Federal Register Vol. 81, No.247,

On June 30, 2016, the FOIA Improvement Act of 2016, Public Law 114-185, 130 Stat. 538 (the Act) was enacted. The Act specifically requires all agencies to review and update their Freedom of Information Act (FOIA) regulations in accordance with its provisions. OGE is making changes to its regulations accordingly, including correcting citations, highlighting the electronic availability of records, implementing the “rule of three” for frequently requested records, notifying requesters of their right to seek assistance from the FOIA Public Liaison and the Office of Government Information Services, changing the time limit for appeals, implementing the foreseeable harm standard, describing limitations on assessing search fees if the response time is delayed, and adding new annual reporting requirements.

Pursuant to 5 U.S.C. 553(b), I find that good cause exists for waiving the general notice of proposed rulemaking and public comment procedures as to these technical amendments. The notice and comment procedures are being waived because these amendments, which concern matters of agency organization, procedure and practice, are being adopted in accordance with mandates required by the FOIA Improvement Act of 2016, which requires that agencies amend their FOIA regulations not later than 180 days after the date of enactment. It is also in the public interest in order to provide notice to requestors of the additional time to file appeals.

As the Director of the Office of Government Ethics, I certify under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this interim final rule would not have a significant economic impact on a substantial number of small entities because it primarily affects individuals requesting records under the FOIA.

The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply because this regulation does not contain information collection requirements that require approval of the Office of Management and Budget.

For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 5, subchapter II), this rule would not significantly or uniquely affect small governments and will not result in increased expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select the regulatory approaches that maximize net benefits (including 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. In promulgating this rulemaking, OGE has adhered to the regulatory philosophy and the applicable principles of regulation set forth in Executive Orders 12866 and 13563. The rule has not been reviewed by the Office of Management and Budget because it is not a significant regulatory action for the purposes of Executive Order 12866.

As Director of the Office of Government Ethics, I have reviewed this rule in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.

For the reasons set out above, OGE amends 5 CFR part 2604 as follows:

Background

The regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-75, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests within the United States.

On May 10, 2016, we published in the Federal Register (81 FR 28758, Docket No. APHIS-2014-0092) a proposal 1 to amend the regulations to allow the importation of commercial consignments of fresh lemons from northwest Argentina into the continental United States, subject to a systems approach.

We solicited comments concerning our proposal for 60 days ending July 11, 2016. We extended the deadline for comments until August 10, 2016, in a document published in the Federal Register on July 11, 2016 (81 FR 44801, Docket No. APHIS-2014-0092). We received 414 comments by that date. They were from domestic and foreign citrus producers, State and national organizations representing citrus producers, State departments of agriculture, an organization of State plant pest regulatory agencies, Argentina's national plant protection organization, the Argentine embassy, lemon importers and wholesalers, longshoremen, U.S. ports of entry, Senators, Representatives, an Argentine organization devoted to citrus research, and private citizens. Forty-seven commenters supported the rule as proposed. Seventy-six commenters generally opposed the proposed rule but did not address any specific provisions. The remaining commenters raised a number of issues and concerns about the proposed rule. These comments are discussed below by topic.

One commenter stated that the proposed rule failed to comply with the requirements of the National Environmental Policy Act (NEPA). Specifically, the commenter stated that the proposed rule is a major Federal action that significantly affects the human environment, as set forth in 40 CFR 1508.18 and 1508.27, respectively, and that the Animal and Plant Health Inspection Service (APHIS) should have prepared an environmental impact statement or environmental assessment (EA). The commenter further stated that none of the APHIS categorical exclusions set forth in 7 CFR 1b.3 apply, therefore at a minimum, APHIS is obligated to prepare an EA.

APHIS notes that the APHIS NEPA implementing regulations in 7 CFR part 372 specify that additional routine measures used by APHIS are categorically exempt from NEPA, in addition to those measures set forth in 7 CFR 1b.3. The measures in this rule that will occur within the United States fall within the scope of these additional routine measures. Accordingly, a categorical exclusion was prepared.

We do not agree that the rule meets Council on Environmental Quality requirements for a “significant” Federal action, and thus, by definition, cannot be a “major” Federal action (a type of significant action). The rule is not contextually significant from a policy standpoint because it does not substantially alter existing policy regarding market access requests, and has severity/intensity only if one concedes that the mitigations specified in the rule are ineffective in precluding the introduction of quarantine pests. We consider them effective, for reasons discussed below.

One commenter stated that APHIS must take all available measures to preclude introduction of invasive species into the United States.

APHIS agrees. Under the Plant Protection Act (7 U.S.C. 7701 et seq.), we are responsible for regulating exports, imports, and interstate commerce in agricultural products and other commodities that pose a risk of harboring plant pests or noxious weeds in ways that are based on sound science and that will reduce the risk of dissemination of plant pests or noxious weeds. For this reason we prepared a pest risk assessment (PRA) and assigned mitigations with a proven track record in the risk management document (RMD).

One commenter noted that APHIS has also recently published proposed rules to allow for the importation of citrus from South Africa (79 FR 51273, Docket No. APHIS-2014-0015) and Chile (81 FR 19063, Docket No. APHIS-2015-0051). The commenter stated that because both of those proposals deal with a disease or pest of concern which is also of concern in the Argentine proposal, APHIS should not finalize this rulemaking until we have responded to the comments on the other proposed rules.

We disagree with the commenter that the other rules must be finalized before we can proceed with this rule. APHIS considers each of its rulemakings as a distinct regulatory action. This is consistent both with the language of the Administrative Procedure Act (5 U.S.C. 551-559) and with case history regarding its implementation.

Many commenters stated that APHIS should conduct an additional site visit before the rule is implemented. Many of those commenters also stated that representatives of State governments and subject matter experts should be involved in the site visit.

APHIS conducted an additional site visit to review the details of the draft operational workplan in September of 2016. In addition to APHIS personnel, a representative from the California Department of Food and Agriculture and a former plant pathologist from the United States Department of Agriculture, Agricultural Research Service (ARS) participated in the site visit as observers. The site visit revealed nothing that would require a revision of the PRA.

Some commenters stated that the site visit should include a holistic review of Argentina's production system. Other commenters stated that Argentina's traceability system provides holistic records of their production system.

APHIS conducted a thorough review of Argentina's traceability system. We looked at the requirements for growers signing up, initial site visits of production sites, ongoing oversight during the growing season, field and packinghouse inspection, approval for movement and the final inspection for phytosanitary certificates. We also reviewed the computer system they use, how users are added, who controls movement and harvest approvals, and who issues phytosanitary certificates. Based on that review, we consider Argentina's traceability system to be robust, and we will use it for traceback as necessary. However, as specified in the proposed rule, we also consider it necessary to be able to identify lots of lemons through the export process, from the place of production to arrival at the port of entry. This establishes traceability beyond the scope of the Argentine domestic traceability system.

One commenter stated that Argentina's traceability system will not be able to trace detections of quarantine pests in U.S. orchards or urban areas back to places of production.

APHIS is confident that if the mitigations in the rule are adhered to, quarantine pests will not be introduced into United States orchards or urban areas.

One commenter stated that Argentina's traceability system has limited utility for citrus black spot (CBS), given its prolonged latency period.

As we explained in the PRA, fruit is not a pathway for CBS.

One commenter stated that the site visit should specifically focus on the infrastructure of the national plant protection organization (NPPO) of Argentina. Another commenter stated that the site visit should specifically focus on NPPO oversight of places of production.

The NPPO of Argentina is the Servicio Nacional de Sanidad y Calidad Agroalimentaria (SENASA). During the September 2016 site visit, we looked at SENASA's infrastructure and asked questions to address their capacity to provide oversight. We remain confident that SENASA will be able to adhere to the requirements of the systems approach.

Some commenters stated that the site visit should specifically focus on identifying pest populations in or near production sites.

During the site visit, we asked questions about pest populations, and we looked ourselves at fruit fly traps and at the citrus for signs of pests. We did not discover anything that requires revisions to the PRA.

One commenter stated that the site visit should specifically focus on organic production sites.

APHIS did specifically ask about organic production. Argentina may in the future ship organic fruit, but currently they do not. Current packinghouse practices include chemical treatments that are not organic, so any fruit that arrived from an organic production site would lose its organic status during packinghouse processing.

We will ask SENASA about organic production in northwest Argentina, as well as pest control guidelines they have developed for organic producers. We note that there are provisions in the systems approach that preclude the commingling of organic lemons and lemons for export to the United States later in the production chain.

One commenter stated that the site visit should be conducted during the summer months in Argentina.

The 2015 site visit occurred in June, during harvest season in Argentina. For this reason, APHIS considered a second site visit during the September/October timeframe to be sufficient.

One commenter stated that two additional site visits are needed. Specifically, the commenter stated that after the September site visit, a second fact-finding trip should be made to review the harvesting and packing operations in Argentina. The commenter stated that a trip at that time is needed since so many steps in the systems approach take place during the harvesting and packing operations.

APHIS disagrees. As we explained above, the 2015 site visit occurred in June, which is during the harvest season in Argentina. For this reason, we do not consider two additional site visits to be necessary.

Two commenters stated that industry stakeholders should be allowed to consult with trip members on their findings.

APHIS prepared a site visit report outlining the findings of the visit. The site visit report is available on the APHIS Web site at https://www.aphis.usda.gov/aphis/ourfocus/planthealth/import-information/proposal-import-lemons-argentina.

Many commenters expressed concern that the findings of the 2007 site visit are outdated.

The trip in 2007 was conducted by APHIS risk assessors to evaluate pest complexes in Argentina in order to prepare the PRA. Information from this trip served as a baseline primarily for the pest list in the PRA. The PRA, as other commenters noted, has been continually updated since this trip through means that APHIS routinely uses to update PRAs, such as literature review and ongoing consultation with the NPPO of Argentina. More specifically, the PRA was updated in 2014 after publication of new research results on seed transmission of citrus variegated chlorosis (CVC) in citrus. The PRA was also updated in 2014 in response to a new finding of citrus greening, also known as Huanglongbing (HLB), in Argentina. The PRA was reviewed by APHIS personnel at the same time to address comments from Argentina regarding the pest list. Furthermore, APHIS conducted a site visit just last year, in June of 2015, and the information gathered during that visit was used to update the PRA before the proposed rule was published.

Two commenters stated that the 2015 site visit was not a technical review of Argentina's program.

The commenters are mistaken. The 2015 site visit was a technical review of Argentina's program.

Three commenters stated that APHIS did not provide enough information to the public regarding the 2015 site visit to evaluate its adequacy. Two commenters stated that APHIS' slow response to a Freedom of Information Act (FOIA) request for documents regarding the 2015 site visit is an indication of the inadequacy of the trip.

APHIS has received the FOIA request and is in the process of responding to it. The time taken to respond to the FOIA request is consistent with normal timeframes for such requests and not a reflection of the adequacy of the trip.

One commenter stated that APHIS' willingness to conduct another site visit is an indication of the inadequacy of the 2015 site visit.

Usually, APHIS conducts one site visit as close to the implementation of a new systems approach as possible in order to aid in development of the operational workplan. It was therefore entirely in keeping with APHIS policy to conduct the September 2016 site visit prior to implementing this final rule, and is not indicative of flaws in the 2015 visit.

The 2015 site visit team included several APHIS risk managers who have extensive experience in evaluating foreign production systems to determine the ability of those systems to meet requisite mitigation measures.

One commenter stated that updated information appears to have been incorporated into the PRA in a piecemeal fashion, without checking whether any conclusions or assumptions were affected.

APHIS notes that we have updated the PRA several times. Appendix 1 of the PRA summarizes updates to the draft PRA in response to public and peer review comments; Appendix 2 summarizes updates to the PRA made between 2008 and 2015 in response to new scientific information. Any time we incorporated new material into the PRA we reviewed the PRA to check the conclusions.

One commenter stated that information provided by SENASA is unreliable.

We disagree with the commenter. We have conducted two site visits during which we have verified the information provided by SENASA. They have also answered all the questions we have asked and provided all information we have requested.

Two commenters stated that stakeholder comments on the PRA appear to have been ignored.

APHIS posts PRAs and other documents for stakeholder review. As noted on the Web site on which the documents are posted, while stakeholder comments may result in changes to the PRA, as well as the RMD and the rule, it is not APHIS policy to compile or post responses to the comments received. This is because these documents are also made available for review and comment along with the rules and notices that propose to grant market access. Any comments that we receive on the documents during that comment period are addressed in a final regulatory action.

APHIS reviewed all of the comments that we received on the PRA and RMD. Certain comments, such as statements agreeing that Brevipalpus chilensis should be listed as a pest of lemons that is known to exist in Argentina, or that green lemons should not be required to be treated for Mediterranean fruit fly (Medfly), required no changes to the PRA or RMD because the commenters' requests were already reflected in the PRA or RMD. Other comments, such as a request to indicate whether the mites B. californicus, B. obovatus, and B. phoenicis (Brevipalpus spp.) were surface feeders, were incorporated into the PRA and RMD.

Other suggested revisions, such as revising the RMD to prohibit the importation of lemons with leaves attached, would have made the rule more stringent that our domestic requirements for the interstate movement of citrus fruit from areas quarantined for pests and diseases of citrus, and were not incorporated for that reason. Similarly, other revisions would have made the PRA or RMD inconsistent with how other APHIS documents discuss the same pest of concern or mitigation structure.

Finally, certain comments, such as that the NPPO of Argentina could not be trusted to abide by the systems approach, were reiterated during the comment period and dismissed for reasons discussed below under the heading “Risk Management Document.”

One commenter stated that a footnote in the Executive Summary to the PRA seems to define the term “commercially produced,” but in fact only describes conditions of the fruit after harvest and processing. The commenter stated that the term “commercially produced” should be limited to conditions at places of production.

The term “commercially produced” is equivalent to “commercial consignments.” It includes all aspects of the production system: The manner in which the fruit was grown and harvested, the quality of the fruit, the manner in which it is packaged, the quantities packaged, and the requisite accompanying documentation.

One commenter stated that the PRA and proposed rule did not identify pests of concern for Argentine lemons.

The pest list in the PRA identifies pests of lemons that are known to exist in Argentina.

One commenter stated that four pathogens—Elsinoë australis, Phyllosticta citricarpa, Xanthomonas citri subsp. citri (Xcc), and citrus leprosis virus—can all infect fruit and stay viable while on the fruit, even though capacity for transmission from infected fruit may be low. The commenter stated that the answer to the question “Can it follow the pathway?” for all four pathogens should be changed to “yes.”

APHIS notes that, while these could follow the pathway, the capacity for introduction or transmission of disease is so epidemiologically insignificant that further analysis was not warranted.

One commenter stated that citrus leprosis virus should have been selected for further analysis in the PRA as it is a quarantine pest likely to follow the pathway.

Citrus leprosis virus is not systemic and cannot be transmitted apart from viruliferous Brevipalpus spp. mites. It can follow the pathway only if it is vectored by the mites. For this reason we do not consider the virus to be a quarantine pest likely to follow the pathway.

One commenter stated that the citation in the PRA to the APHIS domestic fruit fly quarantine and regulations, which address Medfly was outdated and have been replaced with 7 CFR 301.32. The commenter noted that in the current regulations, only yellow lemons are regulated articles for Medfly.

The commenter is correct; the citations were outdated. However, this does not affect the conclusions of the PRA that green lemons are a poor host for Medfly.

Several commenters stated that the pest risk associated with importation of lemons is too high, and that the domestic citrus industry would suffer as a result of pest introductions.

If the mitigations in the rule are adhered to, this pest risk will be mitigated. Furthermore, some of these commenters appear to have overestimated the likelihood of introduction associated with certain of the pests. For example, Cryptoblabes gnidiella and Gymnandrosoma aurantianum have never been intercepted in commercial shipments of citrus from South America. Both are associated with poorly managed or non-commercial citrus, like backyard fruit.

One commenter stated that B. chilensis should have been rated as high risk in the PRA.

APHIS notes that B. chilensis was in fact rated as high risk in the PRA.

One commenter stated that Brevipalpus spp. mites should all have been rated “High Risk.” The commenter cited a scientific article on Brevipalpus mites and the diseases they transmit 2 in support of this statement.

In that article, Childers and Rodrigues state that the only confirmed vector of citrus leprosis in the Western Hemisphere is B. phoenicis. The other mites are suspected to be vectors, but are not known vectors. Given that we consider B. californicus, B. obovatus, and B. phoenicis to be quarantine pests only insofar as they may vector citrus leprosis virus, and there is some uncertainty regarding the ability of B. californicus and B. obovatus to vector this disease, we consider a medium risk rating to be appropriate. It is also consistent with how we have rated these pests in other PRAs.

More importantly, a high risk rating would not have changed our mitigations for the pests. Under APHIS policy, both medium risk and high-risk pests are subject to pest-specific mitigations beyond port of entry inspection, and the mitigations we prescribed to address Brevipalpus spp. are based on the possibility that they may vector citrus leprosis virus, rather than the risk rating ascribed to the pests.

One commenter stated that the overall risk rating should have been higher.

As we explained above, a higher overall risk rating would not have changed the mitigation structure.

One commenter asked why, if “not be detected at the port of entry” did not impact risk ratings, port of entry inspection is a component of the systems approach.

“Not be detected at the port of entry” was removed as a criterion in the PRA because APHIS does not have enough information about relative likelihood of detection at the port of entry to be able to weight this criterion relative to other elements. As a result, this criterion could not substantially impact the risk ratings.

This does not imply that port of entry inspections are an ineffective component of a systems approach. Port of entry inspections by U.S. Customs and Border Protection (CBP) are, in fact, capable of detecting quarantine pests and are a significant mitigation against pests entering the United States. For example, in December 2015, CBP detections of Medfly larvae on Spanish tomatoes and Moroccan citrus led us to suspend market access for those commodities, pending investigations.

One commenter asked why, if fruit is not an “epidemiologically significant” pathway for E. australis, P. citricarpa, and Xcc, the PRA says “additional specified risk management options may be required.”

While we do not consider fruit to be an epidemiologically significant pathway for these pests, the pests are subject to domestic quarantines within the United States. For the sake of consistency with domestic regulations regarding the interstate movement of fruit from areas quarantined for CBS, sweet orange scab, and Xcc, we would require fruit to be washed, brushed, waxed, and surface disinfected. It is worth noting that such washing, brushing, waxing, and disinfecting are standard packinghouse procedures both domestically and internationally.

Likelihood and Consequences of Establishment

Several commenters stated that citrus-producing areas are particularly at risk for establishment of quarantine pests that could follow the pathway.

Incorporating information regarding likelihood of establishment would not have affected the pest risk ratings or the risk mitigation structure. As we explained above, both medium and high-risk pests are subject to pest-specific mitigations beyond standard port-of-entry inspection.

One commenter stated that the PRA does not acknowledge that backyard citrus in California is in proximity to ports of entry. Other commenters stated that the PRA does not recognize that most quarantine pest introductions first occur in urban areas, and are undetected. Three commenters stated that urban areas in Texas and California abut production areas and expressed concern that pests could become established in urban areas with backyard citrus and then spread into production areas.

As we noted above, incorporating this information into the PRA would not have affected either the pest risk ratings or the risk mitigation structure.

One commenter stated that Climate-Host interaction for Brevipalpus spp. should have been rated “high.” The commenter cited a 2012 reference in the Ninth Report of the International Committee of Taxonomy of Viruses 3 that said that citrus leprosis virus was transmitted to several other experimental hosts from other genera including Phaseolus vulgaris in support of this statement.

There is no mention in the report of whether the conditions under which transmission to P. vulgaris occurred could be reduplicated outside of laboratory conditions. The sentence the commenter is referring to is immediately preceded by a sentence referring to mechanically administering inoculum to induce symptoms in articles previously considered non-hosts. This, coupled with the use of “experimental” to describe inoculation of P. vulgaris, suggests the study was not intended to reduplicate actual “field” conditions.

In the PRA, we identified the dispersal potential of B. chilensis as “medium” and of Brevipalpus spp. as “high.” One commenter stated that the dispersal potential for both B. chilensis and Brevipalpus spp. should be high.

The commenter is correct that the dispersal potential for both B. chilensis and Brevipalpus spp. should be the same; however, we disagree that the rating for both should be high. Based on the work of Childers and Rodrigues, the dispersal potential for both should be medium. Both B. chilensis and Brevipalpus spp. are very unlikely to move from one orchard tree to another. They both tend to aggregate, they move downwind slowly, and they do not balloon—that is, they do not produce streamers of silk and travel with wind currents for longer distances.

One commenter stated that the environmental impact potential for Brevipalpus spp. is low, but the introduction of this pest infected with citrus leprosis virus would stimulate the use of chemical control. The commenter stated that the risk rating should therefore be changed to medium. The same commenter also stated that consequences of introduction for Brevipalpus spp. should have been considered high.

We consider the ratings given to Brevipalpus spp. to be accurate. Under standard commercial packinghouse procedures, the mites would be washed or brushed off, even in the absence of required mitigations. Furthermore, citrus leprosis virus is not a systemic infection, and mites do not feed on harvested fruit unless doing so is absolutely necessary for survival.

Accordingly, for a non-viruliferous Brevipalpus mite in the United States to become a vector of citrus leprosis virus, the infected portions of the fruit would have to have abnormally high levels of inoculum, the mite would have to be on infested fruit, and the mite would have to specifically consume the infected portions of the fruit, climb up a tree, and infect the tree.

Since citrus leprosis virus inoculum is not shed to offspring, this would also have to occur during the infected mite's lifetime. We consider the probability of this occurring to be extremely remote.

One commenter stated that the likelihood of introduction for Medfly should have considered lemons a conditional host, rather than a conditional non-host.

The designation of lemons as a conditional non-host of Medfly was based on research published by ARS scientists 4 that examined the host status of immature lemons.

One commenter stated that the PRA did not consider introduction via smuggling or diversion. The commenter expressed concern that the fruit could be carried to a home while vectoring a pest or disease.

The PRA addressed the plant pest risk associated with the importation of commercially produced and commercially packed fresh lemon fruit from northwest Argentina into the United States. Fruit that is not commercially grown or packed are outside the scope of the risk assessment.

One commenter stated that the RMD requirements are inadequate to eliminate the risk of introduction of the quarantine pests identified in the PRA, but did not provide the basis for their concern.

Some commenters stated that the RMD and rule contain safeguards to address plant pest risk, and one commenter stated that similar systems approaches for citrus from other countries have proven effective. One commenter, however, stated that there are no similar systems approaches because no other growing area harbors this combination of pests and diseases of citrus, but is still asking to market fresh fruit.

APHIS notes that the PRA for citrus from Uruguay had a very similar quarantine pest list—they did not have B. chilensis or Brevipalpus spp., but had all other quarantine pests identified in the Argentine citrus PRA. Accordingly, many provisions of the Argentine lemons systems approach were modeled on the Uruguay citrus systems approach, which has been in place for 31/2 years now without incident. Furthermore, the Brevipalpus-specific provisions are not new, and have been tested for several different commodities in other countries.

Five commenters expressed concern that Argentina cannot be trusted to abide by mitigations in the RMD and rule. Some of these commenters cited incidents that they believed showed Argentina handling sanitary or phytosanitary issues in deceptive ways. One commenter stated that, as a result of the history of SENASA, APHIS needs to exercise continual monitoring and oversight over the program.

Argentina is a World Trade Organization member country and signatory on the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS agreement). As such, it has agreed to respect the phytosanitary measures the United States imposes on the importation of plants and plant products from Argentina when the United States demonstrates the need to impose these measures in order to protect plant health within the United States. The PRA that accompanied the proposed rule provided evidence of such a need. Argentina has demonstrated the ability to comply with U.S. regulations with respect to other export programs.

We disagree with several of the examples cited as recent prevarication by SENASA. APHIS became aware of the presence of A. fraterculus in blueberries in Argentina because of a scientific paper published by Argentina. The disagreement between APHIS and SENASA regarding the presence of B. chilensis in Argentina was based on differing opinions regarding whether the pest detected had been identified properly. As such, it indicated a difference of scientific opinion, rather than an act of deception.

That said, the 2015 site visit specifically evaluated SENASA's oversight of the Argentine production system for lemons to determine whether the provisions of the systems approach could be implemented and maintained.

Finally, as provided in paragraph (a) of the proposed rule, APHIS would be directly involved in monitoring and auditing implementation of the systems approach in Argentina. A determination that the systems approach had not been fully implemented or maintained would result in remedial actions, including possible suspension of the export program for Argentine lemons.

One commenter expressed concern that the United States Department of Agriculture (USDA) cannot be trusted to abide by mitigations in the RMD and rule. The commenter referred to a scandal at Hunts Point Terminal Produce Market in the Bronx, NY, as an example of USDA personnel accepting bribes and kickbacks. The commenter stated that even if such events are not commonplace, they still must be factored into the risk assessment.

The bribery and kickback scheme referenced by the commenter was revealed in 1999 after a 3-year investigation by the USDA Inspector General and involved Agriculture Marketing Service personnel, who have no role in the implementation of this rule.

One commenter asked why, if the mitigations in the RMD are effective, the PRA discusses likelihood and consequences of introduction.

The PRA follows our guidelines for PRAs. As such, it discusses the likelihood and consequences of quarantine pests that could follow the pathway on lemons from northwest Argentina to the United States, in the absence of any mitigations. This assessment is a necessary aspect of our evaluation of the risk rating for the pests.

The RMD lists the mitigations that will be applied to prevent pests from following the pathway and being introduced.

Three commenters stated that European Union (EU) detections of CBS on fruit from Argentina indicate the inability of Argentina to follow a systems approach.

We disagree with the EU regarding the transmissibility of CBS via commercially produced fruit. The point of these statements in the PRA and RMD was to point out that Argentina has been able to implement and abide by a systems approach for lemons that rests on SENASA having the wherewithal to meet phytosanitary requirements. We note that the RMD stated that Argentina proposed the EU systems approach to us in its entirety as a mitigation structure, and that we rejected adopting it outright. Furthermore, the systems approach for Argentine citrus to the EU is the same systems approach applicable to U.S. citrus to the EU, indicating they consider us equivalent in terms of ability to adhere to phytosanitary requirements.

It is also worth noting that the EU audit 5 attributed the detections to a lack of traceability of individual lots of fruit to the production units in places of production, to some packinghouses commingling lemons destined for export with other fruit, and to some producers not applying pest controls for CBS. These mitigations, which were added to the EU directive following the detections, are all aspects of our systems approach. Our systems approach is, in short, more stringent than the EU directive was prior to the CBS detections.

One commenter stated that there is no evidence the EU systems approach for lemons from Argentina is equivalent to the systems approach proposed by APHIS.

The two systems approaches are not equivalent, and we did not suggest they were. Rather, we made reference to the EU systems approach to illustrate that Argentina has the capacity to adhere to a stringent systems approach, so that it is plausible that they could adhere to our systems approach as well. We state in the RMD that Argentina proposed that we simply adopt the EU systems approach, and we rejected that proposal.

One commenter stated that, because of proximity of ports of entry to urban areas, and urban areas to citrus production in the United States, any lapses from systems approach will have dire consequences.

The commenter seems to be assuming that, if infested or infected fruit is shipped to the United States, it will not be detected at a port of entry inspection, and will necessarily result in the introduction of quarantine pests into the United States. This assumption is, in essence, that port of entry inspections are ineffective at detecting plant pests. We disagree with this assumption; port of entry inspections are an effective mitigation and have precluded two potential introductions of Medfly in the last year alone.

One commenter stated that there is no definition or list of criteria for pests of “quarantine significance” in either the PRA or RMD. The commenter asked what the criteria are for determining what pests are of quarantine significance.

The PRA, RMD, and rule use the terms “quarantine significance” and “quarantine pest” interchangeably. In § 319.56-2 of the regulations, we define a quarantine pest as “[a] pest of potential economic significance to the area endangered by it and not yet present there, or present but not widely distributed there and being officially controlled.”

One commenter noted that the RMD says 9 pests of quarantine significance were identified, but the PRA lists 10. The commenter asked for an explanation of this apparent discrepancy.

The PRA acknowledges that CBS could follow the pathway, and is a quarantine pest, but then cites the 2010 PRA, which determined that, even in the absence of packinghouse procedures, fruit is an “epidemiologically insignificant” pathway for CBS, and the conditions that would allow for transmission from fruit are nearly impossible to occur, even in the absence of standard packinghouse procedures. The RMD looked at commercially produced fruit, that is, fruit subject to packinghouse procedures and standard industry practices. This led us to drop CBS from the list of quarantine pests.

One commenter noted that in section 1 of the RMD, guidelines for growers participating in the program are mentioned as needing to be followed. The commenter asked what these guidelines are.

In the RMD, we explain that these are pest control guidelines that a place of production may need to meet in order to qualify for registration with SENASA.

One commenter asked if the operational workplan will contain only SENASA's requirements.

Generally, the operational workplan pertains to APHIS, the NPPO of the exporting region, and growers, packinghouses, and persons commercially involved in chain of production. It contains details that are necessary for day-to-day operations needed to carry out provisions of the rule and RMD. This one will be no different.

One commenter asked what SENASA's requirements are under the operational workplan.

SENASA's requirements include everything specified within the RMD: Registration; regular inspections; pest control guidelines; and inspections to determine that treatment guidelines are being adhered to.

Additionally, Argentina has place of production requirements apart from APHIS' requirements that pertain to all citrus groves in the country. These include sanitary guidelines that are developed in consultation with Argentine subject matter experts and address regulated nonquarantine pest populations that could affect marketability of the citrus.

One commenter noted that the RMD specifies that SENASA must ensure that growers are following the “export protocols.” The commenter asked what those protocols are, and stated that they should be made available for public review and comment.

The protocols are conditions for export established by APHIS in the operational workplan. The RMD and the regulatory requirements derived from it include a general description of all the phytosanitary measures necessary to mitigate pest risk. The operational workplan specifies details that are necessary for day-to-day operations needed to carry out provisions of the rule and RMD. Operational workplans are available to the public upon request only after a rule has been finalized and the operational workplan has been signed by APHIS and the NPPO of the exporting country. With respect to consulting with stakeholders, APHIS typically conducts outreach and consultation during the risk assessment and management phases.

One commenter stated that section 16 of the RMD should specify that fruit fly detections must fall below a threshold before a registered place of production can resume shipping.

Immature lemons are a poor host of Medfly. Because of this, prevalence levels at a place of production are not germane to whether Medfly are more likely to follow the pathway on immature Argentine lemons, and it would be incommensurate with risk to cut off a place of production based on Medfly detections.

This policy is consistent with our existing importation requirements for lemons from other countries that have Medfly. We have no reason to believe these existing requirements have been ineffective.

One commenter stated that places of production should be suspended if B. chilensis is found on the lemons during NPPO inspections.

In the RMD, we said place of production “may be suspended” and are “subject to suspension” out of recognition that the investigation could determine that the fruit was clean when it left the orchard, and the pest was introduced later in the production chain.

Two commenters noted that the rule doesn't contain mitigations for CVC and its vectors. The commenters expressed concern that potential vectors could transmit CVC if they were allowed to hitchhike on exports.

Glassy-winged sharpshooters are the vector of concern for CVC. They are the subject of consistent surveys and are not in northwest Argentina. Were they to spread into northwest Argentina, the sharpshooters would be removed by washing and brushing and standard packinghouse procedures. Additionally, as external feeders, they are easy to detect during phytosanitary inspections and/or port of entry inspections. Finally, CVC cannot follow the pathway of lemons in the absence of a vector.

One commenter noted that the RMD concludes that seeds are unable to transmit CVC directly. The commenter stated that this directly contradicts the regulations in 7 CFR 319.37-2, which consider CVC to be seed-transmitted.

A Federal Order published on May 19, 2016, relieved restrictions on citrus seed for CVC. The Federal Order is available on the APHIS Web site at https://www.aphis.usda.gov/import_export/plants/plant_imports/federal_order/downloads/2016/2016-31.pdf. A rule codifying this Federal Order is in development. The citrus seed pest list prepared in November 2015 is referenced in this Federal Order. The pest list contains our current thinking about the transmissibility of CVC and other citrus diseases via seed.

Four commenters expressed concern that the rule does not contain mitigations for HLB.

APHIS has examined whether fruit is a pathway for HLB, and determined that HLB is not transmitted via fruit. Therefore, mitigations for HLB are not necessary.

One commenter stated that APHIS should not trust SENASA on the scope of the HLB outbreak in Argentina.

Neither the severity of the HLB outbreak in Argentina, nor its distribution, affect whether HLB-specific mitigations need to be included in the rule. As we explained above, HLB is not transmitted via fruit.

The same commenter stated that APHIS should not trust SENASA on distribution of Asian citrus psyllid (ACP), a vector of HLB, in Argentina.

The distribution of ACP in Argentina is not necessary for us to evaluate the risk of it following the pathway via the importation of lemons. As documented in the PRA, standard packinghouse procedures will remove ACP from the fruit. Only commercially produced fruit, which is subject to such procedures and will therefore be free of ACP, can be exported to the United States.

One commenter stated that the PRA should include information about distribution of HLB in Argentina.

APHIS does not consider this information to be necessary, given that HLB is not transmitted via fruit.

One commenter expressed several concerns about CBS. The commenter stated that CBS is impossible to eradicate once introduced, that it can have a lengthy latency period, and that trees infected with CBS are unmarketable.

APHIS notes that we never questioned the quarantine significance of CBS, just its ability to become established via fruit.

One commenter stated that justifications in the PRA for why CBS will not follow the pathway are not accurate. The commenter stated that the PRA assumes farmers in Argentina all farm in the same intensive manner.

The commenter is mistaken. In the systems approach for Argentina lemons, we have incorporated the same mitigations for CBS for that we are using for Florida citrus. These mitigations are based on a separate scientific review, which can be viewed on the APHIS Web site at https://www.aphis.usda.gov/plant_health/plant_pest_info/citrus/downloads/black_spot/cbs-risk-assessment.pdf.

Several commenters stated that APHIS erred in determining that CBS cannot follow the pathway on fruit. Another commenter expressed concern that CBS could become established in Southern California if infected fruit arrived at and were distributed through the Port of Long Beach.

Both Paul et al.6 and Magarey and Holtz 7 ran infection models which found California's climate, including that of Southern California, unsuitable for establishment of CBS. While isolated microclimates in Southern California could result in small pockets of CBS infection, the overall climatic conditions are unsuitable to establishment and spread.

One commenter stated that APHIS did not take into account either the reality of the residential yards in Southern California, or the numerous interceptions of Argentine citrus for CBS symptoms in shipments to the EU in the years since 2010.

These two facts do not affect the conclusion on the 2010 PRA that the establishment of the disease via the movement of fruit requires a combination of biological and climatic conditions that are unlikely to occur.

One commenter stated that the spread of CBS in Florida could be indicative of errors in the 2010 PRA.

The PRA found Florida's environment to be conducive to the spread of CBS, and examined only transmission via fruit. The spread of CBS within Florida could have occurred through a pathway other than fruit, and is not in itself indicative of errors in the 2010 PRA.

One commenter stated that the EU Food Safety Commission in 2014 issued a scientific opinion which deemed the risk of entry of the causal agent of CBS as moderately likely for citrus fruit without leaves.

APHIS notes that the proposed conditions for importation of lemons from northwest Argentina are the same as the conditions we apply to export citrus from the United States. We also note that the causal organism of CBS has two life cycle stages: A sexual stage represented by the ascospores of Guignardia citricarpa Kiely and an asexual stage represented by the pycnidiospores of P. citricarpa (McAlpine). These two stages are produced at different times, under different environmental conditions, at different locations on the plant and result in different epidemiological dynamics. The sexual stage of the disease may be found in plants and leaves; the asexual stage of the disease is found on fruit. The correlation between ascospore discharge and infection onset showed that pycnidiospores, the asexual stage, do not play a significant role in the disease cycle. For this reason fruit is not considered to be a pathway for CBS.

Several commenters asked how, if we do not know how CBS got into Florida, we know it cannot follow the pathway on fruit.

The PRA examined the biological and climatic conditions necessary for establishment of CBS through infected fruit, and determined that “the establishment of the disease via this pathway [the movement of fruit] requires a combination of biological and climatic conditions that are unlikely to occur.” It is important to acknowledge, as the EU scientific opinion did, that there are many possible pathways for the introduction of CBS, with some (such as smuggling of nursery stock) significantly more likely to result in establishment.

One commenter asked what circumstances would compel APHIS to require further mitigations for CBS in Argentina's packinghouses, and what mitigation steps it would be willing to institute in those circumstances.

We have considered the risk of CBS and how to mitigate it. Standard packinghouse procedures, including washing, brushing, disinfecting, treating, and waxing, address that risk effectively. Under the circumstances, we do not believe further mitigations are needed.

One commenter stated that the rule should restrict exports to areas of northwest Argentina that are free of CBS.

For the reasons discussed above, we do not consider this necessary.

One commenter asked why the Provinces of Catamarca and Jujuy were included in the rule when they are not major lemon-producing regions.

As we explained in the proposed rule, SENASA asked for market access for these provinces. We therefore included them in the PRA and found that lemons could be safely exported from these provinces subject to the conditions described in the proposed rule.

One commenter stated that Brevipalpus spp. should not be listed as quarantine pests, but that citrus leprosis virus should be listed as a quarantine pest.

Citrus leprosis virus is not systemic. It could not be introduced into the United States, unless vectored by Brevipalpus spp. mites. For this reason we consider the mites to be quarantine pests.

One commenter stated that the details of the operational workplan need to be included in the regulations or otherwise made publicly available.

As we explained above, the mitigations in the operational workplan are the same as in the RMD and the rule. The operational workplan specifies details for day-to-day operations that are needed to carry out provisions of the rule and the RMD. As a result, operational workplans are living documents that change periodically to reflect new technologies and operational realities in the field.

One commenter asked what constitutes “direct involvement” in implementation and monitoring of the operational workplan.

The operational workplan provides APHIS with the standard operating procedures that the NPPO, places of production, packinghouses, and others involved in the production of the fruit will follow as part of the export program. Our oversight will include routine reviews and inspections of the program, but not continual oversight. That would be tantamount to mandatory preclearance program, which we do not consider necessary. The frequency with which we conduct site visits and review export program records will increase if any pest concerns are identified.

One commenter stated that a trust fund agreement to pay for APHIS personnel may be necessary.

A trust fund agreement is associated with preclearance programs in which there is continual APHIS oversight, which we do not consider warranted here.

One commenter stated that registration requirements should extend to contiguous orchards to mitigate the chance of contamination of the place of production during harvest after the initial freedom certification.

APHIS does not consider this to be necessary. As discussed above, the Brevipalpus spp. mites that exist in Argentina do not balloon—that is they do not produce streamers of silk and travel with wind currents for longer distances—and have limited mobility. It is unlikely that they could infest contiguous orchards after the initial freedom certification.

One commenter stated that registering small places of production may increase pest risk.

We disagree that small places of production may represent a higher pest risk than large ones. In order to be registered with the NPPO and participate in the export program, the NPPO (and, as warranted, APHIS) must determine that the place of production or packinghouse is able to adhere to the systems approach. This is true regardless of the size of the place of production or packinghouse. Routine inspections by the NPPO, and the possibility of monitoring by APHIS, will corroborate ongoing maintenance of systems approach provisions at registered places of production and packinghouses.

We proposed to require lemons from Argentina to be harvested green and within the time period of April 1 and August 31. If the lemons are harvested yellow or harvested outside of that time period, they would have to be treated for Medfly in accordance with 7 CFR part 305 and the operational workplan. Two commenters asked how we would determine whether a lemon was green or not.

In the ARS study that determined that lemons are a conditional non-host of Medfly, the term “yellow” was used interchangeably with “mature.” Immature lemons were considered to be a poor host. For purposes of the systems approach, we consider any lemon that is not green as ripe enough to require cold treatment. We are using additional ARS research 8 and a market standard on lemon color to determine if lemons are green.

Two commenters asked who will determine whether a lemon is green or yellow. One commenter asked where this determination will be made. That commenter also stated that APHIS employees should make the determination.

In Argentina, lemons are evaluated for color and graded as part of packinghouse procedures. The determination for color and grade is made by graders employed by SENASA.

One commenter stated that the finding that green fruit is harvested from March to May in Argentina appears to be based on 2007 information, which is outdated.

When green fruit is harvested in Argentina is irrelevant to the conclusions of the PRA. As we explained in the proposed rule, lemons that are harvested yellow would have to be treated for Medfly, regardless of the time of year in which they are harvested.

One commenter stated that the RMD and rule should be consistent with regard to when lemons do not need treatment.

The commenter seems to believe that there is a discrepancy between the RMD and the proposed rule because the requirement is phrased slightly differently, but this is not the case. Both the proposed rule and the RMD specify that a lemon must be green and shipped within the April-August window in order to avoid treatment.

One commenter expressed concern that the use of the term “safeguarded” in § 319.56-76(a)(8) is too vague. The commenter stated that the words “and protected from fruit fly infestation” should be inserted after the word “safeguarded” in that paragraph.

APHIS disagrees that this addition is necessary. We use the term “safeguarded” throughout the regulations to mean that fruit must be protected from infestation, or, in the case of treated fruit, reinfestation, by quarantine pests.

One commenter asked whether trucks and workers would be sanitized in between uses for U.S. exports and other uses, and if not, why not.

Packinghouse workers are required to wash their hands and wear clean protective clothing every time they enter the packinghouse. The fruit never touches the trucks; it is harvested and brought to the packinghouse in bins that are disinfected after each use. Fruit for export is shipped in clean new boxes. Old shipping boxes are never reused.

Several commenters asked how APHIS will determine pest-free places of production for B. chilensis, given that Argentine production for fresh consumption and processing is intermixed.

While B. chilensis exists in Argentina, there is no evidence that it exists in northwest Argentina. This is based on extensive and ongoing documentation SENASA has provided to APHIS. Due to the absence of B. chilensis in northwest Argentina, the intermixing of fresh and processed production sites in that area does not have a bearing on whether a site is pest-free for B. chilensis.

It is worth noting that we have no evidence that Argentine producers designate specific sites for fresh or processed production and use different production practices based on the intended use of the lemons. Rather, as a result of grading during packinghouse inspections, highly graded lots are designated for the fresh market, while the rest of the fruit goes to processing and other uses.

That being said, the rule specifies that APHIS will monitor implementation of the systems approach. This includes monitoring the distribution of B. chilensis in Argentina. If the distribution changes, we note that there are still several safeguards that would address the commenter's concern. First, the place of production must be inspected regularly by the NPPO of Argentina; these inspections would include inspections for B. chilensis. Second, the place of production must adhere to any pest control or management practices specified by APHIS and/or SENASA. An orchard that was in an area in which B. chilensis is known to occur, and in proximity to an orchard not participating in the export program, would be subject to management practices to address this risk. Finally, registration of places of production allows for traceback and quick remediation if infested fruit is discovered later in the production chain.

One commenter stated that APHIS should ask SENASA to prepare a grid-type schematic that shows the location of processed orchards as compared with orchards where fruit is grown for the fresh export market. The commenter stated that this analysis is essential, and that if SENASA will not prepare it, then APHIS should prepare it.

The grid suggested by the commenter is not possible. Orchards in Argentina are not designated for a particular type of production. Rather, as we explained above, lots are designated based on grading conducted in packinghouses.

Two commenters stated that the biometric sampling protocol for B. chilensis is insufficient.

APHIS disagrees. Mites have limited mobility. The commenters are referring to the fact that some species of mites are known to travel longer distances by ballooning, where the mites produce streamers of silk and travel with wind currents for longer distances. According to Childers and Rodrigues (2011), Brevipalpus mites do not produce silk and therefore are not capable of ballooning. Childers and Rodrigues indicate there is some evidence that these mites can blow from heavily infested plants downwind to nearby plants. They do not present evidence of long distance movement of Brevipalpus mites by the wind.

B. chilensis mites in Argentina are associated with the wine grape industry in the state of Mendoza (approximately 1,000 miles south of the region where lemons are produced). They are not present in Tucumán where most of the export lemons in Argentina are grown, nor, again, is there any evidence of their presence in the whole northwestern region.

The systems approach for B. chilensis is based on the pest's limited mobility. This systems approach has similarly been used in Chile for citrus for many years without interceptions of this mite in commercial shipments. In addition to the place of production inspection, every shipment of lemons to be exported will also be inspected for mites with the same wash technique. If mites are found on any shipment, that place of production will be removed for the rest of the export season.

One commenter stated that APHIS only described the B. chilensis protocol, without providing evidence of its adequacy. The commenter further stated that the lack of interceptions of the mite on fruit that has entered the United States from Chile is not sufficient evidence for the effectiveness of the protocol. Another commenter stated that there is no literature of evidence that suggests the protocol is effective.

APHIS disagrees. Mites and other small organisms have been studied by collecting them from their habitat through sieves that concentrate them. Southwood and Henderson in their classic textbook Ecological Methods 9 devote chapters to this method of sampling.

This method of sampling has been used since the 18th century; use of Berlese funnels and sieves is ubiquitous in sampling mites and other small organisms in various habitats. The agricultural quarantine and inspection data that APHIS collects routinely suggests that this method, which has been used for almost 20 years by APHIS as a mitigation measure, has been very effective in detecting B. chilensis mites on fruit from Chile.

One commenter stated that it is impossible to know whether 100 samples is sufficient without knowing the size of places of production.

Regardless of the size of the orchard, 100 samples provides 95 percent confidence of a 3 percent infestation rate. This confidence level is sufficient given that B. chilensis is not known to exist within 1,000 miles of northwest Argentina and, biologically, tends to aggregate once established. APHIS believes that the overlapping protections of routine visual inspections, NPPO surveying for B. chilensis spread, and the biometric protocol provide a sufficient degree of phytosanitary protection.

One commenter stated that the B. chilensis biometric sampling protocol is not based on the biology of B. chilensis. The commenter stated that other species of Brevipalpus are known to have particular habitat preferences within a tree, such as the most shaded, humid areas (Childers & Rodrigues 2011). The commenter stated that if something like this is the case for B. chilensis, then a targeted survey, rather than biometric survey of the place of production, is needed to determine prevalence.

APHIS disagrees. Mites, including B. chilensis, reproduce and build up populations in a small area because of their limited dispersal capability. The sampling distribution is based on the premise that if one mite is found, there is a high probability that another mite is nearby. This is called an aggregated distribution. This probability distribution (or variation), is called hypergeometric, or negative binomial, and can be used to model the distribution of most insects and mites.

Very few insects and mites do not have aggregated distributions, and there is no evidence that B. chilensis does not have aggregated distributions. The production site survey is a targeted survey; the samples are taken from the leaves which is where the mite populations are highest. We note, moreover, that this survey is presently strictly precautionary. There is no evidence of B. chilensis in northwest Argentina.

Two commenters stated that biometric sampling may miss immature B. chilensis mites.

The mite exists in populations that contain eggs, immature stages, and adults. Only the adults can be identified reliably through microscopic examination of the filtrate from the sieve. The sieve will collect adult mites. The likelihood of only eggs or nymphs being present is very low, so APHIS can use the sieve sampling method to reliably detect populations of mites at production sites. APHIS will be requiring a number of samples and the probability that only eggs and larvae of the target mite would be present in all of the samples is very low. Moreover, if one sample detects adult B. chilensis mites, the production site will not be certified B. chilensis free.

One commenter asked how APHIS determined the efficacy of Chilean citrus protocol.

As we state in the RMD, our determination was based on the absence of detections of infested fruit in the export pathway over almost 20 years.

One commenter questioned whether it is appropriate to compare the citrus-growing area that exists in Chile to the growing areas in Northwest Argentina for purposes of dealing with Brevipalpus spp. mites. The commenter noted that the growing area in Argentina is much larger than the growing area in Chile, and stated that the growing area in Argentina has high rainfall and high humidity, while the growing area in Chile typically has low rainfall and low humidity. The commenter stated that the difference in climate makes the growing area in Argentina hospitable to certain pathogens, but did not specify which ones.

The commenter is mistaken about the climate in northwest Argentina. The scientists at the Obispo Columbres Agroindustrial Station, SENASA, and the lemon growers in Tucumán told us that northwest Argentina does not have high rainfall. On the contrary, rainfall is low and the lemon groves are often irrigated. Therefore, the mite populations should face similar climates in the citrus growing portions of Chile and the lemon growing parts of northwest Argentina. During the September 2016 site visit, we asked the scientists at the Obispo Columbres Agroindustrial station about the mites. They said that they had found two of the three Brevipalpus mite species (not B. chilensis) in the lemon production areas in northwest Argentina, but that they were not common. Further, the hot dry conditions favor mites more than rainy humid conditions. The mitigations for Brevipalpus mites should not be affected by any climate differences, which appear to be minimal.

One commenter stated that the protocol for citrus from Chile includes species of citrus that may be less hospitable to B. chilensis.

APHIS notes that the protocol for mites from Chile also includes fruit that are better hosts than lemons. The sampling method for determining low prevalence works regardless of mite populations on the host fruit.

Two commenters stated that surveying for B. chilensis around production sites is necessary because if there are high populations in the vicinity, or if wind is a strong factor in dispersal, mites are likely to be constantly moving into the orchard.

As noted above, B. chilensis are a generalist pest, and tend to aggregate. The likelihood of B. chilensis in a neighboring orchard, without spillover into the registered production site, is low. Accordingly, if mites are in the vicinity, they should be detected through routine place of production inspections and the biometric sampling protocol.

One commenter stated that the B. chilensis-specific protocol should be extended to all Brevipalpus spp. mites.

Currently Argentina is sampling for B. chilensis and the three Brevipalpus spp. mites that are potential vectors for citrus leprosis virus. We are only requiring pest free place of production for B. chilensis, because B. chilensis is itself a quarantine pest. We are requiring consignment freedom (by inspection of harvested fruit) for all of the mites. Brevipalpus species other than B. chilensis are only considered quarantine pests if they are carrying the citrus leprosis virus. The probability of movement of the citrus leprosis pathogen from an infected tree in Argentina to a suitable host in the United States via a Brevipalpus mite traveling on a lemon fruit is extremely low, and require several additional steps to acquire and spread the pathogen so we are not requiring production site freedom.

One commenter stated that the B. chilensis protocol should be extended to surrounding areas of production.

As we explained above, B. chilensis is not found within 1,000 miles of northwest Argentina, has low powers of mobility, and tends to aggregate. If it is not found in a registered place of production during routine surveys conducted by the NPPO to evaluate pest spread, as well as routine harvest inspections and two separate biometric samples associated with the systems approach, we are confident that it will not be on fruit for export.

One commenter stated that production sites should be inspected for B. chilensis throughout the harvest season.

If mites were found in a consignment at a packinghouse, the originating production site would lose its free status. For this reason it is not necessary to inspect production sites throughout the harvest season.

One commenter stated that the B. chilensis protocol should include surveying for citrus leprosis virus.

Symptoms of citrus leprosis virus are easy to detect, and fruit with such symptoms will be detected during standard packinghouse culling and phytosanitary inspections.

One commenter stated that fallen fruit should be cut and inspected for Medfly.

This effectively calls for place of production freedom for Medfly. APHIS notes that in the RMD, fallen fruit are specifically forbidden from being included in harvested fruit going to the packinghouse for fresh market. For this reason, we do not consider it necessary to sample fallen fruit for fruit flies or any other pest.

One commenter stated that trapping requirements for Medfly need to be delineated in the rule itself.

Historically, we have put trapping requirements in operational workplans, rather than rules, to allow flexibility in trapping protocols in order to respond to variations in population densities from season to season, as well as the development of new lure and bait technologies.

One commenter stated that trapping should be at least 50 percent with trimedlure and the other 50 percent should be baited with either 3-component or protein bait.

APHIS notes that both the 3-component bait and the protein bait are far less powerful lures for fruit flies than trimedlure, a pheromone. The trimedlure will draw flies in from farther away and is a more sensitive detection system. Trimedlure will also attract males and unmated females, which will make up a significant portion of any fruit fly population. The only thing that the protein or 3-component baits will attract is mated females, and if they are present then males and unmated females should also be present and will have already been detected by the more powerful trimedlure.

One commenter asked for greater detail about the requirements for packinghouses. The commenter specifically asked whether an entire facility would be included as a packinghouse, how many facilities would pack lemons for the U.S. market and what volume could a dedicated packinghouse expect to process.

A packinghouse has to be an entire facility. APHIS is aware of a few packinghouses that would serve as primary packinghouses; however, all packinghouses would be registered with the NPPO. Both the NPPO and APHIS will monitor packinghouses during routine inspections.

One commenter asked how large a consignment of lemons could be, and if there will be a limit on the size of consignments.

Consignments can vary in size. However, regardless of the size of the consignment, the sampling protocol is aimed at detecting a 3 percent infestation rate with at least 95 percent confidence.

One commenter asked how a biometric sample was defined.

The term `biometric sampling' simply means that the sample size that is smaller than a straight 2 percent sample can be used to detect pests on large consignments of the commodity. Taking a biometric sample is more efficient than taking a straight percentage sample.

One commenter stated that the number of samples inspected should be 600. The commenter stated that this is consistent with what other countries require from U.S. growers.

APHIS disagrees that the number of samples inspected should be 600. One hundred samples is consistent with the Chilean protocol, which has been effective at precluding infested fruit from being shipped. Inspecting an additional 500 fruit per sample does not substantially impact the probability of finding an infestation, and would be significantly more resource-intensive.

One commenter asked if the same method will be used to inspect for B. chilensis as is used for the production site protocol.

Yes, the same method will be used for both production sites and packinghouses.

One commenter asked about the efficacy data for post-harvest inspections.

Post-harvest inspections by the NPPO of an exporting country are a long-standing phytosanitary measure that APHIS employs as part of market access requirements. The safe importation of thousands of foreign commodities into the United States over a prolonged period of time is an indication of its efficacy as a phytosanitary measure.

One commenter stated that fruit that is infested with Medfly larvae should be prohibited from being shipped.

APHIS disagrees. In the event that a single immature Medfly is found in or with the lemons, then the lemons must be treated in accordance with part 305 of the regulations and the operational workplan using a cold treatment. This cold treatment has been shown to be effective at mitigating the risk of Medfly in lemons. Additionally, the registered place of production that produced the lemons in the consignment may be suspended from the export program, pending an investigation.

One commenter stated that remedial actions should be identical, regardless of quarantine pest detected.

The remedial action when quarantine pests are detected is that the fruit cannot be exported. Some findings of quarantine pests also disqualify production sites because the mitigation requires the production site to be a pest-free place of production.

One commenter noted that the rule referred to CBP inspectors, but the supporting documents refer to APHIS inspectors. The commenter asked for clarification as to who will conduct port of entry inspections.

CBP conducts inspections at ports of entries pursuant to authority delegated to APHIS. The use of CBP employees to carry out functions specifically delegated to APHIS is authorized by the Homeland Security Act of 2002. Because CBP is effectively acting as agents of APHIS for the purposes of these inspections, we use the term “APHIS.” These inspections sample imported commodities for evidence of pests. If pests are detected, APHIS identifiers will be used to positively identify the pests.

One commenter asked whether port of entry inspections would include biometric sampling for Brevipalpus mites. The commenter also asked how CBP would be able to detect the mites.

The B. chilensis protocol is used to establish place of production freedom, and is also used as part of the phytosanitary inspection by the NPPO. Port of entry inspection for B. chilensis and other Brevipalpus mites will look for the pests, as well as signs and symptoms of infestation, such as bronzing.

One commenter asked why, if information from port of entry inspections is “unreliable,” they can be stated to be effective.

“Not be detected at the port of entry” was removed as a criterion in the PRA because we do not have enough information about relative likelihood of detection at the port of entry to be able to weight this criterion relative to other elements. As a result, this criterion could not substantially impact the risk ratings. This does not imply that port of entry inspections are an ineffective component of a systems approach.

One commenter stated that the rule should specify how APHIS will monitor and enforce the systems approach. The commenter expressed concern that APHIS would have to commit substantial resources to ensure compliance with the operational workplan.

This request is predicated on the stated assumptions that SENASA lacks the ability and intent to abide by systems approach requirements. For reasons discussed above, we disagree with those assumptions.

One commenter stated that APHIS should require cold treatment of lemons from northwest Argentina.

This approach would not impose the least restrictive science-based actions needed to address plant pest risk, and thus would be inconsistent with our obligations under the SPS agreement.

One commenter stated that the rule should prohibit the importation of lemons from northwest Argentina into Florida. The commenter also stated that the rule should limit importation of lemons to areas north of the 38th parallel.

We have determined, for the reasons described in the RMD that accompanied the proposed rule, that the measures specified in the RMD will effectively mitigate the risk associated with the importation of lemons from northwest Argentina. The commenter did not provide any evidence suggesting that the mitigations are not effective. Therefore, we are not taking the action requested by the commenter.

Two commenters expressed concern that Argentine producers may use pesticides or practices that are not authorized in the United States.

We note that the Food and Drug Administration (FDA) of the Department of Health and Human Services regulates the pesticide, herbicide, and fertilizer residues that may be present on imported fruits and vegetables intended for human consumption. If illegal pesticides are detected, FDA will take action to remove them from the marketplace. Additionally, we note that the packinghouse disinfectants and treatments for pathogens that we are proposing for Argentina are the same used domestically.

One commenter stated that importing lemons from Argentina will involve carbon dioxide emissions that should be available to the consumer as they purchase the lemons. The commenter stated that the lemons should be labeled with the pounds of carbon dioxide emitted per pound of lemons.

This request is outside the scope of APHIS' statutory authority.

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

This final rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with 5 U.S.C. 604, we have performed a final regulatory flexibility analysis, which is summarized below, regarding the economic effects of this rule on small entities. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

This analysis examines potential economic impacts of a rule that will allow the importation of fresh lemons from a region in Northwest Argentina into the continental United States. A systems approach to pest risk mitigation will provide phytosanitary protection against pests of quarantine concern. Both U.S. producers and consumers will be affected by the rule. While producers' welfare will be negatively affected, welfare gains for consumers will outweigh producer losses, resulting in a net benefit to the U.S. economy.

Commercial lemon production takes place in California and Arizona. For the 2014/15 season, lemon-bearing acres totaled 55,300 (California 47,000, Arizona 8,300). In the same season, the value of U.S. production of lemons was $694 million. Over the production seasons 2008/09 to 2014/15, U.S. fresh lemon production averaged 535,244 metric tons (MT) per year. Over the same period, annual imports averaged 49,995 MT and exports averaged 101,849 MT. Because lemons imported from Argentina that are harvested green between April 1 and August 31 will not require treatment for Medfly, we expect that most will be imported during this period, which coincides roughly with the months in which U.S. lemon exports are declining and imports are increasing.

Effects of the rule are estimated using a partial equilibrium model of the U.S. lemon sector. Annual imports of fresh lemon from Argentina are expected to range between 15,000 and 20,000 MT, with volumes averaging 18,000 MT. Quantity, price and welfare changes are estimated for these three import scenarios.

If the United States imports 18,000 MT of fresh lemon from Argentina and there is no displacement of lemon imports from other countries, we estimate that the price (custom import value) of fresh lemon will decrease by about 4 percent. Consumer welfare gains of $22.4 million will outweigh producer welfare losses of $19.9 million, resulting in a net welfare gain of $2.5 million. The 15,000 MT and 20,000 MT scenarios show similar effects.

More reasonably, partial import displacement will occur, and price and welfare effects will be proportional to the net increase in U.S. lemon imports. Assuming as an upper-bound that one-half of the quantity of fresh lemons imported from Argentina displaces U.S. fresh lemon imports from elsewhere, we estimate for the 18,000 MT scenario that the price decline will be about 2 percent; consumer welfare gains and producer welfare losses will be $11.1 million and $10.0 million, respectively, yielding a net welfare benefit of $1.1 million.

The majority of businesses that may be affected by the final rule are small entities, including lemon producers, packers, wholesalers, and related establishments.

This final rule allows lemons to be imported into the continental United States from Argentina. State and local laws and regulations regarding lemons imported under this rule will be preempted while the fruit is in foreign commerce. Fresh lemons are generally imported for immediate distribution and sale to the consuming public, and remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. No retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0448, have been submitted for approval to the Office of Management and Budget (OMB). When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

Accordingly, we are amending 7 CFR part 319 as follows:

The regulations regarding USDA OIG's processing of requests for information under the Freedom of Information Act (FOIA), 5 U.S.C. 552, were last published in 1995 (60 FR 52842). Since that time, OIG has had several internal reorganizations. As part of those reorganizations, OIG's FOIA program was transferred from OIG's defunct Office of Policy Development and Resources Management to OIG's Office of Counsel. In order to provide the public with current information regarding which OIG office processes FOIA requests, OIG is amending these regulations, which supplement USDA's FOIA regulations at subpart A of part 1 of this title, including the appendix.

This rule relates to agency organization and internal agency management. Pursuant to 5 U.S.C. 553(A), such rules are not subject to the requirement to provide public notice of proposed rulemaking and opportunity for public comment. Therefore, notice and comment before the effective date are being waived.

OIG has reviewed this rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Orders 12866 and 13563. OIG has determined that this rule is non-significant within the meaning of Executive Order 12866. Therefore, this rule is not required to be and has not been reviewed by the Office of Management and Budget (OMB).

These regulations will not have a significant economic impact on a substantial number of small entities. Therefore, a regulatory flexibility analysis as provided by the Regulatory Flexibility Act, as amended, is not required.

This rule relates to internal agency organization and management. Therefore, it is exempt from the provisions of Executive Order 12291.

These proposed regulations impose no additional reporting and recordkeeping requirements. Therefore, clearance by OMB is not required.

This rule does not have Federalism implications, as set forth in Executive Order 13132. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

OIG has determined that this rule is not a major rule as defined by the Congressional Review Act, 5 U.S.C. 804.

In 1991, the legacy Immigration and Naturalization Service (INS), then part of the Department of Justice (DOJ), published a final rule requiring the registration and fingerprinting of certain nonimmigrants bearing Iraqi and Kuwaiti travel documents, due to various factors, including concerns about misuse of Kuwaiti passports.1 In 1993, INS removed the regulations specific to such nonimmigrants, but added to the regulations at 8 CFR 264.1(f) a provision that allowed the Attorney General to require certain nonimmigrants of specific countries to be registered and fingerprinted upon arrival to the United States, pursuant to section 263(a) of the Immigration and Nationality Act (INA), 8 U.S.C. 1303(a).2 Pursuant to the amendment, the Attorney General could designate countries by Federal Register notice.3

In June 2002, after the September 11, 2001 terrorist attacks, INS proposed to expand the existing registration and fingerprinting program at 8 CFR 264.1(f) to require certain nonimmigrants to report to INS upon arrival, approximately 30 days after arrival, every 12 months after arrival, upon certain events such as a change of address, and at the time of departure from the United States.4 The proposed rule provided that the program would apply to nonimmigrants from countries that INS would designate in Federal Register notices and to individual nonimmigrants designated by either a U.S. consular officer or immigration officer at a U.S. port-of-entry as indicating a need for closer monitoring. Under the proposed rule, designated nonimmigrants would be required to be fingerprinted and photographed and to provide additional biographical information. The proposed rule also authorized INS to designate certain ports of departure for nonimmigrants subject to the program. In addition, INS proposed to amend 8 CFR 214.1 to require nonimmigrants selected for special registration to comply with 8 CFR 264.1(f) as a condition of maintaining nonimmigrant status.

The INS received 14 comments on the proposed rule, some in support of the proposed program and others opposed to it. In August 2002, INS finalized the proposed program, which became known as the National Security Entry-Exit Registration System (NSEERS), without substantial change.5 In September 2002, INS announced by Federal Register notice that the new program would be applied to those who were subject to the earlier registration program—nonimmigrants from Iraq, Iran, Libya, and Sudan—and added nonimmigrants from Syria.6 INS announced in November 2002 that only males 16 years of age and older from designated countries would be required to register under the program.7 Between November 2002 and January 2003, INS added another 20 countries to the compliance list, bringing the total to 25 countries.8 The responsibility for administering NSEERS was transferred to the Department of Homeland Security (DHS) in 2003 as part of the Homeland Security Act of 2002.9

In December 2003, DHS amended the NSEERS regulations by interim final rule to suspend the 30-day post-arrival and annual re-registration requirements.10 DHS determined that automatically requiring 30-day and annual re-registration for designated nonimmigrants was no longer necessary as DHS was implementing other systems to help ensure that all nonimmigrants remain in compliance with the terms of their visa and admission.11 The interim final rule provided that DHS would utilize a more tailored system in which, as a matter of discretion and on a case-by-case basis, the Department would notify nonimmigrants subject to the program to appear for re-registration interviews where DHS deemed it necessary to determine whether they were complying with the conditions of their status and admission. The interim final rule did not affect the procedures at ports-of-entry for nonimmigrants subject to the program.

In 2011, DHS published a notice in the Federal Register indicating that DHS would no longer register nonimmigrants under NSEERS and removing all countries from the NSEERS compliance list.12 DHS had added no new countries to the compliance list since 2003, and it had since implemented multiple new automated systems that capture information of nonimmigrant travelers to the United States and support individualized determinations of admissibility.13 Among the new programs and practices that had been implemented by that time were the United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT), which stores and manages the fingerprint scans and photographs required upon entry to the United States,14 and the Advance Passenger Information System (APIS), which requires that commercial vessels and commercial and private aircraft arriving in or departing the United States submit advance passenger and crew manifest information to U.S. Customs and Border Protection (CBP).15 In light of these and other improved programs and practices, as well as improved information sharing with foreign counterparts, DHS determined that the data captured by NSEERS, which DHS personnel entered manually, had become redundant and no longer provided any increase in security.16 Although the 2011 notice announced that DHS would no longer use the program for any countries, the notice did not remove the regulatory framework for NSEERS from the DHS regulations.

In 2012, the DHS Office of the Inspector General (OIG) issued a report on border security information sharing within DHS that, among other things, recommended DHS fully eliminate NSEERS by removing the regulatory structure for the program.17 The OIG report found that processing NSEERS registrations constituted a significant portion of CBP's workload at ports-of-entry while the program was in operation, and that the NSEERS database often did not function properly. The report noted that CBP officers believed NSEERS reporting to be of little utility and that the time spent processing registrations constituted an inefficient use of resources. The OIG report found that DHS's newer automated targeting systems enabled more sophisticated data analysis and intelligence-driven targeting than under NSEERS, as the newer targeting systems consolidate passenger data from various systems, can search across those systems for certain trends or patterns, and can be updated quickly without the need for public notification in the Federal Register. The OIG report also found US-VISIT to be the more logical system for capturing biometric information at ports-of-entry due to US-VISIT's superior functionality. The OIG report concluded that advancements in information technology had rendered NSEERS obsolete and that leaving the program in place did not provide any discernable public benefit.18 The OIG report thus recommended removing the regulatory structure of NSEERS from DHS regulations.

Although DHS retained the regulations that provide the NSEERS framework, subsequent experience has confirmed that NSEERS is obsolete, that deploying it would be inefficient and divert personnel and resources from alternative effective measures, and that the regulation authorizing NSEERS is unnecessary. Since the suspension of NSEERS in 2011, DHS has not found any need to revive or consider the use of the program. Indeed, during this period, DHS's other targeting, data collection, and data management systems have become even more sophisticated. DHS now engages in security and law enforcement efforts that were not possible when NSEERS was established in 2002, and the Department continues to make significant progress in its abilities to identify, screen, and vet all travelers arriving to the United States; to collect and analyze biometric and biographic data; to target high-risk travelers for additional examination; and to track nonimmigrants' entry, stay, and exit from the country.

The information that was previously captured through NSEERS is now generally captured from nonimmigrants through other, more comprehensive and efficient systems. Below we describe several of DHS's data collections, systems, and procedures relating to nonimmigrants and their relation to the NSEERS program.

• Biometric Information. At the time of NSEERS' implementation in 2002, most nonimmigrants were admitted to the United States without being either photographed or fingerprinted.19 Today, in contrast, CBP fingerprints and photographs nearly all nonimmigrants, regardless of nationality, at the time of entry into the United States. Furthermore, systems such as the Automated Biometric Identification System (IDENT), which were initially implemented by US-VISIT, are now used throughout DHS.20 IDENT is the central DHS-wide system for storage and processing of biometric and associated biographic information for a wide range of uses including national security, law enforcement, immigration and border management, intelligence, and background investigations. IDENT stores and processes biometric data—digital fingerprints, photographs, iris scans, and facial images—and links biometrics with biographic information to establish and verify identities. As noted above, these systems and procedures were not in place in 2002.

• Arrival and Departure Information. CBP receives arrival and departure data from commercial vessel and aircraft carriers, as well as private aircraft, through APIS. CBP tracks this information, which is vetted against various law enforcement databases, in its Arrival and Departure Information System. CBP confirms the accuracy of this data information as part of the interview process for travelers arriving in the United States. And the available biographic departure data are matched against arrival data to determine who has complied with the terms of admission and who has overstayed. These systems and procedures did not exist in their current form in 2002.

• Visa Information. Visa data is automatically vetted through various mechanisms through a joint coordination effort involving CBP, U.S. Immigration and Customs Enforcement, and the Department of State. This effort permits the relevant agency to take appropriate action, such as revoking visas or requiring additional scrutiny. These information sharing systems and procedures were not in place in 2002.

• Nonimmigrant Students. Data on nonimmigrant students is now entered into the Student and Exchange Visitor Information System (SEVIS) by designated school officials at certified institutions and responsible officials in the Exchange Visitor Program. CBP officers at ports-of-entry can interface with SEVIS in real time to determine whether a student or exchange visitor has a current and valid certificate of eligibility to enter the United States. SEVIS did not exist when NSEERS was created.

• Visa Waiver Program. The Electronic System for Travel Authorization (ESTA) now captures information used to determine the eligibility of visitors seeking to travel to the United States without a visa under the Visa Waiver Program (VWP). All travelers who intend to apply for entry under the VWP are now required to obtain an ESTA approval prior to boarding a carrier to travel by air or sea to the United States.21 CBP continuously vets ESTA applications against law enforcement databases for new information throughout the validity period and takes additional action as needed, including revocation of an ESTA approval. In November 2014, February 2016 and June 2016, DHS strengthened the VWP's security by adding additional elements on the ESTA application and revising the eligibility questions.22 The Visa Waiver Program Improvement and Terrorist Travel Prevention Act of 2015, enacted on December 18, 2015, prohibits certain travelers who have been present in or are nationals of certain countries to travel or be admitted to the United States under the VWP.23 None of these measures related to the VWP were in place when NSEERS was promulgated.

• Electronic Visa Update System: The Electronic Visa Update System (EVUS), which became effective on October 20, 2016, is an online system that allows for the collection of biographic and other information from nonimmigrants who hold a passport issued by an identified country containing a U.S. nonimmigrant visa of a designated category.24 Nonimmigrants subject to these regulations must periodically enroll in EVUS and obtain a notification of compliance with EVUS prior to travel to the United States. Though currently limited to nonimmigrants who hold a B1, B2, or B-1/B-2 visa issued without restriction for maximum validity contained in a passport issued by the People's Republic of China,25 additional countries could be added to address emerging national security issues.

Due to such changes, DHS has determined that the NSEERS model for border vetting and security, which focused on designated nationalities for special processing, is outmoded. Since the implementation of NSEERS in 2002, DHS has increasingly moved away from the NSEERS model and instead focused on a targeted, intelligence-driven border security model that identifies current and emerging threats in real time. For these reasons, DHS has concluded that NSEERS is obsolete and inefficient; that its implementation would be counterproductive to the Department's comprehensive security measures; and that the regulatory authority for NSEERS should thus be rescinded. For these reasons, DHS is removing the special registration program regulations found in 8 CFR 264.1(f).

DHS is making a conforming amendment to 8 CFR 214.1(f) to remove the specific reference to 8 CFR 264.1(f), which INS added when it implemented NSEERS in 2002. The amendment reinstates the text of 8 CFR 214.1(f) prior to the implementation of NSEERS, with a minor change to reflect the transfer of duties from INS to DHS.

The Administrative Procedure Act (APA) generally requires agencies to publish a notice of proposed rulemaking in the Federal Register and provide interested persons the opportunity to submit comments.26 The APA provides an exception to this prior notice and comment requirement for “rules of agency organization, procedure, or practice.” 27 This final rule is a procedural rule promulgated for agency efficiency purposes. DHS is removing regulations related to an outdated, inefficient, and decommissioned program. Thus, removing these regulations, which have not been used since 2011, reflects the current practice and procedure of DHS and will not affect the substantive rights or interests of the public.

The APA also provides an exception from notice and comment procedures when an agency finds for good cause that those procedures are “impracticable, unnecessary, or contrary to the public interest.” 28 DHS finds good cause to issue this rule without prior notice or comment, as such procedures are unnecessary. The removal of these regulations will have no substantive effect on the public because the regulations relate to a program which has not been utilized since 2011 and which has been made obsolete by DHS's more advanced and efficient processes, programs, and systems.

Further, the APA generally requires that substantive rules incorporate a 30-day delayed effective date.29 This rule, however, is merely procedural and does not impose substantive requirements; thus DHS finds that a delayed effective date is unnecessary.

This regulation has been drafted and reviewed in accordance with Executive Orders 12866 and 13563. This rule is not a significant regulatory action under Executive Order 12866, and accordingly this rule has not been reviewed by the Office of Management and Budget.

Because DHS is of the opinion that this rule is not subject to the notice and comment requirements of 5 U.S.C. 553, DHS does not consider this rule to be subject to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

The Unfunded Mandates Reform Act of 1995 is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector.

This rule does not include any unfunded mandates. The requirements of Title II of the Act, therefore, do not apply, and DHS has not prepared a statement under the Act.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States companies to compete with foreign-based companies in domestic and export markets.

This rule would not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

For the reasons stated in the preamble, DHS amends chapter 1 of title 8 of the Code of Federal Regulations as set forth below.

Title III Part C 1 of the Energy Policy and Conservation Act of 1975 (“EPCA” or, “the Act”), Public Law 94-163 (42 U.S.C. 6311-6317, as codified), added by Public Law 95-619, Title IV, Sec. 441(a), sets forth a variety of provisions designed to improve energy efficiency and established the Energy Conservation Program for Certain Industrial Equipment, which includes the commercial water heating equipment that is the subject of this rulemaking.2 (42 U.S.C. 6311(1)(K))

Under EPCA, DOE's energy conservation program generally consists of four parts: (1) Testing; (2) labeling; (3) energy conservation standards; and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products and equipment must use as the basis for certifying to DOE that their products and equipment comply with the applicable energy conservation standards adopted under EPCA, and for making other representations about the efficiency of those products. Similarly, DOE must use these test procedures to determine whether such products and certain equipment comply with any relevant standards promulgated under EPCA. (42 U.S.C. 6314) The initial Federal energy conservation standards and test procedures for commercial storage water heaters, instantaneous water heaters, and unfired hot water storage tanks (collectively referred to as “commercial water heating equipment” or “CWH equipment”) were added to EPCA by the Energy Policy Act of 1992 (EPACT 1992), Public Law 102-486. (42 U.S.C. 6313(a)(5) and 42 U.S.C. 6314(a)(4)(A)) These initial CWH equipment standards corresponded to the efficiency levels and equipment classes contained in the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Standard 90.1-1989, in effect on October 24, 1992. The statute provided that if the efficiency levels in ASHRAE Standard 90.1 were amended after October 24, 1992, the Secretary of Energy (Secretary) must establish an amended uniform national standard at new minimum levels for each equipment type specified in ASHRAE Standard 90.1, unless DOE determines, through a rulemaking supported by clear and convincing evidence, that national standards more stringent than the new minimum levels would result in significant additional energy savings and be technologically feasible and economically justified. (42 U.S.C. 6313(a)(6)(A)(ii)(I)-(II)) The statute was subsequently amended to require DOE to review its standards for commercial water heating equipment (and other “ASHRAE equipment”) every six years. (42 U.S.C. 6313(a)(6)(C)) On January 12, 2001, DOE published a final rule for commercial water heating equipment that amended energy conservation standards by adopting the levels in ASHRAE Standard 90.1-1999 for all types of commercial water heating equipment, except for electric storage water heaters.3 66 FR 3336. Most recently, on July 17, 2015, DOE published a final rule for commercial water heating equipment, in which DOE adopted the thermal efficiency level for oil-fired storage water heaters that was included in ASHRAE 90.1-2013. 80 FR 42614.

On December 18, 2012, the American Energy Manufacturing Technical Corrections Act (AEMTCA), Public Law 112-210, was signed into law. In relevant part, it amended EPCA to require that DOE publish a final rule establishing a uniform efficiency descriptor and accompanying test methods for consumer water heaters and certain commercial water heating equipment within one year of the enactment of AEMTCA. (42 U.S.C. 6295(e)(5)(B)) The final rule must replace the energy factor (EF), thermal efficiency, and standby loss metrics with a uniform efficiency descriptor. (42 U.S.C. 6295(e)(5)(C)) On July 11, 2014, DOE published a final rule that fulfilled these requirements, establishing a uniform energy factor (UEF) as the uniform energy descriptor (“July 2014 final rule”).4 79 FR 40542 (July 2014 final rule). AEMTCA requires that, beginning one year after the date of publication of DOE's final rule establishing the uniform descriptor (i.e., July 13, 2015), the efficiency standards for the consumer water heaters and residential-duty commercial water heaters identified in the July 2014 final rule must be denominated according to the uniform efficiency descriptor established in that final rule (42 U.S.C. 6295(e)(5)(D)), and that DOE must develop a mathematical conversion for converting the measurement of efficiency from the test procedures and metrics in effect at that time to the uniform efficiency descriptor. (42 U.S.C. 6295(e)(5)(E)(i))

Pursuant to 42 U.S.C. 6295(e)(5)(E)(ii) and (iii), the conversion factor must not affect the minimum efficiency requirements for covered water heaters, including residential-duty commercial water heaters. Furthermore, such conversions must not lead to a change in measured energy efficiency for covered residential and residential-duty commercial water heaters manufactured and tested prior to the final rule establishing the uniform efficiency descriptor. Id. EPCA also contains what is known as an “anti-backsliding” provision, which prevents the Secretary from prescribing any amended standard that either increases the maximum allowable energy use or decreases the minimum required energy efficiency of a covered product. (42 U.S.C. 6295(o)(1); 6313(a)(6)(B)(iii)(I)) In the December 6, 2016 conversion factor final rule, DOE's methodology for translating the standards ensures equivalent stringency between the then-existing standards (in terms of EF, thermal efficiency and standby loss metrics) and the updated standards (in terms of UEF). (See Docket EERE-2015-BT-TP-0007)

DOE initially presented proposals for establishing mathematical conversion factors for residential-duty commercial water heaters in a NOPR published on April 14, 2015 (“April 2015 conversion factor NOPR”) to be used to convert thermal efficiency and standby loss represented values to UEF represented values for residential-duty commercial water heaters. 80 FR 20116, 20143. DOE also proposed amendments to the minimum energy conservation standards for consumer water heaters and residential-duty commercial water heaters to translate the existing standards to the UEF metric without altering the stringency of the existing energy conservation standards. Id. at 20120. In a May 31, 2016 NOPR, DOE analyzed amended thermal efficiency and standby loss standards for residential-duty gas-fired storage water heaters, and used the conversion factors proposed in the April 2015 conversion factor NOPR to convert the analyzed thermal efficiency and standby loss levels to UEF.5 (“May 2016 CWH ECS NOPR”) DOE also used these conversion factors to develop UEF standard equations (dependent on rated volume) corresponding to the thermal efficiency and standby loss levels selected for each trial standard level (TSL) analyzed. 81 FR 34440, 34477.

Upon further analysis and review of the public comments received in response to the April 2015 conversion factor NOPR, DOE published a supplemental notice of proposed rulemaking on August 30, 2016 (“August 2016 conversion factor SNOPR”). In the SNOPR, DOE proposed revised mathematical conversion factors, as well as updates to the energy conservation standards for residential-duty commercial water heaters denominated in UEF. 81 FR 59736, 59793-59794, 59798. On December 6, 2016, DOE issued a final rule (“December 6, 2016 conversion factor final rule”) that adopted the mathematical conversion factors used to convert thermal efficiency and standby loss to UEF for residential-duty commercial water heaters that were proposed in the August 2016 conversion factor SNOPR. DOE also adopted the energy conservation standards for residential-duty commercial water heaters that were proposed in the August 2016 conversion factor SNOPR and that translate the existing thermal efficiency and standby loss standards to UEF standards. (See Docket EERE-2015-BT-TP-0007) In this NODA, DOE has used the updated conversion factors adopted in the December 6, 2016 conversion factor final rule to convert the thermal efficiency and standby loss levels analyzed in the May 2016 CWH ECS NOPR (i.e., levels more stringent than the existing thermal efficiency and standby loss standards) to UEF levels.

The purpose of this NODA is to present the thermal efficiency and standby loss levels that were considered for residential-duty gas-fired commercial water heaters in the May 2016 CWH ECS NOPR in terms of UEF using the recently updated conversion factors adopted in the December 6, 2016 conversion factor final rule. In response to the May 2016 CWH ECS NOPR, DOE received feedback on the efficiency levels analyzed and the efficiency levels included in each TSL for residential-duty commercial gas-fired storage water heaters. DOE is considering this feedback, and will address the comments received in detail, along with any resulting changes to the analysis and relevant conclusions, in the forthcoming final rule. The NODA, however, does not reflect any change in the efficiency levels or TSLs considered in the May 2016 CWH ECS NOPR.

The December 6, 2016 conversion factor final rule adopted conversion factors for residential-duty commercial water heaters for all four draw patterns: High, medium, low, and very small.6 In the following equations, New UEF is the converted UEF value; Et is the thermal efficiency in fractional form (e.g., 0.80 instead of 80 percent); SL is the standby loss (Btu/h); P is input rate (Btu/h); F and G are coefficients as specified in Table 1 based on the applicable draw pattern; and UEFrd is a parameter for residential-duty commercial storage water heaters developed by DOE based on the water heater analysis model (WHAM) equation.7 The methodology and data used to develop these conversion factors are discussed in detail in the August 2016 conversion factor SNOPR. 81 FR 59750-59751, 59776-59778 (August 30, 2016).

The thermal efficiency and standby loss levels analyzed in the May 2016 CWH ECS NOPR are shown in Table 2 (81 FR 34440, 34472 (May 31, 2016)), and the corresponding updated UEF levels are shown in Table 3. The standby loss and UEF levels correspond to the representative equipment capacities analyzed for residential-duty commercial gas-fired storage water heaters—75 gallon rated storage volume and 76,000 Btu/h rated input. In Table 3, the UEF values correspond to the high draw pattern—DOE believes most, if not all, residential-duty gas-fired storage water heater models will fall into the high draw pattern bin. In the May 2016 CWH ECS NOPR, DOE selected standby loss levels in Btu/h, and translated these values to modified standby loss standard equations using standby loss reduction factors. As proposed in the May 2016 CWH ECS NOPR and presented in this NODA, the standby loss reduction factor is a factor that is multiplied by the current standby loss equation. Because the standby loss reduction factor is a multiplicative factor that is applied to the existing standby loss equation (in lieu of independently changing the coefficients for the volume and input terms of the equation), the standby loss reduction factor preserves the dependence of the existing standby loss equation on rated input and storage volume. 81 FR 34440, 34476 (May 31, 2016).

The energy conservation standards for residential-duty commercial water heaters adopted in the December 6, 2016 conversion factor final rule (i.e., denominated in UEF and translated from the existing thermal efficiency and standby loss standards) are linear equations dependent on rated volume. Therefore, the converted UEF standard equations for residential-duty gas-fired storage water heaters presented in this NODA are consistent with this equation format. DOE based its methodology for developing UEF standard equations for more-stringent thermal efficiency and standby loss levels on the “representative model” method used for determining the converted standards equations in terms of UEF in the December 6, 2016 conversion factor final rule, as outlined below. (See Docket EERE-2015-BT-TP-0007)

DOE developed UEF standard equations corresponding to each combination of thermal efficiency and standby loss levels that DOE selected in the TSLs analyzed in the May 2016 CWH ECS NOPR. DOE converted the thermal efficiency level and standby loss value to UEF for each identified rated volume on the market and for each draw pattern using the conversion factors adopted in the December 6, 2016 conversion factor final rule. (See Docket EERE-2015-BT-TP-0007) To develop the UEF standard equation for each draw pattern and TSL, DOE used a linear regression between volume and UEF (see the December 6, 2016 conversion factor final rule for more details).

Table 4 shows the thermal efficiency and standby loss levels included in each TSL in the May 2016 CWH ECS NOPR for residential-duty commercial gas-fired storage water heaters. 81 FR 34440, 34504 (May 31, 2016). Table 5 shows the updated UEF standard equations, dependent on rated volume, that were developed for each TSL and draw pattern using the conversion factors adopted in the December 6, 2016 conversion factor final rule. (See Docket EERE-2015-BT-TP-0007)

DOE is interested in receiving comments on the conversion of the thermal efficiency and standby loss levels for residential-duty gas-fired storage water heaters that were considered in the May 2016 CWH ECS NOPR to UEF levels and UEF standard equations using the conversion factors adopted by DOE in its December 6, 2016 final rule.

Background

The existing rules that are the subject of these corrections are part of the continuing series of regulations that the Commission has promulgated to implement the Presidential Election Campaign Fund Act, 26 U.S.C. 9001-13, and the Presidential Primary Matching Payment Account Act, 26 U.S.C. 9031-42 (collectively, the “Funding Acts”), and the Federal Election Campaign Act, 52 U.S.C. 30101-46 (“FECA”). The Commission is promulgating these corrections without advance notice or an opportunity for comment because they fall under the “good cause” exemption of the Administrative Procedure Act. 5 U.S.C. 553(b)(B). The Commission finds that notice and comment are unnecessary here because these corrections are merely typographical and technical; they effect no substantive changes to any rule. For the same reason, these corrections fall within the “good cause” exception to the delayed effective date provisions of the Administrative Procedure Act and the Congressional Review Act. 5 U.S.C. 553(d)(3), 808(2).

Moreover, because these corrections are exempt from the notice and comment procedure of the Administrative Procedure Act under 5 U.S.C. 553(b), the Commission is not required to conduct a regulatory flexibility analysis under 5 U.S.C. 603 or 604. See 5 U.S.C. 601(2), 604(a). Nor is the Commission required to submit these revisions for congressional review under FECA or the Funding Acts. See 52 U.S.C. 30111(d)(1), (4) (providing for congressional review when Commission “prescribe[s]” a “rule of law”); 26 U.S.C. 9009(c)(1), (4), 9039(c)(1), (4) (same). Accordingly, these corrections are effective upon publication in the Federal Register.

The Commission has renamed a division within the agency. As a result, throughout 11 CFR chapter I, the Commission is replacing every instance of the phrase “Public Disclosure Division” with the phrase “Public Disclosure and Media Relations Division.”

The Commission is correcting a typographical error in paragraph (b) of this section by adding a comma after the word “maintaining”. This comma was inadvertently omitted when the Commission promulgated this paragraph.

The Commission is correcting a typographical error in paragraph (b) of this section by adding a comma after the word “creating” and a comma after the word “maintaining”. These commas were inadvertently omitted when the Commission promulgated this paragraph.

The Commission is revising paragraphs (c)(2)(i) and (c)(2)(ii)(C) of this section to correctly note the reporting requirements for candidates and authorized committees receiving earmarked contributions from conduits and intermediaries. These paragraphs currently state that candidates and authorized committees are required to report a conduit or intermediary forwarding earmarked contributions which, in the aggregate, exceed $200 in “any calendar year.” In 1999, however, Congress amended FECA to require that authorized committees aggregate and report all receipts and disbursements by election cycle, rather than by calendar year. Treasury and General Government Appropriations Act of 2000, Public Law 106-58, sec. 641, 113 Stat. 430, 477 (1999). In 2000, the Commission implemented this legislation by amending § 104.3(c) of its regulations, Election Cycle Reporting by Authorized Committees, 65 FR 42619-21 (July 11, 2000), but inadvertently failed to update paragraphs (c)(2)(i) and (c)(2)(ii)(C) of § 110.6 to conform to the statute and to revised § 104.3. To correct that oversight, the Commission is amending the relevant portions of the text in paragraphs (c)(2)(i) and (c)(2)(ii)(C).

The Commission is removing paragraph (f) of this section because it is no longer applicable. Paragraph (f) describes the “personal use” rules, which concern the permissible non-campaign uses of campaign funds, that applied to Members of Congress serving in the 102d or an earlier Congress. Because this paragraph does not apply to any Members serving in the 103d or a later Congress, which includes all current and future Members of Congress, the Commission is removing paragraph (f).

The Commission is removing and reserving this section because it contains transitional rules that no longer apply. When the Commission enacted rules concerning the use of non-federal funds in 2002, the Commission also promulgated § 300.12, which outlined how and by what date national committees of political parties were to disburse non-federal funds received before November 6, 2002. Prohibited and Excessive Contributions: Non-Federal Funds or Soft Money, 67 FR 49064, 49091-92 (July 29, 2002); see also Bipartisan Campaign Reform Act, Public Law 107-155, sec. 402, 116 Stat. 81, 112-13 (2002). Since the deadline for the disbursement of these funds has long passed, this section is no longer necessary. Therefore, the Commission is removing and reserving this section. The Commission is also making conforming amendments by removing from § 300.1 two references to § 300.12.

For the reasons discussed above regarding the removal of § 300.12, the Commission is also removing paragraphs (b) and (c) of § 300.13. Paragraph (b) directs national party committees to file termination reports disclosing the disposition of funds in non-federal accounts and building fund accounts by January 31, 2003. Paragraph (c) refers to reporting requirements for receipts and disbursements from national party committee non-federal accounts and building fund accounts for activity occurring between November 6 and December 31, 2002.

For the reasons set out in the preamble, the Federal Election Commission amends 11 CFR chapter I as follows:

I. Background

The Freedom of Information Act (FOIA) sets forth the process for obtaining federal agency records, unless the records (or any portion thereof) are protected from disclosure by one of the FOIA's nine exemptions or by one of its three special law enforcement record exclusions.1 On June 30, 2016, the FOIA Improvement Act of 2016 (the FOIA Improvement Act or the Act) 2 amended the FOIA to, among other changes, require Federal agencies to make certain records electronically available, extend the time available for a requester to appeal an adverse determination, amend the circumstances under which an agency can assess search and duplication fees, establish FOIA dispute resolution procedures, and establish a new standard for the withholding of information pursuant to a FOIA exemption.

Additionally, under section 2222 of the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (EGRPRA),3 the OCC is required to conduct a review at least once every 10 years to identify any outdated or otherwise unnecessary regulations. The OCC completed the last comprehensive review of its regulations under EGRPRA in 2006 and is concluding the current decennial review. As part of its current EGRPRA review, the OCC issued a notice of proposed rulemaking on March 14, 2016, that included proposed technical amendments to the OCC's part 4 FOIA regulations. The OCC did not receive any specific comments on the proposed FOIA amendments, and those changes will be reflected in this rulemaking to the extent they have not been superseded by the FOIA Improvement Act.4

Finally, the OPEN FOIA Act of 2009 (the OPEN FOIA Act),5 limited Exemption 3, which applies to information specifically exempted by statute. To be exempt under Exemption 3 following the OPEN FOIA Act, information must be exempt pursuant to a statute that requires: (1) That the matters be withheld from the public in such a manner as to leave no discretion on the issue, or establishes particular criteria for withholding or refers to particular types of matters to be withheld and, (2) if enacted after the date of enactment of the OPEN FOIA Act, specifically cites to Exemption 3 of the FOIA. Previously, statutes did not need to specifically cite to Exemption 3 of the FOIA.

Twelve CFR part 4, subpart B, sets forth OCC policies regarding the availability of information under the FOIA and establishes procedures for requesters to follow when seeking information. This interim final rule amends 12 CFR part 4, subpart B, to implement the FOIA Improvement Act and the OPEN FOIA Act and to make technical changes to the regulations as a result of the OCC's EGRPRA review.

As part of the EGRPRA proposed rule, the OCC proposed to remove § 4.11(b)(4), which stated that the OCC's FOIA rules did not apply to FOIA requests filed with the former Office of Thrift Supervision (OTS) before July 21, 2011, because the OTS's rules would apply to those requests instead. The OCC adopted this provision when it amended part 4 to reflect the transfer of certain powers, authorities, rights, and duties of the OTS to the OCC pursuant to Title III of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act).6 There are no remaining open FOIA requests that had been submitted to the OTS prior to its integration with the OCC. Therefore, § 4.11(b)(4) is no longer necessary and is removed by this interim final rule.

Pursuant to the Act, the interim final rule amends 12 CFR 4.12 to revise the language about the availability of records in subsection (a), consistent with the FOIA Improvement Act; limit the deliberative process exemption; expand the information segregation provisions; update 12 CFR 4.12(b)(3) to be consistent with the OPEN FOIA Act; and implement proposed clarifications from the EGRPRA review.

Section 4.12(a) currently provides that OCC records are available to the public except for records that the FOIA exempts from disclosure. The FOIA Improvement Act adds new language to the statute that relates to an agency's decision to disclose information that is covered by an exemption. This language provides for the withholding of information pursuant to a FOIA exemption only if an agency “reasonably foresees that disclosure would harm an interest protected by an exemption” or if the disclosure is prohibited by law.7

These considerations will inform the OCC's future determinations about whether to disclose information covered by an exemption. Accordingly, the interim final rule removes the existing reference to “exempt records” in subsection (a) and replaces it with the phrase “[e]xcept as otherwise provided by the FOIA.” This language is broad enough to encompass the “reasonable foreseeability” and the “prohibited by law” language added by the FOIA Improvement Act, and it encompasses the former reference to coverage by an exemption as well. Based on legislative history, in which the sponsors of the Act expressed their intent to preserve the longstanding protections afforded by Exemption 8,8 the OCC does not anticipate that the Act or revised § 4.12(a) will alter the application of FOIA Exemption 8, which protects matters that are “contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions.” 9

The interim final rule also amends the deliberative process exemption in § 4.12(b)(5) to reflect the Act's limitations on records created 25 years or more before the date of an information request. Previously, the deliberative process exemption protected all intra-agency and interagency memoranda and letters not routinely available by law to a private party in litigation, including memoranda, reports, and other documents prepared by OCC employees and records of deliberations and discussions at meetings of OCC employees. After the change, the deliberative process provision as amended by the interim final rule will exempt only those memoranda and letters created within 25 years of the date on which they were requested.

Additionally, although the OCC's rules already provide for the separation and provision of nonexempt information, the interim final rule clarifies that, in cases in which full disclosure is not possible, the OCC considers whether partial disclosure of information is possible and takes reasonable steps necessary to segregate and release nonexempt information. This provision is consistent with current OCC practice.

The interim final rule also amends § 4.12(b)(3) to reflect the OPEN FOIA Act provision that requires that statutes enacted after the date of the enactment of the OPEN FOIA Act must specifically cite to Exemption 3 of the FOIA in order to qualify under Exemption 3. The OPEN FOIA Act was enacted on October 28, 2009, so the requirement applies to statutes enacted after that date.

Finally, the interim final rule adopts the changes to § 4.12(a) and (b) that the OCC proposed as part of its EGRPRA review. Previously, § 4.12(b)(10) exempted from disclosure any OTS information similar to that listed in the exemptions in § 4.12(b)(1) to (b)(9) to the extent the information is in the possession of the OCC. For purposes of clarification, we are amending the § 4.12(a) disclosure standard so that it applies to OTS records, in addition to OCC records, and removing the resulting unnecessary exemption in paragraph (b)(10).

Section 4.14(a) lists the types of information the OCC makes available for public inspection. Consistent with the Act's amendments to 5 U.S.C. 552(a)(2), the interim final rule adds two categories of information to § 4.14(a). New § 4.14(a)(11) specifies that the OCC will make available for public inspection in an electronic format any records, regardless of form or format, that have been released to any person under 5 U.S.C. 552(a)(3) provided that: (1) The OCC determines that, because of the nature of their subject matter, the records are or are likely to become the subject of subsequent requests for substantially the same record; or (2) the records have been requested three or more times.

New § 4.14(a)(12) states that the OCC will provide reference materials or a guide for requesting records or information from the OCC, including an index of all major OCC information systems, a description of major information and record locator systems maintained by the OCC, and a handbook for obtaining various types and categories of public information from the OCC pursuant to FOIA and chapter 35 of title 44.

Finally, the interim final rule makes clarifying and conforming changes to § 4.14, including amending § 4.14(a) and (b) to specify that information will be made available for public inspection in an electronic format to implement section 2 of the Act.

Pursuant to the Act, the interim final rule amends § 4.15, which describes the process for requesting OCC records. Specifically, to implement section 2 of the Act, the interim final rule amends § 4.15(c)(4) to specify that if a request for information is denied, the OCC will notify the requester of the right to seek dispute resolution services from the OCC's FOIA Public Liaison or the Office of Government Information Services through the processes described in new § 4.15(h).

Pursuant to the Act's amendments to 5 U.S.C. 552(a)(6)(A)(i), the interim final rule also extends the time available for administrative appeal of a denial to release records from 35 days to 90 days. Under new § 4.15(d), requesters will have 90 days after the date of an initial denial determination to submit a written administrative appeal of denial of a request for records.

Additionally, the interim final rule expands § 4.15(f), which addresses the time limits for FOIA request responses and provides for extensions in certain situations, including a 10-day extension for unusual circumstances.10 Pursuant to the Act's amendments to 5 U.S.C. 552(a)(6)(A)(i), the interim final rule adds a new § 4.15(f)(4) that provides additional information and alternatives for requesters when the OCC determines that a request will require more than a 10-day extension to process. Under this provision, if unusual circumstances apply to a request for records, and the OCC determines that it cannot respond to the request within the 10-day extension, the OCC will: (1) Notify the requester that the request cannot be processed within the 10-day extension; (2) provide the requester with an opportunity to limit the scope of the request so that it may be processed within the 10-day period or to arrange with the OCC an alternative time frame for processing the request or a modified request; (3) make available the FOIA Public Liaison, who shall assist in the resolution of any disputes between the requester and the OCC; and (4) notify the requester of the right of the requester to seek dispute resolution services from the Office of Government Information Services.

Finally, the interim final rule makes other clarifying and conforming changes to § 4.15, including amending § 4.15(d)(4) to specify that the OCC will provide notification of a denial of an appeal “in writing,” rather than “by mail.” The OCC expects this change will provide greater flexibility and efficiency by permitting other forms of communication, such as electronic mail. The interim final rule also amends § 4.15 to provide updated contact information for the Office of Management and Budget's (OMB) request portal, the OCC's Chief FOIA Officer, and the Federal Deposit Insurance Corporation.

Section 4.17 provides information for the assessment and payment of FOIA request fees. As stated in § 4.17(b)(1), the OCC generally charges fees to fulfill FOIA requests. However, § 4.17(b)(6) provided that the OCC will not assess search or duplication fees, as applicable, if the OCC did not respond within the time limits set forth in § 4.15(f) and no unusual or exceptional circumstances applied. The FOIA Improvement Act provided additional information about the circumstances in which an agency may charge search or duplication fees if the agency does not meet the time limits provided by the FOIA. Thus, pursuant to the Act, the interim final rule amends § 4.17(b)(6) to update the circumstances in which the OCC is permitted to assess search or duplication fees, even if the OCC does not respond within the § 4.15(f) time limits.

For example, amended § 4.17(b)(6) permits the OCC to assess search or duplication fees if the OCC has determined “unusual circumstances” (as defined in § 4.15(f)(3)(i)) apply, has provided timely written notice to the requester, and complies with the extended time limit.11 The interim final rule also permits the OCC to assess search or duplication fees if the OCC has determined that unusual circumstances apply and more than 5,000 pages are necessary to respond to the request. In such a situation, the OCC must provide a timely written notice to the requester in accordance with 5 U.S.C. 552(a)(6)(B) and discuss with the requester via written mail, electronic mail, or telephone (or make not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with 5 U.S.C. 552(a)(6)(B)(ii). Finally, if a court has determined that exceptional circumstances (as defined in 5 U.S.C. 552(a)(6)(C)) apply to the processing of a request, the OCC may assess search or duplication fees for the length of time provided by the court order.

The interim final rule also updates the payment of fees contact information listed in § 4.17(c).

The interim final rule makes a technical amendment to § 4.18(b) to provide updated contact information for the OCC's Communications Division that requesters may use to track the progress of their requests.

The OCC is issuing the interim final rule without prior notice and the opportunity for public comment and the 30-day delayed effective date ordinarily prescribed by the Administrative Procedure Act (APA).12 Pursuant to section 553(b)(B) of the APA, general notice and the opportunity for public comment are not required with respect to a rulemaking when an “agency for good cause finds (and incorporates the finding and a brief statement of the reasons therefor in the rule issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 13 The interim final rule's changes to 12 CFR part 4 are limited to technical changes and those that are necessary to implement the provisions of the FOIA Improvement Act and OPEN FOIA Act. Because the OCC is not exercising discretion with respect to the interim final rule's substantive revisions that implement the Act, the OCC believes the public interest is best served by implementing the interim final rule as soon as possible.

In addition, the OCC believes that providing a notice and comment period prior to issuance of the interim final rule is unnecessary because the OCC does not expect public objection to the regulations being promulgated, as this rule implements the substantive changes specified in the Act and technical, non-substantive updates and clarifications to part 4. Moreover, the OCC expects that the majority of the changes will provide additional services and critical updates that will assist FOIA requesters.

The APA also requires a 30-day delayed effective date, except for (1) substantive rules that grant or recognize an exemption or relieve a restriction; (2) interpretative rules and statements of policy; or (3) as otherwise provided by the agency for good cause.14 The OCC concludes that, because the rules recognize an exemption, the interim final rule is exempt from the APA's delayed effective date requirement.15 Additionally, the OCC finds good cause to publish the interim final rule with an immediate effective date for the same reasons set forth above under the discussion of section 553(b)(B) of the APA.

Pursuant to section 302(a) of the Riegle Community Development and Regulatory Improvement Act (RCDRIA),16 in determining the effective date and administrative compliance requirements for a new regulation that imposes additional reporting, disclosure, or other requirements on insured depository institutions (IDIs), the OCC must consider any administrative burdens that such regulation would place on depository institutions and the benefits of such regulation. In addition, section 302(b) of the RCDRIA requires any such new regulation to take effect on the first day of a calendar quarter that begins on or after the date on which the regulation is published in final form, with certain exceptions, including for good cause. The OCC has considered the administrative burdens that such regulations would place on institutions and the benefits of such regulations in determining the effective date and compliance requirements. Due to the nature of the rule's changes to the OCC's existing FOIA regulations, the interim final rule does not impose additional reporting, disclosure, or other requirements on IDIs, and section 302 of the RCDRIA therefore does not apply. Therefore, for the same reasons set forth above under the discussion of section 553(b)(B) of the APA, the OCC finds good cause exists under section 302 of RCDRIA to publish the interim final rule with an immediate effective date.

While the OCC believes there is good cause to issue the rule without notice and comment and with an immediate effective date, the OCC is interested in the views of the public and requests comment on all aspects of the interim final rule.

The Regulatory Flexibility Act (RFA) 17 applies only to rules for which an agency publishes a general notice of proposed rulemaking pursuant to 5 U.S.C. 553(b). As discussed above, consistent with section 553(b)(B) of the APA, the agencies have determined for good cause that general notice and opportunity for public comment is not necessary. Accordingly, the RFA's requirements relating to initial and final regulatory flexibility analysis do not apply.

The Paperwork Reduction Act of 1995 18 states that no agency may conduct or sponsor, nor is the respondent required to respond to, an information collection unless it displays a currently valid OMB control number. Because the interim final rule does not create a new, or revise an existing, collection of information, no information collection request submission needs to be made to the OMB.

Consistent with section 202 of the Unfunded Mandates Reform Act of 1995,19 before promulgating any final rule for which a general notice of proposed rulemaking was published, the OCC prepares an economic analysis of the final rule. As discussed above, the OCC has determined that the publication of a general notice of proposed rulemaking was unnecessary. Accordingly, the OCC has not prepared an economic analysis of the joint interim final rules.

For the reasons set forth in the preamble, the OCC hereby amends 12 CFR part 4 as set forth below.

Introduction

The final rule implements Section 1614 of the National Defense Authorization Act for Fiscal Year 2014, Public Law 113-66, December 26, 2013 (hereinafter NDAA 2014). Section 1614 amended section 8(d)(6)(D) of the Small Business Act, 15 U.S.C. 637(d)(6)(d), to provide that where a prime contractor has a subcontracting plan for a specific prime contract with an executive agency, as required by Section 8(d) of the Small Business Act, the prime contractor will receive credit towards its subcontracting plan goals for awards made to small business concerns at any tier under the contract, to the extent reported under the subcontracting plan of a lower tier other than small subcontractor. When a prime contractor awards a subcontract to a firm, it is generally considered a first tier subcontract. That subcontractor may award a subcontract, which would be considered a second tier subcontract, and so on. Currently, with few exceptions, a prime contractor cannot receive credit towards its small business subcontracting plan goals for awards made below the first tier.

SBA is amending its regulations to require other than small business prime contractors to count lower tier small business subcontract awards towards their federal small business subcontracting goals on unrestricted federal contracts, to the extent the lower tier subcontractor are required to report the information. With limited exceptions, unrestricted federal procurements and subcontracts over $700,000 ($1.5 million for construction of any public facility) include Federal Acquisition Regulation (FAR) clause 52.219-9 (Small Business Subcontracting Plan), which requires other than small contractors and their lower tier subcontractors to make a good faith effort to meet or to exceed the small business subcontracting goals established in their respective subcontracting plans. Failure to make this effort could result in liquidated damages, default termination, and negative performance reviews. For a subcontracting plan for a specific prime contract, the contractor or subcontractor is required to submit an Individual Subcontract Report (ISR) and Summary Subcontracting Report (SSR). The ISR is submitted semiannually during contract performance and upon contract completion. The SSR is submitted annually to procuring agencies. Both forms are submitted through the Electronic Subcontracting Reporting System (eSRS). Until this final rule, a large prime contractor could not take credit for a subcontract award to a second-tier small business subcontractor. Lastly, large prime contractors are already required to identify the size standard that applies to a subcontract. 13 CFR 121.410, 121.411, 125.3(c)(1)(v). Subcontractor size representation is reviewed during compliance reviews (See 13 CFR 125.3(f)(2)(i)) and size representations at the subcontract level may be protested (See 13 CFR 121.411). In addition, Section 868 of the National Defense Authorization Act of 2016, Public Law 114-92 (November 25, 2015), requires SBA, as part of the its scorecard on agency small business prime contracting and subcontracting performance, to compare “The number of small business concerns, small business concerns owned and controlled by service-disabled veterans, qualified HUBZone small business concerns, small business concerns owned and controlled by socially and economically disadvantaged individuals, and small business concerns owned and controlled by women awarded subcontracts in each North American Industry Classification System code during the fiscal year and a comparison to the number of awarded subcontracts during the prior fiscal year, if available.”

SBA published a proposed rule regarding these changes in the Federal Register on October 6, 2015. 80 FR 60300 (October 6, 2015). SBA received a total of 13 comments. Two of these comments were generally positive without offering any comments on specific provisions. SBA received three comments that were generally opposed to the rule without offering comment on specific provisions. These three commenters generally felt that the statute and the regulations were likely to hurt small business subcontractors rather than help them, and would likely result in large prime contractors attempting to exert more control over their subcontractors. SBA received one comment that was not relevant; this comment made no mention of the proposed regulation.

Two commenters did not think that SBA's regulatory impact analysis took into consideration the extra burden that large businesses would have under these changes. The commenters claimed that the costs and challenges of collecting the data are more than minimal, and that large businesses will incur more than minimal costs. Neither commenter provided data or analysis on what those costs would be, just a general statement that they would be more than minimal. SBA addressed this issue in its proposed rule. Any costs associated with the regulatory implementation of these provisions of the NDAA 2014 will be included in the proposed Federal Acquisition Regulation (FAR) changes. Thus, any Paperwork Reduction Act (PRA) costs associated with proposed rulemaking and implementation will occur during the FAR rulemaking process.

SBA received one comment seeking clarification that this rule and credit for lower tier subcontracting does not affect Agencies' prime contract goaling numbers. This rule only applies to subcontracting plans, not to agency prime contract goaling requirements. Generally, agencies do not count subcontracting dollars awarded to small business concerns towards their prime contract goaling requirements, except for the Department of Energy. This rule does not change reporting under the SSR, which is how agencies receive credit for subcontracting. Firms will continue to report only their first-tier subcontracts on the SSR.

SBA received one comment regarding enforcement of these regulations prior to FAR regulatory implementation and updates to eSRS. As noted in the proposed rule, it is SBA's position that this regulation will require changes to FAR prior to full implementation in eSRS.

SBA proposed amending § 121.411(b) allowing prime contractors to accept a subcontractor's size certification electronically. The list of enumerated methods is illustrative only, and is not exhaustive. SBA received several comments on this issue, and all believed the proposed change was positive, but that more clarity was needed about who may accept the certifications, and whether this applied to socioeconomic certifications. Thus, SBA is adopting the language as proposed, with minor additions for clarity. The final rule now makes clear that prime and subcontractors may rely on any form of electronic certification that they deem appropriate provided it is given in connection with an offer for specific subcontract and it includes the language in SBA's regulation which provides that in order to accept an electronic representation, the representation must be in connection with an offer for a subcontract and the solicitation and subcontract provides that the subcontractor verifies by submission of the offer that the size and socioeconomic representations and certifications are current accurate and complete as of the date of offer for the subcontract. See 13 CFR 121.411(b), 125.3(c)(1)(v).

In proposed § 125.3(a)(1), SBA included the new statutory definition for a subcontract that was enacted by NDAA 2014. SBA received one comment that requested more specificity with regard to what will be considered a subcontract. Specifically, this commenter wanted lists of what would and would not be considered a subcontract, based in part on FAR definitions. The proposed definition is taken from the statute, which was added by NDAA 2014, and SBA is adopting the statutory definition in the final rule. See 15 U.S.C. 632(dd)(1).

In proposed § 125.3(a)(1)(i)(C), SBA provided guidance on when a prime contractor may receive credit for lower tier subcontracting. Specifically, the proposed rule stated that only individual subcontracting plans were entitled to receive the credit. SBA has revised this section based on the comments. Specifically, the final rule clearly states how commercial and individual plans differ, and what the prime contractor's and subcontractor's responsibilities and requirements are for individual subcontracting plans as required by the Small Business Act. SBA received several comments asking for clarification, and several comments asking SBA to also apply the new guidelines to commercial subcontracting plans. SBA addressed this issue in its proposed rule, “Section 1614 applies only when determining whether or not a prime contractor has met its individual subcontracting plan goals. Thus, Section 1614 does not apply where the prime contractor has a commercial plan or comprehensive subcontracting plan.” 80 FR 60300, 60301 (October 6, 2015). The Small Business Act specifically states that the prime contractor shall receive lower tier credit “if the subcontracting goals pertain to a single contract with the executive agency.” 15 U.S.C. 637(d)(16)(A)(i). A commercial plan, like a comprehensive subcontracting plan, applies to more than one government contract, and thus the lower tier credit provisions do not apply to those types of plans.

SBA received two comments on the issue of double counting and the incorporation of subcontracting plans from lower tier, other than small subcontractors. One commenter suggested that SBA amend the language of the regulation and add examples to provide clarity. One commenter requested that SBA remove the requirement that other than small subcontractors are required to have their own subcontracting plan, if their plan is incorporated into the prime contractor's plan. The requirement that subcontractors have their own plan is an independent statutory requirement that must be met. SBA has crafted the final rule to make it clear that incorporation of lower tier goals does not change the requirements of the lower tier subcontractors to have its own subcontracting plans, meet their goals, and report on its first tier performance. Further, the prime contractor will continue to report on performance at the first tier level. The prime contractor's performance towards its lower tier small business subcontracting goals will be based on the reports of its other than small lower tier subcontractors with subcontracting plans to the extent that the lower tier subcontractor are required to report. The prime contractor remains responsible for ensuring accurate reporting to the government.

SBA received two comments on proposed § 125.3(c)(1)(i), which proposed to require that in order for a prime contractor to receive credit for awards made at lower tiers, the prime contractor would be required to have a complete subcontracting plan, including incorporation of its subcontractor's goals, prior to award. The Small Business Act requires that subcontracting plans be submitted, negotiated, and approved before contract award. 15 U.S.C. 637(d)(4)(B) and (C). The commenters contend that having all of the necessary steps done and completed prior to award, including the incorporation of lower tier subcontractor's plans, is not practicable on all contracts. The commenters state that often the prime will not be aware of which companies their subcontractors may be utilizing. The Small Business Act provides that prime contractors “shall” receive credit for subcontractors at any tier pursuant to a subcontracting plan required by section 15 U.S.C. 637(d)(6)(D), which is the statutory requirement to require other than small subcontractors to have subcontracting plans if the subcontract exceeds certain threshold amounts. 15 U.S.C. 637(d)(16)(A)(i). Thus, the prime contractor with an individual subcontracting plan will be obligated to consider and establish goals based on the subcontracting plans of its other than small subcontractors prior to award of the contract.

SBA proposed to amend § 125.3(c)(1)(v) to clarify which NAICS should apply to a subcontract and how primes should inform potential subcontractors which NAICS and corresponding size standard will be applied. SBA's regulations currently require that the prime contractor (or subcontractor that is subcontracting to another concern) must assign a NAICS code to the subcontract that best describes the work being performed or the product being purchased by that subcontract. The contractor may not simply pass down the NAICS assigned to the prime contract to all subcontracts. SBA received five negative comments on this requirement, and one comment that believed it would be in conflict with the FAR. However, this is not a new requirement. SBA's current regulations require that each subcontract have a NAICS assigned that describes the work being performed under the subcontract, with the corresponding size standard. While not a new requirement, SBA believes it is important to reiterate why this requirement is necessary to accurately reflect small business participation in subcontracting. Utilizing the prime contract's NAICS for subcontracts may not always accurately describe the work being done under that subcontract. SBA does not have a one-size-fits-all definition of what a small business is, because whether a firm is small depends largely on what type of work it performs, or what type of product it supplies. Utilizing one NAICS code for all subcontracts would distort the calculation of small business subcontracting performance.

Several comments requested clarification on whether, based on the wording of this rule, all subcontracts would require a solicitation. That was not the intention of the regulation, and SBA has added a sentence to the regulation to make this clear. However, it should also be clear that the prime contractor (or lower tier subcontractor that is subcontracting) assigning the NAICS to the subcontract is responsible for providing notice of the size standard to prospective subcontractors prior to acceptance and formation of a subcontract. This is necessary to ensure that small businesses can accurately certify to their size status. SBA also added parentheticals to make clear that this applies to prime contractors and subcontractors.

SBA proposed to add § 125.3(c)(1)(x) to implement 15 U.S.C. 637(d)(6)(D) of the Small Business Act, requiring prime contractors and subcontractors with subcontracting plans to do various tasks in connection with their subcontractors with subcontracting plans. SBA received one negative comment stating the requirements were too burdensome and one comment requesting clarification concerning whether these requirements pertain to commercial subcontracting plans. SBA also received a comment requesting that the requirements of this paragraph and paragraph (xi) be required only if the prime contractor incorporates its subcontractors' subcontracting plans. The requirements articulated in the proposed rule are required by statute for all subcontracting plans, and thus we are adopting the language as proposed in the final rule. Subcontractors of primes with commercial plans do not have to have subcontracting plans if the subcontract is for a commercial item. Consequently, the requirements of § 125.3(c)(1)(x) apply to a prime with a commercial plan to the extent its subcontractors have their own individual subcontracting plans, not commercial plans

SBA received one comment stating that the dollar value thresholds in SBA's rule are different than the recently updated FAR thresholds. The revised inflation adjusted subcontracting plan thresholds became effective after SBA issued the proposed rule, and SBA has updated the thresholds in this final rule.

SBA proposed to add § 125.3(c)(1)(xi) in order to incorporate new requirements from the statute concerning the records the prime contractor must maintain to demonstrate subcontractors at all tiers comply with the subcontracting plan requirements. Two commenters noted confusion as to what was meant by the phrase “recite the types of records the prime will maintain.” SBA is changing language to make clear that a written statement is required.

Finally, with respect to liquidated damages, the Small Business Act provides that each contract subject to the requirements for a subcontracting plan shall contain a clause for the payment of liquidated damages upon a finding that a prime contractor has failed to make a good faith effort to comply with the requirements imposed on such subcontractor by section 8(d)(4)(F) of the Small Business Act, 15 U.S.C. 637(d)(4)(F). Thus, a prime contractor could be subject to liquidated damages if it fails to make a good faith effort to review and approve subcontracting plans submitted by its subcontractors; monitor subcontractor compliance with its approved subcontracting plans; ensure that subcontracting reports are submitted by its subcontractors when required; acknowledge receipt of its subcontractors' reports; compare the performance of its subcontractors to subcontracting plans and goals; and discuss performance with subcontractors when necessary to ensure its subcontractors make a good faith effort to comply with their subcontracting plans.

The Office of Management and Budget (OMB) has determined that this final rule is a significant regulatory action for the purposes of Executive Order 12866. Accordingly, the next section contains SBA's Regulatory Impact Analysis. This is not a major rule, however, under the Congressional Review Act.

The final regulations implement section 1614 of the National Defense Authorization Act for Fiscal Year 2014. Section 1614(c)(3) requires the Administrator to promulgate regulations necessary to implement the Act.

The benefits of the final regulations are minimal and the final costs cannot be determined until the FAR rules are proposed. Other than small business prime contractors and subcontractors already establish individual subcontracting plan goals and report on their achievements if the subcontracting plan thresholds are met. Under section 1614 of the NDAA 2014, a prime contractor with an individual subcontracting plan will receive credit towards its goals for small business performance at lower tiers. Thus, there will be some costs to the prime contractor to propose subcontracting plan goals that incorporate small business performance at lower tiers and to ensure that their subcontractors have plans and submit required reports, and there will also be costs to the Government to evaluate whether the prime contractor's goals adequately address maximum practicable small business subcontracting opportunity at all tiers. SBA estimates that there were approximately 34,000 individual subcontracting plans in fiscal year 2015, and that approximately 24,000 were at the prime contract level. Other than small firms may have multiple individual subcontracting plans at the prime and sub level, so the number of other than small firms affected by this rule will be less than the number of individual subcontracting plans, but we cannot say with any precision how many will be impacted. There may also be costs to the Government as eSRS may have to be modified to allow other than small prime contractors to receive small business credit at any tier towards their subcontracting plan goals. However, SBA is not able to estimate these costs because the system will be modified when this rule is implemented into the FAR and the process for capturing the lower tier reports is further defined. There should not be any costs imposed on small business concerns as this rule does not change any reporting or recordkeeping requirements for small business concerns.

Many of the final regulations are required to implement specific statutory provisions which require promulgation of implementing regulations. There are no other alternatives that would meet the statutory requirements.

As part of its ongoing efforts to engage stakeholders in the development of its regulations, SBA has solicited comments and suggestions from the public and the procuring agencies on how to best implement section 1614 of NDAA 2014. For example, SBA received comments from the American Bar Association Section of Public Contract Law, the Associated General Contractors of America, the Council of Defense and Space Industry Associations, the U.S. Women's Chamber of Commerce, and Women Impacting Public Policy (WIPP).

SBA has incorporated those comments and suggestions to the extent feasible. SBA has considered the comments received in response to the proposed rule and incorporated public input into the final rule to the extent feasible.

For purposes of Executive Order 12988, SBA has drafted this final rule, to the extent practicable, in accordance with the standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988, to minimize litigation, eliminate ambiguity, and reduce burden. This rule has no preemptive or retroactive effect.

For the purpose of Executive Order 13132, SBA has determined that this final rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various layers of government. Therefore, SBA has determined that this final rule has no federalism implications warranting preparation of a federalism assessment.

For purposes of the Paperwork Reduction Act (PRA), SBA has determined that this final rule, if adopted in final form, would not impose new government-wide reporting and recordkeeping requirements on other than small prime contractors and subcontractors. If any information collection procedures change or are amended during the subsequent FAR rulemaking of this SBA rule, they will be addressed in the FAR rulemaking process.

According to the Regulatory Flexibility Act (RFA), 5 U.S.C. 601, when an agency issues a rulemaking, it must prepare a regulatory flexibility analysis to address the impact of the rule on small entities. However, section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. The RFA defines “small entity” to include “small businesses,” “small organizations,” and “small governmental jurisdictions.” This final rule concerns various aspects of SBA's contracting programs. As such, the rule relates to small business concerns, but would not affect “small organizations” or “small governmental jurisdictions” because those programs generally apply only to “business concerns” as defined by SBA regulations, in other words, to small businesses organized for profit. “Small organizations” or “small governmental jurisdictions” are non-profits or governmental entities and do not generally qualify as “business concerns” within the meaning of SBA's regulations.

This rule will impact other than small business concerns, as small business concerns are not required to have subcontracting plans. Other portions of the rule simply clarify existing regulations, and do not impose new requirements on small business concerns. As discussed previously, SBA's rules currently require firms to certify their size and socioeconomic status in connection with subcontracts. This rule simply clarifies that the requirement to certify applies to the solicitation for the subcontract. In sum, the final rule will not have a disparate impact on small businesses or impose any additional costs on small business concerns. For the reasons discussed, SBA certifies that this final rule will not have a significant economic impact on a substantial number of small business concerns.

For the reasons stated in the preamble, SBA amends 13 CFR parts 121 and 125 as follows:

On November 3, 2016, the Securities and Exchange Commission adopted a temporary rule, Rule 608T, under the Securities Exchange Act of 1934 to extend to November 15, 2016, the date by which the Commission was required to act on the proposed National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan”). Rule 608T solely governed the timeframe for action on the proposed CAT NMS Plan. The Commission adopted the temporary rule as an interim final temporary rule in light of the impending November 10, 2016 date designated by the Commission under Rule 608 as the date by which the Commission would take action on the proposed CAT NMS Plan. The Commission designated 12:01 a.m. on November 16, 2016, as the expiration time for Rule 608T because after that time the temporary rule would no longer be necessary.

On November 3, 2016, the Commission published the temporary rule on its Web site. Due to a subsequent clerical error, the temporary rule was not published in the Federal Register. On November 8, 2016, the Commission provided public notice of its scheduled open meeting to consider the CAT NMS Plan, posting the notice on its Web site, and on November 15, 2016, the Commission approved the CAT NMS Plan at its open meeting. The expiration time of 12:01 a.m. on November 16, 2016 for the temporary rule has now passed.

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device.

On October 26, 2015, Concentric Medical, Inc., submitted a request for classification of the Trevo ProVue and XP ProVue Retrievers (Trevo Retrievers) under section 513(f)(2) of the FD&C Act.

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on September 2, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.5600.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a neurovascular mechanical thrombectomy device for acute ischemic stroke treatment will need to comply with the special controls named in this final order.

The device is assigned the generic name neurovascular mechanical thrombectomy device for acute ischemic stroke treatment, and it is identified as a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

FDA has identified the following risks to health associated specifically with this type of device, as well as the measures required to mitigate these risks in table 1.

FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness.

Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment devices are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109 Prescription devices).

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment they intend to market.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:

In this document, the Bureau of Prisons (Bureau) finalizes a minor technical change to its regulations on contraband and inmate personal property to maintain consistency in language which describes the purpose of the regulations as ensuring the “safety, security, or good order of the facility or protection of the public.”

Variations on this phrase appear throughout the Bureau's regulations in 28 CFR Chapter V. See 28 CFR 500.1(h), 501.2(b), 501.3(b), 511.10(a), 511.11(a), 511.12(a), 511.15(b), 511.17(b), 540.12(a), 540.14(c) and (d), 540.15(d), 540.40, 540.44(c), 540.51(h), 540.70, 540.71(b) and (d), 540.100(a), 540.101(a), 541.12, 541.43(b), 541.63(c), 543.11(f), 543.14(a) and (c), 543.15(c), 543.16(b), 544.20, 544.21(b), 548.10, 548.16-548.18, 549.13(b), 549.50, 549.51(b), 551.1, 551.10, 551.12(d), 551.16(a), 551.31(b), 551.34(b), 551.35, 551.71(d), 551.110(a), 551.112(b), 551.113(a), 551.115(a), 552.13(b), 552.20, 552.21(a) and (d), 553.11(h), 553.12(b).

The Bureau has conformed the phrase in all revised regulations since approximately 2005. This rule likewise conforms this phrase in the Bureau's regulations on contraband. An interim rule on this subject was published on August 3, 2015 (80 FR 45883), and became effective on September 2, 2015, although public comments were accepted until October 2, 2015.

Prior to the September 2, 2015, effective date of the interim rule, the definition of contraband in § 500.1(h) read as follows: “Contraband is material prohibited by law, or by regulation, or material which can reasonably be expected to cause physical injury or adversely affect the security, safety, or good order of the institution.” The interim rule conformed the “security, safety, or good order” phrase to the language we have used in recent years, to read as follows: “Contraband is material prohibited by law, regulation, or policy that can reasonably be expected to cause physical injury or adversely affect the safety, security, or good order of the facility or protection of the public.”

Likewise, to conform the phrase and underscore the importance of prohibiting contraband, we added the phrase to the end of the first sentence of § 553.10, regarding inmate personal property, to read as follows: “It is the policy of the Bureau of Prisons that an inmate may possess ordinarily only that property which the inmate is authorized to retain upon admission to the institution, which is issued while the inmate is in custody, which the inmate purchases in the institution commissary, or which is approved by staff to be mailed to, or otherwise received by an inmate, that does not threaten the safety, security, or good order of the facility or protection of the public.” [Emphasis added.] Further, § 543.12(b) contained another description/definition of contraband, categorizing it as either “hard contraband” or “nuisance contraband.” The interim rule added the “safety, security” phrase to this regulation as well.

It is important to note that neither the interim nor this final rule change the substantive requirements or obligations relating to petitions for commutation of sentence, nor do they seek to alter the Bureau's responsibilities in this regard.

We received two comments on the August 3, 2015 interim rule via the publicly-accessible regulations.gov Web site.

One commenter requested that the Bureau of Prisons “plainly spell out the changes that are being put out for public notice,” indicating confusion with regard to the interim rule changes.

The interim rule contained an explanation of the changes made by the interim rule. It is possible that the commenter may have read only the summary available on the regulations.gov Web site, rather than the entire interim rule document. However, for the benefit of any who may have been confused by the interim rule, we offer the following explanation.

The interim rule document made a minor technical change to the Bureau of Prisons regulations on contraband and inmate personal property: We added the phrase “safety, security, or good order of the facility or protection of the public.” We did this to show that this is the purpose of the contraband regulations—to ensure the “safety, security, or good order of the facility or protection of the public.” We also did this because this phrase appears, for the same purpose, throughout the Bureau's other regulations, and we have used this phrase in new regulations, when possible, since 2005. The addition of the phrase did not change the meaning or requirements of the regulations to which it was added, and did not alter the Bureau's responsibilities.

The second commenter stated as follows: “So many times inmates come to facilities and mix with wrong crowds out of fear or intimidation. Leaving lockers unlocked due to [comfort] and many other reasons. These things should be [taken into account] if this happens three times in one year they should be further reviews on the inmates. This is not tolerated but common for Camps.” This comment is not relevant to the current regulation change, which does not discuss inmate lockers or storage of personal property. The Bureau will take this comment into consideration when developing new policy with regard to inmates in federal prison camps.

For the aforementioned reasons, the Bureau now finalizes the interim rule published on August 2, 2015, without change.

Executive Order 12866. This regulation falls within a category of actions that the Office of Management and Budget (OMB) has determined not to constitute “significant regulatory actions” under section 3(f) of Executive Order 12866 and, accordingly, it was not reviewed by OMB.

Executive Order 13132. This regulation will not have substantial direct effect on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, under Executive Order 13132, we determine that this regulation does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

Regulatory Flexibility Act. The Director of the Bureau of Prisons, under the Regulatory Flexibility Act (5 U.S.C. 605(b)), reviewed this regulation and by approving it certifies that it will not have a significant economic impact upon a substantial number of small entities for the following reasons: This regulation pertains to the correctional management of offenders committed to the custody of the Attorney General or the Director of the Bureau of Prisons, and its economic impact is limited to the Bureau's appropriated funds.

Unfunded Mandates Reform Act of 1995. This regulation will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996. This regulation is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This regulation will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Electronic Availability

This document and additional information concerning OFAC are available from OFAC's Web site (www.treasury.gov/ofac).

OFAC first issued regulations to implement TSRA (22 U.S.C. 7201 et seq.) on July 12, 2001 (66 FR 36683). Since then, OFAC has amended the licensing provisions of the ITSR (and its predecessor, the Iranian Transactions Regulations), 31 CFR part 560, as they relate to the exportation and reexportation of agricultural commodities, medicine, or medical devices to Iran on a number of occasions. As set forth in more detail below, OFAC is adopting a final rule to amend the licensing provisions of the ITSR to expand the scope of medical devices and agricultural commodities generally authorized for export or reexport to Iran and, in response to feedback from the regulated public regarding improving patient safety, provide new or expanded authorizations relating to training, replacement parts, software and services related to the operation, maintenance, and repair of medical devices, and items that are broken or connected to product recalls or other safety concerns.

TSRA provides that, with certain exceptions, the President may not impose a unilateral agricultural sanction or unilateral medical sanction against a foreign country or foreign entity unless, at least 60 days before imposing such a sanction, the President submits a report to Congress describing the proposed sanction and the reasons for it and Congress enacts a joint resolution approving the report. See 22 U.S.C. 7202. Section 906 of TSRA, however, requires in pertinent part that the export of agricultural commodities, medicine, or medical devices to the government of a country that has been determined by the Secretary of State, pursuant to, inter alia, Section 6(j) of the Export Administration Act of 1979 (50 U.S.C. App. 2405(j)), to have repeatedly provided support for acts of international terrorism,1 or to any entity in such a country, shall be made pursuant to one-year licenses issued by the United States Government, except that the requirements of such one-year licenses shall be no more restrictive than general licenses administered by the Department of the Treasury. See 22 U.S.C. 7205(a)(1). Section 906 also specifies that procedures shall be in place to deny licenses for exports of agricultural commodities, medicine, or medical devices to any entity within such country promoting international terrorism.

As provided in Section 221 of the USA PATRIOT Act (Pub. L. 107-56) (codified at 22 U.S.C. 7210), nothing in TSRA shall limit the application or scope of any law, including any Executive order or regulation promulgated pursuant to such law, establishing criminal or civil penalties for the unlawful export of any agricultural commodity, medicine, or medical device to: A Foreign Terrorist Organization; a foreign organization, group, or person designated pursuant to Executive Orders 12947 or 13224 (sanctions on terrorists and certain supporters of terrorism); weapons of mass destruction or missile proliferators; or designated narcotics trafficking entities. In addition, TSRA provides in Section 904(2) that the restrictions on the imposition of unilateral agricultural sanctions or unilateral medical sanctions shall not affect any authority or requirement to impose a sanction to the extent such sanction applies to any agricultural commodity, medicine, or medical device that is controlled on the United States Munitions List (USML), controlled on any control list established under the Export Administration Act of 1979 or any successor statute, or used to facilitate the design, development, or production of chemical or biological weapons, missiles, or weapons of mass destruction. See 22 U.S.C. 7203(2).

On October 22, 2012, OFAC adopted a final rule that, among other things, added a general license in § 560.530(a)(3) of the ITSR that authorized the exportation or reexportation of medicine and basic medical supplies to the Government of Iran, to individuals or entities in Iran, or to persons in third countries purchasing specifically for resale to any of the foregoing, and the conduct of related transactions (see 77 FR 64664). The term “basic medical supplies” was defined to mean those medical devices, as defined in the ITSR, that were included on the List of Basic Medical Supplies made available on OFAC's Web site and published in the Federal Register, but did not include replacement parts. On April 17, 2014, OFAC adopted a final rule that, among other things, updated the definition of “basic medical supplies” to exclude the word “basic” and make related conforming changes, including renaming the list on OFAC's Web site as the “List of Medical Supplies” (see 79 FR 18990). On November 2, 2015 and April 12, 2016, OFAC updated the List of Medical Supplies to add additional medical devices to the list.

Also on April 17, 2014, OFAC expanded an existing general license in § 560.530(a)(2) that authorized the exportation and reexportation of food to authorize the exportation or reexportation of the broader category of agricultural commodities, with certain specified exceptions, to the Government of Iran, to individuals or entities in Iran, or to persons in third countries purchasing specifically for resale to any of the foregoing, and the conduct of related transactions (see 79 FR 18980). OFAC also added a general license in § 560.530(a)(4) authorizing the exportation or reexportation of replacement parts for certain medical devices, provided that the replacement parts are designated as EAR99 or, in the case of replacement parts that are not subject to the EAR, would be designated as EAR99 if they were located in the United States, and further provided that the replacement parts are limited to a one-for-one basis of exchange (i.e., only one replacement part can be exported or reexported to replace a broken or non-operational component).

Since these amendments, in consultation with the Department of State, OFAC has routinely issued specific licenses authorizing the exportation or reexportation of certain additional medical devices and agricultural commodities to the Government of Iran, to individuals or entities in Iran, or to persons in third countries purchasing such goods specifically for resale to any of the foregoing. In addition, OFAC has continued to receive feedback from the regulated public and review its TSRA licensing procedures, particularly the procedures for licensing exports and reexports of medical devices and agricultural commodities.

As a result of this review, OFAC today is amending the general license relating to authorized sales of certain medical devices in § 560.530(a)(3) to expand the scope of medical devices that may be exported or reexported to Iran without specific authorization. OFAC is also narrowing the list of agricultural commodities excluded from the general license relating to authorized sales of agricultural commodities in § 560.530(a)(2). In addition, in response to feedback from the regulated public regarding improving patient safety, OFAC is making the following changes: Expanding existing general licenses to authorize the provision of training for the safe and effective use or operation of agricultural commodities, medicine, and medical devices; expanding an existing general license authorizing the exportation or reexportation to Iran of replacement parts to permit certain additional replacement parts to be exported or reexported and stored for future use; adding a new general license to authorize the exportation and reexportation to Iran of software and services related to the operation, maintenance, and repair of medical devices previously exported pursuant to an OFAC authorization; and adding a new general license to authorize the importation into the United States of items previously exported pursuant to an OFAC authorization in connection with product recalls, adverse events, or other safety concerns, as set forth in more detail below.

Additional medical devices. OFAC is amending the existing general license in § 560.530(a)(3) relating to authorized exports or reexports of certain medical devices specified on the List of Medical Supplies. As amended, the general license has been expanded to authorize the exportation or reexportation to Iran of all items meeting the definition of the term “medical device” as set forth in § 560.530(e)(3), except for certain medical devices that are explicitly excluded from the authorization as specified in a new List of Medical Devices Requiring Specific Authorization, which is maintained on OFAC's Web site on the Iran Sanctions page, as set forth in revised § 560.530(a)(3)(ii). The List of Medical Devices Requiring Specific Authorization will also be published in the Federal Register, as will any changes to this list. The exportation and reexportation of the specified excluded medical devices requires specific authorization from OFAC, as reflected in amended § 560.530(a)(1)(ii)(C). Medical devices other than those specified on the new List of Medical Devices Requiring Specific Authorization may be exported or reexported to Iran without separate authorization from OFAC. In light of these changes, this rule also eliminates reference to the List of Medical Supplies.

Excluded agricultural commodities. OFAC is also narrowing the list of excluded agricultural commodities set forth in § 560.530(a)(2)(ii). Pursuant to this amendment, the general license in § 560.530(a)(2) now authorizes the exportation or reexportation to Iran of shrimp and shrimp eggs.

Training. OFAC is adding a new provision in § 560.530(a)(2)(iv) to generally authorize the provision of training necessary and ordinarily incident to the safe and effective use of agricultural commodities exported or reexported pursuant to the general license in § 560.530(a)(2). OFAC similarly is adding a new provision in § 560.530(a)(3)(v) to authorize the provision of training necessary and ordinarily incident to the safe and effective use or operation of medicine and medical devices exported or reexported pursuant to the general license in § 560.530(a)(3).

Additional replacement parts. OFAC is amending the existing general license in § 560.530(a)(4) authorizing exports or reexports of and related transactions for replacement parts for certain medical devices that are designated as EAR99 or, in the case of replacement parts that are not subject to the EAR, would be designated as EAR99 if they were located in the United States, on a one-for-one export or reexport basis of exchange. As amended, the general license removes the requirement for a one-for-one basis of exchange and allows the exportation and reexportation of such replacement parts provided that they are intended to replace a broken or nonoperational component of a medical device previously exported or reexported to Iran pursuant to an OFAC authorization or that the exportation or reexportation of the replacement part is ordinarily incident and necessary to the proper preventative maintenance of such a medical device, and further provided that the number of replacement parts that are exported or reexported to and stored in Iran does not exceed the number of corresponding parts in use in relevant medical devices in Iran.

Software and services related to the operation, maintenance, and repair of medical devices. OFAC is adding a new general license in § 560.530(a)(5) to authorize the exportation or reexportation to Iran of software and services related to the operation, maintenance, and repair of medical devices that previously were exported or reexported to Iran pursuant to an OFAC authorization, provided that, among other things, such software is designated as EAR99, or in the case of software that is not subject to the EAR, would be designated as EAR99 if it were located in the United States. In § 560.530(a)(5)(i), OFAC is adding an authorization for the exportation or reexportation to Iran of software necessary for the installation and operation of medical devices authorized for export or reexport by OFAC. In § 560.530(a)(5)(ii), OFAC is adding an authorization to allow the exportation or reexportation of software updates for those devices. In § 560.530(a)(5)(iii), OFAC is adding an authorization for repair services for medical devices authorized for export or reexport to Iran by OFAC, including inspection, testing, calibration, and diagnostic services to ensure patient safety or effective operation of such medical devices.

Importation of items that are broken, defective, or non-operational or in connection with product recalls, adverse events, or other safety concerns. OFAC also is adding a new general license in § 560.530(a)(6) to authorize the importation into the United States of certain U.S.-origin agricultural commodities, medicine, and medical devices that previously were exported or reexported to Iran pursuant to the authorization in § 560.530 and that are broken, defective, or non-operational or connected to product recalls, adverse events, or other safety concerns.

Conforming change to section headings. In light of the addition of several new general licenses in § 560.530, OFAC is also making a conforming change to the section heading to reflect the additions. As the new general licenses require the payment and financing terms set forth in § 560.532, OFAC is making a similar conforming change to that section heading to reflect the additions.

To address inquiries from the regulated public, including with regard to the status of goods on vessels and aircraft, OFAC also is amending the definition in § 560.306 of the terms goods of Iranian origin and Iranian-origin goods to clarify that this definition does not include certain categories of goods, provided that such goods were not grown, produced, manufactured, extracted, or processed in Iran. First, the amended definition excludes goods exported or reexported to Iran under an authorization issued pursuant to this part (e.g., a medical device or a personal communications device exported or reexported to Iran pursuant to a general or specific license issued pursuant to this part) and that have subsequently been reexported from and are located outside of Iran. Second, the amended definition also clarifies that it does not include goods transported on a vessel or aircraft, as well as the underlying vessel or aircraft itself, that passed though Iranian territorial waters or stopped at a port or place in Iran en route to a destination outside of Iran and that have not otherwise come into contact with Iran. A note clarifies that, pursuant to this section, goods that are temporarily offloaded from a vessel in Iranian territorial waters or at a port in Iran and reloaded onto the same vessel or another vessel in the same location en route to a destination outside of Iran and that have not otherwise come into contact with Iran are not considered goods of Iranian origin. Similarly, goods that are offloaded from an aircraft at a place in Iran and reloaded onto the same aircraft or another aircraft in the same location en route to a destination outside of Iran and that have not otherwise come into contact with Iran are not considered goods of Iranian origin. This amended definition is relevant to the prohibitions in §§ 560.201 and 560.206 of the ITSR, which remain in place; it is not relevant to the prohibitions in §§ 560.204, 560.205, and 560.211 on exports of goods to Iran and on transactions in goods involving blocked persons, which also remain in place.

Because the amendment of the ITSR involves a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information related to the ITSR are contained in 31 CFR part 501 (the Reporting, Procedures and Penalties Regulations). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. 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 the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends 31 CFR part 560 as follows:

I. Background

On August 1, 2016 (81 FR 50427 and 81 FR 50336), EPA simultaneously published a notice of proposed rulemaking (NPR) and a direct final rule (DFR) for the State of Maryland. On September 16, 2016 (81 FR 63701), EPA withdrew the DFR due to the receipt of a comment on the proposed rulemaking. In the NPR, EPA proposed to include in the Maryland SIP a Maryland regulation which adopted the requirements in EPA's CTG for fiberglass boat manufacturing materials. The formal SIP revision (#15-07) was submitted by Maryland on December 23, 2015.

As described in the DFR published on August 1, 2016 (81 FR 50336), section 172(c)(1) of the CAA provides that SIPs for nonattainment areas must include reasonably available control measures (RACM), including reasonably available control technology (RACT), for sources of emissions. Additionally, Maryland is in the Ozone Transport Region (OTR) established under section 184(a) of the CAA. Pursuant to section 184(b)(1)(B) of the CAA, all areas in the OTR must submit SIP revisions that include implementation of RACT with respect to all sources of volatile organic compounds (VOC) in the states covered by a CTG. See CAA section 184(b)(1).

In September 2008, EPA developed a CTG entitled Control Techniques Guidelines for Fiberglass Boat Manufacturing Materials (Publication No. EPA 453/R-08-004). The CTG for fiberglass boat manufacturing materials provides control recommendations for reducing VOC emissions from the use of gel coats, resins, and materials used to clean application equipment in fiberglass boat manufacturing operations. This CTG applies to facilities that manufacture hulls or decks of boats from fiberglass or build molds to make fiberglass boat hulls or decks.

On December 23, 2015, the Maryland Department of the Environment (MDE) submitted on behalf of the State of Maryland to EPA SIP revision #15-07 concerning implementation of RACT requirements for the control of VOC emissions from fiberglass boat manufacturing materials. Maryland adopted EPA's CTG standards for fiberglass boat manufacturing materials through a regulation found at Code of Maryland Regulations (COMAR) 26.11.19 (relating to VOC from specific processes). This SIP revision adds COMAR 26.11.19.26-1 (control of VOC emissions from fiberglass boat manufacturing materials) to the Maryland SIP and also includes an amendment to COMAR 26.11.19.26 (control of VOC emissions from reinforced plastic manufacturing) which was previously approved into the Maryland SIP. In addition to adopting EPA's CTG standards, COMAR 26.11.19.26-1 includes numerous terms and definitions to support the interpretation of the measures, as well as work practices for cleaning, compliance and monitoring requirements, sampling and testing, and record keeping requirements. The amendment to COMAR 26.11.19.26 at COMAR 26.11.19.26A exempts fiberglass boat manufacturing from provisions within COMAR 26.11.19.26 to avoid duplicative or conflicting requirements. Prior to Maryland's new COMAR 26.11.19.26-1, fiberglass boat manufacturing materials were covered under COMAR 26.11.19.26 which did not address fully EPA's CTG requirements. Thus, with COMAR 26.11.19.26-1 now addressing fiberglass boat manufacturing materials, Maryland has revised COMAR 26.11.19.26A to clarify and exempt fiberglass boat manufacturing materials from COMAR 26.11.19.26A as these are now clearly addressed in COMAR 26.11.19.26-1. EPA finds the provisions in COMAR 26.11.19.26-1 identical to the CTG standards for fiberglass boat manufacturing materials and therefore approvable in accordance with sections 172(c)(1) and 184(b)(1)(B) of the CAA.

EPA received a comment from the Export Inspection Council of India within the Ministry of Commerce and Industry, Government of India (hereinafter referred to as “Commenter”) on the August 1, 2016 NPR.

Comment: The Commenter sought clarification to determine if Maryland's adoption of EPA's CTG guidelines for fiberglass boat manufacturing materials applied to international manufacturing facilities that export fiberglass boats into the United States. Additionally, if the proposed guidelines are applicable to imported boats, the Commenter questioned how EPA will implement the guidelines and if they will add to the international import requirements of fiberglass boats into the United States.

Response: EPA thanks the Commenter for its submission seeking clarification of the Maryland regulation on fiberglass boat manufacturing. COMAR 26.11.19.26-1 applies to fiberglass manufacturing facilities that manufacture hulls or decks of fiberglass boats, assemble fiberglass boats from premanufactured hulls and decks, or build molds to make hulls or decks of fiberglass boats. See COMAR 26.11.19.26-1(B)(5). As such, the regulation applies only to manufacturing, assembling or building occurring within Maryland and does not apply to fiberglass boats imported into the State from other locations, including from locations overseas. In addition, under Annotated Code of Maryland § 2-103(b), Maryland and the Maryland Department of the Environment specifically only have jurisdiction over emissions into the air in the State and over ambient air quality in the State of Maryland. Because Maryland's regulatory authority therefore does not extend to regulating activities outside the State, EPA is clarifying that COMAR 26.11.19.26-1 does not regulate nor apply to fiberglass boat manufacturing done outside the State of Maryland. Because the regulation does not apply to fiberglass boat manufacturing outside the State of Maryland, EPA need not respond to the Commenter's inquiry as to how COMAR 26.11.19.26-1 would be implemented for imported fiberglass boats. Finally, EPA clarifies that COMAR 26.11.19.26-1 does not add to import requirements for fiberglass boats being imported into Maryland.

EPA is approving the December 23, 2015 Maryland SIP submittal, which revises the Maryland SIP by adding new regulation COMAR 26.11.19.26-1 and amending COMAR 26.11.19.26, because the SIP submittal meets the requirement to adopt RACT for sources covered by EPA's CTG standards for fiberglass boat manufacturing materials and is in accordance with requirements in CAA sections 172, 182 and 184.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of COMAR 26.11.19.26-1 and an amendment to COMAR 26.11.19.26 addressing VOC content limits for fiberglass boat manufacturing into the Maryland SIP. Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.1 EPA has made, and will continue to make, these materials generally available through http://www.regulations.gov and/or at the EPA Region III Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 21, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action approving the Maryland SIP revision adding new regulation COMAR 26.11.19.26-1 and amending COMAR 26.11.19.26 may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

EPA Region III is publishing this direct final Notice of Partial Deletion of a portion the North Penn Area 6 Superfund Site from the National Priorities List (NPL). This partial deletion pertains to the soils and groundwater of the Administrative Parcel portion of the Site. The NPL constitutes Appendix B of 40 CFR part 300, which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). This partial deletion of the North Penn Area 6 Site is proposed in accordance with 40 CFR 300.425(e) and is consistent with the Notice of Policy Change: Partial Deletion of Sites Listed on the National Priorities List. 60 FR 55466 (Nov. 1, 1995). As described in 40 CFR 300.425(e)(3) of the NCP, a portion of a site deleted from the NPL remains eligible for Fund-financed remedial actions if future conditions warrant such actions.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses the procedures that EPA is using for this action. Section IV discusses the Administrative Parcel of the North Penn Area 6 Superfund Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the Administrative Parcel portion of the Site from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the Commonwealth, whether any of the following criteria have been met:

i. Responsible parties or other persons have implemented all appropriate response actions required;

ii. all appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

iii. the remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.

Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates such action is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to deletion of the Administrative Parcel portion of the Site:

(1) EPA consulted with the Commonwealth of Pennsylvania prior to developing this direct final Notice of Partial Deletion and the Notice of Intent for Partial Deletion co-published today in the “Proposed Rules” section of the Federal Register.

(2) EPA provided the Commonwealth 30 working days for review of this notice and the parallel Notice of Intent for Partial Deletion prior to their publication today, and the Commonwealth, through PADEP, concurred on the partial deletion of the Site from the NPL.

(3) Concurrently with the publication of this direct final Notice of Partial Deletion, a notice of the availability of the parallel Notice of Intent for Partial Deletion is being published in a major local newspaper, The Reporter. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent for Partial Deletion of the Site from the NPL.

(4) The EPA placed copies of documents supporting the partial deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this partial deletion action, EPA will publish a timely notice of withdrawal of this direct final Notice of Partial Deletion before its effective date, and will prepare a response to comments and continue with the deletion process, as appropriate, on the basis of the Notice of Intent for Partial Deletion and the comments already received.

Deletion of a portion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a portion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

The following information provides EPA's rationale for deleting the Administrative Parcel portion of the Site from the NPL:

The North Penn Area 6 Superfund Site (EPA Identification Number PAD980926976) is located primarily in Lansdale Borough, Montgomery County, Pennsylvania. The Site is comprised of multiple properties contaminated primarily with volatile organic compounds (VOCs) in the soil and associated groundwater contamination. One of the properties consists of approximately 10 acres of land located at 135 East Hancock Street in Lansdale Borough (the “Property”). The Property was formerly occupied by the Tate Andale Company, and later by the Rogers Mechanical Company. The Administrative Parcel is comprised of approximately 6.5 acres located within the Property.

The current owner of the Property, including the Administrative Parcel, is Andale Properties, LLC. Andale Properties, LLC plans to redevelop the Property for future residential purposes. Andale Properties, LLC has divided the Property into four Phases (1 through 4) for redevelopment. The Administrative Parcel is comprised of Phases 2 and 3.

The Property is currently occupied by three buildings, portions of two former structures, and footers and concrete pads from previous on-site buildings. A treatment system operated currently by EPA for treatment of groundwater and multiple monitoring wells are also present at the Property. The Property is bordered to the southwest by East Hancock Street, and to the west, northwest, and east by railroad lines. The ground surface elevation of the Property is approximately 370 feet above mean sea level. The Property consists of relatively flat terrain with a gradual slope towards the southwest. There are no surface water bodies located within the boundaries of the Property. The nearest body of water is the Towamencin Creek, which is located approximately 2,800 feet southwest of the Property. Surface water runoff following precipitation events either infiltrates the ground surface or drains towards the western portion of the Property prior to entering a swale adjacent to the neighboring railroad tracks. Surrounding land use includes commercial, industrial, and residential uses.

The Tate Andale Company formerly occupied the Property dating back to at least the 1920s, and historically used the Property to fabricate oil coolers, heaters, and strainers. Rogers Mechanical Company purchased the Property in 1985 and operated a plumbing and heating business. The former Tate Andale Company was one of twenty-six property owners/operators to be identified as a potentially responsible party (PRP) at the Site following the detection of groundwater contamination in the Lansdale area in 1979. North Penn Area 6 was proposed to the National Priorities List on January 22, 1987 (52 FR 27620), and became a Superfund Site when the listing became final on March 31, 1989 (54 FR 13296). EPA divided the Site into three operable units (OUs). Operable Unit One (OU1) consists of Fund-financed response actions to address the contaminated soils at certain of the properties that comprise the Site. Operable Unit Two (OU2) consists of PRP-financed response actions to address the contaminated soils at certain other properties that comprise the Site. Operable Unit Three (OU3) consists of Fund-financed and PRP-financed response actions to address the contaminated groundwater over the entire Site. All activities associated with investigation and remediation at the Property were performed by EPA and financed by the Fund, and are part of OU1 and OU3. The Administrative Parcel consists of soils and groundwater on the aforementioned approximately 6.5 acre portion of the Property.

Soils at the Property were investigated as part of the OU1 Remedial Investigation and Feasibility Study (RI/FS). The OU1 RI at the Property focused primarily on a coal ash and scrap metal pile located on the southwestern portion of the Property and another area on the eastern portion of the Property. Soil gas and soil samples were collected from these areas, and elevated levels of VOCs were found in the area on the eastern portion of the Property. Trichloroethylene (TCE) was detected at concentrations up to 4600 μg/kg, and contaminants associated with the breakdown of TCE were also found at elevated levels. The Risk Assessment determined that the contaminant levels would present a risk to groundwater, and a cleanup standard of 131 μg/kg for TCE in soil was determined to protect groundwater. An area comprising roughly 18,000 cubic feet of soil on the east side of the Property was determined to require treatment. The OU1 Feasibility Study considered alternatives for remediation of the VOC-contaminated soil including No Action, Containment with Cap, Vapor Extraction, Low Temperature Thermal Desorption, Soil Washing/Biotreatment, Excavation and Off-site Disposal, and In-Place Processing with Hot Air Injection.

The Property was one of four properties addressed in the 1995 Record of Decision (ROD) for OU1. The OU1 Remedial Action Objective was to prevent further contamination of groundwater from contaminated soils. The selected alternative was in-place processing using hot air injection, with excavation and off-site disposal as a back-up. During the Remedial Design, it was determined that hot air injection would not achieve the performance standards of the OU1 ROD, and the backup remedy of excavation and off-site disposal was used to meet performance standards. Approximately 861 cubic yards of contaminated soil were removed from the Property as part of the OU1 remedial action and disposed of in a Resource Conservation and Recovery Act (RCRA) permitted landfill facility in Model City, New York. EPA approved the OU1 remedial action report for the Property in 2001.

OU2 consists of soils investigations at certain enforcement-lead properties. The Property (including the Administrative Parcel to be deleted from the NPL) is not included in OU2.

Groundwater contamination was investigated as part of the RI/FS for OU3. Groundwater contamination at the Property is focused primarily in the southwestern portion of the Property. The OU3 RI/FS found contamination from VOCs at unacceptable levels in monitoring wells and a former production well (TA-1) on the Property. Contamination in well TA-1 was found at concentrations up to 7,740 μg/L of TCE, and the Property was included in the OU3 Feasibility Study to evaluate alternatives for treatment of the groundwater. The OU3 Feasibility Study considered several alternatives involving extraction of contaminated groundwater using differing treatment technologies and differing discharge points.

The Property was included in the OU3 ROD in 2000, which called for construction of groundwater extraction and treatment systems at several properties, including the Property, included in the Site to remediate the contaminated groundwater. The goal of the groundwater extraction and treatment systems is to restore the aquifer to beneficial use as a potable use aquifer. The major components of the selected remedy in the OU3 ROD include the following:

• Completion of a groundwater remedial design study to determine the most efficient design of a groundwater extraction and treatment system.

• Installation, operation, and maintenance of on-site groundwater extraction wells to remove contaminated groundwater from beneath the Site and to prevent contaminants from migrating off-site.

• Installation, operation, and maintenance of air stripping treatment at on-site groundwater extraction wells to treat groundwater to required cleanup levels.

• Construction, operation, and maintenance of a pipeline from the on-site groundwater treatment systems to the nearest surface water body or storm drain leading to a surface water body.

• Periodic sampling of groundwater and treated water to ensure treatment components are effective and groundwater remediation is progressing towards the cleanup levels.

During the Remedial Design of the groundwater extraction and treatment system at the Property, EPA conducted a pump test on the extraction well at the Property. The well failed to produce an adequate yield of contaminated water to treat to significantly improve groundwater quality. As a result, EPA conducted additional testing to determine if adding a vapor extraction unit to the treatment system at the Property would increase contaminant removal and improve the performance of the OU3 selected remedy at the Property. Based on those results, EPA issued an Explanation of Significant Differences (ESD) on September 16, 2009, requiring implementation of a modified remedy at the Property which includes vapor extraction to enhance the performance of the remedy selected in the OU3 ROD. Testing also indicated that significant cost savings could be achieved by replacing the air stripper at the Property with a vessel containing granular activated carbon (GAC). Therefore, the ESD further allowed EPA to modify the OU3 remedy at the Property to allow for this form of treatment. The treatment system at the Property was built, and determined to be operational and functional in 2012. EPA plans on transferring the groundwater treatment system at the Property to PADEP for Operation and Maintenance (O&M) in 2022.

During the Remedial Design of the OU1 remedy to address contaminated soils at the Property, it was determined that the alternative selected in the OU1 ROD would not achieve the performance standards of the ROD; therefore, the backup remedy of excavation and off-site disposal was used to meet the performance standards. Approximately 861 cubic yards of contaminated soil were removed from the Property as part of the OU1 remedial action. EPA approved the OU1 remedial action report for the Property in 2001. No further actions to remediate the soil at the Property have been required.

During the Remedial Design of the OU3 remedy to address contaminated groundwater at the Property, it was determined that the alternative selected in the OU3 ROD would not treat enough contaminated water at the Property to significantly improve groundwater quality. As a result, EPA issued the ESD to require a modified remedy at the Property which includes vapor extraction and allows for the replacement of the air stripper with a vessel containing GAC to enhance the performance of the remedy selected in the OU3 ROD. EPA built the treatment system at the Property, and determined that it was operational and functional in 2012. EPA continues to operate and maintain the groundwater treatment system at the Property.

In the OU1 ROD, EPA selected a soil cleanup level of 131 μg/kg of trichloroethylene (TCE) to be protective of groundwater. To expedite backfilling of excavated areas at the Property, EPA conducted Quality Control sampling prior to excavation to delineate the extent of contamination, and eliminate the need to keep excavation areas open while additional sampling and analysis were being performed to determine if the performance standard (cleanup level) for soil in the OU1 ROD had been met. Thirty samples were collected at the Property and sent for analysis. The performance standard was exceeded at one location; therefore, additional samples were collected further out. As a result of the sampling, the boundary of excavation was extended out five feet to comply with the OU1 performance standard. After the excavation and off-site disposal of soils was completed, EPA certified the OU1 Remedial Action at the Property to be complete.

The OU3 remedy to address contaminated groundwater called for restoration of the aquifer to beneficial use as a potable use aquifer. The OU3 ROD set the groundwater cleanup level as the EPA Maximum Contaminant Level (MCL). The MCL for TCE is 5 ug/L. There are currently ten monitoring wells on or near the Property: ROG-1S, ROG-1D, ROG-2S, ROG-2I, ROG-3S, ROG-3I, ROG-4S, ROG-4I, ROG-5, and ROG-6, in addition to the extraction well TA-1. Currently, only two of the monitoring wells at the Property, ROG-3S and ROG-4S, show contamination above the MCL. Most monitoring wells at the Property have shown downward trends in contamination since the OU3 remedy was implemented. The monitoring wells located in the Administrative Parcel (ROG-1S, ROG1D, ROG-2S, and ROG-2I) have never exhibited contaminant concentrations in excess of the performance standard (cleanup level) for groundwater in the OU3 ROD and are considered to be upgradient from the current contaminated groundwater plume.

There are no O&M requirements and no institutional controls for OU1 at the Property. For OU3, EPA plans on transferring the groundwater treatment system at the Property to PADEP for O&M in 2022. There are no institutional controls for OU3 at the Property. The monitoring wells on the Administrative Parcel will continue to be sampled.

The selected remedial actions, upon completion, will not leave hazardous substances, pollutants, or contaminants on site above levels that allow for unlimited use and unrestricted exposure; however, the OU3 remedial action will require more than five years to complete. As a result, EPA will perform Five Year Reviews at the Site pursuant to Section 121(c) of CERCLA, 42 U.S.C. 9621(c), until the cleanup levels for groundwater in the OU3 ROD are achieved, allowing for unlimited use and unrestricted exposure. Five Year Reviews will be triggered by the date that construction is completed at the entire Site.

The owner of the Property performed additional investigations at the Property subsequent to EPA's investigations. In 2005, fifty soil borings were advanced throughout the Property. A soil sample was collected from each soil boring and analyzed for VOC contamination. No soil samples exceeded EPA's performance standards (cleanup levels) for soil in the OU1 ROD. Nine composite samples were also collected and analyzed for semi-volatile organic compounds (SVOCs), polychlorinated biphenyls (PCBs), pesticides, metals, and cyanide. SVOCs, PCBs, pesticides, and cyanide were not detected at elevated levels in these samples; however, arsenic was detected in three samples at levels that exceeded background and EPA Regional Screening Levels (RSLs). In 2006, the owner of the Property conducted additional sampling in the vicinity of the samples where the elevated levels of arsenic were found. Eighteen additional soil borings were advanced, and two soil samples were collected from each boring. Elevated levels of arsenic were detected in two soil borings. EPA conducted a more rigorous evaluation of the risks associated with the arsenic levels and determined that the risks associated with the concentrations are within EPA's acceptable risk range.

The owner of the Property also conducted sampling to evaluate the planned construction of a stormwater basin on the Lansdale Borough electrical substation property located within the boundaries of the Property. Twelve test pits were excavated, two of which are located within the Administrative Parcel. The test pits were analyzed for VOCs, and a composite sample was analyzed for SVOCs, pesticides, PCBs, metals, and cyanide. No VOCs were detected at levels above EPA's performance standards (cleanup levels) for soil in the OU1 ROD. SVOCs, PCBs, metals, and cyanide were not detected at elevated levels.

The owner of the Property conducted additional sampling in 2016 on an approximately 3,000 cubic yard pile of top soil to be used as ground cover for the residential development. Twelve samples were collected from the pile and analyzed for metals. One sample was analyzed for hexavalent chromium. Metals concentrations were all found to be within EPA's acceptable risk range.

Public participation activities have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket on which EPA relied for recommendation of the deletion of the Administrative Parcel from the NPL are available to the public in the information repositories. The locations of the information repositories are set forth at the end of the Addresses section at the beginning of this notice.

EPA has determined based on the investigations conducted that all appropriate response actions under CERCLA have been implemented at the Administrative Parcel. The remedial action for OU1 removed contaminated soil from the Administrative Parcel. The implemented OU1 remedy for soils has achieved performance standards specified in the OU1 ROD at the Administrative Parcel. The four monitoring wells (ROG1S, ROG1D, ROG2S, and ROG2I) that are located within the Administrative Parcel have not shown significant detections of contaminants. These wells are also considered upgradient from the current contaminated groundwater plume. The implemented OU3 remedy for groundwater has achieved performance standards specified in the OU3 ROD at the Administrative Parcel and will continue to extract and treat contaminated groundwater at other portions of the Property. The selected remedial action objectives and associated cleanup levels for OU1 and OU3 at the Administrative Parcel are consistent with agency policy and guidance and have been achieved at the Administrative Parcel. No further Superfund response action for the Administrative Parcel is needed to protect human health and the environment. Other procedures for deletion required by 40 CFR 300.425(e) are detailed in Section III of this direct Final Notice of Partial Deletion of a portion of the Site.

The EPA, with concurrence of the Commonwealth of Pennsylvania, through the PADEP, has determined that all appropriate response actions under CERCLA, other than five-year reviews and monitoring, have been completed for the Administrative Parcel. Therefore, EPA is deleting the Administrative Parcel portion of the North Penn Area 6 Superfund Site from the NPL.

Because EPA considers this action noncontroversial and routine, EPA is taking it without prior publication. This action will be effective February 21, 2017 unless EPA receives adverse comments by January 23, 2017. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of partial deletion before the effective date of the partial deletion, and it will not take effect. EPA will prepare a response to comments and continue with the deletion process, as appropriate, on the basis of the notice of intent to partially delete and the comments already received. There will be no additional opportunity to comment.

For the reasons set out in this document, 40 CFR part 300 is amended as follows:

I. Does this action apply to me?

The Agency included in the November 17, 2016 final rule a list of those who may be potentially affected by this action.

EPA issued a final rule in the Federal Register of November 17, 2016 (81 FR 81250) (FRL-9953-41) for significant new uses for 57 chemical substances that were the subject of PMN notices. EPA included the wrong Chemical Abstracts Service (CAS) Registry Number for §  721.10949 and the wrong name for § 721.10958. This action corrects these errors.

Section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(3)(B)) provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making this technical correction final without prior proposal and opportunity for comment. The SNUR at § 721.10949 contains the wrong CAS number associated with PMN P-15-614, and the SNUR at § 721.10958 contains the wrong name associated with PMN P-16-52 that was the basis for the SNUR. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

No. For a detailed discussion concerning the statutory and executive order review, refer to Unit XII. of the November 17, 2016 final rule.

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 part 721 is corrected as follows:

In FR Doc. 2016-26152 of November 4, 2016 (81 FR 77834) (hereinafter referred to as the CY 2017 ESRD PPS final rule) there are technical and typographical errors that are discussed in the “Summary of Errors,” and further identified and corrected in the “Correction of Errors” section below. The provisions in this correction notice are effective as if they had been included in the CY 2017 ESRD PPS final rule published in the Federal Register on November 4, 2016.

On page 77874, we inadvertently made technical errors with respect to the calculation of the performance standard values in Table 2, “Improvement of Performance Standards Over Time.”

On page 77886, we inadvertently made technical errors with respect to the calculation based on the most recently available data of the Achievement Threshold and Performance Standard values that apply to the Kt/V Composite, Standardized Transfusion Ratio and Hypercalcemia measures, and the calculation based on the most recently available data of the Achievement Threshold, Benchmark and Performance Standard values that apply to the ICH CAHPS measure in Table 6, “Finalized Numerical Values for the Performance Standards for the PY 2019 ESRD QIP Clinical Measures Using the Most Recently Available Data.” We also inadvertently included values for the Achievement Threshold, Benchmark and Performance Standard for the Standardized Hospitalization Ratio Clinical Measure, which is not a measure that we have adopted for the PY 2019 program.

On page 77897, we inadvertently included values for the Standardized Hospitalization Ratio Clinical Measure, which is not a finalized PY 2019 ESRD QIP measure, in Table 12, “PY 2020 Clinical Measure Including Facilities With at Least 11 Eligible Patients Per Measure.”

On page 77932 we made a technical error in our response to the first comment under “1. Bid Surety Bond Requirement”. In our response, we stated “While we acknowledge that there will be a number of entities that are required to make large expenditures in order to obtain a bid surety bond for each CBA in which they are submitting a bid, we anticipate that this revision on the bid surety bond amount from $100,000 to $50,000 will reduce that overall burden on all suppliers.” We inadvertently included the term “suppliers” at the end of the sentence but the term should read “bidders.”

On page 77933 in our response to the comment on why the bid surety bond was only required until January 1, 2019, we inadvertently included a “1” in the reference to the round of competition in 2019 in which the bid surety bond requirement commences. The reference should read “Round 2019” and not “Round 1 2019.”

At the top of page 77934 in our discussion on “Appeals Process for a DMEPOS Competitive Bidding Breach of Contract Action” we repeated a typographical error from the proposed rule (81 FR 42849) by stating that we proposed removing “§ 414.423(g)(2)(i)” from the regulation. The correct citation in this discussion should read “§ 414.422(g)(2)(i)”, consistent with the proposal to remove corrective action plan from the list of actions for a breach of contract in the regulation, as described in the preamble and regulation text of the proposed and final rules (81 FR 42849, 42878, and 81 FR 77934, 77967).

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date. APA requirements; in cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.

In our view, this correcting document does not constitute rulemaking that would be subject to these requirements. This correcting document is simply correcting technical errors in the preamble and does not make substantive changes to the policies or payment methodologies that were adopted in the final rule, and therefore, it is unnecessary to follow the notice and comment procedure in this instance.

Even if this were a rulemaking to which the notice and comment and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the CY 2017 ESRD PPS final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest for dialysis facilities to receive appropriate payments in as timely a manner as possible, and to ensure that the CY 2017 ESRD PPS final rule accurately reflects our policies as of the date they take effect and are applicable. Further, such procedures would be unnecessary, because we are not altering the payment methodologies or policies. For these reasons, we believe we have good cause to waive the notice and comment and effective date requirements.

In FR Doc. 2016-26152 of November 4, 2016 (81 FR 77834), we make the following corrections:

1. On page 77874, Table 2 is corrected to read as follows:

2. On page 77886, Table 6 is corrected to read as follows:

For the next calendar year, FRA determines the minimum annual random drug testing rate and the minimum annual random alcohol testing rate for railroad employees covered by hours of service laws and regulations (covered service employees) based on the railroad industry data available for the two previous calendar years (for this Notice, calendar years 2014 and 2015). Railroad industry data submitted to FRA's Management Information System (MIS) shows the rail industry's random drug testing positive rate for covered service employees has continued to be below 1.0 percent for the applicable two calendar years. FRA's Administrator has therefore determined the minimum annual random drug testing rate for the period January 1, 2017, through December 31, 2017, will remain at 25 percent of covered service employees under § 219.602 of FRA's drug and alcohol rule (49 CFR part 219). In addition, because the industry-wide random alcohol testing violation rate for covered service employees has continued to be below 0.5 percent for the applicable two calendar years, the Administrator has determined the minimum random alcohol testing rate will remain at 10 percent of covered service employees for the period January 1, 2017, through December 31, 2017, under § 219.608. Because these rates represent minimums, railroads may conduct FRA random testing at higher rates.

In a June 10, 2016, final rule, FRA expanded the scope of part 219 to cover maintenance-of-way (MOW) employees (81 FR 37894). MOW employees will become subject to FRA random drug and alcohol testing on June 12, 2017, when the final rule takes effect. In 1994, when FRA, in concert with the other DOT modes, established a drug MIS system (58 FR 68232, December 23, 1993), FRA set its initial minimum random drug testing rate at 50 percent for covered employees because of the lack of data to gauge the extent of the drug abuse problem at that time. FRA set its minimum random alcohol testing rate for covered employees at 25 percent for the same reason. As its MIS data continued to show consistently low industry-wide drug and alcohol positive rates among covered employees, FRA lowered its minimum annual random drug and alcohol testing rates to their current respective rates of 25 and 10 percent.

Similarly, because FRA has no MIS data for MOW employees yet, the Administrator has determined that for the period June 12, 2017, through December 31, 2017, the minimum annual random drug testing rate will be set at 50 percent of MOW employees, and the minimum annual random alcohol testing rate will be set at 25 percent of MOW employees. As with covered employees, because these rates represent minimums, railroads may conduct FRA random testing of MOW employees at higher rates.

A “rail equipment accident/incident” is a collision, derailment, fire, explosion, act of God, or other event involving the operation of railroad on-track equipment (standing or moving) that results in damages to railroad on-track equipment, signals, tracks, track structures, or roadbed, including labor costs and the costs for acquiring new equipment and material, greater than the reporting threshold for the year in which the event occurs. 49 CFR 225.19(c). A railroad must report each rail equipment accident/incident to FRA using the Rail Equipment Accident/Incident Report (Form FRA F 6180.54). See 49 CFR 225.19(b), (c) and 225.21(a). Paragraphs (c) and (e) of 49 CFR 225.19 further provide that FRA will adjust the dollar figure that constitutes the reporting threshold, if necessary, every year under the procedures in appendix B to 49 CFR part 225 (Appendix B) to reflect any cost increases or decreases.

In addition to periodically reviewing and adjusting the reporting threshold under Appendix B, FRA periodically amends its method for calculating the threshold. In 49 U.S.C. 20901(b), Congress requires that FRA base the reporting threshold on publicly available information obtained from the Bureau of Labor Statistics (BLS), other objective government source, or be subject to notice and comment. In 1996, FRA adopted a new method for calculating the reporting threshold for rail equipment accidents/incidents. See 61 FR 60632, Nov. 29, 1996. In 2005, FRA again amended its method for calculating the reporting threshold because the BLS ceased collecting and publishing the railroad wage data FRA used in the calculation. Consequently, FRA substituted railroad employee wage data the Surface Transportation Board (STB) collects for the data BLS ceased to collect. See 70 FR 75414, Dec. 20, 2005. In a separate rulemaking, FRA intends to evaluate and amend, if appropriate, its method for calculating the reporting threshold and, as a result, the formula used to calculate the reporting threshold may change. FRA intends to reexamine its method for calculating the reporting threshold because new methodologies for calculating the threshold are available. FRA believes updating its methodology to include these advances will ensure the reporting threshold reflects changes in equipment and labor costs as accurately as possible.

Approximately one year has passed since FRA reviewed the reporting threshold. See 80 FR 80683, Dec. 28, 2015. Consequently, FRA has recalculated the reporting threshold under 49 CFR 225.19(c), based on increased costs for labor and increased costs for equipment. FRA has determined that the current reporting threshold of $10,500, which applies to rail equipment accidents/incidents that occur during CY 2016, should increase by $200 to $10,700 for rail equipment accidents/incidents occurring during CY 2017. The specific inputs to the equation set forth in Appendix B (i.e., Tnew = Tprior * [1 + 0.4(Wnew−Wprior)/Wprior + 0.6(Enew−Eprior)/100]) are:

In this rule, FRA has recalculated the reporting threshold based on the formula discussed in detail and adopted, after notice and comment, in the final rule published December 20, 2005. See 70 FR 75414, Dec. 20, 2005. FRA finds both the current cost data inserted into this pre-existing formula and the original cost data that they replace were obtained from reliable Federal government sources. FRA finds this rule imposes no additional burden on any person, but rather is intended to provide a benefit by permitting the valid comparison of accident data over time. Accordingly, finding that notice and comment procedures are either impracticable, unnecessary, or contrary to the public interest, FRA is proceeding directly to a final rule.

FRA regularly reviews and recalculates the reporting threshold using the formula published in Appendix B near the end of each CY. Therefore, any person affected by this rule should anticipate the on-going adjustment of the reporting threshold and has reasonable time to make any minor changes necessary to come into compliance with the reporting requirements. FRA attempts to use the most recent data available to calculate the updated reporting threshold prior to the next CY. FRA has found that issuing the rule no later than December of each CY and making the rule effective on January 1, of the next year, allows FRA to use the most up-to-date data when calculating the reporting threshold and to compile data that accurately reflects rising wages and equipment costs. As such, FRA finds that it has good cause to make this final rule effective January 1, 2017.

FRA evaluated this final rule under existing policies and procedures and determined it is non-significant under both Executive Orders 12866 and 13563, and DOT policies and procedures. See 44 FR 11034, Feb. 26, 1979.

FRA developed this rule under Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”) and DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) to ensure potential impacts of rules on small entities are properly considered.

The Regulatory Flexibility Act requires an agency to review regulations to assess their impact on small entities, unless the Secretary certifies the rule will not have a significant economic impact on a substantial number of small entities. Under Section 312 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), Federal agencies may adopt their own size standards for small entities in consultation with SBA and in consultation with public comment. Under that authority, FRA has published a final statement of agency policy formally establishing for FRA's regulatory purposes “small entities” as railroads, contractors, and hazardous materials shippers that meet the revenue requirements of a Class III railroad as set forth in 49 CFR 1201.1-1 ($20 million or less in inflation-adjusted annual revenues, and commuter railroads or small governmental jurisdictions that serve populations of 50,000 or less). See 49 CFR part 209, appendix C. FRA used this definition for this rulemaking.

About 743 of the approximately 792 railroads in the United States are considered small entities by FRA. FRA certifies that this final rule will have no significant economic impact on a substantial number of small entities. To the extent that this rule has any impact on small entities, the impact will be neutral or insignificant. The frequency of rail equipment accidents/incidents, and therefore also the frequency of required reporting, is generally proportional to the size of the railroad. A railroad employing thousands of employees and operating trains millions of miles is exposed to greater risks than one whose operation is substantially smaller. Small railroads may go for months at a time without having a reportable occurrence of any type, and even longer without having a rail equipment accident/incident. For example, FRA data indicate railroads reported 2,029 rail equipment accidents/incidents in 2011, with small railroads reporting 276 of them. Data for 2012 show railroads reported 1,765 rail equipment accidents/incidents, with small railroads reporting 254 of them. Data for 2013 show that 1,849 rail equipment accidents/incidents were reported, with small railroads reporting 271 of them. In 2014, 1,870 rail equipment accidents/incidents were reported, and small railroads reported 230 of them. In 2015, 1,912 rail equipment accidents/incidents were reported, with small railroads reporting 253 of them. On average over those five calendar years, small railroads reported about 14% (ranging from 12% to 15%) of the total number of rail equipment accidents/incidents. FRA notes that these data are accurate as of the date of issuance of this final rule, and are subject to minor changes due to additional reporting. Absent this rulemaking (i.e., absent increasing the reporting threshold), the number of reportable accidents/incidents in CY 2017 would likely increase, as keeping the 2016 threshold in place would not allow it to keep pace with the increasing dollar amounts of wages and rail equipment repair costs. Therefore, this rule will be neutral in effect. Increasing the reporting threshold will slightly decrease the recordkeeping burden for railroads over time. Any recordkeeping burden will not be significant and will affect the large railroads more than the small railroads, due to the higher proportion of reportable rail equipment accidents/incidents experienced by large entities.

Furthermore, FRA has determined the RFA does not apply to this rulemaking. Given this rule merely updates the reporting threshold for CY 2017 using the formula developed through notice and comment rulemaking and published in Appendix B, FRA finds notice and public comment is unnecessary and would serve no public benefit. The Small Business Administration's A Guide for Government Agencies: How to Comply with the Regulatory Flexibility Act (2012, p.55), provides:

There are no new or additional information collection requirements associated with this final rule. FRA's collection of accident/incident reporting and recordkeeping information is currently approved under OMB No. 2130-0500. Therefore, FRA is not required to provide an estimate of a public reporting burden in this document.

Executive Order 13132, “Federalism” (64 FR 43255, Aug. 10, 1999), requires FRA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the agency may not issue a regulation with federalism implications that imposes substantial direct compliance costs and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or the agency consults with State and local government officials early in the process of developing the regulation. Where a regulation has federalism implications and preempts State law, the agency seeks to consult with State and local officials in the process of developing the regulation.

FRA analyzed this final rule under the principles and criteria in Executive Order 13132. This rule will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and the responsibilities among the various levels of government, as specified in Executive Order 13132. In addition, FRA determined this rule does not impose substantial direct compliance costs on State and local governments. Accordingly, FRA concluded the consultation and funding requirements of Executive Order 13132 do not apply and preparation of a federalism assessment is not required.

FRA evaluated this final rule under its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (64 FR 28545, May 26, 1999) as required by the National Environmental Policy Act (42 U.S.C. 4321 et seq.), other environmental statutes, Executive Orders, and related regulatory requirements. FRA has determined this final rule is not a major FRA action (requiring the preparation of an environmental impact statement or environmental assessment) because it is categorically excluded from detailed environmental review under section 4(c)(20) of FRA's Procedures. See 64 FR 28547, May 26, 1999. Section 4(c)(20) reads as follows:

Consistent with section 4(c)(20) of FRA's Procedures, FRA concluded that no extraordinary circumstances exist with respect to this regulation that might trigger the need for a more detailed environmental review. As a result, FRA finds this rule is not a major Federal action significantly affecting the quality of the human environment.

Under Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law).” Section 202 of the Act (2 U.S.C. 1532) further requires that before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year, and before promulgating any final rule for which a general notice of proposed rulemaking was published, the agency shall prepare a written statement detailing the effect on State, local, and tribal governments and the private sector. This final rule will not result in the expenditure of more than $156,000,000 by the public sector in any one year. Thus, preparation of such a statement is not required.

Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” 66 FR 28355, May 22, 2001. Under the Executive Order, a “significant energy action” is defined as any action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of, a final rule or regulation (including a notice of inquiry, advance notice of proposed rulemaking, and notice of proposed rulemaking) that (1)(i) is a significant regulatory action under Executive Order 12866 or any successor order, and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (2) is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. FRA has evaluated this rule under Executive Order 13211. FRA has determined this rule will not have a significant adverse effect on the supply, distribution, or use of energy, and, thus, is not a “significant energy action” under Executive Order 13211.

Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, and DOT Order 5610.2(a) (91 FR 27534, May 10, 2012) require DOT agencies to achieve environmental justice as part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects, including interrelated social and economic effects, of their programs, policies, and activities on minority populations and low-income populations. The DOT Order instructs DOT agencies to address compliance with Executive Order 12898 and requirements within the DOT Order in rulemaking activities, as appropriate. FRA evaluated this final rule under Executive Order 12898 and the DOT Order and determined it would not cause disproportionately high and adverse human health and environmental effects on minority or low-income populations.

FRA evaluated this final rule under the principles and criteria in Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, dated November 6, 2000. This final rule will not have a substantial direct effect on one or more Indian tribes, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal laws. Therefore, the funding and consultation requirements of Executive Order 13175 do not apply, and a tribal summary impact statement is not required.

The Trade Agreements Act of 1979 (19 U.S.C. 2501 et seq.) prohibits Federal agencies from engaging in any standards setting or related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. FRA assessed the potential effect of this final rule on foreign commerce and concluded its requirements are consistent with the Trade Agreements Act.

Interested parties should be aware that anyone can search the electronic form of all written comments received into any agency docket by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register (65 FR 19477-19478, Apr. 11, 2000) or you may visit http://www.transportation.gov/privacy.

In consideration of the foregoing, FRA amends part 225 of chapter II, subtitle B of title 49, Code of Federal Regulations, as follows:

The regulations at 50 CFR part 11 provide uniform rules and procedures for the assessment of civil penalties resulting from violations of certain laws and regulations enforced by the Service.

On June 28, 2016, the Service published in the Federal Register an interim rule (81 FR 41862) that amended 50 CFR part 11, in accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation Adjustment Act; sec. 701 of Pub. L. 114-74) and Office of Management and Budget guidance, to adjust for inflation the statutory civil monetary penalties that may be assessed for violations of Service-administered statutes and their implementing regulations. We are required to adjust civil monetary penalties as necessary for inflation according to a formula specified in the Inflation Adjustment Act.

The interim rule became effective on July 28, 2016. We accepted public comments for 60 days on the interim rule, ending August 29, 2016. By that date, we did not receive any comments on the interim rule. Therefore, we are affirming the interim rule as a final rule, without change.

The interim rule is available at http://www.regulations.gov under Docket No. FWS-HQ-LE-2016-0045.