Federal Register Vol. 83, No.26,

As described in FAA Advisory Circular 120-104 (http://www.faa.gov/documentLibrary/media/Advisory_Circular/120-104.pdf), several programs have been developed to support initiatives that will ensure the continued airworthiness of aging airplane structure. The last element of those initiatives is the requirement to establish a limit of validity (LOV) of the engineering data that support the structural maintenance program under 14 CFR 26.21. This AD is the result of an assessment of the previously established programs by the design approval holder (DAH) during the process of establishing the LOV for the affected airplanes. The actions specified in this AD are necessary to complete certain programs to ensure the continued airworthiness of aging airplane structure and to support an airplane reaching its LOV.

We issued AD 2005-19-28, Amendment 39-14293 (70 FR 57493, October 3, 2005) (“AD 2005-19-28”), which applied to certain Airbus Model A330-301, -321, -322, -341, and -342 airplanes; and Model A340-200 and A340-300 series airplanes. AD 2005-19-28 was prompted by a report that, during fatigue tests of the wing, cracks were found in the vertical web of the rear spar between ribs 1 and 2 having initiated at the build slot. AD 2005-19-28 required repetitive inspections for cracks in the aft face of the rear spar at the area adjacent to the bolt holes and the end of the build slot, and repair if necessary. AD 2005-19-28 also provided an optional terminating action for the repetitive inspections. We issued AD 2005-19-28 to detect and correct fatigue cracking in the vertical web of the wing rear spar, which could result in reduced structural integrity of the wing.

Since we issued AD 2005-19-28, a new fatigue and damage tolerance assessment was done, taking into account airplane utilization and widespread fatigue damage analysis. This analysis led to the determination that several compliance thresholds and intervals needed to be reduced. We have also determined that the unsafe condition is not applicable to Airbus Model A330-341 airplanes.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2013-0101, dated April 30, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-301, -321, -322, and -342 airplanes; and Model A340-200 and A340-300 series airplanes. The MCAI states:

You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0069.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.

Since there are currently no domestic operators of this product, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0069; Product Identifier 2013-NM-090-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on those comments.

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

Currently, there are no affected U.S.-registered airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition, and doing the actions specified in those instructions. Based on the actions specified in the MCAI AD, we are providing the following cost estimates for an affected airplane that is placed on the U.S. Register in the future:

We estimate the following costs to do any necessary on-condition repairs that would be required based on the results of the required actions:

We acknowledge that since the above actions are retained from AD 2005-19-28, but with reduced threshold and intervals, operators would essentially revise their maintenance or inspection program, as applicable, to incorporate the reduced threshold and intervals. We estimate the revision to an operator's maintenance and inspection program would take approximately 1 work-hour × $85 per hour.

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-0164, dated August 10, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A321-211 and -231 airplanes. The MCAI states:

You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0070.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

Since there are currently no domestic operators of this product, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0070; Product Identifier 2015-NM-146-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on those comments.

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

Currently, there are no affected U.S.-registered airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition, and doing the actions specified in those instructions. Based on the actions specified in the MCAI AD, we are providing the following cost estimates for an affected airplane that is placed on the U.S. Register in the future:

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Discussion

We issued AD 2015-02-18, Amendment 39-18085 (80 FR 5020, January 30, 2015) (“AD 2015-02-18”), which applied to all Airbus Model A330-201, -202, -203, -301, -302, and -303 airplanes. AD 2015-02-18 was prompted by a report of one bolt on the aft engine mount upper beam found totally broken. AD 2015-02-18 required a one-time ultrasonic inspection for fractures of all aft mount-pylon bolts of each engine. We issued AD 2015-02-18 to detect and correct fracture of the aft mount-pylon bolts, which could result in failure of the engine mount and consequent detachment of the engine.

Since we issued AD 2015-02-18, further investigation showed that the pylon bolt failure was caused by inappropriate upper beam installation during production. We have determined that repetitive inspections are necessary to address the unsafe condition.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-0126, dated July 1, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200 and -300 series airplanes. The MCAI states:

You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0029.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

Since there are currently no domestic operators of this product, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0029; Product Identifier 2015-NM-132-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on those comments.

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

Currently, there are no affected U.S.-registered airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition, and doing the actions specified in those instructions. Based on the actions specified in the MCAI AD, we are providing the following cost estimates for an affected airplane that is placed on the U.S. Register in the future:

We estimate the following costs to do any necessary on-condition repairs that would be required based on the results of the required actions:

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2014-0161, dated July 10, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-202, -203, -223, and -243 airplanes; and Model A340-211, -212, -311, and -313 airplanes. The MCAI states:

You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0030.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.

Since there are currently no domestic operators of this product, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0030; Product Identifier 2014-NM-161-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on those comments.

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

Currently, there are no affected U.S.-registered airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition, and doing the actions specified in those instructions. Based on the actions specified in the MCAI AD, we are providing the following cost estimates for an affected airplane that is placed on the U.S. Register in the future:

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

On February 28, 2017, the Commission issued an Annual Update to Fee Schedule for the Use of Government Lands for Hydropower Licensees in the above-captioned proceeding. Pursuant to Annual Charges for the Use of Government Lands in Alaska, Order No. 838, 83 FR 1 (Jan. 2, 2018), FERC Stats. & Regs. ¶ 61,281 (2017), this document updates the per-acre rental fees for the State of Alaska, as reflected in the caption below.

Accordingly, 18 CFR part 11 is corrected by making the following correcting amendment:

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

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-2016-0650 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 April 9, 2018. 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-2016-0650, 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 April 10, 2017 (82 FR 17175) (FRL-9959-61), 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 6E8516) by Interregional Research Project No. 4 (IR-4) Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201, W, Princeton, NJ 08540. The petition requested that 40 CFR 180.650 be amended by establishing tolerances for residues of the herbicide isoxaben, N-[3-(1-ethyl-1-methylpropyl)-5-isoxazolyl]-2, 6-dimethoxybenzamide, in or on the raw agricultural commodities apple at 0.01 parts per million (ppm); the bushberry subgroup 13-07B at 0.01 ppm; the fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; and the nut, tree, group 14-12 at 0.02 ppm. The petition also requested to remove the tolerances in 40 CFR 180.650 in or on the raw agricultural commodities grape at 0.01 ppm; nut, tree, group 14 at 0.02 ppm; and pistachio at 0.02 ppm. That document referenced a summary of the petition prepared by Dow AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

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

Isoxaben shows low acute toxicity by all routes. In chronic oral studies, the liver (mouse) and kidney (rat) were target organs, and decreased body weight was observed in the rat, mouse, and dog. There was no indication of neurotoxicity or immunotoxicity. No evidence of increased susceptibility was observed in the rat or rabbit developmental toxicity studies, but was observed in the rat reproductive toxicity study only at the limit dose.

Isoxaben is currently classified as having “suggestive evidence of carcinogenic potential,” based on the presence of liver tumors in male and female mice. Because the tumors were benign and observed at dose levels exceeding the limit dose of 1,000 mg/kg/day and there was low concern for genotoxicity, the cRfD is considered protective of potential carcinogenicity and a quantitative assessment of cancer risk was not conducted.

Specific information on the studies received and the nature of the adverse effects caused by isoxaben 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 title “Isoxaben. Aggregate Human Health Risk Assessment to Support Proposed New Uses on Bushberry Subgroup 13-07B and Apple, Crop Group Conversion (Tree Nut Group 14-12), and Crop Group Expansion (Small Vine Climbing Fruit Except Fuzzy Kiwifruit Subgroup 13-07F)” on pages 26-31 in docket ID number EPA-HQ-OPP-2016-0650.

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 isoxaben used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isoxaben, EPA considered exposure under the petitioned-for tolerances as well as all existing isoxaben tolerances in 40 CFR 180.650. EPA assessed dietary exposures from isoxaben 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.

No such effects were identified in the toxicological studies for isoxaben; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from the US 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, EPA assumed tolerance-level residues and 100 percent crop treated (PCT).

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 isoxaben. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for isoxaben. Tolerance-level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for isoxaben in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of isoxaben. 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 Surface Water Concentration Calculator (SWCC v1.106) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of isoxaben for chronic exposures are estimated to be 43.6 parts per billion (ppb) for surface water and 909 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the water concentration value of 909 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).

Isoxaben is currently registered for the following uses that could result in residential exposures: Residential turf. EPA assessed residential exposure using the following assumptions: Isoxaben residential uses constitute short- and intermediate-term exposure scenarios. For residential handlers, since a dermal endpoint was not selected, the only route of exposure quantitatively assessed for adult handlers is through inhalation. For post-application exposures, only intermediate-term incidental oral exposures for children were assessed due to the persistence of isoxaben residues in soil. Neither a short-term dermal nor short-term incidental oral endpoint was selected for children. Although there is potential for post-application inhalation exposure of both adults and children, the estimated exposure is anticipated to be negligible; therefore, a quantitative post-application inhalation assessment was not required.

For the purpose of performing an aggregate assessment, the Agency selected only the most conservative, or worst-case, residential adult and child scenarios to be included in the aggregate, based on the lowest overall MOE (highest exposure estimates). For adults, handler inhalation exposure resulting from the application of a granular formulation of isoxaben to residential lawns via push-type spreader has been used to estimate adult aggregate exposure. (The inhalation exposure was added to background exposure from food and water, and compared to the short-term inhalation POD.) Post-application risks for adults in residential settings were not assessed due to the lack of a dermal endpoint.

For children, an intermediate-term aggregate assessment was conducted by adding the incidental soil ingestion exposure, and average food and water exposure (chronic dietary exposure). The incidental oral residential exposure value selected for the aggregate analysis is based on children ingesting soil particles containing pesticide residues while playing on treated turf. Due to the persistence of isoxaben in the soil, the Agency used a conservative approach by using the maximum seasonal application rate for estimating soil ingestion by children rather than the standard maximum single application rate. This scenario resulted in the highest calculated exposure levels; therefore, it is protective for all other oral post-application exposure and risk for children in residential settings.

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 isoxaben to share a common mechanism of toxicity with any other substances, and isoxaben does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isoxaben 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 website 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 Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. No evidence of increased susceptibility was observed in the rat or rabbit developmental toxicity studies, but was observed in the rat reproductive toxicity study only at the limit dose.

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 isoxaben is adequately complete to allow the Agency to assess the toxicological profile of isoxaben.

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

iii. No evidence of increased susceptibility was observed in the rat or rabbit developmental toxicity studies, but was observed in the rat reproductive toxicity study only at the limit dose; however, this risk assessment is protective of the susceptibility observed at the limit dose in the reproductive toxicity study.

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. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to isoxaben in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by isoxaben.

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, isoxaben is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isoxaben from food and water will utilize 98% of the cPAD for all infants less than 1-year old, 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 isoxaben 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).

Isoxaben 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 isoxaben.

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 an aggregate MOE of 6,700 for females 13-49 years old. Because EPA's level of concern for isoxaben is a MOE of 100 or below, this MOE is 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).

Isoxaben is currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to isoxaben.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in an aggregate MOE of 7,200 for children 1-2 years old. Because EPA's level of concern for isoxaben is a MOE of 100 or below, this MOE is not of concern.

5. Aggregate cancer risk for U.S. population. Based on the discussion in Unit III.A., EPA considers the chronic aggregate risk assessment to be protective of any aggregate cancer risk. As there is no chronic risk of concern, EPA does not expect any cancer risk to the U.S. population from aggregate exposure to isoxaben.

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 isoxaben residues.

An adequate residue analytical method (RAM) utilizing liquid chromatography with tandem mass spectrometric detection (LC/MS/MS), GRM 02.26.S.1 (a revision of GRM 02.26), is available for enforcement of isoxaben residues in crop 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 any MRLs for isoxaben.

Seven comments were received in response to the notice of filing. All of the comments were general in nature, not specific to the chemical isoxaben. They included statements such as “I am not in favor of relaxing requirements on pesticides,” “I am opposed to this proposal,” and “My body doesn't live well on pesticides.”

The Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops; however, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. These citizens' comments appear to be directed at the underlying statute and not EPA's implementation of it; the citizens have made no contention that EPA has acted in violation of the statutory framework nor have they provided any specific information or allegation that would support a finding that these tolerances are unsafe.

Therefore, tolerances are established for residues of isoxaben including its metabolites and degradates, in or on apple at 0.01 ppm; the bushberry subgroup 13-07B at 0.01 ppm; the fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; and the nut, tree, group 14-12 at 0.02 ppm. In addition, the following existing tolerances are removed since they are superseded by the new tolerances: Grape, nut, tree, group 14; and pistachio.

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); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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-2015-0629 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 April 9, 2018. 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-2015-0629, 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 October 21, 2015 (80 FR 63731) (FRL-9935-29), 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 5E8395) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR 180.433 be amended by establishing tolerances for residues of fomesafen, 5-[2-cloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide in or on the following raw agricultural commodities: Vegetable, tuberous and corm, subgroup 1C at 0.025 parts per million (ppm); berry, low growing subgroup 13-07G except cranberry at 0.02 ppm; and vegetable, legume group 6 at 0.05 ppm. The petition also requested to amend 40 CFR 180.433 by removing the existing tolerances on the raw agricultural commodities bean, dry at 0.05 ppm; bean, snap, succulent at 0.05 ppm; bean Lima, succulent at 0.05 ppm; pea, succulent at 0.025 ppm; potato at 0.025 ppm; soybean at 0.05 ppm; and soybean, vegetable succulent at 0.05 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

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 fomesafen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fomesafen 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 primary target organs of fomesafen are the liver and hematological system. Generally, hyalinization of hepatocytes provided the most sensitive toxicological endpoint (intermediate, and long term) in mammals. In the subchronic and chronic toxicity studies in rats and mice, food consumption, food efficiency, body weight, body weight gain, and histopathological changes in the liver were parameters that were most often affected. In addition, dogs, rats, and mice also showed hematological changes (e.g., decreased erythrocyte count, hemoglobin, or hematocrit). No progression of hematological effects was observed beyond 90 days. Neurotoxicity (decreased motor activity) was observed at doses above those causing liver toxicity or impacting hematological parameters. Post-implantation loss was noted in the developmental study, but no quantitative or qualitative evidence of increased susceptibility was seen following in utero exposure to rats or rabbits in developmental studies or in the reproduction study. As the etiology of the post-implantation loss is unknown, it is considered to be both a maternal and fetal endpoint. Fomesafen can result in suppression of anti-SRBC IgM response; however, this immunotoxic potential was noted only at high doses.

Carcinogenicity was not observed in the rat chronic toxicity/carcinogenicity study. Liver tumors were produced in the mouse carcinogenicity study; however, the Agency determined that fomesafen should be classified as “Not Likely to be Carcinogenic to Humans.” This decision was based on the weight-of-evidence which supports activation of peroxisome proliferator-activated receptor alpha (PPARα) as the mode of action for fomesafen-induced hepatocarcinogenesis in mice. Fomesafen was not considered to be mutagenic.

Specific information on the studies received and the nature of the adverse effects caused by fomesafen 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 “Fomesafen: Draft Human Health Risk Assessment for Registration Review and for the Section 3 Registration Action on Tuberous and Corm Vegetables (Crop Group 1C), Legume Vegetable (Crop Group 6) and Low Growing Berry (Except Cranberry) (Crop Group 13-07G)” on pages 36-45 in docket ID number EPA-HQ-OPP-2015-0629.

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 fomesafen used for human risk assessment is shown in the Table of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fomesafen, EPA considered exposure under the petitioned-for tolerances as well as all existing fomesafen tolerances in 40 CFR 180.433. EPA assessed dietary exposures from fomesafen 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 fomesafen. In estimating acute dietary exposure, EPA used 2003-2008 food consumption data from the U.S. 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, EPA assumed tolerance level residues and 100 percent crop treated (PCT).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance level residues and 100 PCT.

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

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for fomesafen. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fomesafen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fomesafen. 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 Pesticide in Water Calculator (PWC) model (Version 1.52) the estimated drinking water concentrations (EDWCs) of fomesafen for acute exposures are estimated to be 168 parts per billion (ppb) and for chronic exposures are estimated to be 125 ppb. These modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

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).

Fomesafen is not registered for any specific use patterns that would result in residential exposure.

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 fomesafen to share a common mechanism of toxicity with any other substances, and fomesafen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fomesafen 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 website 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 Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility of rat fetuses to in utero exposure to fomesafen. Post-implantation loss was observed in the rat developmental toxicity study. However, as the etiology of the effect is unknown, it is considered to be a part of both a maternal and fetal effect. The 2-generation reproduction study in rats did not show evidence of increased susceptibility to fomesafen. Although the developmental toxicity study in rabbits was classified as unacceptable due to mortality from bacterial infections, there was adequate information to show that there was no evidence of increased susceptibility of rabbit fetuses due to the treatment with fomesafen.

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 toxicology database for fomesafen is complete and sufficient for assessing potential susceptibility to infants and children. Although the developmental toxicity study in rabbits was classified unacceptable due to mortality from bacterial infections, there was no evidence of increased susceptibility of rabbit fetuses due to the treatment with fomesafen. Therefore, the lack of an acceptable developmental toxicity study in non-rodents is not considered a data gap.

ii. There is no need for a developmental neurotoxicity study or a need to retain the FQPA SF to account for the lack of such study. Decreased motor activity (horizontal and vertical activity and time in central quadrant) was observed in male rats in the acute neurotoxicity screening battery. In the subchronic neurotoxicity test, neither general systemic toxicity nor neurotoxicity was observed at the highest dose tested. All points of departure used in the risk assessment are protective of potential neurotoxicity.

iii. There is no evidence that fomesafen results in increased susceptibility in in utero rats in the prenatal developmental studies or in young rats in the 2-generation reproduction study. Although the developmental toxicity study in rabbits was classified as unacceptable due to mortality from bacterial infections, there was adequate information to show that there was no evidence of increased susceptibility of rabbit fetuses due to the treatment with fomesafen.

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. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fomesafen in drinking water. These assessments will not underestimate the exposure and risks posed by fomesafen.

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 fomesafen will occupy 2.9% of the aPAD for all infants less than 1-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 fomesafen from food and water will utilize 70% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure. There are no residential uses for fomesafen.

3. Short- and Intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Both short- and intermediate-term adverse effects were identified; however, fomesafen is not registered for any use patterns that would result in either short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or 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 either short- or intermediate-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for fomesafen.

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

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

Adequate residue analytical methods are available for the purpose of fomesafen tolerance enforcement for plant commodities. A high performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS) method (GRM045.01A) has previously been submitted as an enforcement method. The method uses extraction procedures similar to previous methods, SPE cleanup procedures, and the final determination step by LC/MS/MS for analysis of fomesafen residues. The validated limit of quantitation (LOQ) of the method is 0.02 ppm.

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 any MRLs for fomesafen.

Two comments were received in response to the notice of filing. The first was related to a different chemical, azoxystrobin, and is therefore not relevant to this action. The second was from the Center for Biological Diversity and centered primarily around impacts on endangered and threatened species. This comment is not relevant to the Agency's evaluation of safety of the fomesafen tolerances under section 408 of the FFDCA, which requires the Agency to evaluate the potential harms to human health, not effects on the environment.

Therefore, tolerances are established for residues of fomesafen, including its metabolites and degradates, in or on the following commodities: Berry, low growing, subgroup 13-07G, except cranberry at 0.02 ppm; vegetable, legume, group 6 at 0.05 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.025 ppm. In addition, the following existing tolerances are removed as unnecessary since they are superseded by the newly established tolerances: Bean, dry at 0.05 ppm; bean, lima, succulent at 0.05 ppm; bean, snap, succulent at 0.05 ppm; pea, succulent at 0.025 ppm; potato at 0.025 ppm; soybean at 0.05 ppm; and soybean, vegetable, succulent at 0.05 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

The following outline is provided to aid in locating information in this preamble.

The EPA is amending 40 CFR 241.4(a) to list additional non-hazardous secondary materials (NHSMs) as categorical non-waste fuels under the authority of sections 2002(a)(1) and 1004(27) of the Resource Conservation and Recovery Act (RCRA), as amended, 42 U.S.C. 6912(a)(1) and 6903(27). Section 129(a)(1)(D) of the Clean Air Act (CAA) directs the EPA to establish standards for Commercial and Industrial Solid Waste Incinerators (CISWI), which burn solid waste. Section 129(g)(6) of the CAA provides that the term “solid waste” is to be established by the EPA under RCRA (42 U.S.C. 7429(g)(6)). Section 2002(a)(1) of RCRA authorizes the Agency to promulgate regulations as are necessary to carry out its functions under the Act. The statutory definition of “solid waste” is stated in RCRA section 1004(27).

Categories and entities potentially affected by this action, either directly or indirectly, include, but may not be limited to the following:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities potentially impacted by this action. This table lists examples of the types of entities of which EPA is aware that could potentially be affected by this action. Other types of entities not listed could also be affected. To determine whether your facility, company, business, organization, etc., is affected by this action, you should examine the applicability criteria in this rule. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

The RCRA statute defines “solid waste” as “any garbage, refuse, sludge from a waste treatment plant, water supply treatment plant, or air pollution control facility and other discarded material . . . resulting from industrial, commercial, mining, and agricultural operations, and from community activities.” (RCRA section 1004(27) (emphasis added)). The key concept is that of “discard” and, in fact, this definition turns on the meaning of the phrase, “other discarded material,” since this term encompasses all other examples provided in the definition.

The meaning of “solid waste,” as defined under RCRA, is of particular importance as it relates to section 129 of the CAA. If material is a solid waste, under RCRA, a combustion unit burning it is required to meet the CAA section 129 emission standards for solid waste incineration units. If the material is not a solid waste, combustion units are required to meet the CAA section 112 emission standards for commercial, industrial, and institutional boilers, or if the combustion unit is a cement kiln, the CAA 112 standards for Portland cement kilns. Under CAA section 129, the term “solid waste incineration unit” is defined, in pertinent part, to mean “a distinct operating unit of any facility which combusts any solid waste material from commercial or industrial establishments.” 42 U.S.C. 7429(g)(1). CAA section 129 further states that the term “solid waste” shall have the meaning “established by the Administrator pursuant to the Solid Waste Disposal Act.” Id at 7429(g)(6). The Solid Waste Disposal Act, as amended, is commonly referred to as the Resource Conservation and Recovery Act or RCRA.

Regulations concerning NHSMs used as fuels or ingredients in combustion units are codified in 40 CFR part 241.1 This action amends the part 241 regulations by adding three NHSMs, summarized below, to the list of categorical non-waste fuels codified in § 241.4(a):

(1) Creosote-borate treated railroad ties, and mixtures of creosote, borate and/or copper naphthenate treated railroad ties that are processed and then combusted in:

(i) Units designed to burn both biomass and fuel oil as part of normal operations and not solely as part of start-up or shut-down operations, and

(ii) Units at major source pulp and paper mills or power producers subject to 40 CFR part 63, subpart DDDDD, designed to burn biomass and fuel oil as part of normal operations and not solely as part of start-up or shut-down operations, but are modified in order to use natural gas instead of fuel oil. The creosote-borate and mixed creosote, borate and copper naphthenate treated railroad ties may continue to be combusted as product fuel only if certain conditions are met, which are intended to ensure that such railroad ties are not being discarded.

(iii) Units meeting requirements in (i) or (ii) that are also designed to burn coal.

(2) Copper naphthenate treated railroad ties that are processed and then combusted in units designed to burn biomass, biomass and fuel oil, or biomass and coal.

(3) Copper naphthenate-borate treated railroad ties that are processed and then combusted in units designed to burn biomass, biomass and fuel oil, or biomass and coal.

The Administrative Procedure Act requires publication of a substantive rule 30 days or more before the effective date unless one of the following conditions in 5 U.S.C. 553(d) are met:

(1)A substantive rule which grants or recognizes an exemption or relieves a restriction;

(2) interpretative rules and statements of policy; or

(3) as otherwise provided by the agency for good cause found and published with the rule.

The Agency first solicited comments on how the RCRA definition of solid waste should apply to NHSMs when used as fuels or ingredients in combustion units in an advanced notice of proposed rulemaking (ANPRM), which was published in the Federal Register on January 2, 2009 (74 FR 41). We then published an NHSM proposed rule on June 4, 2010 (75 FR 31844), which the EPA made final on March 21, 2011 (76 FR 15456).

In the March 21, 2011 (76 FR 15456) rule, the EPA finalized standards and procedures to be used to identify whether NHSMs are solid wastes when used as fuels or ingredients in combustion units. “Secondary material” was defined for the purposes of that rulemaking as any material that is not the primary product of a manufacturing or commercial process, and can include post-consumer material, off-specification commercial chemical products or manufacturing chemical intermediates, post-industrial material, and scrap (codified in 40 CFR 241.2). “Non-hazardous secondary material” is a secondary material that, when discarded, would not be identified as a hazardous waste under 40 CFR part 261 (codified in 40 CFR 241.2). Traditional fuels, including historically managed traditional fuels (e.g., coal, oil, natural gas) and “alternative” traditional fuels (e.g., clean cellulosic biomass) are not secondary materials and thus, are not solid wastes under the rule unless discarded (codified in 40 CFR 241.2).

A key concept under the March 21, 2011 rule is that NHSMs used as non-waste fuels and ingredients in combustion units must meet the legitimacy criteria specified in 40 CFR 241.3(d)(1). Application of the legitimacy criteria helps ensure that the fuel product is being legitimately and beneficially used and not simply being discarded through combustion (i.e., via sham recycling). To meet the legitimacy criteria, the NHSM must be managed as a valuable commodity, have a meaningful heating value and be used as a fuel in a combustion unit that recovers energy, and contain contaminants or groups of contaminants 2 at concentrations comparable to (or lower than) those in traditional fuels which the combustion unit is designed to burn. For NHSMs used as an ingredient, in addition to the other listed criteria, the ingredient must be used to make a valuable product.

Based on these criteria, the March 21, 2011 rule identified the following NHSMs as not being solid wastes:

• The NHSM is used as a fuel and remains under the control of the generator (whether at the site of generation or another site the generator has control over) that meets the legitimacy criteria (40 CFR 241.3(b)(1));

• The NHSM is used as an ingredient in a manufacturing process (whether by the generator or outside the control of the generator) that meets the legitimacy criteria (40 CFR 241.3(b)(3));

• Discarded NHSM that has been sufficiently processed to produce a fuel or ingredient that meets the legitimacy criteria (40 CFR 241.3(b)(4)); or

• Through a case-by-case petition process, it has been determined that the NHSM handled outside the control of the generator has not been discarded and is indistinguishable in all relevant aspects from a fuel product, and meets the legitimacy criteria (40 CFR 241.3(c)).

In October 2011, the Agency announced it would be initiating a new rulemaking proceeding to revise certain aspects of the NHSM rule.3 On February 7, 2013, the EPA published a final rule, which addressed specific targeted amendments and clarifications to the 40 CFR part 241 regulations (78 FR 9112). These revisions and clarifications were limited to certain issues on which the Agency had received new information, as well as targeted revisions that the Agency believed were appropriate in order to allow implementation of the rule as the EPA originally intended. The amendments modified 40 CFR 241.2 and 241.3, added 40 CFR 241.4, and included the following: 4

• Revised Definitions: The EPA revised three definitions discussed in the proposed rule: (1) “Clean cellulosic biomass,” (2) “contaminants,” and (3) “established tire collection program.” In addition, based on comments received on the proposed rule, the Agency revised the definition of “resinated wood.”

• Contaminant Legitimacy Criterion for NHSMs Used as Fuels: The EPA issued revised contaminant legitimacy criterion for NHSMs used as fuels to provide additional details on how contaminant-specific comparisons between NHSMs and traditional fuels may be made.

• Categorical Non-Waste Determinations for Specific NHSMs Used as Fuels. The EPA codified determinations that certain NHSMs are non-wastes when used as fuels. If a material is categorically listed as a non-waste fuel, persons that generate or burn these NHSMs will not need to make individual determinations, as required under the existing rules, that these NHSMs meet the legitimacy criteria. Except where otherwise noted, combustors of these materials will not be required to provide further information demonstrating their non-waste status. Based on all available information, the EPA determined the following NHSMs are not solid wastes when burned as a fuel in combustion units and categorically listed them in 40 CFR 241.4(a).5

You may be affected by this final rule if you manufacture (including import), sell, supply, offer for sale, test, or work with certification firms that certify hardwood plywood, medium-density fiberboard, particleboard, and/or products containing these composite wood materials in the United States. 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:

• Veneer, plywood, and engineered wood product manufacturing (NAICS code 3212).

• Manufactured home (mobile home) manufacturing (NAICS code 321991).

• Prefabricated wood building manufacturing (NAICS code 321992).

• Furniture and related product manufacturing (NAICS code 337).

• Furniture merchant wholesalers (NAICS code 42321).

• Lumber, plywood, millwork, and wood panel merchant wholesalers (NAICS code 42331).

• Other construction material merchant wholesalers (NAICS code 423390), e.g., merchant wholesale distributors of manufactured homes (i.e., mobile homes) and/or prefabricated buildings.

• Furniture stores (NAICS code 4421).

• Building material and supplies dealers (NAICS code 4441).

• Manufactured (mobile) home dealers (NAICS code 45393).

• Motor home manufacturing (NAICS code 336213).

• Travel trailer and camper manufacturing (NAICS code 336214).

• Recreational vehicle (RV) dealers (NAICS code 441210).

• Recreational vehicle merchant wholesalers (NAICS code 423110).

• Engineering services (NAICS code 541330).

• Testing laboratories (NAICS code 541380).

• Administrative management and general management consulting services (NAICS code 541611).

• All other professional, scientific, and technical services (NAICS code 541990).

• All other support services (NAICS code 561990).

• Business associations (NAICS code 813910).

• Professional organizations (NAICS code 813920).

If you have any questions regarding the applicability of this action, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

Following the publication of a Notice of Proposed Rulemaking (see 78 FR 34796 and 78 FR 34820) and promulgation of EPA's December 12, 2016 final rule addressing formaldehyde emission standards for composite wood products (81 FR 89674), multiple voluntary consensus standards that were incorporated by reference have been updated or withdrawn and superseded. EPA is incorporating by reference into the regulations at 40 CFR part 770 current versions of the voluntary consensus standards assembled by:

• APA—the Engineered Wood Association,

• Composite Panel Association (CPA),

• American National Standards Institute (ANSI),

• American Society for Testing and Materials (ASTM),

• International Organization for Standardization (ISO),

• Japanese Standards Association (JIS), and

• National Institute of Standards and Technology (NIST).

EPA is taking action to update several voluntary consensus standards in the formaldehyde emission standards for composite wood products final rule to reflect the current editions that are in-use by regulated entities and industry stakeholders. EPA believes that this action is warranted to facilitate regulated entities using the most up-to-date voluntary consensus standards to comply with the final rule.

1. Direct final rule and notice of proposed rulemaking. The Agency published a direct final rule on October 25, 2017 (82 FR 49287) to update several voluntary consensus standards that since publication of the December 12, 2016 final rule, have been updated, superseded, or withdrawn. Additionally, the action would have updated an existing regulatory provision regarding the correlation of quality control test methods. The Agency solicited public comment on a parallel proposed action by issuing a companion Notice of Proposed Rulemaking (82 FR 49308) with the direct final rule. If EPA received adverse public comment and had to withdraw the direct final rule, this parallel proposed action would continue. EPA received six comments on this action; three comments were not germane to the action, two were supportive, and one of which the Agency considered to be adverse; thus, the direct final rule was withdrawn on December 8, 2017, as published in the Federal Register (82 FR 57874).

Having withdrawn the direct final rule, EPA is taking action based on the companion Notice of Proposed Rulemaking (NPRM), which includes consideration of all public comments submitted in response to the provisions discussed in the direct final rule and companion proposal. EPA is issuing this final rule and a Response to Comments document which addresses all of the comments received on this action. The response to comments document can be found in the supporting documents section of the final rule section of the docket for this action.

2. Final rule. EPA is updating the references for multiple voluntary consensus standards that were incorporated by reference into the formaldehyde emission standards for composite wood products regulations (40 CFR part 770) because they have been updated, superseded, or withdrawn by their respective organization, as proposed in the companion NPRM. Table 1 of this preamble outlines only the voluntary consensus standards being addressed in this rulemaking and their respective updated versions. Under 1 CFR part 51, the Director of the Federal Register indefinitely approves specific versions of individual standards for use in clearly identified sections. The incorporation by reference of any other voluntary consensus standard in part 770 remains unchanged. EPA would need to initiate additional rulemaking to change any material incorporated by reference in the part, including adding, updating, or removing standard.

EPA adopts all of the updated versions of the standards referenced in Table 1 in this rule. Any future versions or updates to withdrawn/superseded standards will be announced by EPA through a separate Federal Register document with opportunity for public comment.

EPA is also taking final action on several technical corrections to references to the ISO/IEC 17020:2012(E) in the testing correlation requirements under § 770.20, as discussed below. The Agency did not receive any adverse comment related specifically to these technical corrections.

EPA received approval to incorporate ISO/IEC 17020: 2012(E) by reference into part 770, as part of the December 2016 final rule, instead of the 1998 version that was originally proposed. However, that updated version was not reflected everywhere in that published rule. This rule corrects those remaining instances and ensures that all of the references are to the version of the standard that is approved for incorporation by reference.

EPA is also finalizing a revision at § 770.20(d)(2)(i) to allow the correlation of the tests conducted through the quality control methods listed in § 770.20(b) to either ASTM E1333-14 or, upon a showing of equivalence, ASTM D6007-14 test chamber tests. The California Air Resources Board (CARB) under its Air Toxic Control Measure (ATCM) has approved the use of ASTM D6007-14 test chambers that have previously shown equivalence under § 770.20(d) to an ASTM E1333-14 test chamber to be correlated to other mill quality control method tests listed in § 770.20(b). According to CARB staff, this is the commonly used method for conducting correlation between test methods. Several third-party certifiers, regulated entities and their associations expressed the importance of allowing mill quality control tests to be correlated to ASTM D6007-14 test chambers as they currently operate under the CARB ATCM using this approach and not allowing test chamber correlation in this manner under TSCA Title VI would significantly disrupt product certifications and supply chain processes. EPA agrees that significant disruptions would occur, including problems with completing testing which would lead to significant shortfalls in supply of TSCA Title VI certified product if the correlation of mill quality control tests were allowed only through the use of ASTM E1333-14 test chambers. Additionally, based on consultations with the CARB staff, allowing correlation to be established through the use of ASTM D6007-14 test chambers in addition to the ASTM E1333-14 test chambers does not result in a decrease in testing reliability and yields comparable results if the ASTM D6007-14 test chambers have shown equivalence to the ASTM E1333-14 test chambers. To maintain consistency with this revision, EPA is also updating the definition of quality control limit (QCL) to allow for the use of the ASTM E1333-14 test chamber, or, upon showing equivalence, the ASTM D6007-14 test chamber.

To aid mills and third-party certifiers in understanding the practical implications of this revision, and to help them implement this revision into the TSCA Title VI program, the Agency is clarifying that data generated beginning December 12, 2016 using an ASTM E1333-10 test chamber, or, upon showing equivalence, an ASTM D6007-02 test chamber, and a panel producer's quality control (QC) test method under § 770.20(b)(1) may be used to establish the required annual correlation. Data generated beginning December 12, 2016 from a panel producer's QC test method under § 770.20(b)(1) that has been correlated to either an ASTM E1333-10 test chamber, or, upon showing equivalence, an ASTM D6007-02 test chamber, may be used to certify compliant composite wood products under the TSCA Title VI program until a new annual correlation is required. Beginning on February 7, 2018, data used to establish correlations must be generated using an ASTM E1333-14 test chamber, or, upon showing equivalence, an ASTM D6007-14 test chamber and the panel producer's QC test method under § 770.20(b)(1).

These regulations are established under authority of Section 601 of TSCA, 15 U.S.C. 2697.

This final rule is not subject to the 30-day delay of effective date generally required by 5 U.S.C. 553(d) because the amendments relieve a restriction. See 5 U.S.C. 553(d)(1). Specifically, the current regulation requires the correlation of the tests conducted through the quality control methods listed in § 770.20(b) to be to ASTM E1333-14 test chamber tests. The amendments allow the correlation of the tests conducted through the quality control methods listed in § 770.20(b) to be to either ASTM E1333-14 or, upon a showing of equivalence, ASTM D6007-14 test chamber tests. This will provide another option for testing and facilitate compliance by the regulated entities. The amendments regarding the voluntary consensus standards reflect the current voluntary consensus standards. To the extent that the regulation required regulated entities to demonstrate compliance according to outdated standards that have been updated, superseded, or withdrawn by their respective organization, this change relieves that restriction. This will avoid confusion over compliance, as the amended versions represent the current voluntary consensus standards in use. Moreover, EPA also finds that there is “good cause” under 5 U.S.C. 553(d)(3) to make the updates to the voluntary consensus standards effective upon publication. The references for the voluntary consensus standards are being updated because the prior versions have been updated, superseded, or withdrawn by their respective organization. If these updates were delayed by 30 days, regulated entities would face uncertainty about whether current standards could be used to comply with the rule. In addition, the regulated entities do not need a 30-day delay in the effective date to prepare for these amendments because they are already familiar with and able to apply the current voluntary consensus standards.

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

This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.

This action does not impose any new information collection burden under the PRA because it does not create any new reporting or recordkeeping obligations. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2070-0185.

The Agency certifies that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This rule updates the voluntary consensus standards that were incorporated by reference in the final rule to the most current versions. The updated versions of the standards are substantially similar to the previous versions. EPA expects that many small entities are already complying with the updated versions of the standards listed in Table

This action would relieve these entities of the burden of having to also demonstrate compliance with outdated versions of these standards. This action also provides an amendment to the equivalence and correlation requirements at § 770.20 that would reduce testing burdens without compromising the integrity of the data collected by panel producers and third party certifiers to demonstrate compliance with the emission standards in the final rule. This action will relieve or have no net regulatory burden for directly regulated small entities.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

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

This action does not have tribal implications as specified in Executive Order 13175. This final rule will not impose substantial direct compliance costs on Indian tribal governments. Thus, Executive Order 13175 does not apply to this action.

This action is not subject to Executive Order 13045, because it does not concern an environmental health risk or safety risk. This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. As addressed in Unit II.A., this action would not materially alter the final rule as published, and will update existing voluntary consensus standards incorporated by reference in the final rule and provide an amendment to the testing requirements at § 770.20.

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

This action involves voluntary consensus standards, many of which EPA is directed to use by TSCA Title VI. Voluntary consensus standards identified in the statute have been updated by the voluntary consensus standard management bodies which antiquates the statutorily required versions.

EPA is updating voluntary consensus standards as issued by ASTM International, ANSI, APA, HPVA, NIST, BSI, and JIS. Copies of the standards referenced in the regulatory text have been placed in the docket for this rule. Additionally, each of these standards is available for inspection at the OPPT Docket in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA, West Bldg., 1301 Constitution Ave. NW, Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. EPA has determined that all of these standards are reasonably available to the class of persons affected by this rulemaking. The following voluntary consensus standards are being updated:

(a) APA, CPA, and HPVA standards. Copies of these standards may be obtained from the specific publisher, as noted below, or from the American National Standards Institute, 1899 L Street NW, 11th Floor, Washington, DC 20036, or by calling (202) 293-8020, or at http://ansi.org. Note that ANSI/APA A190.1-2017 is published by APA—the Engineered Wood Association. ANSI A208.1-2016 and ANSI A208.2-2016 are published by the Composite Panel Association. And ANSI ANSI/HPVA-HP-1-2016 is published by the Hardwood Plywood Veneer Association.

1. ANSI/APA A190.1-2017, Structural Glued Laminated Timber. This standard describes minimum requirements for the manufacture and production of structural glued laminated timber, including size tolerances, grade combinations, lumber, adhesives, and appearance grades.

2. ANSI A208.1-2016, American National Standard, Particleboard. This standard describes the requirements and test methods for dimensional tolerances, physical and mechanical properties and formaldehyde emissions for particleboard, along with methods of identifying products conforming to the standard.

3. ANSI A208.2-2016, American National Standard, Medium Density Fiberboard (MDF) for Interior Applications. This standard describes the requirements and test methods for dimensional tolerances, physical and mechanical properties and formaldehyde emissions for MDF, along with methods of identifying products conforming to the standard.

4. ANSI/HPVA HP-1-2016, American National Standard for Hardwood and Decorative Plywood. This standard details the specific requirements for all face, back, and inner ply grades of hardwood plywood as well as formaldehyde emission limits, moisture content, tolerances, sanding, and grade marking.

(b) ASTM material. Copies of these materials may be obtained from ASTM International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, PA 19428-2959, or by calling (877) 909-ASTM, or at http://www.astm.org.

1. ASTM E1333-14, Determining Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a Large Chamber. This test method measures the formaldehyde concentration in air and emission rate from wood products containing formaldehyde under conditions designed to simulate product use. The concentration in air and emission rate is determined in a large chamber under specific test conditions of temperature and relative humidity. The general procedures are also intended for testing product combinations at product-loading ratios and at air-exchange rates typical of the indoor environment.

2. ASTM D6007-14, Determining Formaldehyde Concentrations in Air from Wood Products Using a Small-Scale Chamber. This test method measures the formaldehyde concentrations in air from wood products under defined test conditions of temperature and relative humidity. Results obtained from this small-scale chamber test method are intended to be comparable to results obtained testing larger product samples by the large chamber test method for wood products, Test Method E 1333.

3. ASTM D5582-14, Determining Formaldehyde Levels from Wood Products Using a Dessicator. This test method describes a small scale procedure for measuring formaldehyde emissions potential from wood products. The formaldehyde level is determined by collecting airborne formaldehyde in a small distilled water reservoir within a closed desiccator. The quantity of formaldehyde is determined by a chromotropic acid test procedure.

4. ASTM D5456-14b, Evaluation of Structural Composite Lumber Products. This specification describes initial qualification sampling, mechanical and physical tests, analysis, and design value assignments. Requirements for a quality-control program and cumulative evaluations are included to ensure maintenance of allowable design values for the product.

5. ASTM D5055-16, Establishing and Monitoring Structural Capacities of Prefabricated Wood I-Joists. This specification gives procedures for establishing, monitoring, and reevaluating structural capacities of prefabricated wood I-joists, such as shear, moment, and stiffness. The specification also provides procedures for establishing common details and itemizes certain design considerations specific to wood I-joists.

(c) CEN materials. Copies of these materials are not directly available from the European Committee for Standardization, but from one of CEN's National Members, Affiliates, or Partner Standardization Bodies. To purchase a standard, go to CEN's website, http://www.cen.eu, and select “Products” for more detailed information.

1. BS EN 12460-3: 2015, Wood-based Panels—Determination of Formaldehyde Release [Part 3: Gas Analysis Method]. This British Version of the European standard describes a procedure for determination of accelerated formaldehyde release from wood-based panels.

2. BS EN 12460-5: 2015, Wood-based Panels—Determination of Formaldehyde Release [Part 5: Extraction Method (Called the Perforator Method)]. This British Version of the European standard describes an extraction method, known as the perforator method, for determining the formaldehyde content of unlaminated and uncoated wood-based panels.

(d) Copies of JIS A 1460: 2015, Determination of the Emission of Formaldehyde from Building Boards—Desiccator Method, English Version, may be obtained from Japanese Industrial Standards, 1-24, Akasaka 4, Minatoku, Tokyo 107-8440, Japan, or by calling +81-3-3583-8000, or at http://www.jsa.or.jp. This method describes a method for testing formaldehyde emissions from construction boards by measuring the concentration of formaldehyde absorbed in distilled or deionized water from samples of a specified surface area placed in a glass desiccator for 24 hours.

(e) NIST material. Copies of these materials may be obtained from the National Institute of Standards and Technology (NIST) by calling (800) 553-6847 or from the U.S. Government Printing Office (GPO). To purchase a NIST publication you must have the order number. Order numbers may be obtained from the Public Inquiries Unit at (301) 975-NIST. Mailing address: Public Inquiries Unit, NIST, 100 Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070. If you have a GPO stock number, you can purchase printed copies of NIST publications from GPO. GPO orders may be mailed to: U.S. Government Printing Office, P.O. Box 979050, St. Louis, MO 63197-9000, placed by telephone at (866) 512-1800 (DC Area only: (202) 512-1800), or faxed to (202) 512-2104. Additional information is available online at: http://www.nist.gov.

1. PS 1-09, Structural Plywood. This standard describes the principal types and grades of structural plywood, covering the wood species, veneer grading, adhesive bonds, panel construction and workmanship, dimensions and tolerances, marking, moisture content and packaging of structural plywood intended for construction and industrial uses. Test methods to determine compliance and a glossary of trade terms and definitions are included, as is a quality certification program involving inspection, sampling, and testing of products identified as complying with this standard by qualified testing agencies.

2. PS 2-10, Performance Standard for Wood-Based Structural-Use Panels. This standard covers performance requirements, adhesive bond performance, panel construction and workmanship, dimensions and tolerances, marking, and moisture content of structural-use panels, such as plywood, waferboard, oriented strand board, structural particle board, and composite panels. The standard includes test methods, a glossary of trade terms and definitions, and a quality certification program involving inspection, sampling, and testing of products for qualification under the standard.

EPA has determined that the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations, as specified in Executive Order 12898. As addressed in Unit II.A., this action would not materially alter the final rule as published, and will update existing voluntary consensus standards incorporated by reference in the final rule and provide an amendment to the testing requirements at § 770.20.

This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2). Section 808 of the CRA allows the issuing agency to make a rule effective sooner than otherwise provided by CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary, or contrary to the public interest. As required by 5 U.S.C. 808(2), this determination is supported by a brief statement in Unit III.

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

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 (OSP). 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) for 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 fishermen 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 2018 LOF generally summarizes data from 2010-2014. NMFS also reviews other sources of new information, including injury determination reports, bycatch estimation reports, observer data, logbook data, stranding data, disentanglement network data, fishermen self-reports (i.e., MMPA mortality/injury 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 interactions 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 Pacific and Alaska SAR includes an appendix with detailed descriptions of each Category I and II fishery on the LOF, including the observer coverage in those fisheries. For Atlantic fisheries, this information can be found in the LOF Fishery Fact Sheets. 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 website 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' website: 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 website: http://www.st.nmfs.gov/observer-home/.

The LOF includes three tables that list all U.S. commercial fisheries by 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 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 those 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 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' website: 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. NMFS began posting Category III fishery fact sheets online with the LOF for 2016.

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 West Coast Region, authorization certificates may be obtained from the website http://www.westcoast.fisheries.noaa.gov/protected_species/marine_mammals/fisheries_interactions.html.

In the Alaska Region, authorization certificates may be obtained by visiting the Alaska Regional Office website https://alaskafisheries.noaa.gov/pr/mmapregistration.

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 website http://www.greateratlantic.fisheries.noaa.gov/mmap/.

In the Southeast Region, NMFS will issue vessel or gear owners an authorization certificate via U.S. mail automatically at the beginning of each calendar year. Vessel or gear owners can receive additional authorization certificates by contacting the Southeast Regional Office at 727-209-5952 or by visiting the Southeast Regional Office website 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. Certificates can also be obtained from the region's website. 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 either with each renewed state fishing license in Washington and Oregon, with their permit renewal for Federal fisheries (the timing of which varies based on target species), or via U.S. mail. 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 an authorization certificate via U.S. mail automatically at the beginning of each calendar year. Additional authorization certificates are available for printing on the Southeast Regional Office website http://sero.nmfs.noaa.gov/protected_resources/marine_mammal_authorization_program/.

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 safely 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 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 MMAP, 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, Long Beach Office, 501 W. Ocean Blvd., Suite 4200, Long Beach, CA 90802-4213, Attn: Dan Lawson;

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

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

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, fishermen self-reports, reports to the SRGs, conference papers, FMPs, and ESA documents.

The LOF for 2018 was based on, among other things, stranding data; fishermen self-reports; and SARs, primarily the 2016 SARs, which are based on data from 2010-2014. The SARs referenced in this LOF include: 2014 (80 FR 50599; August 20, 2015), 2015 (81 FR 38676; June 14, 2016), 2016 (82 FR 29039; June 27, 2017). The SARs are available at: http://www.nmfs.noaa.gov/pr/sars/.

NMFS received letters containing comments on the proposed LOF for 2018 (82 FR 47424; October 12, 2017) from the Marine Mammal Commission (Commission); five non-governmental organizations (Center for Biological Diversity (CBD), Hawaii Longline Association (HLA), Southeast Alaska Fishermen's Alliance (SEAFA), Southeast Alaska Sperm Whale Avoidance Project (SEASWAP), and Turtle Island Restoration Network (TIRN); and two individuals. Responses to substantive comments are below; comments on actions not related to the LOF are not included.

Comment 1: The Commission believes that NMFS' approach to classifying the Gulf of Alaska sablefish longline (GOA SLL) fishery based on the statutory definitions of fishery categories in the MMPA, in the absence of an estimate of PBR, is appropriate. Further, the Commission states that NMFS has the discretion to classify a fishery as Category I in the absence of the data necessary to calculate mortality and serious injury (M/SI) as a fraction of PBR. The Commission notes that while the current M/SI is almost certainly greater than 10 percent of PBR, exactly where M/SI as a percentage of PBR falls relative to the Category I and II thresholds depends on what proportion of the stock's U.S. range was surveyed, and other factors not taken into account in NMFS' analysis. The Commission recommends that the GOA SLL fishery should be classified as at least a Category II fishery. However, two other commenters, SEASWAP and SEAFA, oppose the proposed change to reclassify the GOA SLL from a Category III to a Category II fishery based on interactions with sperms whales. These commenters disagree that these temporary sperm whale entanglements resulted in serious injuries and assert that prorating these serious injuries to mortalities is not appropriate (see comments 3, 4, and 5 below). They urge NMFS to retain the existing Category III ranking for the fishery.

Response: NMFS agrees with the Commission and has reclassified the fishery as Category II. Given our analysis of the estimated mean annual M/SI attributed to the GOA SLL fishery, and our best available information regarding the North Pacific sperm whale stock, the AK Gulf of Alaska sablefish pot fishery will be classified as Category II in the 2018 LOF; NMFS will continue to consider all available data in its future classifications of this fishery.

Comment 2: The Commission recommends that NMFS give high priority to: (1) Surveying enough of the range of sperm whales to provide a reliable estimate of PBR for the portion of the stock that occupies the EEZ in Alaska, (2) increasing observer coverage in the GOA SLL fishery (currently 14-19 percent), and (3) developing a take reduction plan for the North Pacific stock of sperm whales. The Commission comments that these actions will enable NMFS to more definitively classify the GOA SLL fishery and to mitigate the bycatch problem.

Response: NMFS agrees with the Commission on the need for reliable estimates of abundance and PBR for the North Pacific sperm whale stock; however, the funding necessary for surveying sperm whales in the Gulf of Alaska is currently unavailable. Next, observer coverage is determined through the Annual Deployment Plan (ADP) process, which provides a statistically-based sampling approach for the random deployment of human observers onto longline vessels operating in the Gulf of Alaska. The ADP is part of a larger annual process where NMFS consults with the North Pacific Fishery Management Council and its Scientific and Statistical Committee on to determine the amount of coverage for an upcoming year. This method is described in the 2018 ADP (available at https://www.afsc.noaa.gov/Publications/ProcRpt/PR2017-07.pdf). Regarding take reduction plans, NMFS' available resources for Take Reduction Teams (TRTs) are fully utilized at this time. When NMFS lacks sufficient funding to convene a TRT for all stocks that interact with Category I and II fisheries, NMFS gives highest priority for developing and implementing new take reduction plans to species and stocks whose level of incidental mortality and serious injury exceeds PBR, that have a small population size, and that are declining most rapidly, pursuant to MMPA section 118(f)(3).

Comment 3: SEASWAP and SEAFA assert that NMFS' assignment of the significant injury and 75 percent mortality rate to temporary sperm whale entanglements is unsubstantiated and inconsistent with the determination criteria used for other cetacean species, such as beluga and humpback whales. SEASWAP and SEAFA request that NMFS lower the pro-rated mortality rate for sperm whales.

Response: NMFS implemented a policy for distinguishing serious from non-serious injury of marine mammals to increase transparency and consistency nationwide in assessing and quantifying serious injuries of marine mammals in 2012 (NMFS 2012). This policy serves as the basis for evaluating injury reports of marine mammals. The policy involves applying guidelines to determine whether an injury should be considered serious and describes a variety of injuries specific to large cetaceans, small cetaceans, and pinnipeds. The policy and guidelines cover most types of injury and were developed to fit data rich as well as data poor injury events.

Criteria for evaluating large whale injuries include three types of entanglements. Two of these types are “constricting wrap,” a serious injury (SI), and “loose wrap, bridled or draped gear,” a non-serious injury (NSI). If documentation of a confirmed entanglement is inadequate to assign an entanglement to either of these types a third category is used, “evidence of entanglement.” Events falling in this category are prorated. To prorate, the number of events assigned to this category within the assessment period is multiplied by 0.75. This value was calculated based on 114 documented entanglement events with known outcomes that occurred between 2004 and 2008, of which 85 (75 percent) resulted in the whales' deteriorating health or death. Although more severe or prolonged entanglements may be more likely to be reported, the 0.75 prorating reflects the probability that some confirmed entanglement reports lacking detail will be of minor events.

SEASWAP and SEAFA are correct that using a prorate value of 0.75 for sperm whale entanglements reflects assumptions about the fate of the entangled animals. We would welcome data analyses or other information from SEASWAP on sperm whale interactions with longline fisheries that would help inform future injury determinations. The 0.75 value is based on the best available information.

The other injury determinations referenced by SEASWAP are also consistent with NMFS' policy and guidelines for distinguishing serious from non-serious injury. The vessel strike that left a piece of whale skin on a vessel's hull was categorized as a “superficial laceration” and a vessel strike under “vessel any size less than 10 knots,” both of which are considered non-serious injuries. Injuries to small cetaceans, such as beluga whales, are assigned to a category from a list specific to small cetaceans. The beluga entangled in gillnet that was later freed from gear was assigned to the “anchored, immobilized, entangled, or entrapped before being freed without gear attached” category. This category does not have a defined injury value, and instead requires a case-specific assessment. NMFS evaluated the record of the injury and considered it a non-serious injury because the animal was able to surface while entangled and was confirmed to be free of gear when released.

Comment 4: SEASWAP and SEAFA disagree with the conclusion in the March 2016 NOAA report (NOAA-TM-AFSC-315) that the temporary sperm whale entanglements reported during 2010-2014 resulted in 6.25 dead sperm whales. They further assert that of the five cases described by observers, not one included a documented case of the whales remaining entangled or having visible injury from the entanglement, yet “serious injury” was assigned in four cases (Haul numbers 225, 7, 82, and 116). SEASWAP and SEAFA urge NOAA to reassign these “significant injury” designations to “non-serious injury.”

Response: When we review entanglement records, we pay close attention to the observer's recorded description of events. When an observer codes an interaction as “entangled in gear (not trailing gear),” we still assess whether gear could have remained on the animal post hoc. Fishery observers are not trained to assess the severity of marine mammal injuries, and we do not use their assessment of injury severity. This explains the differences SEASWAP noted between the observer's assessment on the marine mammal interaction form and the final injury determinations as reported in “Human-Caused Injury and Mortality of NMFS-managed Alaska Marine Mammal Stocks, 2010-2014” (Helker et al., 2016).

In response to SEASWAP's and SEAFA's comments, we will reevaluate these entanglements and injury determinations; if we determine any changes to the injury determinations due to these entanglements are necessary, they will be reviewed consistent with NMFS policy and reported in the 2018 Marine Mammal Stock Assessment Reports and Human-caused Serious Injury and Mortality Report.

Comment 5: SEASWAP and SEAFA disagree with NMFS' extrapolation of the observed temporary entanglements to the sperm whale/GOA SLL fishery interactions, including the pro-rating to the unobserved fleet, and assert that NMFS is oversimplifying sperm whale behavior near fishing boats. SEAFA argues that because some sperm whales have been documented as serial longline depredators, the actual M/SI is likely less than NMFS' estimate and it is inappropriate to extrapolate across the fleet. SEAFA comments that NMFS does not provide enough information to verify if the extrapolated data is reasonable and how these data were handled prior to and following the restructuring of the observer program to correct for bias in observer coverage.

Response: Extrapolating bycatch events that are observed in fisheries with partial observer coverage, such as components of the GOA SLL fishery, is standard practice. Bycatch extrapolation relies on the observed bycatch in a sampled portion of a fishery to estimate the bycatch across that entire fishery. Depredation by sperm whales is a common occurrence in this fishery, and an entanglement preceded by depredation is treated no differently than other bycatch events since it reflects one of the risks posed to marine mammals by the fishery.

The methodology for estimating bycatch is explained in NOAA Tech. Memo. NMFS-AFSC-260 (Breiwick 2013) and has not changed appreciably since that time. Specifically, the serious injuries are extrapolated only within a stratum defined by the NMFS statistical area, three categories of vessel size (>125, between 60 and 125, <60), and three time periods (January to April, May through August, September through December). The two serious injuries that were extrapolated in 2012 occurred in vessels between 60 and 125 feet, whereas the one serious injury in 2013 that was extrapolated occurred on a vessel <60 feet, so the observer coverage within that stratum is much lower, which is what is actually used to extrapolate the serious injury. We do not extrapolate observed bycatch in one statum to strata where no bycatch was observed. For simplicity, we do not report the observer coverage within the extrapolated strata, but instead report observer coverage for the entire fishery across all strata. Therefore, it is not possible for the reader to extrapolate the observed bycatch to estimate the total bycatch (see Breiwick 2013).

Comment 6: SEAFA notes that the proposed rule suggests breaking the Category III AK Miscellaneous finfish handline/hand troll and mechanical jig fishery into several fisheries by gear type and geography. In order to maintain consistency with the State of Alaska fishery permits, SEAFA recommends the new names for the groundfish troll fisheries be (2) AK BSAI groundfish hand troll and dinglebar troll and (4) AK Gulf of Alaska groundfish hand troll and dinglebar troll.

Response: NMFS agrees. We will adopt and use the suggested clarifications to fisheries names (AK Bering Sea, Aleutian Islands groundfish hand troll and dinglebar troll and AK Gulf of Alaska groundfish hand troll and dinglebar troll) in the 2018 LOF.

Comment 7: SEAFA comments that it is unclear whether the proposed updates in Table 1 for the “estimated number of vessels/persons” participating in a fishery reflects the total number of potential participants or the number of actual participants in a fishery. SEAFA recommends that NMFS consult with the State of Alaska's Commercial Fisheries Entry Commission for the most accurate information about the number of available permits versus the number of permits actively fished, particularly for the AK Southeast shrimp pot fishery and AK Southeast Alaska crab pot fisheries.

Response: NMFS has been making efforts to report the category “estimated number of vessels/persons” across Table 1 more consistently. As SEAFA points out, this is especially important for fisheries where there is a large discrepancy between the number of valid permits versus the number of active permits. Where possible, Table 1 will report the number of active permits to most accurately depict the relative effort of each fishery. In response to this comment, we have revisited the number of participants for the AK Southeast shrimp pot fishery and AK Southeast Alaska crab pot fishery and identified that the wrong permit count was used for the AK Southeast shrimp pot fishery. To correct this, in the final LOF NMFS changed the estimated number of vessels/persons for this fishery to the number of active permits (99).

Comment 8: TIRN and CBD comment that before listing the AK Gulf of Alaska sablefish pot fishery as a Category III fishery, NMFS should analyze the data of all Alaska and West Coast sablefish pot fisheries and humpback interactions and compare it to an updated humpback whale stock assessment. They recommend that, as a precautionary measure, the fishery should be listed as Category II. TIRN and CBD assert that, in the absence of statistically-reliable data regarding humpback whale serious injuries and mortalities for Alaska pot fisheries, NMFS must list these fisheries as Category II until: (a) The MMPA humpback stock is revised to be consistent with the ESA stock listings and (b) NMFS uses available fishing effort and humpback abundance data to determine co-occurrence.

Response: NMFS considers data from several sources for the mean annual M/SI estimates and LOF process, including observer data, self-reports, and stranding data. We acknowledge that reliable data are not always available and that analogous fisheries can provide more insight into the potential for incidental M/SI. However, these situations require a clear justification for which fishery is being considered analogous and why. In the case of the AK Gulf of Alaska sablefish pot fishery, NMFS considers the newly authorized fishery to be most analogous with the other sablefish pot fisheries in the State, which are Category III. Further, the AK Gulf of Alaska sablefish pot fishery has observer coverage, and NMFS will continue to consider any new data collected by the observer program or other sources in future LOF analyses.

Comment 9: TIRN and CBD recommend that humpback whales be listed as marine mammal species and/or stocks incidentally killed or injured in the AK Aleutian Islands sablefish pot fishery and the Category III AK Bering Sea sablefish pot fishery, based on observer records that humpback whales have been incidentally caught in both these fisheries.

Response: The species and/or stocks listed as incidentally killed or injured in Table 1 includes the species and/or stocks in which there are recent reports of incidental mortality or injury by a particular fishery consistent with the information reported in the SARs. Typically, species and/or stocks are removed from Table 1 when recent data do not include documented mortality or injury of that species or stock. NMFS has a report of a humpback whale considered seriously injured in the AK Bering Sea sablefish pot fishery in 2002. However, NMFS has observed this fishery since that time and there were no documented injuries or mortalities. Therefore, in 2013, NMFS removed humpback whales from the list of species/stocks killed or injured in this fishery (78 FR 53336, August 29, 2013).

Comment 10: TIRN and CBD support combining the Category III AK Aleutian Islands sablefish pot fishery in the LOF with the Category III AK Bering Sea sablefish pot fishery for consistency with other regional designations in the LOF, but urge NMFS to analyze humpback whale interactions first before listing this combined fishery as Category III.

Response: The LOF uses data consistent with the SARs, which is generally from a 5-year rolling window to evaluate a fishery's impacts to marine mammal stocks. For the 2018 LOF, 2010-2014 data are considered in the LOF tier analyses. There are no documented reports of incidental M/SI of humpback whales during this time in either of the fisheries being combined. Given all available data, including recent observer data for the AK Bering Sea sablefish pot fishery, NMFS believes that Category III is most appropriate for this location, target species, and gear type. Thus, we will classify the newly combined AK Bering Sea, Aleutian Island sablefish pot fishery as Category III.

Comment 11: The Commission concurs with NMFS that the CA thresher shark/swordfish drift gillnet fishery should be reclassified from Category I to Category II based on the most recent estimate of M/SI for the California/Oregon/Washington stock of sperm whales in this fishery.

Response: NMFS agrees and has reclassified the CA thresher shark/swordfish drift gillnet (≥14 in mesh) fishery from Category I to Category II based on the most recent estimates of marine mammal M/SI in this fishery.

Comment 12: TIRN and CBD comment that more than a year has passed since the listing of the Central America humpback whale distinct population segment (DPS), and reported entanglements are at record highs in the area off California that is the near-exclusive feeding grounds for this DPS. They assert that NMFS should consider the Central American humpback whale DPS as a relevant stock in its determinations for the 2018 List of Fisheries.

Response: For the 2018 LOF, NMFS relied upon information on the current status of humpback whale stocks on the U.S. west coast as described in the most recent SAR available (Carretta et al., 2017a). The most recent SAR available does not contain an MMPA stock delineation for humpback whales that corresponds with the recent ESA-listing decision that established several DPSs of humpback whales that may be present in U.S. west coast waters. While NMFS may consider updates to humpback whale stock delineations under the MMPA in light of the recent ESA-listing decision, we will continue to rely upon the most current SAR for the status of humpback whale stocks on the U.S. west coast relative to human-caused M/SI and the classification of fisheries under the MMPA LOF. Currently, there is no Central America DPS stock of marine mammals delineated under the MMPA. NMFS is currently evaluating the humpback whale stock structure under the MMPA with respect to the ESA listing.

Comment 13: CBD and TIRN urge NMFS to designate the CA Dungeness crab pot fishery as a Category I fishery because it frequently entangles, seriously injures, and kills imperiled humpback whales. CBD and TIRN state that the PBR calculation for the international stock of Central America humpbacks results in an estimated PBR of 0.8 humpback whales per year, and the best estimate of minimum average annual M/SI is 1.35 whales per year, well above the PBR estimate. They further maintain that the average numbers of annual M/SI is an underestimate as it is based on reported entanglements, and does not account for many entanglements that go unobserved, and does not include the 2016 entanglement of 19 humpback whales in the CA Dungeness crab pot fishery. CBD and TIRN suggest that according to the historical rate of serious injury determinations, 84 percent of these entanglements, or 16 whales, resulted in a serious injury or mortality and this is well above the PBR estimate. CBD and TIRN assert that the available information clearly demonstrates that NMFS should reclassify the fishery as Category I.

Response: The most recent SAR for humpback whales on the U.S. west coast does not establish or provide a PBR for the Central America DPS of humpback whales because it is not a delineated MMPA stock, as explained in Comment 12 above. Until such time that the SAR reports a PBR for an MMPA stock delineation of humpback whales that may more closely reflect the Central America DPS as suggested by the commenter, calculation of hypothetical PBRs by any other sources are considered premature. NMFS will continue to rely upon the most recent SAR for the calculation of PBR for humpback whale stocks on the U.S. west coast for classifying fisheries under the LOF. In addition, commenters reference data sources from 2016 that have not yet been reviewed for M/SI in the SARs; NMFS will use those data for classifying fisheries once they have been incorporated into the SARs.

Comment 14: CBD and TIRN state that preliminary evidence shows that the CA Dungeness crab pot fishery, and not the Oregon or Washington Dungeness crab pot fishery, primarily impacts the Central America humpback whale DPS. They recommend that without additional information, all interactions of the CA Dungeness crab pot fishery should be assigned to the Central America DPS.

Response: As described in Comment 12 above, the most current SAR does not delineate a Central America DPS of humpback whales as a stock under the MMPA. Until such time that the humpback whale stock structure under the MMPA with respect to the ESA listing has been completed, assignment of M/SI to humpback stocks in the SAR and under the LOF will continue to reflect the current MMPA stock delineations.

Comment 15: CBD and TIRN recommend that NMFS add blue whales, ENP, Offshore killer whales, and the western North Pacific gray whale to the list of species incidentally killed or injured in the CA Dungeness crab pot fisheries.

Response: Entanglement data from the U.S. west coast that has been reviewed for M/SI include recent data through 2015 (Carretta et al., 2017b). We note that through 2015, no blue whale injuries have been documented in the CA Dungeness crab pot fishery. Information on entanglements reported in 2016 and 2017 referenced by commenters will be used to inform the list of marine mammal stocks incidentally killed or injured in any U.S. west coast fisheries once it has been incorporated into the SARs, at which time NMFS will use those data for the LOF.

We thank the commenter for pointing out that we omitted the identity of the killer whale stock associated with a dead killer whale reported to NMFS in 2015 that was entangled with CA Dungeness crab gear. NMFS is currently reviewing the available information regarding the identification of the stock of killer whales to which this individual belongs. Once this information has been evaluated and reported in a future SAR, NMFS will add the appropriate stock of killer whales to the list of marine mammal stocks incidentally killed or injured by the CA Dungeness crab fishery in the LOF. As stated previously, entanglement information from 2016 has not yet been evaluated for M/SI and will not be used to inform the list of marine mammal stocks incidentally killed or injured in any U.S. west coast fisheries at this time.

NMFS acknowledges that the most recent SAR suggests that because some Western North Pacific gray whales occur in U.S. waters, there is a possibility these whales could be killed or injured by ship strikes or entangled in fishing gear within U.S. waters. However, while it may be possible that at least one or more Western North Pacific gray whales have been among the many gray whales reported entangled on the U.S. west coast historically, NMFS recognizes that relatively few of those instances are known to have involved gear from the CA Dungeness crab fishery. We also acknowledge that many other U.S. commercial fisheries on the U.S. west coast have been identified as associated with entanglements of gray whales historically, and it is likely other U.S. commercial, tribal, and foreign fisheries from countries surrounding gray whale migration routes that have not been identified have also been involved. In the absence of more specific information from any particular entanglement of gray whales that involved CA Dungeness crab gear to suggest those entanglements involved a Western North Pacific gray whale, NMFS does not have sufficient data to conclude that Western North Pacific gray whales have been entangled in CA Dungeness crab gear versus other fisheries throughout the range of gray whales; thus, we will not include Western North Pacific gray whales on the list of stocks incidentally killed or injured in the CA Dungeness crab fishery at this time. Based on the relative population sizes of the Western North Pacific and Eastern North Pacific stocks of gray whales, and what is known about migrations of the Western North Pacific stock to the eastern North Pacific (Moore and Weller 2013), NMFS has concluded the likelihood that any of the particular gray whales that are known to have interacted with CA Dungeness crab fishery were Western North Pacific stock gray whales is extremely low. NMFS strives to collect photographic or genetic data from entangled gray whales that may allow for stock and will continue to develop and promote this aspect as a key data need surrounding all gray whale strandings and entanglements.

Comment 16: TIRN and CBD oppose NMFS' proposal to lower the CA thresher shark/swordfish drift gillnet fishery classification from Category I to Category II. They note that NMFS' decreased annual take estimate of sperm whales may not adequately reflect the mortality or serious injury that the fishery causes for sperm whales. In addition, TIRN/CBD comment that the MMPA Section 101(a)(5)(E) authorization to take humpback and sperm whales by this fishery has expired, and a reclassification of the fishery to Category II prior to the completion of the rulemaking process for a new authorization is premature. Based on the uncertainty stemming from low observer coverage and the past observation of sperm whale M/SI, and the pending MMPA authorization rule-making, TIRN/CBD urge NMFS to maintain the CA thresher shark/swordfish drift gillnet fishery's classification as Category I.

Response: The reclassification of this fishery from Category I to Category II is based upon published scientific information that includes estimates of bycatch and subsequent M/SI in this fishery that are considered robust given annual variance in observer coverage rates. These estimates are based on methodologies that represent an improved approach to estimate relatively rare bycatch events over time compared to methods referenced in previous SARs and classifications under the LOF. NMFS has determined these estimates are appropriate to inform the LOF classification of the CA thresher shark/swordfish drift gillnet (≥14 in mesh) fishery as Category II. Further, classifications made under the LOF are based on the best available science and are not dependent or related to the current status of other regulatory processes including the issuance of authorizations under section 101(a)(5)(E) of the MMPA.

Comment 17: TIRN and CBD support NMFS' proposal to add the CA/OR/WA stock of Dall's porpoise to the list of stocks incidentally killed or injured in the Category I California thresher shark/swordfish drift gillnet (≥14 in mesh) fishery based on a 2014 observed entanglement.

Response: NMFS agrees and has added the CA/OR/WA stock of Dall's porpoise to the list of stocks incidentally killed or injured in the Category I CA thresher shark/swordfish drift gillnet (≥14 in mesh) fishery.

Comment 18: TIRN and CBD recommend, based on interactions between 2010 through 2016, that NMFS add Guadalupe fur seals to the list of species and/or stocks incidentally killed or injured in the California drift gillnet fishery, and the gillnet fisheries that operate from Tillamook County, OR, to Jefferson County, WA, such as the WA Willapa Bay drift gillnet, WA/OR lower Columbia River drift gillnet, and the WA Grays Harbor salmon drift gillnet fishery.

Response: NMFS has reviewed the available information on Guadalupe fur seal interactions and M/SI associated with gillnet entanglements from 2010-2014. Based on information that is available (Carretta et al., 2017a and Carretta et al., 2017b), we are not able to determine the fishery origin of Guadalupe fur seal strandings that have been associated with gillnet entanglements. Guadalupe fur seals have a wide range that brings them into potential contact with numerous gillnet fisheries that include U.S. commercial fisheries as well as tribal and foreign fisheries from neighboring countries. While we continually aim to improve our ability to evaluate incoming information and identify the origins of fishing gear present on all stranded marine mammals, we will not attribute any Guadalupe fur seal M/SI to any U.S. gillnet fisheries or list Guadalupe fur seals as a marine mammal stock that is killed or injured by any U.S. gillnet fisheries at this time absent more specific information regarding the origins of gillnet interactions.

Comment 19: TIRN and CBD recommend NMFS add Guadalupe fur seals to the list of species and/or stocks incidentally killed or injured in the Hawaii deep-set and Hawaii shallow-set longline fisheries based on 2015 and 2016 reported interactions.

Response: The recently observed Guadalupe fur seal interaction from 2015 has not yet been included in a SAR, an injury determination has not been finalized for this interaction, and the interaction has not yet been evaluated as part of the tier analysis for these fisheries. This species will be included in a future LOF, as appropriate.

Comment 20: HLA opposes including the Hawaii stock of Kogia species (Hawaii) on the list of species injured or killed in the Hawaii-based deep-set longline fishery. HLA requests that NMFS remove Kogia species from the list of stocks that are interacting with the deep-set longline fishery, because the most recent SAR (2013) for Hawaii pygmy whales and dwarf sperm whales identifies no observed interactions between either of these stocks and this fishery. However, two other commenters, TIRN and CBD, support NMFS' proposal to add the Hawaii stock of Kogia spp. to the list of stocks incidentally killed or injured in the Category I HI deep-set longline fishery based upon the serious injury of a pygmy or dwarf sperm whale in 2014 in this fishery.

Response: Although the 2013 SAR does not include observed interactions with Hawaii pygmy whales and dwarf sperm whales, a Kogia spp. interaction was observed in the Hawaii deep-set longline fishery on February 25, 2014, resulting in a serious injury (Carretta et al., 2017b). This injury determination has been finalized, and the interaction is included in the draft 2017 SAR (82 FR 60181; December 19, 2017).

Comment 21: The HLA restates a previous comment that 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 notes that (a) the False Killer Whale Take Reduction Plan closed the deep-set longline fishery for almost the entire range of the MHI insular and NWHI stocks, (b) since this change was made in 2013 there have been no interactions between the fishery and an animal from either stock, and (c) there has never been a deep-set longline fishery interaction in the very small area of the stocks' respective ranges that are not closed to longline fishing. HLA requests that NMFS remove these two stocks from the list of marine mammals that interact with the deep-set longline fishery, as the best available information demonstrates the fishery is not interacting with either of these stocks.

Response: This comment has been addressed previously (see 78 FR 53336, August 29, 2013, comment 11; 79 FR 14418, March 14, 2014, comment 4; 79 FR 77919, December 29, 2014, comment 2; and 81 FR 20550, April 8, 2016, comment 5). 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 information on each stock, including range, abundance, PBR, and level of interaction with commercial fishing operations. Determinations in the LOF are based on the information reported in the SARs.

The 2018 LOF is based on the 2016 SARs, which report fishery interactions from 2010-2014; this is the best scientific and commercial information available for the time period examined. As reported in the 2016 SAR, 12 false killer whales were taken within the Hawaiian EEZ between 2010 and 2014, ten of those occurred within the range of the pelagic stock, and two occurred within an overlap zone that included the range of more than one false killer whale stock. Applying the proration methods described in detail in the 2016 SAR for takes in overlap zones, NMFS estimates a five-year average mortality and serious injury level of 0.1 MHI insular and 0.4 NWHI false killer whales per year incidental to the Hawaii-based deep-set longline fishery from 2010-2014 (Carretta et al., 2017a). NMFS is retaining the stocks on the list of marine mammal stocks incidentally killed or injured in the Hawaii deep-set longline fishery.

Comment 22: HLA opposes including the pygmy killer whale (Hawaii stock) on the list of species injured or killed in the Hawaii-based deep-set fishery. HLA requests that NMFS remove the pygmy killer whale from the list of stocks that are interacting with the deep-set fishery, because the most recent SAR (2013) identifies no observed interactions between the stock and the deep-set longline fishery.

Response: The 2013 SAR reports marine mammal interactions with the deep-set fishery that occurred between 2007 and 2011. Although the 2013 SAR does not include any observed interactions with pygmy killer whales, an interaction was observed between a pygmy killer whale and the Hawaii deep-set longline fishery on January 5, 2013, resulting in a serious injury (Carretta et al., 2017b). This injury determination has been finalized, and the interaction is included in the draft 2017 SAR (82 FR 60181; December 19, 2017).

Comment 23: TIRN and CBD support NMFS' proposal to add the Central North Pacific stock of humpback whale to the list of stocks incidentally killed or injured in the Category I Hawaii deep-set longline fishery based upon the serious injury of a humpback in 2014 in this fishery.

Response: NMFS agrees and has added the Central North Pacific stock of humpback whale to the list of stocks incidentally killed or injured in the Hawaii deep-set longline fishery.

Comment 24: TIRN and CBD recommend that the California/Oregon/Washington (CA/OR/WA) humpback whale stock be added to the list of species or stocks incidentally killed or injured in the Category I Hawaii deep-set longline fishery based upon known M/SI to the Central North Pacific humpback stock from interaction with this fishery in 2014. In addition, they comment that NMFS is currently considering an exempted fishing permit to allow the use of both deep-set and shallow-set longline gear within the West Coast EEZ, which would provide this fishery greater access to this stock and further increase the pressure on the stock.

Response: The LOF relies on information reported in the SARs to add/remove species/stocks that are killed or injured in a particular fishery. The 2016 SAR reports a humpback whale from the Central North Pacific stock was seriously injured in 2014 in the Category I Hawaii deep-set longline fishery; consequently, this stock is included in the list of stocks incidentally killed or injured in this fishery. The SAR does not list any mortalities or injuries of the CA/OR/WA humpback whale stock in the Hawaii deep-set fishery in 2014; consequently, this stock is not included in the list of stocks incidentally killed or injured in the Category I Hawaii deep-set longline fishery.

Comment 25: TIRN and CBD request that the CA/OR/WA humpback whale stock be added to the list of stocks incidentally killed or injured in the Category I Hawaii shallow-set longline fishery. They assert that the fishery's potential for interactions with this stock is justified by the inclusion of the Central North Pacific humpback whale stock in the list of species and/or stocks incidentally killed or injured. In addition, TIRN/CBD comment that NMFS currently is considering an exempted fishing permit to allow the use of both deep-set and shallow-set longline gear within the West Coast EEZ, which would provide this fishery greater access to this stock and further increase the pressure on the stock.

Response: NMFS uses the criteria described in the preamble to classify fisheries and list species or stocks that may be incidentally killed or injured by those fisheries. Under these criteria, NMFS lists species or stocks as incidentally killed or injured based on documented mortalities or injuries using the best scientific information available (i.e., SARs). Because there are no documented mortalities or injuries of CA/OR/WA humpbacks, NMFS is not including this stock as incidentally killed or injured by the Category I Hawaii shallow-set longline fishery. Should NMFS approve an exempted fishing permit for the deep-set and shallow-set longline fishery operating within the U.S. West Coast EEZ, NMFS will continue to use all relevant information to inform future LOFs.

Comment 26: HLA contends that the best available science does not support a determination that the Hawaii-based shallow-set longline fishery has “occasional” interactions with the pelagic false killer whale stock and should therefore be listed as Category III. They note that the 2016 SAR attributes a 0.3 M/SI rate to the shallow-set fishery for the Pelagic FKW Stock in the U.S. EEZ, which amounts to 1.07 percent of the Pelagic FKW Stock's PBR level. However, the 0.3 M/SI rate derives entirely from an interaction that occurred in 2012 for which NMFS was unable to make an injury determination (i.e. “cannot be determined” or “CBD” determination). Further, the “CBD” interaction was prorated as 0.3 M/SI because, in the previous five years, there had been three EEZ interactions between the shallow-set fishery and the Pelagic FKW Stock, only one of which (in 2009) was “serious” (a one-third M/SI rate). HLA notes that if the 2012 “CBD” interaction is prorated based upon the five-year lookback period used in the 2016 SAR (2010-14) (the best available data), then it would be 0.0 because there were only two other interactions in 2010-14, both of which were determined to be non-serious. HLA argues that the Category II status of the shallow-set fishery hinges on a single interaction in 2012 for which no injury determination was made and that NMFS prorated based upon data that is no longer relevant or accurate. For these reasons, HLA recommends the shallow-set fishery be listed as Category III, as the fishery is more accurately described as having a “remote likelihood” of interaction with the stock.

Response: NMFS uses the classification criteria described in the preamble to classify fisheries as Category I, Category II, or Category III. A fishery is classified under Category II if the annual mortality and serious injury of a stock in a given fishery is greater than 1 percent and less than 50 percent of the stock's PBR level. Additional details regarding categorization of fisheries is provided in the preamble to the final rule implementing section 118 of the MMPA (60 FR 45086; August 30, 1995). The false killer whale interaction in 2012 that resulted in a “CBD” determination was prorated following the methods described in the 2016 SAR (Carretta et al., 2017a), which prorates serious versus non-serious injuries using the historic rate of serious injury while accounting for changes in gear following implementation of the False Killer Whale Take Reduction Plan in 2013. This proration resulted in a 0.3 M/SI for the Pelagic FKW stock as reported in the 2016 SAR, which is 1.07 percent of PBR and within the range of 1-50 percent of PBR, requiring NMFS to classify the fishery as a Category II fishery consistent with section 118 of the MMPA.

Comment 27: HLA opposes including the rough-toothed dolphin (Hawaii stock) on the list of species injured or killed in the Hawaii-based shallow-set fishery. HLA requests that NMFS remove the rough-toothed dolphin from the list of stocks that are interacting with the shallow-set fishery, because the most recent SAR (2013) identifies no observed interactions between the stock and the shallow-set longline fishery.

Response: The 2013 SAR reports marine mammal interactions with the shallow-set fishery that occurred between 2007 and 2011. Although the 2013 SAR does not include observed interactions with rough-toothed dolphins, an interaction was observed between a rough-toothed dolphin and the Hawaii shallow-set longline fishery on April 24, 2013, resulting in a mortality (Carretta et al., 2017b). This interaction has been finalized and is included in the draft 2017 SAR (82 FR 60181, December 19, 2017).

Comment 28: HLA restates a previous comment that the LOF should distinguish between high seas stocks and U.S. EEZ stocks when listing stocks with which fisheries interact, and requests that NMFS revise the LOF to attribute species interactions in transboundary fisheries to only those geographic regions where interactions are actually observed. HLA recommends that if NMFS does not revise the LOF, then they 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. HLA notes that NMFS readily separates transboundary stocks into high seas and U.S. EEZ components for reporting purposes in its SARs and for the purpose of comparing M/SI rates to PBR levels (a trigger for the take reduction planning process), and asserts that the LOF should make similar distinctions when reporting the stocks with which fisheries interact.

Response: This comment has been addressed previously (see 79 FR 14418, March 14, 2014, comment 7; 79 FR 77919, December 29, 2014, comment 5; and 81 FR 20550, April 8, 2016, comment 8). 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 Tables 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 LOFs when species and stocks are added or deleted.

NMFS renames the newly classified fisheries, “AK BSAI groundfish troll” and the “AK Gulf of Alaska groundfish troll,” as listed in the proposed LOF for 2018, to “AK BSAI groundfish hand troll and dinglebar troll” and “AK Gulf of Alaska groundfish hand troll and dinglebar troll,” respectively. This change is the result of public comment on the proposed rule and maintains consistency with the State of Alaska fishery permits.

NMFS corrects the estimated number of vessels/persons for the AK Southeast shrimp pot fishery (Table 1) from 210, as listed in the proposed LOF for 2018, to 99 in the final LOF based on a reanalysis of permit data.

NMFS corrects the estimated number of vessels/persons for the Gulf of Maine, U.S. Mid-Atlantic tuna, shark, swordfish hook-and-line/harpoon in the Atlantic Ocean, Gulf of Mexico, and Caribbean (Table 2) from 3,084, as listed in the proposed LOF for 2018, to 2,846 in the final LOF based on a review of permit data. Permits for this fishery are based on target species rather than gear type, so these numbers indicate the total number of fishers that have the potential to use the specified gear type.

The following summarizes changes to the LOF for 2018, including the classification of fisheries, fisheries listed, 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. NMFS re-classifies two fisheries in the LOF for 2018. Additionally, NMFS adds two fisheries to the LOF and removes 12 fisheries from the LOF. NMFS makes changes to the estimated number of vessels/persons and list of species and/or stocks killed or injured in certain fisheries. The classifications and definitions of U.S. commercial fisheries for 2018 are identical to those provided in the LOF for 2017 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), GOA (Gulf of Alaska), 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 CA thresher shark/swordfish drift gillnet (≥14 inch (in) mesh) fishery from Category I to Category II.

NMFS reclassifies the Category III AK Gulf of Alaska sablefish longline fishery to Category II based on M/SI of North Pacific sperm whales.

NMFS adds the AK BSAI halibut longline fishery as a Category III fishery.

NMFS adds the AK Gulf of Alaska sablefish pot fishery as a Category III fishery.

NMFS removes the following Category III fisheries from the LOF:

NMFS clarifies that the Category II AK BSAI rockfish trawl fishery includes sablefish as a target species.

NMFS adds a superscript “1” to the CA/OR/WA stock of humpback whale to indicate it is driving the Category II classification of the CA spiny lobster fishery.

NMFS renames the Category III AK salmon purse seine (excluding salmon purse seine fisheries listed elsewhere) fishery to AK salmon purse seine (Prince William Sound, Chignik, Alaska Peninsula) fishery.

NMFS clarifies that the Category III AK Gulf of Alaska rockfish trawl fishery includes sablefish as a target species.

NMFS renames the Category III AK food/bait herring trawl fishery to AK Kodiak food/bait herring otter trawl fishery.

NMFS renames the Category III AK shrimp otter trawl and beam trawl (statewide and Cook Inlet) fishery to AK shrimp otter trawl and beam trawl fishery.

NMFS renames the Category III AK State-managed waters of Cook Inlet, Kachemak Bay, Prince William Sound, Southeast AK groundfish trawl fishery to AK State-managed waters of Prince William Sound groundfish trawl fishery.

NMFS combines the Category III AK Aleutian Islands sablefish pot fishery in the LOF with the Category III AK Bering Sea sablefish pot fishery for consistency with other regional designations in the LOF. The combined fishery is named the AK BSAI sablefish pot fishery.

NMFS separates the Category III AK miscellaneous finfish handline/hand troll and mechanical jig fishery into several fisheries by gear and geography for improved fishery categorization of potential impacts to marine mammals. The new Category III fishery names are: (1) AK BSAI groundfish jig, (2) AK BSAI groundfish hand troll and dinglebar troll, (3) AK Gulf of Alaska groundfish jig, (4) AK Gulf of Alaska groundfish hand troll and dinglebar troll.

NMFS renames the Category III AK North Pacific halibut handline/hand troll and mechanical jig fishery to AK halibut jig fishery for clarity and consistency.

NMFS renames the Category III AK urchin and other fish/shellfish fishery to AK miscellaneous invertebrates hand pick fishery for clarity and consistency.

NMFS makes an administrative change to the Category III Alaska scallop dredge fishery to be renamed AK scallop dredge for consistency.

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

NMFS adds the Central North Pacific stock of humpback whale to the list of species and/or stocks incidentally killed or injured in the Category I Hawaii deep-set longline fishery.

NMFS adds the Hawaii stock of Kogia spp. (Pygmy or dwarf sperm whale) to the list of species and/or stocks incidentally killed or injured in the Category I Hawaii deep-set longline fishery.

NMFS adds the CA/OR/WA stock of Dall's porpoise to the list of species and/or stocks incidentally killed or injured in the Category I CA thresher shark/swordfish drift gillnet (≥14 in mesh) 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 Northern Gulf of Mexico stock of rough-toothed dolphin to the list of species and/or stocks incidentally killed or injured in the Category I Atlantic Ocean, Caribbean, Gulf of Mexico large pelagics longline fishery.

NMFS removes the WNA stock of white-sided dolphin from the species and/or stocks listed as incidentally killed or injured in the Category II Mid-Atlantic mid-water trawl fishery.

NMFS adds the WNA stock of white-sided dolphin to the list of species and/or stocks incidentally killed or injured in the Category II Mid-Atlantic bottom trawl fishery.

NMFS adds the WNA offshore stock of bottlenose dolphin to the list of species and/or stocks incidentally killed or injured in the Category III Gulf of Maine, U.S., Mid-Atlantic tuna, shark, swordfish hook-and-line/harpoon fishery.

NMFS adds three stocks to the list of species and/or stocks incidentally killed or injured in the Atlantic Ocean, Gulf of Mexico, Caribbean commercial passenger fishing vessel fishery. The three stocks are: (1) WNA stock of short-finned pilot whale and (2) Barataria Bay estuarine system stock and (3) Mississippi Sound, Lake Borgne, Bay Boudreau stock of bottlenose dolphins.

NMFS corrects three administrative errors in Table 2. Under species and/or stocks listed as incidentally killed or injured in the Atlantic Ocean, Caribbean, Gulf of Mexico large pelagic longline fishery, NMFS updates the stock name for Atlantic spotted dolphin from “GMX continental and oceanic” to “Northern GMX”. Second, in the Atlantic Ocean, Gulf of Mexico, Caribbean commercial passenger fishing vessel fishery, NMFS updates the stock name for bottlenose dolphin from “Southern SC/GA coastal” to “SC/GA coastal”. Lastly, NMFS removes the WNA stocks of Risso's dolphin and white-sided dolphin from the species and/or stocks listed as incidentally injured or killed in the Category I Mid-Atlantic gillnet fishery.

NMFS removes the Category II Atlantic highly migratory species drift gillnet fishery from the LOF as there are currently no participants.

NMFS designates the list of species and/or stocks incidentally killed or injured in a fishery from “undetermined” to “no information” for clarity that no data are available on mortalities or injuries incidental to a particular fishery.

NMFS updates to the estimated number of vessels/persons on the High Seas (Table 3) as follows:

NMFS adds the Hawaii stock of Kogia spp. (Pygmy or dwarf sperm whale) to the list of species and/or stocks incidentally killed or injured in the Category I Western Pacific Pelagic (HI deep-set component) longline fishery.

NMFS adds the Central North Pacific stock of humpback whale to the list of species and/or stocks incidentally killed or injured in the Category I Western Pacific Pelagic (HI deep-set component) longline fishery.

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 fisherman 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 LOF, 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, fishermen 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 fishermen 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.