Federal Register Vol. 80, No.118,

The National Organic Program (NOP) is authorized by the Organic Foods Protection Act (OFPA) of 1990, as amended (7 U.S.C. 6501—6522). The USDA Agricultural Marketing Service (AMS) administers the NOP. Final regulations implementing the NOP, also referred to as the USDA organic regulations, were published December 21, 2000 (65 FR 80548), and became effective on October 21, 2002. Through these regulations, the AMS oversees national standards for the production, handling, and labeling of organically produced agricultural products. Since becoming fully effective, the USDA organic regulations have been frequently amended, mostly for changes to the National List in 7 CFR 205.601-205.606.

This National List identifies the synthetic substances that may be used and the nonsynthetic (natural) substances that may not be used in organic production. The National List also identifies synthetic, nonsynthetic nonagricultural, and nonorganic agricultural substances that may be used in organic handling. The OFPA and the USDA organic regulations, as indicated in § 205.105, specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any nonorganic agricultural substance, and any nonsynthetic nonagricultural substance used in organic handling appear on the National List.

As stipulated by OFPA, recommendations to propose or amend the National List are developed by the 15 member NOSB, organized under the Federal Advisory Committee Act (5 U.S.C. App. 2 et seq.) to assist in the evaluation of substances to be used or not used in organic production and handling, and to advise the Secretary on the USDA organic regulations. OFPA also requires a review of all substances included on the National List within 5 years of their addition to or renewal on the list. If a listed substance is not reviewed by NOSB and renewed by USDA within the five year period, its allowance or prohibition on the National List is no longer in effect. The NOSB sunset review includes considering any new information pertaining to a substance's impact on human health and the environment, its necessity, and its compatibility with organic production and handling.

To implement the sunset review requirement, AMS initially published an advanced notice of proposed rulemaking on the National List sunset review process on June 17, 2005 (70 FR 35177). This document described the process used by the NOSB to complete their responsibility to review National List substances within the OFPA required five year period. Since announcing the first sunset review process, the NOSB and the USDA completed five separate sunset reviews in 2007 (72 FR 58469), 2008 (73 FR 59479), 2011 (76 FR 46595), 2012 (77 FR 33290) and in 2013 (78 FR 61154).

AMS published a revised sunset review process in the Federal Register on September 16, 2013 (78 FR 56811). This provides public notice on the renewal of National List substances. This renewal occurs after the NOSB review.

At its May and October 2014 meetings, the NOSB considered seven substances that were added to the National List in 2010. AMS has reviewed and accepted the NOSB sunset review and recommendations. Substances in Table 1 having final actions of “renew” will continue to be listed on the National List and will be included in the 2020 sunset review.

On February 27, 2001, FSIS proposed (66 FR 12589) to establish several new requirements for the processing of ready-to-eat (RTE) and other meat and poultry products. The Agency proposed food safety performance standards for all RTE and all partially heat-treated meat and poultry products. FSIS also proposed to eliminate its regulations that require both RTE and not-ready-to eat pork and products containing pork to be treated to destroy trichina (Trichinella spiralis).

Finally, FSIS proposed environmental testing requirements for establishments to verify whether their processes were addressing Lm in RTE meat and poultry products. Specifically, FSIS proposed to require establishments that produce RTE meat and poultry products to test food contact surfaces for Listeria species to verify that the establishments are controlling the presence of Lm within their processing environments. Under the proposal, establishments that developed and implemented Hazard Analysis and Critical Control Point (HACCP) controls for Lm would have been exempt from these testing requirements.

On June 6, 2003, FSIS published the interim final rule “Control of Listeria monocytogenes in Ready-to-Eat Meat and Poultry Products” (68 FR 34208). In the interim final rule, FSIS amended its regulations only in regard to the control of Lm in RTE products. The Agency decided to adopt these regulations before completing action on the other provisions of the proposed rule because of outbreaks of foodborne listeriosis, and because of recalls of meat and poultry products adulterated by Lm. FSIS plans to address the other proposed provisions in future Federal Register publications.

The interim final regulations remain in effect. Under these regulations, an establishment that manufactures post-lethality-exposed RTE meat or poultry products must control Lm in the processing environment through its HACCP plan or prevent contamination of products by the pathogen through sanitation standard operating procedures (Sanitation SOPs) or other prerequisite program. The regulations (9 CFR 430.4(b)(1)-(3)) identify three alternative means of controlling Lm: Alternative 1—use of a post-lethality treatment (e.g., steam pasteurization, hot water pasteurization, radiant heating, high pressure processing (HPP), ultraviolet treatment, infrared treatment, or drying) that reduces or eliminates populations of the organism and use of an antimicrobial agent (e.g., potassium lactate or sodium diacetate) or process (e.g., freezing) that suppresses or limits growth of the organism; Alternative 2—use of either a post-lethality treatment that reduces or eliminates Lm or an antimicrobial agent (Alternative 2a) or process that suppresses or limits growth of the organism (Alternative 2b); Alternative 3—use of only sanitation to control the organism. The regulations require an establishment that uses a post-lethality treatment for controlling Lm to validate the treatment's effectiveness and incorporate it in its HACCP plan. Under the regulations (9 CFR 430.4(b)(1)-(3)), an establishment that uses an antimicrobial agent (Alternative 2a) or process that suppresses or limits growth of Lm (Alternative 2b), or that uses only a sanitation program (Alternative 3) for controlling the pathogen must include food-contact surface testing in its sanitation program.

Under the regulations, an establishment that produces hotdog or deli-meat products considered to be at high risk for Lm contamination and that uses only sanitation to control the pathogen must, after two tests of food-contact surfaces that are positive for Lm or an indicator organism under the conditions described in the regulation, withhold affected product from commerce until the food-contact surface contamination problem is corrected. The establishment may release the held product only after statistically valid sampling shows the product not to be adulterated with Lm, or after the product has been reworked using a process that destroys Lm (9 CFR 430.4 (b)(3)(ii)).

The regulations include requirements for proper documentation of an establishment's Listeria controls, the verification of those controls, and the availability of the documentation to FSIS personnel. In addition, the regulations require an establishment that produces post-lethality-exposed RTE products to provide FSIS, at least annually, with estimates of annual production volume and related information on the types of products it processes under each of the Lm control alternatives (9 CFR 430.4(d)).

FSIS decided to establish the regulatory requirements for preventing Lm contamination of RTE meat and poultry products based on two studies on the public health risk posed by the pathogen in RTE food products. The first study, an FSIS-Food and Drug Administration (FDA) risk ranking of RTE food products, placed hotdog and deli-meat products among products that pose the highest risk in terms of listeriosis cases per annum.1 The second study, a quantitative risk assessment by FSIS of Lm in deli meats, identified combinations of in-plant control measures that showed the greatest potential for reducing the public health risks posed by Lm. 2 The second study enabled FSIS to determine that the first Lm control alternative identified in the interim final rule—post-lethality treatment plus growth limitation or suppression—provided the greatest risk reduction potential, while the third alternative—sanitation only—provided the least.

In the regulations, FSIS advised establishments that it would conduct more testing at establishments if their Lm control measures provide less potential risk reduction than other available control measures. Thus, the regulations provide that FSIS will conduct more testing at an establishment that chooses alternative 2 and uses a post-lethality treatment of product than if it had chosen Alternative 1. Similarly, FSIS will conduct more testing at an establishment that chooses alternative 2 and uses an antimicrobial agent or process that suppresses or limits the growth of Lm than at an establishment that uses a post-lethality treatment (9 CFR 430.4(b)(2)(iv)). FSIS conducts more testing at an establishment that chooses Alternative 3 than at an establishment that has chosen Alternative 1 or 2 (9 CFR 430.4(b)(3)(iii)).

Finally, the regulations allow establishments that use post-lethality treatments or antimicrobial agents or processes that are effective in destroying Lm or in limiting its growth to declare this fact on the labels of their products (9 CFR 430.4(e)). The purpose of the voluntary labeling is to inform consumers about measures that have been taken to ensure the safety of the products and thus to enable the consumers to select such products in preference to others.

On October 6, 2003, the Agency supplemented the interim final rule with the “FSIS Compliance Guideline: Controlling Listeria monocytogenes in Post-lethality Exposed Ready-to-Eat Meat and Poultry Products” (the Compliance Guideline). The Agency also conducted a series of workshops on the interim final rule at several locations around the country during the pre-implementation period before October 6, 2003, when the interim final rule became effective. On January 10, 2014, FSIS made available an updated version of the Compliance Guideline is available on FSIS's Web site at http://www.fsis.usda.gov/wps/wcm/connect/d3373299-50e6-47d6-a577-e74a1e549fde/Controlling-Lm-RTE-Guideline.pdf?MOD=AJPERES.

Based on available data, FSIS is confident that it is successfully carrying out its mission to protect public health by enforcing safeguards designed to control Lm. In the 10 years since FSIS issued the interim final rule described above, the percent positive in FSIS testing for Lm in RTE products has decreased from 0.76 percent in CY 2003 to 0.34 percent in CY 2013. The Agency considers the RTE regulatory results to be an excellent indicator of the trends in pathogen presence in RTE products over several years. This downward trend shows that the interim final rule has been effective in controlling Lm in RTE meat and poultry products. Therefore, FSIS is affirming the interim rule as final with only the minor changes discussed below.

Because some of the approaches to Lm control addressed in the interim final rule were novel, FSIS provided an 18-month comment period (69 FR 70051; December 2, 2004). FSIS also assembled a team of Agency experts to make a preliminary assessment of the interim final rule. FSIS announced in the Federal Register (69 FR 70051; December 2, 2004) that the report “Assessing the Effectiveness of the Listeria Monocytogenes Interim Final Rule” was available in the Agency's Docket Room and on line at http://www.fsis.usda.gov/wps/wcm/connect/4174b07e-8b39-4617-acdf-adc38a249cd7/LM_Assessment_Report_2004.pdf?MOD=AJPERES.

In addition, FSIS asked the National Advisory Committee on Meat and Poultry Inspection (NACMPI) to review the interim final rule and the assessment team's report and to make its own recommendations (69 FR 29124). NACMPI made recommendations on the assessment at its June 2-3, 2004, meeting. The Agency responded to the recommendations at the NACMPI meeting held on November 16-17, 2004 (69 FR 64902). NACMPI recommended that the assessment team focus on the differences among small, very small, and large plants and assess the economic impact on very small and large plants. NACMPI also recommended that FSIS conduct focus groups to determine whether consumers are confused by the provisions for labeling statements explaining that product has undergone post-lethality treatments or has been treated with an antimicrobial. Finally, NACMPI recommended that FSIS determine whether the assumptions on product risk made in the FDA/USDA Quantitative Risk Assessment are accurate.

FSIS agreed to consider variables such as product types and the frequency of production, which reflect differences among small, very small, and large plants. The Agency also agreed to review whether the rule has caused firms, particularly small firms, to go out of business. FSIS also continued to assess the effects of the informational labeling statements allowed under the rule. However, FSIS stated that the informational labeling provision should remain in the final version of the Lm rule as an encouragement to industry to declare that products have undergone post-lethality treatments or have been treated with anti-microbial agents or processes to destroy Lm. FSIS agreed to assess the three alternatives in the rule and evaluate their effectiveness for risk mitigation.

NACMPI's recommendations and FSIS's responses can be viewed at http://www.fsis.usda.gov/wps/wcm/connect/d8be3905-5f3c-458d-a5e7-f5149457b20e/LM_Assessment_Response.pdf?MOD=AJPERES.

Finally, FSIS received comments on the impact of the interim final rule on small businesses from the Office of Management and Budget (OMB) in response to OMB's 2004 Draft Report to Congress on the Costs and Benefits of Federal Regulation (69 FR 7987; February 20, 2004). The commenters stated that FSIS underestimated the costs and overestimated the benefits of the interim final rule. The commenters stated that the rule should be rescinded or amended to replace the regulatory requirements for small and very small processors with a pre-HACCP regulatory environment. In response, FSIS stated that the Agency would consider all comments and respond to them in a final rule.

A summary of the comments and FSIS's response is reflected in the March 2005 OMB report “Regulatory Reform in the U.S. Manufacturing Sector,” which is available at http://www.whitehouse.gov/omb/inforeg_regpol_reports_congress.

In developing this final rule, FSIS considered all comments received in response to the documents described above. Based on information provided by comments, FSIS's experience enforcing the interim final regulations, and analysis of available data, FSIS has decided to affirm the provisions in the interim final rule with two minor changes. The minor changes are explained below and are discussed in more detail in the Agency's responses to comments.

FSIS is clarifying that product that has tested positive for Lm or that has been in contact with an equipment surface that has tested positive for Lm is adulterated and may not be released into commerce. FSIS is also making explicit in 9 CFR 430.4(a), however, that the product may be reprocessed using a method that destroys Lm.

9 CFR 430.4(a) clearly states that “RTE product is adulterated if it contains L. monocytogenes or if it comes into direct contact with a food contact surface which is contaminated with L. monocytogenes.” However, the wording of paragraphs 9 CFR 430.4(b)(2)(iii)(B), (b)(3)(i)(B), and (b)(3)(ii)(B) and (C) has led some establishments to question whether they may perform further confirmation testing after a finding of Lm in RTE product and then release the product into commerce. Therefore, FSIS removed from paragraphs 9 CFR 430.4(b)(2)(iii)(B), (b)(3)(i)(B), and (b)(3)(ii)(B) provisions concerning additional establishment testing in response to Lm results. As revised, the regulations will refer only to additional establishment testing in response to positive indicator organism results. In addition in paragraph 9 CFR 430.4(b)(3)(ii)(C), FSIS has removed provisions that may suggest that establishments may “be able to release into commerce the lots of product that may have become contaminated with L. monocotogenes” because, as is stated in 9 CFR 430.4(a), such product is adulterated and cannot be released into commerce.

FSIS is also removing the requirement that establishments report production volume and related information to FSIS because the Agency now collects this information through PHIS.

In accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553), the Agency finds good cause for making these changes effective September 17, 2015. This rule provides minor conforming amendments to FSIS's regulations and imposes no new or substantive requirements on the public. For these reasons, FSIS has determined that notice and opportunity for public comment on these changes are unnecessary. However, FSIS is providing the public with an opportunity to comment on these minor, conforming changes.

FSIS received comments from five trade associations that represent meat and poultry processors, two consumer organizations, an association that represents small businesses, an association that represents manufacturers, an organization that represents scientists, a very small establishment, and an individual consumer on the interim final and on the other opportunities for comment described above. Following are FSIS's responses to the issues that they raised.

Comment: Several commenters stated that certain classes of products should be exempt from the rule. For example, these commenters stated that products that are exposed to the environment but that receive a validated, post-packaging lethality, such as products that are cooked, repackaged, and then irradiated, thermally processed, or high-pressure processed in their final package, should be exempt from the requirements in the rule. These commenters stated that the fact that there was product exposure to the post-lethality processing environment during the repackaging operation that followed the initial cook should not subject such a product to the Lm control rule. In addition, the commenters stated that, products that remain at a temperature lethal to Lm until the products are filled into the final packaging should be exempt.

Response: An establishment that produces post-lethality exposed RTE products is appropriately required to control Lm through HACCP or a sanitation program because an RTE product that is not free of pathogens, including Lm, can easily cause illness because it will not be subject to a lethality step before consumption. Therefore, FSIS is not exempting such post-lethality-treated products from the requirements in this rule.

Post-lethality exposed product may be at risk of contamination and thus needs to be subject to the requirements in this rule. However, a product that is not post-lethality exposed (not removed from the container in which it is processed) is not subject to the requirements in this rule.

Regarding HPP of RTE product, in most cases that FSIS is aware of, HPP is applied to an RTE product that was previously subject to a lethality treatment, such as cooking, and then was exposed to the environment before being packaged. Thus, HPP is considered a post-lethality treatment that is subject to the Alternative 1 or Alternative 2 requirements of 9 CFR 430.4.

There may be cases in which a treatment is applied to a post-lethality exposed RTE product in such a manner that the product could no longer be regarded as post-lethality exposed and thus would be exempt from the interim final rule. For example, if HPP is validated to achieve at least a 5-log reduction of Lm and other pathogens of concern (e.g., Escherichia coli O157:H7 and Salmonella) for cooked uncured meat patties or at least a 7-log reduction in cooked chicken strips, the process would be considered to achieve full lethality, and the product would not be considered to be post-lethality exposed (see 9 CFR 318.23).

FSIS has explained in its Compliance Guideline (http://www.fsis.usda.gov/wps/wcm/connect/d3373299-50e6-47d6-a577-e74a1e549fde/Controlling-Lm-RTE-Guideline.pdf?MOD=AJPERES) that it considers certain RTE products as not post-lethality exposed; that is, they are not exposed to the environment after the lethality treatment and before packaging. They include fully cooked “cook-in-bag” product that is shipped from the establishment in an intact cooking bag, thermally processed commercially sterile products, and products that receive a lethality treatment and are hot-filled at the lethality temperature.

A product that has undergone a lethality treatment and is hot-filled into packaging may be considered to be an RTE product that has not been post-lethality exposed if the temperature lethal to pathogens and the sanitary handling of the product are continuously maintained to the point where the product is packaged. In this situation, the establishment needs to have documentation on file showing that the lethality temperature and sanitary handling are maintained continuously from the point of lethality to the point of packaging.

Comment: A few commenters objected to the assessment team's statement that Lm is reasonably likely to occur in the production of RTE meat and poultry products. The commenters argued that the assessment team ignored the value of post-lethality treatments.

Response: In the assessment report, the assessment team was expressing a view that Lm is reasonably likely to occur in the absence of controls to eliminate or reduce it. Many in industry, Government, and academe share the view that Lm is ubiquitous in the RTE processing environment, and that a prudent establishment would maintain controls in its production process to prevent the contamination of its food products. Establishments use post-lethality treatments because the pathogen is reasonably likely to occur in the product in the absence of the treatment. For this reason, the regulations require that an establishment that uses a post-lethality treatment include the treatment in its HACCP plan or Sanitation SOP or other prerequisite program (9 CFR 430.4(b)(1)(i)).

Comment: A few commenters suggested that the statements in the questions and answers accompanying FSIS Form 10,240-1 should be reflected in the final rule. According to one such statement on the questions and answers accompanying FSIS Form 10,240-1, products intended for further processing and labeled for further processing are not subject to the rule. According to another, products that otherwise would be considered RTE, but that are shipped to another establishment for use in a non-RTE product (e.g. frozen entrée), should not be subject to the rule.

Response: FSIS has addressed these issues in the Compliance Guideline. A product that is intended for further processing at another FSIS inspected establishment and that is labeled “for further processing” is not considered RTE and, therefore, is not covered by the rule. However, products that are commonly understood to be RTE, such as cooked sausages subject to the standard of identity in 9 CFR 319.180, are commonly understood to be RTE and cannot be labeled for “further processing” as a non-RTE product. In addition, a product that otherwise would be considered RTE, but that is shipped to another FSIS inspected establishment for use in a non-RTE product, is not considered RTE and therefore, is not covered by the rule.

It should be noted that FSIS Form 10,240-1 was discontinued on September 30, 2011. As mentioned above, FSIS continues to collect the same information through PHIS.

Comment: One commenter asked FSIS to explain the criteria for determining when antimicrobial processes also act as post-lethality treatments. In particular, the commenter wanted FSIS to explain why products with a water activity (aw) of less than 0.85 rather than of 0.92 or less will not support Lm growth.

Response: FSIS has addressed this issue in the Compliance Guideline. Low water activity limits the amount of water available to pathogens such as Lm and will not allow them to grow. An aw less than or equal to 0.92 will not support the growth of Lm, and an aw of 0.85 or less (the aw for achieving shelf stability) can sometimes even reduce Lm numbers. FSIS will consider an aw of ≤0.85 at the time the product is packed to be a post-lethality treatment and to be an antimicrobial treatment if the establishment provides supporting documentation that Lm is reduced by at least 1-log before the product leaves the establishment, and that no more than 2-logs of growth of Lm occurs over the shelf life of the product.

Comment: One commenter asked FSIS to clarify for establishments the distinction between RTE and not-RTE products. The commenter stated that documentation for making the determination is not available for a number of products.

Response: In Attachment 1.2 of the Compliance Guideline, FSIS provides a chart that distinguishes three types of products, two not-RTE and one RTE. One type of not-RTE product is a product that contains a meat or poultry product ingredient that has not received a full lethality treatment sufficient to destroy pathogens (e.g., raw products, partially cooked products, or products that are irradiated or HPP-treated and do not achieve at least a 5-log reduction of Lm and other pathogens of concern). This type of not-RTE product could also be a product that has received an adequate lethality for Salmonella but is not defined by a standard of identity or bear a common or usual name that consumers understand to refer to RTE product. The product also does not meet the definition of RTE in 9 CFR 430.1 (e.g., not-RTE ham). The other type of not-RTE product is a product that contains a meat or poultry component that has received a full lethality treatment for pathogens and that also contains non-meat or non-poultry components to which the intended user must apply a lethality treatment (e.g., a meal, dinner, or frozen entrée). An RTE product, on the other hand, may be a heat-treated or not-heat-treated shelf-stable product, a fully cooked, not-shelf-stable product (e.g., hotdogs), or a not-shelf-stable product containing secondary inhibitors (e.g., RTE sausage). The chart in the Compliance Guideline lists HACCP process categories for each product type, the applicability of safe handling labeling, and significant matters that the HACCP plan should address for the product and process.

Comment: A few commenters recommended that the determination of which Lm control alternative is being used at a given establishment should take into account documented processes applied at the establishment to which its RTE product is shipped. For example, the commenters stated that if an Alternative-3 product is shipped to an establishment where it is subject to an Alternative 2-type of process, then FSIS should consider the product as an Alternative 2 product.

Response: The Compliance Guideline discusses situations in which an establishment implementing one type of Lm control to prevent contamination of its post-lethality exposed product ships the product to another establishment that applies the same or another type of Lm control. The determination of which Lm control Alternative requirements apply to the product would depend on the extent of documentation and documentation-sharing by each establishment, as well as on the product distribution controls actually applied by the establishments. If an Alternative-3 product is shipped to an establishment where it is subject to an Alternative 2-type of process, and this process is properly documented in the first establishment's HACCP system, FSIS would consider the product as an Alternative 2-type of product.

Comment: One commenter agreed with FSIS's recommendation that establishments hold all product tested by establishments until test results are known but urged FSIS to say more about when and how tests should be conducted (e.g., before or during production). The commenter stated that FSIS needs to provide specific details and flow diagrams, with examples. FSIS also should provide a hold-and-test scenario flow chart.

Response: The Compliance Guideline includes recommendations on verification testing, methods to be used, recommended sampling plans, and a hold-and-test scenario flow chart. The Compliance Guideline also includes examples of verification sampling programs for the product classes that are subject to the interim final rule.

Establishments are required to hold or maintain control of RTE products that FSIS has tested for Lm and other pathogens, and RTE products that have passed over food-contact surfaces that FSIS has tested for Lm and other pathogens. In addition, establishments in Alternative 3 (who only use sanitation controls) are required to hold product after a second consecutive food-contact surface positive for Lm or an indicator organism until the establishment corrects the problem indicated by the test result (9 CFR 430.4(b)(3)(ii)(B)).

Establishments in Alternative 3 must sample and test the lots of product using a method that will provide a level of statistical confidence that the product is not adulterated (9 CFR 430.4(b)(3)(ii)(C)). FSIS recommends that establishments use the International Commission on Microbiological Specifications for Foods (ICMSF) Tables. The ICMSF Tables provide examples of statistically-based sampling plans that are commonly used for demonstrating lot acceptance. The ICMSF Tables are included in the Compliance Guideline. FSIS also recommends that establishments collect samples at least three hours after the start of operations, if possible, to allow Lm to work its way out to the surface of the equipment. If establishments typically produce RTE product for less than three hours, then the samples can be collected less than three hours after the start of operations.

FSIS recommends that establishments in Alternatives 1 and 2a hold and test product after multiple contact surface positives for an indicator organism. The finding of three consecutive positive food contact surface samples increases the risk that the product is contaminated with Lm. If the establishment does not hold and test the product after the third positive, it should provide other support demonstrating that the product is not likely to be contaminated. The establishment should take preventative steps such as: increase its routine sampling for Lm; collect intensified samples to find sources of harborage and cross contamination; reassess its Sanitation SOPs to determine whether sanitation issues could be leading to positive results; assess the effectiveness of its post-lethality treatment or antimicrobial agents and processes; or reassess its HACCP plan to determine whether the actions it is taking are effective in controlling Lm.

Comment: One commenter stated that FSIS verification sampling should be conducted after the use of Lm control techniques (such as Alternative 3 controls) that are more economically feasible than post-lethality treatments and the use of growth inhibitors. The commenter stated that FSIS should conduct risk-based inspection and data collection on risk factors in the establishment and should use sound statistical techniques in environmental sampling. The commenter also stated that intensified verification testing (IVT) is a return to the command-and-control mode of inspection that FSIS should avoid. (An IVT is an FSIS sample collection activity that the Agency may conduct when, in either FSIS or establishment testing, a surface that comes into contact with post-lethality exposed RTE product tests positive for a pathogen of public health concern. IVTs are performed with a “for cause” Food Safety Assessment (FSA) to provide an in-depth evaluation of food safety systems at the establishment. The FSA may find the vulnerability or the noncompliance that led to the positive result.)

Response: The regulations in 9 CFR part 430 state that products and the processing environment under Alternative 3 are likely to be subject to more frequent verification testing by FSIS than products and the processing environment under Alternative 1 or 2. In fact, Alternative 3 products are sampled at a higher rate in the FSIS risk-based sampling code RTEPROD_RISK (9 CFR 430.4(b)(2)(iv) and (b)(3)(iii)).

FSIS agrees that inspection should be risk-based. To that end, FSIS has developed risk-based verification sampling that focuses the Agency's testing on those products or environments in a process where a problem is most likely to occur. As of August 1, 2013, FSIS combined its random ALLRTE and risk-based RTE001 product sampling projects into a single project called RTEPROD. The RTEPROD sampling project uses two project codes: RTEPROD_RAND for product samples selected randomly, and RTEPROD_RISK for post-lethality-exposed product samples selected based on risk. Under the RTEPROD_RISK project code, establishments are identified for sampling based on a risk-ranking algorithm, which takes into account the control alternative, the production volume, the type of product produced, and the establishment's sampling history.

FSIS also uses the Routine Lm Risk-based (RLm) sampling project. While RTEPROD involves sampling and testing of the RTE meat and poultry products themselves, the RLm program includes sampling and testing of products, product contact surfaces, and environmental surfaces. Thus, RLm provides a means of identifying establishments that present a higher risk of Lm contamination in the food processing environment before product contamination actually occurs.

A routine FSA is conducted at the establishment in conjunction with RLm sampling and testing. Under RLm, samples are scheduled using a FSA prioritization model, which takes into account levels of inspection, control alternative, and type of product produced. Starting in August 2009, RLm sampling was increased so that establishments that produce post-lethality exposed RTE product are sampled at least once every four years under this project.

FSIS also agrees that, to be successful, risk-based verification must be carried out on the basis of solid information. The IVT activity can be a valuable source of information for both the Agency and the inspected establishment when potentially serious problems are found in an establishment's food safety system. The results of an IVT can be used to help the Agency focus its inspection resources where they are most needed and can help the establishment plan improvements in its food safety system. In this regard, the IVT does not constitute a return to a command-and-control system of inspection in which FSIS told the establishment explicitly what it had to do to produce a safe product. Rather, the IVT provides the information on which an establishment may base its own decisions on the most effective control measures to take.

Comment: While conceding that IVT may be appropriate in some circumstances, such as multiple Lm positives on product or food-contact surfaces, a few commenters strongly opposed the assessment team's recommendation that an IVT be performed for multiple contact or product positives for Listeria spp. or Listeria-like organisms. The commenters also urged the Agency not to penalize establishments for trying to actively detect and eliminate potential harborage areas but to verify that appropriate corrective actions have been taken. The commenters also questioned whether the Agency would have the resources necessary to conduct IVT each time an establishment surpasses arbitrary yearly limits, as recommended by the Agency's assessment team.

Response: The FSIS assessment team addressed the actions that the Agency should take with regard to Lm-positive results from tests performed on official samples. It should be understood that every inspected establishment is required by regulation to operate under a HACCP plan and to take corrective actions whenever there is a deviation from critical limits for the CCPs identified in the plan. FSIS personnel are trained to take enforcement action only if there has been a violation of the regulations. If an establishment has found a deviation through its normal HACCP monitoring and verification activities and takes some corrective action based on its findings, the Agency has no regulatory grounds for taking enforcement action because of the deviation.

However, if the Agency has verification testing results or other information that an establishment may have shipped adulterated product, an IVT is one of a number of appropriate actions, including an enforcement action, that the Agency may take in the interest of protecting the public health. Repeated findings of Listeria spp. or Lm on food-contact surfaces or on product may lead to an enforcement action if FSIS determines that the establishment is not properly addressing insanitary conditions.

Comment: One commenter stated that the FSIS sampling program should be modified to provide baseline surveillance information to permit progress to be gauged. The comment said that verification sampling should target the riskiest products, and that there should be a properly designed and conducted annual survey of RTE establishments.

On the results that were available in 2004, when the FSIS assessment team prepared its report, the commenter questioned why FSIS had found no difference among the prevalence levels of Lm in randomly sampled RTE foods (3 of 345 or 0.9%) and in RTE foods for which sampling was targeted (11 of 1,349 or 0.8%). (The results are presented in the “Agency Accomplishments” section of the assessment team's report.) The commenter recommended the reevaluation of establishment HACCP plans and Sanitation SOPs and other prerequisite programs in the event of an FSIS positive Lm sample in a product that supports the growth of the organism. The commenter said that uniform criteria for such reevaluation should be developed.

Response: FSIS's verification sampling and testing program for Lm is designed to focus Agency resources on those products and processes that may pose higher risks of adulteration.

Regarding the apparent similarity in Lm prevalence among RTE products that were sampled randomly and RTE products that were sampled according to risk, the Agency found that, when both ALLRTE and RTE001 samples were scheduled in one month, often only the RTE001 products were collected. In addition, FSIS found that the highest-risk products produced by the establishment were often collected for the ALLRTE project, rather than products collected at random. FSIS determined that combining the ALLRTE and RTE001 sampling projects into the new RTEPROD project would reduce redundancy in sample scheduling and make the sample selection process more efficient. Under RTEPROD, the sampling project codes specify more clearly whether FSIS personnel should select samples randomly (RTEPROD_RAND) or based on risk (RTEPROD_RISK). In addition, FSIS personnel receive either a RTEPROD_RAND or a RTEPROD_RISK sampling request at most once per month per establishment (see FSIS Directive 10340.4, Verification Activities for the Listeria monocytogenes Regulations and the Ready-to-Eat (RTE) Sampling Program). FSIS personnel are not requested to collect both RTEPROD_RAND and RTEPROD_RISK samples in one month to avoid overlap and to increase sampling efficiency.

Regarding the suggestion that establishment HACCP plans and prerequisite programs be reevaluated in the event of an Lm-positive product test, such a reevaluation may be necessary depending on the circumstances of the positive test. If an establishment made such a finding in the course of testing that was part of its HACCP verification procedures, the establishment would follow the corrective actions procedures in its HACCP plan. If the establishment determined that a change affecting the validity of the hazard analysis had occurred, the establishment would reassess its HACCP plan. On the other hand, an Lm-positive test on an official FSIS RTE product sample might indicate that the establishment's HACCP system had failed to prevent the production of adulterated food. In that case, under the HACCP regulations, FSIS would have grounds for finding the establishment's HACCP system to be inadequate. In addition, if the establishment failed to take appropriate corrective action, as required by 9 CFR 417.3, FSIS would have further grounds for finding the establishment's HACCP system to be inadequate.

In the Compliance Guideline, FSIS has listed and explained the elements of adequate validation for post-lethality treatments and growth-suppressing or limiting formulations or processes.

Comment: One commenter noted that the rule did not have a uniform recordkeeping requirement for the results of environmental sampling. Sanitation SOP records are required to be kept for only six months, HACCP records from one to two years. The commenter requested that FSIS explain that an effective environmental sampling program must provide for long-term trend analysis.

Response: Records that are generated under the Lm control regulations may be Sanitation SOP records, HACCP records, or other prerequisite program documentation and records. As the commenter points out, retention requirements apply to Sanitation SOP records and HACCP records. Prerequisite program documentation and records of activities conducted under the Lm control regulations affect hazard analysis decisions and are required to be maintained for at least two years under 9 CFR 417.5 because they are documents used to inform decisions in the establishment's hazard analysis.

FSIS agrees that it is important that an establishment analyze trends in product, food-contact surface, and environmental test results. In the Compliance Guideline, FSIS advises establishments to keep monitoring records, including test results, for use in evaluating their Sanitation SOPs. The monitoring records should be designed to show trends in the development of insanitary conditions. Establishments should review at least the previous month's testing results to determine whether a trend is emerging, or whether it is necessary to revise their sampling plans. Persistent problems may indicate the pathogen's presence in niches in the processing environment. FSIS also advises establishments to adjust their testing frequencies on the basis of data that they have collected over time. FSIS is not, however, proposing to change its record retention requirements because the Agency believes that the requirements are adequate.

Comment: One commenter stated that while the interim final rule required establishments to verify the effectiveness of their Listeria control program through testing, they have no obligation to conduct such testing at any particular frequency, even if they produce high-risk products such as deli meats and hot dogs. The commenter argued that, without mandatory minimum testing frequencies, establishments simply cannot be assured that their controls are working effectively every day to control Listeria.

Response: After reviewing comments on the 2001 proposed rule (66 FR 12589) and the results of the FDA/FSIS risk ranking and the FSIS risk assessment, FSIS concluded that a mandatory testing frequency was not well-founded. The FDA/FSIS risk ranking and FSIS risk assessment showed that post-lethality interventions and formulation of RTE meat and poultry products with growth inhibitors was much more effective in preventing listeriosis than testing product or food contact surfaces. Therefore, FSIS is not making changes to the regulations to require a minimum testing frequency for establishments.

Nevertheless, the Agency regards establishment verification testing of the processing environment and especially of food-contact surfaces to be important in monitoring the sanitary conditions under which post-lethality exposed RTE products are processed. Establishments that produce RTE products and that rely on sanitation procedures alone to control Lm (Alternative 3) should carry out effective verification procedures, including food-contact surface testing, to ensure that their controls are effective, and that the products are not contaminated. Such is the Agency's regard for the value of food-contact surface testing that the Agency has incorporated food-contact surface testing into its RLm sampling program that it is carrying out in RTE establishments.

Comment: One commenter stated that, even though the rule required establishments to make their own testing results available to FSIS inspection personnel upon request, nothing in the interim final rule imposed on establishments an affirmative obligation to disclose test results, particularly positive results, to FSIS at the time the results are obtained. The commenter argued that, without immediate access to these data when a problem is first identified, inspection personnel may be unaware that there is a sanitation problem at a facility, that interventions are not working properly, or that those problems may be persistent and uncorrected.

Response: As the comment acknowledges, when FSIS personnel request testing records, the establishment is required to make them available (9 CFR 430.4(e)) so that FSIS personnel can complete the required verifications. From the verification results FSIS can know whether there is a sanitation problem at the establishment, whether antimicrobial interventions are working properly, whether a corrective action was appropriately taken to address a non-recurring problem, or whether there is mounting evidence of a persistent problem that must be corrected.

Changing the regulations to require immediate notification of FSIS when a positive test is obtained would not affect what either the establishment or FSIS is required to do with respect to product safety in response to the positive test result. Therefore, FSIS is not proposing to change the regulations in this respect.

Comment: A few commenters stated that the Agency should periodically update the Compliance Guideline. Also, commenters stated that the Agency should make available to the industry guidance on acceptable procedures for evaluating the effectiveness of new post-lethality treatments and antimicrobial agents or processes.

Response: FSIS has updated the Compliance Guideline four times since the interim final rule published. The first update in October 2004 responded to comments and questions that FSIS received about the rule and addressed questions that participants asked during the workshops that the Agency held in preparation for the implementation of the interim final rule. The second update in May 2006 included new information on FSIS's risk-based sampling algorithm and acceptable procedures for evaluating the effectiveness of new post-lethality treatments and antimicrobial agents or processes. The third update in September 2012 provided updated technical information on the control alternatives and on how establishments could take corrective actions in response to positive results and new information on developing a listeria control program. The fourth update in January 2014 responded to comments and questions that FSIS received in response to the previous version. FSIS will continue to update the Compliance Guideline as necessary.

Comment: One commenter stated that the labeling claims about treatments that eliminate, suppress, or limit the growth of Lm could be misleading. The commenter argued that allowing companies to provide information about technologies, without also including safe handling instructions, may create further potential to mislead consumers, including susceptible groups, into a false sense of safety and lead to improper handling.

Response: Safe handling instructions are required if the meat or poultry component of a product is raw or partially cooked (i.e., not considered RTE), and if the product is destined for household consumers or institutional users (9 CFR 317.2(1) or 381.125(b)). All food products, including shelf-stable RTE products, must be handled with appropriate care to prevent product adulteration. Findings of a survey conducted by the International Food Information Council (IFIC), which is described in more detail in the response to the next comment, do indicate that label statements about processing for improved product safety may cause some consumers to feel safe about eating product after a “use-by” date. This could be a concern if the “use-by” date were a safety-based date.

FSIS believes, nevertheless, that the processed-for-safety statements can be made if they are adequately supported. Also, as the Agency's own assessment team has recommended, the Agency should give industry flexibility to develop labeling statements that are truthful and not misleading. FSIS will review and approve labels that bear such statements before they are used, as it approves all labels that make special claims. The Agency also will ensure that its food safety education materials for consumers include information about the labels and about Lm.

Comment: IFIC submitted the results of a study that it conducted in collaboration with FSIS. In the study, IFIC tested several different informational statements to determine the impact such labeling has on consumer perceptions of food safety. The IFIC survey found that, while food-safety information can assist consumers in the purchase, preparation, and handling of foods, the food-safety labeling messages that were tested may not achieve this goal. None of the statements tested performed better than control product labeling. Only a very small segment of the population of consumers in the study felt that enhanced food safety was an important reason to purchase a product. Most statements did not enhance consumer perceptions of food safety, although the statements were likely to make consumers feel safe eating product after the “use by” date. Also, the results appeared to indicate that use of labels with certain food safety information may actually drive some consumers away from the product category.

Response: FSIS understands the challenge of providing consumers with useful and important food safety information on product labels. That is why the Agency is not requiring labeling statements about Lm controls but only permitting and encouraging their use.

Comment: A few commenters stated that FSIS should conduct research to determine the magnitude of retail-level contamination. A few commenters agreed with the assessment team finding that efforts to control Lm contamination at retail are warranted. The commenters stated that, in addition to training, there must be measurement, monitoring, and enforcement of best practices at retail. The commenters agreed with the assessment team's finding that regulatory strategies aimed at FSIS-inspected establishments may not be effective in reducing retail-level contamination. Another commenter strongly agreed with the assessment team's recommendation to educate and train retail and food service personnel but noted that this matter is usually outside USDA/FSIS jurisdiction.

One commenter stated that additional training for retail staff is appropriate for reducing Lm contamination of RTE products at that level. The commenter also recommended the use of antimicrobial agents in products sold at retail. The commenter recommended that FSIS investigate the practicality of freezing or other practices during transport of RTE products. In addition, the commenter stated that the FSIS Lm control strategy should focus on preventing cross-contamination at the deli counter.

Response: State and local governments have chief responsibility for the administration of inspections and regulation of retail facilities on a regular basis. Although FSIS does not inspect retail establishments, it may visit them to ensure that the meat, poultry, and egg products that they sell remain safe for human consumption and are not adulterated or misbranded.

FSIS provides information, materials, and assistance to help State and local agencies to achieve food safety goals and conducts outreach programs that are aimed at retail and food service personnel. FSIS also participates with FDA in the development of the Food Code model ordinance. The Food Code sets forth model standards that State and local public health authorities may adopt in their own regulatory programs for the retail sector.

To help minimize the public health burden of listeriosis, FSIS and the FDA conducted an interagency risk assessment to better understand the risk of foodborne illness associated with eating certain RTE foods prepared in retail delis and developed recommendations for changes in current practices that may improve the safety of those products. In 2013, FSIS and FDA made their findings available to the public in the “Interagency Risk Assessment—Listeria monocytogenes in Retail Delicatessens” (Interagency Retail Lm Risk Assessment), which is available on FSIS's Web site at http://www.fsis.usda.gov/wps/portal/fsis/topics/science/risk-assessments.

The agencies conducted the risk assessment to better understand how retail practices (e.g., temperature control, sanitation, worker behavior) influence the risk of listeriosis associated with eating meat, cheeses, and salads sliced or prepared in retail delicatessens. The risk assessment also examines how effective various interventions are in limiting the survival, growth, or cross contamination of Lm.

The risk assessment is based on observations of deli employees' work routines; concentrations of Lm on incoming products and in the deli environment; studies on the ability of Lm to spread in retail delis, such as from a slicer to food; and an existing dose-response model. The study was designed to apply to a range of deli establishments, from small independent operations to the deli departments in large supermarkets.

FSIS agrees that care should be taken in storage, handling, and distribution of RTE meat and poultry products, and that strict temperature controls are important in preventing the outgrowth of any Lm that may be present in products. Using the key findings of the Interagency Retail Lm Risk Assessment along with available scientific knowledge, the FDA Food Code, and lessons learned from controlling Lm in FSIS-inspected meat and poultry processing establishments, FSIS developed the “FSIS Best Practices Guidance for Controlling Listeria monocytogenes (Lm) in Retail Delicatessens,” which provides practical recommendations that retailers can use to control Lm contamination and outgrowth in the deli. The best-practices guidance is available at http://www.fsis.usda.gov/wps/wcm/connect/29d51258-0651-469b-99b8-e986baee8a54/Controlling-LM-Delicatessens.pdf?MOD=AJPERES. FSIS encourages retailers to use the best-practices guidance to help ensure that RTE meat and poultry products in the deli area are handled under sanitary conditions and are not adulterated.

Comment: One commenter noted that the draft of the second risk assessment, initiated in early 2001, was not completed until February 2003—two years after publication of the proposed rule, which addressed control of Lm. The commenter stated that the Agency limited the new assessment to deli meats only (ignoring hot dogs and other high-risk meat and poultry products) and did not include sampling of non-food contact surfaces in the risk model. The commenter also stated that the risk assessment excluded consideration of whether the risk would be reduced if, in addition to other steps, final product testing was required. The final version of FSIS's risk assessment,3 released in May 2003, found that the minimal testing frequency in the proposed Listeria rule would result in a small reduction in Listeria levels, and that a combination of interventions (sanitation and testing of food-contact surfaces, lethality interventions, and growth inhibitors) appeared to be more effective than any single intervention.

Response: The focus of the risk assessment was narrowed on the basis of available data. The available data on hotdogs was not sufficient to be included in a plant-to-table risk assessment. Moreover, deli meat was believed to be the vehicle in most listeriosis cases. From the 2003 FDA-FSIS Quantitative Assessment of the Risk of Listeriosis due to Selected Food Categories (FDA, 2003), the median number of cases of listeriosis per annum from deli meats was estimated to be 1598.7. For frankfurters (reheated and not reheated combined) the number of cases was estimated to be less than 31. For pâté and meat spreads, the estimated number of illnesses was less than 4, and for dry/semi-dry fermented sausages, the estimated number of illness was less than 0.1. Clearly, this document pointed to deli meats as the high-risk food category in 2003.

While FSIS is aware of the limitations of its model, the Agency has concluded that the model is adequate to inform decision-making based on the specific risk management questions posed by FSIS risk managers. A more detailed model would require additional data. The Agency noted in the final version of the risk assessment that the data available in the published literature on Listeria in the processing plant environment are limited. In addition to data limitations, the limited time available and the intended use of the model dictated other restrictions on the scope of the assessment. While the risk model addressed only food-contact surfaces as the source of contamination by Lm, the Agency's risk assessors acknowledged that Lm contamination could arise from inadequate lethality treatment or from cross-contamination from non-food contact surfaces. The risk assessment also made simplifying technical assumptions, such as those regarding a generic food-contact surface, the distribution of Listeria on the surface, and the assumption of a generic product lot.

The comment that the model excluded the effect of product testing, however, is not accurate. The in-plant model incorporated, in addition to food-contact surface testing, product testing and pre- and post-packaging interventions and the effect of growth inhibitors (or product reformulation). The risk assessment describes the role of product testing in the model and discusses the probability of detecting Lm in product samples and the contribution of information from such testing to the development of risk reduction measures.

FSIS is affirming the 2003 risk assessment without updates or changes.

Comment: One commenter disagreed with the assessment team's finding that the interim final rule was not disproportionately affecting small establishments because the number of noncompliance records (NRs) that FSIS issued related to this rule to very small plants was twice that for large plants. Similarly, the commenter stated that FSIS issued more NRs to small plants than large. Another commenter stated that the assessment team's finding that FSIS issued most NRs to very small establishments evidences the need for a much stronger effort at compliance assistance to the small processor.

A few comments that were submitted in response to OMB's February 2004 solicitation of nominations for regulatory reform (69 FR 7987) argued that the Agency greatly underestimated the costs and overestimated the benefits of the interim final rule.

One commenter that responded to the OMB request asserted that the economic analysis of the interim final rule understated the costs to small businesses, particularly to small and very small processing plants, and overstated the benefits of the rule. The commenter noted that FSIS estimated the annual cost of the rule to the industry in the range of $16.6 million, and that benefits were in the range of $44 million to $154 million. However, the commenter estimated that the actual costs were closer to $115 million per year. The commenter charged that for each of the “10,000 plants” (sic) that are subject to the rule, the true costs are closer to $11,500 per year and over $1.15 billion over ten years. According to the commenter, the costs reflect the purchase of new equipment, reconfiguration of plant facilities, accumulated interest of $50,000 per plant, and estimated annual costs of $6,500 for testing to ensure compliance and for consultants. The grand total then would be $115,000 per plant.

The commenter asserted that the rule puts American firms at a competitive disadvantage with foreign firms, and that the burden of the rule is so great that some small and very small plants may cease operations.

The commenter did not present an alternative benefit estimate in dollar terms but asserted that FSIS based its estimates on data that the Centers for Disease Control and Prevention (CDC) gathered through 1997, while CDC data for 1996 to 2000 show a 38 percent decrease in incidence of, and mortality from, Lm. Also the commenter asserted on the basis of the Q&A provided with the 2003 FDA/FSIS joint risk assessment that FSIS used for the interim final rule that it is likely that the annual total cases were less than 1,500, with 300 deaths.

Another commenter recommended that FSIS review the compliance costs of the rule and increase the calculation of those costs to a more reasonable figure.

Response: The commenters misstated the regulatory impact analysis of the interim final rule on key points. For example, rather than 10,000 plants, as one commenter stated, the rule was estimated to affect 2,930 total Federal establishments. In actual fact, the rule affected 2,473 Federal establishments in 2006 and 2,307 Federal establishments in 2013. Thus, the comment, on that basis alone, increased the arguable costs of the rule.

The comment stated that the costs of new equipment, plant reconfiguration, testing, and outside expert technical assistance are a substantial burden on small plants that the Agency ignored in its analysis. However, the interim final rule did not require these plants to upgrade their operations. For this reason, such costs are not a direct effect of the rule. The regulatory impact analysis estimated that the vast majority of very small plants, such as the one submitting the comment, would use Alternative-3 type controls (sanitation only) to control Lm instead of changing from Alternative 3 to Alternative 2 or 1. Costs for Alternative 3 are minimal because it only requires an establishment to control Lm through its sanitation program. An establishment would not need to purchase new equipment for post-lethality treatment or apply antimicrobial agents. Comparing FSIS PHIS data of calendar year (CY) 2013 and the baseline in the 2003 interim final rule, the Agency found that about 77 percent of the small and very small establishments that used alternative 3 still use alternative 3.4 The percentage increases from the baseline to CY 2013 for small and very small establishments using Alternative 2b, Alternative 2a, and Alternative 1 are 17 percent, 1 percent and 1.5 percent, respectively. Therefore, the costs the small and very small establishments would incur would mostly be those attributable to initial and on-going compliance with the sanitation program requirements of the rule.

As to the benefit estimates in the economic analysis of the interim final rule, these were based on the potential risk reductions to be achieved through the adoption by industry of the Listeria control alternatives set out in 9 CFR 430.4. While the comment stated that the CDC data for 1996 to 2000 show a 38 percent decrease in incidence of, and mortality from, Lm, the comment did not take into account an “up spike” in listeriosis illness that occurred in 2002-2003 before the rule went into effect. Thus, when the rule was promulgated, there were a significantly higher number of illnesses to be averted than the comment considered. Finally, the benefit estimates in the interim final rule were based on the differences in the number of illnesses in the risk assessment model results under different scenarios. The risk assessment model estimated the number of illnesses using FSIS simulation models that assess how the in-plant contamination level transfers to the retail contamination level and then assessed the number of illnesses based on the dose-response relationship from the FDA/FSIS exposure retail-to-table model where all models were calibrated for deli meat.5

For these reasons, FSIS is affirming the basic conclusions reached by the Final Regulatory Impact Analysis that was submitted in support of the interim final rule.

Executive Orders 12866 and 13563 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, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “non-significant” regulatory action under section 3(f) of Executive Order (E.O.) 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget under E.O. 12866.

FSIS is affirming the basic conclusions reached by the Final Regulatory Impact Analysis that was submitted in support of the interim final rule. The two changes do not affect the basic conclusions reached by the Final Regulatory Impact Analysis that was submitted with the interim final rule. FSIS is making two changes in this document, making clear in the regulation that products that have been in contact with a Lm contaminated surface would be adulterated if not reprocessed (9 CFR 430.4(a)) and removing the requirement for establishments to report production volume and related information to FSIS because the Agency now routinely collects this information through PHIS (9 CFR 430.4(d)). Neither change will cause establishments to change their practices to comply with the regulation. Therefore, there is no need to conduct a cost or benefit analysis to affirm the interim final rule.

The FSIS Administrator certifies that, for the purposes of the Regulatory Flexibility Act (5 U.S.C. 601-602), the rule will not have a significant economic impact on a substantial number of small entities in the United States.

There are no paperwork or recordkeeping requirements associated with this rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

FSIS and USDA are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601, et seq.) by, among other things, promoting the use of the Internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes.

This rule has been reviewed under the Executive Order 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) no administrative proceedings will be required before parties may file suit in court challenging this rule.

This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” E.O. 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects 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.

FSIS has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, the Food Safety and Inspection Service will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.

No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

Send your completed complaint form or letter to USDA by mail, fax, or email:

Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.

Fax: (202)690-7442.

Email [email protected].

Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202)720-2600 (voice and TDD).

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS Web page located at: http://www.fsis.usda.gov/federal-register.

FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

For the reasons set forth in the preamble, FSIS is adopting as final the interim final rule that amended Title 9, Chapter III, of the Code of Federal Regulations and that was published at 68 FR 34208 on June 6, 2003, with the following amendments:

FHFA is responsible for ensuring that the regulated entities operate in a safe and sound manner, including the maintenance of adequate capital and internal controls; that their operations and activities foster liquid, efficient, competitive, and resilient national housing finance markets; and that they carry out their public policy missions through authorized activities. See 12 U.S.C. 4513. This Order is being issued under 12 U.S.C. 4514(a), which authorizes the Director of FHFA to require by Order that the regulated entities submit regular or special reports to FHFA and establishes remedies and procedures for failing to make reports required by Order. The Order directs the Banks to use a revised public disclosure template for publicly disclosing the severely adverse stress testing scenario results as of September 30, 2014. The revised template replaces the template initially issued on November 14, 2014 and will enhance the transparency of each Bank's public disclosure.

For the convenience of the affected parties, the text of the Order, without the accompanying Summary Instructions and Guidance and appendices, follows below in its entirety. You may access this Order with all of the accompanying material from FHFA's Web site at: http://www.fhfa.gov/Media/PublicAffairs/Pages/FHFA-Issues-Scenarios-and-Guidance-to-FannieMae,-Freddie-Mac-and-the-Federal-Home-Loan-Banks-Regarding-Annual-Dodd-Frank-St.aspx. The Order, new public disclosure template (Attachment 1), and Summary Instructions and Guidance will be available for public inspection and copying at the Federal Housing Finance Agency, Eighth Floor, 400 Seventh St. SW., Washington, DC 20024. To make an appointment, call (202) 649-3804.

The text of the Order is as follows:

Whereas, pursuant to the Federal Housing Finance Agency's (FHFA) regulation implementing section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act requiring each regulated entity to conduct stress tests to determine whether it has the capital necessary to absorb losses resulting from adverse economic conditions and report the results “in the manner and form established by FHFA,” 12 CFR 1238.5(b); and

Whereas, FHFA's rule implementing section 165(i)(2) of the Dodd-Frank Act is codified as 12 CFR part 1238 and requires that “[e]ach regulated entity must file a report in the manner and form established by FHFA,” 12 CFR 1238.5(b); and

Whereas, FHFA's regulation requires that each regulated entity “disclose publicly a summary of the stress test results for the severely adverse scenario,” 12 CFR 1238.7; and

Whereas, on November 14, 2014, FHFA issued to each regulated entity scenarios for stress testing as of September 30, 2014, and on December 1, 2014, issued Orders to each regulated entity together with Summary Instructions and Guidance with prescribed templates for completing, reporting, and disclosing the stress test results; and

Whereas, each Federal Home Loan Bank timely filed its report of stress test results on or before April 30, 2015, as required by 12 CFR 1238.5; and

Whereas, after analyzing the results of each Federal Home Loan Bank's stress testing and the methodologies and practices used therein, FHFA has determined that the original template designed for public disclosure of the summary of each Bank's severely adverse scenario results that accompanied the Orders of December 1, 2014, should be revised; and

Whereas, section 1314 of the Federal Housing Enterprises Financial Safety and Soundness Act, as amended, 12 U.S.C. 4514(a), authorizes the Director of FHFA to require regulated entities, by general or specific order, to submit such reports on their management, activities, and operations as the Director considers appropriate.

Now therefore, it is hereby Ordered as follows:

Each Federal Home Loan Bank shall publicly disclose and report, as required by 12 CFR part 1238, a summary of the severely adverse scenario results of its stress testing using the template provided herewith as the attachment entitled “FHLBank Dodd-Frank Stress Test Template—SEVERLY ADVERSE (Disclosure to the Public).”

It is so ordered, this 10th day of June 2015.

This Order is effective immediately.

Discussion

We received reports of cracks in the PW6122A and the PW6124A HPC 7th stage IB rotor aft integral arm. The root cause is the presence of silver-plated nuts reacting with hot titanium in a high sulfur/high chlorine environment. This AD requires initial and repetitive BSIs of the HPC 7th stage IB rotor. This AD also requires, as terminating action, replacement of the HPC 7th stage IB rotor and HPC 7th stage IB rotor silver-plated nuts with non-silver-plated nuts. This condition, if not corrected, could result in HPC 7th stage IB rotor fractures. We are issuing this AD to prevent HPC 7th stage IB rotor fractures, which could lead to uncontained engine failure and damage to the airplane.

We reviewed PW Engineering Authorization (EA) No. 15MM008, Revision A, dated March 24, 2015. We also reviewed PW Service Bulletin (SB) No. PW6ENG 72-46, dated March 5, 2015. The EA describes procedures for BSIs of the HPC 7th stage IB rotor aft integral arm for cracks using the split-case method. The SB describes removal and replacement of the HPC 7th stage IB rotor, removal of the HPC 7th stage IB rotor silver-plated nuts, and the installation of non-silver plated nuts. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this AD.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires initial and repetitive BSIs of the HPC 7th stage IB rotor. This AD also requires as terminating action to replace the HPC 7th stage IB rotor and HPC 7th stage IB rotor silver-plated nuts with non-silver-plated nuts.

No domestic operators use this product. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2015-0266; Directorate Identifier 2015-NE-03-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

We estimate that this AD will affect 0 engines installed on airplanes of U.S. registry. We also estimate that it would take about 8 hours per engine to comply with this AD. The average labor rate is $85 per hour. Based on these figures, we estimate the total cost of this AD to U.S. operators to be $0.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. The NPRM published in the Federal Register on August 4, 2014 (79 FR 45137). The NPRM was prompted by a report of two cases of heavy (hard to move) aileron control caused by aileron cables stuck in a clump of ice in the wheel bay. The NPRM proposed to require installing drain tubes on the center wing rear spar. We are issuing this AD to prevent accumulated water near or on the aileron control cables, which could freeze and result in reduced control of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2013-0140, dated July 12, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (79 FR 45137, August 4, 2014) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (79 FR 45137, August 4, 2014) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 45137, August 4, 2014).

Fokker Services B.V. has issued Fokker Service Bulletin SBF100-51-021, dated April 23, 2013, including the following attachments:

• Fokker Parts List Local SB10051021-XU-B, Revision A, Sequence 1, dated April 10, 2013.

• Fokker Parts List Supply SB10051021-XU-B, Revision A, Sequence 1, dated April 10, 2013.

• Fokker Parts List Local SB10051021-XU-A, Revision B, Sequence 1, dated April 10, 2013.

• Fokker Parts List Supply SB10051021-XU-A, Revision B, Sequence 1, dated April 10, 2013.

• Fokker Manual Change Notification MCNM F100-160, dated April 23, 2013.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this AD.

We estimate that this AD affects 4 airplanes of U.S. registry.

We also estimate that it will take about 8 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $1,380 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $8,240, or $2,060 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0492; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

NMFS published a proposed rule for this action in the Federal Register on December 3, 2014 (79 FR 71729), and public comments were accepted through January 2, 2015.

The International Pacific Halibut Commission (IPHC) and NMFS manage fishing for Pacific halibut (Hippoglossus stenolepis) through regulations established under authority of the Northern Pacific Halibut Act of 1982 (Halibut Act). The IPHC adopts regulations governing the Pacific halibut fishery under the Convention between the United States and Canada for the Preservation of the Halibut Fishery of the North Pacific Ocean and Bering Sea (Convention), signed at Ottawa, Ontario, on March 2, 1953, as amended by a Protocol Amending the Convention (signed at Washington, DC, on March 29, 1979). For the United States, regulations developed by the IPHC are subject to acceptance by the Secretary of State with concurrence from the Secretary of Commerce. After acceptance by the Secretary of State and the Secretary of Commerce, NMFS publishes the IPHC regulations in the Federal Register as annual management measures pursuant to 50 CFR 300.62. The final rule implementing IPHC regulations for the 2015 fishing season published on March 17, 2015 (80 FR 13771). IPHC regulations affecting sport fishing for halibut and vessels in the charter fishery in Areas 2C and 3A may be found in sections 3, 25, and 28 of that final rule.

The Halibut Act, at sections 773c(a) and (b), provides the Secretary of Commerce with general responsibility to carry out the Convention and the Halibut Act. In adopting regulations that may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act, the Secretary of Commerce is directed to consult with the Secretary of the department in which the U.S. Coast Guard is operating, currently the Department of Homeland Security.

The Halibut Act, at section 773c(c), also provides the North Pacific Fishery Management Council (Council) with authority to develop regulations, including limited access regulations, that are in addition to, and not in conflict with, approved IPHC regulations. Regulations developed by the Council may be implemented by NMFS only after approval by the Secretary of Commerce. The Council has exercised this authority in the development of subsistence halibut fishery management measures, and sport halibut fishery management measures in Convention waters off Alaska, codified at 50 CFR 300.61, 300.65, 300.66, and 300.67. The Council also developed the Individual Fishing Quota Program for the commercial halibut fishery, codified at 50 CFR part 679, under the authority of section 773 of the Halibut Act.

This final rule aligns Federal regulations for charter halibut fishing with State of Alaska regulations for sport fishing to clarify the Council's and NMFS' intent for management of charter halibut fisheries in Areas 2C and 3A in Convention waters off Alaska. The regulatory clarifications also will facilitate enforcement and clarify recordkeeping and reporting requirements for the charter halibut fishery. This final rule does not revise regulations for unguided sport halibut fishing in Alaska found in sections 3, 25, and 28 of the IPHC annual management measures; however, the 2015 IPHC annual management measures for charter halibut fishing were modified to maintain consistency with this final rule. A general description of the halibut fisheries in Alaska was provided in the proposed rule for this action (79 FR 71729, December 3, 2014) and is briefly summarized here.

Sport fishing activities for Pacific halibut in Areas 2C and 3A are subject to different regulations, depending on whether those activities are guided or unguided. Guided sport fishing for halibut is subject to charter restrictions under Federal regulations. These regulations apply if a charter vessel guide is providing assistance for compensation, or sport fishing guide services, to an angler during a fishing trip. Unguided anglers typically use their own vessels and equipment, or they may rent a vessel and fish with no assistance from a guide.

The charter halibut fisheries in Areas 2C and 3A are managed under the Charter Halibut Limited Access Program (CHLAP) and the Catch Sharing Plan (CSP). The CHLAP limits the number of operators in the charter fishery, while the CSP establishes annual allocations to the charter and commercial fisheries and describes a process for determining annual management measures to limit charter harvest to the allocations in each management area. The proposed rule and Section 1.3 of the RIR/IRFA prepared for this action provide additional detail on the charter halibut management programs that have been implemented in Areas 2C and 3A.

The CHLAP established Federal charter halibut permits (CHPs) for operators in the charter halibut fishery in Areas 2C and 3A. Since 2011, all vessel operators in Areas 2C and 3A with charter anglers on board must have an original, valid permit on board during every charter vessel fishing trip on which Pacific halibut are caught and retained. CHPs are endorsed for the appropriate regulatory area and the number of anglers that may catch and retain halibut on a charter vessel fishing trip. Complete regulations for the CHLAP are published at §§ 300.65, 300.66, and 300.67.

The CSP established sector allocations that vary proportionally with changing levels of annual halibut abundance and that balance the differing needs of the charter and commercial halibut fisheries over a wide range of halibut abundance in each area. The CSP describes a public process by which the Council develops recommendations to the IPHC for charter angler harvest restrictions that are intended to limit harvest to the annual charter halibut fishery catch limit in each area. The CSP also authorizes limited annual leases of commercial individual fishing quota for use in the charter fishery as guided angler fish (GAF). GAF authorizes individual charter operators in Area 2C and Area 3A to offer anglers the opportunity to retain additional halibut when charter vessel anglers are subject to a more restrictive daily harvest limit than unguided sport anglers in the same area. Complete regulations for the CSP are published at §§ 300.65 and 300.66. Additional detail on the development and rationale for the CSP can be found in the final rule implementing the program (78 FR 75844, December 12, 2013).

Each year, based on recommendations from the Council, the IPHC annually adopts charter halibut management measures designed to keep charter harvest in Area 2C and Area 3A to the catch limits specified under the CSP. Once accepted by the Secretary of State with the concurrence of the Secretary of Commerce, NMFS publishes in the Federal Register the charter halibut management measures for each area as part of the IPHC annual management measures. The 2015 IPHC annual management measures were published on March 17, 2015 (80 FR 13771).

The Alaska Department of Fish and Game (ADF&G) monitors and estimates charter halibut harvests using the Saltwater Charter Logbook (hereafter, logbook). The logbook is the primary reporting requirement for operators in the charter fisheries for all species harvested in saltwater in Areas 2C and 3A. Logbook data are compiled to show where fishing occurs, the extent of participation, and the species and the numbers of fish caught and retained by individual charter anglers. This information is essential to estimate harvest for regulation and management of the charter halibut fisheries in Areas 2C and 3A. ADF&G collects logbook information from charter vessel guides on halibut harvested by charter vessel anglers to accommodate the information requirements for implementing and enforcing Federal charter halibut fishing regulations, such as daily bag limits and the CHLAP.

This final rule is primarily intended to clarify that (1) compensated assistance to an angler to catch halibut during a fishing trip will be managed under Federal charter fishery regulations, whether or not the person providing that compensated assistance is on board the vessel with the angler, and (2) halibut harvested by an angler receiving compensated assistance will accrue toward charter allocations. These clarifications are necessary to apply Federal charter fishing regulations to a small number of businesses that offer services in which guides provide assistance to halibut anglers for compensation, from adjacent vessels or shore. Under previous Federal regulations, a person providing assistance to an angler during a fishing trip, and who was not on board the vessel with the angler, was not providing sport fishing guide services. As a result, an operator was not required to have a CHP on board the vessel, as required by the CHLAP regulations at § 300.67, if the compensated assistance provided to an angler during a fishing trip was by a person who was not on board the vessel with the angler. In addition, an angler receiving assistance during the fishing trip from a guide that was not on board the vessel with the angler was not subject to regulations that limit a guided angler to more restrictive daily bag and size limits that are intended to limit charter harvest to allocations specified by the Council's CSP for Area 2C and Area 3A.

In recommending the revisions to Federal regulations implemented by this final rule, the Council specified that providing compensated assistance to an angler from an adjacent vessel or from the shore is a de facto form of charter fishing and should be managed under charter fishing regulations. A guide who is not on the same vessel with an angler and who provides assistance for compensation to an angler will be included in the definition of sport fishing guide services under this final rule. The Council was concerned that guide-assisted sport fishing services might increase if no action was taken to define these fishing activities as charter fishing.

This final rule also implements regulations recommended by the Council clarifying that halibut harvests by an angler receiving compensated assistance from a person not on board the vessel with the angler (except GAF, which is an alternative use of commercial halibut individual fishing quota) should accrue to the charter sector allocation under the CSP. This final rule clarifies logbook reporting requirements and will improve harvest estimates by aligning the Federal and State definitions of sport fishing guide services so that halibut harvested by an angler who receives compensated assistance are required to be recorded in the logbook, whether the person providing the assistance is physically present on board the vessel or not. Aligning State and Federal definitions of sport fishing guide services will provide the public with clear and consistent management between management agencies.

This final rule aligns Federal regulatory text regarding sport fishing guide services for Pacific halibut with State regulations in a manner that is consistent with the Council's intent for management of charter halibut fisheries. The revisions will enhance enforcement of sport fishing regulations by an authorized officer by clearly defining when a person is providing sport fishing guide services. This regulatory clarity will also aid anglers and operators providing sport fishing guide services to comply with regulations for the charter halibut fisheries.

This final rule implements clear and consistent regulations that apply to all businesses providing, and all anglers receiving, sport fishing guide services. This final rule will improve the accuracy of the data collected on sport fishing harvest. Specifically, this final rule requires anglers receiving sport fishing guide services, whether or not a charter vessel guide is on board, to comply with the restrictions in place for charter vessel anglers. This final rule requires businesses that provide sport fishing guide services for halibut from separate vessels to obtain CHPs for the vessels on which the anglers are fishing and comply with the restrictions in place for the charter halibut fishery. This final rule does not increase the number of CHPs issued under the CHLAP.

As described in the proposed rule and in Section 1.2 of the RIR/IRFA, this final rule is intended only to address fishing activities for the charter halibut sector, not businesses that provide equipment for unguided (or self-guided) sport fishing. The proposed rule provided a detailed description of the proposed regulatory changes and a brief summary is provided in the following sections. This final rule implements three categories of regulatory changes: (1) Revisions to definitions at § 300.61; (2) revisions to CHLAP and CSP regulations; and (3) other regulatory revisions. The last section describes changes made to the 2015 IPHC annual management measures to aid the implementation of this rule.

Most critically, this final rule revises the definition of “sport fishing guide services,” and adds definitions for “compensation” and “charter vessel” at § 300.61. This final rule also makes technical revisions to the definitions of “charter vessel angler,” “charter vessel fishing trip,” “charter vessel guide,” and “charter vessel operator” at § 300.61 for added clarity and consistency among definitions. These changes are described in detail in Section 2.7 of the RIR/IRFA and in the proposed rule for this action.

The revision to the definition of “sport fishing guide services” removes the requirement that a charter vessel guide be on board the same vessel as the charter vessel angler. This final rule also revises the definition to clarify that services provided by a crew member working directly under the supervision of, and on the same vessel as, a charter vessel guide are not sport fishing guide services for purposes of CHLAP and CSP regulations. This revision clarifies the Council's and NMFS' intent that crew member services will continue to be excluded from the definition of sport fishing guide services for purposes of CHLAP and CSP regulations, to clearly identify that the charter vessel guide, and not a crew member, is the person responsible for complying with the regulations.

The definition of sport fishing guide services in this final rule includes the phrase “accompanying or physically directing the sport fisherman in sport fishing activities during any part of a charter vessel fishing trip.” This phrase is consistent with the State definition for sport fishing guide services. The Federal definition of charter vessel fishing trip at § 300.61 specifies that a charter vessel fishing trip begins when fishing gear is first deployed into the water and ends when one or more charter vessel anglers or any halibut are offloaded from that vessel. The proposed rule and Section 1.3.6 of the RIR/IRFA provides additional detail on this revision to the definition of sport fishing guide services.

This final rule adds a definition for “compensation” to § 300.61 that matches the State's definition (5 AAC 75.995(b)). The Council and NMFS intend for sport fishing for halibut to be considered charter fishing for halibut only if a person providing assistance to a sport angler is receiving compensation. This final rule defines compensation as, “direct or indirect payment, remuneration, or other benefits received in return for services, regardless of the source . . . `benefits' includes wages or other employment benefits given directly or indirectly to an individual or organization, and any dues, payments, fees, or other remuneration given directly or indirectly to a fishing club, business, organization, or individual who provides sport fishing guide services; and does not include reimbursement for the actual daily expenses for fuel, food, or bait.” This definition of compensation also means that payments made by a third party, and non-monetary exchanges of goods and services for taking someone halibut fishing, may also be considered compensation, as well as payments or non-monetary exchanges from a person aboard the charter vessel. The Federal definition does not consider reimbursement for “actual” daily expenses (e.g., bait, fuel, food) to be compensation as explained in the proposed rule and Section 1.3.6.2 of the RIR/IRFA.

This final rule adds a definition for “charter vessel” to Federal regulations at § 300.61. A charter vessel is defined as “a vessel used while providing or receiving sport fishing guide services for halibut.” Under this definition, a charter vessel guide will not be required to be on board the same vessel as the charter vessel angler to be providing sport fishing guide services. If an angler receives sport fishing guide services during a charter vessel fishing trip (i.e., the time between when gear is deployed and when one or more charter anglers or any harvested halibut are offloaded), even if it is from an adjacent or nearby vessel, that angler would be considered to be fishing from a charter vessel.

Under State of Alaska regulations (5 AAC 75.075), charter vessels are required to be registered with the State and are issued identification decals and logbooks. Under this final rule, all charter vessels, including those that will not have charter vessel guides on board, will need to register with the State, display the charter vessel decal while operating as a charter vessel, and have the logbook on board during all charter vessel fishing trips. Each charter vessel from which an angler may catch and retain halibut will also need to have an original CHP on board during charter vessel fishing trips.

The primary responsibility for compliance with charter halibut fishery CHLAP and CSP regulations will continue to be with the charter vessel guide. However, some Federal regulations governing the charter halibut fishery put the burden of compliance on the charter vessel operator. Under this final rule, if no charter vessel guide is on board the vessel with the charter anglers, the charter vessel operator could also be a charter vessel angler. To facilitate compliance in these instances, this final rule implements regulations at § 300.66(s) and (v) to hold the charter vessel operator and the charter vessel guide jointly or severally responsible for compliance with the requirement to have a valid CHP and a logbook on board the charter vessel with the charter vessel anglers if no charter vessel guide is on board the vessel with the charter anglers. If the charter vessel guide is on a separate vessel, or on the shore, the charter vessel operator will be the person on board the charter vessel with the angler (hereafter, “angler vessel”) that could be held jointly responsible with the charter vessel guide to ensure that a valid CHP and the logbook are on the angler vessel. An authorized officer will evaluate the specific circumstances of a fishing trip to determine whether to hold the charter vessel operator and the charter vessel guide jointly or severally responsible for compliance with the requirement to have a valid CHP and a logbook on board the vessel.

Charter vessel guides will remain responsible for complying with the CHLAP and CSP reporting requirements at § 300.65(d), and the person whose business was assigned a logbook will remain responsible for ensuring that the charter vessel guide complies with those requirements. This final rule also implements regulations at § 300.65(d) to require that the logbook remain on the charter vessel with the anglers during the charter vessel fishing trip, even if the guide is on a separate vessel or on shore.

When halibut are retained by charter vessel anglers, the charter vessel guide will remain responsible under regulations at § 300.65(d) for completing the remainder of the logbook data fields by the end of the calendar day, or by the end of the charter vessel fishing trip, whichever comes first. The charter vessel guide is also responsible for ensuring that charter vessel anglers who retained halibut sign the logbook.

Under this final rule, charter vessel guides will remain responsible for complying with the provisions of the GAF program at § 300.65. A GAF permit authorizes a charter vessel angler to retain GAF, and GAF permits are assigned to a single CHP. This final rule implements regulations at § 300.65(c)(5)(iii)(A)(5), to require the guide maintain control of a legible copy of the GAF permit to enable an authorized officer to verify that any GAF retained on the charter vessel were authorized by a valid GAF permit. As described above, regulations at § 300.65(d) require that the CHP and logbook remain on the same charter vessel as the charter vessel anglers.

Regulations at § 300.65(c)(5)(iv)(G) require that upon retention of a GAF halibut, the guide must immediately remove the upper and lower tips of the tail fin lobes to mark and identify that fish as a GAF halibut. This final rule adds a requirement that the guide must be physically present when the GAF is harvested to mark the fish. NMFS anticipates that charter vessel anglers without a guide on board will need to summon the guide (e.g., by cell phone or radio) to be in proximity of the charter vessel before any GAF are harvested. Regulations at § 300.65(d)(4)(iii)(A)(1) require the charter vessel guide to immediately measure and record the total length of the GAF halibut in the GAF permit log on the back of the GAF permit. This final rule does not change this requirement, but adds a reference at § 300.65(d)(4)(iii)(A)(1) to an additional requirement at § 300.65(d)(4)(iii)(A)(5) that the charter vessel guide must immediately record in the logbook the GAF permit number under which the GAF was caught and retained, and the number of GAF retained by the charter vessel angler who caught and retained GAF, if GAF are retained on a charter vessel without a guide on board. The term “immediately,” for enforcement purposes, means that the stated activity (e.g., marking the fish or recording the GAF in the logbook) must occur before the guide or angler moves on to another activity or resume fishing. For example, if a charter vessel angler harvests a GAF, the guide will need to mark and record it before the angler could continue fishing, or transit to another location. If the guide cannot be physically present at the time the GAF is caught, the charter vessel angler will not be authorized to retain that fish.

Regulations at § 300.65(d)(4)(iii)(B) through (E) require a charter vessel guide to electronically report GAF harvests at the end of a charter vessel fishing trip in which GAF is retained. This rule does not revise these regulations and the charter vessel guide will continue to be responsible for electronically reporting GAF harvests.

Regulations at § 300.65(c)(5)(iv)(G) require that if GAF halibut are filleted on board a charter vessel, the carcasses of those GAF halibut must be retained until the end of the charter vessel fishing trip to enable an authorized officer to verify the recorded lengths. This final rule revises CSP regulations at § 300.65(c)(5)(iv)(G) to specify that if any GAF are harvested and filleted on board the charter vessel, those carcasses will also need to be retained on the charter vessel on which the GAF halibut were harvested until the end of the charter vessel fishing trip. In other words, if GAF halibut were harvested on a charter vessel without a guide on board, it will need to stay on the vessel with the angler who harvested it until the end of the fishing trip; it may not be transferred to the vessel that the guide is on for filleting, storage, or otherwise. Similarly, the 2015 IPHC annual management measures at section 28(2)(d) and 28(3)(d) require that the carcasses of size-restricted halibut harvested in the charter fishery in Areas 2C and 3A be retained, if those size-restricted halibut are filleted on board the charter vessel. This final rule adds the same carcass retention requirement to Federal regulations at § 300.65(d)(5) and, once implemented, could be removed from the IPHC annual management measures in future years.

Charter vessel guides, operators, and crew are prohibited from harvesting halibut in Areas 2C and 3A during charter vessel fishing trips under regulations at § 300.65(d)(3). Under this final rule, the charter vessel operator could potentially be a charter vessel angler who is operating a vessel without a charter vessel guide onboard (e.g., the charter vessel guide is on a separate vessel). The Council and NMFS do not intend to prohibit charter vessel anglers who are operating charter vessels without a charter vessel guide onboard from harvesting halibut. Therefore, this final rule revises § 300.65(d)(3) to specify that “a charter vessel guide, charter vessel operator, or crew member may not catch and retain halibut during a charter vessel fishing trip in Commission regulatory area 2C or 3A, except that charter vessel operators who are charter vessel anglers may catch and retain halibut during a charter vessel fishing trip if the charter vessel guide is on a separate charter vessel.”

This final rule makes minor additional changes to regulations at §§ 300.61, 300.65, 300.66, and 300.67 to maintain existing regulatory responsibilities applicable to specific persons and ensure consistency in the charter halibut regulations to meet the intent of this final rule. These changes and the rationale for them are outlined in detail in the proposed rule and in Section 2.7 of the RIR/IRFA for this action and are briefly summarized here.

On January 1, 2015, several Alaska Statutes (A.S. 16.40.260 through 16.40.299) pertaining to sport fishing business and guide licensing and reporting through ADF&G expired. For 2015, there is no ADF&G guide license, fee, or insurance requirement; however, guides are still required to register with ADF&G and to hold an Alaska business license. State of Alaska vessel registration and logbook requirements still apply in 2015. This final rule implements revisions to Federal regulations at § 300.65(d)(4)(ii)(B)(1) and (d)(4)(ii)(D)(4), the definition of “charter vessel guide” at § 300.61, and § 300.67(a)(1) to refer to ADF&G sport fishing guide “licenses or registrations.” NMFS is retaining the word “licenses” in regulations because draft legislation has been submitted to the Alaska State Legislature to reinstate the sport fishing business and guide licensing statutes for future years.

Regulations at § 300.66(h) prohibit subsistence fishing for halibut while commercial fishing or sport fishing. The regulation was intended to prohibit only subsistence fishing for halibut and commercial or sport fishing for halibut from the same vessel on the same day. This final rule revises the prohibition at § 300.66(h) to clarify that it only prohibits subsistence fishing for halibut while commercial or sport fishing for halibut.

The proposed rule (79 FR 71729, December 3, 2014) and Section 2.7 of the RIR/IRFA (see ADDRESSES) for this action described several changes to the IPHC Annual Management Measures that NMFS recommended for consistency among regulations, to improve compliance, and to facilitate enforcement. The IPHC convened in January 2015 and approved NMFS' recommendations. The 2015 IPHC Annual Management Measures were published on March 17, 2015 (80 FR 13771) and reflect the following changes for consistency with this final rule:

(1) Minor technical revisions to management measures at sections 3(1)(c), 28(2)(c), and 28(3)(e) to maintain consistency with revisions to the Federal definition of “charter vessel” and with State of Alaska sport fishing regulations.

(2) Revised section 25(7) to clarify that the charter vessel guide shall be held liable for any violations of annual management measures committed by an angler on a charter vessel, whether the guide is on board the vessel with the angler or on a separate vessel.

(3) Added management measures to section 28(1) to require that all halibut retained by a charter vessel angler remain on the vessel on which they were caught until the end of the charter vessel fishing trip. This revision will facilitate enforcement of daily bag and possession limits by prohibiting anglers on a charter vessel without a guide on board from transferring their harvested halibut to the guide's vessel for processing.

Four minor changes were made to paragraphs (c)(5)(iii)(A)(5) and (c)(5)(iv)(A) of § 300.65 for consistency in wording. These paragraphs describe on which vessel the GAF permit and CHP must be held, depending on whether or not a guide is onboard. In the proposed rule, the language referring to the GAF permit was inconsistent. In one instance it referred to “a legible copy of a GAF permit,” in another it referred to simply “the GAF permit,” and in paragraph (c)(5)(iv)(A) it referred to a “valid GAF permit.” This language has been standardized for consistency in all instances to read “a legible copy of a valid GAF permit.”

The proposed rule for this action was published on December 3, 2014 (79 FR 71729), and public comments on it were accepted until January 2, 2015. NMFS received 8 comment submissions containing 10 unique comments. No comment resulted in a change to the regulatory text from the proposed rule. NMFS summarized and responded to the comments as follows:

Comment 1: The commenter disagrees with the proposed regulations at § 300.66(s) and (v) to hold the charter vessel operator and the charter vessel guide jointly or severally responsible for ensuring that a valid CHP and a logbook are on board the charter vessel with the charter vessel anglers if no charter vessel guide is on board the vessel with the charter anglers. The commenter recommends that, similar to charter halibut operations in which the guide is on board the charter vessel, only the charter vessel guide is responsible for ensuring that the CHP and logbook are on the charter vessel. Considering that enforcement staff would still need to find the charter vessel guide in the case of a violation if he or she is jointly responsible, making the charter vessel angler responsible seems both infeasible and unnecessary.

Response: In the proposed rule for this action, NMFS discussed the rationale for holding the guide, the operator, or both parties responsible for compliance with certain regulations when charter fishing without a guide onboard. In most instances the primary responsibility for compliance with charter halibut fishery regulations is with the charter vessel guide. However, the Federal regulations at § 300.66(s) and (v) put the burden of compliance on the charter vessel operator to have a valid CHP and logbook on board the vessel with the anglers.

The CHP and logbook are critical enforcement tools used by an authorized officer to verify when anglers are on a charter vessel fishing trip and subject to CHLAP, CSP, and other restrictions applicable to charter vessel anglers. If the charter vessel guide is on a separate charter vessel or on the shore, or is not in the vicinity of the charter vessel with anglers aboard (i.e., “angler vessel”), an authorized officer must be able to identify a person on board the angler vessel that is responsible for ensuring that a valid CHP and the logbook are on the vessel to authorize that charter vessel fishing trip. If the charter vessel guide is on a separate vessel, or on the shore, the charter vessel operator should be the person on board the angler vessel that could be held jointly responsible with the charter vessel guide to ensure that a valid CHP and the logbook are on the angler vessel. NMFS notes that enforcement of this provision will depend on the circumstances of a fishing trip. Authorized officers will evaluate the specific circumstances to determine whether to hold the charter vessel operator and the charter vessel guide jointly or severally responsible for compliance with the requirement to have a valid CHP and a logbook on board the vessel.

Charter vessel guides will remain responsible for complying with the CHLAP and CSP reporting requirements at § 300.65(d), and the person whose business was assigned a logbook remains responsible for ensuring that the charter vessel guide complies with those requirements. Before a charter vessel fishing trip begins, the charter vessel guide is required to record in the logbook the first and last names and license numbers of each charter vessel angler who will fish for halibut (exceptions apply for youth, senior, and disabled charter vessel anglers); ensure that the cover of the logbook lists the person named on the CHP(s) and the CHP number(s) being used during that charter vessel fishing trip; and ensure the name and State-issued vessel registration (AK number) or U.S. Coast Guard documentation number of the charter vessel is listed. This final rule implements regulations at § 300.65(d) to require that the logbook remain on the charter vessel with the anglers during the charter vessel fishing trip, even if the guide is on a separate vessel or on shore. With this change, an authorized officer will be able to verify that all anglers are licensed and listed in the logbook, and that the angler endorsement on the CHP has not been exceeded.

NMFS notes that the regulations at § 300.66(s) and (v) are consistent with the IPHC annual management measure at section 25(7) which states, “The operator of a charter vessel shall be liable for any violations of these Regulations committed by an angler on board said vessel. In Alaska, the charter vessel guide, as defined in § 300.61 and referred to in §§ 300.65, 300.66, and 300.67, shall be liable for any violation of these Regulations committed by an angler on board a charter vessel.”

Comment 2: NMFS proposed to define sport fishing guide services as “accompanying or physically directing the sport fisherman in sport fishing activities during any part of a charter vessel fishing trip.” The term “physically directing” is not defined and may be difficult to interpret by both charter guides and NOAA Office of Law Enforcement staff. For example, it is unclear whether providing a chart or GPS coordinates identifying specific fishing locations or contacting a guide or lodge owner for instructions via cell phone or UHF radio would be considered “physically directing.”

Response: Section 1.3.6 of the RIR/IRFA describes that the Council and NMFS contemplated identifying a list of activities that would qualify as “physically directing” under this action. The Council concluded, and NMFS agrees, that defining assistance as “accompanying or physically directing the sport fisherman in sport fishing activities” eliminates the need to list all potential activities that could be considered as providing assistance to an angler. This is consistent with the State of Alaska's definition that does not specifically define “physically directing” as it is used in the definition for “sport fishing guide service” (5 AAC 75.995(a)(42)). One goal of this final rule is to align State and Federal regulations for consistency and improved compliance.

The commenter notes that it is unclear whether providing a chart or GPS coordinates or contacting a guide or lodge owner for instructions via cell phone or UHF radio would be considered “physically directing.” While “physically directing” could imply that the guide must be in proximity to the angler, certain technologies, such as cellular video calls, could allow a person to physically direct an angler to fish without being in proximity to the angler. Therefore, the nature of the activity will be evaluated as needed to determine if it is “physically directing.” We describe this in greater detail in the following paragraphs. The definition of sport fishing guide services implemented by this final rule applies only to assistance provided during any part of a charter vessel fishing trip.

A charter vessel fishing trip is defined as “the time period between the first deployment of fishing gear into the water from a charter vessel by a charter vessel angler and the offloading of one or more charter vessel anglers or any halibut from that vessel.” Assistance, under the definition of sport fishing guide services implemented by this final rule, will therefore be restricted to activities that occur after gear has been deployed. Assistance provided before gear is deployed would not be considered sport fishing guide services.

NMFS notes that determination of assistance for purposes of Federal regulations likely would depend on a combination of factors that, taken together, would indicate that a charter vessel guide was compensated for assisting an angler in a manner intended to result in the taking of halibut. Providing a description, or even a map or GPS coordinates of a fishing location, before a charter vessel fishing trip begins, would not in itself be considered as providing sport fishing guide services because it was not assistance during a charter vessel fishing trip. According to a recent decision in United States v. Dutton, assistance includes, but is not limited to the following activities: anchoring and drifting the vessel on the fishing spots, rigging gear, baiting hooks, changing lures, suggesting use of a different lure and providing it, explaining how to operate the manual downrigger and cranking it up, identifying bottom fish caught, helping land halibut, and netting and bringing fish on board. According to the decision, these activities could reasonably be expected to result in the catching or taking of halibut, and that by performing these activities for compensation, the respondent was providing sport fishing guide services.

Comment 3: The definition of charter vessel fishing trip should be broadened to encompass the initial trip period when clients and fishing gear are aboard the vessel and the vessel is underway to the fishing grounds. A “charter vessel fishing trip” does not begin until an angler deploys gear into the water and ends when one or more charter vessel anglers or any halibut are offloaded from the vessel. Under this definition, a guide could still legally tow or direct clients out to specific, productive fishing locations and show them when, where, or how to fish because the trip would not technically start until the angler deployed his or her gear. These activities should be considered part of a charter vessel fishing trip.

Response: This final rule does not restrict a person from directing clients to fishing grounds or instructing them in how to fish before the clients deploy fishing gear. Once an angler deploys fishing gear, however, the guide may not assist, accompany, or physically direct the angler for that trip to be considered unguided. Determining which activities might be considered fishing before gear is deployed is difficult. The Council determined, and NMFS agrees, that the activity of fishing (i.e., deploying fishing gear) is what defines a charter vessel fishing trip. Therefore, the current definition is consistent with the Council's intent to manage charter halibut fishing in Areas 2C and Area 3A.

Comment 4: The summary section of the preamble of the proposed rule states that “sport fishing for halibut in which anglers receive assistance from a compensated guide would be managed under charter fishery regulations, and all harvest would accrue toward charter allocations” (79 FR 71729). However, GAF do not accrue toward charter allocations. The final rule should clarify that GAF do not accrue toward charter allocations.

Response: NMFS agrees and notes the clarification to the preamble to the proposed rule in this response. The Catch Sharing Plan authorizes transfers of commercial halibut individual fishing quota (IFQ) as guided angler fish (GAF) to qualified charter halibut permit holders for harvest by charter vessel anglers in Areas 2C and 3A. Using GAF, qualified charter halibut permit holders may offer charter vessel anglers the opportunity to retain halibut up to the limit for unguided anglers when the charter management measure in place limits charter vessel anglers to a more restrictive harvest limit. GAF is an alternative use of commercial halibut IFQ and all harvests of GAF accrue toward the commercial catch limit. NMFS has modified the preamble to this final rule to clarify that all charter harvests, except GAF, will accrue toward the charter sectors' allocations.

Comment 5: The proposed definition of sport fishing guide services excludes services provided by a crew member working on a charter vessel. If vessel crew are not covered by these regulations, charter businesses could continue to avoid the charter fishing regulations by placing a crew member on board the angler vessel and a licensed guide on a separate vessel.

Response: NMFS disagrees. A charter vessel guide is defined at § 300.61 as follows: “Charter vessel guide, for purposes of §§ 300.65, 300.66 and 300.67, means a person who holds an annual sport guide license or registration issued by the Alaska Department of Fish and Game, or a person who provides sport fishing guide services.” A crew member is defined at § 300.61 as follows: “Crew member, for purposes of §§ 300.65 and 300.67, means an assistant, deckhand, or similar person who works directly under the supervision of, and on the same vessel as, a charter vessel guide or operator of a vessel with one or more charter vessel anglers on board.” According to these definitions, a crew member must be on the same vessel as the charter vessel guide to be considered a crew member. If an assistant or deckhand is not on the vessel with the charter vessel guide, that person does not meet the definition of crew member at § 300.61. If the assistant or deckhand is providing assistance for compensation, or with the intent to receive compensation, to a person who is sport fishing, to take or attempt to take halibut by accompanying or physically directing the sport fisherman in sport fishing activities during any part of a charter vessel fishing trip, that person would be considered a charter vessel guide, not a crew member, and charter fishing regulations would apply.

The Council and NMFS do not intend for an assistant, deckhand, or other crew member that works directly under the supervision of a charter vessel guide to be the person responsible for compliance with CHLAP and CSP regulations. This final rule maintains current requirements specifying that a person providing sport fishing guide services from a charter vessel is responsible for complying with CHLAP and CSP regulations, whether or not that person has an ADF&G sport fishing guide license or registration on board that vessel. Therefore, this final rule revises the final sentence of the definition of sport fishing guide services to specify that “sport fishing guide services do not include services provided by a crew member, as defined at § 300.61.” The revision implemented by this final rule cites the definition of a crew member for added clarity.

Comment 6: NMFS should consider carefully defining what will be considered “private” (i.e., unguided) sport fishing and what will be “charter” sport fishing and prohibit any practices that do not fit these two descriptions.

Response: This final rule clarifies specific types of fishing activities that are defined and managed as unguided sport fishing and those that are considered to be charter fishing. This final rule is intended to clarify that all sport fishing for halibut in which anglers receive assistance from a compensated guide will be managed under charter fishery regulations. To do that, this final rule aligns State of Alaska and Federal definitions pertaining to sport fishing guide services for Pacific halibut. This final rule requires businesses that currently provide sport fishing services in which a charter vessel guide is not on board the vessel with the anglers to either obtain CHPs and comply with regulations for the charter halibut fishery, or refrain from accompanying or physically directing anglers during a fishing trip, thereby creating a clearer distinction between guided (i.e., charter) and unguided anglers. See also response to Comment 7.

Comment 7: Data from the “self-guided” commercial sport anglers are not distinguished from data from private anglers in the statewide harvest survey (SWHS). The SWHS is mailed in the fall to a sample of sport fishing license holders. The SWHS is not a reliable method to collect data from such a large sector of the harvest. NMFS and ADF&G need to improve data collection to distinguish between anglers who use commercial sport fishing operations and anglers who do not.

Response: The Council and NMFS manage two categories of sport halibut anglers: guided (charter) and unguided (self-guided). The Council and NMFS do not distinguish between unguided anglers who fish using their own boats and gear (what the commenter refers to as “private” anglers) and those who may rent boats and gear from a lodge or outfitter but do not use the services of a charter vessel guide (what the commenter refers to as “self-guided commercial sport” anglers). Both of these types of anglers are considered by NMFS to be unguided. As described in the proposed rule and Section 1.2 of the RIR/IRFA, this final rule is intended only to address fishing activities for the charter halibut sector; no action is proposed to further regulate businesses that do not provide sport fishing guide services.

Sport halibut harvests are estimated from logbooks for the charter sector, and from the SWHS for unguided anglers. In developing and recommending this final rule, the Council did not identify a conservation concern with regard to sport halibut harvest accounting because all harvests are estimated based on information submitted in the logbooks and SWHS. NMFS anticipates this final rule will improve harvest estimates between the charter sector and unguided anglers by clarifying logbook reporting requirements and aligning the Federal and State definitions of sport fishing guide services so that halibut harvested by an angler who receives compensated assistance are required to be recorded in the logbook, whether the person providing the assistance is on board the vessel or not. The Council and NMFS have determined that the recordkeeping and reporting regulations currently in place provide for effective monitoring and enforcement of halibut harvested by charter vessel anglers in Area 2C and Area 3A.

Comment 8: The proposed action will not curtail angling that occurs when a charter vessel guide is not onboard the vessel with the anglers. There are several modes of angling that could develop or expand including (1) allowing clients to run boats themselves after a day or two of fishing with a guide to learn the ropes; (2) sending anglers out in skiffs with GPS coordinates and other guidance; (3) charter businesses or lodges converting from guided to “self-guided” operations; and (4) offering catch and release halibut fishing trips.

Response: The Council recommended this final rule to clarify that all sport fishing for halibut in which anglers receive assistance from a compensated guide will be managed under the CHLAP and the CSP. This final rule is not intended to curtail businesses that provide equipment for unguided sport fishing (e.g., self-guided fishing or bare boat rentals) (see also response to Comment 7). The Council and NMFS recognized and considered the alternative fishing scenarios listed by the commenter in developing Federal regulations for the charter halibut fisheries in Areas 2C and 3A and this final rule. Anglers who feel confident to fish without a guide after fishing with a guide for one or more trips may do so under charter halibut fishing regulations. Anglers may receive advice on where and how to fish before a fishing trip begins (see also response to Comment 2). The proposed rule and Section 1.3.7 of the RIR/IRFA describe that businesses currently providing sport fishing services where the charter vessel guide is not on board a vessel with the anglers may modify those services so that they comply with regulations for guided and unguided anglers. Finally, while catch and release fishing for halibut does not require a charter halibut permit, IPHC regulations at section 25(3) (80 CFR 13771, March 17, 2015) specify that any halibut brought aboard a vessel and not immediately returned to the sea with a minimum of injury will be included in the daily bag limit of the person catching the halibut.

Comment 9: The guideline harvest level regulations that preceded the CSP, the CSP, and this proposed rule are all based on the false premise that charter fishing is a commercial harvesting activity. This proposed rule should be addressing the definition of what constitutes commercial uses of halibut, not what constitutes guiding services.

Response: This final rule is intended to clarify that all sport fishing for halibut in which anglers receive assistance from a compensated guide will be managed under charter fishery regulations and to align State of Alaska and Federal definitions pertaining to sport fishing guide services for Pacific halibut. The Council did not recommend, and NMFS is not implementing changes to commercial halibut fishing regulations as part of this action. Therefore, changing the definition of commercial uses of halibut is beyond the scope of this final rule.

Comment 10: NMFS should insist that charter businesses establish business models that enable managers to establish allocations instead of “guidelines” for the charter sector and that provide for verifiable landing statistics.

Response: The primary objective of this final rule is to clarify the sport fishing activities defined as charter fishing, not to modify the allocations that are assigned to the charter fishery under the CSP. As described in the proposed rule and Section 1.3.3 of the RIR/IRFA, the Council approved and NMFS implemented the CSP in 2014. The CSP established a method by which allocations are set for the charter and commercial halibut fisheries in Areas 2C and 3A. This final rule clarifies that all sport fishing for halibut in which anglers receive assistance from a compensated guide would be managed under charter fishery regulations, and all harvest (except halibut harvested under the GAF Program) would accrue toward charter allocations under the CSP. As described in the response to Comment 7, the Council and NMFS have determined that the recordkeeping and reporting regulations currently in place for sport halibut fisheries provide for effective monitoring of the charter fishery allocation and enforcement of regulations applicable to the charter fishery in Area 2C and Area 3A.

Section 3507(c)(B)(i) of the PRA requires that agencies inventory and display a current control number assigned by the Director, OMB, for each agency information collection. Section 902.1(b) identifies the location of NOAA regulations for which OMB approval numbers have been issued. Because this final rule revises and adds data elements within a collection-of-information for recordkeeping and reporting requirements, 15 CFR 902.1(b) is revised to reference correctly the sections resulting from this final rule.

Regulations governing the U.S. fisheries for Pacific halibut are developed by the IPHC, the Pacific Fishery Management Council, the North Pacific Fishery Management Council, and the Secretary of Commerce. Section 5 of the Halibut Act (16 U.S.C. 773c) allows the Regional Council having authority for a particular geographical area to develop regulations governing fishing for halibut in U.S. Convention waters as long as those regulations do not conflict with IPHC regulations. The Halibut Act at section 773c(a) and (b) provides the Secretary of Commerce with the general responsibility to carry out the Convention with the authority to, in consultation with the Secretary of the department in which the U.S. Coast Guard is operating, adopt such regulations as may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act. This final rule is consistent with the Halibut Act and other applicable laws.

This final rule has been determined to be not significant for purposes of Executive Order 12866. This final rule also complies with the Secretary of Commerce's authority under the Halibut Act to implement management measures for the halibut fishery.

A final regulatory flexibility analysis (FRFA) is required by the Regulatory Flexibility Act. This FRFA incorporates the initial regulatory flexibility analysis (IRFA) prepared for the proposed rule and addresses the applicable requirements of section 604(a) of the RFA. A statement of the need for and objectives of, this final rule has already been provided in the preamble to this final rule (see Purpose of this Final Rule) and is not repeated here.

The proposed rule was published in the Federal Register on December 3, 2014 (79 FR 71729). An initial regulatory flexibility analysis (IRFA) was prepared and described in the Classification section of the proposed rule. The comment period ended on January 2, 2015. NMFS received 8 comment submissions containing 10 unique comments. No comments were received on the IRFA or on the small entity impacts of this action. No comments on the proposed rule were filed with NMFS by the Chief Counsel for Advocacy of the Small Business Administration.

On June 12, 2014, the Small Business Administration (SBA) issued a final rule revising the small business size standards for several industries effective July 14, 2014 (79 FR 33647, June 12, 2014). The new size standards were used to prepare the FRFA for this final rule.

The Small Business Administration (SBA) specifies that for charter fishing vessel operations, a small business is one with annual receipts less than $7.5 million. The largest of these charter vessel operations, which are lodges, may be considered large entities under SBA standards, but that cannot be confirmed because NMFS does not have or collect economic data on lodges necessary to definitively determine total annual receipts. Thus, all charter vessel operations are considered small entities, based on SBA criteria, because NMFS cannot confirm if any entities have gross revenues greater than $7.5 million on an annual basis.

This final rule would directly regulate all CHP holders, and businesses offering sport fishing guide services that the regulations require to have CHPs. As of July 7, 2014, the date of the most recent information available, there were 975 CHPs issued to 580 permit holders in Areas 2C and 3A. Data on business affiliations among permit holders are not available; therefore, the number of CHP holders that are directly regulated cannot be accurately determined, but would not exceed 580. NMFS notes that because there is little incentive for a business that already holds one or more CHPs to offer sport fishing guide services without a guide on board to anglers, the number of current CHP holders (i.e., small entities) affected by this proposed regulation is likely to be very small. The final rule is not expected to adversely impact small entities that possess CHPs.

The final rule, however, may adversely impact those entities that do not hold CHPs and who provide sport fishing guide services using guides that are not on board the vessel with the anglers. A review of logbook data suggests that only a few such entities can be documented. For Area 2C, a minimum of one to three businesses are estimated from logbook data to have routinely offered sport fishing services for halibut that did not meet the Federal definition of sport fishing guide services between 2009 and 2013. Logbook data for Area 3A did not clearly identify any businesses that routinely reported trips in which halibut were harvested and no CHP was recorded as used for the charter vessel fishing trip. It is difficult to estimate how many businesses may be providing sport fishing services where the guide is not on board the vessel with the anglers because some of these businesses may not be registered as charter businesses with the State and may not be completing logbooks. Under the final rule, businesses that provide sport fishing services where the guide is not on board the vessel with the anglers, but do not hold CHPs, would have to either purchase CHPs or change the services they provide so that they refrain from having guides accompany or physically assist anglers in the taking of halibut during any part of a charter vessel fishing trip. Information on availability and price of CHPs is presented in Section 1.3.1.2 of the RIR/IRFA. NMFS does not have or collect data to determine the exact number of businesses offering sport fishing services where the guide is not on board the vessel with the anglers or total annual receipts for these entities. NMFS considers all sport fishing services as small entities, based on SBA criteria, because NMFS cannot confirm if any of these entities have gross revenues greater than $7.5 million on an annual basis.

Community quota entities may apply for and receive community CHPs; therefore, this final rule may directly regulate entities representing small, remote communities in Areas 2C and 3A. There are 20 communities in Area 2C and 14 in Area 3A eligible to receive community CHPs. Of these 34 communities, 21 hold community CHPs. The action is not expected to adversely impact communities that hold CHPs.

A FRFA must describe the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of the Halibut Act and other applicable statues, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency that affect the impact on small entities was rejected.

The status quo alternative (Alternative 1) would continue to require that a guide be on board a charter vessel with a charter vessel angler to be providing sport fishing guide services. Maintaining these regulations is believed to result in an unknown, but relatively small number of anglers fishing under unguided sport fishing regulations, rather than the more restrictive charter fishing regulations. The status quo may result in potential inaccuracies in accounting of sport removals by sector and continued confusion by the angling public as to how to report their halibut harvest. The status quo alternative would not accomplish the Council's objective that receiving compensated assistance while fishing for halibut be managed under charter halibut fishery regulations, whether or not the person providing the compensated assistance is on the same vessel as the person fishing for halibut.

The Council considered one alternative with three options to the status quo. The first option under Alternative 2 would change the definition of “sport fishing guide services” to remove the requirement that a guide be on board the charter vessel with the charter vessel angler to be providing those services. The second option would add a Federal definition for “compensation” and contained two suboptions. The first suboption would add a Federal definition for compensation that matches the State definition. The second suboption would add a Federal definition that substitutes the word “reasonable” for “actual” expenses from the State definition. These suboptions are described in more detail in Section 1.3.6.2 of the RIR/IRFA. The third option under Alternative 2 would add a Federal definition for “assistance” to describe which types of activities fall under sport fishing guide services. Alternative 2 would better align Federal regulations regarding sport fishing guide services for Pacific halibut with State regulations, would incorporate sport fishing services whether or not the person providing the compensated assistance in on the same vessel as the person fishing for halibut under the umbrella of charter regulations, and would improve the accuracy of unguided sport and charter halibut harvest estimates.

The Council recommended a preferred alternative (i.e., this final rule) that would better align the State and Federal definitions of “sport fishing guide services” (Alternative 2, Option 1), and add a definition for “compensation” (Alternative 2, Option 2) to Federal regulations. Instead of separately defining “assistance” as described in Alternative 2, Option 3, the preferred alternative would add language to the definition of sport fishing guide services to define assistance as “accompanying or physically directing the sport fisherman in sport fishing activities.” The preferred alternative incorporates the recommendations developed cooperatively by State and NMFS enforcement and management staff and supported by the discussion of the effects of Alternative 2, Options 1, 2, and 3 in Section 1.3.6 of the RIR/IRFA. The preferred alternative incorporates a description of assistance consistent with State regulations without specifying a list of fishing activities. Broadly defining assistance in this way would eliminate the need to identify all potential activities that could be considered as providing assistance to an angler and the risk that a relevant activity would be inadvertently excluded from the list.

NMFS proposed the Council's preferred alternative, with one exception. Instead of proposing the suboption to Alternative 2, Option 2 that would have added a Federal definition for “compensation” that differs from the State's definition by referring to “reasonable” expenses rather than “actual” expenses, NMFS proposed the suboption that would add a Federal definition that matches the State's definition. The preferred alternative for this option initially incorporated the recommendations developed cooperatively by State and NMFS enforcement and management staff, but upon further discussion, these entities determined that matching the State and Federal definitions for compensation would be more enforceable. Additionally, adopting matching definitions would further the Council's objectives of aligning Federal and State of Alaska regulations.

The entities directly regulated under this action are assumed to be small under the SBA definition. Because the rule serves to benefit the small entities that are directly regulated under the rule by clarifying Federal fishery regulations to better align with Council intent and State fishery regulations, no significant negative economic impacts are expected on directly regulated entities who are CHP holders; however, charter vessel guides who provide sport fishing guide services and are not on board the same charter vessel as the charter vessel angler will be required to change their fishing practices under this final rule. These directly regulated entities are also assumed to be small entities. Thus, NMFS is not aware of any alternatives, in addition to the alternatives considered, that would more effectively meet these Regulatory Flexibility Act criteria at a lower economic cost to directly regulated small entities.

This action does not impose any additional reporting requirements on the participants of the charter halibut fishery. Although the public reporting burden will not change, additional participants would be required to comply with existing requirements. The new participants would be subject to the same recordkeeping and reporting requirements as existing participants.

NMFS has not identified other Federal rules that may duplicate, overlap, or conflict with this final rule.

This final rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA), which have been approved by the Office of Management and Budget (OMB). The collections are presented below by OMB control number.

The ADF&G Saltwater Sport Fishing Charter Trip Logbook, GAF Electronic Landing Report, and GAF Permit Log are mentioned in this final rule. This final rule may require a few more businesses that currently do not complete reports and logbooks to do so; however, the public reporting burden for these items in this collection-of-information are not directly affected by this final rule.

Applications for CHPs and applications for GAF transfers are mentioned in this final rule. This final rule may result in a few more businesses that currently do not have CHPs and GAF transfers to purchase and apply for them, respectively; however, the public reporting burden for these applications in this collection-of-information are not directly affected by this final rule.

Public reporting burden includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES) and by email to [email protected], or fax to 202-395-5806.

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. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

This final rule is consistent with Executive Order 12962 as amended September, 26, 2008, which required Federal agencies to ensure that recreational fishing is managed as a sustainable activity and is consistent with existing law.

For the reasons set out in the preamble, NMFS amends 15 CFR part 902 and 50 CFR part 300 as follows:

In FR Document No. 2015-07305 beginning on page 21806 for Monday, April 20, 2015, the following correction is made:

On page 21906, in the first column, third line, paragraph (e) of Form 1-A is redesignated as paragraph (d).

These temporary regulations are being issued without prior notice and public procedure pursuant to the Administrative Procedure Act (5 U.S.C. 553). For this reason, the collection of information contained in these regulations has been reviewed and, pending receipt and evaluation of public comments, approved by the Office of Management and Budget under control number 1545-2260.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

For further information concerning this collection of information, and where to submit comments on the collection of information and the accuracy of the estimated burden, and suggestions for reducing this burden, please refer to the preamble to the cross-referenced notice of proposed rulemaking on this subject in the Proposed Rules section in this issue of the Federal Register.

Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

Section 432(e)(9) 1 of the Internal Revenue Code (Code) permits the plan sponsor of a multiemployer plan that is projected to have insufficient funds, at some point in the future, to pay the full benefits to which individuals will be entitled under the plan (referred to as a plan in “critical and declining status”) to reduce the pension benefits payable to participants and beneficiaries under the plan if certain conditions are satisfied (referred to as a “suspension of benefits”). MPRA requires the Secretary of the Treasury, in consultation with the Pension Benefit Guaranty Corporation and the Secretary of Labor (generally referred to in this preamble as the Treasury Department, PBGC, and Labor Department, respectively), to issue appropriate guidance to implement the provisions of section 432(e)(9). This document contains temporary regulations under section 432(e)(9) that, together with proposed regulations that are being published elsewhere in this issue of the Federal Register and a revenue procedure being published in the Internal Revenue Bulletin, Rev. Proc. 2015-34, implement section 432(e)(9) as required by the statute. The Treasury Department consulted with the PBGC and the Labor Department on these temporary regulations.

The temporary regulations in this document, which are applicable immediately, provide sufficient guidance to enable a plan sponsor that wishes to apply for approval of a suspension of benefits to prepare and submit such an application, and to enable the Department of the Treasury to begin the processing of such an application. The temporary regulations provide general guidance regarding section 432(e)(9), including guidance regarding the meaning of the term “suspension of benefits,” the general conditions for a suspension of benefits, and the implementation of a suspension after a participant vote. The notice of proposed rulemaking, published elsewhere in this issue of the Federal Register, includes the proposed regulations and requests comments on the provisions of the proposed regulations as well as these temporary regulations. The provisions of the temporary regulations and proposed regulations are expected to be integrated and issued as a single set of final regulations with any changes that are made following consideration of the comments.

The proposed regulations, which are not applicable immediately, contain additional provisions with respect to which the Department of the Treasury intends to consider public comments before finalizing a decision to approve an application for suspension of benefits. The proposed regulations also provide additional guidance regarding section 432(e)(9), including guidance relating to the standards that will be applied in reviewing an application for suspension of benefits and the statutory limitations on a suspension of benefits.

The regulations implementing the statutory suspension of benefits provisions have been divided, as described, into temporary regulations and proposed regulations in order to balance the interest in considering public comments on rules before they apply with the evident statutory intent, reflected in MPRA, to implement the statutory provisions without undue delay. Although the Department of the Treasury is issuing proposed and temporary regulations under section 432(e)(9), it is expected that no application proposing a benefit suspension will be approved prior to the issuance of final regulations. If a plan sponsor chooses to submit an application for approval of a proposed benefit suspension in accordance with the proposed and temporary regulations before the issuance of final regulations, then the plan sponsor may need to revise the proposed suspension (and potentially the related notices to plan participants) or supplement the application to take into account any differences in the requirements relating to suspensions of benefits that might be included in the final regulations.

Rev. Proc. 2015-34 prescribes the specifics of the application process for approval of a proposed benefit suspension. The revenue procedure also provides a model notice that a plan sponsor proposing a benefit suspension may use to satisfy the statutory notice requirement.

Code section 412 contains minimum funding rules that generally apply to pension plans. Code section 431, added by section 211 of PPA '06, sets forth the funding rules that apply specifically to multiemployer defined benefit plans. Code section 432, added by section 212 of PPA '06, sets forth additional rules that apply to certain multiemployer plans in endangered or critical status, and permits plans in critical status to be amended to reduce certain otherwise protected benefits (referred to as adjustable benefits). Section 202 of PPA '06 amended section 305 of the Employee Retirement Income Security Act of 1974, Public Law 93-406 (88 Stat. 829 (1974)), as amended (ERISA), to prescribe parallel rules. PPA '06 provided that Code section 432 and ERISA section 305 would sunset for plan years beginning after December 31, 2014. However, section 101 of MPRA made them permanent, with certain modifications.

Section 201 of MPRA amended Code section 432 to add a new status, called critical and declining status, for multiemployer defined benefit plans. Section 432(b)(6) provides that a plan in critical status is treated as being in critical and declining status if the plan satisfies the criteria for critical status and in addition is projected to become insolvent within the meaning of section 418E during the current plan year or any of the 14 succeeding plan years (or 19 succeeding plan years if the plan has a ratio of inactive participants to active participants that exceeds two to one or if the funded percentage of the plan is less than 80 percent). Section 201 of MPRA also amended Code section 432(e)(9) to prescribe benefit suspension rules for plans in critical and declining status.2

MPRA was enacted on December 16, 2014. Section 201(b)(7) of MPRA provides that, not later than 180 days after the date of enactment, the Treasury Department, in consultation with the PBGC and the Labor Department, is required to publish appropriate guidance to implement section 432(e)(9). Section 201(c) of MPRA provides that the amendments made by section 201 will take effect on the date of enactment.

On February 18, 2015, the Department of the Treasury issued a Request for Information on Suspensions of Benefits under the Multiemployer Pension Reform Act of 2014 in the Federal Register (80 FR 8578). The Request for Information included questions focusing on certain matters to be addressed in guidance implementing section 432(e)(9) and indicated that multiemployer plans should not submit applications for suspensions of benefits prior to a date specified in such future guidance. These temporary regulations, and the proposed regulations published elsewhere in this issue of the Federal Register, reflect consideration of comments received in response to the Request for Information.

Section 201 of MPRA prescribes benefit suspension rules for multiemployer defined benefit plans in critical and declining status. Section 432(e)(9)(A) provides that notwithstanding section 411(d)(6) and subject to section 432(e)(9)(B) through (I), the plan sponsor of a plan in critical and declining status may, by plan amendment, suspend benefits that the sponsor deems appropriate.

The statute defines suspension of benefits as the temporary or permanent reduction of any current or future payment obligation of the plan to any participant or beneficiary under the plan, whether or not in pay status at the time of the suspension of benefits. Any suspension will remain in effect until the earlier of when the plan sponsor provides benefit improvements in accordance with section 432(e)(9)(E) or when the suspension expires by its own terms. Thus, if a suspension does not expire by its own terms, it continues indefinitely.

Under the statute, a plan will not be liable for any benefit payments not made as a result of a suspension of benefits. All references to suspensions of benefits, increases in benefits, or resumptions of suspended benefits with respect to participants will also apply with respect to benefits of beneficiaries or alternative payees 3 of participants. See section 432(e)(9)(B)(iv).

In the case of a plan with 10,000 or more participants, section 432(e)(9)(B)(v) requires the plan sponsor to select a plan participant in pay status to act as a retiree representative. The retiree representative is required to advocate for the interests of the retired and deferred vested participants and beneficiaries of the plan throughout the suspension approval process. The plan must provide for the retiree representative's reasonable expenses, including reasonable legal and actuarial support, commensurate with the plan's size and funded status.

Section 432(e)(9)(C) sets forth conditions that must be satisfied before a plan sponsor of a plan in critical and declining status for a plan year may suspend benefits. Under one of the conditions, the plan actuary must certify, taking into account the proposed suspension of benefits (and, if applicable, a proposed partition of the plan under section 4233 of ERISA (partition)), that the plan is projected to avoid insolvency within the meaning of section 418E, assuming the suspension of benefits continues until it expires by its own terms or if no such expiration date is set, indefinitely.

Another condition requires a plan sponsor to determine, in a written record to be maintained throughout the period of the benefit suspension, that although all reasonable measures to avoid insolvency have been taken (and continue to be taken during the period of the benefit suspension), the plan is still projected to become insolvent unless benefits are suspended. In making this determination, the plan sponsor may take into account factors including a specified list of 10 statutory factors.4 See section 432(e)(9)(C)(ii).

Section 432(e)(9)(D) contains limitations on the benefits that may be suspended, some of which apply to plan participants and beneficiaries on an individual basis and some of which apply on an aggregate basis. Under the statute, an individual's monthly benefit may not be reduced below 110 percent of the monthly benefit that is guaranteed by the PBGC under section 4022A of ERISA on the date of the suspension. In addition, no benefits based on disability (as defined under the plan) may be suspended.

In the case of a participant or beneficiary who has attained age 75 as of the effective date of a suspension, section 432(e)(9)(D)(ii) provides that the suspension may not exceed the applicable percentage of the individual's maximum suspendable benefit (the age-based limitation). The maximum suspendable benefit is the maximum amount of an individual's benefit that would be suspended without regard to the age-based limitation. The applicable percentage is a percentage that is calculated by dividing (i) the number of months during the period that begins with the month after the month in which the suspension is effective and ends with the month in which that participant or beneficiary attains the age of 80 by (ii) 60 months.

Section 432(e)(9)(D) also requires the aggregate benefit suspensions (considered, if applicable, in connection with a partition) to be reasonably estimated to achieve, but not materially exceed, the level that is needed to avoid insolvency.

Under the statute, any suspension of benefits must be equitably distributed across the participant and beneficiary population, taking into account factors that may include one or more of a list of 11 statutory factors.5 Finally, with regard to a suspension of benefits that is made in combination with a partition, section 432(e)(9)(D)(v) provides that the suspension may not occur before the effective date of the partition.

Section 432(e)(9)(E) sets forth rules relating to benefit improvements made while a suspension of benefits is in effect. Under this provision, a benefit improvement is defined as a resumption of suspended benefits, an increase in benefits, an increase in the rate at which benefits accrue, or an increase in the rate at which benefits become nonforfeitable under the plan.

The statute also provides that, while a suspension of benefits is in effect, a plan sponsor generally has discretion to provide benefit improvements. However, a sponsor may not increase plan liabilities by reason of any benefit improvement for any participant or beneficiary who is not in pay status (in other words, those who are not yet receiving benefits, such as active employees or deferred vested employees) unless (1) this benefit improvement is accompanied by an equitable distribution of benefit improvements for those who have begun to receive benefits (typically, retirees), and (2) the plan actuary certifies that, after taking those benefit improvements into account, the plan is projected to avoid insolvency indefinitely.6 Whether an individual is in pay status for this purpose is generally based on whether the individual's benefits began before the first day of the plan year for which the benefit improvement took effect.

A plan sponsor may not suspend benefits unless notice is provided in accordance with section 432(e)(9)(F). Under this section, concurrently with an application to suspend benefits under section 432(e)(9)(G), the plan sponsor must give notice to plan participants and beneficiaries who may be contacted by reasonable efforts, each employer that has an obligation to contribute (within the meaning of section 4212(a) of ERISA) under the plan, and each employee organization that represents plan participants employed by those employers for purposes of collective bargaining. The notice must contain sufficient information to enable individuals to understand the effect of any suspension of benefits, including an individualized estimate, on an annual or monthly basis, of the effect on each participant or beneficiary. The notice must also contain certain other specified information.7 Notice must be provided in a form and manner prescribed in agency guidance, written in a manner so as to be understood by the average plan participant, and provided in written, electronic, or other appropriate form to the extent it is reasonably accessible to those to whom notice must be furnished.

Any notice provided under section 432(e)(9)(F)(i) will satisfy the requirement for notice of a significant reduction in benefits described in section 4980F. See section 432(e)(9)(F)(iv).

Section 432(e)(9)(G) describes the process for approval or rejection of a plan sponsor's application for a suspension of benefits. Under the statute, the Treasury Department, in consultation with the PBGC and the Labor Department, must approve an application upon finding that the plan is eligible for the suspensions and has satisfied the criteria of sections 432(e)(9)(C), (D), (E), and (F) (each described earlier). In evaluating whether a plan sponsor has met the criteria in section 432(e)(9)(C)(ii) (a plan sponsor's determination that, although all reasonable measures have been taken, the plan will become insolvent if benefits are not suspended), the plan sponsor's consideration of factors under that clause must be reviewed. The statute also requires that the plan sponsor's determinations in an application for a suspension of benefits be accepted unless they are clearly erroneous.

Section 432(e)(9)(G) also requires an application for a suspension of benefits to be published on the Web site of the Department of the Treasury and requires the Treasury Department to publish a Federal Register notice within 30 days of receiving a suspension application, soliciting comments from contributing employers, employee organizations, and participants and beneficiaries of the plan for which a suspension application was made, as well as other interested parties.

Within 225 days after an application for a suspension of benefits is submitted, the statute requires the Treasury Department, in consultation with the PBGC and the Labor Department, to approve or deny the application. If the plan sponsor is not notified that it has failed to satisfy one or more applicable criteria within that 225-day period, the application is deemed approved. If the application is denied, a notice to the plan sponsor must detail the specific reasons for the rejection, including reference to the specific requirement not satisfied. Approval or denial of an application is treated as final agency action for purposes of 5 U.S.C. 704 (that is, the approval or denial is treated as final agency action for purposes of the Administrative Procedure Act, Public Law 79-404, 60 Stat. 237, as amended (APA)).

If a suspension application is approved, it then goes to a vote of plan participants and beneficiaries. See section 432(e)(9)(H). The vote will be administered by the Treasury Department, in consultation with the PBGC and the Labor Department, within 30 days after approval of the suspension application. The plan sponsor is required to provide a ballot for a vote (subject to approval by the Treasury Department, in consultation with the PBGC and the Labor Department). The statute specifies information that the ballot must include.8 If a majority of plan participants and beneficiaries do not vote to reject the suspension, the statute requires the Treasury Department to issue a final authorization to suspend benefits within seven days after the vote.

If a majority of plan participants and beneficiaries vote to reject the suspension, the statute requires the Treasury Department, in consultation with the PBGC and the Labor Department, to determine whether the plan is a systemically important plan. A systemically important plan is a plan for which the PBGC projects the present value of projected financial assistance payments to exceed $1.0 billion, as indexed, if suspensions are not implemented.

If a majority of plan participants and beneficiaries vote to reject the suspension and the plan is not a systemically important plan, a final authorization to suspend benefits will not be issued. In such a case, the statute provides that the plan sponsor may submit a new application for approval of a suspension of benefits to the Treasury Department.

Within 30 days after a plan is determined to be a systemically important plan, the Participant and Plan Sponsor Advocate selected under ERISA may submit recommendations to the Treasury Department with respect to the suspension that was rejected by the vote or recommendations for any revisions to that suspension. Notwithstanding the vote rejecting the suspension, the statute requires the Treasury Department, in consultation with the PBGC and the Labor Department, to permit the plan sponsor to implement either the proposed benefit suspension or a modification by the Treasury Department, in consultation with the PBGC and the Labor Department, of that suspension. The Treasury Department must complete this requirement within 90 days after the results of a vote rejecting a suspension for a systemically important plan are certified, and a modification of the suspension by the Treasury Department is only permitted if the plan is still projected to avoid insolvency under the modification.

If the Treasury Department is required to permit the suspension or a modified suspension to go into effect in the case of a systemically important plan with respect to which there has been a vote rejecting the suspension, the statute requires the Treasury Department to issue the final authorization to suspend at a time sufficient to allow the suspension to be implemented by the end of the 90-day period following certification of the results of that vote.

Section 432(e)(9)(I)(i) allows a plan sponsor to challenge a denial of an application for suspension only after the application is denied. Under the statute, an action challenging the approval of a suspension may be brought only following the issuance of a final authorization to suspend. The statute also provides that a court will review an action challenging approval of a suspension of benefits in accordance with 5 U.S.C. 706 (that is, the standard of review applicable for purposes of the APA) and will not grant a temporary injunction with respect to a suspension unless it finds a clear and convincing likelihood that the plaintiff will prevail on the merits. Under section 432(e)(9)(I)(iii), participants and beneficiaries affected by a suspension “shall not have a cause of action under this title.” An action challenging either the approval of a suspension of benefits or the denial of an application for a suspension of benefits may not be brought more than one year after the earliest date on which the plaintiff acquired or should have acquired actual knowledge of the existence of the cause of action. See section 432(e)(9)(I)(iv).

These temporary regulations provide guidance on certain requirements under section 432(e)(9) regarding suspension of benefits for multiemployer defined benefit plans in critical and declining status. The temporary regulations do not address certain other requirements that are addressed in the text of the proposed regulations (REG-102648-15) set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section of this issue of the Federal Register. The provisions of these temporary regulations are cross referenced in the proposed regulations so that comments on these provisions may be included with comments on the proposed regulations. In addition to the proposed and temporary regulations, the procedural requirements for submitting an application to suspend benefits, as well as a model notice, are set forth in Rev. Proc. 2015-34.

These temporary regulations provide that, subject to section 432(e)(9)(B) through (I), the plan sponsor of a multiemployer plan that is in critical and declining status within the meaning of section 432(b)(6) for a plan year may, by plan amendment, implement a suspension of benefits that the plan sponsor deems appropriate. Such a suspension is permitted notwithstanding the generally applicable anti-cutback provisions of section 411(d)(6). The plan amendment implementing a suspension of benefits must be adopted in a plan year in which the plan is in critical and declining status.

Under the regulations, once a plan is amended to suspend benefits, a plan may pay or continue to pay a reduced level of benefits pursuant to a suspension only if the terms of the plan are consistent with the requirements of section 432(e)(9) and the regulations.

The temporary regulations include definitions for the terms pay status and plan sponsor. A person is in pay status under a multiemployer plan if, as described in section 432(j)(6), at any time during the current plan year, the person is a participant, beneficiary, or alternate payee under the plan and is paid an early, late, normal, or disability retirement benefit under the plan (or a death benefit under the plan related to a retirement benefit).

The term plan sponsor means the association, committee, joint board of trustees, or other similar group of representatives of the parties that establishes or maintains the multiemployer plan. However, in the case of a plan described in section 404(c), or a continuation of such a plan, the term plan sponsor means the association of employers that is the employer settlor of the plan.

The temporary regulations provide that the term suspension of benefits means the temporary or permanent reduction, pursuant to the terms of the plan, of any current or future payment obligation of the plan with respect to any participant under the plan. A suspension of benefits can apply with respect to a participant of the plan regardless of whether the participant, beneficiary, or alternate payee has commenced receiving benefits before the effective date of the suspension of benefits. If a plan pays a reduced level of benefits pursuant to a suspension of benefits that complies with the requirements of section 432(e)(9), then the plan is not liable for any benefits not paid as a result of the suspension.

A suspension of benefits may be of indefinite duration or may expire as of a certain date. Under the regulations, if the suspension of benefits has an expiration date, that date must be specified in the plan amendment implementing the suspension.

The temporary regulations provide that a plan sponsor may amend the plan to eliminate some or all of a suspension of benefits, provided that the amendment satisfies the requirements that apply to benefit improvements in the proposed rules under section 432(e)(9)(E).

The temporary regulations clarify that, except as otherwise specified, all references to suspensions of benefits, increases in benefits, or resumptions of suspended benefits with respect to participants also apply with respect to benefits of beneficiaries or alternate payees (as defined in section 414(p)(8)) of participants.

A retiree representative must be selected for a plan with 10,000 or more participants. The temporary regulations implement this condition by requiring that a retiree representative be selected if 10,000 or more participants were reported on the most recently filed Form 5500, “Annual Return/Report of Employee Benefit Plan.” 9 The plan sponsor must select the retiree representative at least 60 days before the plan sponsor submits an application to suspend benefits. The retiree representative must be a plan participant who is in pay status and may or may not be a plan trustee.

The role of the retiree representative is to advocate for the interests of the retired and deferred vested participants and beneficiaries of the plan throughout the suspension approval process. However, in the discretion of the plan sponsor, the retiree representative may continue in this role throughout the period of the benefit suspension. This would enable the retiree representative to monitor compliance with the ongoing requirements during the period of the suspension, such as the requirement that the plan sponsor make annual determinations that all reasonable measures to avoid insolvency have been taken and that a suspension is necessary to avoid insolvency as well as to monitor compliance with the rules relating to benefit improvements. The regulations refer to section 432(e)(9)(B)(v)(III) for rules relating to the fiduciary status of a retiree representative, but do not provide additional guidance with respect to this provision.

The plan must pay reasonable expenses incurred by the retiree representative, including reasonable legal and actuarial support, commensurate with the plan's size and funded status. Upon request, the plan sponsor must promptly provide the retiree representative with relevant information, such as plan documents and data, that is reasonably necessary to enable the retiree representative to perform the representative's role, described earlier under this paragraph V.

The temporary regulations permit a plan sponsor of a plan that has reported fewer than 10,000 participants to select a retiree representative in connection with an application for approval of a suspension of benefits in order to encourage such a plan sponsor to do so. If a retiree representative is selected for such a plan, the rules that apply to retiree representatives for plans with 10,000 or more participants (other than the rule concerning the size of the plan and the timing of the appointment) will apply.

A plan sponsor of a plan in critical and declining status 10 may suspend benefits only if the actuarial certification requirement in section 432(e)(9)(C)(i) and the plan-sponsor determinations requirements in section 432(e)(9)(C)(ii) are satisfied.

Under the temporary regulations, the actuarial certification requirement in section 432(e)(9)(C)(i) is satisfied if, taking into account the proposed suspension of benefits (and, if applicable, a proposed partition of the plan), the plan's actuary certifies that the plan is projected to avoid insolvency within the meaning of section 418E, assuming the suspension of benefits continues until it expires by its own terms or if no such expiration date is set, indefinitely. The temporary regulations do not provide guidance on this topic. However, the proposed regulations provide rules for the comparable requirement that the suspension (in combination with a partition, if applicable) be reasonably estimated to avoid insolvency under section 432(e)(9)(D)(iv).

A plan may not suspend benefits unless the plan sponsor makes initial and annual determinations that the plan is projected to become insolvent unless benefits are suspended, although all reasonable measures to avoid insolvency have been taken and continue to be taken.

Under the temporary regulations, a plan satisfies the initial-plan-sponsor determinations requirement only if the plan sponsor determines that (1) all reasonable measures to avoid insolvency, within the meaning of section 418E, have been taken, and (2) the plan is projected to become insolvent within the meaning of section 418E unless the proposed suspension of benefits (or another suspension of benefits under section 432(e)(9)) is implemented for the plan.

In making its determination that all reasonable measures to avoid insolvency have been taken, the plan sponsor may take into account the non-exclusive list of factors set forth in section 432(e)(9)(C)(ii). In making the initial determination that the plan is projected to become insolvent without the proposed suspension of benefits (or another suspension under section 432(e)(9)), a plan sponsor may rely on the actuarial certification made pursuant to section 432(b)(3)(A)(i) that the plan is in critical and declining status for the plan year.

The rules relating to the annual-plan-sponsor determinations are included in the proposed regulations.

The proposed and temporary regulations reflect the individual and aggregate limitations on a suspension of benefits under section 432(e)(9)(D).11 The temporary regulations provide that after applying the individual limitations, the overall size and distribution of the suspension is subject to the aggregate limitations.

The temporary regulations provide that the monthly benefit payable to a participant, beneficiary, or alternate payee may not be reduced below 110 percent of the monthly benefit that would be guaranteed by the PBGC under section 4022A of ERISA if the plan were to become insolvent as of the effective date of the suspension. The proposed regulations provide more detailed rules for applying this limitation.

The temporary regulations reflect the statutory prohibition in section 432(e)(9)(D)(iii) on applying a suspension of benefits to benefits based on disability (as defined under the plan). The proposed regulations include more detailed rules for applying this limitation.

The rules regarding the age-based limitation of section 432(e)(9)(D)(ii) and the aggregate limitations of section 432(e)(9)(D)(iv) and (vi) are set forth in the proposed regulations.

In any case in which a suspension of benefits with respect to a plan is made in combination with a partition of the plan, the suspension of benefits may not take effect prior to the effective date of the partition. This requirement will not be satisfied if the partition order under section 4233 of ERISA has not been provided to the Treasury Department by the last day of the 225-day review period described in section 432(e)(9)(G)(iii), after which deemed approval of the suspension would occur.

The rules regarding restrictions on benefit improvements are set forth in the proposed regulations.

The temporary regulations prescribe rules implementing the statutory notice requirements in section 432(e)(9)(F).

Specifically, the temporary regulations require the plan sponsor to provide notice of a proposed suspension to all plan participants, beneficiaries of deceased participants, and alternate payees (regardless of whether their benefits are proposed to be suspended) except those who cannot be contacted by reasonable efforts; each employer that has an obligation to contribute (within the meaning of section 4212(a) of ERISA) under the plan; and each employee organization which, for purposes of collective bargaining, represents plan participants employed by such an employer. The temporary regulations provide two examples illustrating what efforts constitute reasonable efforts to contact individuals for purposes of this notice requirement. These examples indicate that it is not sufficient to merely send notices to the individuals' last known mailing addresses and illustrate additional steps that may be used to satisfy these requirements if the plan sponsor becomes aware that some individuals did not receive notice.

The temporary regulations require the notice to contain the following in order to satisfy the requirement that the notice contain sufficient information to enable plan participants and beneficiaries to understand the effect of the suspension of benefits:

• An individualized estimate, on an annual or monthly basis, of the effect of the suspension on the participant or beneficiary. However, if it is not possible to provide an individualized estimate on an annual or monthly basis of the quantitative effect of the suspension on the participant or beneficiary, such as in the case of a suspension that affects the payment of any future cost-of-living adjustment, a narrative description of the effect of the suspension;

• A statement that the plan sponsor has determined that the plan will become insolvent unless the proposed suspension (and, if applicable, the proposed partition) takes effect, and the year in which insolvency is projected to occur without a suspension of benefits (and, if applicable, a proposed partition);

• A statement that insolvency of the plan could result in benefits lower than benefits paid under the proposed suspension and a description of the projected benefit payments upon insolvency;

• A description of the proposed suspension and its effect, including a description of the different categories or groups affected by the suspension, how those categories or groups are defined, and the formula that is used to calculate the amount of the proposed suspension for individuals in each category or group;

• A description of the effect of the proposed suspension on the plan's projected insolvency;

• A description of whether the suspension will remain in effect indefinitely or will expire by its own terms; and

• A statement describing the right to vote on the suspension application.

The notice of proposed suspension may not include false or misleading information (or omit information so as to cause the information provided to be misleading). The notice is permitted to include information in addition to the required information that is listed under this paragraph IX., including information relating to an application for partition under section 4233 of ERISA, provided that it satisfies these requirements.

The notice of proposed suspension must be written in a manner that can be readily understood by the average plan participant. The temporary regulations provide that the Treasury Department will provide a model notice. The use of the model notice will satisfy the content requirement and the readability requirement with respect to the language provided in the model.

The temporary regulations provide that notice may be provided in writing or in electronic form to the extent that the electronic form is reasonably accessible to persons to whom the notice is required to be provided. Permissible electronic methods include those permitted under regulations of the Department of Labor at 29 CFR 2520.104b-1(c) and those described at § 54.4980F-1, Q&A-13(c) of the Excise Tax Regulations.

Section 432(e)(9)(F) provides that the notice of proposed suspension must be given “concurrently” with the submission of an application to the Treasury Department, but does not specify a precise timeframe for satisfying this requirement. Interpreting “concurrently” as meaning either simultaneously or on the same day was rejected because it would require the difficult synchronization of the plan sponsor's electronic submission of its application and its giving of notice in written and/or in electronic form. Because the temporary regulations require a plan sponsor to submit its application electronically but authorize it to give notice in writing, interpreting the term “concurrently” to allow a plan sponsor to give written notice a few days earlier than the electronic submission of the application will allow for the receipt of such written notices on or about the time that a plan sponsor submits its application. The temporary regulations thus permit a plan sponsor to give notice no earlier than four business days before the submission of its application.

The temporary regulations also anticipate that a plan sponsor is permitted to give written notice no later than four business days after the submission of its application. This period of time will enable the Department of the Treasury to make a preliminary “completeness check” of the application during the first two business days, and the plan sponsor two business days thereafter to give the required notices.12 This approach will help participants by minimizing the risk of confusion and plan expense. For example, if a plan sponsor submits an incomplete application, compiles the additional information, and then finds the individualized estimates that the plan sponsor already gave to be inaccurate (or simply takes too long to compile the additional information), the plan sponsor would have to re-send the notices, increasing the likelihood that the notice would not be understood by the average plan participant as a result of receiving two different notices, each with a different individualized estimate. Although the temporary regulations allow plan sponsors to give participants notice when or before the application is submitted, sponsors are encouraged to delay giving notice until after the Department of the Treasury provides notification that the application is complete. If additional individuals who are entitled to notice are located after the time notice is required to be delivered, the plan sponsor must give those newly located individuals notice as soon as practicable after they are located.

The temporary regulations further provide that a notice of proposed suspension satisfies the requirement for notice of a significant reduction in benefits described in section 4980F that would otherwise be required as a result of that suspension of benefits. To the extent that other reductions accompany a suspension of benefits, such as a reduction in the future accrual rate described in section 4980F for active participants or a reduction in adjustable benefits under section 432(e)(8), notice that satisfies the requirements (including the applicable timing requirements) of section 4980F or section 432(e)(8), as applicable, must be provided.

The temporary regulations provide that the plan sponsor of a plan in critical and declining status for a plan year that seeks to suspend benefits must submit an application for approval of the proposed suspension of benefits to the Treasury Department. The Treasury Department will approve, in consultation with the PBGC and the Labor Department, a complete application upon finding that the plan is eligible for the suspension and has satisfied the criteria of section 432(e)(9)(C), (D), (E), and (F). An application must be submitted electronically.

After receiving a submission, the plan sponsor will be notified within two business days whether the submission constitutes a complete application. If the submission is a complete application, the application will be treated as submitted on the date on which it was originally submitted to the Treasury Department. If a submission is incomplete, the notification will inform the plan sponsor of the information that is needed to complete the submission and give the plan sponsor a reasonable opportunity to submit a complete application. In such a case, the complete application will be treated as submitted on the date on which the additional information needed to complete the application is submitted to the Treasury Department.

Additional guidance that may be necessary or appropriate with respect to applications, including procedures for submitting applications and the information required to be included in a complete application, may be published in the form of revenue procedures, notices, or other guidance published in the Internal Revenue Bulletin.

In the case of a plan sponsor that is not submitting an application for suspension in combination with an application to PBGC for a plan partition, the temporary regulations provide that the application for suspension generally will not be accepted unless the proposed effective date of the suspension is at least nine months after the date on which the application is submitted. This is to ensure adequate time to review the proposed suspension without a need to delay the effective date of the proposed suspension. A delayed effective date could require other changes to the design of the suspension. For example, if, as a result of a delayed effective date, the age-based limitation under section 432(e)(9)(D)(ii) applies to more participants than under the terms of the proposed suspension, then benefits of other participants may be subject to greater reductions in order to satisfy the limitation in section 432(e)(9)(D)(iv) that the suspension, in the aggregate, must be reasonably estimated to achieve, but not materially exceed, the level necessary to avoid insolvency. However, in appropriate circumstances, an earlier effective date may be permitted. Appropriate circumstances could include an application for a proposed suspension that is a modification of a previous submission that was withdrawn or denied.

In the case of an application for suspension in combination with an application for partition, the impact of a delayed effective date for the suspension would be larger benefits for retirees rather than a redesign of the suspension. Accordingly, these temporary regulations do not apply the rule described in the preceding paragraph to such an application. See Part 4233 of the PBGC regulations for a coordinated application process that applies in the case of a plan sponsor that is submitting an application for suspension in combination with an application to PBGC for a plan partition under section 4233 of ERISA.

The temporary regulations provide that, no later than 30 days after receiving a complete application, the application will be published on the Web site of the Department of the Treasury, and the Treasury Department will publish a notice in the Federal Register soliciting comments from contributing employers, employee organizations, and participants and beneficiaries of the plan for which an application was made, and other interested parties. The notice soliciting comments will generally request that comments be submitted no later than 45 days after publication of that notice in the Federal Register, but the comment period may be shorter in appropriate circumstances. Appropriate circumstances could include an application for a proposed suspension that is a modification of a previous submission that was withdrawn or denied. Comments received in response to this notice will be made publicly available.

Under the temporary regulations, a complete application will be deemed approved unless, within 225 days after the complete application is submitted, the Treasury Department notifies the plan sponsor that its application does not satisfy one or more of the requirements for approval. If the Treasury Department denies a plan sponsor's application, the notification of the denial will detail the specific reasons for the denial, including reference to the specific requirement or requirements not satisfied. If the Treasury Department approves a plan sponsor's application and believes that the plan is a systemically important plan, then the Treasury Department will notify the plan sponsor of that belief and that it will be required to provide individual participant data upon request. This data may be used in the event of a vote to reject the suspension in order to assist the Treasury Department in determining whether to permit a modification of the rejected suspension.

The temporary regulations provide that the Secretary of the Treasury may appoint a Special Master for purposes of section 432(e)(9). If a Special Master is appointed, the Special Master will be an employee of the Department of the Treasury, will coordinate the implementation of the regulations and the review of applications for the suspension of benefits and other appropriate documents, and will provide recommendations to the Secretary of the Treasury with respect to decisions required under these regulations.

Certain rules relating to the Treasury Department's review of an application under section 432(e)(9)(G) are included in the proposed regulations.

The temporary regulations provide that if an application for suspension is approved by the Treasury Department, then the Treasury Department, in consultation with the PBGC and the Labor Department, will administer a vote of all plan participants and all beneficiaries of deceased participants (eligible voters). Any suspension of benefits will take effect only after the vote and after a final authorization to suspend benefits.

Under the temporary regulations, any ballot provided by the plan sponsor in connection with a vote on the suspension must be approved by the Treasury Department, in consultation with the PBGC and the Labor Department. The ballot must be written in a manner that can be readily understood by the average plan participant and may not include any false or misleading information. The information that is required to be included in the ballot is described in the proposed regulations.

The temporary regulations provide that unless a majority of all eligible voters vote to reject the suspension, it is permitted to go into effect. If a majority of all eligible voters vote to reject the suspension, the suspension is not permitted to go into effect, except that the suspension or a modified suspension will be permitted to go into effect if the plan is a systemically important plan as described later under this paragraph XI. A plan sponsor is permitted to submit a new suspension application to the Treasury Department for approval in any case in which a suspension is prohibited from taking effect as a result of a vote.

The temporary regulations set forth rules for systemically important plans. If a majority of all eligible voters vote to reject the suspension, the Treasury Department will consult with the PBGC and the Labor Department to determine if the plan is a systemically important plan. The Treasury Department is required to make this determination no later than 14 days after the results of the vote are certified. No later than 30 days after a determination that the plan is a systemically important plan, the Participant and Plan Sponsor Advocate selected under section 4004 of ERISA may submit recommendations to the Treasury Department with respect to the suspension or any revisions to the suspension.

If a plan is a systemically important plan for which a majority of all eligible voters vote to reject the suspension, then the Treasury Department is required to either permit the implementation of the suspension that was rejected by the vote or permit the implementation of a modification of that suspension. Under any such modification, the plan must be projected to avoid insolvency in accordance with section 432(e)(9)(D)(iv). No later than 60 days after the results of a vote to reject a suspension are certified, the Treasury Department will notify the plan sponsor that the suspension or modified suspension is permitted to be implemented.

The temporary regulations define a systemically important plan as a plan with respect to which the PBGC projects that the present value of financial assistance payments will exceed $1.0 billion if the suspension is not implemented. For calendar years beginning after 2015, this dollar amount will be replaced by an amount equal to the product of the dollar amount and a fraction, the numerator of which is the contribution and benefit base (determined under section 230 of the Social Security Act) for the preceding calendar year and the denominator of which is the contribution and benefit base for calendar year 2014. If that amount is not a multiple of $1.0 million, it will be rounded to the next lowest multiple of $1.0 million.

The temporary regulations provide that, in any case in which a proposed suspension (or a modification of a proposed suspension) is permitted to go into effect, the Treasury Department, in consultation with the PBGC and the Labor Department, will issue a final authorization to suspend with respect to the suspension. If a suspension is permitted to go into effect following a vote, the final authorization will be issued no later than seven days after the vote. If a suspension is permitted to go into effect following a determination that the plan is a systemically important plan, the final authorization will be issued at a time sufficient to allow the implementation of the suspension prior to the end of the 90-day period beginning on the date the results of the vote rejecting the suspension are certified. Under the temporary regulations, no later than 60 days after the certification, the Treasury Department will notify the plan sponsor that the suspension that was rejected by the vote or a modified suspension is permitted to be implemented.

The temporary regulations provide that, in any case in which a suspension of benefits with respect to a plan is made in combination with a partition of the plan under section 4233 of ERISA, the suspension of benefits is not permitted to take effect prior to the effective date of the partition.

These regulations apply on and after June 17, 2015 and expire on June 15, 2018.

For copies of recently issued revenue procedures, revenue rulings, notices and other guidance published in the Internal Revenue Bulletin, please visit the IRS Web site at http://www.irs.gov or contact the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.

Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. For the applicability of the Regulatory Flexibility Act (5 U.S.C. chapter 6) please refer to the Special Analyses section of the preamble to the cross-referenced notice of proposed rulemaking published in the Proposed Rules section in this issue of the Federal Register. Pursuant to section 7805(f) of the Code, these regulations have been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

For general questions regarding these regulations, please contact the Department of the Treasury at (202) 622-1559 (not a toll-free number). For information regarding a specific application for a suspension of benefits, please contact the Department of the Treasury at (202) 622-1534 (not a toll-free number).

Accordingly, 26 CFR parts 1 and 602 are amended as follows:

Executive Summary Purpose of the Regulatory Action

This interim final rule implements provisions of the Multiemployer Pension Reform Act of 2014 (MPRA) 1 that prescribe the statutory conditions and notice requirements that must be met before PBGC may partition an eligible multiemployer plan under section 4233 of ERISA.

PBGC's legal authority for this action comes from section 4002(b)(3) of ERISA, which authorizes PBGC to issue regulations to carry out the purposes of title IV of ERISA, and section 4233 of ERISA, as amended by MPRA, which requires that the partition process be conducted in accordance with regulations prescribed by PBGC.

This rule adds a new part 4233 to PBGC's regulations. Part 4233 prescribes the application process to ensure the timely processing of applications for partition and related notice requirements.

This interim final rule provides necessary guidance to plan sponsors on the application and notice requirements under section 4233 of ERISA for partitions of eligible multiemployer plans. To understand the effect of a partition of a multiemployer plan under MPRA, however, it is first helpful to understand the structure and operation of PBGC's multiemployer insurance program.

PBGC is a Federal corporation created under title IV of ERISA to guarantee the payment of pension benefits earned by more than 41 million American workers and retirees in nearly 24,000 private-sector defined benefit pension plans. The purpose of PBGC and the title IV insurance program is (1) to encourage the continuation and maintenance of voluntary private pension plans for the benefit of their participants; (2) to provide for the timely and uninterrupted payment of pension benefits under insured plans; and (3) to maintain premiums at the lowest level consistent with PBGC's obligations.

PBGC administers two insurance programs—one for single-employer defined benefit pension plans and a second for multiemployer defined benefit pension plans. This interim final rule applies only to the multiemployer program. The multiemployer program protects the benefits of approximately 10 million workers and retirees in approximately 1,400 plans. A multiemployer plan is a collectively bargained pension arrangement involving two or more unrelated employers, usually in a common industry, such as construction or trucking. Multiemployer plans pay an annual premium to PBGC. Under MPRA, the annual premium for 2015 increased from $13 to $26 per participant. For plan years beginning after 2015, the annual premium will increase based on increases in the national average wage index.

In general, a multiemployer plan may be terminated in one of two ways: (1) By plan amendment that “freezes” the accrual and vesting of benefits after a specified date, or that converts the plan into a defined contribution plan; or (2) every employer withdraws from the plan or ceases to have an obligation to contribute to the plan. In contrast to the single-employer program, however, plan termination is not an insurable event. In other words, plan termination does not trigger the payment of PBGC-insured, guaranteed benefits to participants and beneficiaries. The insurable event under the multiemployer program is plan insolvency, which generally occurs when a plan is unable to pay benefits at the level promised for the plan year.

The PBGC guarantee for multiemployer plans is lower than the guarantee for single-employer plans, and is based on a participant's credited service and accrual rate, as defined in section 4022A. The maximum monthly benefit payable by PBGC under the multiemployer program is equal to a participant's years of service multiplied by the sum of—

• 100 percent of the first $11 of the accrual rate, and

• 75 percent of the next $33 of the accrual rate.

Under this formula, benefits in excess of $3,960 per year are only partially guaranteed, and the maximum guarantee amount payable per year is capped at $12,870 (applicable to a participant with 30 years of service and with an annual benefit in excess of $15,840).2

Another important difference between the single-employer program and the multiemployer program is the manner in which PBGC pays guaranteed benefits. Under the multiemployer program, PBGC does not pay guaranteed benefit amounts directly to participants and beneficiaries. Rather, when a multiemployer plan becomes insolvent, PBGC provides financial assistance in the form of loans to the insolvent plan sufficient to pay guaranteed benefit amounts to participants and beneficiaries. Despite this difference, the receipt of guaranteed benefit amounts from an insolvent multiemployer plan receiving financial assistance from PBGC is considered the receipt of benefits guaranteed by PBGC under title IV of ERISA.

Although many multiemployer plans are healthy, a significant minority of financially troubled plans are projected to become insolvent over the next two decades.3 PBGC's multiemployer insurance program is also projected to become insolvent within that timeframe. During 2013 and 2014, congressional committees held several hearings on the problems facing these plans and PBGC. Those challenges include, among other things, investment market declines, employer withdrawals, and demographic changes.

In December 2014, Congress enacted, and the President signed, the Consolidated and Further Continuing Appropriations Act, 2015, Public Law 113-235 (128 Stat. 2130 (2014)), of which MPRA is a part. MPRA contains a number of statutory reforms intended to help financially troubled multiemployer plans, and to improve the financial condition of PBGC's multiemployer insurance program. In addition to increased premiums, sections 121 and 122 of MPRA provide PBGC with new statutory authority to assist financially troubled multiemployer plans under certain conditions, if doing so would reduce potential future costs to PBGC and if PBGC can certify that its ability to meet existing financial assistance to other plans will not be impaired.

In addition, section 201 of MPRA amended the funding rules under section 305 of ERISA to add a new “critical and declining” status for financially troubled multiemployer plans. Under section 305(b)(6) of ERISA, a plan is in critical and declining status if it satisfies the criteria for critical status under section 305(b)(2), and is projected to become insolvent within the meaning of section 4245 of ERISA during the current plan year or any of the 14 succeeding plan years (19 succeeding plan years if the plan has a ratio of inactive participants to active participants that exceeds two to one, or if the funded percentage of the plan is less than 80 percent). Section 305(e)(9) of ERISA, as added by MPRA, prescribes new benefit suspension rules for multiemployer defined benefit plans in critical and declining status. The Department of the Treasury (Treasury) has interpretative jurisdiction over the subject matter in section 305 of ERISA and is contemporaneously issuing regulatory guidance in this area.4

As noted above, the purpose of this rule is to implement application and notice requirements under section 122 of MPRA, which prescribes the statutory conditions and notice requirements that must be met before PBGC may partition an eligible multiemployer plan. PBGC expects to publish a proposed rule on facilitated mergers involving critical and declining status plans under section 121 of MPRA in a separate rulemaking.

Before MPRA, PBGC could partition a multiemployer plan likely to become insolvent upon application by a plan sponsor or on its own accord. In either case, partition was only available in certain limited circumstances involving employer bankruptcies, and the liabilities transferred were restricted to the nonforfeitable benefits directly attributable to service with bankrupt employers, along with an equitable share of assets. The new plan created by the partition order was a successor plan under section 4022A of ERISA, and a terminated multiemployer plan to which section 4041A(d) applies.5 In addition, if the new plan did not have sufficient assets to pay the transferred benefits as of the date of the partition order, which generally was the case, it would be insolvent within the meaning of section 4245(b)(1) of ERISA. In such a case, PBGC provided financial assistance to the new plan so that it could make benefit payments to participants whose benefits had been transferred to the new plan, but reduced to the PBGC guarantee level. In contrast, participants in the ongoing plan continued to receive unreduced plan benefits. Due in part to the eligibility limitations for partition, PBGC had partitioned only a few plans prior to the enactment of MPRA.

Section 122 of MPRA replaced the rules for partition with a new framework of rules. One of the most obvious changes is that PBGC may approve a partition without requiring an employer bankruptcy and, therefore, the benefits subject to transfer in a partition are no longer limited to those attributable to service with a bankrupt employer. The statute imposes a number of new eligibility requirements, however, such as a requirement that the plan be in critical and declining status as defined in section 305 of ERISA, and new statutory conditions and obligations that apply both before and after a partition, including a new, ongoing benefit payment obligation that applies to the eligible multiemployer plan that requested the partition.

Another important change under MPRA is the relationship between the partition rules under section 4233 and the suspension of benefits rules under section 305(e)(9) of ERISA.6 Section 305(e)(9) permits critical and declining status plans to apply to Treasury for approval to suspend certain benefits following the provision of specified notice, consideration of comments, Treasury review and approval, and satisfaction of other specified conditions (including a participant vote). One example of the interplay between an application for partition and an application for suspension of benefits is that before Treasury can approve an application for suspension, the plan actuary must certify that, taking into account a proposed suspension of benefits and, if applicable, a proposed partition under section 4233, the plan is projected to avoid insolvency within the meaning of section 4245, assuming the suspension of benefits continues until the suspension expires by its own terms or, if no such expiration date is set, indefinitely.

Another example of the interplay between an application for partition and an application for suspension of benefits is that before PBGC may order a partition, it must first determine, in consultation with the Participant and Plan Sponsor Advocate,7 that the plan sponsor has taken (or is taking concurrently with an application for partition) all reasonable measures to avoid insolvency, including maximum benefit suspensions under section 305(e)(9), if applicable. In addition, section 305(e)(9)(D)(iv) provides that any suspension of benefits, in the aggregate (and, if applicable, in combination with a partition), must be reasonably estimated to achieve, but not materially exceed, the level that is necessary to avoid insolvency. Finally, section 305(e)(9)(D)(v) requires that in any case in which an application for suspension of benefits to Treasury is made in combination with an application for partition to PBGC, the suspension of benefits may not take effect prior to the effective date of the partition.

Given the interplay between MPRA's partition and suspension of benefits provisions, PBGC staff has consulted with staff of Treasury and the Department of Labor in developing this interim final rule. PBGC will continue to work closely with these agencies as part of the interagency consultative process required under section 305(e)(9) of ERISA.

The following is a summary of the new statutory framework for partitions under MPRA.

Section 4233(a)(1) of ERISA states that, upon application by the plan sponsor of an eligible multiemployer plan, PBGC may order a partition of the plan in accordance with that section. As under prior law, PBGC's decision to order a partition is discretionary. Unlike prior law, however, the statute requires PBGC to make a determination not later than 270 days after the date such application was filed (or, if later, the date such application was completed), in accordance with regulations promulgated by PBGC.

In addition, section 4233(a)(2) states that not later than 30 days after submitting an application for partition, the plan sponsor shall notify the participants and beneficiaries of such application, in the form and manner prescribed by regulations issued by PBGC.

Section 4233(b) of ERISA contains five statutory conditions that must be satisfied before PBGC may order a partition. They are discussed below:

Critical and declining status. In accordance with section 4233(b)(1), the plan must be in critical and declining status as defined in section 305(b)(6) of ERISA. As noted above, a plan is in critical and declining status if the plan satisfies the criteria for critical status under section 305(b)(2), and is projected to become insolvent within the meaning of section 4245 during the current plan year or any of the 14 succeeding plan years (or 19 succeeding plan years if the plan has a ratio of inactive participants to active participants that exceeds two to one or if the funded percentage of the plan is less than 80 percent). Section 305(b)(3)(A)(i) requires an annual certification from the plan actuary on whether a plan is or will be in critical and declining status for such plan year. Treasury has interpretative jurisdiction over the subject matter in section 305 of ERISA.

PBGC determination on reasonable measures. Under section 4233(b)(2) of ERISA, PBGC must determine, after consultation with the Participant and Plan Sponsor Advocate, that the plan sponsor has taken (or is taking concurrently with an application for partition) all reasonable measures to avoid insolvency, including maximum benefit suspensions under section 305(e)(9) of ERISA, if applicable.

The term “maximum benefit suspensions” is not defined in section 305(e)(9) of ERISA.8 However, based on the structure and operation of section 305(e)(9)—specifically, the statutorily defined limitations and protections contained in section 305(e)(9)(D), which limits the maximum amount of a suspension so that the post-suspension benefit is no less than 110 percent of the PBGC guarantee under section 4022A, exempts certain categories of individuals based on their age, and exempts benefits based on disability—PBGC interprets the term “maximum benefit suspensions” in section 4233(b)(2) of ERISA to mean the maximum benefit suspensions permissible under section 305(e)(9). For example, the maximum benefit suspension permissible for an individual with a plan benefit based on disability would be zero, because benefits based on disability may not be suspended under section 305(e)(9)(D)(iii).

The requirement under section 4233(b)(2) that a plan sponsor has taken (or is currently taking) all reasonable measures to avoid insolvency is similar to the demonstration that a plan sponsor must make under section 305(e)(9)(C)(ii) relating to an application for suspension of benefits. Under that provision, the plan sponsor must maintain a written record demonstrating that the plan is projected to become insolvent unless benefits are suspended, although all reasonable measures have been taken (and continue to be taken during the period of the benefit suspension).

Although it is possible for a plan to file only an application for partition (and not an application for suspension of benefits under section 305(e)(9) of ERISA), the only instance in which that may occur would be if all participants and beneficiaries are older than 80, and/or receive benefits based on disability, or have accrued benefits not greater than 110 percent of the monthly benefit guaranteed by PBGC under section 4022A. Therefore, PBGC expects that most applicants for partition will also apply to Treasury for a suspension of benefits.

While the statute does not require a plan sponsor to file concurrent applications for partition and suspension of benefits, PBGC strongly encourages plan sponsors to do so because of the interplay between these provisions. For example, under section 305(e)(9) of ERISA, it is necessary for Treasury to review whether a proposed suspension of benefits and partition combined will allow the plan to avoid insolvency, and both PBGC and Treasury must make overlapping findings for each application. Furthermore, participant communications may be simplified if participants and beneficiaries receive a notice of partition concurrently with that of suspension. Finally, applications for partition and suspension that are not closely coordinated may also make it difficult for the agencies to comply with the statutory timeframes.

Long-term loss and plan solvency. In accordance with section 4233(b)(3) of ERISA, PBGC must reasonably expect that—

• Partition will reduce PBGC's expected long-term loss with respect to the plan; and

• Partition is necessary for the plan to remain solvent.

Certification to Congress. In accordance with section 4233(b)(4) of ERISA, PBGC must certify to Congress that its ability to meet existing financial assistance obligations to other plans (including any liabilities associated with multiemployer plans that are insolvent or that are projected to become insolvent within 10 years) will not be impaired by the partition.

Source of funding. In accordance with section 4233(b)(5) of ERISA, the cost to PBGC arising from the partition must be paid exclusively from the PBGC fund for basic benefits guaranteed for multiemployer plans.

Upon PBGC's approval of an application for partition, section 4233(c) of ERISA provides that PBGC's partition order shall provide for a transfer to the plan created by the partition order (the successor plan) the minimum amount of the original plan's liabilities necessary for the original plan to remain solvent.

Sections 4233(d)(1) and (2) of ERISA describe the nature of the successor plan, and assign responsibility for its management. Specifically, section 4233(d)(1) provides that the plan created by the partition order is a successor plan to which section 4022A applies. Section 4233(d)(2) provides that the plan sponsor of the original plan and the administrator of such plan shall be the plan sponsor and administrator, respectively, of the successor plan.

As noted above, unlike the partition rule under prior law, MPRA imposes a number of ongoing statutory obligations on the solvent, original plan and its contributing employers. For example, section 4233(d)(3) of ERISA prescribes a new withdrawal liability rule that applies for 10 years following the date of the partition order. Under the new withdrawal liability rule, if an employer withdraws from the original plan within 10 years following the date of the partition, withdrawal liability is computed under section 4201 with respect to the original plan and the successor plan. If, however, the withdrawal occurs more than 10 years after the date of the partition order, withdrawal liability is computed under section 4201 only with respect to the original plan (and not with respect to the successor plan). In either case, withdrawal liability is payable to the original plan (and not the successor plan).

Section 4233(e)(1) imposes an ongoing benefit payment obligation on the original plan with respect to each participant or beneficiary of the original plan whose guarantee amount was transferred to the successor plan pursuant to a partition order. With respect to these individuals, the original plan must pay a monthly benefit for each month in which such benefit is in pay status following the effective date of the partition in an amount equal to the excess of—

• The monthly benefit that would be paid to such participant or beneficiary for such month under the terms of the plan (taking into account benefit suspensions under section 305(e)(9) and any plan amendments following the effective date of such partition) if the partition had not occurred, over

• The monthly benefit for such participant or beneficiary that is guaranteed under section 4022A.9

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking COTP Captain of the Port A. Regulatory History and Information

The regulation for this recurring marine event may be found at 33 CFR 100.501, Table to § 100.501, section (a), line “4”. This year, the date is different than published in the Table, so this temporary final rule has been issued.

The Coast Guard is issuing this 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 information about the new date was not received by the Coast Guard with sufficient time to publish a Notice of Proposed Rulemaking.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register for the same reason: There was not enough time to publish the final rule more than thirty days before the event date.

The legal basis and authorities for this rulemaking establishing a special local regulation are found in 33 U.S.C. 1233, which authorize the Coast Guard to establish and define special local regulations.

The purpose of this special local regulation is to provide for the safety of participants, spectator craft, and other vessels transiting the event area while the boat race is occurring.

The Coast Guard has previously published a list of annual marine events within the Fifth Coast Guard District and special local regulation locations at 33 CFR 100.501. The Table to § 100.501 identifies special local regulations by COTP zone, with the COTP Delaware Bay zone listed in section “(a.)” of the Table. The Table to § 100.501, at section (a.) event Number “4”, describes the enforcement date and regulated location for this marine event.

The date listed in the Table has the marine event on the fourth Sunday of June. However, this temporary rule changes the marine event date to June 20, 2015 and June 21, 2015, to reflect the actual date of the event.

The Coast Guard will temporarily suspend the regulation listed in Table to § 100.501, section (a) event Number “4”, and insert this temporary regulation at Table to § 100.501, at section (a.) as event Number “15”, in order to reflect that the special local regulation will be effective and enforced from 10:00 a.m. until 6:00 p.m. on June 20, 2015 and June 21, 2015. This change is needed to accommodate the sponsor's event plan. No other portion of the Table to § 100.501 or other provisions in § 100.501 shall be affected by this regulation.

The regulated area of this special local regulation includes all the waters of the North Atlantic Ocean, adjacent to Atlantic City, New Jersey, bounded by a line drawn between the following points: From a point along the shoreline at latitude 39°21′50″ N, longitude 074°24′37″ W, thence southeasterly to latitude 39°20′40″ N, longitude 074°23′50″ W, thence southwesterly to latitude 39°19′33″ N, longitude 074°26′52″ W, thence northwesterly to a point along the shoreline at latitude 39°20′43″ N, longitude 074°27′40″ W, thence northeasterly along the shoreline to point of origin at latitude 39°21′50″ N, longitude 074°24′37″ W.

A fleet of spectator vessels is anticipated to gather nearby to view the marine event. Due to the need for vessel control during the marine event vessel traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels. Under provisions of 33 CFR 100.501, during the enforcement period, vessels may not enter the regulated area unless they receive permission from the Coast Guard Patrol Commander.

The Coast Guard may assign an event patrol, as described in 33 CFR 100.40, to each regulated event listed in the table. Additionally, a Patrol Commander may be assigned to oversee the patrol. The event patrol and Patrol Commander may be contacted on VHF-FM Channel 16. During the event, the Coast Guard Patrol Commander may forbid and control the movement of all vessels in the regulated area(s). When hailed or signaled by an official patrol vessel, a vessel in these areas shall immediately comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both. The Coast Guard Patrol Commander may terminate the event, or the operation of any vessel participating in the event, at any time it is deemed necessary for the protection of life or property. Coast Guard Sector Delaware Bay will notify the public by broadcast notice to mariners at least one hour prior to the times of enforcement.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or 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. Although this regulation will restrict access to the regulated area, the effect of this rule will not be significant because: (i) The Coast Guard will make extensive notification of the Special local regulation to the maritime public via maritime advisories so mariners can alter their plans accordingly; (ii) vessels may still be permitted to transit through the special local regulation with the permission of the Captain of the Port on a case-by-case basis; and (iii) this rule will be enforced for only the duration of the boat race.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. 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 may be small entities: the owners or operators of vessels intending to anchor or transit in the waters of the North Atlantic Ocean, adjacent to Atlantic City, New Jersey, on June 20, 2015 and June 21, 2015 from 10:00 a.m. to 6:00 p.m., unless cancelled earlier by the Captain of the Port.

This special local regulation will not have a significant economic impact on a substantial number of small entities for the following reason: vessel traffic will be allowed to transit through the area with permission of the Coast Guard Captain of the Port, Delaware Bay, or his designated representative and the special local regulation is limited in size and duration. Sector Delaware Bay will issue maritime advisories widely available to all waterway users.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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, above. 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 would not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule would 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 would not create an environmental risk to health or risk to safety that might disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 rule 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 implementation of regulations within 33 CFR part 100, applicable to special local regulations on the navigable waterways. This zone will temporarily restrict vessel traffic from transiting the waters of the Atlantic Ocean adjacent to Atlantic City, NJ, in order to protect the safety of life and property on the waters for the duration of the air show. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. A preliminary 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 part 100 as follows:

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 with respect to this rule because the Coast Guard did not receive necessary information about the event until April 23, 2015. As a result, the Coast Guard did not have sufficient time to publish a notice of proposed rulemaking and to receive public comments prior to the event. Any delay in the effective date of this rule would be contrary to the public interest because immediate action is needed to minimize potential danger to the race participants, spectators and the general public.

The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to ensure safety of life and property on navigable waters of the United States during the Grand National Drag Boat Races.

On Saturday, June 20, 2015, and Sunday, June 21, 2015, the Bucksport Marina will host Grand National Drag Boat Races, a series of high-speed boat races. The event will be held on a portion of the Atlantic Intracoastal Waterway in Bucksport, South Carolina. Approximately 30 high-speed race boats are anticipated to participate in the races.

The special local regulation encompasses certain waters of the Atlantic Intracoastal Waterway in Bucksport, South Carolina. The special local regulation will be enforced daily from 9 a.m. until 7 p.m. on June 20, 2015 and June 21, 2015. The special local regulation consists of a regulated area around vessels participating in the event. Persons and vessels that are not participating in the event are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area unless specifically authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated area by contacting the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16 to seek authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such permission must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

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.

The economic impact of this rule is not anticipated to be significant for the following reasons: (1) Although persons and vessels will not be able to enter, transit through, anchor in, or remain within the race area without authorization from the Captain of the Port Charleston or a designated representative, they may operate in the surrounding area during the effective period; (2) persons and vessels may still enter, transit through, anchor in, or remain within the race area if authorized by the Captain of the Port Charleston or a designated representative; and (3) advance notification will be made to the local maritime community via broadcast notice to mariners.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. 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 may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion that portion of the Atlantic Intracoastal Waterway encompassed within the regulated area from 9:00 a.m. until 7:00 p.m. on June 20, 2015 and June 21, 2015. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

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 calls for no 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 have determined that it 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 affect 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 a special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. 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 part 100 as follows:

The Coast Guard is issuing this 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), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Amtrak Bridge, that once required draw operations in 33 CFR 117.215(a), now opens on signal at all times; therefore, the regulation is no longer applicable and shall be removed from publication. It is unnecessary to publish an NPRM because this regulatory action does not purport to place any restrictions on mariners but rather removes a restriction that has no further use or value.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the Federal Register. The bridge has been opening on signal at all times for many years and this rule merely requires an administrative change to the Federal Register, in order to omit a regulatory requirement that is no longer applicable or necessary. The removal of the regulation will not affect mariners currently operating on this waterway. Therefore, a delayed effective date is unnecessary.

The Amtrak Bridge at mile 0.0, across the Niantic River, at Niantic, Connecticut, has a vertical clearance of 16 feet at mean high water and 19 feet at mean low water. The drawbridge operation regulations are listed at 33 CFR 117.215(a).

The waterway users are commercial and seasonal recreational vessels of various sizes.

The owner of the bridge, Amtrak, submitted a request to the Coast Guard to change the drawbridge operating regulations that presently allows the bridge to open on signal; except that, from April 1 through October 31, from 8 p.m. to 4 a.m. and from November 1 through March 31 from 6 p.m. to 6 a.m., the draw shall open on signal if at least one hour notice is given.

When a train is scheduled cross the bridge without stopping has entered the drawbridge block, a delay in opening the draw may occur until the train has cleared the block.

Under this final rule the Amtrak Bridge will open on signal at all times; however, the paragraph that refers to any delay in opening the draw should a train be within the drawbridge block shall remain in effect.

The Amtrak Bridge has been opening on signal at all times for many years despite the requirement in the drawbridge operation regulation listed at 33 CFR 117.215(a) to provide a one hour advance notice at certain times of year.

The owner of the bridge requested the regulation for the Amtrak Bridge be changed to reflect the present operation of the bridge, to open on signal at all times.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. We believe that this rule is not a significant regulatory action because the changes to the regulation will remove the advanced notice burden for mariners at all times.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard received no comments from the Small Business Administration on this rule. 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 have no effect on small entities for the following reason: The Amtrak Bridge will open on signal at all times.

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, 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 calls for no 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 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 have determined that it 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 would not create an environmental risk to health or risk to safety that might 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 Concerns 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 guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction.

Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:

The Ocean City Police Department on behalf of the Maryland State Highway Administration, has requested a temporary deviation from the current operating regulation of the US Route 50 Bridge across Isle of Wight (Sinepuxent) Bay, mile 0.5, at Ocean City, MD. This temporary deviation allows the US Route 50 Bridge to remain closed to navigation from 9:30 p.m. to 11:30 p.m. on July 4, 2015. This is an additional 30 minutes before and after the normal operating schedule for this bridge during that time. This additional closure has been requested to ensure the safety of spectators that attend the annual Ocean City July 4th fireworks show and allow for the heavy volume of vehicular traffic that transit across the drawbridge. For these reasons, should inclement weather prevent the fireworks event from taking place as planned, this deviation permits the bridge to remain closed from 9:30 p.m. to 11:30 p.m. on July 5th, 2015.

The vertical clearance of this bascule bridge is 13 feet above mean high water in the closed position and unlimited in the open position. The current operating regulation is outlined at 33 CFR 117.559(c), which allows the bridge to remain closed to navigation from 10 p.m. to 11 p.m. to accommodate the annual July 4th fireworks show

Vessels able to pass under the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies and the Atlantic Ocean can be used as an alternate route for vessels with mast heights greater than 13 feet. The Coast Guard will also inform the users of the waterways, through our Local and Broadcast Notices to Mariners, of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Coast Guard is issuing this 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. In May of this year, the Coast Guard discovered an error in the coordinates for the safety zone for the Bridgefest Regatta Fireworks in 33 CFR 165.943(a)(1). On May 4, 2015, the COTP Duluth signed a NPRM to correct the error (USCG-2015-0215). This NPRM has yet to publish in the Federal Register. Because the fireworks event is scheduled for June 20, 2015, there is insufficient time to accommodate the comment period. Thus, delaying the effective date of this rule to wait for the comment period to run would be both 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 the fireworks display.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this 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; 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 10 p.m. and 11 p.m. on June 20, 2015, Bridgefest Regatta fireworks display will take place within the Portage Canal in Hancock, MI. The likely combination of recreation vessels, darkness punctuated by bright flashes of light, and fireworks debris falling into the water presents risks of collisions which could result in serious injuries or fatalities. Establishing a safety zone around the launch site will help ensure the safety of persons and recreational boats during the fireworks display.

In light of the aforementioned hazards, the Captain of the Port Duluth has determined that a temporary safety zone is necessary to ensure the safety of spectators and participants during the fireworks display. This safety zone will encompass all waters of the Portage Canal within an area bounded by a circle with a 280 foot radius at position 47° 07′ 22″ N, 088° 35′ 39″ W.

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth 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 13 of these statutes or 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 an hour on a single day. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. 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. Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this temporary rule on small entities. This rule would affect the following entities, some of which might be small entities: the owners or operators of recreational vessels intending to transit or anchor in a portion of the Portage Canal in Hancock, MI from 10 p.m. to 11 p.m. on June 20, 2015.”

This safety zone will not have a significant economic impact on a substantial number of small entities for the reasons cited in the Regulatory Planning and Review section. Additionally, before the enforcement of the zone, we would issue local Broadcast Notice to Mariners so vessel owners and operators can plan accordingly.

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, 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 establishing a safety zone. This rule 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 part 165 as follows:

In 2014, VA commissioned the National Academy of Sciences' Institute of Medicine (IOM) to conduct a consensus study of all available scientific literature and knowledge on the subject of residual exposure to Agent Orange from service on aircraft formerly used during Operation Ranch Hand in Vietnam. VA commissioned this study to get a better understanding of the potential harmful exposures and health effects involved in serving on these aircraft after the conclusion of herbicide spraying operations in Vietnam. Specifically, VA requested that the IOM “determine whether there had been exposures that could lead to excess risk of adverse health outcomes among [Air Force] Reserve personnel who flew in and/or maintained C-123 aircraft (outside of Vietnam) that had previously been used to spray Agent Orange.” See Institute of Medicine, National Academy of Sciences, Post-Vietnam Dioxin Exposure in Agent Orange-Contaminated C-123 Aircraft 10 (2015), available at http://www.publichealth.va.gov/exposures/agentorange/publications/institute-of-medicine.asp.

According to the IOM's 2015 report on C-123 exposures, from 1972 to 1982, approximately 1,500 to 2,100 Air Force Reserve personnel trained and worked on C-123 aircraft, of which approximately 30 had formally been used to spray herbicides in Vietnam. Id. at 9. The report noted that the aircraft had been assigned to a few Air Force Reserve units where they were used for military airlift, medical transport, and cargo transport operations in the United States and internationally. Id. at 26. Regarding the potential for harmful exposures, the IOM found that Reservists who served as flight crew (pilot, navigator, flight engineer, and loadmaster), ground maintenance crew, and aero-medical personnel had regular and repeated contact with the aircraft. Id. at 26-27. The report identified the specific aircraft and the Reserve units to which they were assigned, and concluded, “it is probable that the [herbicide] exposures of at least some [Air Force] Reservists exceeded levels equivalent to some guidelines established for office workers in enclosed settings.” Id. at 62. The IOM determined that it is “plausible that the C-123s did contribute to some adverse health consequences among [Air Force] Reservists who worked in [Operation Ranch Hand] C-123s after the planes returned from Vietnam.” Id. at 62-63.

Based upon the IOM report, the Secretary of Veterans Affairs has decided that VA will acknowledge exposure to Agent Orange for approximately 1,500 to 2,100 Air Force and Air Force Reserve personnel whose military service involved regular and repeated contact with the contaminated C-123 aircraft. Therefore, this interim final rule establishes a presumption of exposure to herbicides for individuals who performed service in the Air Force or Air Force Reserve under circumstances in which the individual concerned regularly and repeatedly operated, maintained, or served onboard C-123 aircraft known to have been used to spray an herbicide agent during the Vietnam era. However, most individuals with such service were members of the Air Force Reserve at the time. Basic eligibility for VA benefits requires that an individual be a “veteran” as that term is defined in 38 U.S.C. 101(2): “The term `veteran' means a person who served in the active military, naval, or air service, and who was discharged or released therefrom under conditions other than dishonorable.” Service as a member of a reserve component during a period of active duty for training or inactive duty training does not qualify an individual as a “veteran” because it does not constitute “active military, naval or air service” unless the individual is disabled or dies during that period of service as provided under 38 U.S.C. 101(24)(B) and (C).

Pursuant to the Secretary's general rulemaking authority under 38 U.S.C. 501(a), VA has provided presumptions of service connection for diseases associated with exposure to an herbicide agent. 38 CFR 3.309(e). These presumptions of service connection are consistent with the disease-based presumptions under 38 U.S.C. 1116 for Vietnam Veterans with service in the Republic of Vietnam who are presumed by law to have been exposed to an herbicide agent during such service. Because an individual must quality as a “veteran” before they are eligible for presumptions of service connection, see Smith v. Shinseki, 24 Vet. App. 40, 44 (2010) (noting “[t]he Court has held that, without previously established veteran status, the presumptions of service connection . . . are inapplicable”), VA estimates that most of the servicemembers addressed by the IOM report are not presently eligible for the regulatory disease-based presumptions of service connection.

This interim final rule establishes factual presumptions that will allow Air Force Reservists who are presumed under this interim final rule to have been exposed to herbicide during their reserve service to establish veteran status as a result of that service. Although section 101(24) requires a period of active duty for training or inactive duty training “during which the individual concerned was disabled or died” for a period of active duty for training or inactive duty training to constitute “active military, naval, or air service,” the latent effects of herbicide exposure were unrecognized when section 101(24) was enacted in 1958. Operation Ranch Hand spraying commenced in 1962 and concluded in 1971, and Congress recognized the need for presumptions of service connection for Agent Orange-related conditions and regular evaluation of the science related to such conditions in the Agent Orange Act of 1991, Public Law 102-4. Pursuant to this law, the IOM in 1992 entered into an agreement with VA to review and summarize scientific evidence concerning the association between herbicide exposure during Vietnam service and conditions that might be associated with such exposure. It issued its first report on the subject in 1994. See Institute of Medicine, National Academy of Sciences, Veterans and Agent Orange: Health Effects of Herbicides Used in Vietnam (1994), available at http://www.publichealth.va.gov/exposures/agentorange/publications/institute-of-medicine.asp. Thus, in enacting section 101(24), Congress was necessarily unaware of later scientific understanding of the potential latent effects of herbicide exposure. Indeed, Congress was necessarily informed by the science that existed at the time of enactment in 1958.

The legislative history regarding the enactment of section 101(24) does not specifically explain Congress' intent in requiring that the individual “was disabled or died” during the period of service. It is probable that Congress required a reserve component member to have been disabled “during” training because the medical science of the time understood that, if an in-service injury were to result in disability, at least some aspect of that disability generally would be manifest contemporaneous with the injury. However, subsequent developments with regard to herbicide use in Vietnam and advancements in medical understanding of the health effects of herbicide exposure raise a question regarding the application of section 101(24) to disability associated with such exposure. Viewing the generally beneficial purpose of section 101(24) in light of the evolved medical understanding, we believe it is reasonable to create a factual presumption that disability occurred during the period of service as required under section 101(24) when an individual has a present disability now scientifically associated with exposure to an herbicide agent. Specifically, the existing herbicide-related disease presumptions enumerated in 38 CFR 3.309(e), coupled with the potential for clinical uncertainty regarding when such diseases first manifested, provide a reasonable basis for presuming that disability occurred during a period of reserve service for purposes of satisfying the requirements under section 101(24)(B) or (C) in order to ensure compensation and health care for reservists disabled as a result of herbicide exposure on reserve duty.

For the above reasons, we are amending 38 CFR 3.307 regarding disease associated with exposure to certain herbicide agents to add new paragraph (a)(6)(v). As amended, § 3.307 will presume exposure to herbicide for “[a]n individual who performed service in the Air Force or Air Force Reserve under circumstances in which the individual concerned regularly and repeatedly operated, maintained, or served onboard C-123 aircraft known to have been used to spray an herbicide agent during the Vietnam era.” Further, in consideration of the reserve component members with such service, VA will consider this presumed herbicide exposure to be an “injury” under section 101(24)(B) and (C). In turn, if such individual develops a presumptive disease listed in 38 CFR 3.309(e), as specified in 38 CFR 3.307(a)(6)(ii), “it will be presumed that the individual concerned became disabled during that service for purposes of establishing that the individual has active military, naval, or air service.” VA will make the factual presumption that the individual concerned was disabled during the qualifying service so that such individual's service will constitute “active, military, naval, or air service.” As explained, we believe this is consistent with section 101(24) because herbicide exposure has uniquely latent effects which were largely unrecognized in 1958. Covered individuals may therefore establish veteran status for purposes of VA's disability compensation, dependency and indemnity compensation, medical care, and burial benefits related to any Agent Orange-related presumptive condition.

The Secretary of Veterans Affairs finds under 5 U.S.C. 553(b)(B) that there is good cause that advance notice and opportunity for public comment are impracticable, unnecessary, or contrary to the public interest and under 5 U.S.C. 553(d)(3) that there is good cause to publish this rule with an immediate effective date. This interim final rule provides a presumption of herbicide exposure for individuals who performed certain military service. This interim final rule also establishes a presumption that if such an individual develops a presumptive herbicide-related condition, the individual concerned became disabled during that service for purposes of establishing that the individual has active military, naval, or air service. These changes will make individuals who were exposed to herbicide during service eligible for some VA benefits for disabilities resulting from herbicide-related diseases. Based on the age of the individuals affected by this rule and the potential severity of the disabilities associated with their herbicide exposure, it is likely that affected individuals will have significant and urgent financial and medical needs. In order for these individuals to have access to VA benefits to include VA health care, it is essential that these rules be made effective as soon as possible.

For the above reasons, the Secretary issues this rule as an interim final rule. However, VA will consider and address comments that are received within 60 days of the date this interim final rule is published in the Federal Register.

This rule contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

Because no notice of proposed rulemaking is required in connection with the adoption of this interim final rule, no regulatory flexibility analysis is required under the Regulatory Flexibility Act, 5 U.S.C. 601-612. Even so, the Secretary of Veterans Affairs certifies that this interim final rule will not directly affect any small entities. It will directly affect only VA beneficiaries. Accordingly, this interim final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act.

Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined that it is not an economically significant regulatory action under Executive Order 12866. VA's regulatory impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its regulatory impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.”

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector.

The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.102, Compensation for Service-Connected Deaths for Veterans' Dependents; 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.105, Pension to Veterans Surviving Spouses and Children; 64.106, Specially Adapted Housing for Disabled Veterans; 64.109, Veterans Compensation for Service-Connected Disability; and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, Department of Veterans Affairs, approved this document on May 11, 2015, for publication.

For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 3 to read as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0249 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 18, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0249, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8250) by Taminco US, Inc., Two Windsor Plaza, Suite 411, 7540 Windsor Drive, Allentown, PA 18195. The petition requested that 40 CFR 180.132 be amended by establishing a tolerance for residues of the fungicide thiram in or on avocado at 8 parts per million (ppm). That document referenced a summary of the petition prepared by Taminco US, Inc, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

For reasons that are discussed in Unit IV.C., EPA is establishing a tolerance for avocado at 15 ppm.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for thiram including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with thiram follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Thiram is a dimethyl dithiocarbamate fungicide. Thiram has been shown to cause neurotoxicity following acute and subchronic exposures. In the acute and subchronic neurotoxicity studies submitted, neurotoxicity is characterized as lethargy, reduced and/or tail pinch response, changes in the functional-observation battery (FOB) parameters, increased hyperactivity, changes in motor activity, and increased occurrences of rearing events. No treatment-related changes were observed in brain weights or in the histopathology of the nervous system. In a non-guideline study published in the open literature, chronic feeding of thiram to rats caused neurotoxicity, with onset of ataxia in some animals 5-19 months after beginning of treatment. However, no evidence of neurotoxicity was seen following chronic exposures in mice or rats in guideline studies submitted to the Agency. The chronic toxicity profile for thiram indicates that the liver, blood, and urinary system are the target organs for this chemical in mice, rats, and dogs. There is no evidence for increased susceptibility following in utero exposures to rats or rabbits and following pre- and post-natal exposures to rats for 2 generations. There is evidence of quantitative susceptibility in the developmental neurotoxicity (DNT) study. However, there is low concern for the increased susceptibility seen in the DNT study since the dose response is well defined with a clear NOAEL and this endpoint is used for assessing the acute dietary risk for the most sensitive population. Thiram is classified as “not likely to be carcinogenic to humans” based on lack of evidence for carcinogenicity in mice or rats. There are no mutagenic/genotoxic concerns with thiram. The available toxicological database for thiram suggests that this chemical has a low to moderate acute-toxicity profile.

Specific information on the studies received and the nature of the adverse effects caused by thiram as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Thiram. Revised Human Health Risk Assessment for the Import Use of Thiram on Avocado, PP#4E8250 and Banana, PP#4E8268”.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for thiram used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of February 12, 2014 (79 FR 8295) (FRL-9904-22).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to thiram, EPA considered exposure under the petitioned-for tolerances as well as all existing thiram tolerances in 40 CFR 180.132. EPA assessed dietary exposures from thiram in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

A partially refined probabilistic acute dietary-exposure assessment was performed using 100 percent crop treated (PCT), average field trial residues or pulp residues for blended commodities, distributions of field trial residues, highest pulp residue, and empirical processing factors.

ii. Chronic exposure. Tolerances-level residues, average field-trial residues, and highest pulp residues for avocado with 100 PCT were used for the chronic dietary exposure analysis for all crops. Empirical processing factors were also used.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that thiram does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use PCT information in the dietary assessment for thiram. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for thiram in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of thiram. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of thiram for acute exposures are 0.0478 ppm and 0.0025 ppm for chronic exposures (for non-cancer assessments) for surface water. Ground water sources were not included (for acute or chronic exposures), as the EDWCs for ground water are minimal in comparison to those for surface water. Surface water EDWCs were incorporated in Dietary Exposure Evaluation Model Food Commodity Intake Database (DEEM-FCID) into the food categories “water, direct, all sources” and “water, indirect, all sources” for the dietary assessments.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Thiram is not available for sale or use by homeowner applicators; therefore, there are no residential handler exposure scenarios. However, there is potential for residential post-application dermal exposure from treated golf course greens and tees. Residential exposures resulting from dermal contact with thiram-treated turf were assessed for children 6 to <11 years old, children 11 to <16 years old, and adults as described in document “Thiram. Revised Human Health Risk Assessment For Import Use of Thiram on Avocado,” p. 14.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike the N-methyl carbamate pesticides, EPA has not found thiram (a dithiocarbamate) to share a common mechanism of toxicity with any other substances, and thiram does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that thiram does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There was no evidence of increased susceptibility following in utero exposure to rats or rabbits or following prenatal and post-natal exposures to rats. There is evidence of quantitative susceptibility in the DNT study. However, there is low concern for the enhanced susceptibility seen in the DNT study because:

i. Clear NOAELs/LOAELs were established for the offspring effects.

ii. The dose-response is well defined.

iii. The behavioral effect of concern were observed only in females on one evaluation time period.

iv. The dose/endpoint is used for acute dietary risk for the most sensitive population subgroup (females 13-49 years old). Consequently, there are no residual uncertainties for pre- and post-natal toxicity.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for thiram is complete with acceptable neurotoxicity, developmental, and reproductive toxicity studies.

ii. As explained in this unit, there are no residual uncertainties for prenatal and post-natal toxicity.

iii. There are no residual uncertainties in the thiram database with regards to dietary exposure. A refined probabilistic acute dietary-exposure assessment was performed using maximum PCT, tolerance, the highest residue found during field-trials, distribution of field trial residues, Federal Drug Administration (FDA) monitoring data for apples, and empirical processing factors. A refined chronic dietary-exposure assessment was performed using tolerances and average estimated PCT. EPA made conservative (protective) assumptions in the water modeling used to assess exposure to thiram in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children. These assessments will not underestimate the exposure and risks posed by thiram.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. The acute dietary risk estimates are not of concern to EPA (<100% aPAD) at the 95th exposure percentile for the general U.S. population and all other population subgroups. The acute dietary exposure was 62% of the aPAD for females 13-49 years old, the population subgroup with the highest percent aPAD.

2. Chronic risk. The chronic aggregate risk assessment takes into account exposure estimates from dietary consumption of thiram (food and drinking water). The chronic dietary risk estimates are not of concern to EPA (<100% cPAD) for the general U.S. population and all other population subgroups. The chronic dietary exposure was 70% of the cPAD for children 1-2 years old, the population subgroup with the highest estimated chronic dietary exposure.

3. Short-term and intermediate-term risk. In aggregating short- and intermediate-term risk, the Agency routinely combines background chronic dietary exposure (food + water) with short/intermediate-term residential exposure (dermal only). The combined exposure may then be used to calculate an MOE for aggregate risk. Using the golfer scenario for adult males, adult females, and children >6 years old, combined with the applicable subpopulation with the greatest dietary exposure, the total short/intermediate-term food and residential aggregate MOEs are 570, 540, and 280, respectively. As these MOEs are above the target MOE of 100, the short- and intermediate-term aggregate risks are not of concern. For children <6 years old, there is no residential exposure, therefore, a short/intermediate term aggregate risk assessment is not required for this population.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, thiram is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to thiram residues.

Adequate enforcement methodology (colorimetric analytical method) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for thiram in or on avocado.

The petitioner requested a tolerance for residues of thiram on avocado at 8 ppm. EPA is establishing a tolerance at 15 ppm based on available data and the Organization for Economic Cooperation and Development (OECD) Tolerance Calculation Procedures.

Therefore, a tolerance is established for residues of thiram in or on avocado at 15 ppm.

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action 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 action 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).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

On January 1, 2005, the Federal Motor Carrier Safety Administration (FMCSA) began the HMSP program for intrastate, interstate, and foreign motor carriers transporting specified types and amounts of particularly dangerous hazardous material. HMSPs are required for a small subset of motor carriers transporting the following DOT-regulated hazardous material:

1. Highway Route Controlled Quantity (HRCQ) of a Class 7 (radioactive) material;

2. More than 55 pounds of a Division 1.1, 1.2, or 1.3 Explosive, or an amount of a Division 1.5 material requiring placarding;

3. Certain Poison by Inhalation Hazard (PIH) materials, including anhydrous ammonia, and

4. Compressed or refrigerated liquefied methane or liquefied natural gas in packaging equal to or greater than 3,500 water gallons.

FMCSA's Motor Carrier Management Information System (MCMIS) contains records for approximately 525,000 active interstate motor carriers operating in the United States. MCMIS records show almost 11,000 interstate and intrastate motor carriers that have had an inspection indicating that they transport hazardous material requiring placards.1 Approximately 1,500 motor carriers possess an HMSP.

The HMSP program is based on the premise that carriers transporting certain amounts of particularly dangerous hazardous material must maintain a higher minimum level of safety in their operations than other carriers and must additionally demonstrate compliance with the critical regulatory requirements in the DOT Hazardous Materials Regulations (HMR), 49 CFR parts 171-180, and Federal Motor Carrier Safety Regulations (FMCSR), 49 CFR parts 350-399. Under FMCSA's current program, in order to obtain or renew a HMSP, a carrier must demonstrate that it meets the following regulatory requirements specified in the FMCSR at 49 CFR 385.407 and 387.7:

1. Maintains the minimum level of financial responsibility required by 49 CFR part 387.

2. Maintains current Pipeline and Hazardous Materials Safety Administration (PHMSA) registration.

3. Certifies that it has security and communications plans that comply with 49 CFR part 172 of the HMR and 49 CFR part 385 of the FMCSR.

4. Is assigned a “satisfactory” safety fitness rating.

5. Additionally, at the time of initial application and renewal, the carrier's crash and inspection records in MCMIS for the prior 12 month period may not exceed the threshold rate established by FMCSA, based on crash and out-of-service rates for the hazardous material motor carrier industry, indicating that the carrier has:

a. A crash rate in the “top 30 percent of the national average,” or

b. A driver, vehicle, hazardous material, or total out-of-service (OOS) rate in the “top 30 percent of the national average.”

As stated above, section 33014 of MAP-21, Pub. L. 112-141, div. C, title III, 126 Stat. 405, 840 (July 6, 2012) (set out as a note to 49 U.S.C. 5109) required the Secretary to conduct a study and submit a report to Congress on the implementation of the DOT's HMSP program. Congress further directed the Secretary to include in the study a review of “actions the Secretary could implement to improve the program, including whether to provide opportunities for an additional level of fitness review prior to the denial, revocation, or suspension of a safety permit.” Finally, section 33014 required the Secretary to institute a rulemaking to make any necessary improvements to the HMSP program or publish in the Federal Register the Secretary's justification for why a rulemaking is not necessary.

DOT completed the study and submitted its “Hazardous Materials Safety Permit Program Implementation Report” (HMSP Report) to Congress in March 2014. This notice announces implementation of two of the six recommendations in the report to Congress: (1) Fully utilize the Safety Measurement System (SMS) as part of the HMSP review process and (2) institute an ongoing requirement to conduct comprehensive investigations for HMSP motor carriers with insufficient data to utilize SMS. This Federal Register publication provides notice of the Agency's revised interpretation of certain regulations in 49 CFR part 385, subpart E, in accordance with congressional directives and the recommendations in the report to Congress.

On December 16, 2014, Congress passed the 2015 Omnibus Appropriations law entitled, “Consolidated and Further Continuing Appropriations Act, 2015,” Pub. L. 113-235, 128 Stat. 2130 (Dec. 16, 2014) which restricts FMCSA's use of appropriated funds “to deny an application to renew a Hazardous Materials Safety Program permit for a motor carrier based on that carrier's Hazardous Materials Out-of-Service rate, unless the carrier has the opportunity to submit a written description of corrective actions taken, and other documentation the carrier wishes the Secretary to consider, including submitting a corrective action plan, and the Secretary determines the actions or plan is insufficient to address the safety concerns that resulted in that Hazardous Materials Out-of- Service rate.” Pub. L. 113-235, div. K, Title I, § 134. By using SMS scores to identify a HMSP holder for a safety fitness review, the Agency, while complying with this congressional limitation, will ensure that transportation of the hazardous materials specified in 49 CFR 385.403 does not present an undue safety risk to the public.

FMCSA provides notice herein that the Agency is distinguishing the requirements for issuance of an initial HMSP as specified in 49 CFR 385.407, from the requirements for HMSP renewal, as specified in 49 CFR 385.419. Distinguishing these requirements, as discussed below, enables the Agency to more actively monitor an HMSP holder's safety and compliance status, while providing more flexibility to HMSP holders attempting to correct identified deficiencies. Pursuant to the 2015 spending restriction, the Agency is no longer denying HMSP renewals based on a carrier's unacceptable hazardous materials out-of-service rate. Upon the effective date of this notice, the Agency will no longer deny a HMSP holder's application for renewal of its HMSP based on a crash rate, driver, vehicle, hazardous material or total out-of-service rate that is in the top, or worst-performing, 30 percent of the national average.

New applicants for HMSPs, which includes any applicant that is not a current HMSP holder, and holders of temporary HMSPs (T-HMSP) will continue to be subject to the established crash, driver, vehicle, hazardous material or total out-of-service threshold rates in order to qualify for the initial issuance of a HMSP. The requirement that new applicants not have a crash rate or a driver, vehicle, hazardous material, or total out-of-service (OOS) rate for the prior 12 months, as shown below, remains unchanged:

a. A crash rate in the “top 30 percent of the national average,” or

b. A driver, vehicle, hazardous material or total out-of-service (OOS) rate in the “top 30 percent of the national average.”

Pursuant to the interpretive rule announced in this Notice, non-temporary HMSP holders will no longer be required to have crash and OOS rates that are below the “30 percent threshold” at the time of the HMSP holder's two-year renewal. Rather, FMCSA will continually monitor these HMSP holders using SMS analysis as a basis for a compliance review referral or proposed revocation or suspension based on the criteria listed in 49 CFR 385.421. HMSP holders will continue to be subject to the renewal provisions in 49 CFR 385.419, which require the carrier to submit its biennial update.

The first recommendation in the HMSP Report to Congress was for FMCSA to fully utilize the Agency's SMS to provide continuous monitoring of HMSP holders' safety performance in order to determine a carrier's continuing suitability to retain or renew a non-temporary HMSP. Carriers applying for a six-month T-HMSP will be subject to the requirements for initial issuance of a HMSP in § 385.407. Temporary HMSPs are issued when a motor carrier meets all of the qualifications in § 385.407 except for having a safety rating assigned. If the carrier has no safety rating, the T-HMSP is issued, and the motor carrier is assigned for a comprehensive investigation within six months of the FMCSA field staff being notified. FMCSA may extend the T-HMSP for two months, when necessary due to the Agency's inability to schedule a comprehensive investigation during the initial six-month timeframe. Once the carrier receives a comprehensive investigation, and subsequently is assigned a satisfactory safety rating, the carrier is eligible for a full, non-temporary HMSP subject to the initial requirements in § 385.407. Once the non-temporary HMSP is issued, the Agency will place the carrier under the continuous monitoring program described herein.

Non-temporary HMSP carriers will continue to be subject to the current intervention thresholds for all carriers of placarded hazardous material under the seven Behavior Analysis and Safety Improvement Categories (BASIC) in SMS. These intervention thresholds are listed below:

• 60th percentile for Unsafe Driving, Hours of Service Compliance, and Crash Indicator;

• 75th percentile for Driver Fitness, Controlled Substances/Alcohol, and Vehicle Maintenance; and

• 80th percentile for Hazardous Material Compliance.

The SMS approach provides a strengthened, continuous monitoring process for HMSP holders, which merit heightened oversight and monitoring due to the dangerous nature of the materials they transport. SMS monitoring further allows the Agency to expeditiously identify carrier problems and better focus on specific areas that the carrier must address immediately, in order to avoid potential suspension or revocation of its HMSP under 49 CFR 385.421(a).

If a carrier fails to comply with the applicable regulations, or an order issued under those regulations, indicating that the carrier is not fit to transport hazardous material that requires a HMSP, such conduct could similarly trigger a proposed suspension or revocation under § 385.421(a)(5), (6), (7), (8), or (10). It should be noted that a proposed suspension or revocation under 385.421(a)(5) would be based on serious instances of non-compliance, a less than satisfactory safety rating, or loss of operating authority. The proposed suspension or revocation would be subject to the 30-day notice requirement in § 385.421(c)(2), and the carrier would have an opportunity to take corrective action and/or to apply for administrative review under § 385.423 before FMCSA took final action.

If a carrier's non-temporary HMSP is denied, suspended or revoked pursuant to § 385.421, the carrier will have various options for seeking administrative review and providing evidence of corrective action. If the suspension or revocation is based on a less than satisfactory safety rating, the carrier may request administrative review of the proposed rating under § 385.15, or may request upgrade of a proposed safety rating based on corrective action under § 385.17, as provided in § 385.423(a). The carrier may seek administrative review of other grounds for a proposed suspension or revocation as provided in § 385.423(c). A proposed suspension or revocation under § 385.421(c)(2) will not become effective during the pendency of a request for administrative review that is timely-filed during the 30-day timeframe from the date of service of the written notice of proposed suspension or revocation. The 30-day effective date and the tolling of this date by a request for administrative review of proposed suspensions or revocations that are not related to a less than satisfactory safety rating allows the carrier time to take and submit evidence of corrective action.

The second recommendation in the HMSP Report to Congress was for FMCSA to institute an ongoing requirement to more closely monitor HMSP carriers with insufficient SMS data—that is, HMSP carriers that rarely undergo roadside inspections and have a safety rating over 4 years old. Because of the lack of information and oversight on these carriers, FMCSA will conduct comprehensive investigations for HMSP carriers when the carrier has insufficient data to calculate a percentile in SMS during any month of the previous 48-month period. HMSP carriers will not be allowed to operate for more than four years without either having enough safety performance data to confirm compliance, or having received a compliance review that results in a satisfactory rating. By instituting a specific 4-year investigation cycle for non-temporary HMSP carriers with insufficient safety data, these carriers will become subject to increased oversight.

These changes will be effective August 18, 2015.

The summer flounder, scup, and black sea bass fisheries are managed cooperatively under the provisions of the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) developed by the Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission, in consultation with the New England and South Atlantic Fishery Management Councils. The management units specified in the FMP include summer flounder (Paralichthys dentatus) in U.S. waters of the Atlantic Ocean from the southern border of North Carolina northward to the U.S./Canada border, and scup (Stenotomus chrysops) and black sea bass (Centropristis striata) in U.S. waters of the Atlantic Ocean from 35°13.3′ N. lat. (the approximate latitude of Cape Hatteras, North Carolina) northward to the U.S./Canada border. States manage these three species within 3 nautical miles (4.83 km) of their coasts, under the Commission's plan for summer flounder, scup, and black sea bass. The applicable species-specific Federal regulations govern vessels and individual fishermen fishing in Federal waters of the exclusive economic zone (EEZ), as well as vessels possessing a summer flounder, scup, or black sea bass Federal charter/party vessel permit, regardless of where they fish.

A proposed rule to implement the 2015 Federal recreational management measures (minimum fish size, season, and possession limit) for the summer flounder, scup, and black sea bass fisheries was published in the Federal Register on May 5, 2015 (80 FR 25656), with a 15-day comment period that ended on May 20, 2015. Additional background and information on the process to develop the measures described is provided in the preamble to the proposed rule and is not repeated here.

NMFS is implementing the following measures that would apply in the Federal waters of the EEZ. These measures apply to all federally permitted party/charter vessels with applicable summer flounder, scup, or black sea bass permits, regardless of where they fish, unless the state in which they land implements measures that are more restrictive. These measures are intended to achieve, but not exceed, the previously established recreational harvest limits for these fisheries (December 30, 2014; 79 FR 78311). More detail on these proposed measures is provided in the following sections.

This rule implements the Council and Commission recommendation to use conservation equivalency to manage the 2015 summer flounder recreational fishery. The 2015 recreational harvest limit for summer flounder is 7.38 million lb (3,347 mt). Final landings for 2014 were 7.39 million lb (3,354 mt), just above the recreational harvest limit for 2015.

Conservation equivalency, as established by Framework Adjustment 2 (July 29, 2011; 66 FR 36208), allows each state to establish its own recreational management measures to achieve its state harvest limit partitioned by the Commission from the coastwide recreational harvest limit, as long as the combined effect of all of the states' management measures achieves the same level of conservation as would Federal coastwide measures. Framework Adjustment 6 (July 26, 2006; 71 FR 42315) allowed states to form regions for conservation equivalency in order to minimize differences in regulations for anglers fishing in adjacent waters.

The Council and Board voted to maintain the conservation equivalency structure that was in place for fishing year 2014, as follows: (1) Massachusettes; (2) Rhode Island; (3) Connecticut, New York, and New Jersey; (4) Delaware, Maryland, and Virginia; and (5) North Carolina. All states within a region must implement identical measures (i.e., minimum size, possession limit, and season length). By implementing conservation equivalency, the Federal summer flounder regulations are suspended, and vessels are only subject to the measures for the state in which they land. This means that minimum fish sizes, possession limits, and fishing seasons developed and adopted by the five regions from Massachusetts to North Carolina replace the Federal waters measures for 2015.

The Commission notified the NMFS Greater Atlantic Regional Administrator by letter dated April 30, 2015, that the 2015 summer flounder recreational fishery management measures implemented by the states and regions described above have been reviewed by the Commission's Technical Committee and approved by the Commission's Summer Flounder Management Board. The correspondence indicates that the Commission-approved management measures are projected to restrict 2015 recreational summer flounder coastwide landings consistent with the state-specific requirements established by the Technical Committee and Board through the Commission process.

Based on the recommendation of the Commission, we find that the recreational summer flounder fishing measures implemented for 2015 in state waters are, collectively, the conservation equivalent of the season, minimum size, and possession limit prescribed in §§ 648.104(b), 648.105, and 648.106(a), respectively. According to § 648.107(a)(1), vessels subject to the recreational fishing measures of this part and landing summer flounder in a state with an approved conservation equivalency program shall not be subject to Federal measures, and shall instead be subject to the recreational fishing measures implemented by the state in which they land. Section 648.107(a) has been amended to recognize state-implemented measures as conservation equivalent of the coastwide recreational management measures for 2015. The 2015 summer flounder management measures adopted by the individual states vary according to the state of landing, as specified in Table 2.

In addition, this action maintains the current default coastwide measures (18-inch (45.7-cm) minimum size, 4-fish possession limit, May 1-September 30 open fishing season), that become effective January 1, 2016, when conservation equivalency expires.

NMFS is implementing the Council and Commission's recommended scup recreational management measures for 2015 in Federal waters. The measures for the 2015 scup recreational fishery are: 9-inch (22.9-cm) minimum fish size; 50-fish per person per trip possession limit; and an open season of January 1 through December 31.

The 2015 scup recreational harvest limit is 6.80 million lb (3,084 mt). Final 2014 scup recreational landings were 4.12 million lb (1,870 mt). The increase in the possession limit from 30 to 50 fish is intended to promote an increase in recreational scup fishing in order to more fully achieve, but not exceed, the recreational harvest limit.

This final rule implements the Council and Commission's recommended recreational management measures to constrain landings for black sea bass in 2015: A 12.5-inch (31.8-cm) minimum size, 15-fish possession limit, and open seasons of May 15-September 21 and October 22-December 31. The 2015 black sea bass recreational harvest limit is 2.33 million lb (1,056 mt). The final 2014 landings were 3.65 million lb (1,656 mt). During development of these and the state measures, projected landings for 2014 were 3.45 million lb (1,565 mt), which requires a 33-percent reduction in landings relative to the 2015 recreational harvest limit.

Recreational black sea bass catch occurs primarily in state waters in the states of New Jersey through Massachusetts (i.e., the northern region). Since 2011, the management measures in the northern region have been more restrictive than in Federal waters. The northern states, through the Commission process, have implemented 2015 measures to achieve the 33-percent reduction in landings from each state that was projected to be needed when this action was under development. This reduction, in combination with the Council's recommendation of maintaining the status quo measures in Federal waters, are intended to achieve, but not exceed, the recreational harvest limit and recreational annual catch limit in 2015. The southern region states (Delaware through Cape Hatteras, North Carolina) have implemented state waters measures that are equivalent to the Federal measures. The states of Maine and New Hampshire have implemented recreational black sea bass measures for the first time in response to the stock being more commonly found in these states' waters.

In 2012, recreational black sea bass catch exceeded the annual catch limit of 2.52 million lb (1,143 mt) by 129 percent. In 2013, recreational black sea bass catch exceeded the annual catch limit of 2.9 million lb (1,315 mt) by 5 percent. Because the average catch for these two years exceeds the average annual catch limit from the same timeframe, as described in the regulations, an accountability measure is applicable to the 2015 fishery. An accountability measure was implemented for the 2014 fishing year because of the 2012 overage. The 2015 measures are functionally the same as those implemented last year to comply with the accountability measure (12.5-inch (31.8-cm) minimum size, 15-fish possession limit, and 201-day fishing season). Continuing these regulations preserves the accountability measure that was applied last year; as such, no further accountability measures are necessary for 2015.

This rule also clarifies that the regulations for summer flounder, scup, and black sea bass possession limits are per person, per trip. While it is clear in the FMP and subsequent amendments and framework adjustments that the possession limits are intended to apply for the entirety of a fishing trip, regardless of the length of that trip, the regulations were less specific. This action corrects that oversight.

Three comments were received on the proposed rule. These comments were not directly related to the 2015 recreational management measures as proposed, but raised more general issues. No changes to the 2015 recreational management measures are being made as a result.

Comment 1: The first commenter expressed concern that reduced black sea bass fishing would result in increased pressure on other stocks, such as red hake, bluefish, and winter flounder, and noted a marked increase in fishing on red hake when other recreational fisheries have restrictive measures. The commenter advised leaving the fishery open during the summer months.

Response: The Federal black sea bass fishery will be open during the summer months, but some states may implement more restrictive seasons in order to achieve the reduction necessary, described above. NMFS has no authority over the states' measures and they are not the subject of this rule. In addition, the other species noted by the commenter are all federally managed species with annual catch limits and accountability measures designed to ensure catch stays within scientifically-based levels.

Comment 2: The second commenter was not specific to which measures he was referring, but noted that recreational measures should not be made more restrictive and that more restrictive measures should be placed on the commercial fishery.

Response: This rulemaking is specific to the recreational fisheries for summer flounder, scup, and black sea bass only. For all three species managed under the Summer Flounder, Scup, and Black Sea Bass FMP, the commercial and recreational sectors have separate annual catch limits. The amount of landings allocated to each sector is specified in the FMP. This allocation structure is intended to ensure that neither sector is held accountable for catch overages in the other sector. The commercial fisheries are regulated with seasonal, gear, permit, and landings restrictions. These combinations of measures, both in Federal and state waters, are designed to achieve, but not exceed, the commercial coastwide landings quotas. The commercial accountability measures require a pound-for-pound payback of any quota or annual catch limit overages. In recent years, small overages of the commercial quota or commercial annual catch limit have been accounted for by reducing the following year's quota equal to the amount of the overage, as needed. Further restrictions on the commercial fishery are not warranted at this time. Should the commercial catch need to be reduced for any of these species, those changes would be implemented in a commercial sector-specific rulemaking.

Comment 3: The commenter noted that limits on the number and size of fish caught recreationally were important to the long-term sustainability of the fisheries.

Response: NMFS agrees and is implementing these measures specifically to ensure that the scientifically-based recreational harvest limits are not exceeded.

The Administrator, Greater Atlantic Region, NMFS, determined that the rule implementing the 2015 summer flounder, scup, and black sea bass recreational management measures is necessary for the conservation and management of the summer flounder, scup, and black sea bass fisheries and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

The Assistant Administrator for Fisheries, NOAA, finds good cause to waive the requirement for a 30-day delay in effectiveness under the provisions of section 553(d) of the Administrative Procedure Act because a delay in its effectiveness would not serve any legitimate purpose, while unfairly prejudicing federally permitted charter/party vessels. This action will increase the possession limit for the recreational scup fishery in Federal waters and allow federally permitted charter/party vessels to be subject to the new summer flounder measures in their respective states. Because some states' summer flounder fisheries are already open or will open during the 30-day period following publication of this rule, federally permitted charter/party vessels would be restricted to the existing summer flounder coastwide regulations (18-inch (45.7-cm) minimum size and a 4-fish per person possession limit) until the Federal regulations are effective. This would unnecessarily disadvantage federally permitted vessels, which would be subject to the more restrictive measures while state-licensed vessels could be engaged in fishing activities under this year's management measures. If this final rule were delayed for 30 days, the fishery would likely forego some amount of landings and revenues during the delay period.

While these restrictions would be alleviated after this rule becomes effective, fishermen may be not able to recoup the lost economic opportunity of foregone trips that would result from delaying the effectiveness of this action. Finally, requiring a 30-day delay before the final rule becomes effective would not provide any benefit to the regulated parties. Unlike actions that require an adjustment period to comply with new rules, charter/party operators will not have to purchase new equipment or otherwise expend time or money to comply with these management measures. Rather, complying with this final rule simply means adhering to the published management measures for each relevant species of fish while the charter/party operators are engaged in fishing activities.

For these reasons, the Assistant Administrator finds good cause to waive the 30-day delay and to implement this rule upon publication in the Federal Register.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared. There are no new reporting or recordkeeping requirements contained in any of the alternatives considered for this action.

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows: