivia, animal identification, vaccination controls, and other concerns. Another commenter stated that Argentina has demonstrated non-compliance in the course of routine USDA and EC FVO audits in the past.

We do not agree that wildlife-livestock interactions in Argentina play a significant role in the transmission of FMD. Although several South American wild animal species are susceptible to FMD, research into FMD in South America has determined that wildlife populations, including feral swine, do not play a significant role in the maintenance and transmission of FMD. During outbreak situations, wildlife may become affected by FMD; however, as discussed in the environmental assessment and the risk analysis, the likelihood that they would become carriers under field conditions is rare. Therefore, it is unlikely that FMD would be introduced into Northern Argentina through movement of infected wildlife. Further, Argentina's biosecurity measures, surveillance activities, and response capabilities, which we evaluated in our risk analysis, would mitigate the already low risk of the FMD virus spreading from wildlife to livestock in the exporting region of Northern Argentina.

We have made additions to the risk analysis that address the commenters' point regarding the EC FVO audits.4 As described in the updated risk analysis, at the time the risk analysis that accompanied the proposed rule was finalized, no FMD outbreaks had been reported in South America for over 3 years. Based on the history of the disease in the continent, Argentina's veterinary infrastructure, and SENASA's prompt response to the FMD outbreaks that occurred in neighboring countries (Brazil 2006, Bolivia, 2007, and Paraguay 2011/12), APHIS concluded that it is unlikely that the disease could be reintroduced from adjacent areas into the export region. Our review of the most recent EC FVO report, from 2014, revealed that the EC FVO had concluded that the official FMD control system in place for Argentina is reliable and meets EU requirements. APHIS has also concluded that the veterinary infrastructure, surveillance, prevention, and control measures implemented by Argentina are sufficient to minimize the risk of introducing FMD into the United States for the purpose of beef imports. Further, the 2012 EC FVO report specifically states that, “the FMD vaccination programme covers more than 80% of the susceptible population.”

In terms of the specifically mentioned Argentine border with Bolivia, local veterinarians in the Bolivian border region, as coordinated and supervised by the SENASA Coordinator of Animal Health, have instituted additional measures to strengthen sanitary controls in that area, including:

• Enhancing controls concerning transhumant animals (i.e., animals moved from one grazing ground to another, usually seasonally), which include periodic visits to areas with higher likelihood of transhumance and the application of sanitary measures (e.g., compulsory vaccinations, frequent visits with owners to discuss health-related issues).

• Revising and updating the registry of subsistence producers to improve the vaccination controls and animal movements in the region.

• Increasing the frequency of vaccinator audits, and implementing additional sanitary measures such as movement restrictions in irregular cases (e.g., an animal lacking paperwork or an animal whose ownership is unknown).

• Increasing animal movement controls on roads, which include both fixed and mobile checkpoints.

• Identifying risk areas related to the possible presence of swine in rubbish dumps and other places of exposure to sources of irregular feeding, and implementing responsive sanitary measures according to those findings.

• Continuing awareness campaigns and education for the community on FMD and animal health in general, in order to minimize the risk of introduction of the FMD virus in the region.

As stated previously, the regulations in § 92.2 provide for monitoring of regions after APHIS authorizes imports. If we determine, via audit or other means, that the required measures have not been fully implemented or maintained, or that SENASA is unable to certify that the specific certification requirements are met, we will take appropriate remedial action to ensure that the importation of fresh (chilled or frozen) beef from Northern Argentina does not result in the importation of FMD into the United States.

Several commenters said that APHIS had concluded in the risk analysis and the proposed rule that there is a risk of reintroduction of FMD from adjacent areas into the export region, as long as the disease is endemic in the overall region in South America. The commenters stated that even though the risk of introducing FMD to the United States is low, if all of the conditions are met as outlined in the proposed rule, the risk is still present and must be viewed in light of the devastation it would cause to the U.S. beef industry if an FMD outbreak were to occur.

We took this information into account in our risk analysis and determined that the Argentine production and export system is robust and capable of meeting the standards for exportation set forth by APHIS. APHIS does not adopt a zero tolerance for risk for international trade in meat products. Our risk analysis process is designed to determine whether a product can be imported safely into the United States. If, based on our risk analysis, we conclude that the production system in the country in question is insufficient to provide an appropriate level of protection, then we will not authorize the importation of the particular commodity. That is not the conclusion we reached regarding the importation of fresh (chilled or frozen) beef from Northern Argentina.

Several commenters questioned the efficacy of Argentina's internal animal movement controls. One commenter claimed that there is no required branding program or other animal identification program. The commenter further stated that non-symptomatic carriers of FMD exist in South America and therefore a qualified laboratory is required to identify these carriers. Another commenter stated that in a large, diverse nation such as Argentina, it is quite possible for FMD virus to have been circulating among various species in various regions undetected for long periods of time. A third commenter said that it is common practice in the beef industry to ship livestock from place to place and, as a result, the risk of cattle from outside the designated area being transshipped through the area then to the United States is tremendous. The commenter asserted that all imports cannot be inspected and tested. Another commenter stated that greater market opportunities and the resulting higher prices offered in the export region might foster illegal animal movements into that region from the surrounding countries.

We do not agree with these comments. Based on our review of the veterinary infrastructure in Argentina, we determined that SENASA, which oversees animal movement within the country, has the legal authority, technical capabilities, and personnel to implement the FMD program within Argentina. Movement controls in Argentina are stringent. We evaluated these controls and concluded that cattle movements follow particular requirements, which are described in detail in the risk analysis, and that cattle whose beef is destined to be exported to the United States are required to be accompanied by documentation at slaughter showing that they were born and raised in the Northern Argentina region. APHIS evaluated the system and concluded that SENASA has the ability to certify that this requirement has been met.

As described in the risk analysis, in 2007, Argentina instituted a compulsory cattle identification program, requiring that all calves born after September 2007 carry official tags (Resolution 754/2006). Resolution 563/2012 requires that bovines from the older age groups be individually identified. At the time of the 2013 site visit, SENASA reported that the entire Argentine herd was individually identified. Individual identification of bovines is unique and permanent. The number of tags needed is requested by the animal owner and is crosschecked at the local office to the inventory in the integrated management system for animal health (Sistema Integrado de Gestión en Sanidad Animal—SIGSA). The animals' owner is responsible for applying the tags and then notifying the local office as to which tags have been used. The color of tags issued to cattle holders is determined by the FMD status of the region in which the cattle reside. Green tags are used in regions that are FMD-free without vaccination, yellow for regions that are FMD-free with vaccination, red in buffer areas, and blue tags are used for tag replacement purposes only. SENASA requires that all premises with agricultural animal production register with SENASA and obtain a RENSPA (Registro National Sanitario de Productores Agropecuarios or National Sanitary Registry of Agricultural Producers) number. The local SENASA office must issue an animal movement permit (DT-e), which is required whenever animals are moved. The local SENASA office is responsible for verifying that the vehicle transporting the animals has been cleaned and disinfected as required by law. Any inspection associated with animal movement involves checking the documents and verifying the animal information, as well as clinical observation of animal health.

Argentina's surveillance system includes active surveillance (which involves ongoing laboratory-based testing). We are confident that the SENASA laboratory, which is responsible for the screening and confirmatory diagnosis of FMD, is fully capable of carrying out those responsibilities.

Any beef product that is imported into the United States from Argentina must be certified by SENASA as meeting all requirements set out in the regulations. This certification must accompany each shipment and is subject to review by the U.S. Customs Border and Protection (CBP) officials that cover each port of entry into the United States. Any shipments not meeting that requirement are refused entry and CBP reserves the right to question documentation or packaging at the port of entry based upon inspection. Imported meat products are then forwarded to an FSIS Inspection House for re-inspection. We are confident that these measures supply the necessary level of inspection required to minimize the risk of introducing FMD into the United States.

Some of the commenters did not believe the requirement for chilling the carcass after slaughter would be an effective mitigation against the FMD virus. One commenter stated that chilling beef may be inadequate for eliminating the virus, since that virus can remain active in blood clots. Two commenters said that research shows that the FMD virus can survive in frozen bone for up to 6 months.

APHIS agrees that chilling alone may not be adequate to eliminate the virus. Other tissues, organs, etc., that may harbor FMD virus, such as blood clots, heads, feet, viscera, bones, and major lymph nodes, do not undergo acidification, allowing the virus to survive the maturation process and subsequent low-temperature storage. Under this rulemaking, however, as noted previously, these tissues, bones, and organs must be removed from the carcasses prior to export to the United States. We have also added a more detailed discussion of viral inactivation to the risk analysis.

Two commenters noted that, in the past, APHIS has characterized other countries, e.g., Argentina, Japan, and South Korea, as low-risk countries for FMD, and that, soon after we did so, outbreaks of the disease occurred in those countries.

Because disease situations are fluid and no country, not even the United States, can guarantee perpetual freedom from a disease, APHIS' risk analyses consider whether a country can quickly detect, respond, and report changes in disease situations. In our evaluation, conducted according to the factors identified in § 92.2, “Application for recognition of the animal health status of a region,” we concluded that Argentina has the legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs, and emergency response systems necessary to detect, report, control, and manage FMD outbreaks.

As a member of OIE, Argentina is obligated to immediately notify the organization of any FMD outbreak or other important epidemiological event. The notification must include the reason for the notification, the name of the disease, the affected species, the geographical area affected, the control measures applied, and any laboratory tests carried out or in progress.

Upon notification of an FMD outbreak in the exporting region of Argentina, APHIS would implement critical prevention measures to respond to the outbreak, including alerting CBP inspectors at all ports of entry. Because § 94.29(b) of this final rule requires that FMD must not have been diagnosed in the exporting region within the past 12 months, fresh beef from the region would no longer meet our requirements, and we would immediately stop allowing it to be imported.

One commenter said that Argentina is surrounded by FMD positive countries and inquired about the disease status of southern Argentina. Another commenter stated that reliance on natural barriers to protect against FMD is an inadequate prevention tool for a region that shares multiple borders with countries known to have FMD or are FMD free with vaccination.

No FMD outbreaks have been reported in South America since 2012. Most South American countries have been recognized by the OIE as being FMD free with vaccination (Uruguay) or without vaccination (Chile and Guyana) or with free regions with vaccination (Argentina, Bolivia, Brazil, Colombia, Peru) or without vaccination (Argentina, Bolivia, Brazil, Colombia, Peru). No outbreaks have been reported in Brazil since 2006, in Paraguay since 2012, and in Bolivia since 2007. In that regard, the risk of introduction from neighboring countries is low. Any risk is of introduction is mitigated by following a regional approach to FMD eradication. APHIS acknowledges many enhancements in border control activities along the northern borders with Bolivia, Paraguay, and Brazil.

Further, Argentina does not solely rely on natural barriers to protect the export region from FMD; rather, it is one of many elements that contribute to Argentina's overall sanitary security. As long as FMD is considered endemic only in small areas of South America, there is a very low risk of reintroduction of FMD from those small, adjacent affected areas into the export region and therefore a low likelihood that beef destined for the United States could originate from or be commingled with animals or animal products from affected neighboring areas.

In the event FMD were to be introduced into the northwest of Argentina, the consequences would not be major (as demonstrated in the Tartagal outbreak, 2003) mainly due to the low animal density, low animal movements, and effective veterinary infrastructure in the area. The FMD outbreak that occurred in 2006 shows that SENASA is able to immediately notify and contain the disease, even before confirming diagnosis. APHIS acknowledges that SENASA has adopted several measures to prevent the introduction of the FMD virus from the south of Brazil, Bolivia, and Paraguay. Both Argentina and the OIE divide the areas south of Northern Argentina into three major parts: Patagonia North A, Patagonia North B, and Patagonia South. Patagonia North A was recognized by the OIE as FMD free without vaccination in 2014, however, as stated in footnote 3, APHIS has made no similar determination. For export purposes, APHIS includes Patagonia North A in the Northern Argentina region and any fresh (chilled or frozen) beef exported from that area would be required to be treated in the same manner as beef exported from the slightly smaller region known to Argentina and the OIE as Northern Argentina. On August 29, 2014, we published in the Federal Register (79 FR 51528-51535, Docket No. APHIS-2013-0105) 5 a notice that we were adding Patagonia North B and Patagonia South to the list of regions that APHIS considers free of FMD.

One commenter specifically cited the feral swine population of Texas as a potential vector for the rapid spread of FMD if it were to enter into the United States via the importation of fresh (chilled or frozen) beef from Argentina.

FMD susceptible scavengers, such as feral swine, might ingest discarded FMD-contaminated meat, such as raw meat trimmings, and become infected. The frequency of scavenging incidents is similar to risk factors analyzed in connection with the waste feeding pathway (e.g., the amount of imported, contaminated, uncooked meat in household garbage). Therefore, we consider the risk of the scavenging pathway to be equivalent to or lower than that of the waste feeding pathway. We have updated the exposure assessment section of the risk analysis to include further discussion of the risk related to susceptible scavenger and waste feeding of swine.

Another commenter cited the practice of some cowboys in the Patagonia Region who capture and sell feral cattle stating, that cattle of this type are not tested and therefore could be carriers of FMD.

Feral cattle that are captured and enter the Argentine beef production system must come into compliance with the Argentine FMD program requirements, including compulsory vaccination and identification, as is necessary for cattle from any other source in Argentina. Vaccination campaigns take special consideration of the distribution and reach of feral populations.

The risk analysis for Northern Argentina includes an in-depth evaluation of the 11 factors used by APHIS to evaluate the animal health status of a region prior to 2012. In August 2012, APHIS consolidated the 11 factors listed in § 92.2(b) into 8 factors. APHIS introduced this simplification in order to facilitate the application process; however, since the evaluation of the Northern Argentina started before 2012, and the topics addressed by the 11 factors are encapsulated in the 8, this analysis follows the 11 factor format. One commenter objected to our use of the 11 factor format. The commenter characterized the reason for the change as the fact that “the list of 11 factors can be confusing.” The commenter said that the use of the 11 factor analysis is arbitrary and contrary to APHIS' current regulations and should not be permitted.

We disagree. As stated in the proposed rule, the topics addressed by the 11 factors are encapsulated in the 8. Appendix II of the risk analysis describes the correspondence between the 8 and 11 factors. The commenter's assertion that APHIS amended its evaluation factors because they were confusing is an incomplete assessment of the situation at the time of the August 2012 rule. Specifically, we said that the 11 factor list could be confusing because the information requested in some of the factors overlapped with information requested in other factors. We therefore amended the list so as not to receive redundant information from requesting countries. Given that the development of our risk analysis took years and given that the 11 factors are included in the 8 factors, rewriting the analysis in the way the commenter suggests would involve a time-consuming, non-substantive consolidation process, which is not warranted under the circumstances.

Some commenters questioned the methodology we employed for the site visits to Argentina. It was claimed that there is no obvious evidence of any established protocol or methodology to allow for consistency and assurance in the quality of the APHIS site visit reviews and that documentation pertaining to the visits was lacking or unavailable for public review. According to one commenter, documents pertaining to the specific methodology and measurements used during the site visits to support the qualitative risk analysis should have been available for the public to review. It was stated that without sufficient documentation, there was no way to distinguish between data obtained from the site visits and data supplied by the Government of Argentina. It was recommended that APHIS develop a protocol, which it should make available to the public, to be used for site visits so that our assessments can be analyzed and summarized more objectively.

The purpose of the site visit is to verify and complement the information previously provided by the country. APHIS site visits consist of an in-depth evaluation of the risk factors identified by APHIS in § 92.2 to consider in assessing the risk of the relevant animal disease posed by a region. The animal disease risks identified in the risk analysis come from the information gathered pertaining to these factors during the site visits and APHIS' document review; and whenever mitigations are considered necessary, such mitigations are discussed in the risk analysis.

APHIS has also published guidance on our approach to implementing our regionalization process and the way in which we apply risk analysis to the decisionmaking process for regionalization. This document can be found on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/downloads/regionalization_process.pdf. Site visit findings are thoroughly described throughout the risk analysis.

Two other commenters stated that a request for information had been made under the Freedom of Information Act (FOIA) to APHIS related to the site visits to Argentina and documented reporting procedures and established methodology used to conduct those site visits. The commenters said that the rule should not be finalized until the commenters receive, review, and have the opportunity to make additional comments based on the information obtained through FOIA.

We disagree with the commenter's suggestion. As stated previously, the initial 60-day public comment period was extended by 60 days, providing stakeholders with a total of 120 days to share information relevant to each rule. FOIA requests are processed and fulfilled separately from the regulatory process.6

Two commenters said that some citations in the risk analysis, such as references to APHIS internal publications or unpublished reports, did not seem credible because those sources were not readily available to stakeholders for review. The commenters added that each of the primary supporting documents included with the rule on Regulations.gov should have been explicitly referenced in the risk analysis.

We disagree. The information referenced and the conclusions reached are thoroughly described in the risk analysis. In addition, the final risk analysis includes further discussion and references regarding some of the issues about which other commenters had questions.

Two commenters raised issues regarding the scope of our risk analysis. It was stated that the release assessment, exposure assessment, and consequence assessment appeared to be incomplete with regard to the necessary steps and requirements described in the OIE Terrestrial Animal Health Code.

We conducted the risk analysis in accordance with chapter 2.1 of the OIE Terrestrial Animal Health Code, “Import Risk Analysis.” The Code recommends that risk analyses include four steps: An entry assessment, an exposure assessment, a consequence assessment, and an overall risk estimation based on the data compiled in the previous three steps. A description of each of those steps is included. In conducting our risk analysis of Northern Argentina, we followed the steps listed in the OIE Terrestrial Animal Health Code. Where there are differences, they have more to do with terminology than methodology. For example, we refer to what the OIE terms the entry assessment as a release assessment.

Many commenters stated that the U.S. Government Accountability Office (GAO) has accepted a request submitted by several members of Congress to review the APHIS country review and verification process and the risk analysis used to formulate this proposed rule. The commenters said that no further action on the rule should be taken until the GAO review is completed. One commenter stated that a USDA Office of the Inspector General (OIG) review is also a possibility and that APHIS should wait for the reports from both bodies before proceeding with further action.

While an audit has been requested, that request has not been processed by the GAO. The GAO is an independent agency and, as such, its audit process exists independently of the APHIS regulatory process. If, in the future, the GAO conducts such an audit and releases findings and recommendations, APHIS will review them and adjust our process accordingly. As for the OIG audit referenced by the commenter, at this time such a request has not been submitted. If it is submitted in the future, the OIG will conduct the audit independently of APHIS, and we will take any findings into consideration at the time they are released.

Several commenters made reference to a report released by a third-party scientific review team from the University of Minnesota College of Veterinary Medicine, Center for Animal Health and Food Safety, and the Center for Veterinary Population Medicine which evaluated the APHIS risk analysis. The commenters stated that the report found limited or lacking scientific methodological approaches in performing the risk analysis, poorly defined scope regarding the specific animal types and products for the risk analysis, lack of sufficient detail for geographical landmarks outlining the region, and maps lacking the necessary level of detail to be useful to determine the region.

We have not been made privy to this report and therefore cannot provide a detailed response to topics beyond those cited by the commenters. Both APHIS and the OIE support the use of a qualitative risk analysis model for the purpose of animal health status evaluation. In the OIE's “Handbook on Import Risk Analysis for Animal and Animal Products,” qualitative risk analyses, such as the one that informs our decision to allow for the importation of fresh (chilled or frozen) beef from Northern Argentina, are cited as both an appropriate and the most common type of assessment used to support import decisions. The risk factors evaluated by APHIS and described in detail in the risk analysis are almost identical to those evaluated by the OIE.7 Additionally, we disagree that the specific animal types and products are undefined. The sole product under consideration for importation in the risk analysis is fresh (chilled or frozen) beef that has been matured and deboned in accordance with the regulations. We also disagree with the claims regarding lack of geographical detail. As described previously, figure 12, which is located on page 52 of the risk analysis, is a map showing the various regions in Argentina, including Northern Argentina. The region under consideration is located north of the Patagonia Region, which includes the region located south of the 42nd parallel known as Patagonia South, and the region immediately north of the 42nd parallel known as Patagonia North B. The full description of the area is found earlier in this document. We have also added further description of the area to the risk analysis.

Some commenters stated that APHIS should prepare a quantitative risk analysis for beef from Northern Argentina and make it available for public review. Commenters took the position that the qualitative risk analysis methodology that we employed is too subjective because it fails to quantify objectively the probability of risk and adequately assess the magnitude of the consequences of a disease outbreak. Noting that APHIS prepared a quantitative risk analysis in 2002 in support of the rulemaking allowing the importation of fresh beef from Uruguay, commenters questioned why APHIS chose to prepare only a qualitative risk analysis for Northern Argentina.

One commenter stated that although the commenter recognized that the analysis was qualitative, some categories that define what USDA considers “low” risk would be helpful and are necessary for a clear understanding of the risk associated with importation of a given commodity.

Most of APHIS' risk analyses for FMD have been, and continue to be, qualitative in nature. APHIS believes that, when coupled with site visit evaluations, qualitative risk analyses provide the necessary information to properly assess the risk of the introduction of FMD through importation of commodities such as fresh beef. Quantitative risk analysis models are not the best tool to use to assess the risk of FMD posed by exports from a country where the types of data required by such models are unavailable or inadequate. In these instances, APHIS characterizes the risk of potential outbreak qualitatively in order to determine what appropriate measures to implement in order to mitigate the risk posed to the United States in the event of an outbreak in the exporting country (e.g., maturation and pH of beef, no diagnosis of FMD in the previous 12 months).

Contrary to the assertion that a qualitative analysis should define an explicit level of risk or a range of risk, the relative flexibility afforded by a qualitative analysis allows us to evaluate commodity import programs in a holistic manner.

Some commenters viewed the documentation supporting our risk analysis as insufficient. It was further noted that some of those supporting documents were in Spanish. As a result, according to the commenters, transparency was lacking regarding our research methodology and the manner in which we arrived at our conclusions. It was also claimed that the documents we did make available lacked consistency and evidence of verification of our findings.

APHIS acknowledges that some of the documents used as references in the risk analysis were submitted to APHIS in Spanish; APHIS personnel were able to read and evaluate these documents without the necessity of translation into English. In most instances, the same or related data were provided in English in other documents or verbally presented to APHIS during site visits. However, the information provided by Argentina and the conclusions reached are thoroughly described in English in the risk analysis that was made available for public review and comment.

As stated in the proposed rule, although there has not been a major outbreak of FMD since 2001/2002, APHIS does not consider Northern Argentina to be free of FMD because of the vaccination program in that region. One commenter stated that the sanitary security of the United States would be more effectively protected by continuing only to allow for importation from countries that are certified as FMD free without vaccination.

We disagree with the commenter. Our conclusion regarding the decision to allow for the importation of fresh (chilled or frozen) beef from Northern Argentina was reached based upon our understanding of the disease situation in that region and the efficacy of mitigation measures for beef. It has been 9 years since the last FMD detection of any size in Northern Argentina; and the changes in SENASA's infrastructure following earlier outbreaks, as detailed in the risk analysis provide adequate protection against the importation of FMD into the United States via fresh (chilled or frozen) beef from Northern Argentina.

Another commenter observed that the source for APHIS' report that SENASA had officially inspected over 31 million cattle and sheep in 2009 was noted as being a discussion between APHIS and SENASA officials during APHIS' 2005 site visit. The commenter questioned the reliability of this source.

The date of the discussion regarding inspection that took place during the site visit was incorrect in the risk analysis that accompanied the proposed rule. We have corrected the reference in the updated risk analysis to indicate that the discussion occurred during APHIS' 2009 site visit.

Another commenter asked that APHIS address the impact of FMD on the economy and individuals, the duration of the disease, meat inspection procedures, and uncertainties about Argentine sanitary security.

These topics and more are covered by the risk analysis. Further, we would note that in 2003 APHIS authorized the importation of fresh (chilled or frozen) beef under the same conditions that are found in this rule from Uruguay, a region that, like Northern Argentina, is free of FMD with vaccination. Since that time, importation of Uruguayan beef has not been associated with an increased risk of FMD.

Some of the commenters expressed reservations about the efficacy of the maturation requirements contained in the proposed rule, which included chilling the carcass after slaughter for a minimum of 24, and a maximum of 48, hours to ensure that the pH in the loin muscle will be below 6.0. One commenter observed that the risk analysis and the environmental assessment that accompanied the proposed rule were inconsistent concerning whether the FMD virus is totally inactivated as stated in the risk analysis, or whether a small proportion of the virus particles that are relatively resistant to the effects of heat and pH in most populations would remain, as stated in the environmental assessment. The commenter concluded that, if the latter situation were true, the presence of even a small number of virus particles undermined APHIS' claim that the risk posed by the importation of chilled (fresh or frozen) beef from Northern Argentina is low since the virus would not be truly inactivated.

Based on the existing scientific literature, it is generally accepted that FMD virus is inactivated at pH 6.0 or below after maturation at a temperature of 4 °C. Acidification of skeletal muscle that takes place during carcass maturation is normally sufficient to inactivate FMD virus in this tissue, even when cattle are killed at the height of viremia. Because it is known that the required level of acidification cannot be guaranteed under all circumstances, measuring of the pH level of the carcass muscle can be used to ensure that it has occurred. This rule requires that measurements for pH be taken at the middle of both longissimus dorsi muscles; any carcass in which the pH does not reach less than 6.0 may be allowed to maturate an additional 24 hours, and if the carcass still has not reached a pH of less than 6.0 after 48 hours, the meat from the carcass may not be exported to the United States. We have updated the risk analysis and the environmental assessment based on this comment to include further references and explanation of the issue.

One commenter noted that both the rate of pH fall and the ultimate pH achieved in the muscle tissue are influenced by factors such as species, type of muscle in an animal, genetic variability between animals, administration of drugs which affect metabolism, environmental factors prior to slaughter such as feeding or stress, and post-mortem temperature. The commenter stated that therefore a precise protocol must be followed, and expressed doubt that Argentine producers would be capable of adhering to this protocol.

Contrary to the commenter's point regarding different muscle types reaching varying pH levels, we have specified that pH readings must be taken from the longissimus dorsi muscle. Additionally, transportation and carcass resting both influence the likelihood that the muscle tissue will reach the required pH level since, as stated previously, acidification of the skeletal muscles takes place during this time. Even if one or more of the various influencing factors were to affect the pH of the muscle tissue, any carcasses that do not reach the required pH level will not be allowed to be exported into the United States, regardless of how that level was reached. As stated previously, we have added more discussion on the maturation process and the effectiveness of the process in FMD virus inactivation to the final risk analysis.

Two commenters said that the proposed mitigations involving the maturation of the fresh beef and deboning appeared inconsistent with the OIE guidelines for FMD risk mitigation. The commenters stated that the proposed requirements established deboning and maturation as two separate and unrelated mitigations, but the OIE recommendations clearly state that deboning should occur after the meat has matured and reached a pH less than 6.0 at the middle of both longissimus dorsi muscles.

While it was always our intention—and is our practice concerning importation of fresh (chilled or frozen) beef from Uruguay—that deboning occur after the meat had matured and reached the required pH level, we have amended, for clarification purposes, the language in this final rule describing this process.

The same commenters pointed out that neither the proposed rule nor the risk analysis provided information regarding freezing procedures, even though the product proposed for import was chilled or frozen beef.

Both chilling and freezing of meat after maturation are standard industry practices, crucial for food safety and quality regardless of the final destination of the meat. The procedure is as follows: After slaughter, beef carcasses are kept in the chilling rooms at appropriate refrigeration temperatures (carcasses will begin chilling within 1 hour from bleed-out). As previously stated, bovine carcasses are then required to maturate at 40 to 50 °F (4 to 10 °C) for a minimum of 24 hours and must reach a pH below 6.0 in the loin muscle at the end of this period. Measurements for pH must be taken at the middle of both longissimus dorsi muscles. The maturation process critical for FMD virus inactivation via pH drop is temperature dependent, which is why we specified the required temperature range in the proposed rule.

The process of carcass fabrication begins immediately after a carcass leaves the chilling room and takes place in the deboning room where beef cuts are obtained and blood clots and lymph nodes are removed under environmental refrigeration temperatures. These temperatures vary but are generally less than 50 °F (10 °C). Carcass temperature (usually between 4 and 7 °C) and pH are controlled before the carcass enters the deboning room in order to ensure compliance with SENASA authorities and the specifications of importing countries. After the carcass is processed into cuts of meat, those cuts are packed and stored either in a chiller separate from the chiller used for carcass maturation, or in a freezer. A description of the inactivation process has been added to the final risk analysis.

Another commenter observed that, unlike the risk analysis APHIS completed concerning the importation of fresh (chilled or frozen) beef from Brazil, the risk analysis for Northern Argentina does not disclose the number of practicing veterinarians in Argentina, instead stating that SENASA employs 1,054 veterinarians. The commenter said that the absence of the total number of veterinarians in Argentina made a true picture of the veterinarian-to-livestock ratio in Argentina impossible. The commenter further stated that the SENASA-employed veterinarian-to-livestock population ratio of approximately 1 government-employed veterinarian for each 54,080 head of cattle suggests that Argentina lacks an adequate number of veterinarians to effectively monitor the health of Argentina's cattle herd. The commenter said that APHIS should explain the discrepancy in approach between the risk analyses for Brazil and Northern Argentina.

In conducting our evaluation of any animal health program, APHIS is mainly concerned with the veterinary authority of the responsible organization and its available resources for conducting emergency response, vaccination, enforcing movement restrictions, etc. We evaluate the veterinary infrastructure and authority in the context of detection and prevention of FMD, which includes the ability of the veterinary authority to certify that the required mitigations are met. That evaluation may or may not include number of veterinarians. Brazil provided that number with its application and Argentina did not. As in the United States, many veterinarians in Argentina operate mixed veterinary practices that encompass care of both large and small animals in varying proportion. Therefore, any information provided regarding total number of veterinary practices in Argentina would be misleading. Consequently, we do not consider the number to be a significant aspect of a country's sanitary infrastructure; however, we do provide such information in the risk analysis if it is included in the information provided to us.

The same commenter stated that, in the risk analysis accompanying APHIS' proposal to declare the State of Santa Catarina, Brazil, free of FMD, APHIS disclosed the type and quantity of high-risk imports that were known to enter Santa Catarina, the numbers and origins of FMD-susceptible animals that had entered Santa Catarina for breeding purposes, swine movement into and within the State of Santa Catarina, and imports of animals and products from FMD-susceptible animals into the State of Santa Catarina. The commenter said that these data enabled reviewers to evaluate the risk and formulate opinions regarding the specific import practices of the state that had requested to export FMD-susceptible animals and products to the United States and observed that APHIS provided no comparable data in the risk analysis accompanying the Argentine proposed rule.

The commenter specifically cited a statement from the risk analysis that “an area near the border with Paraguay [is] considered endemic for FMD [and] [t]his endemic area appears to have active virus present in restricted niches or patches, which could potentially lead to outbreaks in cattle populations with low FMD immunity,” and concluded that APHIS knows that it is likely, if not highly likely, that an active FMD virus is present in Northern Argentina.

As described in the two risk analyses, both the State of Santa Catarina, Brazil, and the region of Northern Argentina follow OIE guidelines for the importation of FMD-susceptible commodities. The particular imports as well as the guidelines followed are different since both regions have different status. Argentina is a net exporter of cattle, and the number of imported cattle is insignificant. According to SENASA, the last importation of cattle from Paraguay (which was for breeding purposes only) occurred in 2010 (11 head), no cattle imports have been reported from Brazil or Bolivia since 2010, and Argentina's imports from Uruguay are generally less than 200 head of cattle per year. The primary imports of beef into Argentina are from Uruguay under the same type of conditions that are currently in place for the importation of fresh (chilled or frozen) beef from Uruguay into the United States.

The risk analysis we performed pursuant to declaring the State of Santa Catarina free of FMD specifically evaluated the disease situation for four swine diseases, including FMD. The State of Santa Catarina is a major swine-producing state, and an assessment of swine movements was critical to our analysis. In the case of Northern Argentina, swine imports into the region are negligible as Argentina is not a major swine-producer. According to SENASA, 1,521 swine were imported into Argentina in 2014, all of which were from Brazil.

Further, the commenter has taken the statement about the Paraguay-Argentina border out of its original context in the risk analysis. The statement refers to the situation in Argentina in a particular area at the time of the most recent FMD outbreak in Argentina, which was 9 years ago. The current epidemiological situation and evidence supports APHIS' conclusion that either the disease does not exist in that region or that the vaccination coverage is high and the disease is under control. At the time the State of Santa Catarina, Brazil, risk analysis was finalized in August 2010, there were other regions of South America experiencing outbreaks. As a result, our consideration of risk for the State of Santa Catarina, Brazil, was based in part on the disease situation in the surrounding region, which differs here since there has been no outbreak of FMD reported in South America for the past 3 years.

One commenter stated that farmers who own property spanning the borders between Argentina and Paraguay and Argentina and Bolivia are of particular concern as this increases the potential for animal movements across the borders. The commenter added that nomadic people in the area would also be likely to move animals without proper documentation. Another commenter specifically cited the border with Paraguay as being of continuing concern given that the risk analysis identified illegal movement of livestock from Paraguay as a likely source of historical FMD introduction to Argentina.

Argentina collaborates with neighboring countries to harmonize FMD-related programs and restrictions. Mechanisms have been established to provide for immediate notification between these countries if an outbreak occurs. High-risk surveillance areas have been established on Argentina's borders with Brazil, Paraguay, and Bolivia. This program includes: Strengthening infrastructure of the veterinary services; harmonizing procedures for control, prevention, and eradication of FMD; harmonizing vaccination procedures in areas of geographic contiguity; and conducting vaccinations under APHIS supervision. That being said, in response to the comment we are adding a clarifying statement to both the risk analysis and the environmental assessment to emphasize that if FMD exists at all in South America, it likely does so only in very small regions as evidenced by the lack of reports of the disease over the past 3 years.

One commenter said that the nature of the border control and biosecurity measures in place between the Northern Argentina region and neighboring countries was not clearly described in the risk analysis. Another commenter stated that while APHIS described enhancements to the border control activities and infrastructure in the Provinces of Formosa, Salta, and Jujuy, we failed to explain what enhancements were made in the Provinces of Misiones, Chaco, and Corrientes.

As stated in the risk analysis, border control activities include, but are not limited to, vaccinations, surveillance, animal census, education, and animal identification. Contrary to the second commenter's assertion, enhancements made to border control activities, which include activities that occur in the Provinces of Misiones, Chaco, and Corrientes since they are located on the border of Argentina, are described in the risk analysis as follows: Following the recommendations of the OIE mission that visited Argentina, Brazil, and Paraguay in December 2006, the heads of the veterinary services and the Pan American Foot-and-Mouth Disease Center defined an area of high-level surveillance within the border regions of Argentina, Brazil, Paraguay, and Bolivia. Initially the program was intended to last 2 years and be subjected to periodic reviews and evaluations. During the 2009 and 2013 site visits, SENASA reported that the program was still effectively operating, with a redefinition of the high surveillance area in 2013 to include the border regions of Argentina, Paraguay, and Bolivia. Most of the financing has been obtained from the World Bank and the Inter-American Development bank. Among others, the general actions include:

• Strengthening infrastructure of the veterinary services;

• Harmonizing procedures for control, prevention, and eradication of FMD;

• Harmonizing vaccination procedures in areas of geographic contiguity; and

• Conducting vaccinations under APHIS supervision.

The same commenter observed that APHIS included data on the buffalo population in our risk analyses for both the State of Santa Catarina, Brazil, and for the 14 additional Brazilian States that have requested to export fresh (chilled or frozen) beef to the United States, as buffalo are an FMD-susceptible species. The commenter noted that there is no mention of buffalo in the Northern Argentina risk analysis despite the existence of Internet advertisements for hunting water buffalo in Argentina. The commenter concluded that, for such advertisements to exist there must be a significant population of water buffalo in the region, which represent a risk of FMD transmission.

In 2014, the buffalo population in Argentina was less than 94,000 head 8 and vaccination and movement requirements for those buffalo are identical to those for cattle. We have added an explanation to this effect in the final risk analysis.

The same commenter stated that APHIS provides no discussion regarding the likelihood that wildlife in Argentina has developed a natural immunity to the FMD virus. The commenter posited that, with such immunity, wildlife could serve as asymptomatic carriers of the disease and because Argentina has been vaccinating cattle for FMD for a considerable period of time, the transmission of the FMD virus between wildlife and domestic livestock would not be expected to result in a symptomatic response.

Other commenters also took issue with the release assessment for suggesting that wildlife does not play a significant role in the transmission of FMD. It was claimed that the statement lacked support in the scientific literature. One commenter specifically cited the feral swine population in the Gran Chaco region and the endangered and protected Chacoan peccary that are allowed to move freely within the Gran Chaco as a potential source of wildlife transmission for FMD between Northern Argentina, Bolivia, Paraguay, and Brazil.

The first commenter provided no evidence to support the supposition that species of wildlife are likely to become asymptomatic carriers of the FMD virus in the particular region under consideration and there is no epidemiological data supporting such a claim. As stated previously, research into FMD in South America has determined that wildlife populations do not play a significant role in the maintenance and transmission of FMD. During outbreak situations, wildlife may become affected by FMD; however, the likelihood that they would become carriers under field conditions is rare. Therefore, it is unlikely that FMD would be introduced into Northern Argentina through movement of infected wildlife.

The epidemiology of the disease in South America over time and the information provided in the surveillance section of the risk analysis clearly demonstrate that the role of wildlife in disease transmission in the area under consideration is insignificant. Many decades of experience with the disease have shown no consistent relationship between outbreaks in domestic animals and coexistence of susceptible wild animals in South America. In addition, results of repeated serological testing focusing on cattle as the most susceptible species do not reveal evidence of viral activity in domestic ruminants that are likely to contact wild animals. If wild animals were carriers or reservoirs of FMD, evidence of viral activity would be expected in domestic species coexisting in the same regions as infected wild animals.

A commenter said that, while the APHIS risk analysis states that, as of 2006, there were 52 eligible plants in Argentina certified to export meat to the United States, the most recent FSIS audit of the Argentine meat industry states that there are only 14 such establishments. The commenter said that APHIS' assessment of risk associated was therefore wrongly assuming that the volume of potentially export-eligible beef per plant was lower; a situation which would allow for more careful oversight within those plants than is actually the case given the FSIS data.

All plants approved by SENASA are federally inspected. Prior to the finalization of this rule, only cooked or cured beef was eligible for export from Northern Argentina under the regulations in 9 CFR 94.4, due to that region's FMD status. In response to the comment we are deleting the number of plants since that number will be updated after FSIS conducts its equivalence determination. Moreover, the number of eligible plants is subject to relatively frequent change, most likely due to ongoing compliance cost assessments made by individual owners in Argentina. Regardless, we do not make assumptions regarding how much beef a plant will produce; rather we evaluate the likelihood that FMD could be introduced into the United States via the importation of beef. It is unlikely, given the expected low import volume, that beef will be imported from Argentina at levels that will overwhelm the existing processing infrastructure.

The same commenter pointed out that the endnote citation listed in the risk analysis as supporting an assertion regarding the rate of pH change in the longissimus dorsi muscle referred to an FSIS report on Argentine plants eligible to export meat to the United States and not to any scientific literature.

The commenter correctly pointed out that our reference number was mistaken and we have corrected it in the final risk analysis.

One commenter said that the underlying assumption in APHIS' entire economic model is that U.S. cattle are grain fed and, therefore, of higher quality, while imports from Argentina will be beef from grass fed cattle. The commenter characterized these assumptions as false, citing the USDA Foreign Agricultural Service's (FAS's) September 2014 GAIN report, which states that most of the beef currently consumed in Argentina is grain fed. The commenter concluded that therefore beef from Argentina will be comparable to high-quality U.S. beef and, therefore, more competitive in the U.S. market.

We acknowledge the fact that a large percentage of beef cattle in Argentina now complete their feeding regimen in feedlots. It is true that the grain fed beef imported from Argentina will be more directly competitive with U.S. sourced beef, but the overall conclusion of our analysis remains the same: The relatively small quantity of Argentine beef expected to be imported will not significantly impact the U.S. market. In 2013, Argentina exported approximately 7 percent of its total production and consumed the remaining 93 percent. Given Argentina's production capacity and its promotion of domestic consumption of beef, it is unlikely that Argentina's beef will strongly compete in the U.S market. In terms of value, the EU continues to be the main destination for Argentina's beef exports, as it is able to enter the EU market under the Tariff Quota regulated by EC Regulation No. 936/97 of 27 May 1997. Argentina has been recently approved by the EU to access the quota for premium quality (Beef 481) with no fee. Other countries already authorized under this quota are the United States, Australia, Canada, New Zealand, and Uruguay. This quota differs from the Tariff Quota regulated by EC Regulation No. 936/97 described earlier in this document in that it is not allotted by portions to each of the participant nations, but it is a general quota for which all the countries involved must compete. Argentina's beef exports will therefore most likely be intended for multiple locations, not only for the U.S. market.

The same commenter said that in 2012, the price for heavy fed steers in Argentina was $8.80 pesos per live kilo (approximately $0.47 U.S. dollars per pound) and the price for heavy fed steers in the United States in that year was approximately $1.23 U.S. dollars per pound. The commenter observed that Argentine cattle are priced at about one-third of the price of U.S. cattle and this price differential will create incentive for multinational corporations to source beef from Argentine cattle and therefore quickly increase supplies of beef comparable to U.S. beef in the U.S. market.

Argentina's proposed export quantity represents less than 1 percent of U.S. beef production and is unlikely to have a major impact on the U.S. domestic market. In addition, Argentine beef will be exported to the United States under a quota, and quantities over that quota will be assessed an import duty of 26.4 percent. The EU is the largest market for Argentina's beef. Given projected import levels, above-quota duties, and existing market patterns, the economic impact of Argentine beef imports is likely to be small.

The same commenter stated that the economic analysis likely ignores the extreme sensitivity of U.S. cattle prices to changes in supply. The commenter cited studies that show that farm level elasticity of demand for slaughter cattle is such that a 1 percent increase in supply can reduce prices by up to 2.5 percent. The commenter observed that domestic cattle prices jumped $26 per hundredweight after trade restrictions were imposed on imports of cattle and beef from Canada in 2003, thus demonstrating the sensitivity of the market.

The economic analysis uses a partial equilibrium model for which more details can be found in Paarlberg et al.9 In mapping interactions among the grain, livestock, and livestock product sectors, the model assumes price-taking economic decisionmakers who maximize well-defined objective functions. Utility maximization for consumers yields a set of per capita demand functions. Three sets of parameters drive the model: The livestock feed-balance calculator, the revenue shares for all industries, and elasticities used in the model solution. The livestock feed-balance calculators are critical because they relate the stocks and flows of animals for each quarter to the feed supplies available, forming the critical vertical linkage between the animal agriculture component and the crop component. Elasticities are critical parameters and are grouped into several sets. Most own- and cross-price elasticities of retail demand are based on estimates from econometric models. Cross-price elasticities are non-negative, implying that the commodities involved are substitutes. Substitution elasticities describe derived demand behaviors and affect supplies of the output commodities in the equation from which they are derived. Substitution elasticities are either obtained from the literature or generated consistent with commonly accepted supply elasticity values.

The percentage change in cattle and beef prices in 2003, which was because of trade restrictions due to the discovery of BSE in Canada, were significantly greater than the percentage price changes expected as a result of the importation of fresh (chilled or frozen) beef from Argentina. Immediately following the discovery of BSE in Canada in May 2003, the United States closed its border to imports of Canadian feeder cattle, fed cattle, cull cows, and beef. Later in 2003, the United States reopened its border to imports of Canadian boneless beef obtained from animals less than 30 months of age. Prior to May 2003, almost half of the cattle sold in Canada were exported as either live animals or meat. In 2002, about 90 percent of Canadian beef exports went to the United States and accounted for 55 percent of U.S. beef imports.

In contrast to the relatively sudden loss of such a large traded volume of beef in 2003, expected annual imports from Argentina of 20,000 MT of fresh beef would be the equivalent of less than 2 percent of average annual U.S. beef imports and less than 0.2 percent of the U.S. beef supply, 2009-2013.

The commenter cites studies indicating that a 1 percent increase in the supply of beef can reduce slaughter cattle prices by up to 2.5 percent. Other studies, such as Marsh et al. (2005), find a coefficient closer to 1.5 (beef price flexibility coefficient at the slaughter-wholesale market level).10 When this coefficient is multiplied by the percentage increase in the U.S. beef supply expected with this rule (20,000 MT, when assuming no displacement of beef imports from other sources), the percentage impact on slaughter cattle prices, 0.25 percent, is found to be essentially the same as shown in the last row of table 3 of the economic analysis.11

A commenter expressed the view that the rulemaking would depress markets for U.S. producers.

The commenter did not present data that would support the proposition that Argentina's beef exports are likely to increase so precipitously as a result of this rulemaking that U.S. producers would experience negative effects.

One commenter stated that the rule did not represent any benefit to U.S. producers.

Using a partial equilibrium model and considering three scenarios of 16,000, 20,000 and 24,000 metric tons, there are net welfare gains in each scenario. Under the 20,000 MT import scenario, producers would experience a decline in surplus of $7.63 million or 0.42 percent, while consumers would benefit from the decrease in price by an increase in their surplus of $130.24 million or 0.30 percent. The overall impact would be a net welfare gain of $122.61 million or 0.27 percent for U.S. beef consumers. The net welfare gain for the beef sector would be $0.61 million or 0.002 percent.

In the initial regulatory flexibility analysis prepared in connection with the proposed rule regarding the economic effects of the rule on small entities, we stated that the primary entities affected by the rule would be cattle producers, feedlots, and slaughter facilities, the majority of which were considered to be small businesses. We also stated that there could be other categories of small entities affected and invited commenters to supply us with any information we might be lacking on the number and nature of those entities. Two commenters cited this as evidence that APHIS did not adequately prepare for the publication of this proposed rule by presenting a full list of potentially affected small entities.

The economic analysis for the proposed rule considered the entities that may be directly affected. Under the Regulatory Flexibility Act, agencies are required to consider impacts on small entities and request additional information if it is not readily available. We estimate that cattle (steer) prices and wholesale beef prices are likely to decline between about 0.2 and 0.3 percent due to beef imports from Argentina. These measures of price effects are industry-wide. How reductions in producer surplus because of these price declines may be distributed among livestock operations and other affected entities cannot be determined from the information available.

Many commenters expressed concern about the potentially devastating economic effect an outbreak of FMD in the United States could have on U.S. cattle producers. It was stated that the potential economic risks greatly outweigh the benefits of this rulemaking, and that the economic analysis accompanying the August 2014 proposed rule failed to take into account those potential costs. Some commenters recommended that we revise the economic analysis to account for those potential costs. It was suggested that we should perform a comprehensive, up-to-date economic analysis to identify consequences for all U.S. commodity groups potentially affected by an FMD outbreak.

It is true that an outbreak of FMD in the United States, whatever its source, could have very serious effects on the U.S. cattle industry. In the economic analysis accompanying the August 2014 proposed rule, we modeled expected benefits and costs of annual imports of fresh (chilled or frozen) beef from Northern Argentina for three scenarios: Importation averaging 16,000 MT, 20,000 MT, and 24,000 MT, and found that the expected changes in U.S. beef production, consumption, and exports would be inconsequential. We have added a discussion of the potential impacts of an FMD outbreak for the U.S. economy to the final economic analysis. We also note that we examined the potential economic and other consequences of an FMD outbreak in the United States at some length in the consequence assessment section of our risk analysis.

Several commenters cited the “Site-Specific Biosafety and Biosecurity Mitigation Risk Assessment” 12 conducted for the Department of Homeland Security's National Bio and Agro-Defense Facility and the economic impact models used to estimate the impact of an outbreak of FMD, suggesting that APHIS consult those models in our own analyses.

The report referenced by the commenters shows the cumulative impact on the entire industry for a worst case disease scenario. Given the risk mitigation measures in place, it is highly unlikely that FMD would be introduced into the United States via fresh (chilled or frozen) beef from Argentina.

While specific comments on the initial regulatory flexibility analysis are addressed above, we also received a number of comments concerning the overall economic effect of the rule as it relates to potential costs to U.S. consumers.

Several commenters stated that an analysis of the long term costs to consumers and the livestock industry resulting from an outbreak of FMD in the United States was not included in the proposed rule.

While we agree with the commenters that the consequences of an FMD outbreak in the United States would be severe, the likelihood of such an outbreak occurring due to exposure of the domestic livestock population to chilled (fresh or frozen) beef imported from Northern Argentina is low. Therefore, the overall risk of FMD to U.S. animal health from imports of these commodities is also low.

A commenter stated that allowing imports of beef from Northern Argentina may cause a loss of consumer confidence in other types of meat in addition to beef, resulting in a loss of profits for U.S. producers.

This is a hypothetical statement for which the commenter presents no supporting evidence.

One commenter stated that the environmental assessment accompanying the proposed rule marginalized empirical evidence demonstrating FMD spread in domestic wildlife by relying upon cursory studies.

There has been no confirmed spread of FMD in wildlife in the United States. Due to the lack of epidemiological data on FMD in U.S. wildlife, FMD research has had to rely on experimental infections or mathematical modeling. While experimental data indicates that many U.S. wildlife species are susceptible to FMD, transmission by persistently infected livestock or wildlife to susceptible animals has not been proven despite decades of worldwide research.

The same commenter said that the environmental assessment cited an 11-year-old study to assert that “experts generally consider the transfer of FMD from wildlife to domestic animals to be unlikely,” while, according to FMD disease notifications submitted to the OIE, the Republic of South Africa attributed its 2009 outbreak of FMD to contact with wild species as did Botswana.

Apart from the African buffalo (Syncerus caffer) in sub-Saharan Africa, wildlife has not been demonstrated to play a significant role in the transmission of FMD. More often, wildlife are passively infected when outbreaks of FMD occur in domestic livestock, and, in some wild ungulates, infection results in severe disease. Efforts to control FMD in wildlife may not be successful when the disease is endemic in livestock and may cause more harm to wildlife, human livelihoods, and domestic animals. Currently in sub-Saharan Africa, the complete eradication of FMD on a subcontinental scale in the near term is not possible, given the presence of FMD-infected African buffalo and the existence of weak veterinary infrastructures in some FMD-endemic countries.

The same commenter reasoned that since the environmental assessment states that likely results of an outbreak of FMD in the United States would include loss of livestock, rare species, and habitat due to the culling process, and the pollution of the environment from mass carcass disposals, then APHIS must initiate a Section 7 Consultation with the U.S. Fish and Wildlife Service and/or the National Marine Fisheries Service (the Services) for a determination by the appropriate Service as to whether APHIS' proposed action is likely to adversely affect a listed species or its designated critical habitat under the Endangered Species Act.

APHIS is not required to consult with the Services if we determine that an action will not immediately affect listed species or critical habitat. As stated previously, in our risk analysis, APHIS concluded that Argentina's legal framework, animal health infrastructure, movement and border controls, diagnostic capabilities, surveillance programs and emergency response systems are adequate to detect and control any future FMD outbreaks within the national boundaries of the export region of consideration. Although consequences of an FMD outbreak in the United States are potentially substantial, the likelihood of an outbreak occurring via exposure of the domestic livestock population to fresh (chilled or frozen) beef imported from Northern Argentina under the required conditions is low. In addition, the environmental assessment also concluded that the potential for infection of wildlife from the proposed action is unlikely. The United States has retained an FMD-free status since 1929, and APHIS is very effective at assessing and implementing necessary mitigations to prevent FMD outbreaks in this country. In the unlikely event that FMD was discovered in the United States (most likely from an illegal importation of FMD-infected products or animals) and APHIS were to implement an eradication program, we would immediately enter into an emergency Section 7 consultation with the Services' offices to implement necessary protection measures for federally listed species and critical habitat in the eradication area.

One commenter objected to the environmental assessment's description of SENASA's sanitary enhancements as “adequate” and stated that the level of monitoring must be more than merely “adequate.”

By “adequate” monitoring, we mean that APHIS has determined that Argentina has established the necessary controls that would allow for rapid detection, restrictions, quarantine, and reporting to the international community. In the event of such an event, the United States could impose the necessary restrictions on potentially affected products in a timely manner.

One commenter asked about the impact of the proposed action on the environment in Argentina given that the number of cattle raised in Argentina will increase significantly upon finalization of the rule.

While Executive Order 12114, “Environmental Effects Abroad of Major Federal Actions” furthers the purpose of the National Environmental Policy Act with respect to the environment outside of the United States, APHIS' proposed action is importation of fresh (chilled or frozen) beef from Northern Argentina into the United States. Therefore, the focus of the environmental assessment is to evaluate the potential impacts of allowing for the importation of fresh, maturated, and deboned beef from Northern Argentina into the United States, and not on the sustainability of cattle ranching in Argentina. The commenter's presumption regarding increased production may not be correct, in that the export of beef from Argentina may result in changes to the destination of product rather than substantial increases in domestic production.

Two commenters stated that the importation of fresh (chilled or frozen) beef would allow terrorists to intentionally introduce a foreign animal disease into the United States.

Another commenter observed that U.S. Department of Homeland Security has classified FMD as a national security issue. The commenter said that a terrorist with the intention of crippling the U.S. economy might use FMD as a mechanism to do so if the materials were made available.

This is a hypothetical statement for which the commenters presented no supporting evidence. Importation of a veterinary select agent or toxin such as FMD, which is among those agents and toxins that have been determined to have the potential to pose a severe threat to animal health or animal products, is strictly regulated by APHIS and the Centers for Disease Control and Prevention. With respect to the possibility of obtaining FMD virus from imported beef from Northern Argentina, as we have detailed elsewhere, we are confident that the conditions Argentina will be required to meet in order to import fresh (chilled or frozen) beef into the United States will preclude the importation of FMD.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the change discussed in this document.

This final rule has been determined to be economically significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also provides a final regulatory flexibility analysis that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

This analysis examines potential economic impacts of a final rule that will allow fresh (chilled or frozen) beef from a region in Northern Argentina to be imported into the United States provided certain conditions are met. Economic effects of the rule for both U.S. producers and consumers are expected to be small. Producers' welfare will be negatively affected. Welfare gains for consumers will outweigh producer losses, however, resulting in a net benefit to the U.S. economy. APHIS has concluded that the risk of exposing U.S. livestock to FMD via fresh beef imports from Argentina is sufficiently low such that imports are safe.

The United States is the largest beef producer in the world, and yet still imports a significant quantity. Annual U.S. beef import volumes from 1999 to 2013 averaged 0.9 million MT or roughly 11 percent of U.S. production. Much of the beef imported by the United States is from grass-fed cattle, and is processed with trimmings from U.S. grain-fed cattle to make ground beef. Australia, Canada, and New Zealand are the main foreign suppliers of beef to the United States.

Effects of the final rule are estimated using a partial equilibrium model of the U.S. agricultural sector. Economic impacts are estimated based on intra-sectoral linkages among the grain, livestock, and livestock product sectors. Annual imports of fresh (chilled or frozen) beef from Argentina are expected to range between 16,000 and 24,000 MT, with volumes averaging 20,000 MT. Quantity, price, and welfare changes are estimated for these three import scenarios. The results are presented as average annual effects for the 4-year period, 2015-2018.

A portion of the beef imported from Argentina will displace beef that would otherwise be imported from other countries. The model indicates that the net annual increase in U.S. fresh beef imports will be 12,955 MT (81 percent of 16,000 MT) under the 16,000 MT scenario; 15,895 MT (79 percent of 20,000 MT) under the 20,000 MT scenario; and 19,458 MT (81 percent of 24,000 MT) under the 24,000 MT scenario.

If the United States imports 20,000 MT of beef from Argentina, total U.S. beef imports will increase by 1.3 percent. Due to the supply increase, the wholesale price of beef, the retail price of beef, and the price of cattle (steer) are estimated to decline by 0.32, 0.12, and 0.35 percent, respectively. U.S beef production will decline by 0.01 percent, while U.S. beef consumption and exports will increase by 0.1 and 0.4 percent, respectively. The 16,000 MT and 24,000 MT scenarios show similar quantity and price effects.

The fall in beef prices and the resulting decline in U.S. beef production will translate into reduced returns to capital and management in the livestock and beef sectors. Under the 20,000 MT import scenario, beef producers will experience a welfare decline of $13.86 million or 0.4 percent, while consumers will benefit from the decrease in price by a welfare gain of $190.97 million or 0.6 percent. Cattle producers will experience decline in welfare of $107.05 million or 4 percent. The overall impact will be a net welfare gain of $177.11 million or 0.5 percent for producers and consumers in the beef processing sector. For the combined beef and cattle sectors, there will be a $70.06 million net welfare gain (0.18 percent net benefit).

The 16,000 MT and 24,000 MT scenarios show similar welfare impacts, with net benefits increasing broadly in proportion to the quantity of beef imported. The largest impact will be for the beef sector; consumers of pork and poultry meat will benefit negligibly. While most of the establishments that will be affected by this rule are small entities, based on the results of this analysis, APHIS does not expect the impacts to be significant.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

An environmental assessment and finding of no significant impact have been prepared for this final rule. The environmental assessment provides a basis for the conclusion that the importation of fresh beef from Northern Argentina under the conditions specified in this rule will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

The environmental assessment and finding of no significant impact may be viewed on the Regulations.gov Web site.13 Copies of the environmental assessment and finding of no significant impact are also available for public inspection at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 799-7039 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0428, have been submitted for approval to the Office of Management and Budget (OMB). When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

Accordingly, we are amending 9 CFR part 94 as follows:

The U.S. Department of Energy (DOE) published a final rule in the Federal Register on July 11, 2014 (“the July 2014 final rule”), amending the test procedures for consumer and certain commercial water heaters. 79 FR 40542. In the rule, DOE incorporated by reference the American Society for Testing and Materials (ASTM) D2156-09, “Standard Test Method for Smoke Density in Flue Gases from Burning Distillate Fuels,” at 10 CFR 430.3(h)(1) for use in 10 CFR part 430, subpart B, Appendix E. The effective date for this rule is July 13, 2015.

On January 6, 2015, DOE published a final rule in the Federal Register (“the January 2015 final rule”) amending the test procedures for direct heating equipment and pool heaters. 80 FR 792. The January 2015 final rule incorporated by reference the same industry standard, ASTM D2156-09, at 10 CFR 430.3(i)(1) for use in 10 CFR part 430, subpart B, Appendix O. The effective date for this rule was February 5, 2015.

The July 2014 final rule instruction to incorporate by reference ASTM D2156-09 at 10 CFR 430.3(h)(1) conflicts with the January 2015 final rule instruction to incorporate by reference ASTM D2156-09 at 10 CFR 430.3(i)(1). The instruction in the July 2014 final rule would be in error if implemented as written, because it would needlessly duplicate the incorporation by reference of ASTM D2156-09, which was already incorporated by reference by the January 2015 final rule.

Amendatory instruction 8 on page 40567 of the Federal Register in the July 2014 final rule at 79 FR 40542 is, therefore, corrected to modify 10 CFR 430.3 to incorporate by reference ASTM D2156-09 for use in both Appendix E and Appendix O to subpart B. DOE notes that ASTM D2156-09 has already been approved for incorporation by reference for Appendix E (79 FR 40542) and Appendix O (80 FR 792), and, therefore, no additional action is necessary. The effective date of the July 2014 final rule at 79 FR 40542 remains July 13, 2015.

In FR Doc. 2014-15656 appearing on page 40542 in the issue of Friday, July 11, 2014, the following correction is made:

This final rule incorporates by reference into part 430 the following industry standard:

AHAM OV-1-2011, (“AHAM OV-1”), Procedures for the Determination and Expression of the Volume of Household Microwave and Conventional Ovens, (2011).

Copies of AHAM standard can be purchased from the Association of Home Appliance Manufacturers, 1111 19th Street NW., Suite 402, Washington DC 20036, 202-872-5955, or www.aham.org.

This AHAM standard is discussed further in section III.D.

Title III of the Energy Policy and Conservation Act of 1975 (42 U.S.C. 6291, et seq.; “EPCA” or, “the Act”) sets forth a variety of provisions designed to improve energy efficiency. (All references to EPCA refer to the statute as amended through the Energy Efficiency Improvement Act of 2015, Public Law 114-11 (Apr. 30, 2015). Part B of Title III, which for editorial reasons was redesignated as Part A upon incorporation into the U.S. Code (42 U.S.C. 6291-6309, as codified), establishes the “Energy Conservation Program for Consumer Products Other Than Automobiles.” These include cooking products,1 and specifically consumer conventional ovens, the subject of this document. (42 U.S.C. 6292(a)(10))

Under EPCA, the energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products must use as the basis for (1) certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA, and (2) making representations about the efficiency of those products. Similarly, DOE must use these test procedures to determine whether the products comply with any relevant standards promulgated under EPCA.

Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA provides that any test procedures prescribed or amended under this section shall be reasonably designed to produce test results which measure energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2)) Finally, in any rulemaking to amend a test procedure, DOE must determine to what extent, if any, the proposed test procedure would alter the measured energy efficiency of any covered product as determined under the existing test procedure. (42 U.S.C. 6293(e)(1))

This final rule fulfills, in part, DOE's obligation to periodically review its test procedures under 42 U.S.C. 6293(b)(1)(A). DOE anticipates that its next evaluation of this test procedure for conventional ovens will occur in a manner consistent with the timeline set out in this provision.

DOE's test procedures for conventional ranges, conventional cooking tops, conventional ovens, and microwave ovens are codified at appendix I to subpart B of Title 10 of the Code of Federal Regulations (CFR) part 430 (Appendix I).

DOE established the test procedures in a final rule published in the Federal Register on May 10, 1978. 43 FR 20108, 20120-20128. DOE revised its test procedures for cooking products to more accurately measure their efficiency and energy use, and published the revisions as a final rule in 1997. 62 FR 51976 (Oct. 3, 1997). These test procedure amendments included: (1) A reduction in the annual useful cooking energy; (2) a reduction in the number of self-cleaning oven cycles per year; and (3) incorporation of portions of International Electrotechnical Commission (IEC) Standard 705-1988, “Methods for measuring the performance of microwave ovens for household and similar purposes,” and Amendment 2-1993 for the testing of microwave ovens. Id. The test procedures for conventional cooking products establish provisions for determining estimated annual operating cost, cooking efficiency (defined as the ratio of cooking energy output to cooking energy input), and energy factor (defined as the ratio of annual useful cooking energy output to total annual energy input). 10 CFR 430.23(i); Appendix I. These provisions for conventional cooking products are not currently used for compliance with any energy conservation standards because the present standards are design requirements, and there is not an EnergyGuide 2 labeling program for cooking products.

DOE subsequently conducted a rulemaking to address standby and off mode energy consumption, as well as certain active mode testing provisions, for dishwashers, dehumidifiers, and conventional cooking products. DOE published a final rule on October 31, 2012 (77 FR 65942, hereinafter referred to as the October 2012 Final Rule), adopting standby and off mode provisions that satisfy the EPCA requirement that DOE include measures of standby mode and off mode energy consumption in its test procedures for residential products, if technically feasible. (42 U.S.C.6295(gg)(2)(A))

On January 30, 2013, DOE published a NOPR (78 FR 6232, hereinafter referred to as the January 2013 NOPR) proposing amendments to Appendix I that would allow for measuring the active mode energy consumption of induction cooking products; i.e., conventional cooking tops and ranges equipped with induction heating technology for one or more surface units 3 on the cooking top. DOE proposed to incorporate induction cooking tops by amending the definition of “conventional cooking top” to include induction heating technology. Furthermore, DOE proposed to require for all cooking tops the use of test equipment compatible with induction technology. Specifically, DOE proposed to replace the solid aluminum test blocks currently specified in the test procedure for cooking tops with hybrid test blocks comprising two separate pieces: An aluminum body and a stainless steel base. In the January 2013 NOPR, DOE also proposed amendments to include a clarification that the test block size be determined using the smallest dimension of the electric surface unit. 78 FR 6232 (Jan. 30, 2013).

On December 3, 2014, DOE published a supplemental NOPR (SNOPR) (79 FR 71894, hereinafter referred to as the December 2014 SNOPR), modifying its proposal from the January 2013 NOPR to more accurately measure the energy efficiency of induction cooking tops. DOE proposed to add a layer of thermal grease between the stainless steel base and aluminum body of the hybrid test block to facilitate heat transfer between the two pieces. DOE also proposed additional test equipment for electric surface units with large diameters (both induction and electric resistance) and gas cooking top burners with high input rates. 79 FR 71894 (Dec. 3, 2014). In addition, DOE proposed methods to test non-circular electric surface units, electric surface units with flexible concentric cooking zones, and full-surface induction cooking tops. Id. Furthermore, DOE proposed to incorporate methods for measuring conventional oven volume, clarify that the existing oven test block must be used to test all ovens regardless of input rate, and provide a method to measure the energy consumption and efficiency of conventional ovens equipped with an oven separator. Id.

DOE received a number of comments from interested parties on the cooking top active mode test procedure proposed in the December 2014 SNOPR. The majority of comments stated that additional analysis was necessary before establishing a test procedure for conventional cooking tops. AHAM requested an extension of the comment period for the December 2014 SNOPR, citing the difficulty its members had procuring the specified test equipment materials. Therefore, AHAM stated, many manufacturers were not able to properly assess the new specifications, testing variation, repeatability, and reproducibility of the proposed test procedure before the comment period closed. (AHAM, No. 14 at p. 1) 4 AHAM also expressed concern with DOE's choice to pursue an accelerated rulemaking schedule for cooking products, stating that the rulemaking schedule did not allow for a thorough technical examination. AHAM asked DOE to seek additional input from interested parties on the December 2014 SNOPR and commented that the proposed cooking top test procedure may result in technical problems. (AHAM, No. 18 at pp. 1-2)

BSH Home Appliances Corporation (BSH) and General Electric Appliances (GE) stated that delays associated with acquiring the hybrid test block materials necessitated additional time for them to evaluate DOE's proposal. (BSH, No. 16 at p. 2; GE, No. 17 at p. 1) BSH commented that the proposed hybrid test block method did not include certain specifications necessary for test procedure reproducibility, such as test load sizing and positioning, and recommended that DOE consider the specifications in International Electrotechnical Commission (IEC) Standard 60350-2 Edition 2, “Household electric appliances—Part 2: Hobs—Method for measuring performance” (IEC Standard 60350-2). (BSH, No. 16 at p. 1) Further, AHAM, BSH, and GE suggested that DOE specify additional test block diameters because these commenters asserted that the proposed test block sizes do not adequately reflect surface unit sizes currently available on the market. (BSH, No. 16 at p. 5; GE, No. 17 at p 2; AHAM, No. 18 at p. 2)

Interested parties also expressed a significant number of concerns with the use of thermal grease. GE noted that since receiving DOE's proposal, it has not been able to replicate the DOE test results using the methods described. (GE, No. 17 at p. 2) Specifically, GE observed during its testing that the aluminum body slid off the stainless steel base, the thermal grease dried out, and the amount of grease between the blocks changed from one test to another. (GE, No. 17 at p. 2) AHAM, BSH, and GE requested that DOE specify an operating temperature range for the thermal grease as well as an application thickness, but also noted that the thermal conductivity and viscosity of the grease may change over time or after repeated use at high temperatures. (BSH, No. 16 at p. 11; GE, No. 17 at p. 2; AHAM, No. 18 at p. 3) GE further commented that the variation introduced by the hybrid test block due to the inability to reliably maintain the specified flatness, thermal grease, and inadequate sizing, may be small individually, but collectively result in a test procedure that cannot reliably discern efficiency differences between similar products, alternate technology options, and product classes. Thus, GE believes the proposal for conventional cooking tops in the December 2014 SNOPR results in too much variability to serve as the basis for establishing a standard. (GE, No. 17 at p. 3)

The California IOUs also stated that they prefer an alternative to the hybrid test block and recommended that DOE require water-heating test methods to measure the cooking efficiency of conventional cooking tops. Specifically, the California IOUs requested that DOE align the residential cooking product test methods with existing industry test procedures, such as American Society for Testing and Materials (ASTM) standard F1521-12, Standard Test Methods for Performance of Range Tops, and IEC Standard 60350-2, Household electric cooking appliances—Part 2: Hobs—Methods for measuring performance. (California IOUs, No. 19 at p. 1) The California IOUs commented that they plan to conduct additional testing to better characterize the differences between the water-heating and hybrid test block test procedures, and will provide these results to DOE. According to the California IOUs, the differences in test procedure standard deviation between the hybrid test block and water-heating test method as presented in the December 2014 SNOPR did not sufficiently show that the hybrid test block method is more repeatable than a water-heating method. (California IOUs, No. 19 at p. 2) Additionally, the California IOUs believe cooking efficiencies derived using a water-heating test method are more representative of the actual cooking performance of cooking tops as opposed to a test procedure using hybrid test blocks, since many foods prepared on cooktops have relatively high liquid content. (California IOUs, No. 19 at p. 1)

In February and March of 2015, DOE conducted a series of interviews with manufacturers of conventional cooking products representing the majority of the U.S. market to discuss key issues with the proposed cooking top test procedure. Manufacturers agreed that the hybrid test block method, as proposed, presented many issues which had not yet been addressed, and which left the repeatability and reproducibility of the test procedure in question. These concerns were similar to those expressed in written comments but were received from a larger group of manufacturers and included:

• Difficulty obtaining the hybrid test block materials;

• Difficulty obtaining and applying the thermal grease without more detailed specifications (i.e., thermal conductivity alone was not sufficient to identify a grease that performed according to DOE's descriptions in the December 2014 SNOPR);

• Difficulty testing induction cooking tops that use different programming techniques to prevent overheating (some manufacturers observed that power to the heating elements cut off prematurely during testing with the hybrid test block even after adding thermal grease); and

• The need for larger test block sizes to test electric surface units having 12-inch and 13-inch diameters and gas surface units with high input rates.

Interviewed manufacturers that produce and sell products in Europe uniformly supported the use of a water-heating test method and harmonization with IEC Standard 60350-2 for measuring the energy consumption of electric cooking tops. These manufacturers cited the benefits of adopting a test method similar to the IEC water-heating method as including: (1) Compatibility with all electric cooking top types, (2) additional test vessel diameters to account for the variety of surface unit sizes on the market, and (3) the test load's ability to represent a real-world cooking top load.

After reviewing public comments and information received during manufacturer interviews, as well as performing additional analyses, DOE concluded that further study is required before a cooking top test procedure can be established that produces test results which measure energy use during a representative average use cycle, is repeatable and reproducible, and is not unduly burdensome to conduct. For these reasons, this final rule addresses test methods for conventional ovens only, including conventional ovens that are a part of conventional ranges. This final rule also addresses minor technical corrections to existing calculations and definitions in Appendix I for both conventional cooking tops and ovens.

DOE plans to address test procedures for cooking tops in a separate rulemaking in order to consider any additional data and information that will allow it to further conduct the analysis of cooking tops, particularly when using a water-heating method to evaluate energy consumption. As part of that rulemaking, DOE will carefully consider and address remaining cooking top-related comments on the December 2014 SNOPR.

This final rule amends the current DOE test procedure for conventional ovens. These changes will primarily clarify the manner in which to test for compliance with potential energy conservation standards for conventional ovens. The final rule establishes that the existing oven test block should be used to test all ovens, including ovens having input rates greater than 22,500 British thermal units per hour (Btu/h). The final rule additionally amends the current DOE test procedure to include test methods for conventional ovens equipped with an oven separator. Conventional ovens equipped with an oven separator shall be tested in each possible oven configuration (i.e., full oven cavity, upper cavity, and lower cavity), with the results averaged.

Because Appendix I does not currently contain a measure of conventional oven volume, the final rule incorporates by reference in the DOE test procedure the relevant sections of AHAM Standard OV-1-2011 “Procedures for the Determination and Expression of the Volume of Household Microwave and Conventional Ovens” (AHAM-OV-1-2011) for determining conventional oven cavity volume. As part of its rulemaking that is considering amended standards for conventional ovens, DOE proposed standards as a function of oven cavity volume.

Additionally, this final rule is clarifying the current definitions for “freestanding” and “built-in” installation configurations. Because the manufacturer instructions of some conventional ovens state the oven can be used in either a freestanding or built-in configuration, this final rule is clarifying that ovens with this option be tested in the built-in configuration, as ovens designed to be used in a built-in configuration incorporate fan-only mode for thermal management, and the energy consumption of these products is likely higher than for comparable ovens designed for use only in a freestanding configuration. Furthermore, the final rule is clarifying the term “self-cleaning operation” when referring to an oven's self-cleaning process. The existing test procedure in Appendix I does not include an explicit definition, although section 3 of Appendix I, Test Methods and Measurements, requires measurement of self-cleaning operation.

Finally, the final rule includes technical corrections to the calculation of derived results from test measurements in section 4 of Appendix I. Section 4 contains a number of references to incorrect units of measurement and an incorrect value for the annual useful cooking energy output for gas cooking tops. The final rule also restores headings for sections 4.2 and 4.2.1 in Appendix I regarding the calculations for conventional cooking tops, which were inadvertently removed in the October 2012 Final Rule.

As discussed in section I of this final rule, section 6292(a)(10) of EPCA covers kitchen ranges and ovens, or “cooking products.” DOE's regulations define “cooking products” as consumer products that are used as the major household cooking appliances. They are designed to cook or heat different types of food by one or more of the following sources of heat: Gas, electricity, or microwave energy. Each model may consist of a horizontal cooking top containing one or more surface units 5 and/or one or more heating compartments. Cooking products include the following classes: Conventional ranges, conventional cooking tops, conventional ovens, microwave ovens, microwave/conventional ranges and other cooking products. (10 CFR 430.2) In this final rule, DOE is addressing test procedures for conventional ovens.

DOE notes that conventional ranges are defined in 10 CFR 430.2 as a class of kitchen ranges and ovens which is a household cooking appliance, consisting of a conventional cooking top and one or more conventional ovens. Because ranges consist of both a cooking top and at least one oven, any potential cooking top energy conservation standard or oven energy conservation standard would apply to each of these cooking systems individually. Thus, the test procedures presented in this final rule also apply to the oven portion of a conventional range.

As part of the previous energy conservation standards rulemaking for conventional cooking products, DOE decided not to analyze conventional gas cooking products with higher burner input rates, including products marketed as “commercial-style” or “professional-style,” in its consideration of energy conservation standards due to a lack of available data for determining the efficiency characteristics of those products. At the time, DOE considered commercial-style ovens to be gas ovens with burner input rates greater than 22,500 Btu/h. 74 FR 16040, 16054 (Apr. 8, 2009); 72 FR 64432, 64444-64445 (Nov. 15, 2007). In the December 2014 SNOPR, DOE noted that the current definitions for “conventional oven” and “conventional range” in 10 CFR 430.2 already cover conventional gas ovens with higher input rates (including commercial-style gas ovens), as these products are household cooking appliances with compartments intended for the cooking or heating of food by means of a gas flame.

Sub-Zero Group, Inc. (Sub-Zero) commented that DOE's findings based on manufacturer feedback in the previous energy conservation standards rulemaking are still relevant. Specifically, the small market size, the limited energy savings potential, and the lack of energy consumption data for ovens with high input rates are reasons to exclude these products from coverage. (Sub-Zero, No. 20 at pp. 2, 3) Sub-Zero further commented that “high performance” is a better descriptor of cooking products with high input rates rather than “commercial-style,” noting that the “high performance” segment appeals to consumers demanding restaurant-style cooking performance in their homes. (Sub-Zero, No. 20 at p. 2) Sub-Zero suggested that high performance (i.e., “commercial-style”) products be defined as cooking products that offer residential consumers restaurant-quality performance at a safety and convenience level that is acceptable for residential use. (Sub-Zero, No. 20 at p. 2)

DOE excluded “commercial-style” conventional gas ovens from its analysis in the previous energy conservation standards rulemaking due to a lack of available data for determining efficiency characteristics of those products. 74 FR 16040, 16054 (Apr. 8, 2009); 72 FR 64432, 64444-64445 (Nov. 15, 2007). As discussed in section III.C of this final rule, DOE conducted testing in support of the December 2014 SNOPR that demonstrated that the existing conventional oven test procedure is appropriate for ovens with high input rates. Additionally, DOE is not aware of any data or test procedures that establish whether a conventional oven with burner input rates greater than 22,500 Btu/h delivers “restaurant-quality performance” as compared to an oven with burner input rates lower than 22,500 Btu/h. Furthermore, through testing, reverse engineering analyses, and discussions with manufacturers conducted in support of the concurrent energy conservation standards rulemaking for cooking products, DOE determined that the primary differentiation between conventional gas ovens with lower burner input rates and those with higher input rates, including those marketed as commercial-style, was design and construction related to aesthetics rather than improved cooking performance. Some examples of design and construction related features include heavier gauge cavity walls, extra interior support structure for heavier gauge racks, and ball-bearing extension racks. These features add to the overall thermal mass that must be heated during the baking process but do not necessarily improve cooking performance.

For these reasons, DOE notes in this final rule that the current definitions for “conventional oven” and “conventional range” in 10 CFR 430.2 already cover conventional gas ovens with higher input rates (including commercial-style gas ovens), as these products are household cooking appliances with compartments intended for the cooking or heating of food by means of a gas flame.

The amended test procedure becomes effective 30 days after this test procedure final rule is published in the Federal Register. Pursuant to EPCA, manufacturers of covered products must use the applicable test procedure as the basis for determining that their products comply with the applicable energy conservation standards adopted pursuant to EPCA and for making representations about the efficiency of those products. (42 U.S.C. 6293(c); 42 U.S.C. 6295(s)) Beginning 180 days after publication of this test procedure final rule, representations related to the energy consumption of conventional ovens must be based upon results generated under the applicable provisions of the amended test procedure in Appendix I. (42 U.S.C. 6293(c)(2))

Because DOE is considering in a separate rulemaking energy conservation standards for conventional ovens, including gas ovens with high input rates, DOE evaluated the appropriateness of the existing test methods in Appendix I for use with conventional gas ovens that have burner input rates greater than 22,500 Btu/h. In the December 2014 SNOPR, DOE proposed that the existing test methods in Appendix I should be used to test ovens with high input rates, including gas ovens marketed as commercial-style. 79 FR 71916 (December 3, 2014).

The current active mode test procedure for conventional ovens involves setting the temperature control for the normal baking cooking cycle such that the temperature inside the oven is 325 ± 5 degrees Fahrenheit (°F) higher than the room ambient air temperature (77 ± 9 °F). An 8.5-pound (6.25-inch diameter) cylindrical anodized aluminum test block is then heated in the oven from ambient room air temperature ± 4 °F until the test block temperature has increased 234 °F above its initial temperature. If an oven permits baking by either forced convection by using a fan, or without forced convection, the oven is tested using the procedure described above in each of those two cooking modes. After the baking test(s), if the oven is equipped with a self-cleaning function, the self-cleaning process is initiated in accordance with the manufacturer's instruction and allowed to run until completion. The measured energy consumption during these test cycles is used to calculate the oven's cooking efficiency and integrated annual energy consumption (IAEC).6

DOE's review of the gas oven cavity volumes currently available on the U.S. market indicated that there is significant overlap in oven cavity volume between products marketed as standard, residential-style ovens and those marketed as commercial-style ovens. The primary differentiating factor between the two oven types was burner input rate, which is greater than 22,500 Btu/h for most commercial-style gas ovens. In the December 2014 SNOPR, DOE investigated the effect of increasing oven test block size on oven cooking efficiency. DOE sought to determine whether a larger test block would provide a more representative measure of cooking efficiency at higher input rates. DOE also sought to determine whether the smaller block was inadequate to properly measure the efficiency of commercial-style ovens. In its testing, DOE found that while cooking efficiency increased with the larger test block, it scaled by approximately the same factor for all ovens tested regardless of a particular oven's input rate or cavity volume, or whether the oven was marketed as residential-style or commercial-style. The relative ranking of cooking efficiency for ovens with high input rates as compared to ovens with input rates lower than 22,500 Btu/h did not change with increased test block size. This suggested that thermal losses are large enough in comparison to the heat absorbed by either sized test block that they account for much of the additional oven energy input for ovens with high input rates. Thus, the thermal losses from the cavity are driven largely by input rate alone and do not change greatly with increased test block size. 79 FR 71915-71916 (December 3, 2014).

Sub-Zero stated that the proposed test procedure does not accurately measure the performance and efficiency of the larger, higher-output components. (Sub Zero, No. 20 at p. 2) Additionally, Sub-Zero commented that an analysis based largely on 30-inch wide gas or electric ranges cannot adequately evaluate the very different performance attributes offered by high-performance products which are essential to consumer utility. (Sub-Zero, No. 20 at p. 2) Thus, Sub-Zero believes that DOE's conclusion that the existing test procedure in Appendix I is appropriate for ovens with high input rates is incorrect. (Sub-Zero, No. 20 at p. 3) Sub-Zero requested that high performance products be exempted until adequate further analysis is conducted such that these products can be accurately and fairly evaluated. (Sub Zero, No. 20 at p. 3)

In support of the December 2014 SNOPR and in support of the parallel energy conservation standards rulemaking for conventional ovens, DOE tested eight conventional gas ovens that were selected to capture a range of design features that might impact performance, including infrared broilers, convection fans, and hidden bake elements. The basic design features and measured IAEC are shown in Table III-1. The test sample included 30-inch wide models as well as models with widths greater than 30 inches. DOE observed that many of the same features found in gas ovens marketed as commercial-style were also available in ovens marketed as residential-style. By comparing the design features and the measured energy consumption of the ovens in its test sample, DOE determined that the major differentiation between conventional gas ovens with lower burner input rates and those with higher input rates, including those marketed as commercial-style, was design and construction related to aesthetics rather than improved cooking performance. Available information also indicates that the high thermal mass of products marketed as commercial-style likely lead to a low oven cooking efficiency and require higher oven input rates to compensate for the heat lost to the cavity.

DOE also investigated the time it took each oven in its sample to heat the test block to the required final temperature of 234 °F above its initial temperature. As shown in Table III-2, gas ovens with burner input rates greater than 22,500 Btu/h do not heat the test block significantly faster than the ovens with lower burner input rates, and two out of the three units with the higher burner input rates took longer than the average time to heat the test block.

Considering the testing results and analysis described above, and because interested parties did not provide data or information to support the assertion that the performance of conventional ovens with input rates greater than 22,500 Btu/h as compared to ovens with lower input rates cannot be accurately measured using the existing test procedure, DOE maintains in this final rule that the existing test block and existing conventional oven test method are appropriate to test conventional ovens with input rates greater than 22,500 Btu/h.

As discussed in section I of this final rule, DOE has initiated a rulemaking to determine whether to amend the current energy conservation standards for conventional ovens. As part of that rulemaking, DOE has proposed standards as a function of oven cavity volume.

In the December 2014 SNOPR, DOE proposed to amend section 3.1.1 of Appendix I to incorporate by reference the industry test standard AHAM-OV-1-2011, which includes a method for determining oven cavity volume. DOE proposed to incorporate section 3, “Definition,” section 5.1, “General Principles,” and section 5.2 “Overall Volume” of AHAM-OV-1-2011, as these sections provide a repeatable and reproducible method to measure cavity dimensions and calculate overall volume by including clear definitions of oven characteristics and tolerances for dimensional measurements. 79 FR 71916 (December 3, 2014). Section 5.1 of AHAM-OV-1-2011 specifies that if depressions or cutouts exist in the cavity wall, dimensions are taken from the plane representing the largest area of the surface. Section 5.1 of AHAM-OV-1-2011 also specifies that oven lights, racks, and other removable features shall be ignored in the overall volume calculation, and the volume of non-rectangular cavities is calculated by measuring the rectangular portion of the cavity and non-rectangular cavity separately and adding their volumes together.

AHAM-OV-1-2011 also includes a measurement of the oven's usable space, which is the volume inside the oven cavity available for the placement of food, but DOE did not propose to incorporate this measurement in Appendix I. The usable space is oven-specific and determined by measuring either the size of the cavity door aperture or the distance between barriers, racks, and rack supports inside the cavity or on the cavity walls. The lesser of these dimensions is used to calculate the volume of the usable space.

Although DOE did not receive any public comments on its proposal to incorporate the overall cavity volume measurement described in section 5.1 and 5.2 of AHAM-OV-1-2011, one manufacturer commented during interviews conducted in February and March of 2015 that DOE should instead consider incorporating the usable space measurement described in section 5.3 of AHAM-OV-1-2011. The manufacturer cited difficulty in determining the plane representing the largest area of the cavity wall surface, and also stated that the oven test procedure used by National Resources Canada (NRCan) bases its energy efficiency regulations on the volume of usable oven space and not overall cavity volume.

DOE notes that during February and March 2105 manufacturer interviews conducted to discuss the December 2014 SNOPR, the majority of manufacturers confirmed that the cavity volume currently published in marketing materials and product literature typically represents overall cavity volume. DOE does not believe that requiring this measurement will place additional burden on manufacturers. Manufacturers already provide exterior dimensions in the installation instructions and may also be able to use the configuration and dimensions of indentions in the oven cavity walls provided in engineering drawings to determine the plane representing the largest area of the cavity wall surface. Incorporating a cavity measurement into Appendix I would, in most circumstances, add only the three additional measurements of cavity height, width, and depth. Furthermore, DOE believes the overall cavity volume measurement provides a more accurate representation of the relationship between cavity volume and cooking efficiency as measured by the DOE test procedure in Appendix I. Any mass in the overall cavity volume outside of the usable space is heated during the bake cycle, contributes to the thermal mass, and thus impacts the cooking efficiency of the oven.

For the reasons discussed above, DOE amends in this final rule section 3.1.1 of Appendix I to incorporate by reference Sections 3, 5.1, and 5.2 of AHAM-OV-1-2011 for measuring the overall oven cavity volume.

In the December 2014 SNOPR, DOE observed one conventional electric oven equipped with an oven separator on the U.S. market that allows for cooking using the entire oven cavity in the absence of the separator or, if the separator is installed, splitting the oven into two smaller cavities that may be operated individually with independent temperature controls. DOE proposed to test conventional ovens equipped with an oven separator in each possible oven configuration (i.e., full oven cavity, upper cavity, and lower cavity) with the cooking efficiency and total annual energy consumption averaged. DOE noted that while the current test procedure in Appendix I includes provisions for measuring the energy consumption and cooking efficiency of single ovens and multiple (separate) ovens,7 it does not include provisions for how to test a single oven that can be configured as a full oven or as two separate smaller cavities. 79 FR 71916-71917 (December 3, 2014).

During the subsequent manufacturer interviews, several manufacturers commented that without an easy or convenient way to store the separator, consumers would rarely use the feature. One manufacturer suggested that DOE consider applying a consumer usage factor to the oven separator when calculating annual energy consumption instead of using an equally-weighted average.

DOE is not aware of any consumer usage data indicating how often consumers might use an oven separator in each configuration. Additionally, DOE notes that the annual energy consumption of conventional ovens having multiple, permanent cavities of different volumes are currently averaged with an equal weighting in the existing oven test procedure in Appendix I. Therefore, DOE has no basis to adopt a weighted average of cooking efficiency and annual energy consumption as part of the test procedure for ovens equipped with an oven separator. In this final rule, DOE amends the oven test procedure in Appendix I to require the test of conventional ovens equipped with an oven separator in each possible oven configuration and to calculate cooking efficiency and annual energy consumption as an equal average of the results measured in each configuration.

EPCA requires that DOE amend its test procedures for all covered consumer products, including conventional ovens, to include measures of standby mode and off mode energy consumption, if technically feasible. (42 U.S.C. 6295(gg)(2)(A)) Accordingly, DOE conducted a rulemaking for conventional cooking products, dishwashers, and dehumidifiers to address standby and off mode energy consumption.8 In the October 2012 Final Rule, DOE addressed standby mode and off mode energy consumption, as well as active mode fan-only operation, for conventional cooking products. 77 FR 65942 (Oct. 31, 2012).

DOE noted in the December 2014 SNOPR that because conventional gas ovens with higher input rates are covered under the definition of “cooking products” in 10 CFR 430.2, these products are covered by the standby and off mode test procedures discussed above. During testing of conventional ovens with both standard and higher input rates in its test sample, DOE did not observe any standby mode or off mode operation or features unique to these products that would warrant any changes to the standby mode and off mode test methods. 79 FR 71917 (December 3, 2014). Because DOE received no comments objecting to these findings, this final rule does not amend the standby mode and off mode test methods currently specified in Appendix I section 3.1.

DOE did not receive comments on its proposal to correct the units of measurement in section 4 of Appendix I nor did DOE receive comments on its correction of the integrated energy factor for conventional electric cooking tops, IRCT. In this final rule, DOE corrects the following sections of Appendix I to reference the appropriate units: 4.1.2.1.1, 4.1.2.2.1, 4.1.2.4.3, 4.1.2.5.3, 4.1.4.1, 4.1.4.2, 4.2.1.2, 4.2.2.2.1, and 4.2.2.2.2. DOE also corrects the value of the annual useful cooking energy output, OCT, used to calculate IRCT, to 173.1 kWh per year.

DOE did not receive comments on its proposal in the December 2014 SNOPR to restore headings to section 4.2 “Conventional cooking top,” and section 4.2.1, “Surface unit cooking efficiency” in Appendix I to appropriately describe these sections. Therefore DOE has included these modifications in this final rule.

Appendix I contains definitions for various cooking product installation conditions and specifies that the unit under test must be installed in an enclosure in accordance with the manufacturer's instructions. The test procedure in Appendix I currently defines “freestanding” as an installation configuration where the product is not supported by surrounding cabinetry, walls, or other similar structures. A “built-in” installation condition means the product is supported by surrounding cabinetry, walls, or other similar structures. “Drop-in” means the product is supported by horizontal surface cabinetry. During interviews after publication of the December 2014 SNOPR, manufacturers commented that the current definitions for “freestanding,” “built-in,” and “drop-in” should be amended. Specifically, manufacturers noted that some conventional ovens and conventional ranges are designed to be used in both a freestanding or built-in configuration, and that it is currently unclear in which configuration the oven should be tested.

During its testing, DOE observed that built-in ovens consume energy in fan-only mode, whereas freestanding ovens do not. The additional energy required to exhaust air from the oven cavity is necessary to meet safety-related temperature requirements for built-in installation configurations, in which the oven is enclosed in cabinetry. Because built-in ovens consume additional energy in fan-only mode, as part of DOE's ongoing energy conservation standards rulemaking for conventional ovens, DOE has proposed to establish separate product classes for built-in and freestanding ovens using the definitions provided in Appendix I. 80 FR 33030, 33045-46 (June 10, 2015). DOE also recognizes that the current definition of built-in configurations does not adequately describe the installation conditions that require built-in ovens to have a separate fan assembly and fan-only mode.

In this final rule, DOE is clarifying that conventional ovens or ranges that may be used in either a freestanding or built-in configuration are to be tested in the built-in configuration to account for any additional energy-consumption related to fan-only mode in this configuration. DOE is also clarifying that the definition of built-in means the product is enclosed in surrounding cabinetry, walls, or other similar structures on at least three sides.

The existing test procedure in Appendix I does not include a definition for the self-cleaning operation or self-cleaning process of conventional ovens, although it specifies the measurement energy consumption during self-cleaning operation in section 3 Test Methods and Measurements. The existing test procedure specifies setting the conventional oven's self-cleaning process in accordance with the manufacturer's instructions, and if the self-cleaning process is adjustable, using the average time recommended by the manufacturer for a moderately soiled oven. DOE is clarifying in the final rule that self-cleaning operation is an active mode not intended to heat or cook food that is user-selectable, separate from the normal baking mode, and dedicated to cleaning and removing cooking deposits from the oven cavity walls.

EPCA requires that any new or amended test procedures for consumer products must be reasonably designed to produce test results which measure energy efficiency, energy use, or estimated annual operating cost of a covered product during a representative average use cycle or period of use, and must not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

As part of the December 2014 SNOPR, DOE tentatively concluded that the amended test procedures would produce test results that measure the energy consumption of conventional ovens during representative use, and that the test procedures would not be unduly burdensome to conduct. 79 FR 71917-71918 (Dec. 3, 2014).

As discussed in section III.C of this document, the final rule amends the test procedure for gas ovens to require that the existing test block be used for all ovens, including ovens with high input rates. DOE does not expect any increase in testing burden compared to the existing test procedure, since these tests follow the same methodology, use the same test equipment, and can be conducted in the same facilities used for the current energy testing of conventional ovens. As discussed in section III.D of this document, the final rule also incorporates by reference AHAM-OV-1-2011 for measuring the overall oven cavity volume. DOE estimates that it would take on the order of one-half to one hour to conduct the cavity volume measurement for a single oven, and $50 to $100 per test for labor. Additionally, because manufacturers may already be using the AHAM procedure to measure oven cavity volume, DOE does not anticipate this measurement to be unduly burdensome to conduct. As discussed in section III.E of this document, the final rule amends the test procedure so that conventional ovens equipped with an oven separator are tested in each possible oven configuration. DOE notes, based on its testing, that this may add two oven tests for the additional cavity configurations, and add approximately $2,750 for labor. DOE does not believe this additional cost represents an excessive burden for test laboratories or manufacturers given the significant investments necessary to manufacture, test and market consumer appliances.

The Office of Management and Budget (OMB) has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB).

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires preparation of an initial regulatory flexibility analysis (IFRA) for any rule that by law must be proposed for public comment and a final regulatory flexibility analysis for any such rule that an agency adopts as a final rule, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (August 16, 2002), DOE published procedures and policies on February 19, 2003 to ensure that the potential impacts of its rules on small entities are properly considered during the DOE rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's Web site: http://energy.gov/gc/office-general-counsel.

DOE reviewed this final rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. The final rule clarifies that the existing test method for ovens is applicable to gas ovens with higher input rates. The final rule also includes a test method for conventional ovens with oven separators and incorporates by reference a test method to measure oven cavity volume.

The Small Business Administration (SBA) considers a business entity to be a small business, if, together with its affiliates, it employs less than a threshold number of workers or earns less than the average annual receipts specified in 13 CFR part 121. The threshold values set forth in these regulations use size standards and codes established by the North American Industry Classification System (NAICS) that are available at: http://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf. The threshold number for NAICS classification code 335221, titled “Household Cooking Appliance Manufacturing,” is 750 employees; this classification includes manufacturers of residential conventional ovens.

Most of the manufacturers supplying conventional ovens are large multinational corporations. DOE surveyed the AHAM member directory to identify manufacturers of conventional ovens and conventional ranges. DOE then consulted publicly-available data, purchased company reports from vendors such as Dun and Bradstreet, and contacted manufacturers, where needed, to determine if they meet the SBA's definition of a “small business manufacturing facility” and have their manufacturing facilities located within the United States. Based on this analysis, DOE estimates that there are seven small businesses that manufacture conventional ovens and conventional ranges subject to the proposed test procedure amendments.

For the reasons stated in the preamble, DOE has concluded that the final rule would not have a significant impact on small manufacturers under the applicable provisions of the Regulatory Flexibility Act. The final rule clarifies that DOE's existing test procedures in Appendix I for conventional ovens are applicable to conventional ovens with higher input rates. These tests follow the same methodology, use the same test equipment, and can be conducted in the same facilities used for the current energy testing of conventional ovens, so there would be no additional facility costs required by the final rule. Additionally, the incorporation by reference of AHAM-OV-1-2011 to measure oven cavity volume and the addition of a test method to measure conventional ovens with an oven separator will not significantly impact small manufacturers under the applicable provisions of the Regulatory Flexibility Act. DOE estimates a cost of $4,500 for an average small manufacturer to measure the cavity volume of all of its product offerings which is only 0.03 percent of the average annual revenue of the seven identified small businesses. This estimate assumes $100 per test as described in section III.K of this notice, with up to 44 tests per manufacturer. Additionally, no small conventional oven manufacturer, as defined by the SBA, offers a product with an oven separator.

For these reasons, DOE concludes and certifies that this final rule would not have a significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE has transmitted the certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the SBA for review under 5 U.S.C. 605(b).

Manufacturers of conventional ovens must certify to DOE that their products comply with any applicable energy conservation standards. In certifying compliance, manufacturers must test their products according to the DOE test procedures for conventional ovens, including any amendments adopted for those test procedures. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including conventional ovens. 76 FR 12422 (March 7, 2011). The collection-of-information requirement for the certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB under OMB control number 1910-1400. In an application to renew the OMB information collection approval for DOE's certification and recordkeeping requirements, DOE included an estimated burden for manufacturers of conventional ovens. OMB has approved the revised information collection for DOE's certification and recordkeeping requirements through November 30, 2017. 80 FR 5099 (January 30, 2015). DOE estimated that it will take each respondent approximately 30 hours total per company per year to comply with the certification and recordkeeping requirements based on 20 hours of technician/technical work and 10 hours clerical work to submit the Compliance and Certification Management System templates. This rulemaking would include recordkeeping requirements on manufacturers that are associated with executing and maintaining the test data for this equipment. DOE recognizes that recordkeeping burden may vary substantially based on company preferences and practices.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

In this final rule, DOE amends its test procedure for conventional ovens. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this rule amends an existing rule without affecting the amount, quality or distribution of energy usage, and, therefore, will not result in any environmental impacts. Thus, this rulemaking is covered by Categorical Exclusion A5 under 10 CFR part 1021, subpart D, which applies to any rulemaking that interprets or amends an existing rule without changing the environmental effect of that rule. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE examined this final rule and determined that it will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this final rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.

Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a regulatory action resulting in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available at http://energy.gov/gc/office-general-counsel. DOE examined this final rule according to UMRA and its statement of policy and determined that the rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure of $100 million or more in any year, so these requirements do not apply.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This final rule will not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), that this regulation will not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use if the regulation is implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.

This regulatory action is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.

Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101), DOE must comply with section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788; FEAA) Section 32 essentially provides in relevant part that, where a proposed rule authorizes or requires use of commercial standards, the notice of proposed rulemaking must inform the public of the use and background of such standards. In addition, section 32(c) requires DOE to consult with the Attorney General and the Chairman of the Federal Trade Commission (FTC) concerning the impact of the commercial or industry standards on competition.

The proposed modifications to the test procedures addressed by this action incorporate testing methods contained in the AHAM OV-1-2011 standard, “Procedures for the Determination and Expression of the Volume of Household Microwave and Conventional Ovens.” DOE has evaluated this standard and is unable to conclude whether this industry standard fully complies with the requirements of section 32(b) of the FEAA, (i.e., that it was developed in a manner that fully provides for public participation, comment, and review). DOE has consulted with both the Attorney General and the Chairman of the FTC about the impact on competition of using the methods contained in these standards and has received no comments objecting to their use.

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule before its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The Secretary of Energy has approved publication of this final rule.

For the reasons stated in the preamble, DOE amends part 430 of Chapter II of Title 10, Code of Federal Regulations as set forth below:

Over the past several years, one of our highest priorities has been to improve the efficiency of our hearing process for the Old Age, Survivors, and Disability Insurance (OASDI) programs under title II of the Social Security Act (Act) and the Supplemental Security Income (SSI) program under title XVI of the Act. We began a pilot program in July 2010 (75 FR 39154), under which the agency, rather than the ALJ, may set the time and place of the hearing under certain circumstances. Because we expect to continue to face significant challenges in dealing with the historically large number of hearing requests, we must maintain programs and policies that can provide us with the flexibility we need to improve the efficiency of our hearing process.

When we published a final rule on July 8, 2010 authorizing the agency to set the time and place for a hearing before an ALJ, we explained that we would implement our authority as a temporary pilot program. (75 FR 39154). Therefore, we included in sections 404.936(h) and 416.1436(h) of the final rule a provision that the pilot program would end on August 9, 2013, unless we decided to either terminate the program earlier, or extend it beyond that date by publication of a final rule in the Federal Register. Most recently, on July 18, 2014, we extended the deadline until August 10, 2015. (79 FR 41881).

During the pilot program, we tracked ALJ productivity closely, working with ALJs to addresss any concerns about our hearing process. We are continuing to work with ALJs who do not promptly schedule their hearings, and we are using a variety of authorties available to correct these situations. To date, our efforts have been largely successful. We are retaining this authority in our regulations to provide us with the flexibility we need to manage the hearing process appropriately.

During this extension of the pilot program, we will continue to monitor the productivity of ALJs and to work with our ALJs to address any concerns regarding our hearing process. Accordingly, we are extending our authority to set the time and place for a hearing before an ALJ for another year, until August 12, 2016. As before, we reserve the authority to end the program earlier, or to extend it by publishing a final rule in the Federal Register.

We follow the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 when developing regulations. Section 702(a)(5) of the Social Security Act, 42 U.S.C. 902(a)(5). Generally, the APA requires that an agency provide prior notice and opportunity for public comment before issuing a final rule. The APA provides exceptions to its notice and public comment procedures when an agency finds there is good cause for dispensing with such procedures because they are impracticable, unnecessary, or contrary to the public interest. We have determined that good cause exists for dispensing with the notice and public comment procedures for this rule. 5 U.S.C. 553(b)(B). This final rule only extends the date on which the pilot program will no longer be effective. It makes no substantive changes to our rules. Our current regulations expressly provide that we may extend the expiration date of the pilot program by notice of a final rule in the Federal Register. Therefore, we have determined that opportunity for prior comment is unnecessary, and we are issuing this rule as a final rule.

In addition, for the reasons cited above, we find good cause for dispensing with the 30-day delay in the effective date of this final rule. 5 U.S.C. 553(d)(3). We are not making any substantive changes in our rules. Without an extension of the expiration date for the pilot program, we will not have the flexibility we need to ensure the efficiency of our hearing process. Therefore, we find it is in the public interest to make this final rule effective on the publication date.

We consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB did not review the final rule.

We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

This final rule does not create any new or affect any existing collections and, therefore, does not require OMB approval under the Paperwork Reduction Act.

For the reasons stated in the preamble, we are amending subpart J of part 404 and subpart N of part 416 of title 20 of the Code of Federal Regulations as set forth below:

Executive Summary Purpose and Coverage of the Final Rule

The final rule removes the codified GST 1 regulations for biological products which will update outdated requirements and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is finalizing this action because the existing codified GST regulations are duplicative of requirements that are also specified in BLAs, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to Executive Order (E.O.) 13563 of January 18, 2011.

The final rule removes the requirements contained in §§ 610.11, 610.11a, and 680.3(b) (21 CFR 610.11, 610.11a, and 680.3(b)) from the regulations. Section 610.11 requires a GST for the detection of extraneous toxic contaminants in certain biological products intended for administration to humans. Section 610.11a concerns the GST requirements for inactivated influenza vaccine. Section 680.3(b) concerns GST requirements for allergenic products. Removal of these regulations, however, would not remove GST requirements specified in individual BLAs. A biological product manufacturer would continue to be required to follow the GST requirements specified in its BLA unless the manufacturer advised FDA of its elimination or modification of the test by a submission filed in accordance with § 601.12 (21 CFR 601.12). FDA would review proposed changes to a manufacturer's approved biologics license on a case-by-case basis so that FDA can ensure that any such action is appropriate.

FDA is finalizing this action because the existing codified GST regulations are duplicative of requirements that are also specified in BLAs, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. Because this final rule would impose no additional regulatory burdens, this rule is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.

As part of FDA's retrospective review of its regulations to promote improvement and innovation under Executive Order 13563, FDA is removing the codified GST requirements as specified in this rule. We believe this action is appropriate because in many instances, the GST regulations duplicate requirements that are also specified in the BLA requirements for biological products intended for human use under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), or they are outmoded or otherwise unnecessary to help ensure the continued safety, purity, and potency of biological products. FDA published the proposed rule “Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications” in the Federal Register of August 22, 2014 (79 FR 49727). FDA corrected the title of that proposed rule to “Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications” in the Federal Register of September 10, 2014 (79 FR 53670).

For a number of years, FDA has not codified specific test methods as standards for licensed biological products, in part because codifying specific test methods as standards can diminish the ability of the Agency and industry to respond to technological developments. Instead the Agency has required manufacturers to provide a full description of manufacturing methods, including test methods, in manufacturers' BLAs (§ 601.2(a) (21 CFR 601.2(a))). Since FDA issued the March 2003 final rule “Revision to the General Safety Requirements for Biological Products” in the Federal Register of March 4, 2003 (68 FR 10157), it has become increasingly clear that the codified GST regulations are too restrictive for certain biological products because alternatives may be available which provide the same or greater level of assurance of safety as the GST. Thus, the Agency believes that the GST regulations may not always reflect the scientific community's assessment of the best current testing procedures, although in certain circumstances the GST may still be appropriate. The Agency believes that a more efficient way of prescribing testing requirements for particular products would be to allow such requirements to be specified in the BLA, which will enhance flexibility to make appropriate changes to testing methods.

FDA is adopting as final, without material change, the proposed revocation of general safety test requirements that are duplicative of requirements in BLAs.

• The final rule is removing §§ 610.11, 610.11a, and 680.3(b), the regulations that require that manufacturers of biological products perform a specified test for general safety of biological products. FDA is taking this action because the existing codified GST regulations are duplicative, outmoded, or are otherwise unnecessary to help ensure the continued safety, purity, and potency of licensed biological products.

• As set forth in an approved BLA or BLA supplement, for products that present specific safety concerns, manufacturers will be required to perform appropriate safety test(s) to address those concerns. For example, the BLA may require testing for a specific toxicity.

• The appropriate tests will be specified in the manufacturer's BLA or BLA supplement rather than codified as regulations.

• Elimination of the codified GST regulations would encourage the implementation of the principles of the “3Rs,” to reduce, refine, and replace animal use in testing. This addresses the need to minimize the use of animals in such testing and promotes more humane, appropriate and specific test methods for assuring the safety of biological products.2

• The finalization of this rule does not automatically revise a manufacturer's BLA or BLA supplement.

• Manufacturers would continue to be required to perform the GST unless the manufacturer's BLA were revised through a supplement to eliminate or modify the test in accordance with § 601.12.

• The requirements for a licensed biological product manufacturer to report changes in its product, product labeling, production process, quality controls, equipment, facilities or responsible personnel, as established in its approved BLA, are detailed in § 601.12.

• Under § 601.12, manufacturers must report each change to the Agency in one of several different types of submissions. The applicable submission category depends on the potential for the change(s) at issue to have an adverse effect on the identity, strength, quality, purity, or potency of the particular biological product as it may relate to the safety or effectiveness of the product.

• FDA anticipates that changes involving the discontinuance of the GST or the reliance on a test other than the GST would have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as it may relate to the safety or effectiveness of the product. Such changes must be identified in a supplement submitted under § 601.12(c) (changes requiring supplement submission at least 30 days prior to distribution of the product made using the change).

FDA is issuing this regulation under the biological products and communicable disease provisions of the PHS Act (42 U.S.C. 262 and 264), and the provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321 et seq.) applicable to drugs. Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure, among other things, that biological products are safe, pure, and potent and manufactured in accordance with current Good Manufacturing Practice, and to prevent the introduction, transmission, or spread of communicable disease.

The Agency received two letters of comments on the proposed rule. Comments were received from a trade association, and an animal welfare organization.

To make it easier to identify the comments and our responses, the word “Comment” and a comment number appear in parentheses before each comment's description, and the word “Response” in parentheses precedes each response. We have also numbered each comment to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was received. Certain comments were grouped together because the subject matter of the comments was similar.

(Comment 1) Both letters of comments support the proposed rule.

(Response) FDA acknowledges and appreciates that the comments we received agree with the need for this rulemaking. As stated previously, the rule removes the requirements contained in §§ 610.11, 610.11a, and 680.3(b) from the regulations because the existing codified GST regulations are duplicative of requirements that are also specified in BLAs, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. Removal of these regulations provides a more efficient way of prescribing testing requirements and enhances flexibility to make appropriate changes to testing methods.

(Comment 2) One comment requests that FDA encourage manufacturers who have a GST described in their BLAs for their licensed products to submit supplements to their BLAs to eliminate or modify the test and that FDA take additional steps to ensure that the final rule will have the intended effect of eliminating the use of animals in safety testing.

(Response) As stated in the preamble of the proposed rule (79 FR 49727 at 49729), we anticipate that the elimination of the codified GST regulations will encourage the implementation of the principles of the “3Rs,” to reduce, refine, and replace animal use in testing. Moreover, on our own initiative, as discussed elsewhere in this document, we have determined that the effective date of the final rule will be 30 days after the date of its publication in the Federal Register to give manufacturers the flexibility to submit supplements to their BLAs for their licensed products as soon as possible.

(Comment 3) One comment requests that we add language to § 601.2 or other relevant biologics regulation to clarify our intent to encourage the implementation of the principles of the 3Rs.

(Response) FDA declines to adopt this recommended change because the request to add language to § 601.2 or other relevant biologics regulations is outside the scope of this rulemaking.

(Comment 4) One comment requests that FDA establish user fees with respect to the continued use of the GST after the effective date of this final rule, or that FDA establish other clear policies that will provide economic incentives to discontinue the use of the GST. Further, the comment refers to Executive Order 13563, which encourages Federal Agencies to “. . . assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees . . . .”

(Response) We decline to adopt these suggested changes because they are beyond the scope of this rule. The proposed rule did not address user fees or economic incentives. This rule allows, but does not require, current BLA holders to submit to FDA supplements to their BLAs to eliminate or modify the GST.

(Comment 5) One comment states that a manufacturer who submits a supplement to eliminate or modify a GST in its BLA will not be able to stop conducting the GST until FDA determines that the manufacturer has appropriately reported this change.

(Response) We disagree in part. As stated in the preamble to the proposed rule (79 FR 49727 at 49730), a manufacturer who desires to discontinue the GST in its approved BLA or utilize an alternative method other than the GST approved in its BLA must submit a BLA supplement reporting the change in accordance with § 601.12. Should a manufacturer wish to discontinue the GST described in the approved BLA, or to utilize an alternative method other than the GST approved in its BLA, FDA anticipates that the change would have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as it may relate to the safety or effectiveness of the product. Accordingly, a manufacturer who desires to make such a change must submit a BLA supplement reporting the change in accordance with § 601.12(c). Within 30 days of the date FDA receives the submission, FDA will determine if the change has been reported in the proper category and if any of the required information is missing, and will inform the applicant accordingly. If FDA does not so notify the applicant, distribution of the product made using the change may begin not less than 30 days after receipt of the supplement by FDA.

As part of this final rule, we need to make conforming changes when the removed provisions are referenced elsewhere in the CFR. The final rule removes “§ 610.11” from § 601.2(c)(1) and 21 CFR 601.22.

We are making this rule effective 30 days after the date of publication in the Federal Register. We are making this change in the interest of reducing unnecessary regulatory burden to give manufacturers the flexibility to submit supplements right away, should they wish to do so.

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action as defined under Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule generally increases flexibility for safety testing and would result in the reduction of certain regulatory burdens and does not add any new regulatory responsibilities, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

This final rule amends the biologics regulations by removing the GST requirements for biological products found in §§ 610.11, 610.11a and 680.3(b). FDA is finalizing this action because the current codified GST regulations are duplicative of requirements that are also specified in biologics licenses, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. The removal of the GST regulations for biological products, however, would not remove GST requirements specified in individual BLAs. All manufacturers that currently conduct a GST are already required, as part of the standards specified in their BLAs, to perform the GST and would thus continue to be required to perform the GST unless the BLA were revised to eliminate or modify the test through a supplement in accordance with § 601.12. Because this rule would impose no additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.

This final rule refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in § 601.12 have been approved under OMB control number 0910-0338. Therefore, FDA tentatively concludes that the requirements in this document are not subject to review by OMB because they do not constitute a “new collection of information” under the PRA.

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

Therefore under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 601, 610, and 680 are amended as follows:

On July 1, 2014, the Department published a final rule revising Category XI of the USML, 79 FR 37535, effective December 30, 2014. This final rule, consistent with the two prior proposed rules for USML Category XI (78 FR 45017, July 25, 2013 and 77 FR 70958, November 28, 2012), revised paragraph (b) of Category XI to clarify the extent of the control and maintain the existing scope of control on items described in paragraph (b) and the directly related software described in paragraph (d). The Department has determined that exporters may read the revised control language to exclude certain intelligence analytics software that has been and remains controlled on the USML. Therefore, the Deputy Assistant Secretary of State for Defense Trade Controls determined that it is in the interest of the security of the United States to temporarily revise USML Category XI paragraph (b), pursuant to the provisions of 22 CFR 126.2, while a long term solution is developed. The Department will publish any permanent revision to USML Category XI paragraph (b) addressing this issue as a proposed rule for public comment.

This temporary revision clarifies that the scope of control in existence prior to December 30, 2014 for USML paragraph (b) and directly related software in paragraph (d) remains the same. This clarification is achieved by reinserting the words “analyze and produce information from” and by adding software to the description of items controlled. In effect, this rule modifies USML Category XI paragraph (b) until December 29, 2015.

The Department is publishing this rule as a final rule based upon good cause, and its determination that delaying the effect of this rule during a period of public comment would be impractical, unnecessary and contrary to public interest. 5 U.S.C. 553(b)(3)(B). In addition, the Department is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States Government and that rules implementing this function are exempt from sections 553 (rulemaking) and 554 (adjudications) of the Administrative Procedure Act (APA).

Since the Department is of the opinion that this rule is exempt from the provisions of 5 U.S.C. 553, there is no requirement for an analysis under the Regulatory Flexibility Act.

This rulemaking does not involve a mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

The Department does not believe this rulemaking is a major rule under the criteria of 5 U.S.C. 804.

This rulemaking does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this rulemaking.

The Department believes that benefits of the rulemaking outweigh any costs, which are estimated to be insignificant. It is the Department's position that this rulemaking is not a significant rule under the criteria of Executive Order 12866, and is consistent with the provisions of Executive Order 13563.

The Department of State has reviewed this rulemaking in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.

This rulemaking does not impose or revise any information collections subject to 44 U.S.C. Chapter 35.

For reasons stated in the preamble, the State Department amends 22 CFR part 121 as follows:

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking TFR Temporary Final Rule A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a maritime fireworks display. Therefore, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed above, waiting for a 30 day notice period to run would be impracticable.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

Between 9:15 p.m. and 10 p.m. on July 5, 2015, a fireworks display will be held on the shoreline of the Saint Lawrence River on Heart Island in Alexandria Bay, NY. It is anticipated that numerous vessels will be in the immediate vicinity of the launch point. The Captain of the Port Buffalo has determined that such a launch proximate to a gathering of watercraft pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris.

With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the Alexandria Bay Chamber of Commerce fireworks display. This zone will be enforced from 9:15 p.m. until 10 p.m. on July 5, 2015. This zone will encompass all waters of the Saint Lawrence River, Heart Island, Alexandria Bay, NY within an 800-foot radius of position 44°20′38.5″ N and 075°55′19.1″ W (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this rule on small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of the Saint Lawrence River on the evening of July 5, 2015.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this safety zone would be effective, and thus subject to enforcement, for only 45 minutes late in the day. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the enforcement of the zone, we would issue local Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the “For Further Information Contact” section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone and, therefore it is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 165 as follows:

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking TFR Temporary Final Rule A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a maritime fireworks display.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable and contrary to the public interest.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

Between 9:45 p.m. and 10:35 p.m. on July 4, 2015, a fireworks display will be held on the shoreline of Lake Erie, Bay Village, OH. It is anticipated that numerous vessels will be in the immediate vicinity of the launch point. The Captain of the Port Buffalo has determined that such a launch proximate to a gathering of watercraft pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris.

With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the Bay Village Independence Day Celebration fireworks display. This zone will be enforced from 9:45 p.m. until 10:35 p.m. on July 4, 2015. This zone will encompass all waters of Lake Erie; Bay Village, OH within a 560-foot radius of position 41°29′23.9″ N. and 081°55′44.5″ W. (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this rule on small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Lake Erie on the evening of July 4, 2015.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be effective, and thus subject to enforcement, for only 50 minutes late in the day. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the enforcement of the zone, we would issue local Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone and, therefore it is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 165 as follows:

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking TFR Temporary Final Rule A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a maritime fireworks display. Therefore, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed above, waiting for a 30 day notice period to run would be impracticable and contrary to the public interest.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

Between 9:30 p.m. and 10:30 p.m. on July 4, 2015, a fireworks display will be held on the shoreline of Lake Erie, Presque Isle Bay in Erie, PA. It is anticipated that numerous vessels will be in the immediate vicinity of the launch point. The Captain of the Port Buffalo has determined that such a launch proximate to a gathering of watercraft pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris.

With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the Erie Boom on the Bay fireworks display. This zone will be enforced from 9:30 p.m. until 10:30 p.m. on July 4, 2015. This zone will encompass all waters of Lake Erie; Presque Isle Bay, Erie, PA within a 400-foot radius of position 42°8′20″ N. and 080°5′29″ W. (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this rule on small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Presque Isle Bay on the evening of July 4, 2015.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be effective, and thus subject to enforcement, for only 60 minutes late in the day. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the enforcement of the zone, we would issue local Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone and, therefore it is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 165 as follows:

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking TFR Temporary Final Rule A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a maritime fireworks display. Therefore, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed above, waiting for a 30 day notice period to run would be impracticable and contrary to the public interest.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

Between 9:30 p.m. and 10:30 p.m. on July 5, 2015, a fireworks display will be held on the shoreline of Lake Ontario in Oswego, NY. It is anticipated that numerous vessels will be in the immediate vicinity of the launch point. The Captain of the Port Buffalo has determined that such a launch proximate to a gathering of watercraft pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris.

With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the Independence Day Celebration fireworks display. This zone will be enforced from 9:30 p.m. until 10:30 p.m. on July 5, 2015. This zone will encompass all waters of Lake Ontario, Oswego, NY within a 420-foot radius of position 43°27′56.88″ N. and 076°30′43.96″ W. (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this rule on small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Lake Ontario on the evening of July 5, 2015.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be effective, and thus subject to enforcement, for only 60 minutes late in the day. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the enforcement of the zone, we would issue local Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone and, therefore it is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 165 as follows:

On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm). See 73 FR 16436. Under EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is attained when the 3-year average of the annual fourth-highest daily maximum 8-hour average ambient air quality ozone concentrations is less than or equal to 0.075 ppm. See 40 CFR 50.15. Ambient air quality monitoring data for the 3-year period must meet a data completeness requirement. The ambient air quality monitoring data completeness requirement is met when the average percent of days with valid ambient monitoring data is greater than 90 percent, and no single year has less than 75 percent data completeness as determined in appendix I of part 50.

Upon promulgation of a new or revised NAAQS, the Clean Air Act (CAA or Act) requires EPA to designate as nonattainment any area that is violating the NAAQS, based on the three most recent years of ambient air quality data at the conclusion of the designation process. The Memphis, TN-MS-AR Area was designated nonattainment for the 2008 8-hour ozone NAAQS on May 21, 2012 (effective July 20, 2012), using 2008-2010 ambient air quality data. See 77 FR 30088. At the time of designation, the Memphis, TN-MS-AR Area was classified as a marginal nonattainment area for the 2008 8-hour ozone NAAQS. On March 6, 2015, EPA finalized a rule entitled “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements” (SIP Requirements Rule) that establishes the requirements that state, tribal, and local air quality management agencies must meet as they develop implementation plans for areas where air quality exceeds the 2008 8-hour ozone NAAQS.1 See 80 FR 12264. This rule establishes nonattainment area attainment dates based on Table 1 of section 181(a) of the CAA, including an attainment date three years after the July 20, 2012, effective date, for areas classified as marginal for the 2008 8-hour ozone NAAQS. Therefore, the attainment date for the Memphis, TN-MS-AR Area is July 20, 2015.

Based on the nonattainment designation, Mississippi was required to develop a nonattainment SIP revision addressing certain CAA requirements. Specifically, pursuant to CAA section 182(a)(1), Mississippi was required to submit a SIP revision addressing emissions inventory requirements.

Ground level ozone is not emitted directly into the air, but is created by chemical reactions between oxides of nitrogen (NOX) and volatile organic compounds (VOC) in the presence of sunlight. Emissions from industrial facilities and electric utilities, motor vehicle exhaust, gasoline vapors, and chemical solvents are some of the major sources of NOX and VOC. Section 182(a)(1) of the CAA requires states with areas designated nonattainment for the ozone NAAQS to submit a SIP revision providing a comprehensive, accurate, and current inventory of actual emissions from all sources of the relevant pollutant or pollutants in such area. NOX and VOCs are the relevant pollutants because they are the precursors of ozone.

On January 14, 2015, Mississippi submitted a SIP revision containing a base year emissions inventory for its portion of the Memphis, TN-MS-AR Area. EPA is now taking action to approve the portion of the SIP revision addressing the emissions inventory as meeting the requirements of sections 110 and 182(a)(1) of the CAA. More information on EPA's analysis of Mississippi's emissions inventory is provided below.

As discussed above, section 182(a)(1) of the CAA requires states to submit a comprehensive, accurate, and current inventory of actual emissions from all sources of the relevant pollutant or pollutants in each ozone non-attainment area. The section 182(a)(1) base year inventory is defined in the SIP Requirements Rule as “a comprehensive, accurate, current inventory of actual emissions from sources of VOC and NOX emitted within the boundaries of the nonattainment area as required by CAA section 182(a)(1).” See 40 CFR 51.1100(bb). The inventory year must be selected consistent with the baseline year for the RFP plan as required by 40 CFR 51.1110(b),2 and the inventory must include actual ozone season day emissions as defined in 40 CFR 51.1100(cc) 3 and contain data elements consistent with the detail required by 40 CFR part 51, subpart A. See 40 CFR 51.1115(a), (c), (e). In addition, the point source emissions included in the inventory must be reported according to the point source emissions thresholds of the Air Emissions Reporting Requirements (AERR) in 40 CFR part 51, subpart A. 40 CFR 51.1115(d).

Mississippi selected 2011 as the base year for the emissions inventory which is the year corresponding with the first triennial inventory under 40 CFR part 51, subpart A. This base year is one of the three years of ambient data used to designate the Area as a nonattainment area and therefore represents emissions associated with nonattainment conditions. The emissions inventory is based on data developed and submitted by MDEQ to EPA's 2011 National Emissions Inventory (NEI), and it contains data elements consistent with the detail required by 40 CFR part 51, subpart A.4

Mississippi's emissions inventory for its portion of the Area provides 2011 emissions data for NOX and VOCs for the following general source categories: point, nonpoint (excluding biogenic sources), nonroad mobile, and onroad mobile. A detailed discussion of the inventory development is located in Appendix V to Mississippi's January 14, 2015, submittal which is provided in the docket for this action. The table below provides a summary of the emissions inventory.

The Contents of This Preamble Are Listed in the Following Outline I. General Information II. Statutory Authority III. Corrections Made to the Regulatory Text Regarding the Effective Date IV. Statutory and Executive Order Reviews I. General Information A. Does this action apply to me?

This rule applies to all coal combustion residuals (CCR) generated by electric utilities and independent power producers that fall within the North American Industry Classification System (NAICS) code 221112 and may affect the following entities: Electric utility facilities and independent power producers that fall under the NAICS code 221112. The industry sector(s) identified above may not be exhaustive; other types of entities not listed could also be affected. The Agency's aim is to provide a guide for readers regarding those entities that potentially could be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(B), provides that, when an Agency for good cause finds that notice and public procedures are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. Similarly, section 553(d) authorizes an Agency to establish an effective date for a rule that is sooner than 30 days from its publication, “as otherwise provided by the agency for good cause found and published with the rule.”

This final rule only revises the CFR to be consistent with the requirements in RCRA section 4004(c) and the Office of the Federal Register (OFR) regulation at 1 U.S.C. 18.17(b). The EPA is issuing this rule solely to ensure that the CFR accurately reflects the date by which, under current law, the provisions of the rule become effective. Consequently, the EPA has determined that there is good cause for making the technical amendments in this final rule without prior proposal and opportunity for comment, because notice and public comment would be unnecessary. For the same reasons, the EPA has concluded that good cause exists for making the corrections in this final rule effective July 2, 2015.

After publication in the Federal Register, inconsistencies resulting from typographical errors established two different effective dates for the final CCR rule, one that accurately reflects the statutory effective date, and a second, inaccurate date (80 FR 21302, April 17, 2015). This action corrects these inconsistencies in the CFR, so that it accurately reflects the effective date under RCRA section 4004(c) of six months from the publication date of the rule, i.e., October 19, 2015.

Section 4004 (c) of RCRA generally establishes a six month effective date for rules issued under subtitle D, providing that “the prohibition contained in subsection (b) shall take effect on the date six months after the date of promulgation of regulations under subsection (a).” 42 U.S.C. 6944(c). In other words, RCRA requires that six months after promulgation of a rule under section 4004(a), solid waste can only be managed in a manner that complies with the requirements of the rule.

Under RCRA, promulgation of a rule occurs upon signature and publication in the Federal Register. Horsehead Resource Development Co, Inc., v. EPA, 130 F.3d 1090, 1094-1095 (D.C. Cir. 1997) (“We hold . . . at least in the absence of a contrary agency regulation, “promulgation” as used in section [7006(a)(1) of RCRA] means the date of Federal Register publication.”). Thus by operation of law, the requirements in the final CCR rule go into effect six months from the date of its publication in the Federal Register, or October 19, 2015. Based on the rule published in the Federal Register (80 FR 21302, April 17, 2015), the CFR inaccurately reflects the current date by which facilities must be in compliance with certain requirements. This action merely corrects the CFR to accurately reflect these existing legal obligations; it does not alter or affect them in any way, but merely ensures that the public will not be confused by inaccuracies. The EPA has therefore determined that further public comment on this action is unnecessary and that good cause exists for making the corrections in this final rule without prior publication or public comment.

The EPA is also correcting dates for certain provisions that fall on January 18, 2016, which is a Federal holiday. According to 1 CFR 18.07(b), “where the final count would fall on a Saturday, Sunday, or holiday, the date certain will be the next succeeding Federal business day.” To be consistent with 1 CFR 18.07(b), that date needs to be revised to the next Federal business day, or January 19, 2016. Based on the final CCR rule published in Federal Register (80 FR 21302), the CFR inaccurately reflects the current date by which facilities must be in compliance with these requirements. This action merely corrects the CFR to ensure that the public will not be confused. The EPA has therefore determined that further public comment on this action is unnecessary and that good cause exists for making the corrections in this final rule without prior publication or public comment.

This regulation is established under the authority of sections 1008(a), 2002(a), 3001, 4004, and 4005(a) of the Solid Waste Disposal Act of 1970, as amended by the Resource Conservation and Recovery Act of 1976, as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA), 42 U.S.C. 6906(b), 6907(a), 6912(a), 6944 and 6945(a).

In drafting the final CCR rule, the Agency used the following two bracketed “instructions” when referring to the effective date of the CCR rule: (1) [INSERT DATE 180 DAYS AFTER THE DATE OF PUBLICATION IN THE Federal Register]; and (2) [INSERT DATE SIX MONTHS AFTER THE DATE OF PUBLICATION IN THE Federal Register]. These “instructions” provided direction to the OFR for computing and inserting a specified date, in this case, the effective date of the rule.

On April 17, 2015, the CCR rule was published in the Federal Register (80 FR 21302). After publication, the EPA discovered that the two “instructions” used to calculate the effective date had resulted in the computing and inserting of two different effective dates, rather than single effective date established under RCRA 4004(c). The first “instruction” used in the CCR rule for the effective date exactly mirrored the statutory language, i.e., [INSERT DATE 6 MONTHS AFTER DATE OF PUBLICATION IN THE Federal Register], which resulted in a date of October 19, 2015. By contrast, the second “instruction,” paraphrased the statute, i.e., [INSERT DATE 180 DAYS AFTER THE DATE OF PUBLICATION IN THE Federal Register], which resulted in a date of October 14, 2015. In order to correct this error, the EPA is issuing this final rule to revise the CFR so that it accurately reflects the existing effective date for the CCR rule established by RCRA section 4004 (c), i.e., October 19, 2015, which is consistent with the “instruction” of: [INSERT DATE SIX MONTHS AFTER THE DATE OF PUBLICATION IN THE Federal Register].

In addition at § 257.83(b)(3) and § 257.84(b)(3)(i) (Inspection requirements for CCR surface impoundments and CCR landfills respectively) the instructions for calculating and inserting dates in these two sections of the CCR rule were: [INSERT DATE NINE MONTHS AFTER THE DATE OF PUBLICATION IN THE Federal Register]. After publication, the EPA discovered that the computed and inserted date for these provisions was January 18, 2016, which is a Federal holiday. According to 1 CFR 18.07(b) “where the final count would fall on a Saturday, Sunday, or holiday, the date certain will be the next succeeding Federal business day when a date falls on a weekend or a Federal holiday, the [Office of Federal Register] uses the next Federal business day.” To be consistent with 1 CFR 18.07(b), that date needs to be revised to the next Federal business day, or January 19, 2016. Based on the rule published in the Federal Register, the CFR inaccurately reflects the current date by which facilities must be in compliance with these requirements.

In order to aid the public, the following table identifies those sections of the rule which contained particular dates that the EPA is correcting in this action, as well as those sections where no correction is needed. The first column of the following table identifies those sections of the CCR rule where the date of October 14, 2015 was inserted. These sections of the rule are being corrected in this final rule to establish the correct date of October 19, 2015. The second column of the table identifies those rule provisions where the date of January 18, 2016, a Federal holiday, was inserted. These sections of the rule are being corrected to establish the correct date of January 19, 2016. The third column of the table identifies those sections of the regulatory text where the correct effective date of October 19, 2015 was inserted. These sections will not be changed.

In addition to the inconsistencies in the regulatory text, the preamble to the final CCR rule also contained several incorrect effective dates: (1) 80 FR 21302: The DATES section in the preamble states that the effective date of the rule is October 14, 2015 (180 days from the publication date) instead of the correct date of October 19, 2015; and (2) 80 FR 21467: EPA included a sentence in the Congressional Review Act Executive Order stating that the CCR rule “will be effective 180 days after publication in the Federal Register” which equates to October 14, 2015, instead of stating that the CCR rule “will be effective six months after publication in the Federal Register” which equates to October 19, 2015. While the Agency is not correcting the CCR rule preamble language, it is presenting these additional inconsistencies to provide the reader with a complete accounting of the error.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action is not a significant regulatory action and does not impose an information collection burden under the PRA. The changes made to the regulations as a result of this action impose no new or different reporting requirements on regulated parties.

This action does not modify existing legal requirements applicable to any entity. As such, I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This action corrects a typographical error that resulted in the calculation of an incorrect effective date in some sections of the regulation. This action merely corrects that error so that the CFR will reflect the existing effective date for the CCR rule of October 19, 2015, established by section 4004 (c) of RCRA. This action also corrects the dates in two provisions of the CCR rule, which, as published, fall on a Federal holiday. This action corrects the error and revises the CFR to reflect that, consistent with 1 CFR 18.07(b), the correct the date for these two provisions is the next Federal business day after the holiday or January 19, 2016. The impacts on small businesses were already addressed in the rule promulgated on April 17, 2015 (80 FR 21302); and this rule will not impose any requirements on small entities beyond those that have previously been analyzed. We have therefore concluded that this action will have no net regulatory burden for small entities.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action implements mandates specifically and explicitly set forth in the Resource Conservation and Recovery Act without the exercise of any policy discretion by the EPA.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications, as specified in Executive Order 13175. This action merely corrects typographical errors that resulted in the calculation of an incorrect effective date in some sections of the CCR rule. Thus Executive Order 13175 does not apply to this action.

The EPA interprets E.O. 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because does not establish an environmental standard intended to mitigate health or safety risks. This action merely corrects typographical errors that resulted in the calculation of incorrect effective dates in some sections of the CFR.

This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

This rule merely corrects errors in dates and does not concern an environmental health or safety risk. Therefore, Executive Order 12898 does not apply.

This action is subject to the CRA, and the EPA will submit a rule report to each House of Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by U.S.C. 804(2).

For the reasons set out in the preamble, title 40, chapter I, of the Code of Federal Regulations is amended as follows:

I. General Information A. Does this action apply to me?

This action applies to all persons who export or import hazardous waste, export or import universal waste, or export spent lead-acid batteries destined for recovery operations in OECD Member countries, except for Mexico and Canada. Any transboundary movement of hazardous wastes between the United States and either Mexico or Canada will continue to be governed (or addressed) by their respective bilateral agreements and applicable regulations. Potentially affected entities may include, but are not limited to:

This list is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this section could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under the FOR FURTHER INFORMATION CONTACT section of this document.

The current information is as follows:

• Docket ID No. EPA-HQ-RCRA-2005-0018.

• Federal eRulemaking Portal: http://www.regulations.gov.

This amendment updates the list of OECD member countries that have implemented OECD Decision C(2001)107 and can trade hazardous wastes for recovery operations with other OECD countries under the procedure set forth in that Decision. On January 8, 2010, EPA published a final rule in the Federal Register (75 FR 1236), revising Agency regulations including provisions on the transboundary movement of hazardous waste for recovery operations among OECD Member countries. In that final rule, EPA identified thirty OECD Member countries (including Canada and Mexico). That document was accurate and current at the time of publication; however, Estonia, Israel, and Slovenia have since joined the OECD and implemented OECD Decision C(2001)107. As an OECD Member country, the United States, is legally obligated to implement OECD Decisions with respect to all OECD Member countries. Therefore, EPA is adding Estonia, Israel, and Slovenia to update the list of countries in 40 CFR part 262.58(a)(1).

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA believes notice and an opportunity for comment on this amendment to § 262.58(a)(1) to reflect updates to the list of OECD Member countries would be unnecessary, because the United States, as an OECD Member country, is legally obligated to implement OECD Decision C(2001)107 with respect to all OECD Member countries, which now include the addition of Estonia, Israel and Slovenia. Thus, EPA must amend its OECD regulations to add these three countries, and any public comment would be unnecessary for these particular amendments because EPA does not have any discretion as to which OECD countries its regulations must include. EPA finds that this situation constitutes good cause under 5 U.S.C. 553(b)(3)(B).

Under Executive Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 (76 FR 3821, January 21, 2011), this action is not a “significant regulatory action” and is therefore not subject to OMB review. Because this action is not subject to notice and comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) or Sections 202 and 205 of the Unfunded Mandates Reform Act of 1999 (UMRA) (Pub. L. 104-4). In addition, this action does not significantly or uniquely affect small governments. This action does not create new binding legal requirements that substantially and directly affect Tribes under Executive Order 13175 (65 FR 67249, November 9, 2000). This action does not have significant Federalism implications under Executive Order 13132 (64 FR 43255, August 10, 1999). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). This action does not involve technical standards; thus, the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

This action is subject to the Congressional Review Act (CRA), and the EPA will submit a rule report to each House of Congress and to the Comptroller General of the United States. The CRA allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and comment rulemaking procedures are impracticable, unnecessary or contrary to the public interest (5 U.S.C. 808(2)). The EPA has made a good cause finding for this rule as discussed in Section III of the preamble, including the basis for that finding.

For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

This action applies to generators, transporters, and designated facilities (off-site disposal and commercial storage facilities) managing PCB wastes. Potentially affected categories and entities include, but are not necessarily limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this section could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 Code of Federal Regulations (CFR) part 761. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under the FOR FURTHER INFORMATION CONTACT section of this document.

The current information is as follows:

• Docket ID No. EPA-HQ-RCRA-2011-0524.

• Federal eRulemaking Portal: http://www.regulations.gov.

This technical amendment is being issued to correct the item number reference for the Special Handling Instructions Box in 40 CFR part 761.207(a)(1), (2), and (3). EPA published a document in the Federal Register on September 6, 2012 (77 FR 54818), revising Agency regulations. That document incorrectly referenced Item 15 to identify the Special Handling Instructions box on EPA Form 8700-22. This technical amendment is being issued to amend the final rule by revising § 761.207(a)(1), (2), and (3) to correctly identify the item number as 14.

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making this technical amendment final without prior proposal and opportunity for comment, because EPA is merely correcting information that was referenced incorrectly in the previously published final rule. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

Under Executive Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 (76 FR 3821, January 21, 2011), this action is not a “significant regulatory action” and is therefore not subject to OMB review. Because this action is not subject to notice and comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) or Sections 202 and 205 of the Unfunded Mandates Reform Act (2 U.S.C. 1531-1538). In addition, this action does not significantly or uniquely affect small governments. This action does not create new binding legal requirements that substantially and directly affect Tribes under Executive Order 13175 (65 FR 67249, November 9, 2000). This action does not have significant Federalism implications under Executive Order 13132 (64 FR 43255, August 10, 1999). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). This action does not involve technical standards; thus, the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before certain actions may take effect, the agency promulgating the action must submit a report, which includes a copy of the action, to each House of the Congress and to the Comptroller General of the United States. Because this final action does not contain legally binding requirements, it is not subject to the Congressional Review Act

For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

GSA published a final rule in the Federal Register at 75 FR 72965 on November 29, 2010, to update the FTR by removing the Privately Owned Vehicle (POV) rates from the text of the FTR and instead directing travelers to a Web site (at http://www.gsa.gov/ftr) with these rates. Inadvertently, the URL was not for the correct Web page. Therefore, GSA is issuing this amendment correction to the final rule to further amend the FTR by inserting the correct URL.

For the reasons set forth in the preamble, pursuant to 5 U.S.C. 5701-5707, GSA amends 41 CFR part 301-10 as set forth below:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR part 64 is amended as follows:

The Federal Maritime Commission amends its regulations governing access to Commission information and records and its regulations implementing the Freedom of Information Act, 5 U.S.C. 552, found in part 503 of title 46 of the Code of Federal Regulations. The provisions in part 503 are designed to facilitate public availability of information; thereby furthering the spirit of FOIA in ensuring an informed citizenry. The Commission last revised part 503 in 1998 to reflect requirements of the Electronic Freedom of Information Act Amendments of 1996 (Pub. L. 04-231). On December 31, 2007, the OPEN Government Act of 2007 (Pub. L. 110-175) amended procedural aspects of FOIA and established new agency requirements for processing FOIA requests. On October 28, 2009, the OPEN FOIA Act of 2009 (Pub. L. 110-175) further amended FOIA.

The amendments to part 503 update the Commission's regulations to reflect its practices and provisions of the OPEN Government Act of 2007 and the OPEN FOIA Act of 2009.

The Commission is making the following revisions to the subparts of part 503: revise Subpart A—General, Statement of Policy to repurpose this subpart to state the purpose and scope of the rules contained in part 503; update Subpart B—Publication in the Federal Register to recognize that in addition to publishing records in the Federal Register, the Commission also posts records listed in this Subpart on its Web site (www.fmc.gov); revise Subpart C—Records, Information and Materials Generally Available to the Public Without Resort to Freedom of Information Act Procedures to describe records available to the public without the need for a FOIA request, including records available on the Commission's public Web site; amend Subpart D—Requests for Records under the Freedom of Information Act to include procedures for tolling response times, processing FOIA requests under the multitracking system, and expedited processing of FOIA requests; and revise Subpart H—Public Observation of Federal Maritime Commission Meetings and Public Access to Information Pertaining to Commission Meetings to amend a subpart reference.

The Commission revises the heading and language in § 503.1 to use this section to describe the scope and purpose of the provisions contained in part 503. Specifically, the Commission changes the section heading from “Statement of Policy” to “Scope and Purpose.” The Commission also amends this section to include a list of the subparts contained in part 503.

To promote greater access to information and records, the Commission amends and updates § 503.11 to inform the public that the Commission posts records listed in this subpart on its Web site (www.fmc.gov), in addition to publishing these records in the Federal Register.

Sections 503.21 to 503.24 describe records available to the public without the need for a FOIA request. The Commission last revised these sections in 1998 and further revises these sections to reflect the availability of information on the Commission's Web site, eliminate outdated information, and remove duplicative language.

Section 503.31 provides information on the process for requesting records. The Commission is adding a new paragraph encouraging requesters to review the records on the Commission's public Web site prior to initiating a FOIA request. In addition, the Commission amends this section to include requirements for submitting FOIA requests electronically.

FOIA, as amended, allows an agency to make one reasonable request for information from the FOIA requester and stop, or toll, the 20-day clock for responding to a FOIA requester while the agency is waiting for the requested information from the FOIA requester. 5 U.S.C. 552(a)(6)(A)(ii)(I). Agencies may also toll the 20-day response clock as many times as necessary in order to clarify any issues with fee assessment. 5 U.S.C. 552(a)(6)(A)(ii)(II).

Section 503.32 sets forth procedures for responding to requests made under FOIA. This section does not currently include a provision for tolling the statutory 20-day FOIA response period should the Commission need to contact the FOIA requestor to clarify or narrow the scope of the FOIA request. The Commission is adding language that would allow for tolling of response times to implement the Commission's authority to stop the 20-day clock should the Commission need information from the requestor or to clarify issues with fee assessment.

The Commission is adding two new paragraphs, (b)(4) and (5) to § 503.32 to reflect Commission processes used to work with a requestor to clarify or narrow the scope of a FOIA request, and to confirm that the requestor understands and authorizes the assessment of fees. The new paragraphs require the Commission to submit its request to clarify the scope of records requested or fee assessments in writing to the requestor.

FOIA expressly authorizes agencies to promulgate regulations providing for “multitrack processing” of FOIA requests and allows agencies to process requests on a first-in, first-out basis within each track. 5 U.S.C. 552(a)(6)(D). During FY 2012, the Commission initiated a multitrack processing system for FOIA requests to better manage and more efficiently respond to FOIA requests. The Commission revises § 503.32(d) to reflect the Commission's current practices regarding multitrack processing of FOIA requests in which the Commission labels requests as either “simple” or “complex”. The rephrasing of the section clarifies the Commission's current practices and provides that a request may be considered “simple” if the type of records being requested are routinely requested and readily available. Initiating a simple track process has permitted the Commission to respond to relatively simple requests more quickly than requests involving complex and/or voluminous records.

Section 503.32(e) currently provides for expedited processing of a FOIA request when (1) the person requesting the records can demonstrate a compelling need; or (2) in other cases, in the Secretary's discretion. The Commission deletes paragraph (2) from § 503.32(e). This revision simplifies the Commission's criteria for determining which FOIA requests qualify for expedited processing and establish a practice consistent with other Federal agencies that only provide expedited processing when a “compelling need” can be demonstrated.

To ensure timely responses to requests for expedited processing, the Commission revises § 503.32(e)(4) to change “working days” to “calendar days” to coincide with FOIA.

The Commission must submit an annual report on its FOIA related activities to the Attorney General. The Commission revises § 502.23 to reference the activities cited in FOIA, 5 U.S.C. 552(e), rather than list out all activities reported upon.

A technical revision and update of § 503.87(b) accounts for a recent redesignation of subparts with the addition of new subpart E.

This direct final rule is not a “major rule” under 5 U.S.C. 804(2). No notice of proposed rulemaking is required; therefore, the provisions of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., do not apply.

The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires an agency to review regulations to assess their impact on small entities and prepare an initial regulatory flexibility analysis (IRFA), unless the agency determines that a rule is not expected to have a significant impact on a substantial number of small entities. This rulemaking will affect only persons who file FOIA requests, and therefore, the Chairman certifies that this rulemaking will not have a significant or negative economic impact on a substantial number of small entities.

The Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521, requires an agency to seek and receive approval from the Office of Management and Budget (OMB) before making most requests for information if the agency is requesting information from more than ten persons. 44 U.S.C. 3507. The agency must submit collections of information in rules to OMB in conjunction with the publication of the rulemaking. 5 CFR 1320.11. The Commission is not proposing any collections of information, as defined by 44 U.S.C. 3502(3) and 5 CFR 1320.3(c), as part of this rule.

The Commission assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda, available at: http://www.reginfo.gov/public/do/eAgendaMain.

The Commission expects the amendments to be noncontroversial. Therefore, pursuant to 5 U.S.C. 553, notice and comment are not required and this rule may become effective after publication in the Federal Register unless the Commission receives significant adverse comments within the specified period. The Commission recognizes that parties may have information that could impact the Commission's views and intentions with respect to the revised regulations, and the Commission intends to consider any comments filed. The Commission will withdraw the rule if it receives significant adverse comments. Filed comments that are not adverse may be considered for modifications to part 503 at a future date. If no significant adverse comment is received, the rule will become effective without additional action.

For the reasons set forth in the preamble, the Federal Maritime Commission amends 46 CFR part 503 as follows:

This is a summary of the Commission's Effective Competition Order, FCC 15-62, adopted on June 2, 2015 and released on June 3, 2015. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street SW., Room CY-A257, Washington, DC 20554. This document will also be available via ECFS at http://fjallfoss.fcc.gov/ecfs/. Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat. Copies of the materials can be obtained from the FCC's Reference Information Center at (202) 418-0270. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to [email protected] or calling the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

1. In this Report and Order (“Order”), we improve and expedite the effective competition process by adopting a rebuttable presumption that cable operators are subject to “Effective Competition.” 1 Specifically, we presume that cable operators are subject to what is commonly referred to as “Competing Provider Effective Competition.” As a result, each franchising authority 2 will be prohibited from regulating basic cable rates unless it successfully demonstrates that the cable system is not subject to Competing Provider Effective Competition. This change is justified by the fact that Direct Broadcast Satellite (“DBS”) service is ubiquitous today and that DBS providers have captured almost 34 percent of multichannel video programming distributor (“MVPD”) subscribers. This Order also implements section 111 of the STELA Reauthorization Act of 2014 (“STELAR”), which directs the Commission to adopt a streamlined Effective Competition process for small cable operators.3 By adopting a rebuttable presumption of Competing Provider Effective Competition, we update our Effective Competition rules, for the first time in over 20 years, to reflect the current MVPD marketplace, reduce the regulatory burdens on all cable operators, especially small operators,4 and more efficiently allocate the Commission's resources.

2. In the Cable Television Consumer Protection and Competition Act of 1992 (“1992 Cable Act”), Congress adopted a “preference for competition,” pursuant to which a franchising authority may regulate basic cable service tier rates and equipment only if the Commission finds that the cable system is not subject to Effective Competition.5 Section 623(l)(1) of the Act defines the four types of Effective Competition, as follows:

• Low Penetration Effective Competition, which is present if fewer than 30 percent of the households in the franchise area subscribe to the cable service of a cable system;

• Competing Provider Effective Competition, which is present if the franchise area is (i) served by at least two unaffiliated MVPDs each of which offers comparable video programming to at least 50 percent of the households in the franchise area; and (ii) the number of households subscribing to programming services offered by MVPDs other than the largest MVPD exceeds 15 percent of the households in the franchise area;

• Municipal Provider Effective Competition, which is present if an MVPD operated by the franchising authority for that franchise area offers video programming to at least 50 percent of the households in that franchise area; and

• Local Exchange Carrier (LEC) Effective Competition, which is present if a local exchange carrier or its affiliate (or any MVPD using the facilities of such carrier or its affiliate) offers video programming services directly to subscribers by any means (other than direct-to-home satellite services) in the franchise area of an unaffiliated cable operator which is providing cable service in that franchise area, but only if the video programming services so offered in that area are comparable to the video programming services provided by the unaffiliated cable operator in that area.

Section 623 of the Act does not permit franchising authorities to regulate any cable service rates other than the basic service tier rate and equipment used to receive the signal.

3. In 1993, when the Commission implemented the statute's Effective Competition provisions, the existence of Effective Competition was the exception rather than the rule. Incumbent cable operators had captured approximately 95 percent of MVPD subscribers. In the vast majority of franchise areas only a single cable operator provided service and those operators had “substantial market power at the local distribution level.” 6 DBS service had not yet entered the market, and local exchange carriers (“LECs”), such as Verizon and AT&T, had not yet entered the MVPD business in any significant way. Against this backdrop, the Commission adopted a presumption that cable systems are not subject to Effective Competition, and it provided that a franchising authority that wanted to regulate a cable operator's basic service tier rates must be certified by filing FCC Form 328 with the Commission. A cable operator that wishes to challenge the franchising authority's right to regulate its basic service tier rate bears the burden of rebutting the presumption and demonstrating that it is in fact subject to Effective Competition.

4. As described in the Notice of Proposed Rulemaking (“NPRM”) in this proceeding, the MVPD marketplace has changed in ways that substantially impact the test for Competing Provider Effective Competition. After the NPRM was released, the Commission adopted its most recent video competition report containing many of the same statistics cited in the NPRM. Specifically, the video competition report reached the following conclusions, among others:

• Slight increase in DBS subscribership. The number of DBS subscribers increased from year-end 2012 (34.1 million, or 33.8 percent of MVPD subscribers) to year-end 2013 (34.2 million, or 33.9 percent of MVPD subscribers).

• Significant increase in telephone MVPD subscribership. The number of telephone MVPD subscribers increased from year-end 2012 (9.9 million, or 9.8 percent of MVPD subscribers) to year-end 2013 (11.3 million, or 11.2 percent of MVPD subscribers).

• Widespread availability of DBS video service. DIRECTV provides local broadcast channels to 197 markets representing over 99 percent of U.S. homes, and DISH Network provides local broadcast channels to all 210 markets.

• Consumer access to multiple MVPDs. Approximately 99.7 percent of homes in the U.S. have access to at least three MVPDs, and nearly 35 percent have access to at least four MVPDs.

5. The Commission released the NPRM in this proceeding seeking comment on adopting a presumption of Competing Provider Effective Competition. The Commission sought to establish a streamlined Effective Competition process for small cable operators and to adopt policies that would reduce unnecessary regulatory burdens on the industry as a whole while ensuring the most efficient use of Commission resources.

6. We adopt a rebuttable presumption that cable operators are subject to Competing Provider Effective Competition, finding that such an approach is warranted by market changes since the Commission adopted the presumption of no Effective Competition over 20 years ago. When the Commission adopted the presumption of no Effective Competition, incumbent cable operators had approximately a 95 percent market share of MVPD subscribers and only a single cable operator served the local franchise area in the vast majority of franchise areas, which is very different from today's marketplace. As explained above, the two-pronged test for a finding of Competing Provider Effective Competition requires that (1) the franchise area is “served by at least two unaffiliated [MVPDs] each of which offers comparable video programming to at least 50 percent of the households in the franchise area;” and (2) “the number of households subscribing to programming services offered by [MVPDs] other than the largest [MVPD] exceeds 15 percent of the households in the franchise area.” 7 Below we explain how the current state of competition in the MVPD marketplace, particularly with regard to DBS, supports a rebuttable presumption that the two-part test is met.

7. At the outset, we note that out of the 1,440 Community Unit Identification Numbers (“CUIDs”) 8 for which the Commission has made an Effective Competition determination since the start of 2013, it found that 1,433 CUIDs (or more than 99.5 percent of the CUIDs evaluated) have satisfied one of the statutory Effective Competition tests.9 For the vast majority of the CUIDs evaluated (1,150, or approximately 80 percent), this decision was based on Competing Provider Effective Competition.10 Franchising authorities filed oppositions to only 18 (or less than 8 percent) of the total of 228 Effective Competition petitions considered during this timeframe.11 Some commenters object to an analysis of data based on filed Effective Competition petitions, asserting that cable operators do not file petitions where they know the filings would be denied based on a lack of Effective Competition. However, given data that indicates a ubiquitous DBS presence nationwide, we have no reason to believe that the number of Effective Competition petitions granted in recent years is not representative of the marketplace on the whole. Marketplace realities cause us to believe that in nearly all communities where cable operators have declined to file Effective Competition petitions, Effective Competition is present but the cable operator has not found it worthwhile to undertake the expense of filing an Effective Competition petition, perhaps because the vast majority of franchising authorities have chosen not to regulate rates despite the existing presumption of no Effective Competition.

8. With regard to the first prong of the Competing Provider Effective Competition test as related to the new presumption, we find that the ubiquitous nationwide presence of DBS providers, DIRECTV and DISH Network, presumptively satisfies the requirement that the franchise area be served by two unaffiliated MVPDs each of which offers comparable programming to at least 50 percent of the households in the franchise area. Neither DIRECTV nor DISH Network is affiliated with each other.12 To offer comparable programming, the Commission's rules provide that a competing MVPD must offer at least 12 channels of video programming, including at least one channel of non-broadcast service programming.13 The programming lineups of DIRECTV and DISH Network satisfy this requirement. In addition, the widespread presence of DIRECTV and DISH Network justifies a rebuttable presumption that they each offer MVPD service to at least 50 percent of households in all franchise areas. As stated above, DIRECTV provides local broadcast channels to 197 markets representing over 99 percent of U.S. homes, and DISH Network provides local broadcast channels to all 210 markets.14 In the most recent video competition report, the Commission assumed that DBS MVPDs are available to all homes in the U.S., while recognizing that this slightly overstates the actual availability of DBS. Further, the Commission has held in hundreds of Competing Provider Effective Competition decisions that the presence of DIRECTV and DISH Network satisfies the first prong of the test. Notably, the Commission has never determined that the presence of DIRECTV and DISH Network failed to satisfy the first prong of the competing provider test.

9. With regard to the second prong of the test, we will presume that more than 15 percent of the households in a franchise area subscribe to programming services offered by MVPDs other than the largest MVPD. Based on the data presented above, on a nationwide basis competitors to incumbent cable operators have captured approximately 34 percent of U.S. households, or more than double the percentage needed to satisfy the second prong of the competing provider test.15 Nationally, DBS service alone has close to twice the necessary subscribership.16 Further, NCTA has found that competing MVPDs have a penetration rate of more than 15 percent in each of the 210 Designated Market Areas (“DMAs”) in the United States, and most DMAs have a DBS penetration rate above 20 percent. NAB argues that a presumption based on national market share data lacks a rational nexus to the question of whether more than 15 percent of the households in a specific franchise area actually subscribe to programming services offered by MVPDs other than the largest MVPD. We disagree, finding instead that, as NCTA states, “an average figure is not conclusive evidence of the specific penetration in every community” but “it undeniably supports the Commission's proposed rebuttable presumption” and “is a strong predictor that competitors have garnered far in excess of the market share Congress deemed necessary to free cable operators from the vestiges of rate regulation.” The level of competing MVPD penetration in all of the DMAs, along with their ubiquitous service availability, justifies placing the burden on franchising authorities to show a lack of Effective Competition. Under the rebuttable presumption adopted in this Order, local franchising authorities will be able to attempt to demonstrate that the Competing Provider Effective Competition test is not met in a given area. Thus, we will not be basing our finding on the nationwide statistics alone.

10. For all of the above reasons, we conclude that adopting a rebuttable presumption of Competing Provider Effective Competition is consistent with the current state of the video marketplace. We do not, however, find that market changes since the adoption of the original presumption would support a presumption that any of the other Effective Competition tests (low penetration, municipal provider, or LEC) is met. Although some commenters have asked that we also establish a rebuttable presumption of LEC Effective Competition in any franchise area where an LEC MVPD offers video service, we decline to do so at this time. The record lacks evidence to support a presumption that the service area of an LEC MVPD substantially overlaps that of the incumbent cable operator in a sufficient number of franchise areas where an LEC MVPD offers video service to make such a presumption supportable. Accordingly, our presumption of Effective Competition is limited to Competing Provider Effective Competition. Absent a demonstration to the contrary, we will continue to presume that cable systems are not subject to Low Penetration, Municipal Provider, or LEC Effective Competition.

11. Adoption of the presumption of Competing Provider Effective Competition is consistent with section 623 of the Act, which prohibits a franchising authority from regulating basic cable rates “[i]f the Commission finds that a cable system is subject to effective competition.” Contrary to the suggestion of some commenters, we see no statutory bar to applying a nationwide rebuttable presumption of Competing Provider Effective Competition in making this finding. In fact, the NPRM in the proceeding implementing section 623 of the Act initially proposed to require franchising authorities to demonstrate that Effective Competition was not present in the franchise area, explaining that such an approach would be reasonable because the Act “makes the absence of effective competition a prerequisite to regulators' legal authority over basic rates.” Specifically, the statute provides that “[i]f the Commission finds that a cable system is not subject to effective competition, the rates for the provision of basic cable service shall be subject to regulation by a franchising authority, or by the Commission . . . .” Although the Commission ultimately took a different course, that decision was based on what was most efficient given the state of the marketplace at the time the presumption was adopted and it was not mandated by statute. Given the state of the video marketplace today, we find that it is appropriate to presume the presence of Competing Provider Effective Competition on a nationwide basis, provided that franchising authorities have an opportunity to rebut that presumption and demonstrate that the Competing Provider Effective Competition test is not met in a specific area. The franchising authority's ability to file a revised Form 328 pursuant to the procedures discussed below will ensure that the Commission will continue to receive evidence regarding a specific franchise area where the franchising authority deems it relevant. The fact that Effective Competition decisions apply to specific franchise areas does not preclude the Commission from adopting a rebuttable presumption of Competing Provider Effective Competition today based on the pervasive competition to cable from other MVPDs, just as it did not prevent the Commission from adopting a rebuttable presumption of no Effective Competition based on cable's national 95 percent share of the MVPD marketplace in 1993. In the NPRM, we sought comment on whether there were certain geographic areas in which we should not adopt a presumption of Competing Provider Effective Competition. No commenter addressed this issue, and thus we will not adopt different rules for any specific geographic areas.

12. We are not persuaded by commenters who argue that we should not adopt a rebuttable presumption of Competing Provider Effective Competition because of the potential impact of findings of Effective Competition on the basic service tier requirement found in section 623 of the Act. Several commenters argue that our action would enable cable operators to move broadcast stations that elect retransmission consent and public, educational, and governmental access (“PEG”) channels to a higher tier, leading to higher consumer prices. If a finding of Effective Competition results in elimination of the basic service tier requirement—a statutory interpretation issue that we do not address here—that conclusion would apply not only in communities where the new presumption of Effective Competition is not successfully rebutted but also in the thousands of communities in which we have already issued findings of Effective Competition. Despite these widespread findings of Effective Competition, commenters have not pointed to a single instance in which cable operators have even attempted to move broadcast stations or PEG channels off the basic service tier.17 NAB argues that cable operators may not have moved broadcast stations or PEG channels to a higher tier in communities with a finding of Effective Competition at least in part because they do not wish to do so on a fragmented “patchwork” basis but they have provided no support for this assertion. Moreover, a patchwork of communities with and without Effective Competition will continue to exist after the adoption of this Order if any franchising authorities are able to rebut the new presumption and remain certified. We thus find that the concerns expressed by commenters in this regard are unpersuasive. Moreover, they do not speak to the key issue in this proceeding: whether maintaining a presumption of no Effective Competition is consistent with the current state of the MVPD marketplace. Accordingly, we do not believe that they provide a sound basis to retain rules that are no longer justified by marketplace realities and that place unwarranted burdens on cable operators and the Commission.

13. For the reasons stated above, section 623 of the Act provides the Commission with ample authority to adopt a rebuttable presumption of Competing Provider Effective Competition for both large and small cable operators. However, additional support for our decision today is found in STELAR. Specifically, we conclude that adopting a rebuttable presumption of Competing Provider Effective Competition fully effectuates the Commission's responsibilities under section 111 of STELAR. Section 111 directs the Commission “to establish a streamlined process for filing of an effective competition petition pursuant to this section for small cable operators, particularly those who serve primarily rural areas.” The new presumption of Competing Provider Effective Competition will establish a streamlined process for all cable operators, including small operators, by reallocating the burden of providing evidence of Effective Competition in a manner that better comports with the current state of the marketplace. The existing presumption of no Effective Competition requires cable operators to produce information about competing providers' service areas and numbers of subscribers, and to petition the Commission for an affirmative finding of the requisite competition in particular franchise areas. Changing the presumption—which is merely a procedural device—will streamline the process by shifting the burden of producing evidence with respect to Effective Competition. Under our modified rule, franchising authorities remain free to rebut the presumption by presenting community-specific evidence, which the cable operator would then have the burden to overcome based on its own evidence. The new process is streamlined for cable operators because they will be required to file only in response to a showing by a franchising authority that an operator does not face Competing Provider Effective Competition in the franchise area. The burden would then shift to the cable operator to prove Effective Competition. As ACA states:

14. We agree with commenters that there is no statutory restriction on extending the same revised rebuttable presumption of Competing Provider Effective Competition to all cable systems. Section 111 of STELAR directs the Commission to establish streamlined measures for small cable operators within a certain deadline, but it “neither expands nor restricts the scope of the Commission's authority to administer the effective competition process.” 18 As commenters observe, “reducing regulatory burdens on all cable operators, large and small,” will ensure that Commission procedures “reflect marketplace realities and allow for a more efficient allocation of Commission and industry resources.” 19

15. We recognize that STELAR provides that “[n]othing in this subsection shall be construed to have any effect on the duty of a small cable operator to prove the existence of effective competition under this section.” NAB argues that this provision ratifies the Commission's placement of the burden of proving Effective Competition on the cable operators, and prevents the Commission from shifting the burden. We do not read this language as limiting the Commission's authority to eliminate or modify the presumption for cable operators, large or small. The Commission adopted the presumption of no Effective Competition as a procedural mechanism, based in large part on the premise that “the vast majority of cable systems” in 1993 were “not subject to effective competition.” 20 The presumption was never mandated by Congress, and there is nothing in STELAR's provisions that suggests that Congress intended to withdraw the Commission's general rulemaking power to revisit its rules and modify or repeal them if it finds such action is warranted. In the clause that NAB relies on, Congress merely disavows any intent to alter or interfere with the Commission rule requiring proof of the existence of Effective Competition, as applied to small cable operators. It does not require the Commission to maintain the presumption of no Effective Competition. Rather, Congress only requires the Commission to streamline the process for “small cable operators.” Thus, Congress did not “ratify” or lock in place the current presumption. Indeed, if this provision were read to restrict the Commission from changing the presumption for small operators, as NAB urges, it would have the perverse effect of permitting the Commission to reduce burdens on larger operators but not on smaller ones, contrary to the clear intent and narrow focus of section 111. Thus, we find unpersuasive NAB's argument that section 111 of STELAR prohibits the rule modifications adopted in this Order.

16. In the NPRM, the Commission sought comment on alternate streamlined procedures that it could adopt for small cable operators pursuant to section 111. Some commenters proposed that we could implement section 111 through small cable operator Effective Competition reforms other than reversing the presumption, for example, by eliminating filing fees, automatically granting certain petitions, adopting a time limit for Commission review, or otherwise streamlining existing Effective Competition procedures. We have evaluated all of the alternate proposals set forth in the record and we conclude that, while some are already implemented, others would not have a sufficient impact on the costs that burden cable operators, particularly small cable operators, under the existing Effective Competition regime, including the costs of purchasing data indicating what zip codes make up the local franchising area, using the resulting list of zip codes to purchase penetration data, and preparing a formal legal filing. Accordingly, we have concluded that adopting a rebuttable presumption of Competing Provider Effective Competition is the best approach to streamline the process for small cable operators.

17. In this section, we adopt new procedures to implement the rebuttable presumption of Competing Provider Effective Competition. With certain exceptions discussed below, we adopt procedures largely comparable to those discussed in the NPRM. In short, a franchising authority will obtain certification to regulate a cable operator's basic service tier and associated equipment by filing a revised Form 328, which will include a demonstration rebutting the presumption of Competing Provider Effective Competition. A cable operator may continue to oppose a Form 328 by filing a petition for reconsideration of the form.

18. Specifically, as under our existing procedures, a franchising authority that seeks certification to regulate a cable operator's basic service tier and associated equipment will file Form 328. We will revise Question 6 of that form to include a new Question 6a, which will state the new presumption of Competing Provider Effective Competition. Question 6a will ask a franchising authority to provide an attachment containing evidence adequate to satisfy its burden of rebutting the presumption with specific evidence. A franchising authority may continue to rely on the current presumption that Low Penetration, Municipal Provider, and LEC Effective Competition are not present unless it has actual knowledge to the contrary. Hence, a franchising authority need not submit evidence regarding a lack of Effective Competition under those three tests; it need only submit evidence regarding the lack of Competing Provider Effective Competition. Question 6b of the revised form will state the presumption that cable systems are not subject to any other type of Effective Competition excluding Competing Provider Effective Competition, and it will retain the question in the current form asking the franchising authority to indicate whether it has reason to believe that this presumption is correct. We will revise the instructions for completing Form 328 to reflect the changes to Question 6. In addition, we note that instruction number 2 to the form was not previously updated to reference LEC Effective Competition, even though the form itself contains such an update. For accuracy and completeness, we will revise instruction number 2 to reference LEC Effective Competition.

19. Except as otherwise discussed, we will retain the existing provisions in section 76.910 of our rules governing franchising authority certifications. As stated in current section 76.910, the certification will become effective 30 days after the franchising authority files Form 328 unless the Commission notifies the franchising authority otherwise.21 We find that this approach is consistent with a presumption of Competing Provider Effective Competition, because the franchising authority is required to submit a rebuttal of that presumption with Form 328. This approach also is consistent with the statutory requirement that in general, a franchising authority's certification must become effective 30 days after the date filed.22 Once a franchising authority files revised Form 328, the Commission may deny a certification based on failure to meet the applicable burden, consistent with the Commission's authority to dismiss a pleading that fails on its face to satisfy applicable requirements. Accordingly, if a franchising authority files a revised Form 328 that fails to meet the required standards to regulate rates, we will promptly deny the filing and it thus will not become effective 30 days after filing. We see no need to require a franchising authority to wait one year before filing a new Form 328 after one is denied, as ACA requests; we believe that franchising authorities should remain able to file a new Form 328 at any time if circumstances change such that they can submit new data rebutting the presumption of Competing Provider Effective Competition.

20. We also find that deeming a certification effective 30 days after it is filed is consistent with STELAR's requirement that we streamline the Effective Competition process for small cable operators. We expect that few franchising authorities will file the revised Form 328 because they will be unable to produce the necessary evidence to rebut the presumption of Competing Provider Effective Competition in most franchise areas, due to the ubiquity of DBS service. Cable operators thus will likely need to address only a small number of filed Form 328s. In fact, if the Commission finds that the attachment accompanying a franchising authority's Form 328 fails to show the evidence required to rebut the presumption, and the Commission thus dismisses the form based on failure to meet the applicable burden, then the cable operator will not need to take any affirmative action. The new approach adopted herein thus will streamline the Effective Competition process for all cable operators, including small ones. The NPRM sought comment on whether a cable operator should have an opportunity before the 30-day period expires to respond to a franchising authority's showing. Commenters did not address this issue and we find it unnecessary to do so, given that a cable operator may file a petition for reconsideration that would automatically stay the imposition of rate regulation, as discussed below.

21. As discussed in the NPRM, under our current rules a cable operator may oppose a certification by filing a petition for reconsideration pursuant to section 76.911 of our rules, demonstrating that it satisfies any of the four tests for Effective Competition.23 Similarly, under the new rules, the cable operator may file a petition for reconsideration in which it either (a) disagrees with a franchising authority's rebuttal of the presumption of Competing Provider Effective Competition, or (b) attempts to demonstrate the presence of one of the other types of Effective Competition (low penetration, municipal provider, or LEC). We see no need to make any revisions to existing section 76.911. The procedures set forth in section 1.106 of our rules for the filing of petitions for reconsideration will continue to govern petitions for reconsideration of Form 328 and responsive pleadings.24 In addition, a cable operator's filing of a petition for reconsideration alleging that Effective Competition exists will continue to automatically stay the imposition of rate regulation pending the outcome of the reconsideration proceeding. Although the NPRM sought comment on whether we should deem a petition for reconsideration granted if the Commission does not act on it within six months, we find that such an approach is unnecessary given the automatic rate regulation stay.

22. Our rules currently permit cable operators to request information from a competitor about the competitor's reach and number of subscribers, if the evidence necessary to establish Effective Competition is not otherwise available. We will retain that provision, while adding a similar provision to benefit franchising authorities now that they will bear the burden of demonstrating the lack of Competing Provider Effective Competition. Specifically, we will amend our rules to provide that, if a franchising authority filing Form 328 wishes to demonstrate a lack of Competing Provider Effective Competition and necessary evidence is not otherwise available, the franchising authority may request directly from an MVPD information regarding the MVPD's reach and number of subscribers in a particular franchise area. As currently required for such requests by cable operators, we will require the MVPD to respond to such a request within 15 days, and we will permit such responses to be limited to numerical totals related to subscribership and reach. Third-party MVPDs must timely respond to these requests, and the Commission may use its enforcement power to ensure compliance. We understand that currently, third-party MVPDs or their agents sometimes charge cable operators for access to this data. We will revisit the issue of the cost of the data if we receive complaints that the cost of such data makes the filing of Form 328 cost-prohibitive to franchising authorities.

23. Even under the new approach to Effective Competition adopted herein, we expect that cable operators still on occasion may wish to file petitions for a determination of Effective Competition pursuant to section 76.907 of our rules. In particular, if a franchising authority is certified under the new rules and procedures, a cable operator may at a later date wish to file a petition demonstrating that circumstances have changed and one of the four types of Effective Competition exists. Accordingly, we will retain existing section 76.907, but we will revise section 76.907(b) to reflect the new presumption. Once a franchising authority is certified under the new rules adopted herein, after having demonstrated a lack of Competing Provider Effective Competition, we agree with ACA that it would not make sense for a cable operator filing a decertification petition to benefit from the presumption of Effective Competition; rather, in this instance the cable operator must demonstrate that circumstances have changed and Effective Competition is now present in the franchise area.25 We will clarify in revised section 76.907(b) that the new presumption of Competing Provider Effective Competition does not apply in this instance.

24. All of the new rules and procedures for Effective Competition will go into effect once the Commission announces approval by the Office of Management and Budget (“OMB”) of the rules that require such approval and of revised Form 328. Although some of the rules, such as the new rebuttable presumption of Competing Provider Effective Competition itself, do not require OMB approval, we conclude that none of the rules should go into effect until the OMB approval is obtained. Although some commenters have argued that cable operators generally should benefit from the new presumption as soon as it is adopted, we find that tying the effective date to the OMB approval is appropriate where, as here, all of the rules are so closely tied to the submission of a revised form that requires OMB approval.

25. Overall, we find that the new rules and procedures discussed above will create an Effective Competition process that is more efficient for cable operators, especially small cable operators, than the current approach. Cable operators will not be required to file petitions for a determination of Effective Competition in the first instance; instead, franchising authorities will have to rebut the presumption of Competing Provider Effective Competition in those limited locations in which the statutory test is not met. The record demonstrates that filing Effective Competition petitions has forced cable operators to incur significant costs, such as the cost of purchasing zip code and competing provider penetration data and preparing formal legal filings, merely to confirm what the marketplace data already suggests about the likely application of the statutory Effective Competition tests in almost all communities. According to ACA, only one cable operator with fewer than 1,000,000 total subscribers has filed an Effective Competition petition since December 30, 2011, even though such operators are likely subject to Effective Competition to the same degree as other, larger operators. Given the ubiquitous nationwide presence and penetration levels of DBS, we find that it no longer makes sense to burden cable operators with the costs of filing an Effective Competition petition in the first instance. It is far more efficient to require franchising authorities to rebut the presumption in those relatively rare instances where there may not be Effective Competition. Contrary to NAB's suggestion, the burdens imposed on cable operators under the current presumption, which is no longer supportable by marketplace data, justify adoption of the new presumption as the most efficient approach. The fact that cable operators benefit from a finding of Effective Competition does not alter this analysis. We expect that the volume of new Form 328s filed by franchising authorities will be far less than the volume of cable operator Effective Competition petitions currently filed, which will conserve resources of cable operators as well as the Commission. Contrary to the suggestion of some commenters, we do not expect franchising authorities in thousands of communities to file new Form 328s. Rather, we anticipate that few franchising authorities will be able to present data to rebut the presumption of Competing Provider Effective Competition, given the ubiquity and penetration of DBS. In this regard, we agree with NCTA that, “[g]iven competitive conditions throughout the country and the relatively few [franchising authorities] that currently rate regulate, shifting the presumption is extraordinarily unlikely to unleash an avalanche of [franchising authority] filings.”

26. We recognize that franchising authorities, including small franchising authorities, will face additional burdens in preparing revised Form 328 with an attachment rebutting the presumption of Competing Provider Effective Competition, and we also recognize that some franchising authorities have limited resources. We conclude that any such burdens are justified by the efficiency gained by conforming the presumption to marketplace realities. In 1993, the Commission stated that it was “mindful of franchising authorities' concern that they do not have access to the information or the resources necessary to show the absence of effective competition as a threshold matter of jurisdiction.” 26 Today, in contrast, Effective Competition exists in the vast majority of franchise areas and we anticipate few franchising authorities will have a basis for filing a revised Form 328 demonstrating a lack of Competing Provider Effective Competition. In addition, we have ensured that franchising authorities will have access to the information needed to demonstrate a lack of Competing Provider Effective Competition by implementing procedures pursuant to which a franchising authority may request directly from an MVPD information regarding the MVPD's reach and number of subscribers in a particular franchise area. With regard to the burden on the franchising authorities, ACA explains that unlike cable operators, governmental entities can receive zip code data from the post office free of charge, and governmental entities likely know all of the zip codes within their jurisdiction in any event. Overall, the costs to franchising authorities will be outweighed by the significant cost-saving benefits of a presumption that is consistent with market data showing that the vast majority of communities would satisfy the Competing Provider Effective Competition standard. We will monitor the marketplace to determine whether the burdens of filing a revised Form 328 are dissuading franchising authorities from filing, and if so, we will reconsider whether changes should be made to reduce their costs.

27. Many franchising authorities were certified over 20 years ago to regulate the basic service tier rates and equipment based on the existing presumption of no Effective Competition. Based on the changes in the marketplace that have occurred in the last 20 years, discussed above, we believe that the factual foundation for those findings is no longer valid in most cases. Therefore, all franchising authorities with existing certifications that wish to remain certified must file revised Form 328, including the attachment rebutting the presumption of Competing Provider Effective Competition, within 90 days of the effective date of the new rules.27 If a franchising authority with an existing certification does not file a new certification (Form 328) during the 90-day timeframe, its existing certification will expire at the end of that timeframe as long as there is not pending for the franchise area an opposed Effective Competition petition or an opposed or unopposed petition for reconsideration of certification, petition for reconsideration of an Effective Competition decision, or application for review of an Effective Competition decision.28 The Media Bureau will issue a public notice at the conclusion of the 90-day timeframe identifying all franchising authorities that filed a revised Form 328 as well as those franchising authorities that are party to one of the above-listed pending proceedings, and stating its finding of Competing Provider Effective Competition applicable to all other currently certified franchising authorities. This public notice will address commenters' concerns that the Act requires the Commission to make a franchise area-specific finding of Effective Competition before revoking existing certifications. The Media Bureau's finding of Competing Provider Effective Competition will be based on the new presumption coupled with the franchising authority's failure to attempt to retain its certification by resubmitting Form 328 accompanied by the requisite showing of no Competing Provider Effective Competition. We thus find that the approach adopted herein, which the NPRM sought comment on in the alternative, is preferable to administratively revoking all existing certifications since it will afford franchising authorities an opportunity to rebut the new presumption while their existing certification is still in effect and requires a Commission finding of Effective Competition for each franchise area.

28. Where currently certified franchising authorities file revised Form 328, their certifications will remain valid unless and until the Media Bureau issues a decision denying the new certification request.29 We will not automatically deny a Form 328 that we do not act on within a certain timeframe, finding that doing so would be inconsistent with the statutory requirement that franchising authority certifications become effective 30 days after the date filed and with the procedures adopted above. If a currently certified franchising authority files revised Form 328 and there is a pending cable operator Effective Competition petition, petition for reconsideration of certification, petition for reconsideration of an Effective Competition decision, or application for review of an Effective Competition decision applicable to the franchise area, the Media Bureau will consider the record from that filing along with the new certification in making its determination regarding whether the franchising authority has overcome the presumption of Competing Provider Effective Competition.30 If a currently certified franchising authority files revised Form 328 but there is no applicable pending proceeding, the Media Bureau may consider the form itself as well as other relevant data available to the Bureau in making its determination.

29. Where existing franchising authority certifications expire pursuant to the procedures discussed above, the Commission itself will not regulate rates. Section 76.913(a) of the Commission's rules, which generally directs the Commission to regulate rates upon revocation of a franchising authority's certification, will not apply upon the expiration of existing certifications discussed above. The Act precludes a franchising authority or the Commission from regulating rates where Effective Competition is present, and the expirations will be based on just such a finding. Section 623(a)(6) of the Act does not apply to this situation because it requires the Commission to “exercise the franchising authority's regulatory jurisdiction” over cable basic service tier rates if the Commission either (1) “disapproves a franchising authority” due to specified legal or procedural infirmities, or (2) revokes the franchising authority's jurisdiction to regulate rates following petition by a cable operator or other interested party based upon a finding “that the State and local laws and regulations are not in conformance with” the Commission's basic service tier rate regulations. The expiration of existing franchising authority certifications based on a rebuttable presumption of Competing Provider Effective Competition combined with the franchising authority's subsequent failure to attempt to retain its certification is distinguishable from a Commission finding of legal or procedural infirmities following an initial certification submission. Contrary to NAB's suggestions, the expiration of existing franchising authority certifications is justified for the reasons discussed above, and it does not matter that the expirations will be unrelated to a petition by a cable operator or other interested party.

30. There are currently 58 pending cable operator petitions seeking a finding of Effective Competition, and a total of 17 pending petitions for reconsideration of certification, petitions for reconsideration of an Effective Competition decision, and applications for review of an Effective Competition decision. As explained above, if one of these pending proceedings involves a currently certified franchising authority that files revised Form 328, the record from the pending proceeding will be considered along with the revised Form 328 submission when the Media Bureau makes its certification determination. If, however, the pending proceeding involves a franchising authority that does not file revised Form 328 during the 90-day timeframe but either (i) the proceeding is an opposed cable operator Effective Competition petition, or (ii) the proceeding is a petition for reconsideration of certification, petition for reconsideration of an Effective Competition decision, or application for review of an Effective Competition decision, then the Media Bureau or the Commission will adjudicate the pending proceeding based on the record before it. With regard to pending unopposed cable operator Effective Competition petitions where the franchising authority does not file revised Form 328, the Media Bureau will grant such petitions based on a finding that the new presumption of Competing Provider Effective Competition applies and the franchising authority has not attempted to rebut it. The Media Bureau will issue a public notice at the conclusion of the 90-day timeframe for filing revised Form 328, granting all pending unopposed cable operator Effective Competition petitions where the franchising authority has not filed revised Form 328, with the grant based on a finding of Competing Provider Effective Competition. That finding will be premised on the new presumption of Competing Provider Effective Competition, as well as the franchising authority's failure to oppose the cable operator Effective Competition petition in the first instance.

31. As required by the Regulatory Flexibility Act of 1980, as amended (“RFA”), an Initial Regulatory Flexibility Analysis (“IRFA”) was incorporated in the Notice of Proposed Rulemaking in this proceeding. The Federal Communications Commission (“Commission”) sought written public comment on the proposals in the NPRM, including comment on the IRFA. The Commission received no comments on the IRFA, although some commenters discussed the effect of the proposals on smaller entities, as discussed below. This present Final Regulatory Flexibility Analysis (“FRFA”) conforms to the RFA.

32. In the Report and Order (“Order”), the Commission improves and expedites the effective competition process by adopting a rebuttable presumption that cable operators are subject to “Effective Competition.” 31 Specifically, we presume that cable operators are subject to what is commonly referred to as “Competing Provider Effective Competition.” As a result, each franchising authority 32 will be prohibited from regulating basic cable rates unless it successfully demonstrates that the cable system is not subject to Competing Provider Effective Competition. This change is justified by the fact that Direct Broadcast Satellite (“DBS”) service is ubiquitous today and that DBS providers have captured almost 34 percent of multichannel video programming distributor (“MVPD”) subscribers. The Order also implements section 111 of the STELA Reauthorization Act of 2014 (“STELAR”), which directs the Commission to adopt a streamlined Effective Competition process for small cable operators.33 By adopting a rebuttable presumption of Competing Provider Effective Competition, we update our Effective Competition rules, for the first time in over 20 years, to reflect the current MVPD marketplace, reduce the regulatory burdens on all cable operators, especially small operators,34 and more efficiently allocate the Commission's resources.

33. No comments were filed in response to the IRFA. In response to the NPRM, some commenters discussed the effect of the proposals on smaller entities. Specifically, while some commenters advocated the benefits that a presumption of Competing Provider Effective Competition would have on cable operators, including small cable operators, other commenters expressed concern about the burdens that would be imposed on franchising authorities, including small franchising authorities. In addition, as explained above, section 111 of STELAR directs the Commission to adopt a streamlined Effective Competition process for small cable operators. While some commenters expressed their view that adopting a presumption of Competing Provider Effective Competition would best fulfill section 111, others advocated alternate ways to reform the Effective Competition process for small cable operators.

34. The RFA directs the Commission to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the rules adopted in the Order. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA. Below, we provide a description of such small entities, as well as an estimate of the number of such small entities, where feasible.

35. Small Governmental Jurisdictions. The term “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” Census Bureau data for 2011 indicate that there were 89,476 local governmental jurisdictions in the United States. We estimate that, of this total, a substantial majority may qualify as “small governmental jurisdictions.” Thus, we estimate that most governmental jurisdictions are small.

36. Wired Telecommunications Carriers. The 2007 North American Industry Classification System (“NAICS”) defines “Wired Telecommunications Carriers” as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies. Establishments in this industry use the wired telecommunications network facilities that they operate to provide a variety of services, such as wired telephony services, including VoIP services; wired (cable) audio and video programming distribution; and wired broadband Internet services. By exception, establishments providing satellite television distribution services using facilities and infrastructure that they operate are included in this industry.” The SBA has developed a small business size standard for wireline firms within the broad economic census category, “Wired Telecommunications Carriers.” Under this category, the SBA deems a wireline business to be small if it has 1,500 or fewer employees. Census data for 2007 shows that there were 3,188 firms that operated for the entire year. Of this total, 2,940 firms had fewer than 100 employees, and 248 firms had 100 or more employees. Therefore, under this size standard, we estimate that the majority of businesses can be considered small entities.

37. Cable Companies and Systems. The Commission has developed its own small business size standards, for the purpose of cable rate regulation. Under the Commission's rate regulation rules, a “small cable company” is one serving 400,000 or fewer subscribers, nationwide. According to SNL Kagan, there are 1,258 cable operators. Of this total, all but 10 incumbent cable companies are small under this size standard. In addition, under the Commission's rules, a “small system” is a cable system serving 15,000 or fewer subscribers. Current Commission records show 4,584 cable systems nationwide. Of this total, 4,012 cable systems have fewer than 20,000 subscribers, and 572 systems have 20,000 subscribers or more, based on the same records. Thus, under this standard, we estimate that most cable systems are small.

38. Direct Broadcast Satellite (“DBS”) Service. DBS service is a nationally distributed subscription service that delivers video and audio programming via satellite to a small parabolic “dish” antenna at the subscriber's location. DBS, by exception, is now included in the SBA's broad economic census category, “Wired Telecommunications Carriers,” which was developed for small wireline firms. Under this category, the SBA deems a wireline business to be small if it has 1,500 or fewer employees. Census data for 2007 shows that there were 3,188 firms that operated for the entire year. Of this total, 2,940 firms had fewer than 100 employees, and 248 firms had 100 or more employees. Therefore, under this size standard, the majority of such businesses can be considered small. However, the data we have available as a basis for estimating the number of such small entities were gathered under a superseded SBA small business size standard formerly titled “Cable and Other Program Distribution.” The 2002 definition of Cable and Other Program Distribution provided that a small entity is one with $12.5 million or less in annual receipts. Currently, only two entities provide DBS service, which requires a great investment of capital for operation: DIRECTV and DISH Network. Each currently offers subscription services. DIRECTV and DISH Network each report annual revenues that are in excess of the threshold for a small business. Because DBS service requires significant capital, we believe it is unlikely that a small entity as defined by the SBA would have the financial wherewithal to become a DBS service provider.

39. Open Video Systems. The open video system (“OVS”) framework was established in 1996, and is one of four statutorily recognized options for the provision of video programming services by local exchange carriers. The OVS framework provides opportunities for the distribution of video programming other than through cable systems. Because OVS operators provide subscription services, OVS falls within the SBA small business size standard covering cable services, which is “Wired Telecommunications Carriers.” The SBA has developed a small business size standard for this category, which is: all such firms having 1,500 or fewer employees. Census data for 2007 shows that there were 3,188 firms that operated for the entire year. Of this total, 2,940 firms had fewer than 100 employees, and 248 firms had 100 or more employees. Therefore, under this size standard, the majority of such businesses can be considered small. In addition, we note that the Commission has certified some OVS operators, with some now providing service. Broadband service providers (“BSPs”) are currently the only significant holders of OVS certifications or local OVS franchises. The Commission does not have financial or employment information regarding the entities authorized to provide OVS, some of which may not yet be operational. Thus, at least some of the OVS operators may qualify as small entities.

40. Small Incumbent Local Exchange Carriers. We have included small incumbent local exchange carriers in this present RFA analysis. A “small business” under the RFA is one that, inter alia, meets the pertinent small business size standard (e.g., a telephone communications business having 1,500 or fewer employees), and “is not dominant in its field of operation.” The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent local exchange carriers are not dominant in their field of operation because any such dominance is not “national” in scope. We have therefore included small incumbent local exchange carriers in this RFA analysis, although we emphasize that this RFA action has no effect on Commission analyses and determinations in other, non-RFA contexts.

41. Incumbent Local Exchange Carriers (“ILECs”). Neither the Commission nor the SBA has developed a small business size standard specifically for incumbent local exchange services. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. Census data for 2007 shows that there were 3,188 firms that operated for the entire year. Of this total, 2,940 firms had fewer than 100 employees, and 248 firms had 100 or more employees. Therefore, under this size standard, the majority of such businesses can be considered small entities.

42. Certain rule changes adopted in the Order will affect reporting, recordkeeping, or other compliance requirements. Pursuant to the rules and policies adopted in the Order, the Commission will presume that cable operators are subject to Competing Provider Effective Competition, with the burden of rebutting this presumption falling on the franchising authority. A franchising authority seeking certification to regulate a cable operator's basic service tier and associated equipment will file revised FCC Form 328, including an attachment containing evidence adequate to satisfy its burden of rebutting the presumption with specific evidence. Franchising authorities are already required to file Form 328 to obtain certification to regulate a cable system's basic service tier, but the attachment rebutting the presumption of Competing Provider Effective Competition will be a new requirement. Cable operators, including small cable operators, will retain the burden of demonstrating the presence of any other type of Effective Competition, which a cable operator may seek to demonstrate if a franchising authority rebuts the presumption of Competing Provider Effective Competition. A cable operator opposing a certification will be permitted to file a petition for reconsideration pursuant to section 76.911 of our rules, as is currently the case, demonstrating that it satisfies any of the four tests for Effective Competition. The procedures set forth in section 1.106 of our rules for the filing of petitions for reconsideration will continue to govern petitions for reconsideration of Form 328 and responsive pleadings. While a certification will become effective 30 days after the date filed unless the Commission notifies the franchising authority otherwise, the filing of a petition for reconsideration based on the presence of Effective Competition will automatically stay the imposition of rate regulation pending the outcome of the reconsideration proceeding. All of the new rules and procedures will go into effect once the Commission announces approval by the Office of Management and Budget (“OMB”) of the rules that require such approval and of revised Form 328.

43. All franchising authorities with existing certifications that wish to remain certified must file revised Form 328, including the attachment rebutting the presumption of Competing Provider Effective Competition, within 90 days of the effective date of the new rules. At the conclusion of the 90-day timeframe, the Media Bureau will issue a public notice identifying all franchising authorities that filed a revised Form 328 as well as those franchising authorities that are party to a pending opposed Effective Competition petition or a pending opposed or unopposed petition for reconsideration of certification, petition for reconsideration of an Effective Competition decision, or application for review of an Effective Competition decision. The public notice will state the Media Bureau's finding of Competing Provider Effective Competition applicable to all other currently certified franchising authorities. Where currently certified franchising authorities file revised Form 328, their certifications will remain valid unless and until the Media Bureau issues a decision denying the new certification request. If a currently certified franchising authority files revised Form 328 and there is a pending cable operator Effective Competition petition, petition for reconsideration of certification, petition for reconsideration of an Effective Competition decision, or application for review of an Effective Competition decision applicable to the franchise area, the Media Bureau will consider the record from that filing along with the new certification in making its determination regarding whether the franchising authority has overcome the presumption of Competing Provider Effective Competition.35 If a pending proceeding involves a franchising authority that does not file revised Form 328 during the 90-day timeframe but either (i) the proceeding is an opposed cable operator Effective Competition petition, or (ii) the proceeding is a petition for reconsideration of certification, petition for reconsideration of an Effective Competition decision, or application for review of an Effective Competition decision, then the Media Bureau or the Commission will adjudicate the pending proceeding based on the record before it. With regard to pending unopposed cable operator Effective Competition petitions where the franchising authority does not file revised Form 328, the Media Bureau will issue a public notice granting the petitions based on a finding of Competing Provider Effective Competition.

44. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance, rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.” The NPRM invited comment on the benefits and burdens of the approach we adopt herein on all entities, including small entities.

45. Overall, we expect that the approach the Commission adopts today will lessen the number of Effective Competition determinations addressed by the Commission and thus will reduce regulatory burdens on cable operators, and will more efficiently allocate the Commission's resources. In paragraph 25 of the Order, the Commission finds that the new rules and procedures will create an Effective Competition process that is more efficient for cable operators, especially small cable operators, since they will not be required to file petitions for a determination of Effective Competition in the first instance. The Commission explains the significant costs imposed on cable operators by the current Effective Competition process, and it explains how the new presumption will alleviate those costs.

46. In paragraph 26 of the Order, the Commission discusses the impact of the new rules and procedures on franchising authorities, including small franchising authorities. The Commission concludes that the burdens of filing revised Form 328 are justified by the efficiency gained by conforming the presumption to marketplace realities. The Commission also anticipates that few franchising authorities will have a basis for filing a revised Form 328 demonstrating a lack of Competing Provider Effective Competition as a result of the presence of Effective Competition in the vast majority of franchise areas. In addition, the Commission states that it has ensured that franchising authorities will have access to the information needed to demonstrate a lack of Competing Provider Effective Competition.36 Overall, the costs to franchising authorities will be outweighed by the significant cost-saving benefits of a presumption that is consistent with market data showing that the vast majority of communities would satisfy the Competing Provider Effective Competition standard. The Commission states that it will monitor the marketplace to determine whether the burdens of filing a revised Form 328 are dissuading franchising authorities from filing, and if so, it will reconsider whether changes should be made to reduce their costs.

47. Finally, we note that the Commission considered alternate means to implement section 111 of STELAR. After evaluating all of the alternate proposals set forth in the record, in paragraph 16 the Commission concludes that while some proposals are already implemented, others would not have a sufficient impact on the costs that burden cable operators, particularly small cable operators, under the existing Effective Competition regime. Accordingly, the Commission has concluded that adopting a rebuttable presumption of Competing Provider Effective Competition is the best approach to streamline the process for small cable operators.

48. None.

49. The Commission will send a copy of the Order, including this FRFA, in a report to be sent to Congress pursuant to the Congressional Review Act.37 In addition, the Commission will send a copy of the Order, including this FRFA, to the Chief Counsel for Advocacy of the SBA. The Order and FRFA (or summaries thereof) will also be published in the Federal Register.38

50. We analyzed this Order with respect to the Paperwork Reduction Act of 1995 (“PRA”),39 and it contains modified information collection requirements.40 It will be submitted to the Office of Management and Budget (“OMB”) for review under section 3507(d) of the PRA.41 The Commission, as part of its continuing effort to reduce paperwork burdens, will invite OMB, the general public, and other interested parties to comment on the information collection requirements contained in this document in a separate published Federal Register notice. In addition, we note that pursuant to the Small Business Paperwork Relief Act of 2002,42 we previously sought specific comment on how the Commission might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

51. The Commission will send a copy of this Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

52. For additional information on this proceeding, contact Diana Sokolow, [email protected], of the Policy Division, Media Bureau, (202) 418-2120.

53. Accordingly, it is ordered that, pursuant to the authority found in sections 4(i), 4(j), 303(r), and 623 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 303(r), and 543, and section 111 of the STELA Reauthorization Act of 2014, Public Law 113-200, section 111, this Order is adopted, effective upon announcement in the Federal Register of OMB approval and the effective date of the rules.

54. It is ordered that, pursuant to the authority found in sections 4(i), 4(j), 303(r), and 623 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 303(r), and 543, and section 111 of the STELA Reauthorization Act of 2014, Public Law 113-200, section 111, the Commission's rules are hereby amended as set forth in Appendix A.

55. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

56. It is further ordered that the Commission shall send a copy of this Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 76 as follows:

Background

We published a final rule in the Federal Register on October 8, 2008 (73 FR 59448), to revise our regulations governing falconry in the United States, found in title 50 of the Code of Federal Regulations (CFR) at § 21.29. In 2013, we added the State of California to the list of States to which we delegate permitting for falconry to the State, as provided under the regulations (78 FR 72830, December 4, 2013).

In the falconry regulations at 50 CFR 21.29, we offer two methods to submit required reports or other information: (1) Electronically, by entering the required information in our electronic database at http://permits.fws.gov/186A; and (2) by hard copy, by submitting a paper form 3-186A to the falconer's State, tribal, or territorial agency that governs falconry. The State of California has developed and implemented an online permitting and reporting system that is compatible with the system we use for reporting take of raptors from the wild for falconry (our electronic database at http://permits.fws.gov/186A). Allowing California residents to use that State's reporting system should result in a small savings of resources for both the State and the Service. Therefore, with this rule, we change the web address for falconers in California to report takes, acquisitions, transfers, and losses of falconry birds.

This action is administrative in nature. We are providing regulated entities and the general public with an accurate web address to report take, loss, or transfers of raptors by falconers in California. We delegated the State of California permitting authority for falconry under the regulations at 50 CFR 21.29 (see 78 FR 72830, December 4, 2013). This rule facilitates that State's permitting and reporting requirements, and will enable reporting with our system for reporting take, acquisition, loss, or transfer of any bird for falconry. The change should slightly reduce administration costs for both the State and the Service. The delegation of permitting authority to the State of California has already been subject to public notice-and-comment procedures, and this change simply adds an Internet address to the regulations at 50 CFR 21.29 to allow full use of California's permitting and reporting system. Under 5 U.S.C. 553(b), rules of agency organization, procedure, or practice may be made final without previous notice to the public. This is a final rule.

Executive Order 12866 provides that the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) will review all significant rules. OIRA has determined that this rule is not significant.

Executive Order (E.O.) 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives.

E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 (Pub. L. 104-121), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (that is, small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities.

SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide the statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities.

We have examined this rule's potential effects on small entities as required by the Regulatory Flexibility Act, and have determined that this action will not have a significant economic impact on a substantial number of small entities. This rule simplifies reporting required by 50 CFR 21.29 for residents of California. This rule does not change falconers' costs for practicing their sport, nor does it affect businesses that provide equipment or supplies for falconry. This rule may result in a small savings of time and other resources by the State of California and by the Service, but neither of these is a small entity. Consequently, we certify that, because this rule will not have a significant economic effect on a substantial number of small entities, a regulatory flexibility analysis is not required.

This rule is not a major rule under the SBREFA (5 U.S.C. 804(2)). It will not have a significant economic impact on a substantial number of small entities.

a. This rule does not have an annual effect on the economy of $100 million or more. There are no costs to permittees or any other part of the economy associated with this change to the regulations.

b. This rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. This rule simplifies reporting required by 50 CFR 21.29 for residents of California.

c. This rule will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.), we have determined the following:

a. This rule will not “significantly or uniquely” affect small governments in a negative way. A small government agency plan is not required. The State of California requested that we make this change to the regulations to simply falconry reporting for that State's residents.

b. This rule will not produce a Federal mandate of $100 million or greater in any year. It is not a “significant regulatory action” under the Unfunded Mandates Reform Act.

In accordance with E.O. 12630, the rule does not have significant takings implications. A takings implication assessment is not required. This rule does not contain a provision for taking of private property.

This rule does not have sufficient Federalism effects to warrant preparation of a federalism summary impact statement under E.O. 13132. The State of California requested that we make this change to the regulations to simplify falconry reporting for that State's residents.

In accordance with E.O. 12988, the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.

We examined this rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), and it does not contain any new collections of information that require Office of Management and Budget (OMB) approval. OMB has approved the information collection requirements of the Migratory Bird Permits Program and assigned OMB control number 1018-0022, which expires May 31, 2017. Information from the collection is used to document take of raptors from the wild for use in falconry and to document transfers of raptors held for falconry between permittees. A Federal agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

We evaluated the environmental impacts of the changes to the regulations, and determined that this rule does not have any environmental impacts.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated potential effects on Federally recognized Indian Tribes and have determined that this rule will not interfere with Tribes' ability to manage themselves or their funds or to regulate falconry on Tribal lands.

E.O. 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not a significant regulatory action under E.O. 12866, and will not significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required.

Socioeconomic. This action will not have discernible socioeconomic impacts.

Raptor populations. This rule will not change the effects of falconry on raptor populations. We are simply adding to our regulations at 50 CFR 21.29 a falconry reporting method for residents of California.

Endangered and threatened species. This rule does not change protections for endangered and threatened species.

Section 7 of the Endangered Species Act (ESA) of 1973, as amended (16 U.S.C. 1531 et seq.), requires that “The Secretary [of the Interior] shall review other programs administered by him and utilize such programs in furtherance of the purposes of this chapter” (16 U.S.C. 1536(a)(1)). It further states that the Secretary must “insure that any action authorized, funded, or carried out . . . is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of [critical] habitat” (16 U.S.C. 1536(a)(2)). This rule will not affect threatened or endangered species or their habitats in the United States.

For the reasons stated in the preamble, we amend subpart C of part 21, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as follows:

The snapper-grouper fishery of the South Atlantic, which includes snowy grouper, is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The recreational ACL for snowy grouper is 523 fish. In accordance with regulations at 50 CFR 622.193(b)(2), if the recreational ACL is exceeded, the Assistant Administrator, NOAA (AA), will file a notification with the Office of the Federal Register to reduce the length of the following fishing season by the amount necessary to ensure landings do not exceed the recreational ACL in the following fishing year. NMFS evaluates annual recreational landings with the recreational ACL for snowy grouper based on a 3-year running average of landings. For the 2015 fishing year, the most recent 3-year running average of recreational landings is the average of 2012-2014. Average landings from 2012-2014 exceeded the 2014 recreational ACL by 1,253 fish. Therefore, this temporary rule implements the post-season AM to reduce the fishing season for the recreational snowy grouper component of the snapper-grouper fishery by the amount necessary to ensure recreational landings do not exceed the recreational ACL in 2015. As a result, the recreational sector for snowy grouper will be closed effective 12:01 a.m., local time, July 6, 2015.

During the closure, the bag and possession limits for snowy grouper in or from the South Atlantic EEZ are zero. These limits apply in the South Atlantic for a person on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.193(b)(2). The recreational sector for snowy grouper will reopen on January 1, 2016, the beginning of the 2016 recreational fishing season.

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of snowy grouper and the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.193(b)(2) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds that the need to immediately implement this action to close the recreational sector for snowy grouper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the AMs established by Amendment 17B to the FMP (75 FR 82280, December 30, 2010) and located at 50 CFR 622.193(b)(2) has already been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect the snowy grouper resource, since time for notice and public comment will allow for continued recreational harvest and exceedance of the recreational ACL. Additionally, there is a need to immediately notify the public of the reduced recreational fishing season for snowy grouper for the 2015 fishing year. Prior notice and opportunity for public comment would be contrary to the public interest because many of those affected by the length of the recreational fishing season, particularly charter vessel and headboat operations, book trips for clients in advance and, therefore, need as much time as possible to adjust business plans to account for the reduced recreational fishing season.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

The Gulf of Mexico shark fisheries are managed under the 2006 Consolidated Highly Migratory Species (HMS) Fishery Management Plan (FMP), its amendments, and its implementing regulations (50 CFR part 635) issued under authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.).

Under § 635.5(b)(1), dealers must electronically submit reports on sharks that are first received from a vessel on a weekly basis through a NMFS-approved electronic reporting system. Reports must be received by no later than midnight, local time, of the first Tuesday following the end of the reporting week unless the dealer is otherwise notified by NMFS. Under § 635.28(b)(2), the quotas of certain species and/or management groups are linked. The quotas for non-blacknose SCS and the blacknose shark management group in the Gulf of Mexico region are linked (§ 635.28(b)(3)(iv)). Under § 635.28(b)(2), when NMFS calculates that the landings for any species and/or management group of a linked group has reached or is projected to reach 80 percent of the available quota, NMFS will file for publication with the Office of the Federal Register a notice of closure for all of the species and/or management groups in a linked group that will be effective no fewer than 5 days from date of filing. From the effective date and time of the closure until and if NMFS announces, via notification in the Federal Register, that additional quota is available and the season is reopened, the fisheries for all linked species and/or management groups are closed, even across fishing years.

On December 2, 2014 (79 FR 71331), NMFS announced that the 2015 commercial Gulf of Mexico non-blacknose SCS quota is 45.5 metric tons (mt) dressed weight (dw) (100,317 lb dw) and the blacknose shark quota is 1.8 mt dw (4,076 lb dw).

Dealer reports recently received through June 26, 2015, indicated that 36.9 mt dw or 81 percent of the available Gulf of Mexico non-blacknose SCS quota had been landed and 1.0 mt dw or 52 percent of the available Gulf of Mexico blacknose shark quota had been landed. Based on these dealer reports, landings of non-blacknose SCS have exceeded 80 percent of the quota by June 26, 2015. Accordingly, NMFS is closing both the commercial blacknose shark fishery and non-blacknose SCS management group in the Gulf of Mexico region as of 11:30 p.m. local time July 4, 2015. The only shark species or management groups that remain open in the Gulf of Mexico region are the research large coastal sharks, sandbar sharks within the shark research fishery, the blue shark, and pelagic sharks other than porbeagle or blue shark management groups.

At § 635.27(b)(1), the boundary between the Gulf of Mexico region and the Atlantic region is defined as a line beginning on the East Coast of Florida at the mainland at 25°20.4′ N. lat, proceeding due east. Any water and land to the south and west of that boundary is considered, for the purposes of monitoring and setting quotas, to be within the Gulf of Mexico region.

During the closure, retention of blacknose sharks and non-blacknose SCS in the Gulf of Mexico region is prohibited for persons fishing aboard vessels issued a commercial shark limited access permit (LAP) under § 635.4. However, persons aboard a commercially permitted vessel that is also properly permitted to operate as a charter vessel or headboat for HMS and is engaged in a for-hire trip could fish under the recreational retention limits for sharks and “no sale” provisions (§ 635.22(a) and (c)).

During this closure, a shark dealer issued a permit pursuant to § 635.4 may not purchase or receive blacknose sharks or non-blacknose SCS in the Gulf of Mexico region from a vessel issued a shark LAP, except that a permitted shark dealer or processor may possess blacknose sharks and/or non-blacknose SCS in the Gulf of Mexico region that were harvested, off-loaded, and sold, traded, or bartered prior to the effective date of the closure and were held in storage consistent with § 635.28(b)(5). Similarly, a shark dealer issued a permit pursuant to § 635.4 may, in accordance with relevant state regulations, purchase or receive blacknose sharks and/or non-blacknose SCS in the Gulf of Mexico region if the sharks were harvested, off-loaded, and sold, traded, or bartered from a vessel that fishes only in state waters and that has not been issued a shark LAP, HMS Angling permit, or HMS Charter/Headboat permit pursuant to § 635.4.

Pursuant to 5 U.S.C. 553(b)(B), the Assistant Administrator for Fisheries, NOAA (AA), finds that providing prior notice and public comment for this action is impracticable and contrary to the public interest because the fisheries are currently underway and any delay in this action would result in overharvest of the Gulf of Mexico non-blacknose SCS quota and be inconsistent with management requirements and objectives. Similarly, affording prior notice and opportunity for public comment on this action is contrary to the public interest because if the quota is exceeded, the stock may be negatively affected and fishermen ultimately could experience reductions in the available quota and a lack of fishing opportunities in future seasons. For these reasons, the AA also finds good cause to waive the 30-day delay in effective date pursuant to 5 U.S.C. 553(d)(3). This action is required under § 635.28(b)(2) and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2015 flathead sole, rock sole and yellowfin sole CDQ reserves specified in the BSAI are 2,595, 7,410, and 15,943 metric tons (mt) as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015). The 2015 flathead sole, rock sole, and yellowfin sole CDQ ABC reserves are 4,481, 12,032, and 10,679 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015).

The Yukon Delta Fisheries Development Association has requested that NMFS exchange 50 mt of flathead sole and 250 mt of yellowfin sole CDQ reserves for 300 mt of rock sole CDQ ABC reserves under § 679.31(d). Therefore, in accordance with § 679.31(d), NMFS exchanges 50 mt of flathead sole and 250 mt of yellowfin sole CDQ reserves for 300 mt of rock sole CDQ ABC reserves in the BSAI. This action also decreases and increases the TACs and CDQ ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) are revised as follows:

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Yukon Delta Fisheries Development Association in the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of June 23, 2015.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.