Federal Register Vol. 80, No.191,

On November 23, 2009, the President issued Executive Order 13520 (“Reducing Improper Payments and Eliminating Waste in Federal Programs”). On February 28, 2011, the President issued a Presidential Memorandum (“Administrative Flexibility, Lower Costs, and Better Results for State, Local, and Tribal Governments”). These documents directed OMB to work with Executive Branch agencies to potentially establish reforms on Federal grant policies.

In response, on October 27, 2011, OMB established the Council on Financial Assistance Reform, an interagency group of Executive Branch officials tasked with creating an accountable structure to coordinate financial assistance, streamline Federal grant-making requirements, ease administrative burdens, and strengthen Federal fund oversight to reduce risks of waste, fraud, and abuse.

On February 28, 2012, OMB published an Advanced Notice of Proposed Guidance. See 77 FR 11778. On February 1, 2013, OMB published a Notice of Proposed Guidance. See 78 FR 7282. Both documents solicited public comment on ideas for reforming the requirements that govern the management of Federal financial assistance awards. On December 26, 2013, OMB published the Uniform Guidance, which added Part 200 (“OMB Guidance”) to Title 2 (“Grants and Agreements”) of the Code of Federal Regulations. See 79 FR 75871. The Uniform Guidance included:

• The consolidation of eight previously-issued OMB Circulars on grants and awards;

• A uniform set of administrative requirements for grant recipients;

• A focus on grantee performance over compliance for accountability;

• An emphasis on efficient uses of information technology and shared services;

• A uniform set of cost principles that treats costs transparently and consistently;

• A limitation on allowable costs in order to make best uses of Federal resources;

• The standardization of business processes using consistent data element definitions;

• An emphasis on oversight by reviewing risks prior to awarding grants; and

• A uniform set of audit requirements that prioritizes identifying the risks of fraud, waste, and abuse.

The Uniform Guidance required Federal agencies to implement the policies and procedures applicable to Federal awards by promulgating a regulation to be effective by December 26, 2014. See 2 CFR 200.110.

On December 19, 2014, all Federal award-making agencies promulgated a joint interim final rule implementing the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. See 79 FR 75871. In the interim final rule, DHS adopted OMB's Guidance as DHS's own via 2 CFR part 3002, and FEMA removed 44 CFR part 13 (FEMA's grant administration regulations). Also, throughout Title 44, FEMA replaced all references to Part 13 with corresponding references to 2 CFR parts 200 and 3002, as applicable.

During the joint interim final rule's comment period, OMB received 61 comments from individuals and organizations. No comments OMB received referenced DHS or FEMA. Thus, DHS and FEMA are adopting the interim final rule as final, with one change.

FEMA's mitigation planning regulations are located at 44 CFR part 201, and set forth instructions on the policies and procedures for State, Tribal, and local hazard mitigation planning. Hazard mitigation is any sustained action taken to reduce or eliminate long-term risk to people and property from natural hazards and their effects. The purpose of hazard mitigation planning is to identify policies and actions that can be implemented over the long-term to reduce risk and future losses. State, Indian Tribal, and local governments are required to develop a hazard mitigation plan as one of the conditions for establishing eligibility for certain types of Federal non-emergency disaster assistance and FEMA mitigation grants.

The December 19, 2014 joint interim final rule contained an inadvertent error to FEMA's Standard State Mitigation Planning regulations at 44 CFR 201.4(c)(7) and to FEMA's Tribal Mitigation Planning regulations at 44 CFR 201.7(c)(6). Prior to the December 19, 2014 joint interim final rule, these sections read as published in Title 44 of the Code of Federal Regulations, revised as of October 1, 2014.

In the December 19, 2014 joint interim final rule, FEMA revised the first sentences of 44 CFR 201.4(c)(7) and 44 CFR 201.7(c)(6) with a general citation to 2 CFR parts 200 and 3002. However, FEMA unintentionally removed the second sentence of these sections and thus inadvertently removed a procedure by which States and Indian Tribal governments amend their mitigation plans when necessary to reflect changes in State, Indian Tribal, or Federal laws or regulations. In this final rule, FEMA is reinserting this provision.

While FEMA previously referenced 44 CFR 13.11(d) in both 44 CFR 201.4(c)(7) and in 44 CFR 201.7(c)(6), FEMA, as noted above, removed 44 CFR part 13 and replaced all references to Part 13 with corresponding references to 2 CFR parts 200 and 3002, as applicable. There are no corresponding pinpoint cites in 2 CFR part 200 or Part 3002 that replace the requirements found at 44 CFR 13.11(d). Thus, FEMA cannot carry this reference over to the revised regulations. FEMA regulations have included the procedure for States and Indian Tribal governments since 2002 and 2007, respectively, to amend their plans to reflect changes in State, Indian Tribal, or Federal laws, statutes and regulations, as applicable. As FEMA is simply reinserting an inadvertently removed and longstanding provision, this change does not create new program requirements. FEMA also describes these provisions in various guidance materials and is revising the references as applicable.1

Pursuant to Executive Order 12866, as amended, OMB's Office of Information and Regulatory Affairs (OIRA) has designated this final rule to be not significant.

The Administrative Procedure Act (APA) provides that an agency may dispense with notice and comment rulemaking procedures when it promulgates an interpretive rule, a general statement of policy, or a rule of agency organization, procedure, or practice. See 5 U.S.C. 553(b)(A). DHS is issuing this change to reinstate FEMA procedures inadvertently removed in the interim final rule, related to ensuring mitigation plan compliance with applicable laws and regulations. Thus, DHS finds that this part of the final rule relates to agency procedures and is exempt from notice and comment.

In addition, the APA provides that an agency may dispense with notice and comment rulemaking procedures when an agency, for good cause, finds those procedures are impracticable, unnecessary, or contrary to the public interest. See 5 U.S.C. 553(b)(B). DHS is reinserting two provisions concerning mitigation plan compliance with applicable laws and regulations, a requirement that was already present in 44 CFR 201.4(c)(7) and 44 CFR 201.7(c)(6). Thus, DHS finds that notice and comment is unnecessary and that this part of the final rule is exempt from notice and comment.

The Regulatory Flexibility Act (RFA) requires an agency that is issuing a final rule to provide a final regulatory flexibility analysis or to certify that the rule will not have a significant economic impact on a substantial number of small entities. This final rule imposes no cost as the common interim rule implemented OMB final guidance issued on December 26, 2013, and did not have a significant economic impact beyond the impact of the December 2013 guidance.

The Unfunded Mandates Reform Act of 1995, Public Law 104-4, 109 Stat. 48 (Mar. 22, 1995) (2 U.S.C. 1501 et seq.), requires Federal agencies to assess the effects of their discretionary regulatory actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. As the final rule would not have an impact greater than $100,000,000 or more in any one year, it is not an unfunded Federal mandate.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Ch. 3506; 5 CFR Appendix A.1) (PRA), DHS and FEMA reviewed this final rule and have determined that there are no new collections of information contained therein.

Executive Order 13175, “Consultation and Coordination With Indian Tribal Governments,” (65 FR 67249, Nov. 9, 2000), applies to agency regulations that have Tribal implications, that is, regulations that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Under this Executive Order, to the extent practicable and permitted by law, no agency shall promulgate any regulation that has Tribal implications, that imposes substantial direct compliance costs on Indian Tribal governments, and that is not required by statute, unless funds necessary to pay the direct costs incurred by the Indian Tribal government or the Tribe in complying with the regulation are provided by the Federal Government, or the agency consults with Tribal officials. DHS and FEMA have determined that this final rule does not have any Tribal implications.

DHS and FEMA have determined that this final rule does not have any federalism implications, as required by Executive Order 13132.

Accordingly, the interim final rule amending 2 CFR part 3002 and 44 CFR parts 13, 78, 79, 152, 201, 204, 206, 207, 208, 304, 360, and 361, which was published in the Federal Register at 79 FR 75871 on December 19, 2014, is adopted as final with the following changes:

The golden nematode (Globodera rostochiensis) is a destructive pest of potatoes and other solanaceous plants. Potatoes cannot be economically grown on land that contains large numbers of the nematode. The golden nematode has been determined to occur in the United States only in parts of the State of New York.

In 7 CFR part 301, the golden nematode quarantine regulations (§§ 301.85 through 301.85-10, referred to below as the regulations) set out procedures for determining the areas regulated for golden nematode and impose restrictions on the interstate movement of regulated articles from regulated areas.

Paragraph (a) of § 301.85-2 states that the Deputy Administrator, Plant Protection and Quarantine, Animal and Plant Health Inspection Service (APHIS), shall list as regulated areas each quarantined State or each portion thereof in which golden nematode has been found or in which there is reason to believe that golden nematode is present, or which it is deemed necessary to regulate because of their proximity to infestation or their inseparability for quarantine enforcement purposes from infested localities.

Paragraph (b) of § 301.85-2 states that the Deputy Administrator or an authorized inspector may temporarily designate any other premises in a quarantined State as a regulated area and a suppressive or generally infested area, in accordance with the criteria specified in paragraph (a).

Paragraph (c) of § 301.85-2 states that, in accordance with the criteria listed in § 301.852(a), the Deputy Administrator shall terminate the designation of any area listed as a regulated area and suppressive or generally infested area when he or she determines that such designation is no longer required.

Surveys and other data have revealed that certain areas in Orleans, Nassau, and Suffolk Counties of New York are free of golden nematode. Accordingly, on September 17, 2014, APHIS issued a Federal Order 1 to terminate the quarantine designation of specified areas within these three counties, thereby removing 600,524 acres from the golden nematode regulations. As a result, it is no longer necessary to regulate these areas or restrict the interstate movement of golden nematode regulated articles from these areas.

Approximately 509 acres will remain under regulation in Nassau County, 68 acres in Orleans County, and 221,504 acres in Suffolk County. Further analysis continues in each of these counties that may lead to additional acres being eligible to be removed from regulation in the future.

In an interim rule dated January 9, 2013 (78 FR, 1713-1715, Docket No. APHIS-2012-0079), we amended the golden nematode regulations by removing areas in Livingston and Steuben Counties in New York from the list of generally infested areas. In that rule, the coordinates we used to delineate the revised areas under quarantine were formatted in such a way that they did not accurately represent the areas we wished to lift from restrictions. Therefore, we are publishing the corrected coordinates of the areas remaining under quarantine in Livingston and Steuben Counties in this rule.

Immediate action is warranted to relieve restrictions that are no longer necessary on the specified areas in Orleans, Nassau, and Suffolk Counties in New York that have been regulated for golden nematode. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this action effective less than 30 days after publication in the Federal Register.

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register. The document will include a discussion of any comments we receive and any amendments we are making to the rule.

This interim rule is subject to Executive Order 12866. However, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. The full analysis may be viewed on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov) or obtained from the person listed under FOR FURTHER INFORMATION CONTACT.

APHIS has removed 600,524 acres from the golden nematode regulations in specific areas in three New York counties: Orleans, Nassau, and Suffolk. Of the areas remaining under regulation, 221,504 acres are in Suffolk County, 509 acres are in Nassau County, and 68 acres are in Orleans County.

Golden nematode is a major pest of potato and other many other solanaceous plants. Sale of many soil-related products is negatively impacted in areas under quarantine for golden nematode. We impose sanitation requirements on movement of agricultural equipment and non-agricultural entities that use earth-moving equipment. The pest is spread by the transport of cysts in soil, in particular through the inadvertent movement of infested soil attached to agricultural products, farming equipment, and other regulated articles.

In 2014, the State of New York harvested 15,800 acres of potatoes valued at approximately $55 million, with Suffolk County being the number one county in potato production. While there are no detailed potato data published by county, 42 entities in Suffolk County have been affected by the deregulation and of these 18 entities are potato growers. One potato farm has been affected by the deregulation in Nassau County. Deregulation of quarantine areas in Orleans County is not known to have affected any entities.

The 43 affected entities will benefit from no longer needing to satisfy compliance requirements of the quarantine. They may also find improved export opportunities. While the potato farmers as well as the rest of the affected entities may qualify as small entities, they are few in number and their share of the nation's potato industry is small. Even though New York ranks 12th in volume among the States that produce potatoes, the value of its production is only 1.7 percent of the value of all U.S. production.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

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

This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Accordingly, we are amending 7 CFR part 301 as follows:

Background

The regulations in 7 CFR part 319 prohibit or restrict the importation of certain plants and plant products into the United States to prevent the introduction of quarantine plant pests. The regulations contained in “Subpart—Plants for Planting,” §§ 319.37 through 319.37-14 (referred to below as the regulations), prohibit or restrict, among other things, the importation of living plants, plant parts, and seeds for propagation or planting.

The regulations differentiate between prohibited articles and restricted articles. Prohibited articles are plants for planting whose importation into the United States is not authorized due to the risk the articles present for introducing or disseminating plant pests. Restricted articles are articles authorized for importation into the United States, provided that the articles are subject to measures to address such risk.

Section 319.37-5 of the regulations lists restricted articles that may be imported into the United States only if they are accompanied by a phytosanitary certificate that contains an additional declaration either that the restricted articles are free of specified quarantine pests or that the restricted articles have been produced in accordance with certain mitigation requirements. Within the section, paragraph (r) contains requirements for the importation of restricted articles (except seeds) of Pelargonium or Solanum spp. into the United States. Solanum spp. restricted articles include tomato (Solanum lycopersicum) plantlets, in addition to other species and cultivars within the genus.

Paragraph (r)(1) of § 319.37-5 authorizes the importation into the United States of Pelargonium or Solanum spp. restricted articles from Canada under the provisions of a greenhouse-grown restricted plant program. Paragraph (r)(3) contains conditions for the importation into the United States of Pelargonium or Solanum spp. restricted articles that do not meet the conditions in paragraph (r)(1), and are from a country in which Ralstonia solanacearum race 3 biovar 2 is known to occur.

Conditions for the importation into the United States of restricted articles in growing media are specifically found in § 319.37-8. Within that section, the introductory text of paragraph (e) lists taxa of restricted articles that may be imported into the United States in approved growing media, subject to the mandatory provisions of a systems approach. In § 319.37-8, paragraph (e)(1) lists the approved growing media, and paragraph (e)(2) contains the provisions of the systems approach. Within paragraph (e)(2), paragraphs (i) through (viii) contain provisions that are generally applicable to all the taxa listed in the introductory text of paragraph (e), and paragraphs (ix) through (xi) contain additional taxon-specific conditions.

In response to a request from the national plant protection organization (NPPO) of Mexico, in a proposed rule 1 published in the Federal Register (80 FR 11946-11950, Docket No. APHIS-2014-0099) on March 5, 2015, we proposed to amend the regulations to authorize the importation into the continental United States of tomato (Solanum lycopersicum) plantlets from Mexico in growing media, subject to a systems approach. Because we considered R. solanacearum race 3 biovar 2 to exist in Mexico, the proposed systems approach included the measures specified in paragraph (r)(3) of § 319.37-5. Because the plantlets would be imported in growing media, the systems approach also included the general conditions in § 318.37-8 for all taxa of plants for planting imported into the United States in growing media. Finally, we also proposed that the plantlets would have to be imported into greenhouses in the continental United States and the importers of the plantlets from Mexico or the owners of the greenhouses in the continental United States would have to enter into compliance agreements regarding the conditions under which the plants from Mexico must enter and be maintained within the greenhouses.

We solicited comments concerning our proposal for 60 days ending May 4, 2015. We received 19 comments by that date. They were from an NPPO, two State departments of agriculture, an organization representing State departments of agriculture, U.S. tomato producers, importers of tomato plantlets, professors who specialize in U.S. tomato production, a U.S. Senator, local and municipal governments, and a private citizen.

Most of the commenters urged us to finalize the proposed rule, as written. Several commenters were generally supportive of the rule, but requested clarifications regarding the provisions of the rule, or modification to those provisions. Finally, several commenters did not support the rule. We discuss the comments that we received below, by topic.

In the request that we received from the NPPO of Mexico to authorize the importation of tomato plantlets into the continental United States in approved growing media, the NPPO specified that the plantlets would be produced from certified seed, would be produced in greenhouses constructed and maintained to be pest-exclusionary, would be shipped in growing media maintained under similar conditions, and would be safeguarded during movement to the continental United States to prevent plant pests from being introduced to the plantlets.

To evaluate this request, we prepared a pest risk assessment (PRA) that analyzed the potential pest risks associated with the importation of tomato plantlets from Mexico produced under such conditions. The PRA concluded that a number of quarantine pests of tomato plantlets exist in Mexico, including R. solanacearum race 3 biovar 2, but that, if the plantlets are produced in accordance with the conditions specified by the NPPO, they would present a negligible risk of quarantine pests being introduced into the continental United States through their importation in approved media.

Based on the findings of the PRA, a risk management document (RMD) that also accompanied the proposed rule recommended that, among other requirements, the plantlets should be authorized importation subject to paragraph (r)(3) of § 319.37-5 because of the presence of R. solanacearum race 3 biovar 2 in Mexico.

A commenter disputed the presence of R. solanacearum race 3 biovar 2 in Mexico. The commenter stated that, of the ten references 2 that APHIS cited in the PRA regarding the presence of R. solanacearum race 3 biovar 2 in Mexico, five only stated that R. solanacearum race 3 is present in Mexico, and did not identify the biovar; three isolated R. solanacearum from samples obtained from Mexico, but did not state that the samples became infected in Mexico or delineate where in Mexico the samples originated; and the remaining two suggested that plantlets affected with R. solanacearum race 3 biovar 2 have been detected in Mexico, but did not rule out that the plantlets were germinated from infected, imported seed. The commenter also stated that most of the references cited could be classified as “unreliable” pursuant to the International Plant Protection Convention's International Standards for Phytosanitary Measures (ISPM) No. 8, and that ISPM No. 8 prohibits importing countries from assessing the pest status of a foreign region based on unreliable records.

For these reasons, the commenter concluded that APHIS should state that the presence of R. solanacearum race 3 biovar 2 in Mexico is unknown because of unreliable pest detection records, and remove the R. solanacearum race 3 biovar 2-specific provisions from the systems approach.

Similarly, another commenter pointed out that R. solanacearum race 3 biovar 2 has been detected in the United States on two occasions, yet there are no R. solanacearum race 3 biovar 2-specific restrictions on the interstate movement of tomato plantlets within the United States. The commenter asked us to explain or address this discrepancy.

Unlike other phytopathogenic bacteria, race classifications for R. solanacearum are not based on gene-for-gene interactions across host species, but rather on pathogenicity in different types of host plants. Biovars of R. solanacearum, in contrast, do cross species. There is, accordingly, generally no correlation between races and biovars of R. solanacearum, and, in general, one cannot presume a specific biovar of R. solanacearum has been detected in a host plant based on knowledge of the race isolated.

However, this is not true of race 3 and biovar 2 of R. solanacearum. There exists a distinct and close correlation between this race and biovar of the disease, such that, in the international taxonomic community, references to race 3 of R. solanacearum are presumed to refer to biovar 2, and references to biovar 2 of R. solanacearum are presumed to refer to race 3. The five references in the PRA that referred to the presence of R. solanacearum race 3 in Mexico (CABI 1999, CABI 2012, EPPO 1997, EPPO 2012, and Hernández-Romano et al.) used this common taxonomic practice, and thus do refer to R. solanacearum race 3 biovar 2.

Of the three articles that the PRA referenced in which R. solanacearum was isolated from samples obtained from Mexico (Meng et al., Milling et al., and Sanchez-Perez et al.), one (Meng et al.) explicitly states that the isolate of R. solanacearum race 3 biovar 2 used in the study is from Mexico. The other two state that the isolates were obtained from a collection that is housed at the University of Wisconsin, and is identified as being of Mexican origin. While none of the references identify the exact location in Mexico where the isolates originated, that location is not germane to determining whether or not R. solanacearum race 3 biovar 2 is present in Mexico.

Of the remaining two articles, we agree that one (Xu et al.) does not conclude that R. solanacearum race 3 biovar 2 is present in Mexico, and will no longer use it as a reference in future discussions of the presence of R. solanacearum race 3 biovar 2 in Mexico.

We disagree, however, that the other article (Perea et al.) could merely provide evidence that infected imported seed was used to germinate tomato plantlets within Mexico. Seed transmission of R. solanacearum race 3 biovar 2 is extremely rare; soil, water, and plant debris are far more common pathways for the disease. Additionally, the infected plantlets identified by Perea et al. exhibited no signs of infection during the early stages of production, when they were potted and housed in greenhouses; the plantlets only appeared symptomatic well after they were planted in an outdoor field. When potted plants are infected with R. solanacearum race 3 biovar 2, however, they tend to appear symptomatic within 30 days. This suggests that the seed from which the plantlets were germinated was not infected with R. solanacearum race 3 biovar 2. Rather the evidence provided in Perea et al. strongly suggests that the plantlets became infected in an outdoor field through contact with infected soil, water, or debris.

We agree with the commenter that the references are of varying reliability, but disagree with the commenter's interpretation of ISPM No. 8. ISPM No. 8 does not distinguish between reliable and unreliable records, but rather provides criteria by which an importing country should assess the relative reliability of a record in comparison to other records. The ISPM acknowledges that determining whether a particular plant pest exists in a foreign region is, however, ultimately a subjective “expert judgment” made by the importing country.

After reviewing the records available to us in light of the commenter's concerns, we have determined that there is significant evidence that R. solanacearum race 3 biovar 2 exists in the natural environment within Mexico. This differs from the United States, where outbreaks of R. solanacearum race 3 biovar 2 have been limited to greenhouses and arisen from the importation of infected plants.

Accordingly, we consider it appropriate to maintain R. solanacearum race 3 biovar 2-specific provisions as part of our systems approach for the importation of tomato plantlets in growing media from Mexico, and have made no changes to the provisions of the proposed rule in response to this comment.

In a similar vein, a commenter asked us why the proposed rule had contained R. solanacearum race 3 biovar 2-specific provisions, given that the PRA found that it “highly unlikely” that tomato plantlets from Mexico would become infected with the disease.

The PRA found such transmission to be highly unlikely, provided that the plantlets are produced under the provisions of the systems approach. The PRA did not evaluate the likelihood that plantlets produced under different conditions would become infected with R. solanacearum race 3 biovar 2. Because we consider that disease to exist in the natural environment within Mexico, the risk would be considerably higher, and thus the need for the required provisions.

Several tomato producers within the United States supported the proposed rule, and stated that they would like to import tomato plantlets in growing media from Mexico if the rule is finalized. However, the commenters stated that they are certified organic by the United States Department of Agriculture (USDA), and expressed concern that several of the mitigation measures specified in the risk management document (RMD) that accompanied the proposed rule appeared to require fumigation with methyl bromide and the use of disinfectants that are not approved by USDA for organic production. The commenters noted, however, that the proposed rule itself did not appear to require either fumigation or the use of such disinfectants. The commenters inquired whether there was a discrepancy between the RMD and the proposed rule, and, if so, which provisions they would be expected to adhere to.

Paragraph (r)(3)(viii) of § 319.37-5 requires Solanum spp. plants for planting from countries in which R. solanacearum race 3 biovar 2 is known to occur to be grown in growing media that is free of R. solanacearum race 3 biovar 2. In order for growing media to be considered free of R. solanacearum race 3 biovar 2, guidance that we have developed for producers states that the growing media should either be fumigated with methyl bromide at 3 grams per liter of media for 72 hours at 21° Celsius or above, or steam sterilized so that the media reaches a temperature of 80° Celsius for at least 2 hours. The RMD referred to both of these options, and either option would fulfill the requirements of the regulations.

Paragraph (r)(3)(vi) of § 319.37-5 requires all equipment that comes in contact with articles of Solanum spp. within a production site to be adequately sanitized so that R. solanacearum race 3 biovar 2 cannot be transmitted between plants or enter from outside the production site via equipment, while paragraph (r)(3)(vii) of § 319.37-5 requires production site personnel to adequately sanitize their clothing before entering the production site to prevent the entry of R. solanacearum race 3 biovar 2 into the production site.

APHIS has determined that several disinfectants may be used to meet these sanitation requirements. One of them, hydrogen peroxide, is approved by USDA for organic production.

One commenter suggested that we should authorize the importation of tomato seeds from Mexico, rather than tomato plantlets in growing media.

The regulations already authorize the importation of tomato seeds from Mexico. The market access request from the NPPO of Mexico was for tomato plantlets in growing media.

One commenter suggested that we consider authorizing the importation of tomato plantlets from Mexico under “Good Seed and Plant Production Practices” (GSPPPs), an international accreditation standard for pest-free production of plants for planting.

Generally applicable standards such as the GSPPPs may not always address taxon-specific plant pest risks. Additionally, the regulations are currently written in a manner which does not facilitate the use of such generally applicable standards. However, if finalized, a proposed rule 3 published in the Federal Register on April 25, 2013 (78 FR 24634-24663; Docket No. APHIS-2008-0011) would restructure the regulations to facilitate the potential use of GSPPPs.

Two commenters stated that certain areas of the continental United States are more hospitable to the establishment of quarantine pests of tomatoes than others, and the rule should be amended to prohibit the importation of tomato plantlets in growing media from Mexico into those areas.

If the provisions of the proposed rule are adhered to, the plantlets will present a negligible risk of introducing quarantine pests into any area of the continental United States. Therefore, the relative likelihood of establishment of these pests in a particular part of the continental United States is not germane, and we are making no changes to the provisions of the systems approach based on these comments.

We proposed that the production site where the plantlets were produced would have to test for R. solanacearum race 3 biovar 2 and maintain records regarding such testing for at least two growing seasons.

A commenter stated that indoor production facilities have growing cycles, rather than growing seasons, and inquired whether maintaining the records for two growing cycles would suffice to meet this requirement.

Operationally, we rely on the definition of “growing season” provided in ISPM No. 5, “Glossary of Phytosanitary Terms.” 4 This definition considers a growing season to be the period or periods of the year when plants actively grow in an area, place of production, or production site.

The commenter did not specify what they meant by “growing cycle.” However, if the commenter meant the time period during which a particular set of tomato plantlets are in active growth within the producer's facility, from establishment to harvest, then the term “growing season” is equivalent to the term “growing cycle.”

We proposed that the greenhouses in which the plantlets are produced in Mexico would have to be surrounded by a 1-meter sloped buffer.

One commenter asked whether the buffer had to be around the perimeter of each of the greenhouses, or whether the greenhouses could collectively be surrounded by the buffer.

Either type of buffer suffices to meet this requirement.

We proposed that the plantlets would have to be handled and packed in a manner which precludes the introduction of R. solanacearum race 3 biovar 2 to the articles.

One commenter asked whether these procedures would prevent insect pests from being introduced onto the plantlets during movement to the United States.

Safeguarding procedures which prevent the introduction of R. solanacearum race 3 biovar 2 onto host plants are also sufficient to prevent the introduction of insect pests.

Finally, we proposed that the plantlets would have to be imported directly into a pest-exclusionary greenhouse in the continental United States.

One commenter asked whether the plantlets could be offloaded into a pest-exclusionary docking station at the same production site in the United States that contains the pest-exclusionary greenhouses, then resealed and moved to the greenhouses at a further stage of production.

Provided that the docking station has been evaluated by APHIS and provides an equivalent level of pest exclusion as do the greenhouses themselves, they may.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change.

This 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.

The rule will allow the importation of tomato plantlets in approved growing media from Mexico into the continental United States. Currently, tomato plantlets in growing media are not admissible into the United States except from Canada. The imported plantlets will be allowed to be imported only to APHIS-approved facilities under compliance agreements, and will be used only for fruit production.

Data are not available on the production or trade of tomato plantlets. However, U.S. greenhouse (more generally termed protected-culture) tomato production and import levels provide evidence of the expanding derived demand for tomato plantlets. In 2011, protected-culture tomatoes made up 40 percent of the U.S. tomato supply, up from less than 10 percent in 2004; they now dominate retail tomato sales. The value of protected-culture tomato imports by the United States grew by two-thirds between 2009 and 2013, in response to expanding consumer demand, from $795 million to $1.33 billion.

Reportedly, there are few nurseries in the United States that produce tomato plantlets and their volume of production is relatively small. The final rule will enable U.S. producers of protected-culture tomatoes to draw upon Mexican plantlet suppliers in addition to imports from Canada, and is expected to have a positive economic impact on the protected-culture tomato industry.

Protected-culture tomato producers are classified in the North American Industry Classification System within Other Vegetable (except Potato) and Melon Farming (NAICS 111219), for which the Small Business Administration small-entity standard is annual receipts of not more than $750,000. The average market value of agricultural products sold by operations in this industry in 2012 was about $314,000. While we are unable to determine the number of businesses that will be affected by the final rule, we can assume that at least some of them are small entities.

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

An environmental assessment and finding of no significant impact have been prepared for this final rule. The environmental assessment provides a basis for the conclusion that the importation into the continental United States of tomato plantlets in growing media from Mexico, subject to a required systems approach, will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

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

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

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0431, 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 EGovernment 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 final rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

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

Background

The regulations in 7 CFR chapter III and 9 CFR chapter I, subchapters D and G, require inspection, laboratory testing, certification, or quarantine of certain animals, poultry, animal byproducts, germ plasm, organisms, vectors, plants, plant products, or other regulated commodities or articles intended for importation into, or exportation from, the United States. With some exceptions, which are explained below, when these services must be provided by an Animal and Plant Health Inspection Service (APHIS) employee on a Sunday or on a holiday, or at any other time outside the APHIS employee's regular duty hours, the Government charges an hourly overtime fee for the services in accordance with 7 CFR part 354 and 9 CFR part 97.

Based on changes to the costs associated with providing agricultural inspection, laboratory testing, certification, and quarantine services, we determined that adjustments to the overtime rates in 7 CFR part 354 and 9 CFR part 97 were necessary in order for APHIS to recover the full cost of providing these services. Therefore, we proposed to set hourly overtime rates for inspection, laboratory testing, certification, and quarantine services provided outside of an employee's normal tour of duty for fiscal years (FYs) 2014 through 2018. Our proposal was published in the Federal Register on April 25, 2014 (79 FR 22887-22895, Docket No. APHIS-2009-0047).1 The proposed overtime rates were based on our costs of providing the services, including direct labor costs, area delivery costs, billing and collection costs, program direction and support costs, agency/management support costs, central/departmental changes, and a reserve component, plus adjustments for inflation and anticipated annual increases in the salaries of employees who provide the services.

We also proposed to include language in 7 CFR 354.1, 9 CFR 97.1, and 9 CFR 130.50 to clarify and inform the public that any agricultural inspection performed by an employee of the Department of Homeland Security (DHS) Bureau of Customs and Border Protection (CBP) on a Sunday, holiday, or anytime outside of the employee's normal tour of duty may be billed in accordance with the regulations in 5 CFR part 551, 7 CFR 354.1, 9 CFR 97.1, 9 CFR 130.50, or 19 CFR 24.16. Such billing is necessary because the costs associated with the DHS agricultural inspections and incurred by DHS may differ from those incurred by APHIS. Therefore, varying overtime charges may apply in such circumstances in order for DHS to properly recover their costs and adequately fund their program operations.

We solicited comments concerning our proposal for 60 days ending June 24, 2014. We received 43 comments by that date. They were from producers, importers, industry groups, and private individuals. Two were supportive of the proposed action. The remainder are discussed below by topic.

As previously stated, we proposed to establish the hourly overtime rates for FY 2014 through FY 2018. We note that, as FYs 2014 and 2015 have ended, the overtime rates covered by this final rule are now only for FYs 2016 through 2018. The FY 2016 rates will become effective 30 days after the date of publication of this final rule; the FY 2017 and FY 2018 rates would become effective on the first day of each of the fiscal years, and the FY 2018 rates would remain in effect until new rates were established.

One commenter stated that our aim of seeking set rates for anticipated costs over a 5 year period is too speculative and far too difficult to predict with accuracy. The commenter suggested that APHIS use a 5 year projection as a planning tool only and constrain specific overtime cost increases to a shorter timeframe.

We disagree with the commenter's assessment. Based on our experience with past overtime fee increases, information regarding such increases that covers a longer timeframe allows users of APHIS' services to incorporate the rates into their budget planning. In addition, we arrive at our projected figures using those gross domestic product (GDP) figures provided by the Office of Management and Budget (OMB) in the Presidential budget, which is the Government standard for such fees and is not subject to rate instability. Moreover, as explained above, the actual timeframe of this rule will be based on a shorter 3 year period since it will only apply to FYs 2016 through 2018.

The commenter went on to assert that our calculations should address not only the cost of providing overtime service, but also specify what steps are being taken to reduce costs to the Agency and thereby also reduce customer costs.

While the main cost driver of reimbursable overtime is the cost of salaries and benefits, APHIS has taken steps in recent years to achieve efficiencies as part of United States Department of Agriculture's (USDA) Blueprint for Stronger Service.2 For example, APHIS centralized certain services such as information technology, customer service support, telecommunications, and vehicle inventory while also enacting additional controls on purchases. APHIS continues to look for opportunities to reduce operating costs where possible while maintaining the level of services needed to carry out our mission of safeguarding U.S. agriculture.

We calculated our overtime rates to cover the full cost of providing inspection, testing, certification, or quarantine services at laboratories, border ports, ocean ports, rail ports, quarantine facilities, and airports outside of the normal tour of duty of the employee providing these services. The cost of providing these services includes direct and indirect costs. The direct costs are an employee's salary and specific benefits, which are APHIS' payment of the hospital insurance tax and its contribution to the Federal Insurance Contribution Act (FICA), and the Agency's costs for work performed at night. The indirect costs are area delivery costs, billing and collection costs, program direction and support costs, central/departmental charges, and unfunded leave costs.

A number of commenters observed that, in the calculation of overtime rates, only the variable cost of providing the additional service outside of regular business hours should be included in the assessment of the overall cost. Specifically, the commenters stated that there is no justification for the inclusion of most of the components identified in area delivery, imputed costs, agency level program delivery, agency level administrative support, and central/departmental charges.

We followed Federal guidance related to fee setting and managerial cost accounting in determining program costs. Specifically, we followed OMB Circular A-25: User Charges, which provides guidance on setting fees in the Federal Government, and SFAS No. 4, which includes, among other things, a definition of full cost. OMB Circular A-25, which may be viewed at http://www.whitehouse.gov/omb/circulars_default, establishes the requirement that fees be set at full cost to the Government, and provides a definition and examples for full cost. OMB Circular A-25 very specifically defines full cost to include the costs referenced by the commenters.

Another commenter asked to review APHIS's full revenue-costs statements as well as the full economic impact assessment. The commenter stated that the information was not included with the proposed rule.

Our full calculation of all aspects of overtime fees, starting with direct labor costs and including all indirect costs and overhead elements, was included in the proposed rule, which is available for public review on the Internet at: http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0047. The regulatory impact analysis and initial regulatory flexibility analysis were also made available on Regulations.gov along with the proposed rule as part of the rule's supporting documents. We maintain that this level of detail provides the highest degree of transparency and supports the required increase needed in our rates.

As detailed above, APHIS calculates its overtime fees based on a variety of sources apart from employee salary considerations. Per OMB Circular A-25, the overtime program is a full cost recovery program, which includes the direct and indirect costs outlined previously.

One commenter stated that APHIS should reconsider its cost estimates since the initial impetus for the proposed rule was work done in 2010 at the height of the financial crisis. The commenter went on to say that, since that time, the rate of importation and export has increased significantly, which would increase Agency funds that might be used to cover these costs instead.

We disagree with the commenter's assessment. While there are other components involved, much of the cost of overtime inspection is made up of inspector salaries. The APHIS budget provides funding for inspectors working within business hours, Monday through Friday, except holidays. Any work performed outside that timeframe is, by definition, additional and irregular. As detailed in OMB Circular A-25, Federal agencies are charged to recoup their costs in such instances via the assessment of overtime fees. Any additional funds that APHIS (or DHS for that matter) may receive via any increases in trade would remain in the accounts used by the specific Agency and programs that provide the services and incur the costs.

Two commenters stated that most, if not all, of the ports require that overtime be requested and paid for in a minimum of 4-hour blocks regardless of whether those 4 hours are needed or used. The commenters suggested that APHIS change its overtime billing policy so that importers would only be charged for the time required to conduct the requested inspection. The commenters also suggested that, if an inspector is called for overtime work in the 4 hour block described above and the whole of that time is not used, that inspector should then remain onsite for the remainder of the 4 hour time period in order to deal with any other vessels or cargoes that may arrive and require immediate inspection.

In § 354.1, paragraph (a)(2) states that a minimum charge of 2 hours will be made for inspection services performed by an APHIS employee outside of his or her normal tour of duty on Saturdays, holidays, weekdays, or Sundays. In addition, overtime fees may include a commuted traveltime period (CTT), which is established by APHIS to cover the time an employee spends reporting to and returning from the place where the requested overtime duties are performed.3 We believe the 4-hour minimum cited by the commenters includes the minimum overtime work time of 2 hours in addition to 2 hours of CTT. Although CTT ranges from 1 to 12 hours, 2 hours is the allotted CTT at many of our busiest ports. Regarding the commenters' second point concerning inspectors remaining onsite to perform other unexpected inspection; an arrangement of this nature is not precluded by the regulations. However, APHIS leaves such administrative details to the knowledge and discretion of the individual ports. The actual management of staffs, inspectors, hours, staffing for arrival, and identification of risk and needs varies from port to port and is best handled by port directors equipped with the detailed information necessary to make daily staffing decisions.

Two commenters observed that, in many instances, vessels and cargoes are ready for inspection during normal business hours only to find that DHS inspectors are not available due to the volume of inspections required for other vessels. The commenters stated that users should not be made to pay for services rendered in overtime periods that could have been conducted during normal business hours had sufficient personnel been available.

We have considered the commenters' point and have received detailed information from DHS regarding their staffing policies at the ports. Overall, DHS employs a rigorous, data-driven methodology to identify staffing requirements. It is composed of multiple elements—some fixed, others variable—that may be adjusted according to changing priorities, risks, and threats. In early 2014, a risk-based Agriculture Resource Allocation Model was finalized, which will serve as an important component of DHS's methodology. The Agriculture Resource Allocation Model will more accurately calculate the number of agricultural inspectors required to efficiently handle workflow at the ports. DHS will integrate the results of the Agriculture Resource Allocation Model into its existing methodology in order to provide a more holistic view of DHS's staffing requirements. Generally speaking, APHIS and DHS staffing decisions for agricultural inspections are continuously being reformulated based on changing conditions so that the ports may operate at a constantly improving level of service.

Two commenters stated that the regulations should stipulate that any overtime fees collected should be returned to the port where the services are rendered. The commenters said that this would ensure that sufficient funds are available where needed, and the Agencies would not be required to utilize appropriated funds or cash reserves to cover expenses associated with overtime fees.

We disagree with the commenters. It would be administratively burdensome for APHIS (or DHS for that matter) to maintain and track reimbursable overtime collections for agricultural inspection to a port-by-port level. Because the application of reimbursable overtime rates distinctively mirrors the work the employees perform and are paid for, there is no need to track collections and costs to this level. Program budgeters carefully consider the amount of reimbursable overtime work at their ports in providing budget estimates from year to year. Finally, APHIS and DHS overtime fee collections are already tracked to the agency level; those collections remain in the appropriate accounts to fund each Department's respective overtime operations.

Two commenters observed that both APHIS and DHS must be able to provide invoices for all overtime fees in a timely manner. The commenters suggested that the regulations stipulate that invoices will be provided within 30 days of the inspection date.

Comments referring to specific billing practices are outside the scope of the current rulemaking. Invoices are generally provided simultaneous to inspection; however the commenters should contact the port director with any questions or concerns about the timeliness of billing.

Other commenters stated that it would be possible for APHIS and DHS to assess overtime fees at a lower rate if industry were involved in negotiations between those Agencies and the inspectors' union.

Any discussion of union contract negotiation is outside the scope of the current rulemaking.

A commenter observed that greater responsiveness to current industry practices is needed. The commenter went on to state that, at the port in Atlanta, GA, importers cannot request weekend overtime after 3 p.m. on Friday, however it is impossible to determine with certainty by that time how much overtime will be necessary. The commenter is engaged in the importation of plant cuttings or live plants, which are perishable, and the busiest importing days, based on industry need and long-established industry practice, include Saturdays and Sundays.

Another commenter stated that the port in Miami, FL, had recently extended its weekday operational hours. The commenter urged APHIS to maintain those hours.

As previously stated, APHIS leaves such administrative details as the deadline for requesting weekend overtime and the operational hours of the ports to the knowledge and discretion of those individual ports. If the first commenter wishes to propose an extension of the deadline for requesting weekend overtime and the second commenter would like to maintain extended weekday hours of operation they should contact their local port directors.

A number of commenters expressed concern at the cost numbers supplied by APHIS in the proposed rule.

Several commenters observed that the proposed rule would increase the cost for overtime services by 30 to 49 percent (some commenters cited the increase as 45 to 55 percent); a number that represents 3 to 5 times the rate of inflation since the last increase in 2002. Further, the commenters remarked that the U.S. Department of Labor had reported only a 10 percent increase in the Consumer Price Index since 2002. The commenters were troubled by the difference between the inflation rate, the Consumer Price Index rate, and the proposed percentage increase to overtime fees.

Overtime fees are not solely based on either the rate of inflation or the Consumer Price Index. As stated previously, the cost of providing these services includes direct and indirect costs. The direct costs are an employee's salary and specific benefits, which are APHIS' payment of the hospital insurance tax and its contribution to the FICA, and the Agency's costs for work performed at night. The indirect costs are area delivery costs, billing and collection costs, program direction and support costs, central/departmental charges, and unfunded leave costs.

Another commenter suggested that the cost increases should be made incrementally over the next several years to lessen the burden on producers and exporters and help them maintain their competitive position.

A phase-in of the proposed changes would simply delay achieving the rule's objectives: To properly recover costs and adequately fund program operations. We would add that the decision to request overtime services, and therefore to incur additional costs, is left to the importer and such importers may realize price efficiencies by scheduling inspections during regular business hours.

Several commenters observed that the increase in the overtime fees will come in conjunction with a new fee of $375 per treatment for various types of treatments currently offered at no charge. The commenters asserted that the cumulative effect of these cost increases will have a chilling effect on the perishable goods import/export market in the United States.

The fee to which the commenters refer was included in a proposal to add new fee categories and adjust current fees charged for certain agricultural quarantine and inspection services provided in connection with certain commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers arriving at ports in the customs territory of the United States.4 While the fees discussed in that rule are compulsory, overtime fees represent the cost of providing the additional service outside of regular business hours. As stated previously, the decision to request overtime services, and therefore to incur additional costs, is left to the importer.

A number of commenters from Florida stated that the proposed increase in overtime fees would prove detrimental to trade, commerce, and the economy of that State.

We disagree with the commenters' assessment. Based on the economic assessment included with the proposal, we estimate that the impact of this rule will be minor. Further, the commenters did not provide any economic data in support of their claim for APHIS to examine.

Another commenter observed that Florida has successfully worked with APHIS to implement the first ever cold treatment pilot project for perishable commodities. The commenter was concerned that increased overtime fee rates would prove economically detrimental to the future of that project both in Florida and other areas where cold treatment is already permitted.

We disagree with the commenter's statement. APHIS' agreement with the shipping lines in the Florida cold treatment pilot program requires that cold treatment be completed before the ship arrives at the port because there are no approved cold treatment facilities available in Florida. Since the cold treatment must take place prior to shipment arrival, any information regarding application of cold treatment may be transmitted to the ports during regular business hours.

We received several requests for an extension of the comment period on the proposed rule. After careful consideration, we determined to keep the original deadline. While APHIS has not updated its overtime fees since 2005, these increases remain a routine cost-recovery measure for the Agency.

Two commenters stated that, to the extent APHIS and CBP are performing the same inspection services, the shipping community has a reasonable right to expect that the rates charged will be consistent across the agencies and that any internal conflicts in pay and rate schedules should be transparent to the service recipient. The commenters concluded that, to the extent one agency is acting on behalf of the other, it is imperative that the agency which is incurring the costs retains the appropriate percentage of the revenues collected.

We agree with the commenters' observations. Providing clarity while allowing APHIS and DHS to recoup inspection costs was our intent in publishing this rule.

Finally, one commenter said that there is confusion about which agencies have responsibility for and jurisdiction over various functions. The commenter said that the rule should clearly delineate which functions are performed by APHIS and which are performed on behalf of APHIS by DHS. The commenter concluded that fees should be listed only in the relevant sections of the CFR, and there must be no question that both APHIS and DHS are not billing individually for the same services.

Generally speaking, most of the agricultural inspections discussed in this rule are performed by DHS pursuant to the Homeland Security Act. Examples of agricultural inspections performed by APHIS include those associated with the importation of live plants, which occur at designated plant inspection stations, and APHIS oversight of certain port of entry treatments. As stated in the proposed rule, DHS conducts billings of their overtime charges in accordance with the regulations in 5 CFR part 551, 7 CFR 354.1, 9 CFR 97.1, 9 CFR 130.50, or 19 CFR 24.16. The DHS fees for agricultural inspection overtime work are not listed in a specific section of the CFR as the Homeland Security Act that first established DHS did not provide any new regulatory authority to DHS but rather used the existing regulatory authority of those agencies or programs whose functions were transferred to DHS. So APHIS' regulatory authority is used to enumerate or revise agricultural inspection overtime rates.

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

This final rule is subject to Executive Order 12866. However, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

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.

APHIS charges hourly overtime rates to individuals, firms, and corporations requesting inspection, testing, certification, or quarantine services at laboratories, border ports, ocean ports, rail ports, quarantine facilities, and airports outside of the regularly established hours of service. These overtime rates are charged to the individuals, firms, or corporations requesting the services, and the fees vary depending on the type of service performed and when the service is provided. This rule amends the fees for reimbursable overtime to reflect increased costs associated with providing these services.

APHIS is updating these fees to take into account the routine increases in the cost of conducting business during overtime hours. The cost to the import/export program to provide these services has increased year to year, and these proposed increases are necessary to more accurately provide the full cost recovery of this Agency activity.

Currently, APHIS charges $51 per hour per employee for inspection, testing, certification, or quarantine of animals or agricultural products outside the employee's regular tour of duty, and $67 per hour per employee for inspection, testing, certification, or quarantine of animals or agricultural products that is performed on Sundays outside the employee's regular tour of duty. APHIS charges $41 per hour per employee for commercial airline inspection services that are performed outside of the regularly established hours of service on a holiday or any other period and $55 per hour per employee for commercial airline inspection services that are performed outside of the regularly established hours of service on a Sunday. This rule establishes hourly overtime rates for each of the fiscal years 2016 through 2018. From FY 2016 through FY 2018, these rates would increase by $24 for inspection, testing, certification, or quarantine of animals or agricultural products outside the employee's regular tour of duty (Monday through Saturday and holidays), by $33 for inspection, testing, certification, or quarantine of animals or agricultural products that is performed on Sundays outside the employee's regular tour of duty, by $24 for commercial airline inspection services that are performed outside of the regularly established hours of service on a holiday or any other period, and by $31 for commercial airline inspection services that are performed outside of the regularly established hours of service on a Sunday.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

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

This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Accordingly, we are amending 7 CFR part 354 and 9 CFR parts 97 and 130 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 188 series airplanes. The NPRM published in the Federal Register on March 24, 2015 (80 FR 15525). The NPRM was prompted by an evaluation by the DAH indicating that the upper and lower wing skin planks at the attachment of the MLG ribs at certain wing-stations are subject to WFD. The NPRM proposed to require an inspection (for cracking) and modification of the chordwise fastener rows of the upper and lower wing planks at the attachments to the MLG ribs at certain wing-stations. We are issuing this AD to prevent fatigue cracking of the upper and lower wing skin planks at the attachment of the MLG ribs, which could result in failure of the wing.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 15525, March 24, 2015) or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the NPRM (80 FR 15525, March 24, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 15525, March 24, 2015).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We reviewed Lockheed Martin Electra Service Bulletin 88/SB-721, dated April 30, 2014. This service information describes procedures for doing a bolt-hole eddy current (BHEC) inspection for cracking and repair of cracking. This service information also describes procedures for modification of the chordwise fastener rows of the upper and lower wing planks at the attachments to the MLG ribs at wing-station (WS) 167 and WS 209 by removing the original fasteners and replacing them with new first oversize fasteners of the same type or approved substitute type for original fasteners. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this AD.

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

We estimate the following costs to comply with this AD:

We have received no definitive data that will enable us to provide cost estimates for the on-condition actions specified in this AD.

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

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to The Boeing Company Model 777 airplanes equipped with Rolls-Royce Trent 800 series engines. The NPRM published in the Federal Register on March 3, 2014 (79 FR 11725); corrected March 11, 2014 (79 FR 13592). The NPRM was prompted by reports of in-flight separation of the engine's aft plug from the forward plug, which are the two parts of the turbine exhaust plug assembly. The NPRM proposed to require installation of a serviceable turbine exhaust plug assembly (for certain airplanes), and a general visual inspection (for certain airplanes) to determine the diameter of the bolt used at the forward and aft plug interface, and applicable corrective actions. We are issuing this AD to prevent separation of the aft plug from the forward plug of the turbine exhaust plug assembly, which could result in parts departing the airplane and hitting the empennage, and destabilizing the airplane during a critical flight phase. In addition, parts remaining on a runway could pose a hazard to another airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (79 FR 11725, March 3, 2014; corrected March 11, 2014 (79 FR 13592); and the FAA's response to each comment.

Cathay Pacific requested that we ensure that the AD compliance date will be the same as the compliance time of Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012; or Boeing Special Attention Service Bulletin 777-78-0051, Revision 4, dated February 7, 2014. Cathay Pacific reasoned that paragraph (i) of the proposed AD specified compliance within 60 months after the effective date of the proposed AD, and both revisions of this service information specify a compliance time that is within 60 months after the Revision 3 date of the service bulletin.

We infer that Cathay Pacific is requesting that we reduce the compliance time of this final rule to match the compliance time listed in the service information. We do not agree with the commenter's request. In developing an appropriate compliance time for this action, we considered not only the degree of urgency associated with addressing the subject unsafe condition, but the manufacturer's recommendation for an appropriate compliance time, the time required for the rulemaking process, the availability of required parts, and the practical aspect of installing the required modification within an interval of time that corresponds to the typical scheduled maintenance for the majority of affected operators. Under the provisions of paragraph (l) of this AD, we may approve requests for adjustments to the compliance time, if data are submitted to substantiate that such an adjustment would provide an acceptable level of safety. We have not changed the AD in this regard.

Cathay Pacific requested that we revise paragraph (j) of the proposed AD; corrected March 11, 2014 (79 FR 13592) to define “serviceable” plug assemblies. Cathay Pacific reasoned that both pre- and post-Boeing Service Bulletin 777-78-0051 plug assemblies can be installed, and the modification can be completed before the required compliance time of the NPRM (79 FR 11725, March 3, 2014; corrected March 11, 2014 (79 FR 13592)).

We do not agree to revise paragraph (j) of this AD because serviceable assemblies are already defined in paragraph (h) of this AD. This definition applies to the entire AD. Also, pre- Boeing Service Bulletin 777-78-0051 plug assemblies do not meet the definition of serviceable, as specified in the service information.

American Airlines (AA) requested that we revise paragraph (h) of the proposed AD to add another definition: Serviceable plug assemblies, as those maintained in accordance with the operator's continued airworthiness maintenance program (CAMP), prior to issuance of Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012. AA explained that prior to release of Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012, due to reported events of exhaust plug losses by other operators, AA recognized that multiple removals of the exhaust aft plug causes the 3/16″ nutplate locking feature to wear out, which could then result in loss of the aft plug. As a result, AA implemented a maintenance program as part of its CAMP, which offers a level of safety equivalent to that of Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012. During every engine removal, for a refurbishment or overhaul shop visit, the pre-Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012, exhaust aft plug nutplates are replaced with new nutplates.

In addition, AA stated that the holes are inspected for elongation and cracks in accordance with procedures equivalent to Boeing Special Attention Service Bulletin 777-78-0051 inspection procedures. Model 777 Airplane Maintenance Manual Chapter 78-11-02-400-803-R00, requires that the minimum fastener run‐on torque of 2 in‐lbs is met during every installation of the aft exhaust plug. In addition, each of the exhaust aft plug fasteners receives a general visual check, using a ladder/stand and a bright light, every 150 flight hours. AA expressed that it is currently the largest Model 777-200 Trent 800 operator in the worldwide fleet and has not lost an exhaust aft plug due to loose or missing fasteners, as its CAMP demonstrates an equivalent level of safety to the service information.

As an alternative, AA requested that we revise the NPRM (79 FR 11725, March 3, 2014; corrected March 11, 2014 (79 FR 13592)) to include, as serviceable exhaust aft plugs, those maintained in accordance with the operator's own maintenance program, such as AA's approved CAMP prior to issuance of Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012, and to remain in service until the next engine removal for refurbishment or overhaul shop visit, or 60 months from the effective date of the AD, whichever is later.

We do not agree to include the requested provision. The maintenance program described by AA is likely to be acceptable in lieu of direct compliance with portions of this AD; however, the description of that program provided in AA's comment is not sufficient to serve as engineering data for the FAA to approve as an optional method of compliance in this AD. Operators can submit a request for approval of an alternative method of compliance (AMOC), with a more detailed proposal to use the maintenance program, if sufficient data are submitted to substantiate that the change would provide an acceptable level of safety. We have not changed this AD in this regard.

Boeing and Cathay Pacific requested that we revise paragraph (j) of the proposed AD to change the installation limitation from the effective date of the AD to the compliance deadline for the AD. Boeing reasoned that paragraph (j) of the proposed AD currently creates an alternative and indeterminate compliance deadline. Boeing explained that during the compliance interval and prior to the AD deadline, operators may be required, due to unforeseen circumstances, to install a unit that is not a serviceable unit, and that under the current wording, this would unnecessarily ground the airplane.

We do not agree to revise paragraph (j) of this AD to change the installation limitation from the effective date of the AD to the compliance date of the AD. Grace period compliance times are provided in ADs in recognition that an immediate unscheduled modification requirement would be disruptive. A grace period is included to give operators a reasonable period of time to schedule and perform actions that are required by the AD and that otherwise would not have occurred. A parts installation limitation is included in some cases to require that, if the parts affected by the AD are already being removed for a reason other than the AD itself, that opportunity to correct the unsafe condition should be taken. We determine whether such a parts installation limitation should be included in the AD, and what the specific requirements of the limitation will be, based on the risk level associated with the unsafe condition and the expected availability of required replacement parts.

In this case, we made a determination that the risk warranted the consideration of a parts installation limitation. We also determined that sufficient parts would be available to meet that limitation, and that sufficient time to perform any required actions to make a nozzle assembly serviceable as defined in paragraph (h) of this AD would exist in situations where the nozzle might be removed in maintenance. Specifically, we considered the case of an unscheduled engine change where an operator may not have included a serviceable nozzle assembly with the replacement engine. Modification of a nozzle assembly to meet the definition of a serviceable nozzle can be performed in roughly the same or less elapsed time than it takes to perform the engine replacement itself. We did not foresee any other commonly occurring situation where an engine nozzle assembly would be removed for maintenance. However, as discussed in response to the comment issue “Request to Revise Definition of a Serviceable Assembly,” if an operator specifically and adequately addresses the management of this unsafe condition within its CAMP, we will consider AMOC approvals to allow installation of nozzle assemblies that do not meet the definition of serviceable nozzle in paragraph (h) of this AD.

We clarified paragraph (j) of this AD as a result of these comments. We considered the explanatory statements about the intent of the parts installation limitation language used in several recent ADs, and determined that different language should be used in this case to more clearly convey the intent of the parts installation limitation contained in this AD. We have added the words “or re-install” to paragraph (j) to clarify that any installation of a nozzle assembly, regardless of the reason for the removal of the nozzle assembly and regardless of the source of the replacement nozzle assembly, is subject to the parts installation limitation of paragraph (j) of this AD.

AA requested that we clarify paragraph (j) of the proposed AD. AA explained that paragraph (j) of the proposed AD allows that only a serviceable turbine exhaust plug assembly may be installed on any airplane as of the effective date of this AD, while paragraph (i) of the proposed AD requires a compliance time within a certain time after the effective date of this AD, without any referral to serviceable turbine exhaust plug assembly. AA reasoned that as written, these steps are confusing and could lead operators to believe the actions required by the AD are due as of the effective date of this AD.

We agree with the commenter and have clarified paragraph (j) of this AD by including references to paragraphs (h)(1) and (h)(2) of this AD.

Boeing requested that we revise paragraph (k)(3) of the proposed AD (paragraph (l)(3) of this AD) to indicate that an AMOC, approved for a repaired serviceable unit is to be attached to, and travel with, the repaired serviceable unit. Boeing explained that the AMOC approval should apply to the deviation on the serviceable unit and thereby travel with the serviceable unit, which is rotable and could be installed on numerous airplanes during its service life. Boeing also explained that a unit repaired in accordance with an approved AMOC will fulfill the intent of airplane safety when the unit is installed on an airplane, and that the unit will be in compliance with the AD as long as the part is serviceable as defined by the AD.

We agree with the commenter and have revised paragraph (l)(3) of this AD accordingly.

AA requested that we revise the NPRM (79 FR 11725, March 3, 2014; corrected March 11, 2014 (79 FR 13592)), to include language that allows the optional re-identification of the exhaust plug with the correct post-Boeing Special Attention Service Bulletin 777-78-0051, part number identity in accordance with a method approved by the operator's approved CAMP, as the CAMP provides an equivalent level of safety. AA explained that prior to the release of Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012, AA implemented a maintenance program to install data plates on the forward and aft exhaust plug. The plates were installed because the manufacturer part number and serial number, which were chemical-etched on the exhaust plug skin by the manufacturer, were no longer legible. AA stated that the data plates contain the original part number, a company-assigned serial number, and the text “MATCHED SET. DO NOT SEPARATE.” AA added that the installed identification plates are in the same location as, but a different length than, the plates specified in Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012.

We agree to allow alternative permanent part-marking methods. If the markings contain the required information and are permanent, the intent of the marking requirement is addressed, and additional flexibility is provided to operators. Therefore, part-marking methods for the CAMP might be approved, provided that the markings are permanent and contain the information specified in Boeing Special Attention Service Bulletin 777-78-0051, Revision 4, dated February 7, 2014. We have added this information to paragraph (g) of this AD accordingly.

AA requested that we revise paragraph (h) of the proposed AD, to allow repairs accomplished prior to the release of this AD, in accordance with Boeing instructions and approved per 14 CFR part 121.379, or a Boeing ODA, to be included as acceptable repairs in this AD, without the requirement to obtain a Boeing ODA AMOC or Seattle Aircraft Certification Office AMOC approval.

AA explained that, prior to release of the NPRM (79 FR 11725, March 3, 2014; corrected March 11, 2014 (79 FR 13592)); exhaust aft plugs have received repairs at the exhaust aft plug mate line during inspection or during incorporation of Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012, utilizing procedures provided by Boeing without Boeing ODA approval; rather, the repair was approved per 14 CFR part 121.379. AA expressed that paragraph (h) of the proposed AD specifies using a repair method approved in accordance with the procedures specified in paragraph (k) of the proposed AD, and these previously accomplished repairs, which followed Boeing repair instructions, offer an equivalent level of safety to the NPRM.

We partially agree with the request. We agree to add paragraph (l)(4) in this AD to eliminate the requirement for subsequent AMOC approval for repairs that were previously approved by the Boeing ODA, using an FAA Form 8100-9, and having met the requirements of paragraph (h) of this AD, for the definition of serviceable turbine exhaust plug assemblies. We are confident that the Boeing ODA repair approval process ensures that each repair is reviewed by qualified engineering staff with knowledge of the original airplane design and compliance substantiation. At the same time, we want to ensure that those repairs would have a configuration that meets the definition of serviceable turbine exhaust plug assemblies as defined in the service information. We have added paragraph (l)(4) in this AD to state that repairs approved prior to the effective date of this AD, by the Boeing ODA using FAA Form 8100-9, and having met the requirements of paragraph (h) of this AD for the definition of serviceable turbine exhaust plug assemblies, do not require AMOC approval.

We disagree, however, to eliminate the AMOC approval requirement for repairs approved by other means. Even though Boeing Service Engineering may have provided a “no technical objection” statement, qualified engineering staff with knowledge of the original airplane design and compliance substantiation may not have been involved in evaluating the repair. We have not changed this AD in this regard.

We have revised this AD to refer to Boeing Special Attention Service Bulletin 777-78-0051, Revision 4, dated February 7, 2014, as the appropriate source of service information for the required actions. Among other things, this service information adds Group 2 airplanes to paragraph 1.E., “Compliance;” includes a maintenance records check; adds a general visual inspection to determine the diameter of the bolt used at the forward and aft plug interface; and adds applicable corrective actions—all of which we have clarified in new paragraph (g)(4) of this AD. Paragraphs (g)(3) and (c) of the proposed AD already accounted for the Group 2 airplanes defined in Boeing Special Attention Service Bulletin 777-78-0051, Revision 4, dated February 7, 2014. Paragraph (g)(2) of the proposed AD accounted for the required actions.

We have also added a new paragraph (k) to this AD to provide credit for certain actions, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012. We have redesignated the subsequent paragraphs of this AD accordingly.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (79 FR 11725, March 3, 2014; corrected March 11, 2014 (79 FR 13592)) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 11725, March 3, 2014; corrected March 11, 2014 (79 FR 13592)).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We reviewed Boeing Special Attention Service Bulletin 777-78-0051, Revision 4, dated February 7, 2014. Among other things, this service information adds Group 2 airplanes to paragraph 1.E., “Compliance;” includes a maintenance records check; adds a general visual inspection to determine the diameter of the bolt used at the forward and aft plug interface; and adds applicable corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this AD.

We estimate that this AD affects 35 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacement that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this replacement:

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

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

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

I. Background

On July 21, 2010, President Obama signed the Dodd-Frank Act into law. 1 Title VII of the Dodd-Frank Act 2 amended the CEA 3 to establish a comprehensive framework for the regulation of over-the-counter derivatives, also known as swaps. Among other reforms, Title VII requires that any person who operates a facility to trade swaps register as a designated contract market (“DCM”) or a swap execution facility (“SEF”); 4 the latter is a category of trading market newly established under the law. Concurrently, Title VII eliminated from the CEA two categories of exempt markets for the trading of derivatives originally established in the CEA by the Commodity Futures Modernization Act of 2000 (“CFMA”): 5 exempt commercial markets (“ECMs”) and exempt boards of trade (“EBOTs”).

Under the CFMA's revisions to the CEA, ECMs could trade exempt commodities 6 (i.e. any commodity other than an excluded commodity 7 and agricultural commodities) on electronic trading facilities between eligible commercial entities 8 without complying with comprehensive designation criteria and core principles that were applicable to designated contract markets. A facility that elected to operate as an ECM was generally exempt from regulation, but was still required to comply with certain informational and recordkeeping requirements, if the market satisfied the conditions for the exemption found in Sections 2(h)(3) through (5) of the CEA, 7 U.S.C. 2(h)(3)-(5), including a requirement that the ECM notify the Commission of its intent to rely upon the exemption.9

Under CEA Section 5d, 7 U.S.C. 7a-3, EBOTs were facilities that traded commodities (other than securities or securities indexes) that had a nearly inexhaustible deliverable supply and either no cash market or a cash market so liquid that any contract traded on the commodity was highly unlikely to be susceptible to manipulation. EBOT transactions were limited to eligible contract participants 10 and subject to minimal trading prohibitions, including anti-fraud and anti-manipulation restrictions. EBOTs were required to file notice with the Commission of their election to operate as an EBOT.11

Section 723 of the Dodd-Frank Act repealed CEA Section 2(h)(3) as it then existed,12 thus eliminating the ECM category. Section 734 of the Dodd-Frank Act similarly repealed CEA Section 5d,13 thus eliminating the EBOT category. Both Sections 723 and 734 of the Dodd-Frank Act contain grandfather provisions allowing existing ECMs and EBOTs to petition the Commission to continue to operate as ECMs and EBOTs subject to the requirements of the CEA Sections 2(h)(3) and 5d, respectively, for a limited period of time.14 Pursuant to these grandfather provisions, the Commission issued an order in September 2010 granting petitioning ECMs and EBOTs up to one year of grandfather relief from the general effective date of the Dodd-Frank Act amendments to the CEA (“Grandfather Relief Order”).15

Subsequent to the Grandfather Relief Order, the Commission issued a series of orders 16 and Commission staff issued various no-action letters 17 that effectively extended expiration of the relief provided to ECMs and EBOTs in the Grandfather Relief Order. Collectively, the Grandfather Relief Order and subsequent Commission orders and staff no-action letters allowed ECMs and EBOTs, as well as other markets that relied on various pre-Dodd-Frank Act provisions of the CEA,18 to continue operations under a regulatory status quo and, thus, ensured that industry practices would not be unduly disrupted during the transition to the new Dodd-Frank Act regulatory regime.19

The Grandfather Relief Order and various subsequent Commission orders have all expired, and entities that previously operated as ECMs or EBOTs are seeking registration to become either DCMs or SEFs to continue their operations. Accordingly, the Commission is removing all references to the Commission exemptive orders from Title 17 of the Code of Federal Regulations.

As discussed in section III.A. below, the Commission is publishing this final rule pursuant to the Administrative Procedure Act, 5 U.S.C. 553(b)(A), which provides that the requirements for notice and opportunity for public comment do not apply to “rules of agency organization, procedure, or practice . . . .” 20 The rulemaking conforms the Commission's regulations to the statutory requirements of the CEA by removing provisions that are of no legal effect because they concern exempt market categories that Congress, through the Dodd-Frank Act, removed from the statute; the Commission has no authority or discretion under the statute to retain the ECM and EBOT category designations in its regulations. As such, the amendments effected through this rulemaking—which have no impact on substantive rights or obligations under the CEA, as amended by the Dodd-Frank Act—are entirely ministerial and procedural in nature.

The Commission is removing part 36 of its regulations in its entirety in order to reflect the Dodd-Frank Act's elimination of the two categories of exempt markets—ECMs and EBOTs—from the CEA.

The Commission is removing from parts 15, 18, 40, and 140 all references to the Grandfather Relief Orders added to the Commission's regulations by Adaptation of Regulations To Incorporate Swaps rulemaking,21 as the authority under which those orders were issued has expired, and is removing all references in the Commission's regulations to the terms ECMs, EBOTs, and electronic trading facilities (as sometimes used in the Commission's regulations to refer to ECMs).22

1. Regulation 15.05: Designation of agent for foreign persons.

The Commission is removing from regulation 15.05 all references to contracts identified in part 36.

2. Regulation 18.05: Maintenance of books and records.

The Commission is removing from regulation 18.05 all references to ECMs and EBOTs.

3. Regulation 40.8: Availability of public information.

The Commission is removing from regulation 40.8 all references to electronic trading facilities on which significant price discovery contracts are traded or executed.

4. Appendix D to Part 40—Submission Cover Sheet and Instructions.

The Commission is removing from Appendix D to part 40 the reference to electronic trading facilities with a significant price discovery contract.

5. Regulation 140.99: Requests for exemptive, no-action and interpretative letters.

The Commission is removing from regulation 140.99 all references to ECMs and EBOTs.

The Administrative Procedure Act (“APA”) 23 generally requires a Federal agency to publish notice of a proposed rulemaking in the Federal Register and allow opportunity for public comment before propounding a final rule.24 This requirement does not apply, however, to non-legislative rules of “agency organization, procedure, or practice.” 25 In this case, the revisions to the Commission's regulations in this rulemaking do not establish any new substantive or legislative rules. Rather, this final rule makes technical amendments to various Commission regulations to reflect the fact that Congress has eliminated the ECM and EBOT category designations from the CEA. As such, the amendments effected through this rulemaking—which have no impact on substantive rights or obligations under the CEA, as amended by the Dodd-Frank Act—are entirely ministerial and procedural in nature. This final rule shall become effective upon publication in the Federal Register.

The Regulatory Flexibility Act requires the Commission to consider whether the regulations it adopts will have a significant economic impact on a substantial number of small entities.26 The Commission certifies that this rulemaking will have no significant impact on a substantial number of small entities as defined in the Regulatory Flexibility Act.27 There is no additional submission required as a result of this action. Accordingly, the Commission is not obligated to conduct a regulatory flexibility analysis for this rulemaking.

The Commission may not conduct or sponsor, and a respondent is not required to respond to, a collection of information contained in a rulemaking unless the information collection displays a currently valid control number issued by the Office of Management and Budget (“OMB”) pursuant to the Paperwork Reduction Act.28 This rulemaking contains no collection of information that obligates the Commission to obtain a control number from OMB.

We are adopting an updated EDGAR Filer Manual, Volume I, Volume II, and Volume III. The Filer Manual describes the technical formatting requirements for the preparation and submission of electronic filings through the EDGAR system.1 It also describes the requirements for filing using EDGARLink Online and the Online Forms/XML Web site.

The revisions to the Filer Manual reflect changes within Volume I entitled EDGAR Filer Manual, Volume I: “General Information,” Version 23 (September 2015), Volume II entitled EDGAR Filer Manual, Volume II: “EDGAR Filing,” Version 34 (September 2015), and Volume III entitled EDGAR Filer Manual, Volume III: “N-SAR Supplement,” Version 5 (September 2015). The updated manual will be incorporated by reference into the Code of Federal Regulations.

The Filer Manual contains all the technical specifications for filers to submit filings using the EDGAR system. Filers must comply with the applicable provisions of the Filer Manual in order to assure the timely acceptance and processing of filings made in electronic format.2 Filers may consult the Filer Manual in conjunction with our rules governing mandated electronic filing when preparing documents for electronic submission.3

The EDGAR system will be upgraded to Release 15.3 on September 14, 2015 and will introduce the following changes:

As part of the final rules adopted on January 14, 2015 for regulating security-based swap data repositories (SDR), the following submission form types will be added to EDGAR: 4

These submission form types can be accessed by selecting the `EDGARLink Online Form Submission' link on the EDGAR Filing Web site. Additionally, applicants may construct XML submissions for SDR-CCO and SDR-CCO/A by following the “EDGARLink Online XML Technical Specification” document available on the SEC's Public Web site (http://www.sec.gov/info/edgar.shtml).

Submission form types SDR-CCO and SDR-CCO/A will include the “Request Confidentiality” check box to allow applicants to request confidential treatment for each attached document. After an SDR-CCO or SDR-CCO/A filing is submitted, SEC staff will review the submission and make a determination of whether the information for which confidential treatment is requested should be made public. EDGAR will only disseminate the attached documents of the submission that the SEC staff has determined to be public.

In connection with the Commission's revised rules and forms for disclosure by asset-backed securities issuers, new exhibit EX-36 (Depositor Certification for shelf offerings of asset-backed securities) will be available on EDGARLink Online for submission form types SF-3, SF-3/A, 8-K, and 8-K/A.5 This change will allow registrants to file a certification required for shelf offerings of asset-backed securities as an EX-36. Filers will have the option to attach exhibit EX-36 in official HTML or ASCII format (and unofficially in PDF format) on submission form types SF-3 and SF-3/A and on submission form types 8-K and 8-K/A, when the SIC code associated with the Primary Filer CIK is 6189 (Asset-Backed Securities).

EDGAR will be updated to include the following XBRL document types for submission form types SDR, SDR/A, SDR-A, and SDR-W:

Filers will now be able to submit SDR Exhibit K and Exhibit L in XBRL format for submission form types SDR, SDR/A, SDR-A, and SDR-W. Filers can continue to provide SDR Exhibit K and Exhibit L in ASCII or HTML formats for submission form types SDR, SDR/A, SDR-A, and SDR-W.

XBRL file attachments will be considered valid if they contain multiple identically tagged XBRL facts.

Documentation updates were made to Chapter 2 of the “EDGAR Filer Manual, Volume I: General Information” and Chapters 2, 3, and 7 of the “EDGAR Filer Manual, Volume II: EDGAR Filing” relating to Form NRSRO.

Formatting changes were made to “EDGAR Filer Manual, Volume I: General Information”, “EDGAR Filer Manual, Volume II: EDGAR Filing”, and “EDGAR Filer Manual, Volume III: N-SAR Supplement” for compliance with Section 508 of the U.S. Rehabilitation Act.

The Filer Manual is also being revised to address software changes made previously in EDGAR. On July 10, 2015, EDGAR Release 15.2.e.4 introduced the following change:

Along with the adoption of the Filer Manual, we are amending Rule 301 of Regulation S-T to provide for the incorporation by reference into the Code of Federal Regulations of today's revisions. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

The updated EDGAR Filer Manual will be available for Web site viewing and printing; the address for the Filer Manual is http://www.sec.gov/info/edgar.shtml. You may also obtain paper copies of the EDGAR Filer Manual from the following address: Public Reference Room, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m.

Since the Filer Manual and the corresponding rule changes relate solely to agency procedures or practice, publication for notice and comment is not required under the Administrative Procedure Act (APA).6 It follows that the requirements of the Regulatory Flexibility Act 7 do not apply.

The effective date for the updated Filer Manual and the rule amendments is October 2, 2015. In accordance with the APA,8 we find that there is good cause to establish an effective date less than 30 days after publication of these rules. The EDGAR system upgrade to Release 15.3 is scheduled to become available on September 14, 2015. The Commission believes that establishing an effective date less than 30 days after publication of these rules is necessary to coordinate the effectiveness of the updated Filer Manual with the system upgrade.

We are adopting the amendments to Regulation S-T under Sections 6, 7, 8, 10, and 19(a) of the Securities Act of 1933,9 Sections 3, 12, 13, 14, 15, 23, and 35A of the Securities Exchange Act of 1934,10 Section 319 of the Trust Indenture Act of 1939,11 and Sections 8, 30, 31, and 38 of the Investment Company Act of 1940.12

In accordance with the foregoing, Title 17, Chapter II of the Code of Federal Regulations is amended as follows:

Background

The Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) administers regulations published in title 27, chapter II, Code of Federal Regulations (CFR). On August 11, 2014, the Department of Justice (DOJ) published in the Federal Register a final rule that made technical amendments and corrected typographical errors in ATF regulations in the CFR (79 FR 46690). Many of the technical changes were made to reflect changes in nomenclature resulting from the transfer of ATF to DOJ from the Department of the Treasury, pursuant to the Homeland Security Act of 2002. The changes were designed to provide clarity and enhance uniformity throughout these regulations.

The 2014 technical amendments inadvertently contained an incorrect definition for “Customs officer” in 27 CFR part 555. This final rule corrects the changes in the Code of Federal Regulations made by the 2014 technical amendments by revising the definition. Section 555.11, defining “Customs officer,” is being amended so that it no longer contains a reference to “Customs Service.” The new definition reads as follows: “Any officer of U.S. Customs and Border Protection, any commissioned, warrant, or petty officer of the Coast Guard, or any agent or other person authorized by law to perform the duties of a customs officer.”

This final rule has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), The Principles of Regulation, and Executive Order 13563, “Improving Regulation and Regulatory Review,” section 1, General Principles of Regulation. This rule is limited to agency organization, management, or personnel matters as described by Executive Order 12866, section 3(d)(3) and, therefore, is not a “regulation” or “rule” as defined by that Executive Order.

This final rule will not have substantial direct effects on the States, on the relationship between the Federal 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, “Federalism,” the Attorney General has determined that this regulation does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, “Civil Justice Reform.”

This final rule is purely a matter of agency management. Accordingly, this rule is exempt from the usual requirements of prior notice and comment and a 30-day delay in the effective date. See 5 U.S.C. 553(a)(2). In addition, prior notice and comment are not required because the final rule is a rule of agency organization, procedure, or practice. See 5 U.S.C. 553(b). Moreover, the Department finds good cause for exempting the rule from those requirements. Because this final rule makes a technical correction for accuracy and to improve the clarity of the regulations, the Department finds it unnecessary to publish this rule for public notice and comment. See 5 U.S.C. 553(b). Similarly, because delaying the effective date of this rule would serve no purpose, the Department also finds good cause to make this rule effective upon publication. See 5 U.S.C. 553(d)(3).

The Attorney General, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities because it pertains to personnel and administrative matters affecting the Department. Further, a Regulatory Flexibility Analysis is not required for this final rule because the Department was not required to publish a general notice of proposed rulemaking for this matter. See 5 U.S.C. 604.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804. 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-based enterprises to compete with foreign-based enterprises in domestic and export markets.

This rule was not preceded by a published notice of proposed rulemaking; will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year; will not significantly or uniquely affect small governments; and does not contain significant intergovernmental mandates. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1535.

This final rule does not impose any new reporting or recordkeeping requirements under the Paperwork Reduction Act, 44 U.S.C. 3501-3521.

This action pertains to agency organization, procedure, or practice, and does not substantially affect the rights or obligations of non-agency parties and, accordingly, is not a “rule” as that term is used by the Congressional Review Act (Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996). See 5 U.S.C. 804(3). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.

Accordingly, for the reasons discussed in the preamble, 27 CFR part 555 is amended as follows:

This rule revises the DoD-DIB cybersecurity information sharing program regulation to implement new statutory requirements for DoD contractors and subcontractors to report cyber incidents that result in an actual or potentially adverse effect on a covered contractor information system or covered defense information residing therein, or on a contractor's ability to provide operationally critical support. The program also retains the voluntary information sharing activities for cybersecurity information that is outside the scope of the mandatory reporting requirements.

Regarding the mandatory reporting, this part has been revised to set forth mandatory cyber incident reporting requirements that will apply to all forms of contracts or other agreements between DoD and DIB companies (e.g., procurement contracts, cooperative agreements, other transaction agreements). Thus, all relevant contracts or agreements are required to include these cyber reporting requirements (e.g., through incorporation of the reporting requirements by reference, or by expressly setting forth reporting requirements consistent with this part). The revisions provided in this rule are part of DoD's efforts to establish a single reporting mechanism for such cyber incidents on unclassified DoD contractor information systems. These requirements are focused on cyber incidents that threaten specific types of DoD program information, such as technical information controlled under the International Traffic in Arms Regulations or the Export Administration Regulations or otherwise controlled by DOD and operational security information that relates to DoD activities. Additional cyber incident reporting requirements for other important types of controlled unclassified information (CUI) (e.g., personally identifiable information (PII), budget or financial information) are more specifically addressed through other regulatory mechanisms, and thus are outside the scope of this rule. To clarify this distinction, the rule explicitly states that reporting under this program does not abrogate the contractor's responsibility for any other applicable cyber incident reporting requirements (§ 236.4(o)).

The rule also revises the program's definitions to better harmonize with definitions that are already established and used by DoD and other Government agencies in similar contexts, such as those relating to the handling and safeguarding of Controlled Unclassified Information as used by the National Archives and Records Administration pursuant to Executive Order 13556 “Controlled Unclassified Information” (November 4, 2010) (see http://www.archives.gov/cui/), and those widely used in the context of cybersecurity activities (see the Committee on National Security Systems Instruction No. 4009, “National Information Assurance Glossary”).

This rule is intended to streamline the reporting process for DoD contractors and minimize duplicative reporting processes, while preserving distinctions where appropriate. Cyber incident reporting involving classified information on classified contractor systems will be in accordance with the National Industrial Security Program Operating Manual (DoD-M 5220.22 (http://www.dtic.mil/whs/directives/corres/pdf/522022m.pdf)).

This rule also modifies eligibility criteria to permit greater participation in the voluntary DoD-DIB CS information sharing program. Expanding participation in the DoD-DIB CS information sharing program is part of DoD's comprehensive approach to counter cyber threats through information sharing between the Government and DIB participants. The DoD-DIB CS information sharing program allows eligible DIB participants to receive Government furnished information (GFI) and cyber threat information from other DIB participants, thereby providing greater insights into adversarial activity targeting the DIB. The activities in this rule implement DoD statutory authorities to establish programs and activities to protect sensitive DoD information, including when such information resides on or transits information systems operated by contractors or others in support of DoD activities (e.g., 10 U.S.C. 391 and 2224, the Federal Information Security Modernization Act (FISMA), codified at 44 U.S.C. 3551 et seq., section 941 of the NDAA for FY 2013 (Public Law 112-239)). Activities under this rule also fulfill important elements of DoD's critical infrastructure protection responsibilities, as the sector specific agency for the DIB sector (see Presidential Policy Directive 21 (PPD-21), “Critical Infrastructure Security and Resilience,” available at https://www.whitehouse.gov/the-press-office/2013/02/12/presidential-policy-directive-critical-infrastructure-security-and-resil).

Under this rule, contractors will incur costs associated with requirements for reporting cyber incidents of covered defense information on their covered contractor information system(s) or those affecting the contractor's ability to provide operationally critical support. Costs for contractors include identifying and analyzing cyber incidents and their impact on covered defense information, or a contractor's ability to provide operationally critical support, as well as obtaining DoD-approved medium assurance certificates to ensure authentication and identification when reporting cyber incidents to DoD. Government costs include onboarding new companies under the voluntary DoD-DIB CS information sharing program, and collecting and analyzing cyber incident reports, malicious software, and media.

A foundational element of these new mandatory reporting requirements, as well as the voluntary DoD-DIB CS information sharing activities, is the recognition that the information being shared between the parties includes extremely sensitive information that requires protection. For additional information regarding the Government's safeguarding of information received from the contractors that require protection, see the Privacy Impact Assessment (PIA) for the DIB Cybersecurity/Information Assurance Activities located at http://dodcio.defense.gov/Portals/0/Documents/DIB%20CS-IA%20PIA_FINAL_signed_30jun2011_VMSS_GGMR_RC.pdf. The PIA provides detailed procedures for handling personally identifiable information (PII), attributional information about the strengths or vulnerabilities of specific covered contractor information systems, information providing a perceived or real competitive advantage on future procurement action, and contractor information marked as proprietary or commercial or financial information.

This rule is being published as an interim rule in order to comply with statutory guidance under Section 941 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013, and section 391 of Title 10, United States Code (U.S.C.), requiring defense contractors to rapidly report cyber incidents on their unclassified networks or information systems that may affect unclassified defense information, or that affect their ability to provide operationally critical support to the Department. Issuing this rule as an interim final rule underscores the importance of better protecting unclassified defense information against the immediate cyber threat, while preserving the intellectual property and competitive capabilities of our national defense industrial base. The interim final rule enables DoD to better assess, in the near term, when mission critical capabilities and services are affected by cyber incidents and reinforces DoD's overall efforts to defend DoD information, protect U.S. national interests against cyber-attacks, and support military operations and contingency plans worldwide. Cybersecurity is a Congressional priority and this interim final rule supports the Administration's national cybersecurity strategy emphasizing public-private information sharing.

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB).

It has been determined that this rule is not a “major” rule under 5 U.S.C. 801, enacted by Public Law 104-121, because it will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local Government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

It has been determined that this rule does not contain a Federal mandate that may result in expenditure by State, local and tribal Governments, in aggregate, or by the private sector, of $100 million or more in any one year.

It has been certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

It has been determined that 32 CFR part 236 does contain reporting or recordkeeping requirements under the Paper Reduction Act (PRA) of 1995. These reporting requirements apply existing collection approvals under Office of Management and Budget (OMB) Control Numbers: 0704-0489, “Defense Industrial Base Cyber Security/Information Assurance (DIB CS/IA) Cyber Incident Reporting,” and 0704-0490, “Defense Industrial Base Cyber Security/Information Assurance (DIB CS/IA) Points of Contact (POC) Information.”

DoD has submitted a revision for the 0704-0489 collection to OMB under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35) in response to 32 CFR part 236 expanding the number of companies under mandatory cyber incident reporting requirements. Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology.

Title: Cyber Incident Reporting by DoD Contractors

Type of Request: Revision.

Number of DoD contractors impacted is 10,000.

Projected Responses Per Participant Per Year: 5.

Annual Total Responses: Up to 50,000.

Average Burden Per Response: 7 hours (this includes searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information).

Annual Total Burden Hours: 250,000 hours for all participants.

Needs and Uses: The requested information supports the mandatory cyber incident reporting requirements under Section 941 of the NDAA for Fiscal Year (FY) 13 and Section 1632 of the NDAA for FY 15, and facilitates cyber situational awareness and cyber threat information sharing. DoD contractors report incidents using the standard Incident Collection Format (ICF). The primary means of reporting is through a secure unclassified web portal, but a company may report incidents through other communication means if necessary.

Affected Public: DoD contractors with the provisions of 32 CFR part 236 in their agreements with DoD.

Frequency: On occasion.

Respondent's Obligation: Mandatory.

DoD has submitted a revision for the 0704-0490 collection to OMB under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35) in response to 32 CFR part 236 expanding the number of companies eligible to participate in the voluntary DIB CS information sharing program. Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology.

Title: Defense Industrial Base Cybersecurity Activities Points of Contact (POC) Information.

Type of Request: Revision.

Number of DoD contractors impacted is 8,500. DoD estimates that no more than 10% of the total eligible population of cleared defense contractors will apply to the voluntary DIB Cybersecurity Activities program resulting in 850 cleared defense contractors impacted annually. An additional 10% of the population or 85 contractors may provide updated points of contact for the program, as required.

Projected Responses Per Participant: Initial collection is one per company with updates on a case-by-case basis.

Annual Total Responses: 935.

Average Burden Per Response: 20 minutes.

Annual Total Burden Hours: 312 hours for all participants.

Needs and Uses: The Government will collect business points of contact (POC) information from all Defense Industrial Base (DIB) Cybersecurity program participants on a one-time basis, with updates as necessary, to facilitate communications and the sharing of share unclassified and classified cyber threat information.

Affected Public: Business or other for-profit and not-for-profit institutions.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer:

Written comments and recommendations on these information collections should be sent to Ms. Jasmeet Seehra at the Office of Management and Budget, DoD Desk Officer, Room 10102, New Executive Office Building, Washington, DC 20503, with a copy to the Director, DoD-DIB Cybersecurity Activities Office, at the Office of the DoD Chief Information Officer, 6000 Defense Pentagon, Attn: DIB CS Activities Office, Washington, DC 20301-6000, or email at [email protected].

You may also submit comments, identified by docket number and title, by the following method:

Federal Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

It has been determined that this rule does not have federalism implications, as set forth in Executive Order 13132. This rule does not have substantial direct effects on:

(a) The States;

(b) The relationship between the National Government and the States; or

(c) The distribution of power and responsibilities among the various levels of Government.

Accordingly, 32 CFR part 236 is revised to read as follows:

The Copyright Royalty Judges (“Judges”) received a joint motion from SoundExchange, Inc. (“SoundExchange”), National Public Radio, Inc. (“NPR”) and the Corporation for Public Broadcasting (“CPB”) in which they announced a partial settlement in the above proceeding (“Settlement”) regarding royalty rates and terms for certain internet transmissions by NPR, American Public Media, Public Radio International, and certain public radio stations (“covered entities”). The parties to the agreement requested that the Judges adopt the Settlement as a determination of rates and terms under Sections 112(e) and 114 of the Copyright Act for eligible transmissions by covered entities through their Web sites and related ephemeral recordings, as more specifically set forth in the Settlement. The Judges published the proposed Settlement and requested comments from the public. 80 FR 15958 (March 26, 2015).

Section 801(b)(7)(A) of the Copyright Act authorizes the Judges to adopt rates and terms negotiated by “some or all of the participants in a proceeding at any time during the proceeding” provided the settling parties submit the negotiated rates and terms to the Judges for approval. That provision directs the Judges to provide those who would be bound by the negotiated rates and terms an opportunity to comment on the agreement. Unless a participant in a proceeding objects and the Judges conclude that the agreement does not provide a reasonable basis for setting statutory rates or terms, the Judges adopt the negotiated rates and terms. 17 U.S.C. 801(b)(7)(A).

The Judges “may decline to adopt the agreement as a basis for statutory terms and rates for participants that are not parties to the agreement,” only “if any participant [to the proceeding] objects to the agreement and the [Judges] conclude, based on the record before them if one exists, that the agreement does not provide a reasonable basis for setting statutory terms or rates.” 17 U.S.C. 801(b)(7)(A)(ii).

Section 801(b)(7)(A) limits the circumstances under which the Judges may decline to adopt aspects of an agreement; nevertheless it does not preclude the Judges from declining to adopt portions of an agreement that would be contrary to the provisions of the applicable license or otherwise contrary to statutory law. See Review of Copyright Royalty Judges Determination, 74 FR 4537, 4540 (Jan. 26, 2009).

By its terms, this partial Settlement applies to “covered entities,” which are defined as NPR, American Public Media, Public Radio International, Public Radio Exchange, and up to 530 originating public radio stations as named by CPB. Proposed Regulation 380.31. Notwithstanding the royalty rates and terms set forth in the partial Settlement, copyright owners and licensees are permitted, consistent with the partial Settlement, to adopt rates and terms that would apply in lieu of those established in the partial Settlement. Proposed Regulation 380.30(c). According to the Joint Motion, “[b]ecause the Settlement applies to only a closed group of licensees, and has a single payor (CPB), the Settlement is being submitted to the Judges for adoption as a statutory rate and terms [sic] only so that it will be binding on all copyright owners and performers, including those that are not members of SoundExchange.” Joint Motion at 3.

The Judges received one comment in response to their request for comments published in the Federal Register. In that comment, Intercollegiate Broadcasting System (“IBS”), a participant in the captioned proceeding, objected to adoption of the Settlement prior to the Judges' issuance of a determination in the proceeding, arguing that doing so would be premature, given that the proceeding is still pending.1 IBS contends that if the Judges were to adopt the partial Settlement prior to issuing a final determination in the proceeding, the application of the settled rates and terms could prejudice the other noncommercial webcasters remaining in the proceeding. Comments of IBS at 1. IBS contends that there are “few or no legal, FCC licensing, ownership, and locational differences between IBS members and NPR-CPB-qualified public radio stations and webcasters.” Id. at 4. As a result, IBS contends that differences in royalty rates between these two groups should be a function of usage and that entities purportedly represented by IBS would qualify for lower rates than those set by the Settlement. Id. at 5.

Notwithstanding IBS's objection, the Judges find that the partial Settlement provides a reasonable basis for setting statutory terms and rates and therefore they adopt the partial Settlement, with one exception, discussed below. The IBS position is clearly at odds with the language of Section 801(b)(7)(A), which authorizes adoption of settlements “at any time during the proceeding.” Further, the proposed Settlement pertains solely to public broadcasting entities, which are expressly excluded from the definition of “noncommercial educational webcasters” in existing regulations. See 37 CFR 380.21. To emphasize the limits of the proposed rates and terms, the settling parties proposed adoption of the Settlement as a separate Subpart, Subpart D, of the existing regulations.

IBS's concern that some unnamed webcasters could be prejudiced by the adoption of the Settlement is speculative, unsupported by evidence, and does not, without more, challenge the validity of the Settlement in establishing a reasonable basis for setting statutory terms or rates. Without evidence to the contrary, the Judges find that the agreement reached voluntarily between the Settling Parties does in fact establish a reasonable basis for setting statutory terms and rates.

The Judges do not adopt at this time, however, the provision in proposed § 380.31, which states: “For the 2016-2020 license period, the collective is SoundExchange, Inc.” Designation of the Collective under the statutory license is within the Judges' purview and they will make that designation in the Judges' final determination in the proceeding.2 With that exception, therefore, the Judges adopt the proposed regulations that codify the partial Settlement. In doing so, the Judges make clear that the adoption of the partial Settlement should in no way suggest that they are more or less inclined to adopt the reasoning or proposals of any of the parties remaining in the proceeding.

For the reasons set forth in the preamble, the Copyright Royalty Judges amend 37 CFR part 380 as follows:

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of a proposed or final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376) (FRL-3658-5). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use. Persons who must report are described in § 721.5.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.

To determine what would constitute a significant new use for the 30 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.

EPA is establishing significant new use and recordkeeping requirements for 30 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (assigned for non-confidential chemical identities).

• Basis for the TSCA section 5(e) consent order or the basis for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section 5(e) consent orders).

• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).

• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

This rule includes 8 PMN substances that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “TSCA section 5(e) SNURs” on these PMN substances are promulgated pursuant to §  721.160, and are based on and consistent with the provisions in the underlying consent orders. The TSCA section 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.

In addition, this rule includes one SNUR on a PMN substance that is subject to an “exposure-based” consent order under TSCA section 5(e)(1)(A)(ii)(II), wherein EPA determined that the PMN substance is expected to be produced in substantial quantities, and that there may either be significant or substantial human exposure and/or the PMN substance may enter the environment in substantial quantities. The TSCA section 5(e) consent order requires submission of certain test data to EPA before the manufacturer may exceed a specified production volume. These SNURs designate as a “significant new use” the absence of the protective measures or exceedance of the production volume limit required in the TSCA section 5(e) consent order.

This rule also includes SNURs on 21 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “TSCA non-section 5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all TSCA non-section 5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.

Chemical name: Fatty acids compound with cyclohexanamine (generic) (P-12-69 and 70) and Fatty acids amine salt (generic) (P-12-0520).

CAS numbers: Claimed Confidential.

Effective date of TSCA section 5(e) consent order: February 11, 2015.

Basis for TSCA section 5(e) consent order: The PMNs states that the generic (non-confidential) use of the substances will be as a lubricity additive (P-12-69 and P-12-70) and a chemical component for fuel additives (P-12-520). Based on structure-activity relationship (SAR) analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms to occur at concentrations that exceed 52 parts per billion (ppb) (P-12-69), 4 ppb (P-12-70) and 180 ppb (P-12-520) of the PMN substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMNs, exceed releases from the use described in the PMNs. For the uses described in the PMNs, environmental releases did not exceed 52 ppb, 4 ppb, or 180 ppb, respectively, for more than 20 days per year. The consent order for these PMN substances was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that the uncontrolled manufacture, processing, distribution in commerce, use and disposal may present an unreasonable risk to the environment. To protect against these risks, the consent order requires manufacturing, processing, or use of the substance for the specific confidential uses stated in the PMNs. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of a fish early life-stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnia chronic toxicity test (OPPTS 850.1300) would help characterize the environmental effects of the PMN substances. Testing should be done on P-12-69 only. The submitter has agreed not to exceed a confidential volume limit without performing this testing.

CFR citations: CFR 721.10852 (P-12-69 and P-12-70) and 40 CFR 721.10856 (P-12-520).

Chemical name: Fluoro-modified acrylic copolymer (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: March 19, 2015.

Basis for TSCA section 5(e) consent order: The PMN states that the use of the substance will be as a substrate wetting and leveling agent for organic solvent-based paints and inks. EPA has concerns for potential incineration or other decomposition products of the PMN substance. These fluorinated decomposition products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers, which suggests that, under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. These concerns are based on data on analogous chemical substances, including perfluorooctanoic acid (PFOA) and other perfluorinated alkyls, including the presumed environmental degradant. The order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that these substances may present an unreasonable risk of injury to the environment and human health, the substances may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substances and their potential degradation products. To protect against these exposures and risks, the consent order requires:

1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substance may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into a Material Safety Data Sheet (MSDS), within 90 days.

2. Submission of certain physical/chemical property and environmental fate testing on a related PMN substance prior to exceeding the confidential production volume limits as specified in the consent order of the PMN substance.

3. Recording and reporting of certain fluorinated impurities in the starting raw material and the initially isolated intermediates; and manufacture of the PMN substance not to exceed the maximum established impurity levels of certain fluorinated impurities. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain physical/chemical property and environmental fate testing identified in the TSCA 5(e) consent order would help characterize possible effects of the substance and its degradation products. The Order prohibits the Company from exceeding specified confidential production volumes unless the Company submits the information described in the Testing section of this Order in accordance with the conditions specified in the Testing section. Further, EPA has identified certain toxicity and environmental fate testing described in the Pended Testing section of the Preamble to the Order that would help characterize the possible effects of the PMN substance. The Order does not require submission of the pended testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10853.

Chemical name: Siloxanes and Silicones, alkyl, alky propoxy ethyl, methyl octyl, alkyl polyfluorooctyl (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: March 19, 2015.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a coating additive. EPA has concerns for potential incineration or other decomposition products of the PMN substance. These fluorinated decomposition products may be released to the environment from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers, which suggests that, under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. These concerns are based on data on analogous chemical substances, including perfluorooctanoic acid (PFOA) and other perfluorinated alkyls, including the presumed environmental degradant. The order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that these substances may present an unreasonable risk of injury to the environment and human health, the substances may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substances and their potential degradation products. To protect against these exposures and risks, the consent order requires:

1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substances may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into a MSDS, within 90 days.

2. Submission of certain physical/chemical property and environmental fate testing on a related PMN substance prior to exceeding the confidential production volume limits as specified in the consent order of the PMN substances.

3. Recording and reporting of certain fluorinated impurities in the starting raw material and the initially isolated intermediates; and manufacture of the PMN substances not to exceed the maximum established impurity levels of certain fluorinated impurities. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain physical/chemical property and environmental fate testing identified in the TSCA 5(e) consent order would help characterize possible effects of the substances and their degradation products. The Order prohibits the Company from exceeding specified confidential production volumes unless the Company submits the information described in the Testing section of this Order in accordance with the conditions specified in the Testing section. Further, EPA has identified certain toxicity and environmental fate testing described in the Pended Testing section of the Preamble to the Order that would help characterize the effects of the PMN substances. The Order does not require submission of the pended testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10854.

Chemical name: Partially fluorinated alcohol, reaction products with phosphorus oxide (P2O5), amine salts (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: March 16, 2015.

Basis for TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) use of the substances will be as coating additives and surface active agents. EPA has concerns for potential incineration or other decomposition products of the PMN substances. These perfluorinated decomposition products may be released to the environment from incomplete incineration of the PMN substances at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers, which suggests that, under some conditions, the PMN substances could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. These concerns are based on data on analogous chemical substances, including perfluorooctanoic acid (PFOA) and other perfluorinated alkyls, including the presumed environmental degradant. The order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that these substances may present an unreasonable risk of injury to the environment and human health, the substances may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substances and their potential degradation products. To protect against these exposures and risks, the consent order requires:

1. Risk notification. If as a result of the test data required, the company becomes aware that the PMN substances may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into a MSDS, within 90 days.

2. Submission of certain physical/chemical property and environmental fate testing on a related PMN substance prior to exceeding the confidential production volume limits as specified in the consent order of the PMN substances.

3. Recording and reporting of certain fluorinated impurities in the starting raw material and the initially isolated intermediates; and manufacture of the PMN substances not to exceed the maximum established impurity levels of certain fluorinated impurities. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain physical/chemical property and environmental fate testing identified in the TSCA 5(e) consent order would help characterize possible effects of the substances and their degradation products. The Order prohibits the Company from exceeding specified confidential production volumes unless the Company submits the information described in the Testing section of this Order in accordance with the conditions specified in the Testing section. Further, EPA has identified certain toxicity and environmental fate testing described in the Pended Testing section of the Preamble to the Order that would help characterize the effects of the PMN substances. The Order does not require submission of the pended testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10855.

Chemical name: Organophosphorus polymer (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: February 13, 2015.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an additive for polymers. Using available exposure information from the public literature (i.e., measured values for similar substances in house dust in homes), and certain assumptions for mouthing behavior by young children, EPA identified concerns for potential exposure to the general population. However, there is uncertainty about the risk from this scenario due to the absence of hazard data on the PMN substance itself and information on the ability for the PMN substance to migrate or leach out of certain consumer products. Consumer exposure is possible if the PMN migrates from these products or decomposes to form dust particles that can be inhaled or ingested. Analogous chemicals, including Tris(2-chloroethyl)phosphate (TCEP) and Tris(1,3-dichloro-2 propyl) phosphate (TDCPP), can be found in household dust, and are widespread in the environment. Assuming similar use patterns over time, the PMN substance may be expected to display similar exposure patterns. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(II), based on a finding that this substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substances and their potential degradation products. To address potential exposures and hazards, the consent order requires certain testing by certain confidential production volume limits.

Recommended testing: EPA has determined that the results of certain physical/chemical property, toxicity, potential for migration from products, and dermal and other absorption testing identified in the TSCA 5(e) consent order would help characterize possible effects of the substance. The Order prohibits the Company from exceeding specified confidential production volumes unless the Company submits the information described in the Testing section of this Order in accordance with the conditions specified in the Testing section.

CFR citation: 40 CFR 721.10857.

Chemical name: Fluorinated acid alkylester (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: February 27, 2015.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate. EPA has concerns that the PMN substance will persist in the environment, could bioaccumulate, and be toxic (“PBT”) to humans, other mammals, and birds. EPA's concerns are based on data on the PMN substance, and analogy to perfluorobutanoic acid (PFBA), PFOA, perfluorooctanol sulfonate (PFOS), and other analogs. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that this substance may present an unreasonable risk of injury to the environment and human health. To protect against these exposures and risks, the consent order requires:

1. Risk notification. If the company becomes aware that the PMN substances may present a risk of injury to human health or the environment, the company must incorporate this new information, and any information on methods for protecting against such risk into a Material Safety Data Sheet (MSDS), within 90 days.

2. Use of personal protective equipment including impervious gloves and a National Institute of Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10, when there is potential exposure.

3. Establishment and use of a hazard communication program, including health hazard precautionary statements on each label and the MSDS.

4. Use of the PMN substance only as a chemical intermediate. Any chemical substance manufactured using the PMN substance may contain residuals of the PMN substance at a certain maximum level.

5. Recover and convert, capture (destroy), recycle, or reuse the substance at a certain overall efficiency when the PMN substance is used as an intermediate in accordance with the provisions.

6. Not use the PMN substance in consumer products.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain toxicity, metabolism and pharmacokinetics testing described in the Pended Testing section of the Preamble to the Order would help characterize the human health effects of the PMN substance. The Order does not require submission of the pended testing at any specified time or production volume. However, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10858.

Chemical name: Quaternary alkyl methyl amine ethoxylate methyl chloride (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a cleaner/degreaser. Based on submitted test data on the PMN substance as well as SAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 29 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations exceeding 29 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in releases to surface water concentrations exceeding 29 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10859.

Chemical name: Substituted carboxamide (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a material for highly dispersive use in consumer products and component of a consumer product. Based on submitted test data on the PMN substance as well as SAR analysis of test data on analogous amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations exceeding 3 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in releases to surface water concentrations exceeding 3 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) and would help characterize the environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10860.

Chemical name: Phosphoric acid, sodium titanium (4+) salt (3:1:2).

CAS number: 22239-24-3.

Basis for action: The PMN states that the substance will be used as a component in anode material in sealed batteries. Based on SAR analysis of test data on analogous inorganic phosphates and titanium compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations exceeding 4 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in releases to surface water concentrations exceeding 4 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075), an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10861.

Chemical names: Oxirane, 2-methyl-, polymer with oxirane, monohexadecyl ether, phosphate (P-15-1); Oxirane, 2-methyl-, polymer with oxirane, monohexadecyl ether, phosphate, sodium salt (P-15-2); Oxirane, 2-methyl-, polymer with oxirane, monohexadecyl ether, phosphate, potassium salt (P-15-3); Oxirane, 2-methyl-, polymer with oxirane, monohexadecyl ether, phosphate, ammonium salt (P-15-4); Ethanol, 2-amino-, compd. with 2-methyloxirane polymer with oxirane monohexadecyl ether phosphate (P-15-5); and Ethanol, 2,2′2″,-nitrilotris-, compd. with 2-methyloxirane polymer with oxirane monohexadecyl ether phosphate (P-15-6).

CAS numbers: 73361-29-2 (P-15-1); 151688-56-1 (P-15-2); 1456802-88-2 (P-15-3); 1456802-89-3 (P-15-4); 1456803-12-5 (P-15-5); and 1456803-14-7 (P-15-6).

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as inert surfactants in pesticide formulations. Based on SAR analysis of test data on analogous anionic surfactant compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 18 ppb in aggregate of the PMN substances in surface waters. As described in the PMNs, releases of the substances are not expected to result in surface water concentrations exceeding 18 ppb in aggregate. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances that results in aggregate releases to surface waters exceeding 18 ppb may result in significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test (OPPTS Test Guideline 850.1075), an acute invertebrate toxicity test (OPPTS Test Guideline 850.1010), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances. The recommended testing may be performed on any one of the 6 PMN chemicals.

CFR Citation: 40 CFR 721.10862.

Chemical name: Nitrile amine (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a site-limited chemical intermediate. Based on submitted test data on the PMN substance as well as SAR analysis of test data on analogous neutral organic compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations exceeding 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in releases to surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10863.

Chemical name: 1,3-Propanediamine, N1, N1-alkyl (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a friction modifier. Based on submitted test data on an analogous substance as well as SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 32 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations exceeding 32 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in releases to surface water concentrations exceeding 32 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substance and mixtures (Organisation for Economic Co-operation and Development (OECD) Test Guideline 23) be consulted to facilitate solubility in the test media, because of the PMN substance's low water solubility.

CFR Citation: 40 CFR 721.10864.

Chemical name: 2-Pyridinecarboxylic acid, 4,5,6-trichloro-.

CAS number: 496849-77-5.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on SAR analysis of test data on analogous pyridine-alpha-acids and neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 30 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations exceeding 30 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in releases to surface water concentrations exceeding 30 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075), an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010), an algal toxicity test (OCSPP Test Guideline 850.4500), and the aerobic/anaerobic transformation in soil test (OECD 307) would help characterize the environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10865.

Chemical name: Imidazoliurn, polymer with cyclic anhydride and alkenoic acid, alkali salt (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a leather chemical. Based on SAR analysis of test data on analogous polyanionic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 200 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 200 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as listed in the PMN may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110), a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10866.

Chemical name: Hydrochlorofluorocarbon (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate in the production of a hydrofluorocarbon (HFC). Based on SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 99 ppb of the PMN substance in surface waters. Further, based on test data on analogous organohalogen compounds, there were health concerns regarding anesthesia at high inhalation doses from exposure to the PMN substance via dermal and inhalation exposure. As described in the PMN, exposure is expected to be minimal due to use of adequate dermal and respiratory personal protection equipment and releases of the substance are not expected to result in surface water concentrations exceeding 99 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in releases to surface waters exceeding 99 ppb, or any use without the use of NIOSH-certified organic vapor cartridge respirator with an assigned protection factor of at least 25, or any use other than as a chemical intermediate may result in serious human health or significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a an acute inhalation toxicity test (OPPTS Test Guideline 870.1300), fish acute toxicity test (OPPTS Test Guideline 850.1075), an aquatic invertebrate acute toxicity test (OPPTS Test Guideline 850.1010), and algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10867.

Chemical name: Alkylalkenoic acid copolymer (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an encapsulating polymer. Based on test data on analogous high molecular weight polymers, EPA identified concerns for lung toxicity. As described in the PMN, EPA does not expect significant worker inhalation exposure due to no domestic manufacture, and the substance is not manufactured, processed, or used in the form of a powder. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the substance or any import, processing, or use of the substance in the form of a powder may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test with a 60-day holding period (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.

CFR Citation: 40 CFR 721.10868.

Chemical name: D-Glucitol, alkylamino-N-acyl derivs. (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the substance will be used as a surfactant in cleaning products and liquid soaps. Based on test data on the PMN substance, as well as SAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 14 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 14 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a ready biodegradability test (OECD Test Guideline 301) would help characterize the environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10869.

Chemical name: Cyclohexanedicarboxylic acid, dialkyl ester (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adjuvant used in reaction processes. Based on SAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 10 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 10 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10870.

Chemical name: Isocyanate prepolymer (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as ingredient in an industrial adhesive. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for irritation and sensitization to the skin and lungs. As described in the PMN, EPA does not expect significant occupational dermal or inhalation exposure due to use of adequate personal protective equipment and consumer exposures are not expected as the PMN substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified particulate respirator with an APF of at least 10 where there is a potential for inhalation exposure, or any use in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.

CFR Citation: 40 CFR 721.10871.

Chemical name: Heteropolycyclic, polymer with alkanedioic acid, di-alkenoate (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a coating resin. Based on test data on analogous acrylates, EPA identified concerns for oncogenicity, developmental toxicity, liver and kidney toxicity, sensitization, irritation, and acute toxicity. Further, based on SAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 120 ppb of the PMN substance in surface waters. As described in the PMN, occupational exposures are expected to be minimal due to the use of impervious gloves, goggles, and NIOSH-certified particulate respirators with an APF of at least 10. Further, releases of the substance are not expected to result in surface water concentrations exceeding 120 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without use of impervious gloves and goggles, when there is a potential dermal exposure; use of the substance without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; or any use of the substance that results in releases to surface waters exceeding 120 ppb may result in significant adverse health and environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity with the reproduction/developmental toxicity screening test (OPPTS 870.3650); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.10872.

Chemical name: Methylene diisocyanate polymer with diols and triols (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an industrial adhesive. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for respiratory and dermal sensitization and lung and mucous membrane irritation based on the isocyanate moiety As described in the PMN, EPA does not expect significant occupational dermal or inhalation exposure due to use of adequate personal protective equipment and consumer exposures are not expected as the PMN substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified particulate respirator with an APF of at least 10 where there is a potential for inhalation exposure, or any use in consumer products, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.

CFR Citation: 40 CFR 721.10873.

Chemical name: Polymer of isophorone diisocyanate and amine-terminated propoxylatedpolyol (generic).

CAS numbers: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a crosslinker. Based on analogous diisocyanates, EPA identified concerns for potential dermal and respiratory sensitization from dermal and inhalation exposures, and for pulmonary toxicity from inhalation exposure, to the PMN substance when the average molecular weight is below 2500 daltons and any molecular weight species is below 1000 daltons. EPA does not expect significant exposures from the form of the PMN substance as described in the PMN. Therefore, EPA has not determined that the proposed manufacture of the substance may present an unreasonable risk. EPA has determined, however, that any manufacture of the PMN substance with an average molecular weight of below 2500 daltons and any molecular weight species below 1000 daltons may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a skin sensitization test (OPPTS Test Guideline 870.2600) and a 90-day subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.

CFR Citation: 40 CFR 721.10874.

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 9 of the 30 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to §  721.160 (see Unit VI.).

In the other 21 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at §  721.170 were met, as discussed in Unit IV.

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• EPA will receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• EPA will be able to regulate prospective manufacturers or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA section 5(e), 5(f), 6, or 7.

• EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

EPA is issuing these SNURs as a direct final rule, as described in §  721.160(c)(3) and §  721.170(d)(4). In accordance with §  721.160(c)(3)(ii) and §  721.170(d)(4)(i)(B), the effective date of this rule is December 1, 2015 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before November 2, 2015.

If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before November 2, 2015, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) consent orders have been issued for 9 of the 30 chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which would be designated as significant new uses. The identities of 22 of the 30 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per §§ 720.25 and 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

Therefore, EPA designates October 2, 2015 as the cutoff date for determining whether the new use is ongoing. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 for a more detailed discussion of the cutoff date for ongoing uses.

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:

1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).

2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).

In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

In the TSCA section 5(e) consent orders for several of the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Potential benefits of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1).

Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in §  721.1725(b)(1) with that under §  721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

According to §  721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and § 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2015-0388.

This action establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:

1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

2. The SNUR submitted by any small entity would not cost significantly more than $8,300.

A copy of that certification is available in the docket for this action.

This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:

• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

• Submission of the SNUN would not cost any small entity significantly more than $8,300.

Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

This action 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 responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action.

This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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 parts 9 and 721 are amended as follows:

This action corrects inadvertent errors in a rulemaking related to BCAQMD's SIP-approved definitions. On June 11, 2015 (80 FR 33195), the EPA published a direct final rulemaking action approving revisions to various sections of the California State Implementation Plan (SIP). This action contained regulatory text amendments to 40 CFR part 52, subpart F. The amendments, which incorporated material by reference into section 52.220, Identification of plan, paragraph (c)(457), omitted regulatory language that addressed the replacement of Butte County Air Pollution Control District (BCAPCD) Rule 101—“Title” and parts of BCAPCD Rule 102—“Definitions” with BCAQMD Rule 101—“Definitions” as described in Footnote 1 of 80 FR 33195. This action adds regulatory text to clarify the rules or portions of rules that were superseded in the Butte County AQMD portion of the California SIP by our June 11, 2015 direct final action.

The EPA has determined that this action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation where public notice and comment procedures are impracticable, unnecessary, or contrary to the public interest. Public notice and comment for this action is unnecessary because this action correcting inadvertent regulatory text errors included in the EPA's June 11, 2015 final rule is consistent with the substantive revision to the California SIP as described in the preamble of said action concerning definitions for the BCAQMD portion of the California SIP. In addition, the EPA can identify no particular reason why the public would be interested in having the opportunity to comment on the correction prior to this action being finalized, since this correction action does not change the EPA's analysis or overall action related to the approval of BCAQMD's revisions to their definitions into the California SIP.

The EPA also finds that there is good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action. Section 553(d)(3) of the APA allows an effective date of less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed in APA section 553(d)(3) is to give affected parties a reasonable time to adjust their behaviour and prepare before the final rule takes effect. This rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, this action merely corrects inadvertent errors for the regulatory text of the EPA's prior rulemaking for the California SIP. For these reasons, the EPA finds good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action.

As published, the final regulations omitted amendatory language that addressed the replacement of BCAQMD Rule 101.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation with State officials as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), or involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994).

Because this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)

Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business Regulatory Enforcement Fairness Act of 1996, the 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 General Accounting Office prior to publication of this rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Accordingly, 40 CFR part 52 is corrected by making the following correcting amendments:

Throughout this document “we,” “us,” or “our” refer to EPA. This section provides additional information by addressing the following:

The EPA is taking direct final action to approve revisions to the SIP submitted by the State of Missouri relating to the Limited Maintenance Plan for the St. Louis area for the 8-hour CO NAAQS.

Eight years after an area is redesignated to attainment, CAA section 175A(b) requires the state to submit a subsequent maintenance plan to EPA, covering a second 10-year period. This maintenance plan must demonstrate continued compliance with the NAAQS during this second 10-year period.

On April 8, 2014, the MDNR submitted to EPA a second 10-year maintenance plan for the St. Louis area for the CO NAAQS and requested that EPA approve this revision as meeting the CAA section 175A requirements. This maintenance plan addresses maintenance of the CO NAAQS for a second 10-year period beyond the original redesignation.

This revision to Missouri's SIP does not have an adverse effect on air quality and EPA's approval of this SIP revision is being done in accordance with the requirements of the CAA.

Under section 107(d)(1)(C) of the Act, any area designated before the date of enactment of the CAA Amendments of 1990 was to be designated upon enactment by operation of law. CO nonattainment areas that had not violated the CO standard in either year for the two-year period 1988-1989 were to be designated nonattainment and identified as “not classified” nonattainment areas. Accordingly, because the St. Louis area had not violated the standard in the 1988-1989 period, on November 6, 1991, the St. Louis area was designated nonattainment for the CO NAAQS and identified as “not classified” on November 6, 1991 (56 FR 56786).

On June 13, 1997, the State requested EPA to redesignate the St. Louis nonattainment area to attainment and submitted a limited maintenance plan to demonstrate maintenance of the standard for a 10-year period. EPA published approval of the redesignation request and maintenance plan on January 26, 1999 (64 FR 3855). The State has maintained the standard since and recently submitted a second 10-year maintenance plan to EPA on April 8, 2014.

An areas design value (DV) for the 8-hour CO NAAQS is calculated by finding the second maximum 8 hour average value at each monitor, for each year, for two years. The higher second maximum is used as the areas DV and the 8-hour CO standard is attained when the daily average 8-hour CO concentration of 9.0 parts per million (ppm) is not exceeded more than once a year.

Since the redesignation of the St. Louis area to attainment for CO on January 26, 1999, the second highest concentration in any calendar year measured by the EPA approved monitoring network was 5.7 ppm, which is less than 9.0 ppm.

In addition, areas that can demonstrate design values at or below 7.65 ppm (85 percent of the 9.0 ppm CO NAAQS) for 8 consecutive quarters may use a limited maintenance plan option. The State has opted to develop a limited maintenance plan to fulfill the second 10-year maintenance plan required by the CAA. The base year in the State's second 10-year maintenance plan is 2008, which has a design value of 2.8 ppm. EPA also reviewed air quality monitoring data (2011-2012) and the 8-hour CO design value for the St. Louis area is 1.8 ppm. Thus, the area is well below the 7.65 ppm (85 percent of the 9.0 ppm CO NAAQS) for 8 consecutive quarters and qualifies to use the limited maintenance plan option.

The state submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, the revision meets the substantive SIP requirements of the CAA, including Section 110 and implementing regulations.

EPA has reviewed the St. Louis area second 10-year CO maintenance plan and concludes that the submittal meets the requirements of section 175A(b) of the Act. The following is a summary of the requirements and EPA's evaluation of how each requirement is met.

The plan must contain an attainment year emissions inventory to identify a level of emissions in the area which is sufficient to attain the CO NAAQS. The St. Louis area second 10-year CO maintenance plan contains an emissions inventory for the base year 2008 that is consistent with EPA's most recent guidance on maintenance plan emission inventories. The emissions inventory is a list, by source, of the air contaminants directly emitted into the St. Louis area. The data in the emissions inventory is based on calculations using emission factors, which is a method for converting source activity levels into an estimate of emissions contributions for those sources. Because violations of the CO NAAQS are most likely to occur on winter weekdays, the inventory prepared is in a “typical winter day” format. The table below shows the tons of CO emitted per winter day in 2008 by source category.

On June 21, 2013, the Commonwealth Pennsylvania submitted, on behalf of Allegheny County, a formal revision to its SIP. The SIP revision consisted of the 2006 24-hour PM2.5 NAAQS attainment plan for the Liberty-Clairton Area, which included among other things, an attainment demonstration, a 2007 base year emissions inventory, a reasonably available control measures (RACM) analysis, and a description of contingency measures. On July 31, 2014, the SIP revision was supplemented to include additional information regarding control measures as part of the attainment demonstration and insignificance findings for transportation conformity purposes for both the 1997 and 2006 24-hour PM2.5 NAAQS.

Today's action only pertains to the approval of the 2007 base year emissions inventory to satisfy the requirement of section 172(c)(3) of the CAA and the transportation conformity insignificance findings to satisfy EPA's requirements at 40 CFR 93.118(e)(4) and 40 CFR 93.109(f).

On July 16, 1997, EPA established an annual PM2.5 NAAQS at 15.0 micrograms per cubic meter (μg/m3) (hereafter referred to as “the 1997 annual PM2.5 NAAQS”), based on a 3-year average of annual mean PM2.5 concentrations (62 FR 38652, July 18, 1997). At that time, EPA also established a 24-hour standard of 65 μg/m3 (hereafter referred to as “the 1997 24-hour PM2.5 NAAQS”). See 40 CFR 50.7. The 1997 PM2.5 standards were based on significant evidence and numerous health studies demonstrating that serious health effects are associated with exposures to particulate matter.

On January 5, 2005 (70 FR 944), EPA published its nonattainment area designations for the 1997 annual PM2.5 NAAQS based upon air quality monitoring data for calendar years 2001-2003. These designations, effective on April 5, 2005, included the Liberty-Clairton Area as a nonattainment area. The Liberty-Clairton Area for the 1997 annual PM2.5 NAAQS is comprised of the following portion of Allegheny County: The boroughs of Lincoln, Glassport, Liberty, and Port Vue and the City of Clairton. See 40 CFR 81.339 (Pennsylvania). The Liberty-Clairton Area is surrounded by, but separate and distinct from, the Pittsburgh-Beaver Valley PM2.5 nonattainment area.

On September 21, 2006, EPA retained the 1997 annual PM2.5 NAAQS at 15.0 μg/m3 (hereby “the 2006 annual PM2.5 NAAQS”) based on a 3-year average of annual mean PM2.5 concentrations, and promulgated a new 24-hour standard of 35 μg/m3 (hereafter “the 2006 24-hour PM2.5 NAAQS”) based on a 3-year average of the 98th percentile of 24-hour concentrations (71 FR 61144, October 17, 2006). The revised 2006 24-hour PM2.5 standard became effective on December 18, 2006. See 40 CFR 50.13. The more stringent 2006 24-hour PM2.5 NAAQS is based on significant evidence and numerous health studies demonstrating that serious health effects are associated with short-term exposures to PM2.5 at this level.

Many petitioners challenged aspects of EPA's 2006 revisions to the PM2.5 NAAQS. See American Farm Bureau Federation and National Pork Producers Council, et al. v. EPA, 559 F.3d 512 (D.C. Cir. 2009). As a result of this challenge, the U.S. Court of Appeals for the District of Columbia Circuit (DC Circuit) remanded the 2006 annual PM2.5 NAAQS to EPA for further proceedings. The 2006 24-hour PM2.5 NAAQS was not affected by the remand and remains in effect.

On November 13, 2009, EPA published designations for the 2006 24-hour PM2.5 NAAQS (74 FR 58688). These designations, effective on December 14, 2009, included the Liberty-Clairton Area as a nonattainment area for the 2006 24-hour PM2.5 NAAQS, retaining the same geographical boundaries as for the 1997 annual PM2.5 NAAQS. See 40 CFR 81.339 (Pennsylvania).

A nonattainment designation under the CAA triggers additional planning requirements for states to show attainment of the NAAQS in the nonattainment areas by a statutory attainment date, as specified in the CAA. Since 2005, EPA had implemented the 1997 and 2006 PM2.5 NAAQS based on the general implementation provisions of subpart 1 of Part D of Title I of the CAA (subpart 1). On January 4, 2013, in Natural Resources Defense Council v. EPA (NRDC v. EPA), the DC Circuit determined that EPA should be implementing its PM2.5 pollution standard under additional CAA requirements than those EPA had been following in subpart 1 and remanded to EPA the “Final Clean Air Fine Particle Implementation Rule” (1997 PM2.5 Implementation Rule) (72 FR 20586, April 25, 2007) and the “Implementation of the New Source Review (NSR) Program for Particulate Matter Less than 2.5 Micrometers (PM2.5)” final rule (2008 NSR PM2.5 Rule).1 706 F.3d 428 (D.C. Cir. 2013). The DC Circuit found that the EPA erred in implementing the 1997 annual PM2.5 NAAQS solely pursuant to subpart 1, without consideration of the particulate matter specific provisions of subpart 4 of Part D of Title I of the CAA (subpart 4).

While the regulatory provisions of EPA's 1997 PM2.5 Implementation Rule do not explicitly apply to the 2006 24-hour PM2.5 NAAQS, EPA's underlying statutory interpretation has been the same for both standards. On March 2, 2012, EPA provided implementation guidance for the 2006 24-hour PM2.5 NAAQS which reaffirmed and continued the framework and policy approaches of the 1997 PM2.5 Implementation Rule. On June 6, 2013, EPA withdrew the implementation guidance for the 2006 24-hour PM2.5 NAAQS, subsequent to the DC Circuit's decision in NRDC v. EPA. 2

Although the DC Circuit declined to establish a deadline for EPA's response, EPA intends to respond promptly to the Court's remand and to promulgate new generally applicable implementation regulations for the PM2.5 NAAQS in accordance with the requirements of subparts 1 and 4. In the interim, however, states and EPA still need to proceed with implementation of the PM2.5 NAAQS in a timely and effective fashion in order to meet statutory obligations under the CAA and to assure the protection of public health intended by those NAAQS.

The statutory provisions in subpart 4 require EPA, among other things, to classify nonattainment areas for the PM2.5 NAAQS based on the severity of their pollution problem. Under EPA's prior approach to implementing the 1997 annual and 2006 24-hour PM2.5 standards according to subpart 1, EPA was not required to, and thus did not, identify any classifications for areas designated nonattainment. In contrast, subpart 4 of the CAA, at section 188, provides that all areas designated nonattainment are initially classified “by operation of law” as “Moderate” nonattainment areas, and they remain classified as Moderate nonattainment areas unless and until EPA later reclassifies them as Serious nonattainment areas or EPA determines that an area has not attained the PM2.5 NAAQS by the area's applicable attainment date.

On April 25, 2014, EPA finalized a rule identifying the classification of all PM2.5 areas currently designated nonattainment for the 1997 annual and 2006 24-hour PM2.5 NAAQS as “Moderate,” consistent with subpart 4 of the CAA. See 79 FR 31566 (June 2, 2014). Consequently, the Liberty-Clairton Area was classified as Moderate for the 1997 annual and 2006 24-hour PM2.5 NAAQS.

On July 10, 2015 (80 FR 39696), EPA determined that the Liberty-Clairton Area had attained the 2006 24-hour PM2.5 NAAQS, based on quality-assured and certified ambient air quality data for the 2012-2014 monitoring period. This “clean data determination” suspended Pennsylvania's obligations to submit for the Liberty-Clairton Area an attainment demonstration, reasonably available control measures (RACM), reasonable further progress (RFP), and contingency measures for the 2006 24-hour PM2.5 NAAQS pursuant to subparts 1 and 4 of the CAA, for so long as the Area continues to attain the standard.

EPA incorporated its Clean Data Policy interpretation in both its 8-Hour Ozone Implementation Rule in 40 CFR 51.918 and in its 1997 PM2.5 Implementation Rule in 40 CFR 51.1004(c). See 72 FR 20585, 20665 (April 25, 2007). While the DC Circuit in its January 4, 2013 decision remanded the 1997 PM2.5 Implementation Rule, the Court did not address the merits of that regulation regarding our Clean Data Policy in 40 CFR 51.1004(c), nor cast any doubt on EPA's existing interpretation of the statutory provisions for the Clean Data Policy.3

After EPA's final clean data determination for the Liberty-Clairton Area for the 2006 24-hour PM2.5 NAAQS, effective on August 10, 2015, the only pending statutory requirement for the Area relates to emissions inventories pursuant to section 172(c)(3) of subpart 1 of the CAA. Specifically, section 172(c)(3) of the CAA requires states to submit a comprehensive, accurate, and current inventory of actual emissions for each nonattainment area. EPA's requirements for an emissions inventory for the PM2.5 NAAQS are set forth in 40 CFR 51.1008.

As discussed earlier, the Liberty-Clairton's base year emissions inventory was submitted by Pennsylvania Department of the Environmental Protection (PADEP), on behalf of Allegheny County Health Department (ACHD), as part of the June 21, 2013 SIP revision to demonstrate attainment of the 2006 24-hour PM2.5 NAAQS for the Liberty-Clairton Area. The June 21, 2013 SIP revision was amended on July 31, 2015 to include, among other things, the transportation conformity insignificance findings for both the 1997 annual and 2006 24-hour PM2.5 NAAQS. In this rulemaking action, EPA is only acting on the portions of the submittals corresponding to the 2007 base year emissions inventory and the transportation conformity insignificance findings. A brief summary of the SIP revisions is provided in this section.

The 2007 base year emissions inventory for the Liberty-Clairton Area intends to satisfy the requirements of section 172(c)(4) of the CAA for the 2006 24-hour PM2.5 NAAQS. The 2007 base year emissions inventory includes emissions estimates that cover the general source categories of point sources, area sources, non-road mobile sources, and on-road mobile sources. The pollutants that comprise the inventory are NOX, volatile organic compounds (VOC), PM2.5, coarse particles (PM10), ammonia, and sulfur dioxide (SO2). ACHD selected 2007 as the base year for the emissions inventory, in accordance with 40 CFR 51.1008(b).

The 2007 emissions inventory submitted is the most current accurate and comprehensive actual emissions inventory of direct PM2.5, PM10, NOX, SO2, VOC, and ammonia for the Liberty-Clairton Area with respect the 2006 24-hour PM2.5 NAAQS. The actual emissions were estimated based on pollutant emission factors and throughputs or capacities of each emission source. A summary of the Liberty-Clairton's 2007 base year emissions inventory is provided in Table 1.

EPA has reviewed the procedures and methodologies used by ACHD for the 2007 base year emissions inventory submitted as part of the June 21, 2013 SIP revision and finds the inventory approvable. Further analysis of the emissions inventory development can be found in technical support document (TSD) dated August 12, 2015 included as part of the docket for this rulemaking action.

Transportation conformity is required under section 176(c) of the CAA to ensure that federally supported highway, transit projects, and other activities are consistent with (conform to) the purpose of the SIP. The CAA requires federal actions in nonattainment and maintenance areas to “conform to” the goals of SIP. This means that such actions will not cause or contribute to violations of a NAAQS; worsen the severity of an existing violation; or delay timely attainment of any NAAQS or any interim milestone. Actions involving Federal Highway Administration (FHWA) or Federal Transit Administration (FTA) funding or approval are subject to the Transportation Conformity Rule (40 CFR part 93, subpart A). Under this rule, metropolitan planning organizations (MPOs) in nonattainment and maintenance areas coordinate with state air quality and transportation agencies, EPA, FHWA, and FTA to demonstrate that their metropolitan transportation plans and transportation improvement plans (TIPs) conform to applicable SIPs. This is typically determined by showing that estimated emissions from existing and planned highway and transit systems are less than or equal to the motor vehicle emissions budgets (MVEBs) contained in a SIP.

For MVEBs to be approvable, they must meet, at a minimum, EPA's adequacy criteria found at 40 CFR 93.118(e)(4). However, the Transportation Conformity Rule at 40 CFR 93.109(f) allows areas to forgo establishment of a budget(s) where it is demonstrated that regional motor vehicle emissions for a particular pollutant or precursor pollutant are an insignificant contributor to the air quality problem in the area. The general criteria for insignificance determinations per 40 CFR 93.109(f) are based on a number of factors, including: (1) The percentage of motor vehicle emissions in context of the total SIP inventory; (2) the current state of air quality as determined by monitoring data for that NAAQS; (3) the absence of SIP motor vehicle control measures; and (4) historical trends and future projections of the growth of motor vehicle emissions in the area.

The Liberty-Clairton's attainment demonstration for the 2006 24-hour PM2.5 NAAQS submitted by the Commonwealth of Pennsylvania, on behalf of Allegheny County, includes a request for EPA to make insignificance findings for NOX and directly emitted PM2.5 for the Area for both the 1997 annual and 2006 24-hour PM2.5 NAAQS. Pursuant to Section 93.118(e)(4) and 93.109(f) of the Transportation Conformity Rule, EPA has reviewed the Commonwealth of Pennsylvania's justification for the findings of insignificance for direct PM2.5 and also for NOX as a precursor of PM2.5 in the Liberty-Clairton Area for both the 1997 annual and 2006 24-hour PM2.5 NAAQS. EPA agrees with Pennsylvania's conclusion that on-road emissions of PM2.5 and NOX in the Liberty-Clairton Area are insignificant for transportation conformity purposes for both NAAQS.

EPA bases these findings on several factors: (1) The fact that the motor vehicle emissions constitute a low percentage of the total SIP inventory. In particular, for the 2007 base year, the direct PM onroad mobile source constitutes 0.99 percent (%) of the Liberty-Clairton Area's total PM2.5 emissions and decreases in the later analysis year to 0.88% (2014). For the 2007 base year, the NOX onroad mobile source constitutes 4.9% of the Area's total NOX emissions and decreases in the later analysis year to 3.07% (2014); (2) The fact that the Liberty-Clairton Area has been determined to attain the 1997 annual PM2.5 standard (October 25, 2013, 78 FR 63881) and the 2006 24-hour PM2.5 standard (July 10, 2015, 80 FR 39696), and continues to attain the standards with the most recent three years of complete, quality-assured monitoring data; (3) The absence of local on-road control measures; and (4) The continued downward trend, historically and in modeled future projections, of on-road NOX and PM2.5 emissions.

With regard to on-road emissions of SO2, VOC, and ammonia, Allegheny County did not provide an insignificance demonstration because it concluded, consistent with EPA's presumptions regarding these PM2.5 precursors, that the emissions of these precursors from motor vehicles are not significant contributors to the Liberty-Clairton Area's PM2.5 air quality problem. Therefore, EPA finds adequate, and is also approving as SIP revision, Pennsylvania's insignificance determinations for the Liberty-Clairton Area with respect both the 1997 annual and 2006 24-hour PM2.5 standards. Additional information pertaining to the review of the motor vehicle emission inventories can be found in the TSD dated August 27, 2015, as part of the docket for this final rulemaking action.

In this direct final rulemaking action, EPA is initiating the process for determining whether or not the motor vehicle emission inventories are adequate for transportation conformity purposes. The publication of this document starts a 30-day public comment period on the adequacy of the submitted motor vehicle emission inventories. This comment period is concurrent with the comment period on this direct final rulemaking action. Any comments on the motor vehicle emission inventories should be submitted to the docket for this rulemaking. The public can find the posting of these motor vehicle emissions inventories on EPA's adequacy Web page (http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm). The adequacy of the motor vehicle emission inventories as well as the approval of the findings of insignificance will become effective upon the effective date of this direct final rulemaking action. Upon the effective date of this direct final rulemaking action, the Liberty-Clairton Area is no longer required to perform a regional emissions analysis for directly emitted PM2.5, or NOX, as part of future PM2.5 conformity determinations for the 1997 annual and 2006 24-hour PM2.5 NAAQS.

EPA is approving as a revision to the Pennsylvania SIP the Liberty-Clairton Area's 2007 base year emissions inventory for the 2006 24-hour PM2.5 NAAQS submitted as part of the June 21, 2013 SIP revision. EPA finds that the 2007 base year emissions inventory satisfies the requirements of 40 CFR 51.1008 and section 172(c)(3) of the CAA for the 2006 24-hour PM2.5 NAAQS for the Liberty-Clairton Area. EPA finds adequate and is also approving as a revision to the SIP Pennsylvania's determinations for both the 1997 annual and 2006 24-hour PM2.5 standards that onroad emissions of PM2.5 and NOX are insignificant contributors to PM2.5 concentrations in the Liberty-Clairton Area for transportation conformity purposes, as submitted as part of the July 31, 2014 supplemental SIP revision. Upon the effective date of this direct final rulemaking action, the Liberty-Clairton Area is no longer required to perform a regional emissions analysis for directly emitted PM2.5, or NOX, as part of future PM2.5 conformity determinations for the 1997 annual and 2006 24-hour PM2.5 NAAQS.

EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 1, 2015 without further notice unless EPA receives adverse comment by November 2, 2015. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

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 Order 12866 (58 FR 51735, October 4, 1993);

• 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).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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 December 1, 2015. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking action. This action, approving the 2007 base year emissions inventory for the Liberty-Clairton Area with respect the 2006 24-hour PM2.5 NAAQS and the transportation conformity insignificance findings for the Liberty-Clairton Area with respect the 1997 annual and 2006 24-hour PM2.5 NAAQS, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

South Dakota's July 29, 2013 submittal covers the following rule changes: (1) Removal of obsolete language regarding variance provisions and clean units, and renumbering to reflect the deletions; and (2) Revisions to the date of federal regulations referenced throughout ARSD Article 74:36 to July 1, 2012. A cross-walk table that identifies EPA's action on South Dakota's revisions is included in the docket for this rulemaking.

South Dakota's July 29, 2013 submittal also requests EPA approval of rule revisions for provisions that are not required to be included in SIPs under section 110 of the CAA, most notably additions to the State's New Source Performance Standards, National Emissions Standards for Hazardous Air Pollutants and Title V permitting. These revisions, on which EPA is not taking action, are outlined in the cross-walk table located in the docket for this rulemaking.

EPA is finalizing action on South Dakota's July 29, 2013 submittal as outlined in Section III. of the proposal published on July 14, 2015, with one exception; EPA's proposed approval of South Dakota's updates to 74:36:05, “Operating Permits for Part 70 Sources,” as part of its July 14, 2015 action (80 FR 40953). EPA published a notice of correction of the proposal on August 24, 2015 (80 FR 51152), because CAA Title V requirements are not subject to Section 110 of the Clean Air Act and are thus not required to be incorporated into a SIP. Therefore, EPA is not taking any action on South Dakota's updates to 74:36:05.

Under CAA sections 110(a)(1) and (2), states are required to submit infrastructure SIPs to ensure their SIPs provide for implementation, maintenance, and enforcement of the National Ambient Air Quality Standards (NAAQS). On January 29, 2015, EPA took final action on the infrastructure submittals which addressed several different NAAQS from the State of South Dakota (80 FR 4799). As part of the January 29, 2015 action, EPA approved South Dakota's 1997 PM2.5 NAAQS interstate transport infrastructure sub-element (CAA section 110(a)(2)(D)(i)(II)). However, EPA had already approved this sub-element in a final rulemaking on May 8, 2008 (73 FR 26019, effective July 7, 2008). Therefore, in this action EPA is clarifying that no action was required on this sub-element for this NAAQS in the January 29, 2015 approval of CAA section 110(a)(2)(D)(i)(II) for the 1997 PM2.5 NAAQS and the effective date of approval remains July 7, 2008.

EPA received one comment on the July 14, 2015 proposal with respect to air quality measurements. EPA acknowledges this comment but does not consider the comment to be relevant to the proposed action.

In this rulemaking, EPA is approving most remaining portions of South Dakota's July 29, 2013 submittal as outlined in the crosswalk table located in the docket for this action. EPA is not taking action on certain portions of this submittal as described in the proposed rulemaking and the notice of correction to the proposal. Finally, EPA is also clarifying no action was required in the January 29, 2015 final action (80 FR 4799) regarding the effective date of approval for South Dakota's SIP regarding CAA section 110(a)(2)(D)(i)(II) for the 1997 PM2.5 NAAQS as EPA had already approved this sub-element in a prior rulemaking.

In this rulemaking, EPA is including final EPA rule regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, EPA is incorporating by reference the rules in ARSD Article 74:36 submitted by South Dakota for action which are identified within this notice of rulemaking. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this rule's preamble for more information).

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act 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 Clean Air Act. 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 Order 12866 (58 FR 51735, October 4, 1993);

• 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 in 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 Clean Air Act; 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 SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 1, 2015. 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 may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2)).

40 CFR part 52 is amended as follows:

I. Background

On December 22, 2014, the Commonwealth of Pennsylvania, through the Pennsylvania Department of Environmental Protection (PADEP), formally submitted a request to redesignate the Pittsburgh Area from nonattainment to attainment for the 1997 annual and 2006 24-hour PM2.5 NAAQS. Concurrently, PADEP submitted a maintenance plan for the Pittsburgh Area as a SIP revision to ensure continued attainment throughout the Pittsburgh Area over the next 10 years. The maintenance plan includes the 2017 and 2025 PM2.5 and NOX MVEBs for the Area for the 1997 annual and 2006 24-hour PM2.5 NAAQS, which EPA is approving for transportation conformity purposes. PADEP also submitted 2007 and 2011comprehensive emissions inventories that were included in the maintenance plan for the 1997 annual and 2006 24-hour PM2.5 NAAQS, respectively, for NOX, sulfur dioxide (SO2), volatile organic compounds (VOC), and ammonia (NH3).

On May 20, 2015 (80 FR 28906), EPA published a notice of proposed rulemaking (NPR) for Pennsylvania. In the NPR, EPA proposed approval of Pennsylvania's December 22, 2014 request to redesignate the Pittsburgh Area to attainment for the 1997 annual and 2006 24-hour PM2.5 NAAQS. EPA also proposed approval of the associated maintenance plan as a revision to the Pennsylvania SIP for the 1997 annual and 2006 24-hour PM2.5 NAAQS, which includes the 2017 and 2025 PM2.5 and NOX MVEBs for both NAAQS, which EPA proposed to approve for purposes of transportation conformity. In addition, EPA proposed approval of the 2007 and 2011 emissions inventories included in the Pittsburgh Area's maintenance plan for the 1997 annual and 2006 24-hour PM2.5 NAAQS, respectively, to meet the emissions inventory requirement of section 172(c)(3) of the CAA.

The details of Pennsylvania's submittal and the rationale for EPA's proposed actions are explained in the NPR and will not be restated here. No adverse public comments were received on the NPR.

EPA is taking final actions on the redesignation request and SIP revisions submitted on December 22, 2014 by the Commonwealth of Pennsylvania for the Pittsburgh Area for the 1997 annual and 2006 24-hour PM2.5 NAAQS. First, EPA finds that the monitoring data demonstrates that the Area has attained the 1997 annual and 2006 24-hour PM2.5 NAAQS, and continues to attain both NAAQS. Second, EPA is approving Pennsylvania's redesignation request for the 1997 annual and 2006 24-hour PM2.5 NAAQS, because EPA has determined that the request meets the redesignation criteria set forth in section 107(d)(3)(E) of the CAA for both NAAQS. Approval of this redesignation request will change the official designation of the Pittsburgh Area from nonattainment to attainment for the 1997 annual and 2006 24-hour PM2.5 NAAQS. Third, EPA is approving the associated maintenance plan for the Pittsburgh Area as a revision to the Pennsylvania SIP for the 1997 annual and 2006 24-hour PM2.5 NAAQS because it meets the requirements of section 175A of the CAA. The maintenance plan includes the 2017 and 2025 PM2.5 and NOX MVEBs submitted by Pennsylvania for the Pittsburgh Area for transportation conformity purposes. In addition, EPA is approving the 2007 and the 2011 emissions inventories for the Pittsburgh Area as meeting the requirement of section 172(c)(3) of the CAA for 1997 annual and 2006 24-hour PM2.5 NAAQS, respectively.

In accordance with 5 U.S.C. 553(d), EPA finds there is good cause for this rulemaking action to become effective immediately upon publication. A delayed effective date is unnecessary due to the nature of a redesignation to attainment, which eliminates CAA obligations that would otherwise apply. The immediate effective date for this rulemaking action is authorized under both 5 U.S.C. 553(d)(1), which provides that rulemaking actions may become effective less than 30 days after publication if the rule “grants or recognizes an exemption or relieves a restriction,” and section 553(d)(3), which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Today's rulemaking action, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, today's rulemaking action relieves the Commonwealth of Pennsylvania of the obligation to comply with nonattainment-related planning requirements for the Pittsburgh Area pursuant to part D of the CAA and approves certain emissions inventories and MVEBs for the Pittsburgh Area. For these reasons, EPA finds good cause under 5 U.S.C. 553(d) for this rulemaking action to become effective on the date of publication.

Under the CAA, redesignation of an area to attainment and the accompanying approval of the maintenance plan under CAA section 107(d)(3)(E) are actions that affect the status of a geographical area and do not impose any additional regulatory requirements on sources beyond those required by state law. A redesignation to attainment does not in and of itself impose any new requirements, but rather results in the application of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the Act 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 Order 12866 (58 FR 51735, October 4, 1993);

• 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).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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 December 1, 2015. 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 redesignation request and maintenance plan for the Pittsburgh Area for the 1997 annual and 2006 24-hour PM2.5 NAAQS and the comprehensive emissions inventories for the Pittsburgh Area for the 1997 annual and the 2006 24-hour PM2.5 NAAQS, respectively, may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR parts 52 and 81 are amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2013-0141 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 1, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2013-0141, by one of the following methods:

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

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

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In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions (PP 2E8123 and 2F8121) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, NC 27419. Petition 2E8123 requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide, benzovindiflupyr in or on coffee, bean, green at 0.09 parts per million (ppm) and sugarcane, cane at 0.04 ppm. Petition 2F8121 requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide, benzovindiflupyr in or on apple, wet pomace at 0.6 ppm; barley, grain at 1.5 ppm; barley, hay at 15 ppm; barley, straw at 15 ppm; corn, field, grain at 0.02 ppm; corn, field, forage at 3 ppm; corn, field, stover at 15 ppm; corn, pop, grain at 0.02 ppm; corn, pop, stover at 15 ppm; corn, sweet, ear at 0.01 ppm; corn, sweet, forage at 4 ppm; corn, sweet, stover at 5 ppm; cottonseed, subgroup 20C at 0.15 ppm; cotton, gin byproducts at 3 ppm; vegetables, cucurbits, crop group 9 at 0.2 ppm; fruits, pome, crop group 11-10 at 0.2 ppm; fruits, small vines climbing, except fuzzy kiwi subgroup 13-07F at 1 ppm; grain, aspirated fractions at 7 ppm; oat, grain at 1.5 ppm; oat, hay at 15 ppm; oat, straw at 15 ppm; peas and bean, dried shelled, except soybean, subgroup 6C at 0.2 ppm; peas, hay at 7 ppm; peas, vine at 1.5 ppm; peanut, nutmeat at 0.01 ppm; peanut, hay at 15 ppm; potato, wet peel at 0.1 ppm; raisin at 4 ppm; rapeseed, subgroup 20A at 0.15 ppm; rye, grain at 0.1 ppm; rye, hay at 15 ppm; rye, straw at 10 ppm; soybean, seed at 0.07 ppm; soybean, forage at 15 ppm; soybean, hay at 50 ppm; vegetables, fruiting, crop group 8-10 at 0.8 ppm; vegetables, tuberous and corm subgroup 1C at 0.02 ppm; wheat, grain at 0.1 ppm; wheat, forage at 4 ppm; wheat, hay at 15 ppm; wheat, straw at 10 ppm; and at 0.01 ppm in or on the following animal commodities: cattle, goat, horse, and sheep fat, kidney, liver, meat, and meat byproducts; egg; hog, fat, liver, meat, and meat byproducts; milk; milk, fat; and poultry, byproducts, fat, liver, meat, and skin.

That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has modified the requested tolerances and levels for the reasons explained in Unit IV.D.

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

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

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

Benzovindiflupyr has low acute toxicity by the dermal and inhalation routes, with moderate toxicity via the oral route. It is not a dermal sensitizer, but causes mild skin irritation and moderate eye irritation. The target organs for effects of benzovindifulpyr are the liver, thyroid, and kidneys.

Benzovindiflupyr produced effects in rat fetuses (i.e. decreased fetal weight and ossification) in developmental toxicity studies but only at maternally toxic doses. In the rabbit developmental study, there were no adverse effects in either the does or the fetuses at the highest dose tested. In reproduction studies, offspring effects occurred at doses higher than the doses causing parental effects; thus, there was no quantitative increase in sensitivity in rat pups. There are indications of reproductive toxicity in rats such as decreased follicle counts, but these effects did not result in reduced fertility.

No evidence of specific neurotoxicity was observed in the acute neurotoxicity (ACN) or subchronic neurotoxicity (SCN) studies. Benzovindiflupyr caused decreased activity and decreased grip strength in the neurotoxicity studies; however, there were no supportive neurohistopathology in any toxicological study, even at the highest doses tested.

There was no evidence of immune system toxicity in a study conducted in the mouse, or in any other toxicity studies in the database.

Benzovindiflupyr caused tumors in the thyroid in the chronic rat study at the highest dose tested. In mice, no tumor formation was observed. Benzovindiflupyr was negative in all mutagenicity studies. Based on the fact that evidence of tumors were found in only one species at only the highest dose tested and lack of mutagenicity, the Agency has determined that using a non-linear approach (i.e., RfD; reference dose) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to benzovindiflupyr.

Specific information on the studies received and the nature of the adverse effects caused by benzovindiflupyr as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Benzovindiflupyr New Active Ingredient Human Health Risk Assessment to Support the Proposed Uses on Cereals (wheat, triticale, barley, rye, and oat), Blueberries (non-bearing), Corn (field, pop, and sweet), Peanuts, Turf, and Ornamentals; Crop Groups 8-10, 9, and 11-10; Crop Subgroups 1C, 6C, 13-07F, 20A, and 20C; and Establishment of Tolerances on Imported Coffee and Sugarcane in docket ID number EPA-HQ-OPP-2013-0141.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for benzovindiflupyr used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to benzovindiflupyr, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from benzovindiflupyr in food as follows:

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

Such effects were identified for benzovindiflupyr. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA), Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA conducted a highly conservative acute dietary risk assessment which used tolerance-level residues for food except for livestock commodities, anticipated residues (based on maximum theoretical diets) for livestock commodities, and 100% crop treated for all commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA, CSFII. As to residue levels in food, EPA conducted a highly conservative chronic dietary risk assessment which used tolerance-level residues for food, anticipated residues (based on maximum theoretical diets) for livestock commodities, and 100% crop treated for all commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach was appropriate for assessing cancer risk to benzovindiflupyr; therefore, a separate dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. Tolerance-level residues for food and anticipated residues (based on maximum theoretical diets) for livestock commodities were used and 100% CT was assumed for all commodities.

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

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

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of benzovindiflupyr for acute exposures are estimated to be 8.4 parts per billion (ppb) for surface water and 0.14 ppb for ground water. For chronic exposures for non-cancer assessments are estimated to be 5.4 ppb for surface water and <0.14 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 8.4 parts per billion (ppb) for surface water was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 5.4 ppb for surface water was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Benzovindiflupyr is proposed for registration for the following uses that could result in residential exposures: turf (e.g. golf courses, recreational parks, home lawns, and sod farms) and ornamentals (residential landscape areas). EPA assessed residential exposure using the following assumptions. The proposed uses of benzovindiflupyr on turf and ornamentals in a residential setting by homeowners may result in residential handler (adults who are involved in the pesticide application process) exposure.

Residential handler exposure is expected to be short-term (ST) in duration. Intermediate-term (IT) exposures are not likely because of the intermittent nature of applications by homeowners. In addition, since the toxicity endpoints and PODs are the same for all durations, the ST assessment will be protective of any longer term exposures that may result from residential uses. Since no dermal hazard was identified for benzovindiflupyr in the toxicological database, only inhalation exposure assessments were conducted for residential handlers.

There is the potential for post-application exposure to individuals (adults and children) as a result of being in an environment that has been previously treated with benzovindiflupyr. Post-application inhalation exposures while performing activities in previously treated turf or ornamentals are not expected and were not assessed primarily due to the very low vapor pressure and the expected dilution in outdoor air after an application has occurred. In addition, no dermal hazard was identified in the toxicity database for benzovindiflupyr and, therefore, a quantitative residential post-application dermal risk assessment is not required and was not completed. However, incidental oral exposures to children contacting treated turf have been assessed. Residential post-application exposures are generally considered to be intermittent and short-term in duration. Since the benzovindiflupyr toxicity endpoints and PODs are the same regardless of duration, the short-term assessment is protective of any longer term exposures that may occur from the residential uses of benzovindiflupyr. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found benzovindiflupyr to share a common mechanism of toxicity with any other substances, and benzovindiflupyr does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that benzovindiflupyr does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. Benzovindiflupyr produced effects in rat fetuses (i.e. decreased fetal weight and delayed ossification) in developmental toxicity studies at maternally toxic doses (i.e., ataxia, hunched posture, and decreased activity); the Agency does not consider the fetal effects to be evidence of increased qualitative susceptibility since ossification is not considered to be a malformation and is reversible (based on the reproduction study), and maternal effects are fairly severe at the same dose levels. In the rabbit developmental study, there were no adverse effects in either the dose or the fetuses at the highest dose tested. In rat reproduction studies, offspring effects occurred at higher doses higher than those causing parental effects, thus there was no quantitative increase in sensitivity in rat pups. There were no single-dose developmental effects identified in the developmental toxicity studies in rats or rabbits. Although decreases in growing follicle counts were noted in the reproduction toxicity study, this effect did not result in reduced functional fertility in the rat. Furthermore, the antral follicle counts at a later stage in development were not decreased, so the decreased growing follicle count effect is not considered adverse.

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

i. The toxicity database for benzovindiflupyr is complete.

ii. There is no indication that benzovindiflupyr is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that benzovindiflupyr results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to benzovindiflupyr in drinking water. EPA also made conservative assumptions for dietary food exposures (residues on food and feed crops based on tolerance level residues, assuming 100% crop treated) resulting in high-end estimates of dietary food. EPA used similarly conservative assumptions based on conservative default (non-chemical specific) assumptions to assess postapplication exposure of children, including incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by benzovindiflupyr.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to benzovindiflupyr will occupy 30% of the aPAD for children 1-2 years old.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to benzovindiflupyr from food and water will utilize 14% of the cPAD for children 1-2 years old. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of benzovindiflupyr is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Benzovindiflupyr is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to benzovindiflupyr. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of ≥180,000 for all scenarios. Because EPA's level of concern for benzovindiflupyr is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners and the likely short-term duration of exposures.

5. Aggregate cancer risk for U.S. population. Based on the results of the chronic risk assessment, the Agency does not expect benzovindiflupyr to pose a cancer risk.

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

Adequate enforcement methodology (A Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) multi-residue method (EN15662:2009)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for benzovindiflupyr.

EPA received a comment to the notice of filing, which requested that the Agency reconsider the acceptable residue levels of toxic chemicals on food. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.

Benzovindiflupyr was evaluated by undergoing a global joint review between the EPA, the Pest Management Regulatory Agency (PMRA) of Canada, and the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) of Mexico. Based upon review of the data supporting the petition and calculation procedures for tolerance determination, several tolerances modifications were required. Specifically, commodity definitions were modified for pea, hay; pea, vine; peanut, nutmeat; raisin; and potato, processed waste to reflect the current nomenclature used by the Agency. Several tolerance levels were adjusted to account for differences in the input data used for the calculation procedures for tolerance determination. For example, several trials considered to be independent trials by the petitioner were determined by the Agency to be replicate (not independent) trials and, as such, these data are inputed differently than data from independent trails. Based on this discrepancy, the Agency is establishing tolerances for the following commodities that are different from what the petitioner requested: Cattle, fat; cattle, liver; coffee, green bean; fruit, pome, group 11-10; goat, fat; goat, liver; horse, fat; horse, liver; milk, fat; pea and bean, dried shelled, except soybean, subgroup 6C; potato, processed waste; rye, straw; sheep, fat; sheep, liver; vegetable, cucurbit, group 9; vegetable, fruiting, group 8-10; wheat, grain; and wheat, straw. Also, based on the Agency's calculation, the available data supports reducing the raisin tolerance (from 4 ppm to 3 ppm) and increasing the aspirated grain fractions tolerance (from 7 ppm to 15 ppm).

A tolerance was recommended for lowbush variety of blueberry in non-cropping years following a 365-day PHI. However, no tolerance will be established on the basis that it would cover non-bearing blueberries which are considered to be a non-food use. Also, the petitioner did not include this use in their notice filing. Although the petitioner did not request a separate tolerance for tomato, dried, tomato processing study data show that residues concentrate in dried tomatoes (7.8X). To cover the higher residues and to harmonize with Canada, EPA is establishing a tolerance for tomato, dried at 4 ppm. Finally, the applicant requested tolerances for apple, wet pomace. As a fruit, pome, group 11-10 tolerance of 0.2 ppm will cover any potential residues in processed apple, a separate tolerance is not needed.

Therefore, tolerances are established for residues of benzovindiflupyr, in or on barley, grain at 1.5 ppm; barley, hay at 15 ppm; barley, straw at 15 ppm; cattle, fat at 0.02 ppm; cattle, liver at 0.06 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts, except liver at 0.01 ppm; coffee, green bean at 0.09 ppm; corn, field, forage at 3.0 ppm; corn, field, grain at 0.02 ppm; corn, field, stover at 15 ppm; corn, pop, grain at 0.02 ppm; corn, pop, stover at 15 ppm; corn, sweet, forage at 4.0 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 5.0 ppm; cottonseed, subgroup 20C at 0.15 ppm; cotton, gin byproducts at 3.0 ppm; fruit, pome, group 11-10 at 0.20 ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 1 ppm; goat, fat at 0.02 ppm; goat, liver at 0.06 ppm; goat, meat at 0.01 ppm; goat, meat byproducts, except liver at 0.01 ppm; grain, aspirated fractions at 15 ppm; horse, fat at 0.02 ppm; horse, liver at 0.06 ppm; horse, meat at 0.01 ppm; horse, meat byproducts, except liver at 0.01 ppm; milk at 0.01 ppm; milk, fat at 0.02 ppm; oat, grain at 1.5 ppm; oat, hay at 15 ppm; oat, straw at 15 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.20 ppm; pea, field, hay at 7.0 ppm; pea, field, vine at 1.5 ppm; peanut at 0.01 ppm; peanut, hay at 15 ppm; potato, processed potato waste at 0.10 ppm; grape, raisin at 3.0 ppm; rapeseed, subgroup 20A at 0.15 ppm; rye, grain at 0.1 ppm; rye, hay at 15 ppm; rye, straw at 15 ppm; sheep, fat at 0.02 ppm; sheep, liver at 0.06 ppm; sheep, meat at 0.01 ppm; sheep meat byproducts, except liver at 0.01 ppm; soybean, forage at 15 ppm; soybean, hay at 50 ppm; soybean, hulls at 0.20 ppm; soybean, seed at 0.07 ppm; sugarcane, cane at 0.04 ppm; tomato, dried at 4.0 ppm; vegetable, cucurbit, group 9 at 0.30 ppm; vegetable, fruiting, group 8-10 at 1.5 ppm; vegetable, tuberous and corm, subgroup 1C at 0.02 ppm; wheat, forage at 4 ppm; wheat, grain at 0.10 ppm; wheat, hay at 15 ppm; and wheat, straw at 15 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

This final rule reflects the administrative action of changing the street address of the Eastern States office of the BLM. This rule changes both the postal and street address for the personal filing of documents relating to public lands in Arkansas, Iowa, Louisiana, Minnesota, Missouri, and all States east of the Mississippi River, but makes no other changes in filing requirements. The BLM has determined that the rule has no substantive impact on the public, imposes no costs, and merely updates a list of addresses included in the Code of Federal Regulations for the convenience of the public. The Department of the Interior, therefore, for good cause finds that under 5 U.S.C. 553(b)(B) and 553(d)(3) notice and public comment procedures are unnecessary and that the rule may take effect immediately.

This final rule is an administrative action to change the address for one BLM State Office. This rule was not subject to review by the Office of Management and Budget under Executive Order 12866. The rule imposes no costs, and merely updates a list of addresses included in the Code of Federal Regulations for the convenience of the public.

The BLM has found that this final rule is of a procedural nature and thus is categorically excluded from environmental review under Section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4332(2)(C), pursuant to 43 CFR 46.210(i). In addition, this final rule does not present any of the 12 extraordinary circumstances listed at 43 CFR 46.215. Pursuant to 43 CFR 46.205 and the Council on Environmental Quality regulations at 40 CFR 1508.4, the term “categorical exclusion” means a category or kind of action that has no significant individual or cumulative effect on the human environment and therefore requires neither an environmental assessment nor an environmental impact statement.

Congress enacted the Regulatory Flexibility Act of 1980 (5 U.S.C. 601, et seq.) to ensure that Government regulations do not unnecessarily or disproportionately burden small entities. This final rule is a purely administrative regulatory action having no effect upon the public or the environment and it has been determined that the rule will not have a significant effect on the economy or small entities.

This final rule is a purely administrative regulatory action having no effects upon the public or the economy. This is not a major rule under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 804(2)). This rule will not have an annual effect on the economy of $100 million or more. This rule will not cause a major increase in costs of prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. This rule will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to complete with foreign-based enterprises.

The BLM has determined that this final rule is not significant under the Unfunded Mandates Reform Act of 1995 because the rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. Further, this final rule will not significantly or uniquely affect small governments. It does not require action by any non-Federal government entity. Therefore, the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.), is not required.

As required by Executive Order 12630, the Department of the Interior has determined that this rule would not cause a taking of private property. No private property rights would be affected by a rule that merely reports an address change for the Eastern States Office. The Department therefore certifies that this final rule does not represent a governmental action capable of interference with constitutionally protected property rights.

In accordance with Executive Order 13132, the BLM finds that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This final rule does not have substantial direct effects on the States, on the relationship between the national governments and the States, or the distribution of power and the responsibilities among the various levels of government. This final rule does not preempt State law.

This final rule is a purely administrative regulatory action having no effects upon the public. It will not unduly burden the judicial system, and meets the requirements of Sections 3(a) and 3(b)(2) of the Executive Order.

In accordance with the Executive Order 13175, the BLM finds that this rule does not include policies that have tribal implications. This final rule is purely an administrative action having no effects upon the public or the environment, imposing no costs, and merely updates the Eastern States Office address included in the Code of Federal Regulations.

In accordance with Executive Order 13211, the BLM has determined that this final rule will not have substantial direct effects on the energy supply, distribution or use, including a shortfall in supply or price increase. This final rule is a purely administrative action and has no implications under Executive Order 13211.

The Paperwork Reduction Act does not apply because this rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

For the reasons discussed in the preamble, the Bureau of Land Management amends 43 CFR part 1820 as follows:

This is a summary of the Commission's Report and Order, FCC 15-111, adopted and released on September 2, 2015. The full text of this document is available electronically via the FCC's Electronic Comment Filing System (ECFS) Web site at http://fjallfoss.fcc.gov/ecfs2/ or via the FCC's Electronic Document Management System (EDOCS) Web site at http://fjallfoss.fcc.gov/edocs_public/. (Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat.) This document is also available for public inspection and copying during regular business hours in the FCC Reference Information Center, Federal Communications Commission, 445 12th Street SW., CY-A257, Washington, DC, 20554. The complete text may be purchased from the Commission's copy contractor, 445 12th Street SW., Room CY-B402, Washington, DC 20554. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to [email protected] or calling the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

1. In this Report and Order, the Commission adopts rules to enable commercial television stations, satellite carriers and cable operators to better serve the interests of their local communities. These rules implement an important provision in the Satellite Television Extension and Localism Act Reauthorization Act of 2014 (“STELAR”) to promote carriage of in-state and other relevant local television programming. Specifically, in the STELAR, Congress recognized that satellite subscribers in some communities across the country are not able to access broadcast stations in their own states via the local television packages offered by satellite carriers. This problem results from the way TV stations are defined as “local” for purposes of satellite carriage. In some cases, subscribers may be included in a local television programming market that is served exclusively, or almost exclusively, by television stations in a neighboring state. As a result, these subscribers are not receiving news, politics, sports, emergency information and other television programming relevant to their home state. The STELAR seeks to address this problem by changing the laws to provide for “market modifications” that add flexibility to the current definition of a local television programming market. Market modifications allow the Commission, upon request, to modify the local market assignment of a station to include such neighboring communities that are located in the same state as the station. As required by the STELAR, the Commission determines whether to grant a market modification based on consideration of five statutory factors that allow petitioners to demonstrate that they provide local service to the community. Significantly, in the STELAR, Congress included a factor requiring consideration of access to television stations that are located in the same state as the community considered for modification. Congress also added this factor to the existing market modification statutory factors applicable to cable operators. Our rules implement the STELAR to achieve the goal of better service for consumers. Finally, Congress recognized that satellite carriage of additional stations might be technically or economically infeasible in some circumstances. Accordingly, our rules implement this exception to the carriage requirements that would otherwise apply for modified markets. We recognize that the ability of the market modification rules to successfully address the problem of consumer access to in-state stations will depend in large part on broadcasters' willingness to grant retransmission consent to be carried in the new community and satellite carriers' technical ability to provide the in-state stations in the new community. Therefore, we strongly urge broadcasters and satellite carriers to work together to provide relief to consumers and achieve the goals of the STELAR (to promote access to in-state programming) in cases where carriage is technically feasible.

2. In this Report and Order, we adopt satellite television market modification rules to implement section 102 of the STELAR.1 The STELAR amended the Communications Act (“Act”) and the Copyright Act to give the Commission authority to modify a commercial television broadcast station's local television market for purposes of satellite carriage rights.2 The Commission previously had such authority to modify markets only in the cable carriage context.3 With section 102 of the STELAR, Congress provides regulatory parity in this regard in order to promote consumer access to in-state and other relevant television programming.4

3. Section 102 of the STELAR, and the Commission's actions in this Report and Order, seek to establish a market modification process for the satellite carriage context and, to the extent possible, address satellite subscribers' inability to receive in-state programming in certain areas, sometimes called “orphan counties.” 5 In this Report and Order, consistent with Congress' intent that the Commission model the satellite market modification process on the current cable market modification process, we implement section 102 of the STELAR by revising the current cable market modification rule, section 76.59, to apply also to satellite carriage, while adding provisions to the rules to address the unique nature of satellite television service.6 In addition to authorizing satellite market modifications, section 102 of the STELAR makes certain conforming amendments to the cable market modification statutory provision 7 and also directs the Commission to consider whether to make other changes to the cable market modification rules.8 Accordingly, as part of our implementation of the STELAR, we make conforming and other minor changes to the cable market modification rules.

4. The following are among the key conclusions adopted in this Report and Order:

• We amend the cable market modification rule, section 76.59 of our rules, to apply also to satellite market modifications, and amend the rule to reflect the STELAR provisions that uniquely apply to satellite carriers, such as an exception if the resulting carriage is “not technically and economically feasible.”

• We conclude that the involved commercial broadcast station, satellite carrier, and county government have standing to file a satellite market modification petition. Petitions must be filed in accordance with the procedures for filing Special Relief petitions in section 76.7 of our rules.

• We conclude that the new in-state factor,9 when applicable, favors any market modification that would promote consumers' access to an in-state station. When applicable, this in-state factor serves as an enhancement, the particular weight of which depends on the strength of showing by the petitioner.