Federal Register Vol. 81, No.68,

The U.S. Office of Personnel Management is issuing a final regulation that revises the definition of spouse under 5 CFR 630.1202 for purposes of the Family and Medical Leave Act. This change stems from the June 26, 2013, decision of the U.S. Supreme Court in United States v. Windsor, 133 S. Ct. 2675 (2013), invalidating Section 3 (1 U.S.C. 7) of the Defense of Marriage Act (Public Law 104-199, 110 Stat. 2419 (1996)). The revised definition establishes in regulation that Federal employees who are in legal marriages with same-sex spouses can use their leave entitlement under FMLA in the same manner as Federal employees who are in legal marriages with opposite-sex spouses.

Two Federal agencies administer regulations governing FMLA. The Department of Labor (DOL) issues regulations for title I of FMLA, which covers non-Federal employees and certain Federal employees not covered under title II. OPM issues regulations for title II of FMLA, which covers most Federal employees. Title II of FMLA directs OPM to prescribe regulations that are consistent, to the extent appropriate, with regulations prescribed by the Secretary of Labor to carry out title I of FMLA. (See 5 U.S.C. 6387.) DOL published its final regulations on the definition of spouse under title I of FMLA on February 25, 2015, at 80 FR 9989.

On June 26, 2013, the U.S. Supreme Court ruled in Windsor that Section 3 of DOMA is unconstitutional. Section 3 states in part: “In determining the meaning of any Act of Congress, or of any ruling, regulation, or interpretation of the various administrative bureaus and agencies of the United States, the word `marriage' means only a legal union between one man and one woman as husband and wife, and the word `spouse' refers only to a person of the opposite sex who is a husband or a wife.” OPM's definition of spouse in the FMLA regulations had its basis in the Section 3 language. In response to this ruling, OPM issued a memorandum on October 21, 2013, informing Federal agencies that the definition of spouse used in OPM's FMLA regulations was no longer valid. (See CPM 2013-14, Family and Medical Leave Act (FMLA) Coverage of Same-Sex Spouses, at https://www.chcoc.gov/content/family-and-medical-leave-act-fmla-coverage-same-sex-spouses.) The memorandum made clear that, effective June 26, 2013, an employee in a legally recognized same-sex marriage, regardless of state of residency, could use his or her FMLA leave entitlement in the same manner as an employee with an opposite-sex spouse.

On June 23, 2014, at 79 FR 35497, OPM published a notice of proposed rulemaking to change the definition of spouse in the regulations implementing title II of FMLA to mirror the definition proposed by DOL for title I employees. OPM also proposed conforming amendments that would revise the definition of parent and add a definition for State to align with DOL's definitions of these terms. We received 27 comments in response to the proposed regulations, of which 24 supported the changes.

The three commenters who opposed the change cited religious and traditional beliefs as reasons for adhering to a definition of marriage that applies only to opposite-sex couples. One supported equal benefits for same-sex couples, but did not agree with redefining marriage as other than between one man and one woman. Another maintained that the Government should not impose this change on States that had previously banned same-sex marriage. The change to the definition complies with the Supreme Court's ruling in Windsor, which invalidated the language in Section 3 of DOMA that had limited Federal recognition of marriages only to opposite-sex marriages, as well as its decision in Obergefell v. Hodges, 135 S.Ct. 2584 (2015), which held that States are required to license marriages between same-sex couples and to recognize same-sex marriages performed in other States. The change is also in accordance with 5 U.S.C. 6387, which directs that OPM's FMLA regulations be consistent, to the extent practicable, with those of the Department of Labor. Moreover, OPM's definition of spouse in these regulations only applies to Federal employee coverage under FMLA and does not affect State marriage licensing practices. We note that, to the extent the commenter is suggesting that a marriage performed in one State should have no effect in a State that banned same-sex marriage, the Supreme Court squarely rejected that position in Obergefell.

Six commenters urged OPM to maintain support for the in loco parentis standard in parent and child FMLA eligibility determinations. Four of these commenters requested that OPM clarify that the regulations will not affect its implementation of the DOL Administrator's Interpretation No. 2010-3, both in how parents may be determined to stand in loco parentis and in recognizing that more than two adults may stand in loco parentis to a child. OPM noted its continuing use of the in loco parentis standard described in Administrator's Interpretation No. 2010-3 in the Supplementary Information to the proposed rule under the section, “Children of Same-Sex Couples,” which referenced OPM's August 31, 2010, memorandum titled Interpretation of `Son or Daughter' Under the Family and Medical Leave Act. (See CPM 2010-15 at https://www.chcoc.gov/content/interpretation-“son-or-daughter”-under-family-and-medical-leave-act.) As noted in the memorandum, Administrator's Interpretation No. 2010-3 applies only to title I of FMLA; however, OPM has adopted the interpretation to also apply to employees covered by title II of FMLA. The memorandum specifies how individuals may be determined to stand in loco parentis and that neither the law nor OPM regulations restrict the number of parents a child may have under FMLA.

Two commenters asked that OPM consider amending the definition of parent to extend eligibility to parents-in-law. The definition of parent in the regulations derives from the statutory definition at 5 U.S.C. 6381(3). Inclusion of parents-in-law would require a statutory change; therefore, it is outside the scope of these regulations.

Three commenters noted that the phrase “in a same-sex or common law marriage” used in the definition of spouse could be interpreted as excluding same-sex common law marriages. We do not see the need to deviate from DOL's definition on this point. The definition uses the term “common law marriage” without exclusion; therefore, it applies to all common law marriages, including same-sex common law marriages. Additionally, OPM's October 21, 2013, memorandum (cited above in the Background section) makes clear that same-sex spouses in common law marriages are included in the definition of spouse.

One commenter said the Federal Government should take legislative action to meet the needs of working families excluded by FMLA because of the business-size threshold and employee tenure and hours-worked requirements. These exclusions do not apply to Federal employees covered by title II of FMLA and, regardless, legislation is outside the scope of the regulations. The same commenter expressed the need for paid family leave. FMLA does not authorize paid family leave; therefore, this comment is outside the scope of the regulations.

A Federal agency suggested adding “at the time of the marriage ceremony” in four places within the definition of spouse to make clear that, for purposes of the FMLA entitlement, the marriage need only have been valid in a State at the point in time that the ceremony took place. We believe that the verb tense used in the definition provides the needed clarity on this point where applicable. Therefore, we are not adopting this suggestion.

We made a minor editorial change to the definition of spouse (changing “was valid” to “is valid” in subparagraph (2)) to conform to the definition used by DOL in its title I regulations. We also made a minor change to the wording of the definition of parent to ensure coverage not only of individuals who stood in loco parentis to an employee but also of individuals who still stand in loco parentis to an employee. Because OPM received no comments requiring further changes to the definitions provided in the proposed rule, we are adopting the definitions as final.

The Office of Management and Budget has reviewed this rule in accordance with E.O. 13563 and 12866.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities because it will apply only to Federal agencies and employees.

Accordingly, OPM amends 5 CFR part 630 as follows:

The final rule entitled Supplemental Nutrition Assistance Program: Review of Major Changes in Program Design and Management Evaluation Systems was published on January 19, 2016. The Office of Management and Budget (OMB) cleared the associated information collection requirements (ICR) on March 10, 2016. This document announces approval of the ICR. The ICR for this rule approved the creation of a new information collection, which has been assigned the OMB Control Number 0584-0579.

Background

Under the regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-74, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.

On April 24, 2015, we published in the Federal Register (80 FR 22927-22930, Docket No. APHIS-2014-0085) a proposal 1 to amend the regulations to allow importation of Andean blackberry (Rubus glaucus Benth) and raspberry (Rubus idaeus Linnaeus) fruit into the continental United States from Ecuador subject to a systems approach. We also prepared a pest risk assessment (PRA) and a risk management document (RMD). The PRA evaluates the risks associated with the importation of fresh Andean blackberry and raspberry fruit from Ecuador into the continental United States. The RMD draws upon the findings of the PRA to determine the phytosanitary measures necessary to ensure the safe importation into the continental United States of fresh Andean blackberry and raspberry fruit from Ecuador.

In the proposed rule, we noted that the PRA rated three plant pests as having a high pest risk potential for following the pathway of fresh Andean blackberry and raspberry fruit from Ecuador into the continental United States: Anastrepha fraterculus (South American fruit fly), Ceratitis capitata (Mediterranean fruit fly, or Medfly), and Copitarsia decolora, a moth.

We determined in the PRA that measures beyond standard port of arrival inspection will adequately mitigate the risks posed by these plant pests and proposed a systems approach that includes requirements for importation in commercial consignments from a pest free production site within a certified low pest prevalence area for fruit flies, pest monitoring, and pest trapping. We also proposed that the fruit be imported in commercial consignments only and accompanied by a phytosanitary certificate issued by the national plant protection organization (NPPO) of Ecuador stating that the consignment was produced and prepared for export in accordance with the systems approach.

We solicited comments concerning our proposal for 60 days ending June 23, 2015. We received five comments during the comment period from members of the public and an employee of a foreign NPPO. The comments are discussed below.

Two commenters stated that the importation of fresh Andean blackberry and raspberry fruit into the continental United States should not be allowed due to the associated plant pest risk. One of these commenters added that production of blackberry and raspberry fruit in the United States, along with existing import agreements with other countries, renders importation of Andean blackberry and raspberry fruit from Ecuador unnecessary.

We are making no changes in response to these comments. Under the Plant Protection Act (7 U.S.C. 7701 et seq.), we have the authority to prohibit or restrict the importation of plants and plant products only when necessary to prevent the introduction into, or dissemination of plant pests or noxious weeds within, the United States. We have determined that fresh Andean blackberry and raspberry fruit from Ecuador may be safely imported into the continental United States under the conditions we are adding to the regulations.

One commenter stated that while the PRA lists Medfly as having a high pest risk potential for following the pathway of Andean blackberries and raspberries imported into the continental United States from Ecuador, the production site requirements we propose do not require mitigation for Medfly beyond standard commercial production and inspection. The commenter requested that we include an additional mitigation measure for Medfly and that we gradually reduce the requirements to commercial production and inspection only.

Another commenter observed that we currently do not require mitigations for Medfly beyond standard commercial production and inspection for raspberries imported from other countries with this pest, including Colombia, Costa Rica, El Salvador, France, Guatemala, Honduras, Nicaragua, and Panama. The commenter asked why no additional mitigations exist to prevent Medfly from following the pathway of raspberries imported into the continental United States from these countries and from Ecuador. The commenter stated that raspberries from all production sites in these countries should be inspected and undergo additional mitigation if they have the potential for bringing Medfly to the continental United States.

We respect the concerns of these commenters regarding the potential introduction of Medfly into the continental United States. However, as we noted in the RMD and the proposed rule, Andean blackberries and raspberries have been established in the scientific literature as being poor hosts for both Medfly and Anastrepha fraterculus. We also noted that there has never been an interception of fruit flies from the family Tephritidae, which includes Medfly as well as Anastrepha fraterculus, in any commercial shipments of fresh Andean blackberries or raspberries from the countries cited by the commenter. For these reasons, APHIS considers standard commercial production and inspection practices to be a sufficient mitigation for Medfly in Andean blackberries and raspberries imported from countries where the pest is present.

We also noted in the proposed rule that a slightly stronger host status potential exists for Anastrepha fraterculus in Andean blackberries and raspberries, and as a result included a requirement for field trapping in order to maintain low pest prevalence for this pest. Furthermore, we added to the proposed rule the requirement that if a single Anastrepha fraterculus, Medfly, or Copitarsia decolora is detected in a consignment, the consignment may not be exported to the United States.

One commenter stated that requiring the production sites of Andean blackberry and raspberry fruit to be free of Anastrepha fraterculus within an area of low prevalence is excessive. The commenter stated that the production sites are over 2,800 meters in altitude with an average temperature of 13 °C, resulting in conditions too adverse for the establishment of Anastrepha fraterculus. The commenter also stated that production centers for Andean blackberries and raspberries are in areas of Ecuador isolated from other fruit crop production. The commenter requested that we remove the requirement that production sites for Andean blackberries and raspberries must be within areas of low prevalence.

We agree with the commenter that given the low temperature and high altitude, the areas in Ecuador in which blackberry and raspberry production sites are located are generally inhospitable to the establishment of Anastrepha fraterculus. However, within Ecuador there is frequent commercial and consumer transport of fruit into these production areas from areas of lower altitude with established populations of Anastrepha fraterculus. Given the risk of Anastrepha fraterculus moving to production areas via host fruit, we will retain the requirement for trapping at each production site to ensure that the sites are free of Anastrepha fraterculus and remain areas of low pest prevalence. Details of trapping requirements will be included in the operational workplan and can be adjusted if necessary based on the frequency of pest interceptions.

One commenter, concerned about potential economic impacts to raspberry and blackberry growers in the United States resulting from imports of Andean raspberry and blackberry from Ecuador, requested that we provide more data on the potential impact to these growers.

In the economic analysis accompanying this rule, we gathered and analyzed data sufficient to determine that this action will not have a significant economic impact on small domestic growers. Between 2008 and 2012, the United States imported 37.22 million pounds of fresh raspberries and between 2011 and 2013 imported 63 million pounds of fresh blackberries. Comparing the volume level of these imports with the proposed maximum level of imports from Ecuador, the Ecuadorian import share would be less than 0.4 percent of the U.S. import share for these fruits.

The same commenter asked what costs APHIS will incur in monitoring and auditing Ecuador's implementation of the systems approach.

APHIS conducts monitoring of production areas and trapping practices, audits of trap records, and other tasks necessary to ensure that the NPPO of Ecuador is implementing the systems approach. The costs of conducting these tasks are included in the APHIS budget.

The commenter also asked if the costs would be feasible for Ecuadorian blackberry and raspberry farmers and whether the regulation imposes burdens on these farmers.

Under Executive Order 12866 and the Regulatory Flexibility Act, we are required to analyze the potential regulatory and economic effects of this action on small entities within the United States. We therefore have not researched the economic effects of this action on Ecuadorian blackberry and raspberry farmers.

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

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

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

The final rule will allow importation into the continental United States of fresh Andean blackberry (Rubus glaucus Benth.) and raspberry (Rubus idaeus L.) fruit from Ecuador. We have information on the total quantity of Andean blackberry and raspberry fruit expected to be imported from Ecuador yearly (less than 180 metric tons (MT)), but not the amount by species. Also, the Andean blackberry is more closely comparable to the loganberry (a blackberry-raspberry hybrid) than it is to the common blackberry (Rubus fruticosus). For these reasons, we base our analysis on aggregate quantities of Rubus species commercially produced by the United States.

The majority of U.S. raspberry and blackberry farms are in three States—California, Oregon, and Washington. They are classified within the North American Industry Classification System under “Berry except Strawberry Farming” (NAICS 111334). For this industry classification, a business is considered to be a small entity if its annual receipts are not more than $750,000. The average 2012 market value of crops sold by farms in this category was less than $135,000. We infer that most fresh raspberry and blackberry fruit production is by small entities.

Over the 5-year period 2008-2012, U.S. raspberry and blackberry production for the fresh market averaged about 96 million pounds and 4 million pounds per year, respectively, for a total of about 100 million pounds, or about 45,372 MT. Expected annual imports from Ecuador of less than 180 MT will be the equivalent of less than 0.4 percent of 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 final rule allows fresh Andean blackberry and raspberry fruit to be imported into the continental United States from Ecuador. State and local laws and regulations regarding fresh Andean blackberry and raspberry fruit imported under this rule will be preempted while the fruit is in foreign commerce. Fresh fruits are generally imported for immediate distribution and sale to the consuming public, and remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. No retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0435, 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.

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

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

In a final rule 1 that was published in the Federal Register on October 23, 2015 (80 FR 64307-64309, Docket No. APHIS-2014-0086), and effective on November 23, 2015, we amended the fruits and vegetables regulations by adding 7 CFR 319.56-74 to allow the importation of fresh peppers from Ecuador into the United States under a systems approach. However, the pest risk analysis we prepared for the rule examined the importation of fresh peppers from Ecuador to the continental United States only and did not examine the risks associated with the fruit entering Hawaii or the U.S. Territories. Therefore, in order for the regulations to be consistent with the scope of the pest risk analysis, we are amending § 319.56-74 to limit the importation of fresh peppers from Ecuador to the continental United States.

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

Energy conservation standards for commercial clothes washers (CCWs) are codified at 10 CFR 431.156. Pursuant to 10 CFR 431.154, the test procedures for clothes washers at 10 CFR part 430, subpart B, appendix J1 must be used to test CCWs to determine compliance with the current energy conservation standards codified at 10 CFR 431.156(b).

DOE published a final rule on March 7, 2012, establishing a new test procedure for clothes washers at 10 CFR part 430, subpart B, appendix J2. 77 FR 13887.

DOE published another final rule on December 3, 2014, revising the test procedure provisions for CCWs at 10 CFR 431.154 to specify that the test procedures for clothes washers at appendix J2 must be used to determine compliance with any amended standards for CCWs based on appendix J2 efficiency metrics published after December 3, 2014. 79 FR 71624.

DOE then published a final rule on December 15, 2014, amending the energy conservation standards for CCWs, which are codified at 10 CFR 431.156(c). 79 FR 74492. These amended standards are based on appendix J2 efficiency metrics, and compliance with the amended standards is required beginning January 1, 2018.

This final rule correction (1) removes obsolete CCW standards listed at 10 CFR 431.156(a), (2) redesignates paragraphs (b) and (c) of 10 CFR 431.156 as paragraphs (a) and (b), and (3) amends the CCW test procedure provisions at 10 CFR 431.154 to clarify that the test procedures at appendixes J1 and J2 must be used to determine compliance with the CCW energy conservation standards at redesignated 10 CFR 431.156(a) and (b), respectively.

The regulatory reviews conducted for this rulemaking are those set forth in the December 3, 2014 final rule that originally codified amendments to DOE's test procedures for commercial clothes washers. 79 FR 71624. The amendments from that final rule became effective January 2, 2015. Id.

Pursuant to the Administrative Procedure Act, 5 U.S.C. 553(b), DOE has determined that notice and prior opportunity for comment on this rule are unnecessary and contrary to the public interest. The amended CCW standards codified at 10 CFR 431.156(c) correspond to the “amended standards based on appendix J2 efficiency metrics published after December 3, 2014” referenced in 10 CFR 431.154. This correction is needed to ensure clarity regarding the amended CCW standards for which the appendix J2 test procedure must be used. This final rule also removes obsolete regulatory provisions.

For the reasons stated in the preamble, DOE amends part 431 of chapter II, subchapter D, of title 10 of the Code of Federal Regulations, by making the following correcting amendments:

The Blynman (SR 127) Bridge across the Annisquam River and Blynman Canal, mile 0.0, at Gloucester, Massachusetts, has a vertical clearance in the closed position of 8.2 feet at mean high water and 16 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.586.

The owner of the bridge, Massachusetts Department of Transportation, requested a temporary deviation from the normal operating schedule to facilitate a public event, the Annual Saint Peter's Fiesta 5K Road Race.

Under this temporary deviation, the Blynman (SR 127) Bridge may remain in the closed position for thirty minutes between 6:15 p.m. and 6:45 p.m. on Thursday June 23, 2016.

The waterways are transited by commercial and seasonal recreational vessels of various sizes. There is an alternate route for vessel traffic around Cape Ann. Also, vessels that can pass under the closed draws during this closure may do so at all times.

The Coast Guard will inform the users of the waterways through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

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

On March 11, 2016, the Coast Guard published a temporary deviation entitled “Drawbridge Operation Regulation; North Landing River, Chesapeake, VA” in the Federal Register (81 FR 12824). Under that temporary deviation, the north span of the bridge opened-to-navigation on the hour and half hour, upon request, from 6 a.m. to 7 p.m., and on demand from 7 p.m. to 6 a.m. Additionally under that deviation, the north and south spans of the bridge would open to navigation concurrently, with the south span only opening partially due to damage, upon request, for scheduled openings at 10 a.m., noon and 2 p.m., Monday through Friday.

The United States Army Corps of Engineers, Norfolk District Office, who owns and operates the S165 (North Landing Road) Bridge, has requested a modified temporary deviation from the currently published deviation to perform additional repairs to the south swing span of the bridge due to damage sustained as a result of a vessel allision with the bridge.

Under this modified temporary deviation, the north span of the bridge will open-to-navigation on the hour and half hour, upon request, from 6 a.m. to 7 p.m., and on demand from 7 p.m. to 6 a.m. The north and south spans of the bridge will open to navigation concurrently, with the south span only opening partially due to damage, upon request, for: (1) Scheduled openings at 9:30 a.m. for vessels transiting southeast, (2) 10:30 a.m. for vessels transiting northwest, and (3) at noon and 2 p.m. for two-way vessel traffic through the bridge, Monday through Friday. The horizontal clearance of the bridge with the south span closed-to-navigation is 38 feet and the horizontal clearance of the bridge with the south span partially open-to-navigation is 70 feet. The modified temporary deviation is necessary to relieve vessel congestion and provide for safe navigation on the waterway. The bridge is a double swing draw bridge and has a vertical clearance in the closed position of 6 feet above mean high water.

The North Landing River is used by a variety of vessels including small U.S. government and public vessels, small commercial vessels, tug and barge, and recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

During the closure times there will be limited opportunity for vessels which are able to safely pass through the bridge in the closed position to do so. Vessels able to safely pass through the bridge in the closed position may do so, after receiving confirmation from the bridge tender that it is safe to transit through the bridge. The north span of the bridge will be able to open for emergencies. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transit to minimize any impact caused by the temporary deviation.

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

This document identifies updates to the product lists, which appear as 39 CFR Appendix A to Subpart A of Part 3020—Mail Classification Schedule. Publication of the updated product lists in the Federal Register is addressed in the Postal Accountability and Enhancement Act (PAEA) of 2006.

Authorization. The Commission process for periodic publication of updates was established in Docket Nos. MC2010-21 and CP2010-36, Order No. 445, April 22, 2010, at 8.

Changes. The product lists are being updated by publishing a replacement in its entirety of 39 CFR Appendix A to Subpart A of Part 3020—Mail Classification Schedule. The following products are being added, removed, or moved within the product lists:

1. Priority Mail Contract 171 (MC2016-48 and CP2016-63) (Order No. 2977), added January 5, 2016.

2. Priority Mail Contract 170 (MC2016-47 and CP2016-62) (Order No. 2978), added January 5, 2016.

3. Priority Mail Contract 176 (MC2016-54 and CP2016-69) (Order No. 2981), added January 6, 2016.

4. Priority Mail Express Contract 31 (MC2016-61 and CP2016-76) (Order No. 2982), added January 6, 2016.

5. Priority Mail Express, Priority Mail & First-Class Package Service Contract 7 (MC2016-55 and CP2016-70) (Order No. 2983), added January 6, 2016.

6. Priority Mail Contract 177 (MC2016-57 and CP2016-72) (Order No. 2984), added January 6, 2016.

7. Priority Mail & First-Class Package Service Contract 11 (MC2016-62 and CP2016-77) (Order No. 2985), added January 6, 2016.

8. Priority Mail Contract 179 (MC2016-63 and CP2016-78) (Order No. 2986), added January 6, 2016.

9. Priority Mail Contract 180 (MC2016-64 and CP2016-79) (Order No. 2987), added January 6, 2016.

10. Priority Mail Contract 183 (MC2016-67 and CP2016-82) (Order No. 2988), added January 6, 2016.

11. Priority Mail & First-Class Package Service Contract 10 (MC2016-58 and CP2016-73) (Order No. 2989), added January 6, 2016.

12. Priority Mail Express & Priority Mail Contract 26 (MC2016-56 and CP2016-71) (Order No. 2990), added January 6, 2016.

13. Priority Mail Contract 175 (MC2016-53 and CP2016-68) (Order No. 2991), added January 6, 2016.

14. Priority Mail Contract 181 (MC2016-65 and CP2016-80) (Order No. 2992), added January 6, 2016.

15. Priority Mail Contract 178 (MC2016-60 and CP2016-75) (Order No. 2993), added January 6, 2016.

16. Priority Mail Express & Priority Mail Contract 27 (MC2016-59 and CP2016-74) (Order No. 2995), added January 6, 2016.

17. Priority Mail Contract 184 (MC2016-66 and CP2016-81) (Order No. 2996), added January 6, 2016.

18. Priority Mail Express, Priority Mail & First-Class Package Service Contract 8 (MC2016-72 and CP2016-87) (Order No. 2997), added January 7, 2016.

19. Priority Mail & First-Class Package Service Contract 12 (MC2016-70 and CP2016-85) (Order No. 2998), added January 7, 2016.

20. Priority Mail Contract 185 (MC2016-69 and CP2016-84) (Order No. 2999), added January 7, 2016.

21. Priority Mail Contract 186 (MC2016-71 and CP2016-86) (Order No. 3001), added January 7, 2016.

22. First-Class Package Service Contract 41 (MC2016-73 and CP2016-88) (Order No. 3002), added January 7, 2016.

23. Priority Mail Contract 182 (MC2016-68 and CP2016-83) (Order No. 3004), added January 7, 2016.

24. Priority Mail Contract 172 (MC2016-49 and CP2016-64) (Order No. 3006), added January 8, 2016.

25. First-Class Package Service Contract 40 (MC2016-51 and CP2016-66) (Order No. 3007), added January 8, 2016.

26. Priority Mail Contract 173 (MC2016-50 and CP2016-65) (Order No. 3009), added January 8, 2016.

27. First-Class Package Service Contract 42 (MC2016-74 and CP2016-91) (Order No. 3018), added January 12, 2016.

28. Parcel Select Contract 13 (MC2016-75 and CP2016-93) (Order No. 3023), added January 12, 2016.

29. Priority Mail & First-Class Package Service Contract 13 (MC2016-76 and CP2016-98) (Order No. 3067), added February 10, 2016.

30. Priority Mail Contract 165 (MC2016-39 and CP2016-48) (Order No. 3069), added February 12, 2016.

31. Priority Mail Contract 166 (MC2016-40 and CP2016-49) (Order No. 3070), added February 12, 2016.

32. Priority Mail Contract 167 (MC2016-41 and CP2016-50) (Order No. 3071), added February 12, 2016.

33. Priority Mail Contract 168 (MC2016-42 and CP2016-51) (Order No. 3072), added February 12, 2016.

34. Priority Mail Contract 169 (MC2016-43 and CP2016-52) (Order No. 3073), added February 12, 2016.

35. Priority Mail Contract 174 (MC2016-52 and CP2016-67) (Order No. 3074), added February 12, 2016.

36. Priority Mail Express, Priority Mail & First-Class Package Service Contract 9 (MC2016-78 and CP2016-103) (Order No. 3102), added February 26, 2016.

37. First-Class Package Service Contract 43 (MC2016-81 and CP2016-106) (Order No. 3110), added February 29, 2016.

38. Priority Mail Contract 188 (MC2016-80 and CP2016-105) (Order No. 3111), added February 29, 2016.

39. Priority Mail Contract 187 (MC2016-79 and CP2016-104) (Order No. 3112), added February 29, 2016.

40. Priority Mail Express Contract 32 (MC2016-77 and CP2016-102) (Order No. 3116), added February 29, 2016.

41. First-Class Package Service Contract 44 (MC2016-82 and CP2016-107) (Order No. 3120), added March 1, 2016.

42. Priority Mail Contract 189 (MC2016-83 and CP2016-108) (Order No. 3135), added March 8, 2016.

43. Priority Mail Express Contract 33 (MC2016-87 and CP2016-112) (Order No. 3136), added March 8, 2016.

44. Priority Mail Contract 190 (MC2016-84 and CP2016-109) (Order No. 3138), added March 8, 2016.

45. Priority Mail & First-Class Package Service Contract 14 (MC2016-88 and CP2016-113) (Order No. 3139), added March 8, 2016.

46. Priority Mail Contract 192 (MC2016-86 and CP2016-111) (Order No. 3140), added March 8, 2016.

47. Priority Mail Contract 191 (MC2016-85 and CP2016-110) (Order No. 3141), added March 8, 2016.

48. Priority Mail & First-Class Package Service Contract 15 (MC2016-89 and CP2016-114) (Order No. 3147), added March 10, 2016.

49. Priority Mail Contract 195 (MC2016-92 and CP2016-117) (Order No. 3152), added March 15, 2016.

50. Priority Mail Contract 193 (MC2016-90 and CP2016-115) (Order No. 3153), added March 15, 2016.

51. Priority Mail Contract 194 (MC2016-91 and CP2016-116) (Order No. 3154), added March 15, 2016.

52. Priority Mail Express Contract 34 (MC2016-93 and CP2016-118) (Order No. 3155), added March 15, 2016.

53. International Merchandise Return Service Agreements with Foreign Postal Operators Non-Published Rates 2 (MC2016-94 and CP2016-119) (Order No. 3160), added March 17, 2016.

54. Priority Mail Contract 196 (MC2016-95 and CP2016-120) (Order No. 3174), added March 22, 2016.

55. First-Class Package Service Contract 45 (MC2016-96 and CP2016-121) (Order No. 3176), added March 23, 2016.

56. Priority Mail Contract 199 (MC2016-100 and CP2016-128) (Order No. 3188), added March 29, 2016.

57. Global Expedited Package Services Contracts Non-Published Rates 10 (MC2016-97 and CP2016-122) (Order No. 3189), added March 29, 2016.

58. Priority Mail Contract 198 (MC2016-99 and CP2016-127) (Order No. 3191), added March 29, 2016.

59. First-Class Package Service Contract 46 (MC2016-103 and CP2016-131) (Order No. 3192), added March 29, 2016.

60. Priority Mail Contract 200 (MC2016-101 and CP2016-129) (Order No. 3194), added March 30, 2016.

61. Priority Mail Express & Priority Mail Contract 28 (MC2016-106 and CP2016-134) (Order No. 3195), added March 30, 2016.

62. First-Class Package Service Contract 47 (MC2016-104 and CP2016-132) (Order No. 3198), added March 30, 2016.

63. Priority Mail & First-Class Package Service Contract 16 (MC2016-105 and CP2016-133) (Order No. 3199), added March 30, 2016.

64. Parcel Select Contract 14 (MC2016-102 and CP2016-130) (Order No. 3200), added March 30, 2016.

65. Priority Mail Express Contract 35 (MC2016-107 and CP2016-135) (Order No. 3201), added March 30, 2016.

66. Priority Mail Contract 197 (MC2016-98 and CP2016-126) (Order No. 3202), added March 30, 2016.

The following negotiated service agreements have expired and are being deleted from the Mail Classification Schedule:

1. Priority Mail Contract 44 (MC2013-2 and CP2013-2) (Order No. 1508).

2. Express Mail & Priority Mail Contract 11 (MC2013-1 and CP2013-1) (Order No. 1509).

3. Priority Mail Contract 50 (MC2013-26 and CP2013-34) (Order No. 1608).

4. Priority Mail Contract 51 (MC2013-31 and CP2013-40) (Order No. 1632).

5. Express Mail Contract 13 (MC2013-32 and CP2013-41) (Order No. 1640).

6. Priority Mail Contract 52 (MC2013-35 and CP2013-46) (Order No. 1646).

7. Priority Mail Contract 53 (MC2013-36 and CP2013-47) (Order No. 1650).

8. Priority Mail Contract 54 (MC2013-37 and CP2013-48) (Order No. 1653).

9. Express Mail Contract 14 (MC2013-41 and CP2013-53) (Order No. 1673).

10. Priority Mail Contract 55 (MC2013-40 and CP2013-52) (Order No. 1675).

11. Priority Mail Contract 48 (MC2013-16 and CP2013-15) (Order No. 1548).

12. Express Mail Contract 11 (MC2011-14 and CP2011-50) (Order No. 644).

Updated product lists. The referenced changes to the product lists are incorporated into 39 CFR Appendix A to Subpart A of Part 3020—Mail Classification Schedule.

For the reasons discussed in the preamble, the Postal Regulatory Commission amends chapter III of title 39 of the Code of Federal Regulations as follows:

You may be potentially affected by this action if you manufacture, process, or distribute in commerce chemical substances and mixtures. 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:

• Textile Product Mills (NAICS code 314).

• Wood Product Manufacturing (NAICS code 321).

• Printing and Related Support Activities (NAICS code 323).

• Chemical Manufacturing (NAICS code 325).

• Plastics and Rubber Product Manufacturing (NAICS code 326).

• Primary Metal Manufacturing (NAICS code 331).

• Fabricated Metal Product Manufacturing (NAICS code 332).

• Machinery Manufacturing (NAICS code 333).

• Computer and Electronic Product Manufacturing (NAICS code 334).

• Electrical Equipment, Appliance, and Component Manufacturing (NAICS code 335).

• Transportation Equipment Manufacturing (NAICS code 336).

• Furniture and Product Related Manufacturing (NAICS code 337).

• Miscellaneous Manufacturing (NAICS code 339).

• Clothing and Clothing Accessory Stores (NAICS code 488).

• Warehousing and Storage (NAICS code 493).

• Repair and Maintenance (NAICS code 811).

• National Security and International Affairs (NAICS code 928).

Other types of entities not listed in this unit could also be affected. The NAICS codes have been provided to assist you and others in determining whether this action might apply to certain entities.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any 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 this final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical information contact listed under FOR FURTHER INFORMATION CONTACT.

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 those listed in TSCA section 5(a)(2). 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 (including import) or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.

This final SNUR will require persons to notify EPA at least 90 days before commencing the manufacture (including import) or processing of TCE for use in a consumer product except for use in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray.

The SNUR was proposed in the Federal Register of August 7, 2015 (80 FR 47441) (FRL-9930-33) (Ref. 1). Please consult the August 7, 2015 Federal Register document for further background information for this final rule. Additionally, please note that the RIN for the proposed SNUR was inadvertently published as RIN 2070-AK50. This final SNUR bears the correct identification, RIN 2070-AK05. EPA received 4 public comments on the proposal and EPA's response to those comments appear in Unit X.

This SNUR is necessary to ensure that EPA receives timely advance notice of any future manufacturing and processing of TCE for new uses that may produce changes in human and environmental exposures. The rationale and objectives for this SNUR are explained in Unit III.

EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of TCE. This analysis (Ref. 2), which is available in the docket, is discussed in Unit IX., and is briefly summarized here.

In the event that a SNUN is submitted, costs are estimated to be less than $8,900 per SNUN submission for large business submitters and $6,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN and the payment of a user fee. The SNUR requires first-time submitters of any TSCA section 5 notice to register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E-payment account before they may submit a SNUN, for a cost of approximately $200 per firm. However, these activities are only required of first time submitters of section 5 notices. In addition, for persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country, which is estimated to be approximately $80 per notification.

This final SNUR applies to TCE (Chemical Abstract Services Registry Number (CASRN) 79-01-6) manufactured (including import) or processed for use in any consumer product, except for use in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray. A consumer product is defined at 40 CFR 721.3 as “a chemical substance that is directly, or as part of a mixture, sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in recreation.”

As discussed in detail in Units II and III of the proposed rule (80 FR 47441; August 7, 2015), TCE has the potential to induce neurotoxicity, immunotoxicity, developmental toxicity, liver toxicity, kidney toxicity, endocrine effects, and several forms of cancer (Ref. 3). EPA is concerned about the adverse health effects of TCE resulting from commercial and consumer uses of the chemical substance. In EPA's final risk assessment of TCE, released on June 25, 2014, the Agency identified risks to workers using TCE and to bystanders for use as degreasers and a spot-cleaner in dry cleaning uses, and EPA also identified health risks to consumers using spray aerosol degreasers and spray fixatives (Ref. 3).

EPA believes that any additional use of this chemical substance in consumer products could significantly increase human exposure, and that such exposures should not occur without an opportunity for EPA review and control as appropriate. However, as discussed in Unit II of the proposed rule (80 FR 47441; August 7, 2015), based on review of Safety Data Sheets and the National Institutes of Health's Household Products Database, EPA believes that cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray presently contain TCE and are therefore ongoing uses of this chemical. EPA believes that other consumer products do not presently contain TCE. Spray fixative product use was discontinued by September 1, 2015, as described in Unit II.A of the proposed rule (80 FR 47441).

Consistent with EPA's past practice for issuing SNURs under TSCA section 5(a)(2), EPA's decision to promulgate a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. Rather, the Agency action is based on EPA's determination that if the use begins or resumes, it may present a risk that EPA should evaluate under TSCA before the manufacturing or processing for that use begins. Since the new use does not currently exist, deferring a detailed consideration of potential risks or hazards related to that use is an effective use of resources. If a person decides to begin manufacturing or processing the chemical for the use, the notice to EPA allows EPA to evaluate the use according to the specific parameters and circumstances surrounding that intended use.

Based on the considerations in Unit III.A., EPA will achieve the following objectives with regard to the significant new use(s) that are designated in this final rule:

1. EPA will receive notice of any person's intent to manufacture or process TCE for the described significant new use before that activity begins.

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

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

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:

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

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

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

4. 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 authorizes EPA to consider any other relevant factors.

To determine what would constitute a significant new use of TCE, as discussed in Unit II of the proposed rule (80 FR 47441), EPA considered relevant information about the toxicity of the substance, likely human exposures and environmental releases associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA (80 FR 47441). EPA has determined as the significant new use: Manufacture or processing for any use in a consumer product, except for use in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray. Because TCE is not used in consumer products (with the limited exceptions of use in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray), EPA believes new use in consumer products could increase the magnitude and duration of human exposure to TCE. Exposure to TCE through inhalation may lead to a wide array of adverse health effects, such as neurotoxicity, immunotoxicity, developmental toxicity, liver toxicity, kidney toxicity, endocrine effects, and several forms of cancer, as further explained in Unit II.C of the proposed rule (80 FR 47441), and because of these potential adverse effects EPA would like the opportunity to evaluate such potential uses in consumer products for any associated risks or hazards that might exist before those uses would begin.

General provisions for SNURs appear under 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 final rule.

Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submissions requirements of TSCA section 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 on 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.

Persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. In accordance with 40 CFR 707.60(b), this final SNUR does not trigger export notification for articles. Persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376; FRL-3658-5) (Ref. 4), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule. If uses begun after publication of the proposed rule were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, persons who begin commercial manufacture or processing of TCE after the proposal was published on August 7, 2015, must cease such activity before the effective date of this final rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires. Uses arising after the publication of the proposed rule are distinguished from uses that exist at publication of the proposed rule. The former would be new uses, the latter ongoing uses, except that uses that are ongoing as of the publication of the proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule. However, recognizing that use in a consumer product of TCE in spray fixatives was to cease and did cease by September 1, 2015 as described in Unit II.A. of the proposed rule (80 FR 47441), EPA considers September 1, 2015 as the date from which the significant new use with respect only to such spray fixatives would be designated. Public commenters on the proposed rule did not identify any additional ongoing uses. EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under 40 CFR 721.45(h), that person would be considered to have met the requirements of the final SNUR for those activities.

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

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)); and

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 section 4 test rule or a section 5(b)(4) listing covering the chemical substance, persons are required to submit only test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters include data that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture, processing, use, distribution in commerce, or disposal. EPA encourages persons to consult with the Agency before submitting a SNUN. As part of this optional pre-notice consultation, EPA would discuss specific data it believes may be useful in evaluating a significant new use. SNUNs submitted for significant new uses without any test data may increase the likelihood that EPA will take action under TSCA section 5(e) to prohibit or limit activities associated with this chemical.

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

• Human exposure and environmental releases that may result from the significant new uses of the chemical substance;

• Potential benefits of the chemical substance; and

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

EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what data may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice 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 721.25 and 40 CFR 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of the chemical substance included in this final rule (Ref. 2). In the event that a SNUN is submitted, costs are estimated at approximately $8,900 per SNUN submission for large business submitters and $6,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN, and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than $40 million when combined with those of the parent company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). EPA's complete economic analysis is available in the public docket for this final rule (Ref. 2).

Under section 12(b) of TSCA and the implementing regulations at 40 CFR part 707, subpart D, exporters must notify EPA if they export or intend to export a chemical substance or mixture for which, among other things, a rule has been proposed or promulgated under TSCA section 5. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications (i.e., the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical covered in this final SNUR, as stated in the accompanying economic analysis of this final SNUR, the estimated cost of the export notification requirement on a per unit basis is approximately $80.

The Agency reviewed and considered all comments received related to the proposed rule. Copies of all comments are available in the docket for this action (EPA-HQ-OPPT-2014-0697). A discussion of the major comments germane to the rulemaking and the Agency's responses follow.

1. Comment. One commenter supports the proposed rule and reiterates human health effects related to TCE exposure. (Docket ID# EPA-HQ-OPPT-2014-0697-0009.)

Response. EPA acknowledges the comment.

2. Comment. One commenter supports the proposed rule and asks EPA to (a) “broaden the scope of the SNUR to: (1) Include certain commercial uses of TCE, and (2) regularly review ongoing uses of TCE and update the SNUR to include any discontinued uses” and (b) “promptly promulgate a TSCA section 6(a) rule to address identified risks of TCE from ongoing uses.” (Docket ID# EPA-HQ-OPPT-2014-0697-0010.)

Response. The commenter points out that there are “widespread ongoing commercial uses of TCE.” Currently ongoing commercial uses of TCE cannot be included in the SNUR. EPA will continue to monitor uses of TCE and consider promulgating future SNURs for discontinued or other non-ongoing uses.

TSCA section 6 provides authority for EPA to ban or restrict the manufacture (including import), processing, distribution in commerce, and use of chemicals, as well as any manner or method of disposal. EPA identified TCE for risk evaluation as part of its Work Plan for Chemical Assessment under TSCA. TCE is used in industrial and commercial processes, and also has some limited uses in consumer products. In the June 2014 TSCA Work Plan Chemical Risk Assessment, EPA identified risks associated with commercial degreasing and some consumer uses. EPA is initiating rulemaking under TSCA section 6 to address these risks. Specifically, EPA will determine whether the use of TCE in some commercial degreasing uses, as a spotting agent in dry cleaning, and in certain consumer products presents an unreasonable risk to human health and the environment such that regulation is warranted under TSCA section 6.

3. Comment. One commenter agrees with the EPA's understanding that TCE is not widely used, with the exception of TCE in cleaners and solvent, degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray. (Docket ID# EPA-HQ-OPPT-2014-0697-0011.)

Response. EPA acknowledges the comment.

4. Comment. One commenter asks the Agency to “rescind any exemption to issuing a notice to any party looking to begin using TCE in the production of any consumer good” because TCE “is known to be a volatile organic compound (VOC) with a close association with many adverse health and environmental effects.” (Docket ID# EPA-HQ-OPPT-2014-0697-0008.)

Response. EPA acknowledges the comment. As described in Unit III.A., by issuing this final rule EPA defers, if and until such time as a SNUN is submitted, the opportunity to evaluate the use according to the specific parameters and circumstances surrounding that intended use before such use could occur. In the event that a SNUN is submitted, EPA will follow all regulations and guidelines, pursuant to TSCA section 5(a)(2), that guide the assessment of any environmental and health concerns resulting from the Significant New Use.

1. Comment. One commenter contends that the final Work Plan Chemical Risk Assessment “should not serve as the basis for regulation” and notes specific concerns with it, asking EPA to respond to each. (Docket ID# EPA-HQ-OPPT-2014-0697-0011.)

Response. The peer-reviewed Work Plan Chemical Risk Assessment referenced by the commenter includes an assessment of the hazard of TCE. As described in the risk assessment, TCE is carcinogenic to humans and TCE exposure is associated with a range of non-cancer health effects in humans and animals, including developmental toxicity, immunotoxicity, kidney toxicity, reproductive toxicity, neurotoxicity and liver toxicity. While EPA considered relevant information about the toxicity of the substance, likely human exposures and environmental releases associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA (80 FR 47441), EPA believes that the commenter's specific concerns are not relevant to the “basis for regulation” for this SNUR.

Under section 5(a)(2), EPA is neither required to determine that a particular new use of any chemical substances presents, nor even that it may present, an unreasonable risk to human health or the environment. Rather, EPA issues a SNUR for a particular new use of a substance if it has reason to anticipate that the use would raise significant questions related to potential exposure, so that it should have an opportunity to review the use before such use should occur. As discussed in Unit IV, EPA based this judgement on a consideration of all relevant factors, including the specific factors identified at section 5(a)(2).

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b). The information collection activities associated with existing chemical SNURs are already approved by OMB under OMB control number 2070-0038 (EPA ICR No. 1188); and the information collection activities associated with export notifications are already approved by OMB under OMB control number 2070-0030 (EPA ICR No. 0795). If an entity were to submit a SNUN to the Agency, the annual burden is estimated to be less than 100 hours per response, and the estimated burden for export notifications is less than 1.5 hours per notification. In both cases, burden is estimated to be reduced for submitters who have already registered to use the electronic submission system.

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 the 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 this SNUR. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320. Since the existing OMB approval was previously subject to public notice and comment before OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend the table 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.

Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I certify that this action will not have a significant economic impact on a substantial number of small entities.

A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. Since this SNUR will require a person who intends to engage in such activity in the future to first notify EPA by submitting a SNUN, no economic impact will occur unless someone files a SNUN to pursue a significant new use in the future or forgoes profits by avoiding or delaying the significant new use. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemical substances, the Agency receives only a handful of notices per year. During the six year period from 2005-2010, only three submitters self-identified as small in their SNUN submission (Ref. 2). EPA believes the cost of submitting a SNUN is relatively small compared to the cost of developing and marketing a chemical new to a firm or marketing a new use of the chemical and that the requirement to submit a SNUN generally does not have a significant economic impact.

Therefore, EPA believes that the potential economic impact of complying with this final SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general determination that proposed and final SNURs are not expected to 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 reason to believe that any State, local, or Tribal government would be impacted by this rulemaking. As such, the requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.

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 (64 FR 43255, August 10, 1999).

This final rule does not have Tribal implications because it is not expected to have any effect (i.e., there will be no increase or decrease in authority or jurisdiction) on Tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, Executive Order 13175 (65 FR 67249, November 9, 2000) does not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This final rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.

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

This final rule does not invoke special consideration of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This action does not affect the level of protection provided to human health or the environment.

This action is subject to the CRA, 5 U.S.C. 801 et seq., and the EPA will submit a rule report to each House of Congress and the Comptroller of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

On January 11, 2016 (81 FR 1136), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Pennsylvania. In the NPR, EPA proposed approval of a revision to Pennsylvania's SIP for the purpose of demonstrating attainment of the 2008 lead NAAQS in the North Reading Area. The formal SIP revision was submitted by Pennsylvania on August 12, 2015.

On November 12, 2008 (73 FR 66964), EPA revised the lead NAAQS, lowering the level from 1.5 micrograms per cubic meter (μg/m3) to 0.15 μg/m3 calculated over a three-month rolling average. Following promulgation of a new or revised NAAQS, EPA is required by the CAA to designate areas throughout the United States as attaining or not attaining the NAAQS; this designation process is described in section 107(d)(1) of the CAA.

On November 22, 2010, EPA designated Alsace and Muhlenberg Townships and the Laureldale Borough, all of which are located in Berks County, Pennsylvania, as the North Reading Area for its nonattainment status with the 2008 lead NAAQS. 76 FR 72097. The designation of the North Reading Area as nonattainment for the 2008 lead NAAQS triggered requirements under section 191(a) of the CAA, requiring Pennsylvania to submit a SIP revision with a plan for how the Area will attain the 2008 lead NAAQS, as expeditiously as practicable, but no later than December 31, 2015.

Section 179(a)(1) of the CAA establishes specific consequences if EPA finds that a state has failed to submit a SIP or, with regard to a submitted SIP, if EPA determines it is incomplete or if EPA disapproves it. Additionally, any of these findings also triggers an obligation for EPA to promulgate a federal implementation plan (FIP) if the state has not submitted, and EPA has not approved, the required SIP within 2 years of the finding pursuant to section 110(c) of the CAA. On February 25, 2014, the EPA issued a finding that Pennsylvania failed to make the required nonattainment SIP submission for the North Reading Area. 79 FR 10391. With this final approval by EPA of Pennsylvania's North Reading attainment plan SIP in accordance with section 172(c) of the CAA, the Agency no longer has any obligation to issue a FIP for the North Reading Area in accordance with section 110(c) of the CAA.

On August 12, 2015, Pennsylvania through the Department of Environmental Protection (PADEP) submitted an attainment plan for the North Reading Area as a SIP revision which includes a base year emissions inventory, an attainment demonstration, an analysis of RACM and RACT, provisions for RFP, and contingency measures.

The SIP revision also includes paragraph 3 of a consent order and agreement (COA), dated June 15, 2015, between Exide Technologies (Exide) and PADEP and paragraphs 5 and 22 of a COA, dated June 12, 2015, between Yuasa Battery, Inc (Yuasa) and PADEP. EPA's analysis of the submitted attainment plan includes a review of these elements for the North Reading Area.

EPA's approval of the attainment plan is based on the Agency's finding that the Area meets all lead NAAQS attainment plan requirements under CAA sections 172, 191, and 192. Due to monitored ambient air quality violations in early 2013, before a major source of lead began idling, the Area did not attain the NAAQS, over 36 consecutive three-month periods, by December 2015, the attainment date. However, as a result of implementation of PADEP's August 12, 2015 SIP revision, EPA and PADEP expect the North Reading Area will attain the 2008 lead NAAQS on the basis of 2014-2016 ambient air quality data. EPA is approving the base year emissions inventory submitted with the plan, as well as the RACM/RACT and RFP analyses, the attainment demonstration including modeling, and the contingency measures for the North Reading Area.

Other specific requirements of the SIP submittal attainment plan for the North Reading Area and the rationale for EPA's proposed action are explained in the NPR and its accompanying Technical Support Documents (TSDs) and will not be restated here.1 No public comments were received on the NPR.

EPA is approving the lead attainment plan for the North Reading Area and paragraph 3 of the COA between PADEP and Exide and paragraphs 5 and 22 of the COA between PADEP and Yuasa, as submitted on August 12, 2015 as a revision to the Pennsylvania SIP. EPA has determined that the SIP meets the applicable requirements of the CAA. Specifically, EPA is taking final action to approve Pennsylvania's August 12, 2015 SIP submission which includes the attainment demonstration, base year emissions inventory, RACM/RACT and RFP analyses, and contingency measures.

With the EPA's final approval of Pennsylvania's North Reading attainment plan submittal, EPA no longer has any obligation to promulgate a FIP for the North Reading Area pursuant to sections 110(c) or 172(c) of the CAA.

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

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

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

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

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

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

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

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

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

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

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 June 7, 2016. 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 Pennsylvania's SIP revision containing the attainment plan and base year inventory for the 2008 lead NAAQS in the North Reading Area may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

I. Background for Final Actions

On May 21, 2012, EPA designated areas as unclassifiable/attainment or nonattainment for the 2008 8-hour ozone NAAQS that was promulgated on March 27, 2008. See 77 FR 30088. The Memphis, TN-MS-AR Area was designated nonattainment for the 2008 8-hour ozone NAAQS on May 21, 2012 (effective July 20, 2012) using 2008-2010 ambient air quality data. See 77 FR 30088. The Memphis, TN-MS-AR Area consists of a portion of DeSoto County in Mississippi, all of Shelby County in Tennessee, and all of Crittenden County in Arkansas. At the time of designation, the Memphis, TN-MS-AR Area was classified as a marginal nonattainment area for the 2008 8-hour ozone NAAQS. In the final implementation rule for the 2008 8-hour ozone NAAQS (SIP Implementation Rule),1 EPA established ozone nonattainment area attainment dates based on Table 1 of section 181(a) of the Clean Air Act (CAA or Act). This established an attainment date three years after the July 20, 2012, effective date for areas classified as marginal areas for the 2008 8-hour ozone nonattainment designations. Therefore, the Memphis, TN-MS-AR Area's attainment date is July 20, 2015.

On December 11, 2015, MDEQ requested that EPA redesignate Mississippi's portion of the Memphis, TN-MS-AR Area to attainment for the 2008 8-hour ozone NAAQS and submitted a SIP revision containing the State's plan for maintaining attainment of the 2008 8-hour ozone standard in the Area, including the MVEBs for NOX and VOC for the year 2027 for the Mississippi portion of the Area.2 In a notice of proposed rulemaking (NPRM) published on February 11, 2016, EPA proposed to determine that the Memphis, TN-MS-AR Area is attaining the 2008 8-hour ozone NAAQS; to approve and incorporate into the Mississippi SIP the State's plan for maintaining attainment of the 2008 8-hour ozone standard in the Area, including the 2027 MVEBs for NOX and VOC for Mississippi's portion of Memphis, TN-MS-AR Area; and to redesignate the Mississippi portion of the Area to attainment for the 2008 8-hour ozone NAAQS. See 81 FR 7269. In that notice, EPA also notified the public of the status of the Agency's adequacy determination for the NOX and VOC MVEBs for Mississippi's portion of Memphis, TN-MS-AR Area. No comments were received on the February 11, 2016, proposed rulemaking. The details of Mississippi's submittal and the rationale for EPA's actions are further explained in the NPRM. See 81 FR 7269 (February 11, 2016).

Approval of Mississippi's redesignation request changes the legal designation of DeSoto County in the Mississippi portion of the Memphis, TN-MS-AR Area, found at 40 CFR 81.325, from nonattainment to attainment for the 2008 8-hour ozone NAAQS. Approval of Mississippi's associated SIP revision also incorporates a plan into the SIP for maintaining the 2008 8-hour ozone NAAQS in the Mississippi portion of the Memphis, TN-MS-AR Area through 2027. The maintenance plan establishes NOX and VOC MVEBs for 2027 for the DeSoto County portion of the Memphis, TN-MS-AR Area and includes contingency measures to remedy any future violations of the 2008 8-hour ozone NAAQS and procedures for evaluating potential violations. The MVEBs for the Mississippi portion of the Memphis, TN-MS-AR Area, along with the allocations from the safety margin, are provided in the table below.3

EPA is taking three separate final actions regarding Mississippi's December 11, 2015, request to redesignate the Mississippi portion of the Memphis, TN-MS-AR Area to attainment and associated SIP revision. First, EPA is determining that the Memphis, TN-MS-AR Area is attaining the 2008 8-hour ozone NAAQS.

Second, EPA is approving and incorporating the maintenance plan for the Memphis, TN-MS-AR Area, including the NOX and VOC MVEBs for 2027, into the Mississippi SIP. The maintenance plan demonstrates that the Area will continue to maintain the 2008 8-hour ozone NAAQS through 2027.

Third, EPA is determining that Mississippi has met the criteria under CAA section 107(d)(3)(E) for redesignation of the State's portion of the Memphis, TN-MS-AR Area from nonattainment to attainment for the 2008 8-hour ozone NAAQS. On this basis, EPA is approving Mississippi's redesignation request. As mentioned above, approval of the redesignation request changes the official designation of DeSoto County in the Mississippi portion of the Memphis, TN-MS-AR Area for the 2008 8-hour ozone NAAQS from nonattainment to attainment, as found at 40 CFR part 81.

EPA is also notifying the public that EPA finds the newly-established NOX and VOC MVEBs for the Mississippi portion of the Memphis, TN-MS-AR Area adequate for the purpose of transportation conformity. Within 24 months from this final rule, the transportation partners will need to demonstrate conformity to the new NOX and VOC MVEBs pursuant to 40 CFR 93.104(e)(3).

Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under 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 imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability 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. See 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, these actions merely approve state law as meeting Federal requirements and do not impose additional requirements beyond those imposed by state law. For this reason, these actions:

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

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

• are 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.);

• do 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);

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

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

• are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• are 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

• will not have disproportionate human health or environmental effects 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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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 June 7, 2016. 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 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-2015-0197 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 June 7, 2016. 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-2015-0197, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of May 20, 2015 (80 FR 28925) (FRL-9927-39), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5E8349) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide fluazinam (3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-2-pyridinamine), including its metabolites and degradates in or on mayhaw at 2.0 parts per million (ppm); cabbage at 3.0 ppm; the squash/cucumber subgroup 9B at 0.05 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.02 ppm. The petition also requested to amend the tolerances in 40 CFR 180.574 in or on the vegetable, Brassica leafy, group 5 at 0.01 by changing it to read “vegetable, Brassica leafy, group 5, except cabbage” at 0.01 ppm and by removing the existing tolerance on potato at 0.02 ppm upon approval of the requested tolerance on the tuberous and corm subgroup 1C. That document referenced a summary of the petition prepared by ISK Biosciences, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

EPA is combining the existing tolerance for the melon subgroup 9A tolerance with the proposed squash/cucumber subgroup 9B tolerance and establishing a tolerance for the entire cucurbit vegetable crop group 9, rather than just subgroup 9B. The reason for these changes is explained in Unit IV.C.

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 fluazinam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluazinam 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.

The liver is a primary target organ for fluazinam and numerous liver effects were observed in rats, mice, and dogs after oral and dermal exposure. After inhalation exposure, portal of entry effects (increased lung/bronchial weights, alveolar macrophages and peribronchiolar proliferation) were seen.

Clinical signs were observed in an acute oral neurotoxicity study in rats; decreases in motor activity and soft stools were seen on the day of dosing at the limit dose. These effects were attributed to systemic toxicity and were not considered to be evidence of frank neurotoxicity. In two subchronic neurotoxicity studies (evaluated together) in rats, no evidence of neurotoxicity was observed. A neurotoxic lesion was observed initially in long-term studies in mice and dogs; however, the lesion is reversible and was later attributed to the presence of an impurity (Impurity-5) in the technical material. A NOAEL for the impurity was determined (based on the maximum concentration of Impurity-5 in technical grade fluazinam), equivalent to a NOAEL for central nervous system (CNS) effects of 20 mg/kg/day for technical grade fluazinam. The current acute and chronic reference doses selected for risk assessment are lower than the determined NOAEL and thus, protective of any possible neurotoxic effects resulting from exposure to Impurity-5.

In an immunotoxicity study in mice, significant suppressions of anti-SRBC AFC assay response were demonstrated at the highest dose tested indicating potential immunotoxicity. However, clear NOAELs and LOAELs were identified for the effects seen in the study and the points of departure (PODs) and endpoints selected for risk assessment are protective of immunotoxic effects.

There was no evidence of increased quantitative or qualitative susceptibility in the rabbit developmental or rat reproduction studies. However, quantitative susceptibility was seen in rat developmental and developmental neurotoxicity (DNT) studies where fetal/offspring effects were observed in the absence of maternal toxicity. The concern is low for the increased susceptibility noted in the studies since clear NOAELs are established, and the most sensitive endpoints/PODs are used for risk assessment and are protective of the observed susceptibility. Therefore, the Food Quality Protection Act (FQPA) safety factor (SF) has been reduced to 1x.

Fluazinam is classified as having “Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential,” based on increases in thyroid gland follicular cell tumors in male rats and increases in hepatocellular tumors in male mice. Although there is evidence of thyroid tumors in male rats and liver tumors in male mice, the NOAEL used (1.12 mg/kg/day) for establishing the chronic reference dose (cRfD) is approximately 3-fold lower than the lowest dose that induced tumors (3.8 mg/kg/day). The Agency has determined that quantification of cancer risk using a non-linear approach (cRfD) would adequately account for all chronic toxicity, including carcinogenicity, which could result from exposure to fluazinam.

Specific information on the studies received and the nature of the adverse effects caused by fluazinam 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 the document titled “Fluazinam. Human Health Risk Assessment to Support Section 3 Registration for New Uses on Tuberous and Corm, Subgroup 1C, Mayhaw, Squash/Cucumber Subgroup 9B; Amended Uses on Cabbage” on page 44 in docket ID number EPA-HQ-OPP-2015-0197.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for fluazinam used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of November 7, 2012 (77 FR 66723) (FRL-9366-6).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluazinam, EPA considered exposure under the petitioned-for tolerances as well as all existing fluazinam tolerances in 40 CFR 180.574. EPA assessed dietary exposures from fluazinam 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 fluazinam. In estimating acute dietary exposure, EPA used food consumption information from the 2003-2008 United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, the acute analysis is based on tolerance-level residues for all commodities and uses high-end residue estimates for the metabolite AMGT ((3-[[4-amino-3-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]amino]-2-nitro-6-(trifluoromethyl) phenyl]thio]-2-(beta-D-glucopyranosyloxy) propionic acid)). In addition, the acute assessment assumes 100 percent crop treated (PCT).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, the chronic analysis is based on tolerance-level residues for all commodities except apples. For apples, the average field trial value was used. As with the acute assessment, it incorporates high-end estimates for AMGT, 100 PCT assumptions, default processing factors for all relevant processed commodities without a separate tolerance.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to fluazinam. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii.

iv. Anticipated residue and PCT information. 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 fluazinam and its transformation products, including DCPA (6-(4-carboxy-3-chloro-2,6-dinitroanilino)-5-chloronicotinic acid), CAPA (3-chloro-6-(3-chloro-2,6-dinitro-4-trifluoromethyl anilino)nicotinic acid), DAPA (3-chloro-N4-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluorotoluene-3,5,5-triamine; 3-chloro-2(2,6-diamino-3-chloro-α,α,α-trifluoro-p-toluidino)-5-(trifluoromethyl) pyridine), HYPA (5-[[3-chloro-5-(trifluoromethyl-2-pyridyl]amino]-α,α,α-trifluoro-4,6-dinitro-o-cresol), and AMPA (2-(6-amino-3-chloro-α,α,α-trifluoro-2-nitro-p-toluidino)-3-chloro-5-(trifluoromethyl)pyridine).

These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluazinam and its transformation products. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the First Index Reservoir Screening Tool (FIRST) and the Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated drinking water concentrations (EDWCs) for total residues of fluazinam and its transformation products for acute exposures are estimated to be 226 parts per billion (ppb) for surface water and 137 ppb for ground water and for chronic exposures are estimated to be 37.8 ppb for surface water and 119 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 226 ppb was used to assess the contribution to drinking water, and for the chronic dietary risk assessment, the water concentration of value 119 ppb 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).

Fluazinam is currently registered for the following uses that could result in residential exposures: golf course turf. EPA assessed residential exposure using the following assumptions: Only short-term dermal exposure is expected for residential post-application scenarios for children, teens, and adults who could potentially be exposed when they play golf on treated turf. No other residential exposures are expected. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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 fluazinam to share a common mechanism of toxicity with any other substances, and fluazinam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluazinam 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 SF. In applying this provision, EPA either retains the default value of 10x, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There was no evidence of increased quantitative or qualitative susceptibility in the rabbit developmental or rat reproduction studies. However, quantitative susceptibility was seen in rat developmental and DNT studies where fetal/offspring effects were observed in the absence of maternal toxicity. The concern is low for the increased susceptibility noted in the studies since clear NOAELs are established, and the most sensitive endpoints/PODs are used for risk assessment and are protective of the observed susceptibility.

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 fluazinam is complete.

ii. Although indications of neurotoxicity and immunotoxicity were observed in the database for fluazinam, there were clear NOAELs for these effects, and the endpoints and doses for risk assessment are protective of the potential effects.

iii. There is no evidence that fluazinam results in increased susceptibility in the rabbit developmental or rat reproduction studies. However, quantitative susceptibility was seen in rat developmental and DNT studies where fetal/offspring effects were observed in the absence of maternal toxicity. The concern is low for the increased susceptibility noted in the studies since clear NOAELs are established, and the most sensitive endpoints/PODs are used for risk assessment.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues for all commodities except apples, where anticipated residues were used in the chronic assessment. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fluazinam and its transformation products in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. These assessments will not underestimate the exposure and risks posed by fluazinam.

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 fluazinam will occupy 32% of the aPAD for females 13-49 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluazinam from food and water will utilize 92% of the cPAD for all infants, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluazinam 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). Fluazinam 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 fluazinam.

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 690 for children 6 to <11 years old, 820 for youth 11 to <16 years old and 890 for adults. Because EPA's level of concern for fluazinam 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).

An intermediate-term adverse effect was identified; however, fluazinam is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for fluazinam.

5. Aggregate cancer risk for U.S. population. EPA assessed cancer risk using a non-linear approach (i.e., RfD) since it adequately accounts for all chronic toxicity, including carcinogenicity, that could result from exposure to fluazinam. As the chronic dietary endpoint and dose are protective of potential cancer effects, fluazinam is not expected to pose an aggregate 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 fluazinam residues.

An adequate Gas Chromatography with Electron Capture Detector (GC/ECD) method is available for enforcing fluazinam tolerances on plant commodities.

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 MRLs for fluazinam for any of the commodities covered by this action.

Because the tolerance level for the existing melon subgroup 9A is the same as the squash/cucumber subgroup 9B tolerance the Agency is establishing, the Agency is combining the tolerances for the two subgroups and establishing a tolerance for the entire cucurbit vegetable crop group 9.

Therefore, tolerances are established for residues of fluazinam (3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-2-pyridinamine), including its metabolites and degradates in or on mayhaw at 2.0 ppm; cabbage at 3.0 ppm; cucurbit vegetables crop group 9 at 0.07 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.02 ppm. In addition, the existing tolerance on the vegetable, Brassica leafy, group 5 at 0.01 is modified to read “vegetable, Brassica leafy, group 5, except cabbage” at 0.01 ppm and the existing tolerance on potato at 0.02 ppm is removed as unnecessary since it is covered by the tolerance on the tuberous and corm subgroup 1C, and the melon subgroup 9A tolerance is removed since it is now replaced by the cucurbit vegetables crop group 9 tolerance.

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 tolerances 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:

What is the list of fisheries?

Section 118 of the MMPA requires NMFS to place all U.S. commercial fisheries into one of three categories based on the level of incidental mortality and serious injury of marine mammals occurring in each fishery (16 U.S.C. 1387(c)(1)). The classification of a fishery on the LOF determines whether participants in that fishery may be required to comply with certain provisions of the MMPA, such as registration, observer coverage, and take reduction plan requirements. NMFS must reexamine the LOF annually, considering new information in the Marine Mammal Stock Assessment Reports (SARs) and other relevant sources, and publish in the Federal Register any necessary changes to the LOF after notice and opportunity for public comment (16 U.S.C. 1387 (c)(1)(C)).

The definitions for the fishery classification criteria can be found in the implementing regulations for section 118 of the MMPA (50 CFR 229.2). The criteria are also summarized here.

The fishery classification criteria consist of a two-tiered, stock-specific approach that first addresses the total impact of all fisheries on each marine mammal stock and then addresses the impact of individual fisheries on each stock. This approach is based on consideration of the rate, in numbers of animals per year, of incidental mortalities and serious injuries of marine mammals due to commercial fishing operations relative to the potential biological removal (PBR) level for each marine mammal stock. The MMPA (16 U.S.C. 1362 (20)) defines the PBR level as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population. This definition can also be found in the implementing regulations for section 118 of the MMPA (50 CFR 229.2).

Tier 1: Tier 1 considers the cumulative fishery mortality and serious injury for a particular stock. If the total annual mortality and serious injury of a marine mammal stock, across all fisheries, is less than or equal to 10 percent of the PBR level of the stock, all fisheries interacting with the stock will be placed in Category III (unless those fisheries interact with other stock(s) in which total annual mortality and serious injury is greater than 10 percent of PBR). Otherwise, these fisheries are subject to the next tier (Tier 2) of analysis to determine their classification.

Tier 2: Tier 2 considers fishery-specific mortality and serious injury for a particular stock.

Category I: Annual mortality and serious injury of a stock in a given fishery is greater than or equal to 50 percent of the PBR level (i.e., frequent incidental mortality and serious injury of marine mammals).

Category II: Annual mortality and serious injury of a stock in a given fishery is greater than 1 percent and less than 50 percent of the PBR level (i.e., occasional incidental mortality and serious injury of marine mammals).

Category III: Annual mortality and serious injury of a stock in a given fishery is less than or equal to 1 percent of the PBR level (i.e., a remote likelihood of or no known incidental mortality and serious injury of marine mammals).

Additional details regarding how the categories were determined are provided in the preamble to the final rule implementing section 118 of the MMPA (60 FR 45086, August 30, 1995).

Because fisheries are classified on a per-stock basis, a fishery may qualify as one Category for one marine mammal stock and another Category for a different marine mammal stock. A fishery is typically classified on the LOF at its highest level of classification (e.g., a fishery qualifying for Category III for one marine mammal stock and for Category II for another marine mammal stock will be listed under Category II). Stocks driving a fishery's classification are denoted with a superscript “1” in Tables 1 and 2.

The tier analysis requires a minimum amount of data, and NMFS does not have sufficient data to perform a tier analysis on certain fisheries. Therefore, NMFS has classified certain fisheries by analogy to other Category I or II fisheries that use similar fishing techniques or gear that are known to cause mortality or serious injury of marine mammals, or according to factors discussed in the final LOF for 1996 (60 FR 67063, December 28, 1995) and listed in the regulatory definition of a Category II fishery: “In the absence of reliable information indicating the frequency of incidental mortality and serious injury of marine mammals by a commercial fishery, NMFS will determine whether the incidental mortality or serious injury is `frequent,' `occasional,' or `remote' by evaluating other factors such as fishing techniques, gear used, methods used to deter marine mammals, target species, seasons and areas fished, qualitative data from logbooks or fisher reports, stranding data, and the species and distribution of marine mammals in the area, or at the discretion of the Assistant Administrator for Fisheries” (50 CFR 229.2).

Further, eligible commercial fisheries not specifically identified on the LOF are deemed to be Category II fisheries until the next LOF is published (50 CFR 229.2).

The LOF includes a list of marine mammal species and/or stocks incidentally killed or injured in each commercial fishery. The list of species and/or stocks incidentally killed or injured includes “serious” and “non-serious” documented injuries as described later in the List of Species and/or Stocks Incidentally Killed or Injured in the Pacific Ocean and the Atlantic Ocean, Gulf of Mexico, and Caribbean sections. To determine which species or stocks are included as incidentally killed or injured in a fishery, NMFS annually reviews the information presented in the current SARs and injury determination reports. The SARs are based upon the best available scientific information and provide the most current and inclusive information on each stock's PBR level and level of interaction with commercial fishing operations. The best available scientific information used in the SARs reviewed for the 2016 LOF generally summarizes data from 2008-2012. NMFS also reviews other sources of new information, including injury determination reports, bycatch estimation reports, observer data, logbook data, stranding data, disentanglement network data, fisher self-reports (i.e., MMPA reports), and anecdotal reports from that time period. In some cases, more recent information may be available and used in the LOF, but in an effort to be consistent with the most recent SARs and across the LOF, NMFS typically restricts the analysis to data within the five-year time period summarized in the current SAR.

For fisheries with observer coverage, species or stocks are generally removed from the list of marine mammal species and/or stocks incidentally killed or injured if no interactions are documented in the five-year timeframe summarized in that year's LOF. For fisheries with no observer coverage and for observed fisheries with evidence indicating that undocumented interactions may be occurring (e.g., fishery has low observer coverage and stranding network data include evidence of fisheries interaction that cannot be attributed to a specific fishery) species and stocks may be retained for longer than five years. For these fisheries, NMFS will review the other sources of information listed above and use its discretion to decide when it is appropriate to remove a species or stock.

The best available information on the level of observer coverage and the spatial and temporal distribution of observed marine mammal interactions is presented in the SARs. Data obtained from the observer program and observer coverage levels are important tools in estimating the level of marine mammal mortality and serious injury in commercial fishing operations. Starting with the 2005 SARs, each SAR includes an appendix with detailed descriptions of each Category I and II fishery on the LOF, including the observer coverage in those fisheries. The SARs generally do not provide detailed information on observer coverage in Category III fisheries because, under the MMPA, Category III fisheries are generally not required to accommodate observers aboard vessels due to the remote likelihood of mortality and serious injury of marine mammals. Fishery information presented in the SARs' appendices and other resources referenced during the tier analysis may include: Level of observer coverage, target species, levels of fishing effort, spatial and temporal distribution of fishing effort, characteristics of fishing gear and operations, management and regulations, and interactions with marine mammals. Copies of the SARs are available on the NMFS Office of Protected Resources Web site at: http://www.nmfs.noaa.gov/pr/sars/. Information on observer coverage levels in Category I, II, and III fisheries can be found in the fishery fact sheets on the NMFS Office of Protected Resources' Web site: http://www.nmfs.noaa.gov/pr/interactions/fisheries/lof.html. Additional information on observer programs in commercial fisheries can be found on the NMFS National Observer Program's Web site: http://www.st.nmfs.gov/observer-home/.

This rule includes three tables that list all U.S. commercial fisheries by LOF Category. Table 1 lists all of the commercial fisheries in the Pacific Ocean (including Alaska); Table 2 lists all of the commercial fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean; and Table 3 lists all U.S.-authorized commercial fisheries on the high seas. A fourth table, Table 4, lists all commercial fisheries managed under applicable take reduction plans (TRPs) or take reduction teams (TRTs).

Beginning with the 2009 LOF, NMFS includes high seas fisheries in Table 3 of the LOF, along with the number of valid High Seas Fishing Compliance Act (HSFCA) permits in each fishery. As of 2004, NMFS issues HSFCA permits only for high seas fisheries analyzed in accordance with the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA). The authorized high seas fisheries are broad in scope and encompass multiple specific fisheries identified by gear type. For the purposes of the LOF, the high seas fisheries are subdivided based on gear type (e.g., trawl, longline, purse seine, gillnet, troll, etc.) to provide more detail on composition of effort within these fisheries. Many fisheries operate in both U.S. waters and on the high seas, creating some overlap between the fisheries listed in Tables 1 and 2 and those in Table 3. In these cases, the high seas component of the fishery is not considered a separate fishery, but an extension of a fishery operating within U.S. waters (listed in Table 1 or 2). NMFS designates these fisheries in Tables 1, 2, and 3 by a “*” after the fishery's name. The number of HSFCA permits listed in Table 3 for the high seas components of these fisheries operating in U.S. waters does not necessarily represent additional effort that is not accounted for in Tables 1 and 2. Many vessels/participants holding HSFCA permits also fish within U.S. waters and are included in the number of vessels and participants operating within those fisheries listed in Tables 1 and 2.

HSFCA permits are valid for five years, during which time Fishery Management Plans (FMPs) can change. Therefore, some vessels/participants may possess valid HSFCA permits without the ability to fish under the permit because it was issued for a gear type that is no longer authorized under the most current FMP. For this reason, the number of HSFCA permits displayed in Table 3 is likely higher than the actual U.S. fishing effort on the high seas. For more information on how NMFS classifies high seas fisheries on the LOF, see the preamble text in the final 2009 LOF (73 FR 73032; December 1, 2008). Additional information about HSFCA permits can be found at: http://www.nmfs.noaa.gov/ia/permits/highseas.html.

Starting with the 2010 LOF, NMFS developed summary documents, or fishery fact sheets, for each Category I and II fishery on the LOF. These fishery fact sheets provide the full history of each Category I and II fishery, including: When the fishery was added to the LOF, the basis for the fishery's initial classification, classification changes to the fishery, changes to the list of species and/or stocks incidentally killed or injured in the fishery, fishery gear and methods used, observer coverage levels, fishery management and regulation, and applicable TRPs or TRTs, if any. These fishery fact sheets are updated after each final LOF and can be found under “How Do I Find Out if a Specific Fishery is in Category I, II, or III?” on the NMFS Office of Protected Resources' Web site: http://www.nmfs.noaa.gov/pr/interactions/fisheries/lof.html, linked to the “List of Fisheries by Year” table. NMFS is developing similar fishery fact sheets for each Category III fishery on the LOF. However, due to the large number of Category III fisheries on the LOF and the lack of accessible and detailed information on many of these fisheries, the development of these fishery fact sheets is taking significant time to complete. As it completes work on each one, NMFS began posting Category III fishery fact sheets online on a rolling basis with the 2016 LOF.

Owners of vessels or gear engaging in a Category I or II fishery are required under the MMPA (16 U.S.C. 1387(c)(2)), as described in 50 CFR 229.4, to register with NMFS and obtain a marine mammal authorization to lawfully take non-endangered and non-threatened marine mammals incidental to commercial fishing operations. Owners of vessels or gear engaged in a Category III fishery are not required to register with NMFS or obtain a marine mammal authorization.

NMFS has integrated the MMPA registration process, implemented through the Marine Mammal Authorization Program (MMAP), with existing state and Federal fishery license, registration, or permit systems for Category I and II fisheries on the LOF. Participants in these fisheries are automatically registered under the MMAP and are not required to submit registration or renewal materials. In the Pacific Islands, West Coast, and Alaska regions, NMFS will issue vessel or gear owners an authorization certificate via U.S. mail or with their state or Federal license or permit at the time of issuance or renewal. In the Greater Atlantic Region, NMFS will issue vessel or gear owners an authorization certificate via U.S. mail automatically at the beginning of each calendar year. Certificates may also be obtained by visiting the Greater Atlantic Regional Office Web site (http://www.greateratlantic.fisheries.noaa.gov/Protected/mmp/mmap/). In the Southeast Region, NMFS will issue vessel or gear owners notification of registry and vessel or gear owners may receive their authorization certificate by contacting the Southeast Regional Office at 727-209-5952 or by visiting the Southeast Regional Office Web site (http://sero.nmfs.noaa.gov/protected_resources/marine_mammal_authorization_program/) and following the instructions for printing the certificate.

The authorization certificate, or a copy, must be on board the vessel while it is operating in a Category I or II fishery, or for non-vessel fisheries, in the possession of the person in charge of the fishing operation (50 CFR 229.4(e)). Although efforts are made to limit the issuance of authorization certificates to only those vessel or gear owners that participate in Category I or II fisheries, not all state and Federal license or permit systems distinguish between fisheries as classified by the LOF. Therefore, some vessel or gear owners in Category III fisheries may receive authorization certificates even though they are not required for Category III fisheries. Individuals fishing in Category I and II fisheries for which no state or Federal license or permit is required must register with NMFS by contacting their appropriate Regional Office (see ADDRESSES).

In Alaska regional and Greater Atlantic regional fisheries, registrations of vessel or gear owners are automatically renewed and participants should receive an authorization certificate by January 1 of each new year. In Pacific Islands regional fisheries, vessel or gear owners receive an authorization certificate by January 1 for state fisheries and with their permit renewal for federal fisheries. In West Coast regional fisheries, vessel or gear owners receive authorization with each renewed state fishing license, the timing of which varies based on target species. Vessel or gear owners who participate in fisheries in these regions and have not received authorization certificates by January 1 or with renewed fishing licenses must contact the appropriate NMFS Regional Office (see FOR FURTHER INFORMATION CONTACT).

In Southeast regional fisheries, vessel or gear owners' registrations are automatically renewed and participants will receive a letter in the mail by January 1 instructing them to contact the Southeast Regional Office to have an authorization certificate mailed to them or to visit the Southeast Regional Office Web site (http://sero.nmfs.noaa.gov/protected_resources/marine_mammal_authorization_program/) to print their own certificate.

In accordance with the MMPA (16 U.S.C. 1387(e)) and 50 CFR 229.6, any vessel owner or operator, or gear owner or operator (in the case of non-vessel fisheries), participating in a fishery listed on the LOF must report to NMFS all incidental mortalities and injuries of marine mammals that occur during commercial fishing operations, regardless of the category in which the fishery is placed (I, II, or III) within 48 hours of the end of the fishing trip or, in the case of non-vessel fisheries, fishing activity. “Injury” is defined in 50 CFR 229.2 as a wound or other physical harm. In addition, any animal that ingests fishing gear or any animal that is released with fishing gear entangling, trailing, or perforating any part of the body is considered injured, regardless of the presence of any wound or other evidence of injury, and must be reported.

Mortality/injury reporting forms and instructions for submitting forms to NMFS can be found at: http://www.nmfs.noaa.gov/pr/interactions/mmap/#form or by contacting the appropriate Regional office (see FOR FURTHER INFORMATION CONTACT). Forms may be submitted via any of the following means: (1) Online using the electronic form, (2) emailed as an attachment to [email protected], (3) faxed to the NMFS Office of Protected Resources at 301-713-0376, or (4) mailed to the NMFS Office of Protected Resources (mailing address is provided on the postage-paid form that can be printed from the web address listed above). Reporting requirements and procedures can be found in 50 CFR 229.6.

Individuals participating in a Category I or II fishery are required to accommodate an observer aboard their vessel(s) upon request from NMFS. MMPA section 118 states that the Secretary is not required to place an observer on a vessel if the facilities for quartering an observer or performing observer functions are so inadequate or unsafe that the health or safety of the observer or the safe operation of the vessel would be jeopardized; thereby authorizing the exemption of vessels too small to accommodate an observer from this requirement. However, U.S. Atlantic Ocean, Caribbean, or Gulf of Mexico large pelagics longline vessels operating in special areas designated by the Pelagic Longline Take Reduction Plan implementing regulations (50 CFR 229.36(d)) will not be exempted from observer requirements, regardless of their size. Observer requirements can be found in 50 CFR 229.7.

Table 4 in this rule provides a list of fisheries affected by TRPs and TRTs. TRP regulations can be found at 50 CFR 229.30 through 229.37. A description of each TRT and copies of each TRP can be found at: http://www.nmfs.noaa.gov/pr/interactions/trt/teams.html. It is the responsibility of fishery participants to comply with applicable take reduction regulations.

Information regarding the LOF and the Marine Mammal Authorization Program, including: Registration procedures and forms; current and past LOFs; descriptions of each Category I and II fishery, and some Category III fisheries; observer requirements; and marine mammal mortality/injury reporting forms and submittal procedures, may be obtained at: http://www.nmfs.noaa.gov/pr/interactions/fisheries/lof.html, or from any NMFS Regional Office at the addresses listed below:

NMFS, Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930-2298, Attn: Allison Rosner;

NMFS, Southeast Region, 263 13th Avenue South, St. Petersburg, FL 33701, Attn: Jessica Powell;

NMFS, West Coast Region, Seattle Office, 7600 Sand Point Way NE., Seattle, WA 98115, Attn: Elizabeth Petras, Protected Resources Division;

NMFS, Alaska Region, Protected Resources, P.O. Box 22668, 709 West 9th Street, Juneau, AK 99802, Attn: Bridget Mansfield; or

NMFS, Pacific Islands Regional Office, Protected Resources Division, 1845 Wasp Blvd., Building 176, Honolulu, HI 96818, Attn: Dawn Golden.

NMFS reviewed the marine mammal incidental mortality and serious injury information presented in the SARs for all fisheries to determine whether changes in fishery classification are warranted. The SARs are based on the best scientific information available at the time of preparation, including the level of mortality and serious injury of marine mammals that occurs incidental to commercial fishery operations and the PBR levels of marine mammal stocks. The information contained in the SARs is reviewed by regional Scientific Review Groups (SRGs) representing Alaska, the Pacific (including Hawaii), and the U.S. Atlantic, Gulf of Mexico, and Caribbean. The SRGs were created by the MMPA to review the science that informs the SARs, and to advise NMFS on marine mammal population status, trends, and stock structure, uncertainties in the science, research needs, and other issues.

NMFS also reviewed other sources of new information, including marine mammal stranding data, observer program data, fisher self-reports through the Marine Mammal Authorization Program, reports to the SRGs, conference papers, FMPs, and ESA documents.

The LOF for 2016 was based on, among other things, stranding data; fisher self-reports; and SARs, primarily the 2014 SARs, which are generally based on data from 2008-2012. The final SARs referenced in this LOF include: 2013 (79 FR 49053, August 19, 2014) and 2014 (80 FR 50599, August 20, 2015). The SARs are available at: http://www.nmfs.noaa.gov/pr/sars/.

NMFS received four comment letters on the proposed LOF for 2016 (80 FR 58427, September 29, 2015). Comments were received from the Marine Mammal Commission (Commission), Hawaii Longline Association (HLA), West Coast Seafood Processors Association (WCSPA), and a joint letter from Center for Biological Diversity (CBD) and Humane Society of the United States (HSUS).

Comment 1: The Commission recommends that NMFS consider alternative methods for the classification of fisheries that rarely interact with marine mammals that would average data over longer periods.

Response: NMFS is currently evaluating the potential for analyzing data over longer periods for rare events and its application to the SARs through the GAMMS process. The method will be considered for its application to the LOF in the future once more discussion has taken place regarding the expanded use of such methods in the SARs.

Comment 2: The Commission urges NMFS to complete the development of the fact sheets for all Category III fisheries.

Response: NMFS acknowledges the importance of having these fact sheets completed and will continue working on completing the remaining Category III fact sheets. Given the limited information for many Category III fisheries, fact sheets are being developed as new information becomes available.

Comment 3: The Commission recommends that NMFS consistently summarize information across regions, as necessary, to evaluate proposed changes to the LOF in 2016 and subsequent LOF reports.

Response: NMFS agrees and will continue to provide a consistent level of detail across regions, where available. Some flexibility will be maintained for cases unique to a region's geography, ecology, management structure, or culture.

Comment 4: The Commission recommends that NMFS assess the potential for interactions between main Hawaiian Islands (MHI) insular false killer whales and hook-and-line fisheries that overlap with the range and habitats used by this stock and reclassify by analogy those fisheries with which MHI insular false killer whales are likely to interact. At a minimum, the Commission recommends that NMFS reclassify the Hawaii troll fishery from Category III to Category II based on analogy to longline fisheries.

Response: NMFS acknowledges the potential for interactions between MHI insular false killer whales and hook-and-line fisheries other than longline. There are a variety of commercial, recreational, and subsistence hook-and-line fisheries in Hawaii that use a mix of gear types and methods. These fisheries are not currently observed, and NMFS has not received any fisher's self-reports of marine mammal hookings or entanglements. Currently available information on MHI insular false killer whale injuries, such as dorsal fin scarring and various hooks within a stranded animal's stomach, indicate interactions are occurring, but they have not been linked to mortalities or serious injuries, nor to any specific commercial fishery.

We do not consider the various Hawaii commercial hook-and-line fisheries on the LOF to be analogous to the Category I or II Hawaii longline fisheries, given, for example, dissimilarities in fishing gear, technique, the number of hooks deployed, and areas fished. Additionally, there are no other hook-and-line fisheries listed as Category I or II on the LOF. At this time, the available information does not support reclassification by analogy of Hawaii hook-and-line fisheries, including the Hawaii troll fishery.

However, given the potential for MHI insular false killer whales to interact with hook-and-line fisheries, we are committed to working with the State of Hawaii and others to assess the frequency and severity of marine mammal interactions in state-managed fisheries and reduce impacts as appropriate. For example, NMFS researchers worked with the Hawaii Department of Land and Natural Resources (DLNR) to analyze marine mammal depredation data on State of Hawaii commercial catch reports (Boggs et al., 2015), which may assist in accurately identifying fisheries that are more likely to have false killer whale interactions. NMFS also recently awarded a 2015 Endangered Species Act Section 6 Grant to the Hawaii DLNR for nearly $1.2 million over three years to strengthen efforts to minimize and mitigate incidental take of MHI insular false killer whales, including spatial and temporal analysis of the overlap between fisheries and false killer whale habitat. We will continue to work with our partners to evaluate the risk the various hook-and-line fisheries may pose to MHI insular false killer whales and whether these fisheries are appropriately classified on the annual LOF.

Comment 5: The Hawaii Longline Association (HLA) contends the Hawaii-based deep-set longline fishery does not interact with the MHI insular or Northwestern Hawaiian Islands (NWHI) stocks of false killer whales. HLA states that (a) there has never been a documented interaction between the fishery and an animal from either stock, (b) the False Killer Whale Take Reduction Plan essentially eliminates any overlap between the longline fisheries and the assumed ranges of the MHI insular and NWHI stocks, and (c) the revised stock boundaries presented in the draft 2015 SAR indicate that there is only a very small area in which longline fishing may overlap with either stock, and no false killer whale interaction has ever occurred in these areas. HLA opposes including the stocks on the list of marine mammals injured or killed in the deep-set fishery. If NMFS retains these species on the list (which HLA opposes), HLA requests that NMFS state in the LOF that there are no confirmed interactions with either stock and no interactions with either stock have ever occurred in the very limited area where longline effort might overlap with either stock's assumed range.

Response: NMFS determines which species or stocks are included as incidentally killed or injured in a fishery by annually reviewing the information presented in the current SARs, among other relevant sources. The SARs are based on the best available scientific information and provide the most current and inclusive information on each stock, including range, abundance, PBR, and level of interaction with commercial fishing operations. Determinations in the LOF are based on the data and calculations contained within the SARs.

The 2016 LOF is based on the 2014 SARs, which report fishery interactions from 2008-2012. NMFS deems this to be the best scientific and commercial information available for the time period examined. During that time period, NMFS estimates a five-year average mortality and serious injury level of 0.9 MHI insular and 0.4 NWHI false killer whales per year incidental to the Hawaii-based deep-set longline fishery from 2008-2012 (Carretta et al., 2015).

NMFS is retaining the stocks on the list of marine mammal stocks incidentally killed or injured in the Hawaii deep-set longline fishery. We disagree with HLA's recommended text and are not including it because false killer whale interactions have been observed in the deep-set longline fishery within the area of overlap between the pelagic, MHI insular, and NWHI stocks of false killer whales as defined in the 2014 SAR. While no genetic samples are available to establish stock identity for these takes, all stocks are considered at risk of interacting with longline gear. For a more complete analysis of the methodology for determining mortality and serious injury of MHI insular false killer whales, NMFS refers the commenter to the 2014 SAR.

Comment 6: HLA restates its comment from the proposed 2015 LOF regarding its opposition to including short-finned pilot whales on the list of species injured or killed in the Hawaii-based shallow-set longline fishery (see Comment 3 in the 2015 LOF final rule, 79 FR 77919, December 29, 2014). HLA commented that NMFS included the species because of a single interaction on the high seas involving an unidentified cetacean that “may have” been a short-finned pilot whale. HLA states that there have been no confirmed short-finned pilot whale interactions in the shallow-set fishery. In the absence of data confirming that the fishery is interacting with short-finned pilot whales, HLA contends NMFS may not add the species to the list of species and/or stocks that are incidentally killed or injured by the fishery.

Response: The estimated average annual mortality and serious injury of short-finned pilot whales in the fishery on the high seas from 2008-2012 is 0.1 (McCracken, 2014). NMFS is retaining short-finned pilot whales on the list of species or stocks that are incidentally killed or injured by the fishery based on the mortality and serious injury estimate presented in McCracken, 2014.

Comment 7: HLA restates its comment from the proposed 2015 LOF regarding its opposition to including pygmy or dwarf sperm whales on the list of species injured or killed in the Hawaii-based shallow-set longline fishery (see Comment 4 in the 2015 LOF final rule, 79 FR 77919, December 29, 2014). HLA maintains that the MMPA requires NMFS to list the species in the LOF that are seriously injured or killed by a fishery. HLA cites the 2013 SAR, which reports a single interaction with a pygmy or dwarf sperm whale in 2008 that was classified as a non-serious injury.

Response: As described in the preamble to this final rule and in the MMPA implementing regulations (50 CFR 229.8(b)(2)), the LOF lists the marine mammals that have been incidentally injured or killed in each commercial fishery. Separately, MMPA implementing regulations at 50 CFR 229.2 specify a tier analysis process for classifying fisheries on the LOF based on their levels of incidental serious injury and mortality of marine mammals. Therefore, while only mortalities and serious injuries are considered in the tier analysis, all species that are injured (seriously or non-seriously) or killed in the fishery are included in the list. Finally, the Kogia species whale (pygmy or dwarf sperm whale) was included in the list for the Hawaii shallow-set longline fishery because a Kogia species whale was non-seriously injured in the fishery in 2008 (McCracken, 2014; Carretta et al., 2015).

Comment 8: HLA restates its comment from the proposed 2015 LOF regarding how marine mammal takes should be listed in transboundary fisheries (see Comment 5 in the 2015 LOF final rule, 79 FR 77919, December 29, 2014). HLA is concerned that fisheries operating in the U.S. EEZ and on the high seas have marine mammals, for which an interaction has occurred in either the EEZ or the high seas, included on the lists of species killed or injured in both the EEZ and the high seas (i.e., on both Tables 1 or 2 and Table 3). HLA is concerned this redundant listing results in a mistaken implication that a given fishery may interact with a certain species in one geographic area (e.g., within the EEZ) when that fishery has only been observed to interact with the species in another geographic area (e.g., on the high seas). HLA requests that NMFS revise the LOF to attribute species interactions in transboundary fisheries to only those geographic regions where interactions are actually observed. HLA contends this change would adequately report species injured or killed, but would avoid the arbitrary result of takes being attributed to fisheries in areas in which no take has ever been observed. HLA requests that if NMFS does not attribute interactions for transboundary fisheries to the geographic regions in which they occurred, then NMFS should include a footnote in the LOF to clarify, for certain stocks and fisheries, that interactions have only been observed on the high seas or in the U.S. EEZ, as appropriate, to more accurately convey the best available information to the public.

Response: As described in the preamble, NMFS has included high seas fisheries in Table 3 of the LOF since 2009. Several fisheries operate in both U.S. waters and on the high seas, creating some overlap between the fisheries listed in Tables 1 and 2 and those in Table 3. In these cases, the high seas component of the fishery is not considered a separate fishery but an extension of a fishery operating within U.S. waters. For these fisheries, the lists of species or stocks injured or killed in Table 3 are identical to their Table 1 or 2 counterparts, except for those species or stocks with distributions known to occur on only one side of the EEZ boundary. Because the fisheries and the marine mammal lists are the same, takes of these animals are not being attributed to one geographic area or the other, even when that information may be available. This parallel list structure is explained in the footnotes for each table. We are not including additional footnotes to individual stocks and fisheries to indicate whether interactions have only been observed on the high seas or in the U.S. EEZ, but that information may be available in previous LOF rules when species and stocks are added or deleted.

Comment 9: The Commission concurs with NMFS that the Alaska Bering Sea/Aleutian Islands Pacific cod longline fishery should be elevated to a Category II fishery.

Response: NMFS acknowledges this comment and finalizes the re-classification of the Alaska Bering Sea/Aleutian Islands Pacific Cod Longline Fishery from Category III to Category II.

Comment 10: The Commission recommends NMFS retain the Alaska Kodiak salmon purse seine and Cook Inlet salmon purse seine fisheries as Category II fisheries because they are unobserved.

Response: The Alaska Kodiak salmon purse seine and Cook Inlet salmon purse seine fisheries were added to the LOF as Category II in the 2007 LOF (72 FR 14466, March 28, 2007) based on one mortality of a humpback whale in each of those fisheries in 2005. Both mortalities occurred in an area of geographic overlap of the Central and Western North Pacific humpback whales stocks. The 2005 mortalities were reported to NMFS through the Stranding/Entanglement program, as the fisheries are not observed. Samples were not obtained from the takes for genetic analysis, resulting in uncertain stock identification for either mortality.

The 2005 mortalities were each included in the standard five-year data sets (resulting in an average 0.4 mortalities/year) used in LOF Tier I and II analyses for the 2007-2011 LOFs. Because of the uncertainty regarding the whales' stock identity, NMFS used the standard precautionary measure of using the lower PBR of the Western North Pacific stock in each year's LOF analysis, which resulted in both fisheries remaining in Category II for the 2007-2011 LOFs. Once they “aged” out of the standard five-year data set, those mortalities continued to be included in the LOF analyses four additional years (2012-2015) as a precautionary measure due to the rarity of documented humpback takes in purse seine fisheries (only two other humpback whale mortalities were previously documented in purse seine fisheries in Alaska in the mid-1990s, a mother and calf taken in one event) and because the fisheries were unobserved. Although the five-year data set used in the 2016 LOF is 2008-2012, no additional humpback whale mortalities were reported in Alaska Kodiak salmon purse seine and Cook Inlet salmon purse seine fisheries from 2013 through 2015. Further, the PBRs for each the Central and Western North Pacific humpback whale stocks have increased substantially since the initial 2005 mortalities. The PBR for the Central North Pacific humpback whales has increased from 12.9 in the 2006 SAR to 82.8 in the 2014 SAR used for the 2007 and 2016 LOFs, respectively. The PBR for the Western North Pacific humpback whales has likewise increased from 1.3 to 3.0 for those same years. Given the absence of other evidence to the contrary, ten years with no additional mortalities or serious injuries reported (since 2005 via the Stranding Network or fisherman self-reports) and a substantial increase in PBR for both North Pacific humpback whale stocks, NMFS is reclassifying the fisheries as Category III fisheries. NMFS will continue to review the most recent data and changes in these fisheries and will update the LOF, as appropriate.

Comment 11: The Commission recommends NMFS assess the potential for all unobserved Category III AK purse seine fisheries to take humpback whales or similar species and, if appropriate, reclassify them by analogy as Category II fisheries.

Response: NMFS believes that because takes are so rare and there are no Table 1 purse seine fisheries analogous to Alaska's fisheries, the fisheries should remain in Category III. NMFS will continue to review stranding and entanglement data as alternative sources of data for these unobserved fisheries.

Comment 12: The Commission recommends NMFS investigate the circumstances and details of the reported interactions with the five stocks of marine mammals proposed to be added to the list of stocks incidentally killed or injured in the Category III CA halibut bottom trawl fishery and consider elevating it to Category II, if warranted. NMFS does not provide information on the sources of information upon which this proposal is based, nor does it provide any information about the number of interactions, their outcomes, or their magnitudes relative to PBR. In the absence of such information, it is difficult to assess the importance of five stocks being added in one year, although the Commission suggests that the number of stocks alone is sufficient to indicate the fishery may pose a greater threat to marine mammals, although of uncertain magnitude, than was previously understood.

Response: NMFS compiled information on marine mammal, seabird, and sea turtle takes observed in the west coast groundfish fisheries for the 2011 report entitled “Estimated Bycatch of Marine Mammals, Seabirds, and Sea Turtles in the U.S. West Coast Commercial Groundfish Fishery, 2002-2009” available at http://www.nwfsc.noaa.gov/research/divisions/fram/observation/data_products/datareport/docs/mmsbt_report02-09.pdf. The report provides observed numbers and estimates of marine mammals, in table 7, that were observed incidentally taken in the groundfish fisheries, including the CA halibut bottom trawl fishery, between 2002 and 2009. The marine mammals reported as killed or seriously injured are California sea lion, Steller sea lion, harbor seal, elephant seal, and harbor porpoise. We reviewed the annual fishery mortality and serious injury estimates and PBRs for each of the five species/stocks. The Tier 1 analysis indicated that mortality and serious injury did not exceed 10 percent of PBR when added to other fishery mortality and serious injury for these stocks, therefore, the fishery remains in Category III.

Comment 13: CBD/HSUS recommend NMFS add bottlenose dolphin, CA/OR/WA offshore stock, humpback whale, CA/OR/WA stock, and sea otter, CA stock, to the list of species and/or stocks incidentally killed or injured by the CA spiny lobster fishery. In addition, CBD/HSUS recommend that NMFS list the CA spiny lobster fishery as Category II based on the interactions with bottlenose dolphin and humpback whale. The most current stock assessment report documents take of: Bottlenose dolphin (one serious injury in 2008) and humpback whale (one serious injury between 2007 and 2011). The list should include sea otters by analogy because the stock assessment report cited controlled experiments conducted by the U.S. Geological Survey and the Monterey Bay Aquarium that demonstrated that sea otters exposed to lobster traps in a captive setting would succeed in entering them (Carretta et al., 2015 (citing Hatfield et al., 2011)). The mean annual take of offshore bottlenose dolphins in the spiny lobster fishery is 0.2, which is 3.6 percent of the PBR of 5.5. The mean annual take of humpback whales in the spiny lobster fishery is 0.2, which is 1.8 percent of the PBR of 11 that is allocated to U.S. waters. The fishery should be classified as Category II because the take of both stocks are between one and fifty percent of PBR.

Response: NMFS notes this oversight and adds bottlenose dolphins and humpback whales to the list of species/stocks incidentally killed or injured in the CA spiny lobster fishery. NMFS will address the classification of this fishery in the proposed 2017 LOF. See Response to Comment 14 regarding the request to add sea otters to the list of species/stocks killed or injured.

Comment 14: CBD/HSUS recommend that NMFS list the CA/OR coonstripe shrimp pot, CA rock crab pot, and WA/OR/CA hagfish pot fisheries as Category II by analogy to other pot fisheries because of the number of entanglements due to unknown fishery interactions and the evidence that pots can attract sea otters (Carretta et al., 2015 (citing Hatfield et al., 2011)). CBD/HSUS noted that from 2000-2015, NMFS received 231 reports of entanglements, 156 of which were confirmed, 114 of which were assigned to a reported fishery and 69 of which were confirmed to a fishery.

Response: NMFS has received similar comments regarding pot/trap fishery classifications in the past. NMFS relies upon the most recently available complete information to evaluate categorizations of fisheries on the List of Fisheries. For the proposed 2016 LOF, the most recent available information is through 2012. NMFS will address reports of entanglements and strandings during 2014 as part of the development of the proposed 2017 LOF. NMFS received a similar comment regarding sea otters for the proposed 2012 LOF (76 FR 73912, November 29, 2011, comment/response 9) as well as 2011 LOF (75 FR 68475, November 8, 2010, comment/response 13) and 2010 LOF (74 FR 58859, November 16, 2009, comment/response 3). As described in the response to comments in the final 2012 LOF and described in detail in the proposed 2009 LOF (73 FR 33760, June 13, 2008), NMFS conducted an extensive review of all available information on marine mammal interactions with pot/trap gear in 2008 and found no evidence of sea otter bycatch at that time or since. The USFWS completed a stock assessment for southern sea otters in 2008, which has not been updated. The USFWS, as part of public comments for the 2012 LOF, submitted a paper by Hatfield et al., (2011), detailing experiments that indicate that sea otters can enter and become entrapped in pots or traps with openings of certain sizes. However, the paper presented no evidence of this occurring during commercial fishing activities off California. The possibility of an interaction is insufficient justification to include southern sea otters on the list of species incidentally killed or injured in particular fisheries. Instead, NMFS needs some indication that mortalities/injuries are occurring or have occurred in these fisheries in recent years (e.g., fisher's self-reports, observer data, stranding data). If additional information becomes available indicating that southern sea otters have been killed or injured in CA trap/pot fisheries in recent years, NMFS will consider including this species on the LOF at that time.

Comment 15: CBD/HSUS recommend that NMFS clarify the discrepancy between the number of vessels participating in the Table 3 “Pacific highly migratory species longline” fishery (estimated 126 vessels/persons) and the Table 1 “California pelagic longline” fishery (estimated one vessel/person) because the definition of the fishery and identification of vessels participating in the fishery drastically affects how to quantify marine mammal interactions and both fisheries operate only on the high seas.

Response: The commenter is correct that the use of longline gear to target HMS within the EEZ is prohibited under the West Coast HMS FMP and that the CA pelagic longline fishery (on Table 1) does occur exclusively on the high seas. We have edited the footnote associated with this fishery. The preamble of the final 2009 LOF describes the relationship between the High Seas Pacific Highly Migratory Species Fisheries (Table 3) and West Coast HMS fisheries on Tables 1 and 2. The CA pelagic longline fishery has been included on the LOF since 2001. The high seas Pacific Highly Migratory Species longline fishery was added to the LOF in Table 3 in 2008 when all high seas fisheries were added to the LOF.

As described in the preamble of the final 2009 LOF (73 FR 73032, December 1, 2008), the number of participants in the high seas fisheries, Table 3, is drawn from the National Permitting System database and does not necessarily reflect actual fishing activity. As shown on Table 1, there is one vessel actively engaged in longline fishing with a West Coast HMS permit. This vessel also has an HSFCA permit. A number of individuals hold West Coast HMS permits endorsed to longline (and HSFCA permits) but are not actively fishing with this gear type. In addition, a number of vessels fish with a HI pelagics FMP permit, but make landings in the U.S. West Coast, which requires a West Coast HMS FMP permit (see the HMS SAFE for more details). There are over 40 vessels with a HSFCA permit that hold both a HI pelagics HMS permit and a West Coast HMS permit, which allows them to fish with longline on the high seas (under the HI pelagics permit) and land into the U.S. West Coast (under the West Coast HMS permit).

The number of HSFCA permits issued by NMFS changes frequently as new permits are added or renewed, or old permits expire, and does not necessarily reflect the effort or vessels in a fishery. NMFS has promulgated a regulation (80 FR 62488, October 16, 2015) to improve the administration and monitoring of the HSFCA, effective January 14, 2016, and requires vessel operators or owners identify the authorized fishery in which he or she intends to fish when applying for an HSFCA permit. There are eight fisheries authorized on the high seas, including the U.S. West Coast Fisheries for Highly Migratory Species, and this regulation should improve the accuracy of Table 3 in the LOF.

Comment 16: The WCSPA recommends that NMFS maintain the Category III designation and separate fishery names for the WA/OR sardine purse seine fishery and the CA anchovy, mackerel, sardine purse seine fishery. WCSPA notes the WA/OR fishery is spatially separate from the CA fishery, and while the quotas that all three fisheries access are set by the Pacific Fishery Management Council under its Coastal Pelagic Species Fishery Management Plan, the day-to-day management of each fishery is different. Each state has its own effort restriction plan and landing limits. There are some signs of a northern sub-population of sardine which forms part of the WA/OR fishery. In the remote occurrence of a marine mammal take that would change the categorization of either the WA/OR or the CA fishery. WCSPA believes it would be unfair to penalize the other spatially separate component.

Response: NMFS appreciates the information and withdraws this recommendation, and leaves the “WA/OR purse seine” and the “CA anchovy, mackerel, sardine purse seine” fisheries in place.

Comment 17: The Commission and CBD/HSUS recommend that NMFS not remove stocks from the list of stocks and/or species incidentally killed or injured in the Category I “Mid-Atlantic gillnet” and Category II “Mid-Atlantic mid-water trawl” fisheries because the fisheries have very low observer coverage.

Response: In general, NMFS lists species incidentally killed or injured in a particular fishery based on data observed from the last five years. The list contained in the LOF is not intended to serve as a historical overview of takes within a fishery as the data are available in individual species SARs as well as Appendix III. The agency does, however, maintain flexibility to analyze fisheries on a case-by-case basis in response to low observer coverage.

Mid-Atlantic gillnet fisheries have been observed at the following percent coverage from 2009-2013: 3%, 4%, 2%, 2% and 3%, respectively. For this fishery, we recommended the removal of Risso's and white-sided dolphins from the list of species incidentally taken in this fishery. The last observed takes of Risso's and white-sided dolphins occurred in 2007 and 1997 when observer coverage was 4% and 3%, respectively. While observer coverage averaged 2.8% over the last five years, Mid-Atlantic gillnet sampling levels are in the developing to mature stage (i.e., sampling 1-2% is recommended for pilot coverage, where coverage greater than 2% is considered developing to mature programs) according to the 2004 NMFS Report on Evaluating Bycatch (http://www.nmfs.noaa.gov/by_catch/SPO_final_rev_12204.pdf) (NMFS, 2004). Therefore, current estimated observer coverage for this fishery is considered adequate for bycatch estimation purposes. More importantly, given what we know about the overlap between species distribution and fishing effort, there is low probability that the Mid-Atlantic gillnet fishery will interact with Risso's and white-sided dolphins, and if they do occur, that they are rare occurrences. Thus, NMFS removes these species from the list of species and/or stocks incidentally killed or injured in the Mid-Atlantic gillnet fishery.

For the Mid-Atlantic mid-water trawl fishery, we proposed to remove short-beaked common dolphin, long-finned pilot whale, and short-finned pilot whale from this fishery. The last documented takes of these species in the Mid-Atlantic mid-water trawl fishery were in 2007. New genetic information on pilot whales (Waring et al., 2015b) and their distribution has also determined that the distribution of short-finned pilot whales does not overlap with the Mid-Atlantic mid-water trawl fishery effort; and, therefore, takes in this fishery are highly unlikely and that previous pilot whale takes should be considered long-finned pilot whales. During the period 2009-2013, analysis has shown that the percent observer sampling coverage for the Mid-Atlantic mid-water trawl fishery is also adequate for understanding marine mammal bycatch in this fishery (NMFS, 2004). NMFS removes these species from the list of species and/or stocks incidentally killed or injured in the Mid-Atlantic mid-water trawl fishery.

In the case of the Mid-Atlantic gillnet and Mid-Atlantic mid-water trawl fisheries, NMFS asserts observer coverage is adequate for determining if recent takes of certain species have occurred within these fisheries. The removal of these species from the list of species incidentally killed or injured from these respective fisheries does not impact the classification of the fisheries in question because other species taken are currently influencing the current classification. NMFS will continue to annually monitor bycatch of marine mammals in these fisheries and will make adjustments to Table 2 should incidental mortalities or injuries occur in the future.

NMFS retains the Category III fisheries, WA/OR sardine purse seine and CA anchovy, mackerel, sardine purse seine, as separate and does not merge and re-name the two fisheries “CA/OR/WA anchovy, mackerel, sardine purse seine” fishery, as proposed.

NMFS adds bottlenose dolphin, CA/OR/WA offshore, and humpback whale, CA/OR/WA, to the list of species and/or stocks incidentally killed or injured in the Category III CA spiny lobster fishery.

The following summarizes the changes to the LOF for 2016, including the fisheries listed in the LOF, the estimated number of vessels/persons in a particular fishery, and the species and/or stocks that are incidentally killed or injured in a particular fishery. In the LOF for 2016, NMFS re-classifies three fisheries. Additionally, NMFS adds two fisheries to the LOF and removes six fisheries from the LOF. NMFS makes changes to the list of species and/or stocks killed or injured in certain fisheries and the estimated number of vessels/persons in certain fisheries, as well as certain administrative changes. While detailed information describing each fishery in the LOF is included within the SARs, a Fishery Management Plan, or a TRP, or by state agencies, general descriptive information is important to include in the LOF for improved clarity; starting with the 2016 LOF, NMFS is releasing Category III fishery fact sheets as they are completed. The classifications and definitions of U.S. commercial fisheries for 2016 are identical to those provided in the LOF for 2015 with the changes discussed below. State and regional abbreviations used in the following paragraphs include: AK (Alaska), BSAI (Bering Sea and Aleutian Islands), CA (California), DE (Delaware), FL (Florida), GMX (Gulf of Mexico), HI (Hawaii), MA (Massachusetts), ME (Maine), NC (North Carolina), NY (New York), OR (Oregon), RI (Rhode Island), SC (South Carolina), VA (Virginia), WA (Washington), and WNA (Western North Atlantic).

NMFS reclassifies the Category III Alaska Bering Sea/Aleutian Island Pacific Cod Longline Fishery as Category II.

NMFS reclassifies the Category II Alaska Kodiak Salmon Purse Seine Fishery as Category III.

NMFS reclassifies the Category II Alaska Cook Inlet Salmon Purse Seine Fishery as Category III.

NMFS adds the CA sea cucumber trawl fishery to the LOF as Category III.

NMFS adds the WA/OR Mainstem Columbia River eulachon gillnet fishery to the LOF as Category III.

NMFS removes the Category III WA/OR herring, smelt, shad, sturgeon, bottom fish, mullet, perch, rockfish gillnet fishery from the LOF.

NMFS removes the Category III WA/OR smelt, herring dip net fishery from the LOF.

NMFS renames the Category III “WA (all species) beach seine or drag seine” as the “WA/OR Lower Columbia River salmon seine” fishery.

NMFS divides out three fisheries from the Category III “AK North Pacific halibut, AK bottom fish, WA/OR/CA albacore, groundfish, bottom fish, CA halibut non-salmonid troll” fishery and renames them as: “WA/OR/CA albacore surface hook and line/troll” fishery, “CA halibut hook and line/handline” fishery, and “CA White seabass hook and line/handline” fishery and removes the remaining fisheries in the group.

NMFS renames the Category III “WA/OR salmon net pens” fishery as the “WA salmon net pen” fishery.

NMFS renames (by revising, separating, and combining) the Category III “WA/OR sea urchin, other clam, octopus, oyster, sea cucumber, scallop, ghost shrimp, dive, hand/mechanical collection” and “CA sea urchin” fisheries to become the “WA/OR bait shrimp, clam hand, dive or mechanical collection” and “OR/CA sea urchin, sea cucumber dive, hand/mechanical collection” fisheries.

NMFS renames the Category III “WA shellfish aquaculture” fishery as the “WA/OR shellfish aquaculture” fishery.

NMFS updates the estimated number of vessels/persons in the Pacific Ocean (Table 1) as follows:

NMFS adds the southwest Alaska stock of northern sea otters to the list of species and/or stocks killed or injured in the Category II Alaska Peninsula/Aleutian Islands salmon set gillnet fishery.

NMFS adds the U.S. stock of California sea lions, unknown stock of harbor porpoise, unknown stock of harbor seals, California breeding stock of northern elephant seals, unknown stock of Steller sea lions to the species and/or stocks incidentally killed or injured by the Category III CA halibut bottom trawl fishery.

NMFS adds bottlenose dolphin, CA/OR/WA offshore, and humpback whale, CA/OR/WA, to the list of species and/or stocks killed or injured in the Category III CA spiny lobster fishery.

NMFS adds the Northwestern Hawaiian Islands stock of false killer whales to the list of species and/or stocks killed or injured in the Category I Hawaii deep-set longline fishery.

NMFS removes the Palmyra Atoll stock of false killer whales from the list of species and/or stocks killed or injured in the Category I Hawaii deep-set longline fishery.

NMFS adds notation “1” to indicate that the Main Hawaiian Islands (MHI) insular stock of false killer whales, along with the HI pelagic stock of false killer whales, is also driving the Hawaii deep-set longline fishery's Category I classification.

NMFS adds the Gulf of Alaska, BSAI transient stock of killer whales to the list of species and/or stocks killed or injured in the Category II Alaska BSAI Pacific cod longline fishery.

NMFS removes notation “1” from the Central North Pacific stock of humpback whales under the Category III fisheries: Alaska Cook Inlet salmon purse seine and Alaska Kodiak salmon purse seine.

NMFS renames and changes the geographic scope of the Category III “U.S. Mid-Atlantic offshore surf clam/quahog dredge” fishery.

NMFS updates the estimated number of vessels/persons in the Atlantic Ocean, Gulf of Mexico, and Caribbean (Table 2) as follows:

NMFS adds the Gulf of Maine/Bay of Fundy stock of harbor porpoise and the Gulf of Mexico stock of pygmy sperm whale to the list of marine mammal species and/or stocks incidentally killed or injured in the Category I Atlantic Ocean, Caribbean, Gulf of Mexico large pelagics longline fishery.

NMFS adds the Western North Atlantic stock of Risso's dolphin to the list of marine mammal species and/or stocks incidentally killed or injured in the Category II Northeast bottom trawl fishery.

NMFS adds the central Georgia estuarine system stock of bottlenose dolphin to the list of marine mammal species and/or stocks incidentally killed or injured in the Category II Atlantic blue crab trap/pot fishery.

NMFS removes the Western North Atlantic stocks of Risso's dolphin and white-sided dolphin from the list of marine mammal species and/or stocks incidentally killed or injured in the Category I Mid-Atlantic gillnet fishery.

NMFS removes the Western North Atlantic stocks of common dolphin, long-finned pilot whale, and short-finned pilot whale from the list of marine mammal species and/or stocks incidentally killed or injured in the Category II Mid-Atlantic mid-water trawl fishery.

NMFS removes the Western North Atlantic stocks of white-sided dolphin, long-finned pilot whale, and short-finned pilot whale from the list of marine mammal species and/or stocks incidentally killed or injured in the Category II Mid-Atlantic bottom trawl fishery.

NMFS removes the Western North Atlantic stocks of white-sided dolphin and short-finned pilot whale from the list of marine mammal species and/or stocks incidentally killed or injured in the Category II Northeast mid-water trawl fishery.

NMFS removes the Western North Atlantic stock of short-finned pilot whale from the list of marine mammal species and/or stock incidentally killed or injured in the Category II Northeast bottom trawl fishery.

NMFS removes the following Category II high seas fisheries from the List of Fisheries: (1) Western Pacific Pelagic Trawl, (2) Pacific Highly Migratory Species Liners, not elsewhere included (NEI), (3) South Pacific Albacore Troll Liners (NEI), and (4) Western Pacific Pelagic Liners (NEI).

NMFS updates the estimated number of HSFCA permits (Table 3) as follows:

The following tables set forth the list of U.S. commercial fisheries according to their classification under section 118 of the MMPA. Table 1 lists commercial fisheries in the Pacific Ocean (including Alaska); Table 2 lists commercial fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean; Table 3 lists commercial fisheries on the high seas; and Table 4 lists fisheries affected by TRPs or TRTs.

In Tables 1 and 2, the estimated number of vessels or persons participating in fisheries operating within U.S. waters is expressed in terms of the number of active participants in the fishery, when possible. If this information is not available, the estimated number of vessels or persons licensed for a particular fishery is provided. If no recent information is available on the number of participants, vessels, or persons licensed in a fishery, then the number from the most recent LOF is used for the estimated number of vessels or persons in the fishery. NMFS acknowledges that, in some cases, these estimates may be inflations of actual effort. For example, the State of Hawaii does not issue fishery-specific licenses, and the number of participants reported in the LOF represents the number of commercial marine license holders who reported using a particular fishing gear type/method at least once in a given year, without considering how many times the gear was used. For these fisheries, effort by a single participant is counted the same whether the fisher used the gear only once or every day. In the Mid-Atlantic and New England fisheries, the numbers represent the potential effort for each fishery, given the multiple gear types for which several state permits may allow. Changes made to Mid-Atlantic and New England fishery participants will not affect observer coverage or bycatch estimates, as observer coverage and bycatch estimates are based on vessel trip reports and landings data. Tables 1 and 2 serve to provide a description of the fishery's potential effort (state and Federal). If NMFS is able to extract more accurate information on the gear types used by state permit holders in the future, the numbers will be updated to reflect this change. For additional information on fishing effort in fisheries found on Table 1 or 2, contact the relevant regional office (contact information included above in SUPPLEMENTARY INFORMATION).

For high seas fisheries, Table 3 lists the number of valid HSFCA permits currently held. Although this likely overestimates the number of active participants in many of these fisheries, the number of valid HSFCA permits is the most reliable data on the potential effort in high seas fisheries at this time. As noted previously in this rule, the number of HSFCA permits listed in Table 3 for the high seas components of fisheries that also operate within U.S. waters does not necessarily represent additional effort that is not accounted for in Tables 1 and 2. Many vessels holding HSFCA permits also fish within U.S. waters and are included in the number of vessels and participants operating within those fisheries in Tables 1 and 2.

Tables 1, 2, and 3 also list the marine mammal species and/or stocks incidentally killed or injured (seriously or non-seriously) in each fishery based on SARs, injury determination reports, bycatch estimation reports, observer data, logbook data, stranding data, disentanglement network data, fisher self-reports (i.e., MMPA reports), and anecdotal reports. The best available scientific information included in these reports is based on data through 2012. This list includes all species and/or stocks known to be killed or injured in a given fishery but also includes species and/or stocks for which there are anecdotal records of a mortality or injury. Additionally, species identified by logbook entries, stranding data, or fishermen self-reports (i.e., MMPA reports) may not be verified. In Tables 1 and 2, NMFS has designated those species/stocks driving a fishery's classification (i.e., the fishery is classified based on mortalities and serious injuries of a marine mammal stock that are greater than or equal to 50 percent [Category I], or greater than 1 percent and less than 50 percent [Category II], of a stock's PBR) by a “1” after the stock's name.

In Tables 1 and 2, there are several fisheries classified as Category II that have no recent documented mortalities or serious injuries of marine mammals, or fisheries that did not result in a mortality or serious injury rate greater than 1 percent of a stock's PBR level based on known interactions. NMFS has classified these fisheries by analogy to other Category I or II fisheries that use similar fishing techniques or gear that are known to cause mortality or serious injury of marine mammals, as discussed in the final LOF for 1996 (60 FR 67063, December 28, 1995), and according to factors listed in the definition of a “Category II fishery” in 50 CFR 229.2 (i.e., fishing techniques, gear types, methods used to deter marine mammals, target species, seasons and areas fished, qualitative data from logbooks or fisher reports, stranding data, and the species and distribution of marine mammals in the area). NMFS has designated those fisheries listed by analogy in Tables 1 and 2 by a “2” after the fishery's name.

There are several fisheries in Tables 1, 2, and 3 in which a portion of the fishing vessels cross the exclusive economic zone (EEZ) boundary and therefore operate both within U.S. waters and on the high seas. These fisheries, though listed separately between Table 1 or 2 and Table 3, are considered the same fisheries on either side of the EEZ boundary. NMFS has designated those fisheries in each table by a “*” after the fishery's name.

The Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) at the proposed rule stage that this rule would not have a significant economic impact on a substantial number of small entities. No comments were received on that certification, and no new information has been discovered to change that conclusion. Accordingly, no regulatory flexibility analysis is required, and none has been prepared.

This rule contains collection-of-information requirements subject to the Paperwork Reduction Act. The collection of information for the registration of individuals under the MMPA has been approved by the Office of Management and Budget (OMB) under OMB control number 0648-0293 (0.15 hours per report for new registrants and 0.09 hours per report for renewals). The requirement for reporting marine mammal mortalities or injuries has been approved by OMB under OMB control number 0648-0292 (0.15 hours per report). These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding these reporting burden estimates or any other aspect of the collections of information, including suggestions for reducing burden, to NMFS and OMB (see ADDRESSES and SUPPLEMENTARY INFORMATION).

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

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

An environmental assessment (EA) was prepared under the National Environmental Policy Act (NEPA) in 1995 and 2005. The 1995 EA examined the effects of regulations implementing section 118 of the 1994 Amendments of the MMPA on the affected environment. The 2005 EA analyzed the environmental impacts of continuing the existing scheme (as described in the 1995 EA) for classifying fisheries on the LOF. The 1995 EA and the 2005 EA concluded that implementation of MMPA section 118 regulations would not have a significant impact on the human environment. NMFS reviewed the 2005 EA in 2009. NMFS concluded that because there were no changes to the process used to develop the LOF and implement section 118 of the MMPA, there was no need to update the 2005 EA. This rule would not change NMFS's current process for classifying fisheries on the LOF; therefore, this rule is not expected to change the analysis or conclusion of the 2005 EA and FONSI, and no update is needed. If NMFS takes a management action, for example, through the development of a TRP, NMFS would first prepare an environmental document, as required under NEPA, specific to that action.

This rule would not affect species listed as threatened or endangered under the Endangered Species Act (ESA) or their associated critical habitat. The impacts of numerous fisheries have been analyzed in various biological opinions, and this rule will not affect the conclusions of those opinions. The classification of fisheries on the LOF is not considered to be a management action that would adversely affect threatened or endangered species. If NMFS takes a management action, for example, through the development of a TRP, NMFS would consult under ESA section 7 on that action.

This rule would have no adverse impacts on marine mammals and may have a positive impact on marine mammals by improving knowledge of marine mammals and the fisheries interacting with marine mammals through information collected from observer programs, stranding and sighting data, or take reduction teams.

This rule would not affect the land or water uses or natural resources of the coastal zone, as specified under section 307 of the Coastal Zone Management Act.