Federal Register Vol. 81, No.165,

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace extending upward from 700 feet above the surface at Marion Municipal Airport, Marion, OH; Greater Portsmouth Regional Airport, Portsmouth, OH; Van Wert County Airport, Van Wert, OH; and Darke County Airport, Versailles, OH.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-8840/Airspace Docket No. 16-AGL-20.” The postcard will be date/time stamped and returned to the commenter.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.regulations.gov.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX, 76177.

This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface:

Within a 7-mile radius (reduced from a 7.4-mile radius) of Marion Municipal Airport, Marion, OH;

Within a 6.8-mile radius (increased from a 6.4-mile radius) of Greater Portsmouth Regional Airport, Portsmouth, OH, and updating the name and geographic coordinates of Southern Ohio Regional Medical Center Heliport (formerly Southern Ohio Medical Center Helipad), Portsmouth, OH, to coincide with the FAA's aeronautical database;

Within a 6.5-mile radius (reduced from a 7-mile radius) of Van Wert County Airport, Van Wert, OH;

And within a 6.4-mile radius (increased from a 6.3-mile radius) of Darke County Airport, Versailles, OH, removing the segment extending 7 miles west of the airport, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

Airspace reconfiguration is necessary due to the decommissioning of NDBs, cancellation of NDB approaches, and implementation of RNAV procedures at the above airports. Controlled airspace is necessary for the safety and management of the standard instrument approach procedures for IFR operations at the airports.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Kirk Field, Paragould, AR.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-8835/Airspace Docket No. 16-ASW-14.” The postcard will be date/time stamped and returned to the commenter.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.regulations.gov.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius (increased from the 6.4-mile radius) of Kirk Field, Paragould, AR, with an extension south of the airport from the 6.5-mile radius 10.1 miles. Airspace reconfiguration is necessary due to the decommissioning of the NDB, cancellation of NDB approach, and implementation of RNAV procedures at the airport. Controlled airspace is necessary for the safety and management of the standard instrument approach procedures for IFR operations at the airport.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace at Silver Springs Airport, Silver Springs, NV.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-6413/Airspace Docket No. 16-AWP-11.” The postcard will be date/time stamped and returned to the commenter.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.

This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet above the surface at Silver Springs Airport, Silver Springs, NV, to accommodate new standard instrument approach procedures for IFR operations at the airport. The Class E airspace area would be established to within a 2-mile radius of Silver Springs Airport, with segments extending from the 2-mile radius to 9 miles northeast, and 7.5 miles northeast of the airport.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace extending upward from 700 feet above the surface at Levelland Municipal Airport, Levelland, TX; Wilbarger County Airport, Vernon, TX; and Winters Municipal Airport, Winters, TX.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-8828/Airspace Docket No. 16-ASW-13.” The postcard will be date/time stamped and returned to the commenter.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.regulations.gov.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface:

Within a 6.6-mile radius (decreased from a 6.7-mile radius) of Levelland Municipal Airport, Levelland, TX, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

Within a 6.6-mile radius (decreased from a 7-mile radius) of Wilbarger County Airport, Vernon, TX, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

And within a 6.6-mile radius (increased from a 6.3-mile radius) of Winters Municipal Airport, Winters, TX, with an extension to the north of the airport from the 6.6-mile radius to 9.3 miles, and with a new extension to the south of the airport from the 6.6-mile radius to 9.6 miles.

Airspace reconfiguration is necessary due to the decommissioning of NDBs, cancellation of NDB approaches, and implementation of RNAV procedures at these airports. Controlled airspace is necessary for the safety and management of the standard instrument approach procedures for IFR operations at the airports.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Background

In general terms, section 731 of the Tariff Act of 1930, as amended (the Act), provides that when a company is selling foreign merchandise in the United States at less than fair value, and the International Trade Commission determines that an industry is materially injured or threatened with material injury by reason of such sales or imports, the Department shall impose an antidumping duty. Furthermore, section 751 of the Act provides that the Department shall periodically review and determine, upon request, the amount of any antidumping duty. Pursuant to section 773(a) of the Act, the Department's analysis involves a comparison between a company's sales price to, or in, the United States (defined either as export price or constructed export price) with the normal value. See 19 CFR 351.401(a); see also section 772 of the Act (defining export price and constructed export price); section 773 of the Act (defining normal value). Although in most circumstances, sales in the exporting country provide the most appropriate basis for normal value, section 773 of the Act also permits the use of third country sales or constructed value as the basis for normal value. See also 19 CFR 351.404(a).

The Department's regulations identify circumstances in which it may rely upon another basis for normal value. The Department may use a basis other than sales in the exporting country where, pursuant to 19 CFR 351.404(b), the Department determines that the exporting country does not constitute a viable market. 19 CFR 351.404(c). In addition, the Department may use a basis other than sales in the exporting country where a proper comparison between sales in the exporting country and sales in the United States is not possible. 19 CFR 351.404(c)(2)(i).1

In those circumstances where the Department determines that sales in the exporting country do not permit an appropriate comparison to United States sales, “[t]he Secretary normally will calculate normal value based on sales to a third country rather than on constructed value if adequate information is available and verifiable . . .” 19 CFR 351.404(f). Thus, although § 404(f) of the Department's regulations contemplates both sales in a third country and constructed value as bases to calculate normal value, it establishes an order of preference in which the Department “normally” will use sales in a third country. Section 404(f) establishes sales in a third country as the preferred basis to calculate normal value where (1) there are no sales of the foreign like product in the exporting country, (2) there are insufficient sales of the foreign like product in the exporting country and thus the market is not viable, or (3) the Department has otherwise determined it cannot use such sales for purposes of determining normal value pursuant to section 773(a)(1)(B)(i) of the Act.

However, the Department has identified some factors in favor of inverting the current order of preference to use, normally, constructed value rather than sales in a third country. First, the proposed preference for constructed value accords with the TPEA, which amended section 773(b)(2) of the Act, regarding the importance of the cost of production in the Department's analysis of unfair trading behavior. Specifically, the TPEA amended section 773(b)(2) of the Act to require that the Department request cost information from individually examined respondent companies in antidumping proceedings. See Trade Preferences Extension Act of 2015, Public Law 114-27, 129 Stat. 362 (2015). As a consequence, the Department, in all segments of its antidumping duty proceedings for which the complete initial questionnaire was not issued as of August 6, 2015, now requires that parties provide cost of production information, which is necessary information for the use of constructed value. See Dates of Application of Amendments to the Antidumping and Countervailing Duty Laws Made by the Trade Preferences Extension Act of 2015, 80 FR 46793, 46794 (August 6, 2015). Therefore, obtaining constructed value information will not generally impose an additional burden upon the Department or respondent parties. By comparison, the Department would not necessarily already have requested the information necessary to calculate normal value based upon sales in a third country.

Second, constructed value normally may be preferable to sales in a third country because it provides a more appropriate comparison to U.S. prices. Based upon the Department's experience, third country sales sometimes involve products that are similar, but not identical, to the products sold in the United States. See 19 CFR 351.404(e). However, as delineated under sections 773(e) and (f) of the Act, constructed value reflects the costs associated with the production and sale of the merchandise.

Given the foregoing considerations, the Department is issuing this proposed rule to modify the regulations at issue pursuant to Administrative Procedure Act (5 U.S.C. 553) notice and comment procedures; the Department invites comments from all parties.

The Department proposes to modify 19 CFR 351.404(f) and 19 CFR 351.405(a) as indicated below. These modifications, if adopted, are intended to establish an order of preference in which, where the exporting country does not constitute a viable market, the Department normally will calculate normal value using constructed value. Although sales in a third country remain an appropriate basis for normal value in certain circumstances, constructed value would represent the approach “normally” used by the Department.

The Department proposes to make this rulemaking effective for segments of antidumping duty proceedings initiated on or after 30 days following the date of publication of the final rule.

The Department invites parties to comment on this proposed rule and the proposed effective date. Further, any party may submit comments expressing its disagreement with the Department's proposal and may propose an alternative approach.

It has been determined that this proposed rule is not significant for purposes of Executive Order 12866.

This proposed rule contains no new collection of information subject to the Paperwork Reduction Act, 44 U.S.C. chapter 35.

This proposed rule does not contain policies with federalism implications as that term is defined in section 1(a) of Executive Order 13132, dated August 4, 1999 (64 FR 43255 (August 10, 1999)).

The Chief Counsel for Regulation has certified to the Chief Counsel for Advocacy of the Small Business Administration under the provisions of the Regulatory Flexibility Act, 5 U.S.C. 605(b), that the proposed rule would not have a significant economic impact on a substantial number of small business entities.

The entities upon which this rulemaking could have an impact include foreign exporters and producers, some of whom are affiliated with U.S. companies, and U.S. importers. Enforcement & Compliance currently does not have information on the number of entities that would be considered small under the Small Business Administration's size standards for small businesses in the relevant industries. However, some of these entities may be considered small entities under the appropriate industry size standards. Although this proposed rule may indirectly impact small entities that are parties to individual antidumping duty proceedings, it will not have a significant economic impact on any entities.

The proposed action alters the Department's approach in instances where the exporting country does not constitute a viable market or, pursuant to 19 CFR 351.404(c)(2), the Department declines to calculate normal value on the basis of exporting country sales. In particular, it would direct the Department normally to rely upon constructed value, rather than sales in a third country, as the basis for normal value. However, if the proposed rule is implemented, no entities would be required to undertake additional compliance measures or expenditures. Specifically, section 773(b)(2) of the Act now requires that the Department request cost of production information from each examined respondent in every segment of an antidumping duty proceeding. As a result, for those individually examined respondents whose exporting country is not viable or where the Department cannot otherwise use the sales in the exporting country, the Department will already have required submission of the information necessary to calculate normal value based upon constructed value, thus obviating the need to request information on sales in a viable third country. Therefore, the proposed rule would not have a significant economic impact upon a substantial number of small business entities. For this reason, an Initial Regulatory Flexibility Analysis is not required and one has not been prepared.

For the reasons stated, 19 CFR part 351 is proposed to be amended as follows:

I. Background

We are announcing the availability of a draft guidance for industry entitled “Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.

Section 103(c) of the FDA Food Safety Modernization Act (FSMA) directed us to conduct rulemaking to clarify the on-farm activities that would, in part, determine when an establishment is required to register with us as a “facility,” or is not required to register with us because the establishment is a “farm.” To do so, we conducted rulemaking to revise and add farm-related definitions to our existing regulation for Registration of Food Facilities in the same rulemaking documents that we issued to establish our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” in part 117 (21 CFR part 117). (See the final rule at 80 FR 55908, September 17, 2015). For the purposes of the draft guidance, we call that rulemaking “the farm definition rulemaking.” The farm definition rulemaking revised the “farm” definition to provide for two types of farms: (1) Primary production farms and (2) secondary activities farms. The farm definition rulemaking also revised three definitions associated with the “farm” definition (i.e., the definitions of “packing,” “holding,” and “manufacturing/processing”) and added more examples of activities in each of these definitions. The farm definition rulemaking also established a new definition associated with the “farm” definition (i.e., the definition of “harvesting”) and included examples of harvesting activities in the definition. During the farm definition rulemaking, several comments asked us to classify specific on-farm activities as harvesting, packing, holding, or manufacturing/processing so that an operation that conducts these activities on a farm can determine whether conducting that specific activity is within, or outside, the “farm” definition. Some comments asked us to make a table of activities prominently available on our Internet site for easy access whenever the public seeks out information regarding regulations to which these activities apply. (See 80 FR 55908 at 55920.) To address these comments, we announced our intent to issue a draft guidance with our current thinking on the classification of activities as “harvesting,” “packing,” “holding,” or “manufacturing/processing” (80 FR 55908 at 55921). The draft guidance that we are making available implements that stated intent.

The draft guidance provides examples of activities classified as “harvesting,” “packing,” “holding,” or “manufacturing/processing,” as well as activities classified in more than one way. We note that the list of examples of activities classified as “holding” in the draft guidance does not include “repacking and blast freezing . . . when product is not exposed to the environment,” despite our statement in the farm definition rulemaking that such activities would be considered practical necessities for distribution and therefore “holding.” See 80 FR 55908 at 55934 (Comment/Response 44). We made similar statements in a related rulemaking to establish our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” in part 507 (21 CFR part 507) (80 FR 56170, September 17, 2015). See 80 FR 56170 at 56192 (Comment/Response 39). Our prior statements were incorrect and we hereby withdraw them. Neither “repacking” nor “blast freezing” should be considered a “holding” activity. We have thought more about what should be considered a “practical necessity” and are explaining our thinking more in the draft guidance.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 1, subpart H have been approved under OMB control number 0910-0502. The collections of information in part 117 have been approved under OMB control number 0910-0751. The collections of information in 21 CFR part 507 have been approved under OMB control number 0910-0789. The collections of information in 21 CFR part 112 have been approved under OMB control number 0910-0816. The collections of information in 21 CFR part 121 have been approved under OMB control number 0910-0812.

Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm153033.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

On June 8, 2016 (81 FR 36818), the Mine Safety and Health Administration (MSHA) published a proposed rule on Examinations of Working Places in Metal and Nonmetal (MNM) mines. The purpose of this proposed rule is to ensure that mine operators identify and correct conditions that may adversely affect miners' safety or health. MSHA conducted public hearings on the proposed rule on July 19, 21, 26, and August 4, 2016. In response to stakeholder requests, MSHA is providing additional time for interested parties to comment on the proposed rule. MSHA is extending the deadline for comments from September 6, 2016, to September 30, 2016.

Under proposed §§ 56.18002(a)(1) and 57.18002(a)(1), MSHA proposed that metal and nonmetal mine operators promptly notify miners in any affected areas of any conditions found that may adversely affect safety or health and promptly initiate appropriate action to correct such conditions. MSHA received comments and testimony requesting that the Agency clarify the proposed requirement “to promptly notify miners.” Upon consideration of such comments and testimony, MSHA clarifies that “to promptly notify miners” means any notification to the miners that alerts them to adverse conditions in their working place so that they can take necessary precautions to avoid an accident or injury before they begin work in that area. This notification could take any form that is effective to notify affected miners of the particular condition: Verbal notification, prominent warning signage, other written notification, etc. MSHA believes that, in most cases, verbal notification or descriptive warning signage would be needed to ensure that all affected miners received actual notification of the specific condition in question.

MSHA also clarifies that a “prompt” notification would occur before miners are potentially exposed to the condition; e.g., before miners begin work in the affected areas, or as soon as possible after work begins if the condition is discovered while they are working in an area. For example, this notification could occur when miners are given work-shift assignments. MSHA seeks comments on proposed §§ 56.18002(a)(1) and 57.18002(a)(1).

MSHA also clarifies that the proposed rule would not change existing standards regarding conditions that present imminent danger. Like the existing rule, the proposed §§ 56.18002(a)(2) and 57.18002(a)(2) continue to require that conditions that may present an imminent danger which are noted by the person conducting the examination shall be brought to the immediate attention of the operator who shall withdraw all persons from the area affected (except persons referred to in section 104(c) of the Federal Mine Safety and Health Act of 1977) until the danger is abated.

As MSHA stated during the public hearings, the proposed rule would not change the existing definition of working place. Existing §§ 56.2 and 57.2 define “working place” as: “Any place in or about a mine where work is being performed.” Regarding the timing of the examination, some commenters expressed concern that the proposed rule would require mine operators to conduct an examination of the entire mine before the start of each shift. It is not MSHA's intent for the mine operator to examine the entire mine before work begins. The proposal would require an examination of “each working place” “before work begins in an area.” A “working place” is not the entire mine unless miners will be working in all areas of the mine. “Before work begins in an area” may or may not coincide with the start of any particular shift; it depends on when miners actually will be working in any particular working place. The proposed rule, like the existing rule, would require examinations in only those areas where work will be performed. As MSHA stated in the preamble, a “working place” applies to all locations at a mine where miners work in the extraction or milling processes. (81 FR 36821.) MSHA clarifies that consistent with the existing definition of “working place,” this includes roads traveled to and from a work area.

MSHA further explained that a working place would not include roads not directly involved in the mining process, administrative office buildings, parking lots, lunchrooms, toilet facilities or inactive storage areas. Unless required by other standards, mine operators would only be required to examine isolated, abandoned, or idle areas of mines or mills when miners have to perform work in these areas during the shift.

In MSHA's June 8, 2016 Federal Register proposed rule (81 FR 36826), the introductory text of §§ 56.18002(b) and 57.18002(b) stated that the person conducting the examination would be required to sign and date the record before the end of the shift for which the examination was made. MSHA has received a number of comments and heard testimony at the public hearings on stakeholder concerns that the proposed requirement to sign the examination record would increase the potential for liability of miners under section 110(c) of the Mine Act for those who conduct workplace examinations. MSHA notes that Mine Act liability as an “agent” of an operator under section 110(c) relates to the substantive duties and delegated responsibilities of the person in question. The proposed rule language would not change the qualification requirements for the “competent person” (although MSHA asked for comments on this issue). The proposal also would not change the substantive requirements either for the areas to be examined or the adverse conditions for which the examination would be made. While the degree of responsibility a particular person may have at any given mine may vary widely, the single act of printing one's initials or name, as opposed to signing one's name, adds no more and no less to the substantive duties and qualifications of the person who conducts the examination.

Nonetheless, some commenters were concerned that the signature requirement would discourage miners from conducting working place examinations and would have a negative impact on the quality of the examination. MSHA seeks comments on an alternative approach of simply requiring that the name of the competent person, rather than the signature, be included in the examination record.

MSHA received a number of comments and heard testimony at the public hearings seeking clarification on the recordkeeping requirements for adverse conditions found that are immediately corrected. Some commenters were concerned that recording every condition and every corrective action would be an excessive burden to mine operators, especially for small operators. As MSHA stated, the Agency believes that making and maintaining a record of adverse conditions found and corrective actions taken would help mine operators and miners and their representatives become more aware of potential dangers and more proactive in their approach to correcting these issues before they cause or contribute to an accident, injury, or fatality. (81 FR 36819). MSHA seeks information on how mine operators have used the examination record to identify and correct systemic adverse conditions that may contribute to an accident, injury, or fatality. In addition, MSHA seeks comment on possible limitations that would be placed on the mine operators' ability to use the examination record to identify and correct systemic adverse conditions if a record of an adverse condition that is immediately corrected is not made.

MSHA received a number of comments and heard testimony at the public hearings asking if MSHA would require the person conducting the working place examination to wait until the end of the shift to make the record. MSHA clarifies that the proposed rule would allow the competent person conducting the exam to make the record any time before the end of the shift.

MSHA's proposed rule contains changes that would affect the burden in an existing OMB Control Number 1219-0089. MSHA, the Department of Labor, and the Office of Management and Budget are particularly interested in comments related to the recordkeeping requirement that:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

MSHA solicits comments from the mining community on all aspects of the proposed rule. Commenters are requested to be specific in their comments and to provide sufficient detail in their responses to enable proper Agency review and consideration. All comments must be received by September 30, 2016.

On June 8, 2016 (81 FR 36826), MSHA published a request for information on Exposure of Underground Miners to Diesel Exhaust. The request for information seeks input from the public that will help MSHA evaluate the Agency's existing standards and policy guidance on controlling miners' exposures to diesel exhaust to evaluate the effectiveness of the protection now in place to preserve miners' health.

On June 27, 2016, (81 FR 41486), MSHA published a notice in the Federal Register announcing the dates and locations for four public meetings on the request for information. MSHA held meetings on July 19, 21, and 26 and August 4, 2016. In response to requests from the public, MSHA is providing additional time for interested parties to comment. MSHA is extending the comment period from September 6, 2016, to November 30, 2016.

FinCEN exercises regulatory functions primarily under the Currency and Financial Transactions Reporting Act of 1970, as amended by the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (“USA PATRIOT Act”) (Pub. L. 107-56) and other legislation. This legislative framework is commonly referred to as the “Bank Secrecy Act” (“BSA”).1 The Secretary of the Treasury (“Secretary”) has delegated to the Director of FinCEN the authority to implement, administer, and enforce compliance with the BSA and associated regulations.2 Pursuant to this authority, FinCEN may issue regulations requiring financial institutions to keep records and file reports that “have a high degree of usefulness in criminal, tax, or regulatory investigations or proceedings, or in the conduct of intelligence or counterintelligence activities, including analysis, to protect against international terrorism.” 3 Additionally, FinCEN is authorized to impose anti-money laundering (“AML”) program requirements for financial institutions.4

Section 352 of the USA PATRIOT Act requires financial institutions to establish AML programs that, at a minimum, include: (1) The development of internal policies, procedures, and controls; (2) the designation of a compliance officer; (3) an ongoing employee training program; and (4) an independent audit function to test programs.5 Section 352 of the USA PATRIOT Act authorizes FinCEN, in consultation with the “appropriate” Federal functional regulator (using the definition of “Federal functional regulator” found in 15 U.S.C. 6809), to prescribe minimum standards for AML programs. In determining the appropriate scope and nature for this proposed rulemaking for financial institutions that are not directly regulated by any Federal functional regulator under any definition of that term, FinCEN considered the Federal functional regulators of similar institutions, including Federal bank supervisory authorities, the U.S. Securities and Exchange Commission (“SEC”), and the Commodity Futures Trading Commission (“CFTC”), to be “appropriate” Federal functional regulators within the meaning of Section 352. In preparing this rule, FinCEN consulted with these regulators and in order to be certain of addressing all important issues, it also consulted with state bank supervisory authorities, and the Internal Revenue Service (“IRS”), which, to date, has been the examining authority for all institutions regulated by FinCEN that do not have a Federal functional regulator.

When prescribing minimum standards for AML programs, FinCEN must “consider the extent to which the requirements imposed [under section 352 of the USA PATRIOT Act] are commensurate with the size, location, and activities of the financial institutions to which [the standards] apply.” 6 In addition, FinCEN may “prescribe an appropriate exemption from a requirement [in the BSA] or regulations [issued under the BSA].” 7 FinCEN used this authority in 2002 to exempt temporarily certain financial institutions identified in section 352 from the requirement to establish an AML program.

Section 326 of the USA PATRIOT Act requires FinCEN to prescribe regulations that require financial institutions to establish programs for account opening that, at a minimum, include: (1) Verifying the identity of any person seeking to open an account, to the extent reasonable and practicable; (2) maintaining records of the information used to verify the person's identity, including name, address, and other identifying information; and (3) determining whether the person appears on any lists of known or suspected terrorists or terrorist organizations provided to the financial institution by any government agency.8 These programs are referred to as Customer Identification Programs (“CIPs”).

When prescribing CIP regulations for financial institutions that engage in financial activities described in Section 4(k) of the Bank Holding Company Act of 1956, 12 U.S.C. 1843(k), FinCEN must prescribe such CIP regulations jointly with the Federal functional regulator (again using the definition of “Federal functional regulator” found in 15 U.S.C. 6809, but also including the CFTC) that is “appropriate” for the affected financial institutions.9 FinCEN generally considers the Federal functional regulator—if any—that actually regulates a financial institution to be the Federal functional regulator appropriate to promulgate regulations for such a financial institution.10 Specifically with respect to CIP rules, FinCEN has maintained publicly since 2003 that, for a CIP rule that applies to institutions not directly regulated by any Federal functional regulator under any definition of that term, it is not “appropriate” for any Federal agency to issue jointly such a CIP rule with FinCEN, given that no Federal agency has direct supervisory authority over such financial institutions comparable in its pervasiveness to the direct authority of the Federal functional regulators over their regulated financial institutions.11 Consistent with these long-held positions, FinCEN proposes to issue the CIP rule set forth here under its sole authority.

Section 312 of the USA PATRIOT Act requires each U.S. financial institution that establishes, maintains, administers, or manages a correspondent account or a private banking account in the United States for a non-U.S. person to subject such accounts to certain anti-money laundering measures.12 In particular, financial institutions must establish appropriate, specific, and, where necessary, enhanced due diligence policies, procedures, and controls that are reasonably designed to enable the financial institution to detect and report instances of money laundering through these accounts. In addition to the general due diligence requirements, which apply to all correspondent accounts for non-U.S. persons, section 5318(i)(2) specifies additional standards for correspondent accounts maintained for certain foreign banks. Section 5318(i) also sets forth minimum due diligence requirements for private banking accounts for non-U.S. persons. Specifically, a covered financial institution must take reasonable steps to ascertain the identity of the nominal and beneficial owners of, and the source of funds deposited into, private banking accounts, as necessary to guard against money laundering and to report suspicious transactions. The institution must also conduct enhanced scrutiny of private banking accounts requested or maintained for, or on behalf of, senior foreign political figures (which includes family members or close associates). Enhanced scrutiny must be reasonably designed to detect and report transactions that may involve the proceeds of foreign corruption.

The following information describes the effect of certain previous rulemakings on banks, and specifically on banks lacking a Federal functional regulator.

Most banks became subject to an AML program requirement pursuant to the BSA with FinCEN's issuance of an Interim Final Rule on April 29, 2002 (the “Interim Final Rule”).13 The Interim Final Rule stated that an institution regulated by a Federal functional regulator “shall be deemed to satisfy the requirements of 31 U.S.C. 5318(h)(1) if it implements and maintains an [AML] program that complies with the regulation of its Federal functional regulator governing such programs.” 14 “Federal functional regulator” is defined at 31 CFR 1010.100(r) to include each of the Federal banking agencies, as well as the SEC and the CFTC.

The Interim Final Rule also deferred AML program requirements for certain financial institutions, including “private bankers.” 15 On November 6, 2002, FinCEN amended the Interim Final Rule.16 The amendment extended the deferral indefinitely,17 and included within the deferral not only private bankers, but any bank “that is not subject to regulation by a Federal functional regulator.” 18

Although banks that lack a Federal functional regulator have not been required to establish an AML program, they are required to comply with many other BSA requirements. For example, banks that lack a Federal functional regulator still must file currency transaction reports (“CTRs”) and suspicious activity reports (“SARs”), and make and maintain certain records.19 In addition, banks that lack a Federal functional regulator must comply with 31 CFR 1010.630, which prohibits covered financial institutions from maintaining correspondent accounts for foreign shell banks and requires covered financial institutions to obtain and retain information on the ownership of foreign banks.20

Despite being subject to the various BSA obligations detailed above, banks that lack a Federal functional regulator have remained exempt from the AML program requirement since the Interim Final Rule. In contrast, FinCEN has already eliminated the exemption and promulgated AML program rules for other institutions that had been exempted under the Interim Final Rule, including insurance companies, certain loan or finance companies, and dealers in precious metals, precious stones, or jewels.

CIP requirements were finalized, through a joint final rule, for banks, savings associations, credit unions, and certain non-Federally regulated banks on May 9, 2003. With this action, certain banks that lack a Federal functional regulator, namely, private banks, non-federally insured credit unions and certain trust companies, were required to comply with CIP requirements.21 On the same day, FinCEN published a notice of proposed rulemaking that would have imposed CIP requirements on all other state-regulated banks without a Federal functional regulator that were not included in the joint rule.22 This rulemaking was never finalized.

On May 11, 2016, FinCEN published a final rule (“CDD Rule”),23 to clarify and strengthen customer due diligence requirements for certain financial institutions, including federally regulated banks, requiring these financial institutions to identify and verify the identity of the beneficial owners of their legal entity customers, subject to certain exclusions and exemptions. The CDD Rule also amends the AML program requirements for these financial institutions. For purposes of regulatory consistency, FinCEN believes that it is appropriate that these requirements should apply to non-federally regulated banks as well, and accordingly proposes these requirements in this notice.

FinCEN has identified the following categories of banks that lack a Federal functional regulator and is interested in identifying additional categories of such entities. However, no discussion of such entities should be thought to be exhaustive. This NPRM proposes that any entity that meets the definition of bank in 31 CFR 1010.100(d) would be required to establish an AML program.

State-chartered non-depository trust companies are generally smaller than depository (or federally regulated non-depository) trust companies, and often provide estate planning and settlement and trust administration on a regional basis.24 Trust companies can provide services similar to investment advisory firms, including securities investment advisers, but are generally exempt from registration as investment advisers with the SEC.25 Trust companies also may provide services to clients similar to the services offered by other financial services firms. The number of state-chartered non-depository trust companies is difficult to determine; however, according to data available from state banking regulator Web sites, there are upwards of 347 of these entities.26

Of the more than 6,273 credit unions nationwide, FinCEN understands that there are approximately 265 state-chartered credit unions that are not federally insured. Aside from their lack of a Federal functional regulator, these credit unions generally are similar in structure to federally insured credit unions.27

A private bank is a bank chartered under state law that is owned by an individual or a partnership and generally provides financial services to individuals with high net worth.28 Although private banks have a long history in certain jurisdictions, including Switzerland and the United Kingdom, at least one private bank remains in the United States.

According to estimates available from state banking regulator Web sites, the number of state-chartered banks and savings and loan or building and loan associations without Federal Deposit Insurance Corporation (“FDIC”) insurance is not more than 12.29 These banks function similarly to other federally insured banks, but are privately insured.

International banking entities, or “entidades bancarias internacionales” (“EBIs”), are not federally insured, but are authorized by Puerto Rican and the U.S. Virgin Islands law to provide banking and other services to non-resident aliens. As of 2014, 33 EBIs were licensed by Puerto Rico.30

The statutory mandate that all financial institutions establish anti-money laundering programs is a key element in the national effort to prevent and detect money laundering and the financing of terrorism. Banks without a Federal functional regulator may be as vulnerable to the risks of money laundering and terrorist financing as banks with one. This proposed rule would eliminate the present regulatory “gap” in AML coverage between banks with and without a Federal functional regulator. FinCEN expects uniform regulatory requirements for all banks to reduce the opportunity for criminals to seek out and exploit banks subject to less rigorous AML requirements.

FinCEN also believes that imposing an AML program requirement on banks that lack a Federal functional regulator would not be unduly burdensome, given that such banks already must comply with various BSA recordkeeping, reporting, and, in some cases, CIP requirements. In order to comply with these existing rules, banks lacking a Federal functional regulator have likely developed procedures and protocol comparable to what would be required under the proposed rule.

In 2005, uniform BSA examination procedures were issued through the first publication of the Federal Financial Institutions Examination Council Bank Secrecy Act/Anti-Money Laundering Examination Manual.31 FinCEN understands that uniform audits or examinations of policies, procedures, internal controls, reporting structures, transaction monitoring, and recordkeeping have caused many banks that lack a Federal functional regulator to adopt procedures similar to the ones that would be required under the proposed rule.

For the reasons of regulatory consistency and protection against systemic vulnerability discussed above in connection with AML programs, FinCEN believes that CIP should also apply to all banks (including all depository institutions chartered under state banking law, even if the charter was not for a credit union, trust company, or private bank), regardless of whether they are Federally regulated. The preamble of the final CIP rule said that it applied to “banks with a Federal functional regulator and to credit unions, trust companies, and private banks without a federal functional regulator.” However, on the same day that the final CIP rule was issued, FinCEN issued a follow-on Notice of Proposed Rulemaking to ensure that there would be no gaps in the scope of the CIP obligations as they apply to banks.32 Because this proposal was never finalized, FinCEN is also re-proposing changes that would explicitly require all banks that lack a Federal functional regulator to establish CIP.

As noted above, the CDD Rule requires that federally regulated banks and certain other financial institutions identify, and verify the identity of, the beneficial owners of their legal entity customers, as set forth in section 1010.230.33 For purposes of regulatory consistency, FinCEN believes that this requirement should apply to non-federally regulated banks as well.

This notice proposes to amend chapter X by adding AML program requirements for banks that lack a Federal functional regulator, and extending CIP and beneficial ownership requirements to those banks not already subject to these requirements. These proposed changes include the following: (1) Amending the provision in § 1010.205 that exempts certain financial institutions from the requirement to establish an AML program; (2) amending the definition of covered financial institution in § 1010.605 so that non-federally regulated banks will be subject to the beneficial ownership requirements pursuant to the CDD Rule (as well as the requirements in §§ 1010.610 and 1010.620); (3) removing the substantive language in the definitions of bank and financial institution in part 1020, Rules for Banks, because there will no longer be a need to make distinctions from the definitions in part 1010's General Definitions; (4) imposing AML program requirements on banks that lack a Federal functional regulator and prescribing minimum standards for the AML programs; and (5) amending the CIP requirements to delete a specific requirement that until banks without a Federal functional regulator are subject to AML program requirements they must have their CIPs approved by their boards of directors. If the proposed changes are implemented, banks without a Federal functional regulator will be required to implement a written AML program approved by their boards of directors or by equivalent functional units within the banks.

Section 1010.205 provides temporary exemptions for certain financial institutions from the requirement to establish an anti-money laundering program.34 The proposed amendments to 31 CFR 1010.205 reflect the removal of: (1) The exemption for private bankers (§ 1010.205(b)(1)(vi)); (2) the broader exemption for banks that lack a Federal functional regulator (§ 1010.205(b)(2)); and (3) the exemption for persons subject to supervision by a state banking authority (§ 1010.205(b)(3)).

General rules that apply to all industries appear in part 1010, and industry-specific rules are contained in other parts within chapter X. Because the definition of bank in part 1010 makes no distinctions as to whether a bank has a Federal functional regulator, there are no proposed changes to that definition of bank in § 1010.100(d).35 Likewise, there are no proposed changes to the general definition of financial institution in § 1010.100(t).36 Specific rules for banks are contained in part 1020, which includes definitions of both “bank” and “financial institution” specific to that part, to note a distinction in the application of AML program and CIP requirements between banks with a Federal functional regulator and those lacking one. FinCEN proposes to amend those definitions, as described below.

The separate definition of bank in § 1020.100(b) reflects the fact that existing CIP requirements do not apply to all banks that lack a Federal functional regulator. The current definition of bank, for the purposes of 31 CFR 1020.220, is (1) A bank, as that term is defined in 31 CFR 1010.100(d), that is subject to regulation by a Federal functional regulator; and (2) A credit union, private bank, and trust company, as set forth in 31 CFR 1010.100(d) of this chapter, that does not have a Federal functional regulator.37

This rulemaking proposes to remove existing § 1020.100(b), which would result in making all banks, regardless of whether they are subject to regulation by a Federal functional regulator, comply with CIP requirements.

The beneficial ownership requirement in the CDD Rule applies to covered financial institutions as defined in § 1010.605(e)(1). This definition includes several types of banks, all of which are federally regulated,38 as well as brokers and dealers in securities, futures commission merchants and introducing brokers, and mutual funds. In order to apply this requirement to non-federally regulated banks, this rulemaking proposes to amend the current definition of covered financial institution by replacing paragraphs (i) through (vii) of § 1010.605(e)(1) with the following, which includes all banks (whether or not federally regulated) that are subject to an AML program requirement “a bank required to have an anti-money laundering compliance program under the regulations implementing 31 U.S.C. 5318(h), 12 U.S.C. 1818(s), or 12 U.S.C. 1786(q)(1).”

The definition of financial institution in § 1020.100(d) reflects the fact that existing AML program requirements are based on whether a bank is subject to regulation by a Federal functional regulator. The current definition of financial institution is (1) For the purposes of 31 CFR 1020.210, a financial institution is defined in 31 U.S.C. 5312(a)(2) or (c)(1) that is subject to regulation by a Federal functional regulator or a self-regulatory organization; (2) For the purposes of 31 CFR 1020.220, a financial institution is defined in 31 U.S.C. 5312(a)(2) or (c)(1).

This rulemaking proposes to remove existing § 1020.100(d)(1), which along with the proposed amendments to § 1020.210 described below, would result in requiring all banks, regardless of whether they are subject to regulation by a Federal functional regulator, to comply with the obligation to implement an AML program.39

Section 1020.210 (as amended by the CDD Rule) sets forth the current AML program requirements for banks. This rulemaking proposes certain changes necessary to ensure that all banks, regardless of whether they are subject to Federal regulation and oversight, are required to establish and implement anti-money laundering programs. One proposed change concerns the title and structure of the section. Currently, the title reads: “Anti-money laundering program requirements for financial institutions regulated only by a Federal functional regulator, including banks, savings associations, and credit unions.” With the proposed change, the title would read: “Anti-money laundering program requirements for banks,” and it would contain one section for banks regulated only by a Federal functional regulator and another section for banks that lack a Federal functional regulator.

As proposed, § 1020.210(a) would be titled: “Anti-money laundering program requirements for banks regulated only by a Federal functional regulator, including banks, savings associations, and credit unions.” The existing language in § 1020.210 states that compliance by a financial institution regulated by a Federal functional regulator that is not subject to the regulations of a self-regulatory organization satisfies the AML program requirement under 31 U.S.C. 5318(h)(1) if its program complies with the requirements of §§ 1010.610 and 1010.620 and the regulations of its Federal functional regulator governing AML programs. FinCEN is unaware of any instance in which a bank is subject to regulations by a self-regulatory organization. Accordingly, FinCEN proposes to remove reference to such regulation from the regulatory text, by striking the words “that is not subject to the regulations of a self-regulatory organization.” This proposed change would appear in § 1020.210(a).40

Proposed new § 1020.210(b) would be titled: “Anti-money laundering program requirements for banks lacking a Federal functional regulator including, but not limited to, private banks, non-federally insured credit unions, and certain trust companies.” New § 1020.210(b)(1) would require banks that lack a Federal functional regulator to establish and implement AML programs reasonably designed to assure ongoing compliance with the Bank Secrecy Act. Section 1020.210(b)(1)(ii)(E) would require compliance with due diligence requirements for correspondent accounts for foreign financial institutions (§ 1010.610) and for private banking accounts (§ 1010.620), and new § 1020.210(b)(1) also would prescribe the minimum standards necessary for an AML program.

With respect to minimum standards, proposed § 1020.210(b)(1)(ii)(A) would require that the AML program include a system of internal controls to assure ongoing compliance with the BSA. As part of implementing an AML program, FinCEN would expect banks that lack a Federal functional regulator to assess the money laundering and terrorist financing risks that are associated with their products, customers, distribution channels, and geographic locations. An assessment of customer-related information is a key component to a robust AML program, and banks must ensure that they obtain all the information necessary for their AML program requirements. For purposes of making the required risk assessment, banks have discretion to determine how best to collect the relevant customer information. FinCEN does not anticipate that this requirement will entail obtaining information not already obtained in the ordinary course of business. Policies, procedures, and internal controls also must be reasonably designed to ensure compliance with BSA requirements. Banks may conduct some of their operations through agents and third-party service providers. Some elements of the compliance program may best be performed by personnel of these entities, in which case it is permissible for banks to contract with such entities to assist them with implementation and operation of those aspects of its AML program. Any bank that contracts with an agent or third party to assist with aspects of its AML program, however, remains fully responsible for the effectiveness of the program, as well as ensuring that compliance examiners are able to obtain information and records relating to the AML program.

Proposed § 1020.210(b)(1)(ii)(B) would require that the program provide for independent testing to monitor and maintain an adequate program. A party external to the bank, such as an outside consultant or accountant, need not perform the testing. The testing may be conducted by an officer, employee, or group of employees, so long as the person or persons conducting the testing are independent of the person or group of persons primarily responsible for implementing the bank's AML program. The frequency of independent testing will depend upon the risks posed.41 Any recommendations that result from the independent testing should be implemented promptly or reviewed by senior management.

Proposed § 1020.210(b)(1)(ii)(C) would require that the bank designate a person or persons who will be responsible for coordinating and monitoring day-to-day compliance with the AML program. The bank may have one individual, or the bank may designate multiple individuals to perform the function as a group. The person or persons should be competent and knowledgeable regarding BSA requirements and money laundering issues and risks, and should be empowered with full responsibility and authority to develop and enforce appropriate policies and procedures. The role of this function is to ensure that the program is implemented effectively and updated as necessary.

Proposed § 1020.210(b)(1)(ii)(D) would require that the program provide for training of appropriate persons. Employee training is an integral part of any AML program. In order to carry out their responsibilities effectively, employees must be trained in requirements under the BSA and money laundering risks generally, as well as the internal policies and procedures of the institution, so that red flags can be identified. Such training may be conducted by third parties or in-house, and may include computer-based training. Employees should receive periodic updates and refreshers to such training. The nature, scope, and frequency of training would depend upon the functions performed by employees.

Proposed § 1020.210(b)(1)(ii)(E) would require that the program include, at a minimum, appropriate risk-based procedures for conducting ongoing customer due diligence, to include, but not be limited to, understanding the nature and purpose of customer relationships for the purpose of developing a customer risk profile; and conducting ongoing monitoring to identify and report suspicious transactions and, on a risk basis, to maintain and update customer information. For purposes of this proposed paragraph, customer information would include information regarding the beneficial owners of legal entity customers (as defined in § 1010.230). FinCEN views this not as a new requirement, but as an explicit statement of the activities that are already required of covered financial institutions in order to monitor for, and detect and report, suspicious transactions.42

Proposed § 1020.210(b)(2) would require that an AML program be approved by the bank's board of directors or, if the bank does not have a board of directors, an equivalent function within the bank. Additionally, a bank would be required to make a copy of its AML program available to FinCEN or its designee upon request.43

Currently, the title reads: Section 1020.220, “Customer identification programs for banks, savings associations, credit unions, and certain non-Federally regulated banks.” With the proposed change, the title would read: “Customer identification program requirements for banks.” This proposed change recognizes that going forward CIP requirements would apply to all banks.

The proposed changes would also delete an unnecessary reference in § 1020.220 that stipulates that credit unions, private banks, and trust companies without a Federal functional regulator must seek board approval for their CIPs. With finalization of this proposal, banks lacking a Federal functional regulator would be required to implement a written AML program approved by their boards of directors. Since CIP would be part of their AML programs, which must be approved by their boards of directors, it would no longer be necessary to stipulate a separate approval of CIP in this section.

FinCEN welcomes comment on all aspects of the proposed rule. In addition, FinCEN seeks comment on the following issues:

• Whether certain banks lacking a Federal functional regulator should be excluded from the proposed rule;

• Whether there are additional bank categories that should be included in the proposed rule;

• Whether non-federally regulated banks should be subject to the requirements contained in the CDD Rule;

• If the requirements contained in the CDD Rule and under Section 312 are imposed on non-federally regulated banks, what time period should be given to these institutions to implement such requirements; and

• Whether there are banks that are, in fact, regulated by self-regulatory organizations.

When an agency issues a rulemaking proposal, the Regulatory Flexibility Act (“RFA”) requires the agency to “prepare and make available for public comment an initial regulatory flexibility analysis” that will “describe the impact of the proposed rule on small entities.” (5 U.S.C. 603(a).) Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the proposed rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

The statutory mandate that all financial institutions establish anti-money laundering programs is a key element in the national effort to prevent and detect money laundering and the financing of terrorism. Banks without a Federal functional regulator may be as vulnerable to the risks of AML and terrorist financing as banks with one. This proposed rule would eliminate the present regulatory “gap” in AML coverage between banks with and without a Federal functional regulator. FinCEN expects that uniform regulatory requirements for all banks will reduce the opportunity for criminals to seek out and exploit banks subject to less rigorous AML requirements.

For the reasons of regulatory consistency and protection against systemic vulnerability discussed above in connection with AML programs, FinCEN believes that CIP should also apply to all banks (including all depository institutions chartered under state banking law, even if the charter was not for a credit union, trust company, or private bank), regardless of whether they are Federally regulated. In July 2002, FinCEN issued a Notice of Proposed Rulemaking to ensure that there would be no gaps in the scope of the CIP obligations as they apply to banks. Because this proposal was never finalized, FinCEN is also re-proposing changes that would explicitly require all banks that lack a Federal functional regulator to establish CIP.

As noted above, the CDD Rule requires that from and after May 11, 2018, federally regulated banks and certain other financial institutions identify, and verify the identity of, the beneficial owners of their legal entity customers, as set forth in section 1010.230. For purposes of regulatory consistency, FinCEN believes that this requirement should apply to non-federally regulated banks as well.

Section 352 of the USA PATRIOT Act requires financial institutions to establish AML programs that, at a minimum, include: (1) The development of internal policies, procedures, and controls; (2) the designation of a compliance officer; (3) an ongoing employee training program; and (4) an independent audit function to test programs. In addition, the CDD Rule described above adds an explicit requirement to conduct ongoing monitoring.

Section 326 of the USA PATRIOT Act requires FinCEN to prescribe regulations that require financial institutions to establish programs for account opening that, at a minimum, include: (1) Verifying the identity of any person seeking to open an account, to the extent reasonable and practicable; (2) maintaining records of the information used to verify the person's identity, including name, address, and other identifying information; and (3) determining whether the person appears on any lists of known or suspected terrorists or terrorist organizations provided to the financial institution by any government agency.

Section 312 of the USA PATRIOT Act requires each U.S. financial institution that establishes, maintains, administers, or manages a correspondent account or a private banking account in the United States for a non-U.S. person to subject such accounts to certain anti-money laundering measures.

Based upon current data, for the purposes of RFA, FinCEN estimates that these rules will impact approximately 347 state chartered non-depository trust companies; 265 state-chartered credit unions that are not federally insured; 12 state-chartered banks and savings and loan or building and loan associations without FDIC insurance; and 115 EBIs licensed in Puerto Rico.44 FinCEN believes it is likely that most or all of the non-federally insured credit unions are small entities, and has no data on the size of the other entities subject to this rulemaking, and therefore assumes that many of them are small entities. Therefore, FinCEN concludes that the proposed rules will apply to a substantial number of small entities.

The proposed rules would prescribe minimum standards for AML programs for banks without a Federal functional regulator to ensure that all banks, regardless of whether they are subject to Federal regulation and oversight, are required to establish and implement written AML programs, including conducting ongoing customer due diligence, and to identify and verify the identity of the beneficial owners of their legal entity customers. The changes would also extend customer identification program requirements to those banks not already subject to these requirements.

Banks lacking a Federal functional regulator are currently required to comply with many existing requirements under the BSA. All banks, including those not subject to Federal regulation and oversight, are already required to file SARs, which necessarily requires a bank to establish a process to detect unusual activity. Certain banks lacking a Federal functional regulator—namely, private banks, non-federally insured credit unions, and certain trust companies—must maintain CIPs. Uniform audits at the state and Federal levels may have caused banks lacking a Federal functional regulator to adopt procedures similar to the ones that would be required under the AML program requirement of the proposed rule.

With respect to the beneficial ownership requirement, the proposed rule would require banks lacking a Federal functional regulator to obtain and maintain the identity of each beneficial owner from each legal entity customer that opens a new account, including name, address, date of birth and identification number. The financial institution would also be required to verify such identity by documentary or non-documentary methods and to maintain in its records for five years a description of (1) any document relied on for verification, (2) any such non-documentary methods and results of such measures undertaken, and (3) the resolution of any substantive discrepancies discovered in verifying the identification information.

The burden on a small non-federally regulated bank at account opening resulting from the final rule would be a function of the number of beneficial owners of each legal entity customer opening a new account, the additional time required for each beneficial owner, and the number of new accounts opened for legal entities by the small banks during a specified period.

None of the small businesses that commented on the CDD Rule's Initial Regulatory Flexibility Analysis (“IRFA”) included an estimate of the amount of time to open a legal entity account; only one noted the number of such accounts it opens per year (70). As a result of the comments FinCEN received to the CDD Rule's-related regulatory impact assessment from other commenters, FinCEN concluded in its Final Regulatory Flexibility Analysis (“FRFA”) 45 that the estimated time for financial institutions to open accounts ranges from 20 to 40 minutes. Based on opening 471 new accounts for legal entities and an average wage of $16.77 for “new account clerks,” 46 this would result in an annual cost to a small bank of $2,550 to $5,100.47 FinCEN also notes that, even among small entities, the costs could be expected to vary substantially.48

In addition, compliance with the beneficial ownership requirement would be expected to require additional training, information technology upgrades, and revisions to policies, procedures, and internal controls. A discussion of the estimated costs for these tasks for small entities is included in the CDD Rule FRFA referred to above.

FinCEN is unaware of any existing Federal regulations that would overlap or conflict with the amendments being proposed.

FinCEN has not identified any alternative means for bringing these categories of non-federally regulated banks into compliance with the same standards as all other banks in the United States. Were FinCEN to exempt small entities from this requirement, those entities would potentially be at greater risk of abuse by money launderers and other financial criminals.

With respect to the CDD pillar of the AML program rule, FinCEN considered several alternatives to that which is being proposed. As described in greater detail elsewhere,49 these alternatives included exempting small financial institutions below a certain asset or legal entity customer threshold from the requirements, as well as utilizing a lower (e.g., 10 percent) or higher (e.g., 50 percent) threshold for the minimum level of equity ownership for the definition of beneficial owner. FinCEN determined, however, that identifying the beneficial owner of a financial institution's legal entity customers and verifying that identity are necessary parts of an effective AML program. Were FinCEN to exempt small entities from this requirement, or entities that establish fewer than a limited number of accounts for legal entities, those financial institutions would be at greater risk of abuse by money launderers and other financial criminals, as criminals would identify institutions without this requirement. FinCEN also considered increasing the threshold for ownership of equity interests in the definition of beneficial ownership to 50 percent or more of the equity interests. Although this higher threshold would reduce the number of individuals whose identity would need to be verified from five to three, thus reducing marginally the onboarding time, this change would not impact the training or IT costs, and therefore, would not substantially reduce the overall costs of the rule and also would provide less useful information. After considering all the alternatives FinCEN has concluded that an ownership threshold of 25 percent is appropriate to maximize the benefits of the requirement while minimizing the burden.

Please provide comment on any or all of the provisions of the proposed rule with regard to their economic impact on small entities, and what less burdensome alternatives, if any, FinCEN should consider.

Section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), Public Law 104-4 (March 22, 1995), requires that an agency prepare a budgetary impact statement before promulgating a rule that may result in expenditure by the State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 202 of the Unfunded Mandates Act also requires an agency to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. Taking into account the factors noted above and using conservative estimates of average labor costs in evaluating the cost of the burden imposed by the proposed regulation, FinCEN has determined that it is not required to prepare a written statement under section 202.

Executive Orders 13563 and 12866 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that this is not a significant regulatory action for purposes of Executive Order 12866. Accordingly, a regulatory impact analysis is not required.

The collection of information contained in this proposed rule is being submitted to the Office of Management and Budget for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). Comments on the collection of information should be sent (preferably by fax (202-395-6974)) to the Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Office of Management and Budget, Paperwork Reduction Project (1506), Washington, DC 20503, or by the Internet to [email protected], with a copy to FinCEN by mail or the Internet. Comments on the collection of information should be received by October 24, 2016.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to the Paperwork Reduction Act unless it displays a valid control number assigned by the Office of Management and Budget.

The collection of information in the proposed rule would be codified at 31 CFR 1020.210, 1020.220, and 1020.230. The information will be used by examining agencies to verify compliance with these provisions. The collection of information is mandatory. Records required to be retained under the BSA must be retained for five years.

Description of Recordkeepers: Banks without a Federal functional regulator, as defined in 31 CFR 1020.210 and 1020.220.

Estimated Number of Affected Institutions: 1,151.

Estimated Average Annual Burden Hours per Recordkeeper: Since this is a new requirement, the estimated average burden associated with the recordkeeping requirement in this proposed rule is 40 hours for development of a written program, and following the initial development, the program must be reviewed on an annual basis, to include a one (1) hour per year burden recognized for annual maintenance and update.

Estimated Total Annual Reporting Burden: 46,040 hours.

This burden will be added to the existing burden listed under OMB Control Number 1506-0035 currently titled AML Programs for insurance companies and loan and finance companies. The new title for this control number will be AML Programs for insurance companies, and residential mortgage lenders and originators, and banks that lack a Federal functional regulator. The new total burden will be 140,240 hours.

Questions for comment: (1) Whether the collection of information is necessary for the proper performance of FinCEN's mission, including whether the information will have practical utility; (2) Whether FinCEN's estimate of the burden of the collection of information is accurate; (3) What are ways to enhance the quality, utility, and clarity of the information to be collected; (4) What are ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology; (5) What are the estimates of capital or start-up costs to implement and then maintain an AML program; (6) How many banks that lack a Federal functional regulator are considered “small businesses” because the entities have less than $550 million in total assets; (7) What is the average number of employees or the average total annual salary expense for banks that lack a Federal functional regulator; and (8) What is the average number of employees dedicated to bank regulation compliance.

For the reasons set forth in the preamble, parts 1010 and 1020 of chapter X of title 31 of the Code of Federal Regulations are proposed to be amended as follows:

The revision reads as follows:

In the “Rules and Regulations” section of this Federal Register, the EPA is approving the State's SIP revision as a direct final rule without prior proposal because the agency views this as a noncontroversial SIP revision and anticipates no adverse comments. A detailed rationale for the approval is set forth in the preamble to the direct final rule.

If the EPA receives no adverse comments, the EPA will not take further action on this proposed rule. If the EPA receives adverse comments, the EPA will withdraw the direct final rule and it will not take effect. The EPA will address all public comments in a subsequent final rule based on this proposed rule.

The EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information, please see the ADDRESSES section of this notice.

Please note that if the EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. See the information provided in the Direct Final action of the same title which is located in the Rules and Regulations Section of this Federal Register.

In the Rules and Regulations section of this Federal Register, EPA is approving the state's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules and Regulations section of this Federal Register.

Section 181(b)(2) of the CAA requires EPA to determine, within 6 months of an ozone nonattainment area's attainment date, whether that area attained the ozone standard by that date. Section 181(b)(2) of the CAA also requires that areas that have not attained the standard by their attainment deadlines be reclassified to either the next higher classification (e.g., marginal to moderate, moderate to serious, etc.) or to the classifications applicable to the areas' design values in Table 1 of 40 CFR 51.1103. CAA section 181(a)(5) provides a mechanism by which the EPA Administrator may grant a 1-year extension of an area's attainment deadline, provided that the relevant states meet certain criteria.

On July 18, 1997, EPA promulgated a revised ozone NAAQS of 0.08 parts per million (ppm), averaged over eight hours. 62 FR 38855. This standard was determined to be more protective of public health than the previous 1979 1-hour ozone standard. In 2008, EPA revised the 8-hour ozone NAAQS from 0.08 to 0.075 ppm (the 2008 ozone NAAQS). See 73 FR 16436 (March 27, 2008). In a May 21, 2012 final rule, the Pittsburgh Area was designated as marginal nonattainment for the more stringent 2008 ozone NAAQS, effective on July 20, 2012. 77 FR 30088. The Pittsburgh Area consists of Allegheny, Armstrong, Beaver, Butler, Fayette, Washington, and Westmoreland Counties in Pennsylvania. See 40 CFR 81.339.

In a separate rulemaking action, also published on May 21, 2012 and effective on July 20, 2012, EPA established the air quality thresholds that define the classifications assigned to all nonattainment areas for the 2008 ozone NAAQS (the Classifications Rule). 77 FR 30160. This rule also established December 31 of each relevant calendar year as the attainment date for all nonattainment area classification categories. Section 181 of the CAA provides that the attainment deadline for ozone nonattainment areas is “as expeditiously as practicable” but no later than the prescribed dates that are provided in Table 1 of that section. In the Classifications Rule, EPA translated the deadlines in Table 1 of CAA section 181 for purposes of the 2008 standard by measuring those deadlines from the effective date of the new designations, but extended those deadlines by several months to December 31 of the corresponding calendar year. Pursuant to a challenge of EPA's interpretation of the attainment deadlines, on December 23, 2014, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) issued a decision rejecting, among other things, the Classifications Rule's attainment deadlines for the 2008 ozone nonattainment areas, finding that EPA did not have statutory authority under the CAA to extend those deadlines to the end of the calendar year. NRDC v. EPA, 777 F.3d 456, 464-69 (D.C. Cir. 2014). Accordingly, as part of the final SIP Requirements Rule for the 2008 ozone NAAQS (80 FR 12264, March 6, 2015), EPA modified the maximum attainment dates for all nonattainment areas for the 2008 ozone NAAQS, consistent with the D.C. Circuit's decision. The State Implementation Plan (SIP) Requirements Rule established a maximum deadline for marginal nonattainment areas of three years from the effective date of designation, or July 20, 2015, to attain the 2008 ozone NAAQS. See 80 FR at 12268; 40 CFR 51.1103.

In a final rulemaking action published on May 4, 2016, EPA determined that the Pittsburgh Area did not attain the 2008 ozone NAAQS by its July 20, 2015 attainment date, based on ambient air quality monitoring data for the 2012-2014 monitoring period. In that same action, EPA determined that the Pittsburgh Area qualified for a 1-year extension of its attainment date, as provided in section 181(a)(5) of the CAA and interpreted by regulation at 40 CFR 51.1107. The new attainment date for the Pittsburgh Area is July 20, 2016. See 81 FR 26697 (May 4, 2016).

Under EPA regulations at 40 CFR part 50, appendix P, the 2008 ozone NAAQS is attained at a monitoring site when the three-year average of the annual fourth highest daily maximum 8-hour average ambient air quality ozone concentration is less than or equal to 0.075 ppm. This three-year average is referred to as the design value. When the design value is less than or equal to 0.075 ppm at each ambient air quality monitoring site within the area, then the area is deemed to be meeting the NAAQS. The rounding convention under 40 CFR part 50, appendix P dictates that concentrations shall be reported in ppm to the third decimal place, with additional digits to the right being truncated. Thus, a computed three-year average ozone concentration of 0.0759 ppm or lower would meet the standard, but 0.0760 ppm or higher is over the standard.

EPA's determination of attainment is based upon data that has been collected and quality-assured in accordance with 40 CFR part 58 and recorded in EPA's Air Quality System (AQS) database. Ambient air quality monitoring data for the three-year period must meet a data completeness requirement. The ambient air quality monitoring data completeness requirement is met when the three-year average of the percent (%) of required monitoring days with valid ambient monitoring data is greater than 90%, and no single year has less than 75% data completeness, as determined according to appendix P of part 50. Tables 1 and 2 show the data completeness and ozone design values, respectively, for each monitor in the Pittsburgh Area for the years 2013-2015.

As shown in Table 1, several monitoring sites do not meet the completeness criteria set out in 40 CFR part 50, appendix P. However, the reasons for the completeness issues were either monitor shutdowns or startup, approved into PADEP's and ACHD's monitoring plans. Because three years of complete data is not possible at these monitoring sites, EPA does not look for valid design values at these sites. However, the circumstances are different for monitoring sites 420031005 and 420031008. The ozone monitor was moved from monitoring site 420031005 to monitoring site 420031008. These sites are within 0.25 miles of each other, and are at similar elevations. Therefore, EPA is able to consider the data at both monitoring sites as representing the same area, and can combine the data for these two locations to calculate a valid design value. When data from both locations is considered, the three-year average completeness is 97%.

Consistent with the requirements contained in 40 CFR part 50, EPA has reviewed the ozone ambient air quality monitoring data for the monitoring period from 2013 through 2015 for the Pittsburgh Area, as recorded in the AQS database. As shown in Table 2, all valid 2013-2015 design values are less than or equal to 0.075 ppm. Therefore, the Pittsburgh Area has attained the 2008 ozone NAAQS, considering 2013-2015 data.

EPA evaluated ozone data from air quality monitors in the Pittsburgh Area in order to determine the area's attainment status under the 2008 ozone NAAQS. State and local agencies responsible for ozone air monitoring networks supplied and quality assured the data. All the monitoring sites with valid data had design values equal to or less than 0.075 ppm based on the 2013-2015 monitoring period. Considering that review, EPA has concluded that this area attained the 2008 ozone NAAQS based on complete, quality assured and certified data for the 2013-2015 ozone seasons. Thus, EPA proposes to determine, in accordance with its statutory obligations under section 181(b)(2)(A) of the CAA and the provisions of the SIP Requirements Rule (40 CFR 51.1103), that the Pittsburgh Area attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2016.

This proposed determination of attainment does not constitute a redesignation to attainment. Redesignations require states to meet a number of additional criteria, including EPA approval of a state plan to maintain the air quality standard for 10 years after redesignation. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.

This rulemaking action proposes to make a determination of attainment on the 2008 ozone NAAQS based on air quality and, if finalized, would not impose additional requirements. For that reason, this proposed determination of attainment:

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

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

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

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

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

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

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

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

In addition, this proposed rule, proposing to determine that the Pittsburgh Area attained the 2008 ozone NAAQS by its July 20, 2016 attainment date, does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because this proposed determination of attainment does not apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

2. Tips for preparing your comments. When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register, date, and page number);

• Follow directions and organize your comments;

• Explain why you agree or disagree;

• Suggest alternatives and substitute language for your requested changes;

• Describe any assumptions and provide any technical information and/or data that you used;

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced;

• Provide specific examples to illustrate your concerns, and suggest alternatives;

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats; and

• Make sure to submit your comments by the comment period deadline identified.

A. On January 28, 2013, the State of North Dakota submitted a SIP revision containing amendments to Article 33-15 Air Pollution Control rules. The amendments: Update the PSD rules; add PM2.5 methods of measurement; revise permit fee processing; remove permitting fees for sources that operate an air monitoring site; and make clarifying changes. The North Dakota State Health Council adopted the amendments on August 14, 2012 (effective January 1, 2013).

B. On April 22, 2014, the State of North Dakota submitted a SIP revision containing amendments to Article 33-15 Air Pollution Control rules. The amendments: Update the PSD rules and the definition of “volatile organic compounds”; revise the PM2.5 state ambient air quality standard and permissible open burning rule; and clarify excess emissions reporting requirements. The North Dakota State Health Council adopted the amendments on February 11, 2014 (effective April 1, 2014).

We evaluated North Dakota's January 28, 2013 and April 22, 2014 submittals regarding revisions to the State's Air Pollution Control rules. We propose to approve some of the revisions and not act on other revisions.

The State's January 28, 2013 SIP submittal includes the following types of amendments to the State's air quality rules: Revisions to update State-specific additions to the incorporation by reference of the PSD rules; revisions to add PM2.5 methods of measurement; revisions to remove permitting fees for sources that operate an air monitoring site; and a revision to streamline the administrative fee process. The revisions also make clarifying changes.

The January 2013 submittal adds a sentence to 33-15-01-13.3, “[t]he provisions of this subsection do not apply to sources that are subject to monitoring requirements in chapter 33-15-21,” to clarify that the alternative monitoring requirements in this rule do not apply to sources that are required to comply with the acid rain rules and exempts sources subject to acid rain requirements in chapter 33-15-21, Acid Rain Program, from the continuous emission monitoring system (CEMS) failures requirements found in 33-15-01-13.3 of the General Provisions chapter. Instead, 33-15-21-09.1 requires that CEMS monitoring, recordkeeping, and reporting requirements found in 40 CFR part 75 and its appendices apply to sources subject to acid rain requirements. This revision is for clarification purposes, and we propose to approve it. Likewise, we propose to approve the State's revisions to 33-15-05-04.3 that indicate PM2.5 measurements must be made in accordance with 40 CFR 51, Appendix M, Recommended Test Methods for State Implementation Plans and clarifies the definition of PM10 determinations under the same method.

The State revised section 33-15-14-02.13.c(4) by deleting “or are subject to a standard under chapter 33-15-22,” to clarify that sources subject to the national emission standards for hazardous air pollutants (40 CFR part 63) in chapter 33-15-22, Emissions Standards for Hazardous Air Pollutants for Source Categories, do not need a permit to construct if they meet the exemption requirements found in 33-15-14-02.13. The State requested this revision to clarify that sources at minor facilities do not require a permit. Since the North Dakota SIP already exempts engine sources whose emissions are below certain thresholds (see 33-15-14-02.13(c)(1), (2), (3)) and also requires major hazardous air pollutant sources subject to maximum achievable control technology (MACT) to obtain a permit (see 33-15-22), we agree that this revision is for clarification purposes and propose to approve it.

The State makes a number of revisions in their January 28, 2013 submittal to their PSD rules found in chapter 33-15-15; some of the revisions we approved in prior actions, while other revisions were superseded by subsequent SIP submittals. First, the State updates the incorporation by reference date in 33-15-15-01.2 for 40 CFR 52.21, paragraphs (a)(2) through (e), (h) through (r), (v), (w), (aa) and (bb) to as they exist on January 1, 2012. We acted on the approval of incorporating 40 CFR 52.21(b)(14)(i) through (iii); (b)(15)(i) and (ii); and paragraph (c) pertaining to major and minor source baseline dates and ambient air increments in our July 30, 2013 final rule (78 FR 45866) approving the State's demonstration that the North Dakota SIP meets the infrastructure requirements of the CAA for the National Ambient Air Quality Standards (NAAQS) promulgated for PM2.5 on July 18, 1997 and on October 17, 2006. In doing so, paragraphs (b)(14)(i) through (iii); (b)(15)(i) and (ii); and paragraph (c) were added to 40 CFR 52.1829 as paragraphs (c) and (d). We are proposing to not act on incorporating the remainder of 40 CFR 52.21 as they exist on January 1, 2012, because this revision is superseded by the revision in the State's April 22, 2014 submittal to incorporate the same portions of 40 CFR 52.21 as they existed on July 1, 2013.

There are additional revisions in the State's January 28, 2013 PSD rules in 33-15-15-01.2. that we propose to approve. First, the State relocates 40 CFR 52.21(b)(50)(i)(c) and (b)(50)(i)(d) to correct numerical order. Second, the State revises 40 CFR 52.21(d) consistent with the federal rule at the same citation by changing “[n]o concentration of a contaminant shall exceed the ambient air quality standards in chapter 33-15-02 for these areas subject to regulation under this article and the national ambient air quality standards in all other areas of the United States” to “[n]o concentration of a contaminant shall exceed: (1) The concentration permitted under the national primary and secondary ambient air quality standards. (2) The concentration permitted by the ambient air quality standards in chapter 33-15-02.” Third, the State revises 40 CFR 52.21(k)(1) consistent with the federal regulations at 40 CFR 52.21(k)(1)(i) by changing “[a]ny ambient air quality standard in chapter 33-15-02 for those areas subject to regulation under this article and the national ambient air quality standards in all other areas of the United States; or” to “[a]ny national ambient air quality standard or any standard in chapter 33-15-02.” The State recognizes their current regulations inadvertently do not include (i) after 40 CFR 52.21(k)(1) and will revise the language to read 40 CFR 52.21(k)(1)(i) in a future submittal.1 Fourth, the State also revised 40 CFR 52.21(v)(2)(iv)(a) consistent with the federal rule at the same citation by adding “national ambient air quality standard or any” and deleting “regulation under this article and the national ambient air quality standards in all other areas of the United States.” We propose to approve all of these changes.

We also propose to approve in the January 28, 2013 submittal revisions to chapter 33-15-23, Fees, allowing billing statements to be sent to applicants before final determinations have been made (33-15-23-02.2.c) and removing the permit fee for sources that operate an air monitoring site (33-15-23-03.1). CAA section 110(a)(2)(E) requires that a state implementation plan provide assurances that the state will have, among other items, adequate funding to carry out the implementation plan. Sending billing statements earlier than currently required under the SIP impacts the timing of when the fees are billed and collected. Therefore, it is appropriate to propose to approve because the change impacts the timing. The deletion of the criteria that describe this category is approvable because under 33-15-23-03.2 North Dakota will continue to charge fees to sources based on actual costs incurred by the State for the following: (1) Observation of source or performance specification testing; and (2) audits of source operated ambient air monitoring networks.

In this submittal, the State also made clarifying revisions to three other SIP provisions. First, the State modified the abbreviation of PM10 (33-15-01-05) by adding the phrase “less than or equal” and deleting the less than or equal to symbol. Second, the State moved and modified language related to agricultural practices and fugitive emissions from chapter 33-15-17 Restriction of Fugitive Emission to chapter 33-15-03 Restriction of Emissions of Visible Air Contaminants (the State deleted from 33-15-17-02.6 “[a]gricultural activities related to the normal operations of a farm shall be exempt from the requirements of this section. However, agricultural practices such as tilling of land, application of fertilizers, and the harvesting of crops shall be managed in such a manner as to minimize dust from becoming airborne,” and then added the following sentence to 33-15-03-04.5 “[h]owever, agricultural practices such as tilling of land, application of fertilizers, harvesting of crops, and other activities shall be managed in such a manner as to minimize dust from becoming airborne”). In doing this the State modified the existing SIP by removing the exemption and requirement related to agricultural activities and fugitive dust under chapter 33-15-17, Restriction of Fugitive Emissions, and adding the same requirement related to agricultural activities and fugitive dust to chapter 33-15-03, Restriction of Emission of Visible Air Contaminants. We view these changes as non-substantive, SIP-strengthening, and clarifying because it removes an exemption and moves a requirement to a related area in the SIP. Third, the State inserted a reference to the exceptions found in 33-15-03-04 to the restrictions on the emission of visible air contaminants in chapter 33-15-03 Restriction of Emissions of Visible Air Contaminants into 33-15-17-02.4, which has the effect of referring the reader to exceptions already located within another chapter of the State's rules, which we characterize as a clarifying revision. We propose to approve all of these as clarifying, SIP-strengthening, and non-substantive revisions.

Finally, we are not acting on the revision to 33-15-01-04 as this revision to the incorporation by reference date is superseded by a revision in the April 2014 submittal. We are also not acting on revisions to 33-15-03-04.4 and 33-15-05-01.2a(1) to remove improper exemptions from emissions limitations as we acted on these previously (79 FR 63045). We will act on revisions to 33-15-14-02.1, 33-15-14-02.5.a and 33-15-15-01-.2 in a future rulemaking and thus are not acting on these revisions at this time.

The State's April 22, 2014 SIP submittal includes the following types of amendments to the State's air quality rules: Revisions to update the dates of incorporation by reference of the (1) PSD rules, and (2) the definition of “volatile organic compounds”; revisions to lower the PM2.5 State ambient air quality standard; revisions to clarify the permissible open burning rule; a revision that clarifies that the required excess emissions reporting requirements are for sources that operate continuous emission monitors; and a revision that removes a category of fees.

The CAA requires the regulation of volatile organic compounds (VOCs) for various purposes. For example, tropospheric ozone, commonly known as smog, is formed when VOC and nitrogen oxides (NOX) react in the atmosphere in the presence of sunlight. Thus, because of the harmful health effects of ozone, the EPA and state governments limit the amount of VOC—organic compounds of carbon—that can be released into the atmosphere. Section 302(s) of the CAA specifies that the EPA has the authority to define the meaning of “VOC,” and hence what compounds shall be treated as VOC for regulatory purposes. The EPA defines VOCs at 40 CFR 51.100(s) and VOC exclusions, determined to have negligible photochemical reactivity, at 51.100(s)(1). In its January 2013 submittal, the State updates 33-15-01-04, Definitions, to include the incorporation by reference of 40 CFR 51.100(s) as it exists on January 1, 2012. Subsequently, in its April 2014 submittal, the State updates 33-15-01-04, Definitions, again to include the incorporation by reference of 40 CFR 51.100(s) as it exists on July 1, 2013. The April 2014 submittal supersedes the January 2013 submittal, thus we are proposing to approve the April 2014 revision because it incorporates by reference the EPA's rule provisions.

The CAA also requires the EPA to set National Ambient Air Quality Standards (40 CFR part 50) for pollutants considered harmful to public health and the environment and identifies two types of national ambient air quality standards: Primary standards provide public health protection, including protecting the health of “sensitive” populations such as asthmatics, children, and the elderly; and Secondary standards provide public welfare protection, including protection against decreased visibility and damage to animals, crops, vegetation, and buildings. In 2012 (78 FR 3086), the EPA revised the primary (health-based) annual PM2.5 standard by lowering the level from 15 micrograms per cubic meter (μg/m3) to 12.0 μg/m3 so as to provide increased protection against health effects associated with long- and short-term exposures (including premature mortality, increased hospital admissions and emergency department visits, and development of chronic respiratory disease). Accordingly, the State's April 2014 submittal revises the PM2.5 primary standard in Table 1. Ambient Air Quality Standards of chapter 33-15-02 from 15.0 μg/m3 to match the federal standard of 12.0 μg/m3. We propose to approve this revision because it is consistent with the federal standard.

In addition, we propose to approve revisions in the April 2014 submittal that revise 33-15-04-02.2.a to require that any type of permissible burning listed in 33-15-04-02.1 will not create “air pollution” as defined by the State in 33-15-04 (33-15-04-02.2.a); and to delete the existing SIP requirement in 33-15-04-02.2.a (73 FR 30308), that prohibited permissible burning listed in 33-15-04-02.1 from creating a public nuisance (“No public nuisance is or will be created”). We propose to approve these revisions because they strengthen the SIP by prohibiting open burning that creates air pollution where “one or more air contaminants in such quantities and duration as is or may be injurious to human health, welfare, or property or animal or plant life, or which unreasonably interferes with the enjoyment of life or property.”

We also propose to approve the clarification to the applicability of excess emissions reporting and recordkeeping requirements for continuous emission monitoring requirements (33-15-06-05.1). We propose to approve this revision because it clarifies the existing SIP provision (58 FR 54041) and explains that the emission monitoring requirements referenced in 33-15-06-05.1 are those performed for continuous emission monitoring (adding the phrase “in accordance with section 33-15-06-04”).

In the April 2014 submittal, the State also revised the incorporation by reference date of 40 CFR 52.21 into the state regulations to July 1, 2013 (33-15-15-01.2). As previously discussed in III.A., we approved the incorporation of 40 CFR 52.21(b)(14)(i) through (iii); (b)(15)(i) and (ii); and paragraph (c) pertaining to major and minor source baseline dates and ambient air increments in our July 30, 2013 final rule (78 FR 45866) by adding paragraphs (c) and (d) to 40 CFR 52.1829. We propose to approve the State's revision of the incorporation by reference date to July 1, 2013 because it references our regulations, and in doing so, propose to delete paragraphs (c) and (d) in 40 CFR 52.1829 as they would no longer be needed and would be duplicative if retained. The State also added the reference to “title” before the federal regulation citation in this section (first paragraph), and as this is for clarification purposes, we propose to approve this addition.

We are proposing to approve the State's deletion of the criteria for the “Monitor” category (33-15-23-03.01) from the SIP. These criteria explain the “Monitor” fee is a charge that applies to minor sources that is “in addition to the annual fee for any source operating a continuous emission monitor system (CEMS) or an ambient monitoring site.” The State's January 2013 SIP submittal indicates that this fee is no longer being charged.2 Thus, removal of the “Monitor” category corresponds to the State's revision in their January 2013 submittal (removing the annual fee for minor sources that operate an emission monitor or ambient air quality monitoring site), which we propose to approve in section III.A.

Finally, we are not acting on the State's revision to 33-15-03-05 and will instead take action on this revision in a future rulemaking.

For the reasons expressed in III.A. and III.B., the EPA is proposing to approve the following revisions, shown in Table 1, to the State's Air Pollution Control rules. We are also proposing to not act on several other revisions, shown in Table 2, for the reasons discussed in III.A. and III.B. and summarized below.

In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference North Dakota Administrative Code as described in section IV. of this preamble. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 8 Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information).

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

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

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

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

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

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

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

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

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

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

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

In the final rules section of this Federal Register, the EPA is approving the Virgin Islands' negative declaration submitted December 1, 2015 as a direct final rule without prior proposal because the Agency views this as a noncontroversial revision amendment and anticipates no adverse comments to this action.

A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated in relation to this action. If the EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed action. The EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. For additional information, see the direct final rule which is located in the rules section of this Federal Register.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: “any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

On February 13, 2015, NMFS received an application from the Corps for the taking of marine mammals incidental to the rehabilitation of the Jetty System at the MCR in Washington and Oregon. On June 9, 2015, NMFS received a revised application. NMFS determined that the application was adequate and complete on June 12, 2015. NMFS issued an incidental harassment authorization (IHA) to the Corps on August 31, 2015 (80 FR 53777, September 8, 2015) to cover pile installation at Jetty A which is valid from May 1, 2016 through April 30, 2017. The Corps proposes to conduct additional work under a Letter of Authorization (LOA) that may incidentally harass marine mammals. A notice of receipt was published in the Federal Register on October 26, 2015 (80 FR 65214). Activities would include pile repairs and removal actions at Jetty A, pile installation at North Jetty, and pile installation and surveys at South Jetty. A revised application including an updated marine mammal monitoring plan was submitted by the Corps on January 15, 2016 and deemed acceptable on January 30, 2016.

The Corps is seeking a LOA for continuation of work begun on Jetty A under an IHA issued by NMFS that expires on April 30, 2017. Remaining work at Jetty A that may need to be completed under the LOA would include pile maintenance and pile removal of a barge offloading facility at that jetty. The following work on the North and South Jetties would be covered under the proposed LOA. The scheduled repair and head stabilization of the North Jetty would require pile installation, maintenance and removal for construction of a single barge offloading facility. The interim repair and head determination of the South Jetty would require pile installation and maintenance and removal of two offloading facilities, one near the tip of the South Jetty and another at a sandy plain southwest of the Columbia River and east of the South Jetty known as the Clatsop Spit.

The current IHA, for which take has been authorized, is valid from May 1, 2016, through April 30, 2017. The LOA would be valid from May 1, 2017, through April 30, 2022. The work season generally extends from April through October, with extensions, contractions, and additional work windows outside of the summer season varying by weather patterns. To avoid the presence of Southern Resident killer whales, the Corps will prohibit pile installation or removal for offloading facilities from October 1 until May1 because that is the killer whales' primary feeding season when they may be present at the MCR plume. Installation and removal would occur from May 1 to September 30 each year.

This activity will take place at the three MCR jetties in Pacific County, Washington, and Clatsop County, Oregon. These are Jetty A, North Jetty and South Jetty. Work will also be conducted near the Clatsop Spit off of the South Jetty. See Figure 1 in the application for a map of the MCR Jetty system and surrounding areas.

There are a number of steps involved in the planned multi-year effort to rehabilitate the MCR Jetty System. This notice will focus only on those components of the project under the MMPA. Additional detailed information about the project in its entirety is contained in the application which may be found at: http://www.nmfs.noaa.gov/pr/permits/incidental/construction.htm.

Construction of a single offloading facility at Jetty A, a single facility at the North Jetty and two additional facilities at the South Jetty will be necessary to transport materials to these specific project locations. Jetty A pile installation is covered under the existing IHA. The proposed LOA will likely cover remaining pile installation, pile maintenance and pile removal at Jetty A depending on how much work is accomplished under the current IHA. The proposed LOA would cover pile installation and removal of one facility at North Jetty and two at South Jetty, including the Clatsop Spit location. In addition, all work related to pedestrian surveys of the South Jetty that could result in visual disturbance to pinnipeds will be covered under the proposed LOA.

The scheduled program of repair and rehabilitation priorities are described in detail in Section 1 of the Corps' LOA application. The proposed sequence and timing for work under the LOA at the three MCR jetties includes:

1. The Jetty A scheduled repairs and head stabilization task will be covered under the current IHA. This would include pile installation related to construction of an offloading facility as well as construction and stone placement. There will be at least one season of in-water work but two seasons are likely to be required to complete these activities. The second season of pile maintenance and removal would occur in 2017 and be covered under the proposed LOA.

2. The North Jetty scheduled repair and head stabilization task would occur under the proposed LOA and include pile installation and removal at an offloading facility. Construction and placement would occur from 2017 through 2019 as this task will require three placement seasons.

3. The South Jetty interim repair and head determination task would occur under the proposed LOA and would include pile installation and removal at two facilities with one being on the trunk near the head and the other at Clatsop Spit. This task would require four placement seasons running from 2018 through 2021.

Installation and removal of piles with a vibratory hammer would introduce sound waves into the MCR area intermittently for up to 7 years (depending on funding streams and construction sequences). In terms of actual on-the-ground work it is possible, but unlikely, that driving could occur at multiple facilities on the same day. For the purposes of this LOA, NMFS will be assuming that driving will occur only at a single facility on any given day.

Construction of all four offloading facilities combined will require up to 96 wood or steel piles and up to 373 sections of Z-piles, H-piles, and sheet pile to retain rock fill. A vibratory hammer will be used for pile installation due to the soft sediments (sand) in the project area and only untreated wood will be used, where applicable. No impact driving will be necessary under this LOA. The piles will be located within 200 ft (60.96 m) of each jetty structure. The presence of relic stone may require locating the piling further from the jetties so that use of this method is not precluded by the existing stone. The dolphins, Z- and H-piles would be composed of either untreated timber or steel piles installed to a depth of approximately 15 to 25 ft (4.5—7.6 m) below grade in order to withstand the needs of offloading barges and heavy construction equipment. Because vibratory hammers will be used in areas with velocities greater than 1.6 ft (0.49 m) per second, the need for hydroacoustic attenuation is not an anticipated issue.

Pile installation is assumed to occur for about 10 hours a day, with a total of approximately 15 piles installed per day. Each offloading facility would have about 25 percent of the total piles mentioned. As noted above, up to 96 piles could be installed, and up to 373 sections of sheet pile to retain rock fill. This is a total of 469 initial installation and 469 removal events, over the span of about 67 days. In order to round the math, NMFS has assumed 68 days, so that each of the four offloading facilities would take about 17 days total for installation and removal. The current IHA covers 17 days of work at Jetty A, which leaves 51 days of work for the three remaining offloading facilities at the North and South Jetties. However, a second season of work at the Jetty A facility is likely. Therefore, NMFS will assume that only ten days of Jetty A-related work will be completed under the existing IHA, resulting in seven days that will need to be covered under the proposed LOA. Additionally, pedestrian surveys on South Jetty outside of the construction seasons are expected to take six additional days. A total of 64 days of work will be required, consisting of 51 days associated with activities at the North and South Jetties, seven days of remaining work at Jetty A and six days of pedestrian surveys at South Jetty.

Piles would be a maximum diameter of 24 inches and would only be installed by vibratory driving method. The possibility also exists that smaller diameter piles may be used but for this analysis it is assumed that 24 inch piles will be driven.

Marine mammals known to occur in the Pacific Ocean offshore at the MCR include whales, orcas, dolphins, porpoises, sea lions, and harbor seals. Most cetacean species observed by Green and others (1992) occurred in Pacific slope or offshore waters (600 to 6,000 feet in depth). Harbor porpoises (Phocoena phocoena) and gray whales (Eschrichtius robustus) were prevalent in shelf waters less than 600 ft (182 m) in depth. Killer whales (Orcinus orca) are known to feed on Chinook salmon at the MCR, and humpback whales (Megaptera novaeangliae) may transit through the area offshore of the jetties. The marine mammal species potentially present in the activity area are shown in Table 1.

Pinniped species that occur in the vicinity of the jetties include Pacific harbor seals (Phoca vitulina richardsi), California sea lions (Zalophus californianus), and Steller sea lions (Eumetopias jubatus). A haulout used by all of these species is located on the open ocean side of the South Jetty.

In the species accounts provided here, we offer a brief introduction to the species and relevant stock. We also provide available information regarding population trends and threats and describe any information regarding local occurrence.

During construction of the project, it is possible that two killer whale stocks, the Eastern North Pacific Southern Resident and Eastern North Pacific West Coast transient stocks could be in the nearshore vicinity of the MCR. However, the Corps is limiting the installation work window to on or after May 1 in order to avoid exposure of Southern Resident killer whales (Orcinus orca) and will avoid installation or removal after September 30. As such, number of either West Coast transient or Southern Resident killer whales present in the project area will be decreased because the selected work window is not their primary feeding season.

Since the first complete census of this stock in 1974, when 71 animals were identified, the number of Southern Resident killer whales has fluctuated annually. Between 1974 and 1993 the Southern Resident stock increased approximately 35 percent, from 71 to 96 individuals (Ford et al., 1994), representing a net annual growth rate of 1.8 percent during those years. Following the peak census count of 99 animals in 1995, the population size has fluctuated and currently stands at 82 animals as of the 2013 census (Carretta et al., 2014).

The Southern Resident killer whale population consists of three pods, designated J, K, and L pods, that reside from late spring to fall in the inland waterways of Washington State and British Columbia (NMFS 2008a). During winter, pods have moved into Pacific coastal waters and are known to travel as far south as central California. Winter and early spring movements and distribution are largely unknown for the population. Sightings of members of K and L pods in Oregon (L pod at Depoe Bay in April 1999 and Yaquina Bay in March 2000, unidentified Southern Residents at Depoe Bay in April 2000, and members of K and L pods off of the Columbia River) and in California (17 members of L pod and four members of K pod at Monterey Bay in 2000; L pod members at Monterey Bay in March 2003; L pod members near the Farallon Islands in February 2005 and again off Pt. Reyes in January 2006) have considerably extended the southern limit of their known range (NMFS 2008a). Sightings of Southern Resident killer whales off the coast of Washington, Oregon, and California indicate that they are utilizing resources in the California Current ecosystem in contrast to other North Pacific resident pods that exclusively use resources in the Alaskan gyre system (NMFS 2008a).

During the 2011 Section 7 Endangered Species Act (ESA) consultation for Southern Resident killer whales, NMFS indicated these whales are known to feed on migrating Chinook salmon in the Columbia River plume during the peak salmon runs in March through April. Anecdotal evidence indicates that killer whales were historically regular visitors in the vicinity of the estuary but have been less common in current times (Wilson 2015). There is low likelihood of them being in close proximity to any of the pile installation locations because it is not their peak feeding season, and there would be minimal overlap of their presence during the peak summer construction season. To further avoid any overlap with Southern Resident killer whales' use during pile installation, the Corps would limit the pile installation window to start on or after May 1 and end on September 30 of each year to avoid peak adult salmon runs. Recent information, however, indicates that Southern Resident killer whales may be present in the area after May 1. Because it may prove difficult to differentiate Southern Resident from transient killer whales, the Corps has agreed to shut down operations any time killer whales are observed in the Level B harassment zone between May 1 and July 1. It is assumed that all killer whales observed after July 1 are transients and any takes will be recorded as such. Southern Resident killer whales were listed as endangered under the ESA in 2005, and, consequently, the stock is automatically considered as a “strategic” stock under the MMPA. This stock was considered “depleted” under the MMPA prior to its 2005 listing under the ESA.

The West Coast transient stock ranges from Southeast Alaska to California. Preliminary analysis of photographic data resulted in the following minimum counts for transient killer whales belonging to the West Coast transient stock (NOAA 2013b). From 1975 to 2012, 521 individual transient killer whales have been identified. Of these, 217 are considered part of the poorly known “outer coast” subpopulation and 304 belong to the well-known “inner coast” population. However, of the 304, the number of whales currently alive is not certain. A recent mark-recapture estimate that does not include the outer coast subpopulation or whales from California for the west coast transient population resulted in an estimate of 243 in 2006. This estimate applies to the population of West Coast transient whales that occur in the inside waters of southeastern Alaska, British Columbia, and northern Washington. Given that the California transient numbers have not been updated since the publication of the catalogue in 1997, the total number of transient killer whales reported above should be considered as a minimum count for the West Coast transient stock (NOAA 2014a).

For this project, it is possible only the inner-coast species would be considered for potential exposure to acoustic effects. However, they are even less likely to be in the project area than Southern Resident killer whales, especially outside of the peak salmon runs. The Corps is avoiding pile installation work during potential peak feeding timeframes in order to further reduce the potential for acoustic exposure. It is possible, however, that West Coast transients come in to feed on the pinniped population hauled out on the South Jetty. The West Coast transient stock of killer whales is not designated as “depleted” under the MMPA nor are they listed as “threatened” or “endangered” under the ESA. Furthermore, this stock is not classified as a strategic stock under the MMPA.

During summer and fall, most gray whales in the Eastern North Pacific stock feed in the Chukchi, Beaufort and Northwestern Bering Seas. An exception is the relatively small number of whales (approximately 200) that summer and feed along the Pacific coast between Kodiak Island, Alaska and northern California (Carretta et al., 2014), also known as the Pacific Coast Feeding Group. The minimum population estimate for the Eastern North Pacific stock using the 2006/2007 abundance estimate of 19,126 and its associated coefficient of variation (CV) of 0.071 is 18,017 animals. In probability theory and statistics, the CV, also known as relative standard deviation (RSD), is a standardized measure of dispersion of a probability distribution or frequency distribution. The minimum population estimate for Pacific Coast Feeding Group gray whales is calculated as the lower 20th percentile of the log-normal distribution of the 2010 mark-recapture estimate, or 173 animals (Carretta et al., 2014). If gray whales were in the vicinity of MCR, the Pacific Coast Feeding Group would be the most likely visitor. Anecdotal evidence indicates they have been seen at MCR but are not a common visitor as they mostly remain in the vicinity of the offshore shelf-break (Griffith 2015). In 1994, the Eastern North Pacific stock of gray whales was removed from the Endangered Species List as it was no longer considered “endangered” or “threatened” under the ESA. NMFS has not designated gray whales as “depleted” under the MMPA. The Eastern North Pacific gray whale stock is not classified as “strategic” under the MMPA.

According to the 2013 Pacific Marine Mammal Stock Assessments Report (Appendix 3), the estimated population of the humpback whale California/Oregon/Washington stock is about 1,918 animals (NOAA 2014a). There are at least three separate stocks of humpback whales in the North Pacific, of which one population migrates and feeds along the west coast of the United States. This population winters in coastal waters of Mexico and Central America and migrates to areas ranging from the coast of California to southern British Columbia in summer/fall (Carretta et al., 2010). Within this stock, regional abundance estimates vary among the feeding areas. Average abundance estimates ranged from 200 to 400 individuals for southern British Columbia/northern Washington, and 1,400 to 1,700 individuals for California/Oregon (Calambokidis et al., 2012).

There is a high degree of site fidelity in these feeding ranges with almost no interchange between these two feeding regions. Humpback whales forage on a variety of crustaceans, other invertebrates, and forage fish. In their summer foraging areas, humpback whales tend to occupy shallow, coastal waters. In contrast, during their winter migrations, humpback whales tend to occupy deeper waters further offshore and are less likely to occupy shallow, coastal waters.

Humpback whales are sighted off the Washington and Oregon coasts regularly (Carretta et al., 2010, Lagerquist and Mate 2002, Oleson et al., 2009). Humpback whales are known to predictably forage an average of 22 mi (35.4 km) offshore of Grays Harbor, Washington during spring and summer months (Oleson et al., 2009). Grays Harbor is approximately 45 mi (72.4 km) north of the project site. Oleson et al. (2009) documented 147 individual humpback whales foraging off Grays Harbor from 2004 to 2008, and foraging whales (1-19 whales sighted per day) were sighted on 50 percent of the days surveyed (22 of 44 survey days). Anecdotally, humpback whales are regularly spotted in areas about 15 (22.14 km) to 20 miles (32.18 km) offshore of MCR (Griffith 2015).

The Corps has limited fine-scale information about humpback whale foraging habits and space use along the Washington coast and does not have specific fine-scale information for the project area. Based on the available information, humpback whales may occur within 4.6 mi (7.4 km) of the MCR jetties or 8.6 mi (13.84 km) of shore (where in-water sound from pile driving activities may be audible) given both their general tendency to occupy shallow, coastal waters when foraging, and the available information on their fine-scale use of a proximate location.

Note that in September 2015, humpback whales were spotted near the Astoria-Megler Bridge located 14 mi (22.53 km) from where the river meets the Pacific Ocean. This was thought to be an unusual occurrence. Their presence at that time may have been due to existing El Niño conditions that drove whales closer to shore in search of food (Wilson 2015). As of March 2016, NOAA determined that El Niño conditions are in decline (Becker 2016). As such, sightings that far up river are less likely to occur. Based on this information, humpback whales are likely to pass through and may forage intermittently in the project area offshore of the Jetty system.

The harbor porpoise inhabits temporal, subarctic, and arctic waters. In the eastern North Pacific, harbor porpoises range from Point Barrow, Alaska, to Point Conception, California. Harbor porpoise primarily frequent coastal waters and occur most frequently in waters less than 328 ft (100 m) deep (Hobbs and Waite 2010). They may occasionally be found in deeper offshore waters.

Harbor porpoise are known to occur year-round in the inland transboundary waters of Washington and British Columbia and along the Oregon/Washington coast. Aerial survey data from coastal Oregon and Washington, collected during all seasons, suggest that harbor porpoise distribution varies by depth. Although distinct seasonal changes in abundance along the west coast have been noted, and attributed to possible shifts in distribution to deeper offshore waters during late winter, seasonal movement patterns are not fully understood. Harbor porpoises are sighted regularly at the MCR (Griffith 2015, Carretta et al., 2014).

According to the online database, Ocean Biogeographic Information System, Spatial Ecological Analysis of Megavertebrate Populations (Halpin et al., 2009), West Coast populations have more restricted movements and do not migrate as much as East Coast populations. Most harbor porpoise groups are small, generally consisting of less than five or six individuals, though for feeding or migration they may aggregate into large, loose groups of 50 to several hundred animals. Behavior tends to be inconspicuous, compared to most dolphins, and they feed by seizing prey which consists of a wide variety of fish and cephalopods, ranging from benthic or demersal.

The Northern Oregon/Washington coast stock of harbor porpoise inhabits the waters near the proposed project area. The population estimate for this stock is calculated at 21,847 with a minimum population estimate of 15,123 (Carretta et al., 2014).

Harbor porpoise are not listed as “depleted” under the MMPA, listed as “threatened” or “endangered” under the ESA, or classified as “strategic.”

The Steller sea lion is a pinniped and the largest of the eared seals. Steller sea lion populations that primarily occur east of 144° W (Cape Suckling, Alaska) comprise the Eastern Distinct Population Segment (DPS), which was de-listed and removed from the Endangered Species List on November 4, 2013 (78 FR 66140). This stock is found in the vicinity of MCR. The population west of 144° W longitude comprises the Western DPS, which is listed as endangered, based largely on over-fishing of the seal's food supply.

The range of the Steller sea lion includes the North Pacific Ocean rim from California to northern Japan. Steller sea lions forage in nearshore and pelagic waters where they are opportunistic predators. They feed primarily on a wide variety of fishes and cephalopods. Steller sea lions use terrestrial haulout sites to rest and take refuge. They also gather on well-defined, traditionally used rookeries to pup and breed. These habitats are typically gravel, rocky, or sand beaches; ledges, or rocky reefs (Allen and Angliss, 2013).

The MCR South Jetty is used by Steller sea lions for hauling out and is not designated critical habitat. Use occurs chiefly at the concrete block structure at the terminus, or head of the jetty, and at the emergent rubble mound made up of the eroding jetty trunk near the terminus.

Previous monthly averages between 1995 and 2004 for Steller sea lions hauled-out at the South Jetty head ranged from about 168 to 1,106 animals. More recent data from Oregon Department of Fish and Wildlife (ODFW) from 2000-2014 reflects a lower frequency of surveys, and numbers ranged from zero animals to 606 Steller sea lions (ODFW 2014). More frequent surveys by the Washington Department of Fish and Wildlife (WDFW) for the same time frame (2000-2014) put the monthly range at 177 to 1,663 animals throughout the year. According to ODFW (2014), most counts determined that animals remain at or near the jetty tip.

Steller sea lions are present all year, in varying abundances, as is shown in the Corps application. Abundance is typically lower as the summer progresses when adults are at the breeding rookeries. Steller sea lions are most abundant in the vicinity during the winter months and tend to disperse elsewhere to rookeries during breeding season between May and July. Abundance increases following the breeding season. However, this is not always true as evidenced by a flyover count of the South Jetty on May 23, 2007, where 1,146 Steller sea lions were observed on the concrete block structure and none on the rubble mound (ODFW 2007). Those counts represent a high-use day on the South Jetty. According to ODFW (2014), during the summer months it is not uncommon to observe between 500-1,000 Steller sea lions present per day, the majority of which are immature males and females (no pups or pregnant females). All population age classes, and both males and females, use the South Jetty to haul out. Only non-breeding individuals are typically found on the jetty during May-July, and a greater percentage of juveniles are present. It is likely that there is turnover in sea lions using the jetty. That is, the 100 or so sea lions hauled out one week might not be the same individuals hauled out the following week. Recent ODFW and WDFW survey data continue to support these findings. The most recent estimate from 2007 put the populations between 63,160 and 78,198 (Allen and Angliss, 2013). The best available information indicates the eastern stock of Steller sea lion increased at a rate of 4.18 percent per year between 1979 and 2010 based on an analysis of pup counts in California, Oregon, British Columbia and Southeast Alaska (Allen and Angliss, 2013).

California sea lions are found along the west coast from the southern tip of Baja California to southeast Alaska. They breed mainly on offshore islands from Southern California's Channel Islands south to Mexico. Non-breeding males often roam north in spring foraging for food. Since the mid-1980s, increasing numbers of California sea lions have been documented feeding on fish along the Washington coast and—more recently—in the Columbia River as far upstream as Bonneville Dam, 145 mi (233 km) from the river mouth. The population size of the U.S. stock of California sea lions is estimated at 296,750 animals (Carretta et al., 2014). As with Steller sea lions, according to ODFW (2014) most counts of California sea lions are also concentrated near the tip of the jetty, although animals sometimes haul out about halfway down the jetty. Survey information (2007 and 2014) from ODFW indicates that California sea lions are relatively less prevalent in the Pacific Northwest during June and July; though in the months just before and after their absence several hundred may be observed using the South Jetty. More frequent WDFW surveys (2014) indicate greater numbers in the summer, and use remains concentrated to fall and winter months. Nearly all California sea lions in the Pacific Northwest are sub-adult and adult males (females and young generally stay in California). Again, turnover of sea lions using the jetty is likely (ODFW 2014).

California sea lions in the United States are not listed as “endangered” or “threatened” under the Endangered Species Act, classified as “depleted” under the MMPA, or listed as “strategic” under the MMPA.

Harbor seals range from Baja California, north along the western coasts of the United States, British Columbia and southeast Alaska, west through the Gulf of Alaska, Prince William Sound, and the Aleutian Islands, and north in the Bering Sea to Cape Newenham and the Pribilof Islands. They haul out on rocks, reefs, beaches, and drifting glacial ice and feed in marine, estuarine, and occasionally fresh waters. Harbor seals generally are non-migratory, with local movements associated with tides, weather, season, food availability, and reproduction. Harbor seals do not make extensive pelagic migrations, though some long distance movement of tagged animals in Alaska (559mi/900 km) and along the west coast of the United States (up to 341 mi/550 km) have been recorded. Harbor seals have also displayed strong fidelity to haulout sites (Carretta et al., 2014).

The 1999 harbor seal population estimate for the Oregon/Washington Coast stock was about 24,732 animals. However, the data used was over eight years old; and therefore, there are no current abundance estimates. Harbor seals are not considered to be “depleted” under the MMPA or listed as “threatened” or “endangered” under the ESA. The Oregon/Washington coast stock of harbor seals is not classified as a “strategic” stock under the MMPA (Carretta et al., 2014).

Further information on the biology and local distribution of these species can be found in the Corps application available online at: http://www.nmfs.noaa.gov/pr/permits/incidental/construction.htm and the NMFS Marine Mammal Stock Assessment Reports, which may be found at: http://www.nmfs.noaa.gov/pr/species/.

This section includes a summary and discussion of the ways that stressors, (e.g. pile driving) and potential mitigation activities, associated with the MCR jetty rehabilitation project, may impact marine mammals and their habitat. The Estimated Take by Incidental Harassment section will include an analysis of the number of individuals that are expected to be taken by this activity. The Estimated Take by Incidental Harassment section, together with the Proposed Mitigation section will also draw conclusions regarding the likely impacts of this activity on the reproductive success or survivorship of individuals and, from that, on the affected marine mammal populations or stocks. The Negligible Impact Analysis section will include the analysis of how this specific activity will impact marine mammals. In this section, we provide general background information on sound and marine mammal hearing before considering potential effects to marine mammals from sound produced by vibratory pile driving.

Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in hertz (Hz) or cycles per second. Wavelength is the distance between two peaks of a sound wave; lower frequency sounds have longer wavelengths than higher frequency sounds and attenuate (decrease) more rapidly in shallower water. Amplitude is the height of the sound pressure wave or “loudness” of a sound and is typically measured using the decibel (dB) scale. A dB is the ratio between a measured pressure (with sound) and a reference pressure (sound at a constant pressure, established by scientific standards). It is a logarithmic unit that accounts for large variations in amplitude; therefore, relatively small changes in dB ratings correspond to large changes in sound pressure. When referring to sound pressure levels (SPLs; the sound force per unit area), sound is referenced in the context of underwater sound pressure to 1 microPascal (μPa). One pascal is the pressure resulting from a force of one newton exerted over an area of one square meter. The source level (SL) represents the sound level at a distance of 1 m from the source (referenced to 1 μPa). The received level is the sound level at the listener's position. Note that all underwater sound levels in this document are referenced to a pressure of 1 μPa, and all airborne sound levels in this document are referenced to a pressure of 20 μPa.

Root mean square (rms) is the quadratic mean sound pressure over the duration of an impulse. Rms is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick 1983). Rms accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures.

When underwater objects vibrate or activity occurs, sound-pressure waves are created. These waves alternately compress and decompress the water as the sound wave travels. Underwater sound waves radiate in all directions away from the source (similar to ripples on the surface of a pond), except in cases where the source is directional. The compressions and decompressions associated with sound waves are detected as changes in pressure by aquatic life and man-made sound receptors such as hydrophones.

Even in the absence of sound from the specified activity, the underwater environment is typically loud due to ambient sound. Ambient sound is defined as environmental background sound levels lacking a single source or point (Richardson et al., 1995), and the sound level of a region is defined by the total acoustical energy being generated by known and unknown sources. These sources may include physical (e.g., waves, earthquakes, ice, atmospheric sound), biological (e.g., sounds produced by marine mammals, fish, and invertebrates), and anthropogenic sound (e.g., vessels, dredging, aircraft, construction). A number of sources contribute to ambient sound, including the following (Richardson et al., 1995):

• Wind and waves: The complex interactions between wind and water surface, including processes such as breaking waves and wave-induced bubble oscillations and cavitation, are a main source of naturally occurring ambient noise for frequencies between 200 Hz and 50 kHz (Mitson 1995). In general, ambient sound levels tend to increase with increasing wind speed and wave height. Surf noise becomes important near shore, with measurements collected at a distance of 5.2 mi (8.5 km) from shore showing an increase of 10 dB in the 100 to 700 Hz band during heavy surf conditions.

• Precipitation: Sound from rain and hail impacting the water surface can become an important component of total noise at frequencies above 500 Hz, and possibly down to 100 Hz during quiet times.

• Biological: Marine mammals can contribute significantly to ambient noise levels, as can some fish and shrimp. The frequency band for biological contributions is from approximately 12 Hz to over 100 kHz.

• Anthropogenic: Sources of ambient noise related to human activity include transportation (surface vessels and aircraft), dredging and construction, oil and gas drilling and production, seismic surveys, sonar, explosions, and ocean acoustic studies. Shipping noise typically dominates the total ambient noise for frequencies between 20 and 300 Hz. In general, the frequencies of anthropogenic sounds are below 1 kHz and, if higher frequency sound levels are created, they attenuate rapidly (Richardson et al., 1995). Sound from identifiable anthropogenic sources other than the activity of interest (e.g., a passing vessel) is sometimes termed background sound, as opposed to ambient sound. Representative levels of anthropogenic sound are displayed in Table 2.

The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10-20 dB from day to day (Richardson et al., 1995). The result is that, depending on the source type and its intensity, sound from the specified activity may be a negligible addition to the local environment or could form a distinctive signal that may affect marine mammals.

When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Based on available behavioral data, audiograms have been derived using auditory evoked potentials, anatomical modeling, and other data. Southall et al. (2007) designate “functional hearing groups” for marine mammals and estimate the lower and upper frequencies of functional hearing of the groups. The functional groups and the associated frequencies are indicated below (though animals are less sensitive to sounds at the outer edge of their functional range and most sensitive to sounds of frequencies within a smaller range somewhere in the middle of their functional hearing range):

• Low frequency cetaceans (13 species of mysticetes): Functional hearing is estimated to occur between approximately 7 Hz and 25 kHz;

• Mid-frequency cetaceans (32 species of dolphins, 6 species of larger toothed whales, and 19 species of beaked and bottlenose whales): Functional hearing is estimated to occur between approximately 150 Hz and 160 kHz;

• High frequency cetaceans (8 species of true porpoises, 6 species of river dolphins, Kogia, the franciscana, and four species of cephalorhynchids): Functional hearing is estimated to occur between approximately 200 Hz and 180 kHz;

• Phocid pinnipeds in water: Functional hearing is estimated to occur between approximately 75 Hz and 100 kHz; and

• Otariid pinnipeds in water: Functional hearing is estimated to occur between approximately 100 Hz and 48 kHz.

Of the four cetacean species likely to occur in the proposed project area, one is classified as low-frequency cetaceans (i.e., humpback, gray whales), one is classified as a mid-frequency cetacean (i.e., killer whale), and one is classified as a high-frequency cetacean (i.e., harbor porpoise) (Southall et al., 2007). Additionally, harbor seals are classified as members of the phocid pinnipeds in water functional hearing group while Steller sea lions and California sea lions are grouped under the otariid pinnipeds in water functional hearing group. A species' functional hearing group is a consideration when we analyze the effects of exposure to sound on marine mammals.

Potential Effects of Pile Driving Sound—The effects of sounds from pile driving might result in one or more of the following: Temporary or permanent hearing impairment, non-auditory physical or physiological effects, behavioral disturbance, and masking (Richardson et al., 1995; Gordon et al., 2004; Nowacek et al., 2007; Southall et al., 2007). The effects of pile driving on marine mammals are dependent on several factors, including the size, type, and depth of the animal; the depth, intensity, and duration of the pile driving sound; the depth of the water column; the substrate of the habitat; the standoff distance between the pile and the animal; and the sound propagation properties of the environment. Impacts to marine mammals from pile driving activities are expected to result primarily from acoustic pathways. As such, the degree of effect is intrinsically related to the received level and duration of the sound exposure, which are in turn influenced by the distance between the animal and the source. The further away from the source, the less intense the exposure should be. The substrate and depth of the habitat affect the sound propagation properties of the environment. Shallow environments are typically more structurally complex, which leads to rapid sound attenuation. In addition, substrates that are soft (e.g., sand) would absorb or attenuate the sound more readily than hard substrates (e.g., rock) which may reflect the acoustic wave. Soft porous substrates would also likely require less time to drive the pile, and possibly less forceful equipment, which would ultimately decrease the intensity of the acoustic source.

In the absence of mitigation, impacts to marine species would be expected to result from physiological and behavioral responses to both the type and strength of the acoustic signature (Viada et al., 2008). The type and severity of behavioral impacts are more difficult to define due to limited studies addressing the behavioral effects of impulse sounds on marine mammals. Potential effects from impulse sound sources can range in severity from effects such as behavioral disturbance or tactile perception to physical discomfort, slight injury of the internal organs and the auditory system, or mortality (Yelverton et al., 1973).

Hearing Impairment and Other Physical Effects—Marine mammals exposed to high intensity sound repeatedly or for prolonged periods can experience hearing threshold shift (TS), which is the loss of hearing sensitivity at certain frequency ranges (Kastak et al., 1999; Schlundt et al., 2000; Finneran et al., 2002, 2005). TS can be permanent (PTS), in which case the loss of hearing sensitivity is not recoverable, or temporary (TTS), in which case the animal's hearing threshold would recover over time (Southall et al., 2007). Marine mammals depend on acoustic cues for vital biological functions, (e.g., orientation, communication, finding prey, avoiding predators); thus, TTS may result in reduced fitness in survival and reproduction. However, this depends on the frequency and duration of TTS, as well as the biological context in which it occurs. TTS of limited duration, occurring in a frequency range that does not coincide with that used for recognition of important acoustic cues, would have little to no effect on an animal's fitness. Repeated sound exposure that leads to TTS could cause PTS. PTS constitutes injury, but TTS does not (Southall et al., 2007). The following subsections discuss in somewhat more detail the possibilities of TTS, PTS, and non-auditory physical effects.

Temporary Threshold Shift—TTS is the mildest form of hearing impairment that can occur during exposure to a strong sound (Kryter 1985). While experiencing TTS, the hearing threshold rises, and a sound must be stronger in order to be heard. In terrestrial mammals, TTS can last from minutes or hours to days (in cases of strong TTS). For sound exposures at or somewhat above the TTS threshold, hearing sensitivity in both terrestrial and marine mammals recovers rapidly after exposure to the sound ends. Few data on sound levels and durations necessary to elicit mild TTS have been obtained for marine mammals, and none of the published data concern TTS elicited by exposure to multiple pulses of sound. Available data on TTS in marine mammals are summarized in Southall et al. (2007).

Given the available data, the received level of a single pulse (with no frequency weighting) might need to be approximately 186 dB re 1 μPa2-s (i.e., 186 dB sound exposure level (SEL) or approximately 221-226 dB p-p (peak)) in order to produce brief, mild TTS. Exposure to several strong pulses that each have received levels near 190 dB rms (175-180 dB SEL) might result in cumulative exposure of approximately 186 dB SEL and thus slight TTS in a small odontocete, assuming the TTS threshold is (to a first approximation) a function of the total received pulse energy.

The above TTS information for odontocetes is derived from studies on the bottlenose dolphin (Tursiops truncatus) and beluga whale (Delphinapterus leucas). There is no published TTS information for other species of cetaceans. However, preliminary evidence from a harbor porpoise exposed to pulsed sound suggests that its TTS threshold may have been lower (Lucke et al., 2009). As summarized above, data that are now available imply that TTS is unlikely to occur unless odontocetes are exposed to pile driving pulses stronger than 180 dB re 1 μPa (rms).

Permanent Threshold Shift—When PTS occurs, there is physical damage to the sound receptors in the ear. In severe cases, there can be total or partial deafness, while in other cases the animal has an impaired ability to hear sounds in specific frequency ranges (Kryter 1985). There is no specific evidence that exposure to pulses of sound can cause PTS in any marine mammal. However, given the possibility that mammals close to a sound source can incur TTS, it is possible that some individuals might incur PTS. Single or occasional occurrences of mild TTS are not indicative of permanent auditory damage, but repeated or (in some cases) single exposures to a level well above that causing TTS onset might elicit PTS.

Relationships between TTS and PTS thresholds have not been studied in marine mammals but are assumed to be similar to those in humans and other terrestrial mammals, based on anatomical similarities. PTS might occur at a received sound level at least several decibels above that inducing mild TTS if the animal were exposed to strong sound pulses with rapid rise time. Based on data from terrestrial mammals, a precautionary assumption is that the PTS threshold for impulse sounds (such as pile driving pulses as received close to the source) is at least six dB higher than the TTS threshold on a peak-pressure basis and probably greater than six dB (Southall et al., 2007). On an SEL basis, Southall et al. (2007) estimated that received levels would need to exceed the TTS threshold by at least 15 dB for there to be risk of PTS. Thus, for cetaceans, Southall et al. (2007) estimate that the PTS threshold might be an M-weighted SEL (for the sequence of received pulses) of approximately 198 dB re 1 μPa2-s (15 dB higher than the TTS threshold for an impulse). Given the higher level of sound necessary to cause PTS as compared with TTS, it is considerably less likely that PTS could occur.

Measured source levels from impact pile driving can be as high as 214 dB rms. Although no marine mammals have been shown to experience TTS or PTS as a result of being exposed to pile driving activities, captive bottlenose dolphins and beluga whales exhibited changes in behavior when exposed to strong pulsed sounds (Finneran et al., 2000, 2005). The animals tolerated high received levels of sound before exhibiting aversive behaviors. Experiments on a beluga whale showed that exposure to a single watergun impulse at a received level of 207 kPa (30 psi) p-p, which is equivalent to 228 dB p-p, resulted in a 7 and 6 dB TTS in the beluga whale at 0.4 and 30 kHz, respectively. Thresholds returned to within 2 dB of the pre-exposure level within four minutes of the exposure (Finneran et al., 2002). Although the source level of pile driving from one hammer strike is expected to be much lower than the single watergun impulse cited here, animals being exposed for a prolonged period to repeated hammer strikes could receive more sound exposure in terms of SEL than from the single watergun impulse (estimated at 188 dB re 1 μPa2-s) in the aforementioned experiment (Finneran et al., 2002). However, in order for marine mammals to experience TTS or PTS, the animals have to be close enough to be exposed to high intensity sound levels for a prolonged period of time. Based on the best scientific information available, these SPLs are far below the thresholds that could cause TTS or the onset of PTS.

Non-auditory Physiological Effects—Non-auditory physiological effects or injuries that theoretically might occur in marine mammals exposed to strong underwater sound include stress, neurological effects, bubble formation, resonance effects, and other types of organ or tissue damage (Cox et al., 2006; Southall et al., 2007). Studies examining such effects are limited. In general, little is known about the potential for pile driving to cause auditory impairment or other physical effects in marine mammals. Available data suggest that such effects, if they occur at all, would presumably be limited to short distances from the sound source and to activities that extend over a prolonged period. The available data do not allow identification of a specific exposure level above which non-auditory effects can be expected (Southall et al., 2007) or any meaningful quantitative predictions of the numbers (if any) of marine mammals that might be affected in those ways. Marine mammals that show behavioral avoidance of pile driving, including some odontocetes and some pinnipeds, are especially unlikely to incur auditory impairment or non-auditory physical effects.

Disturbance includes a variety of effects, including subtle changes in behavior, more conspicuous changes in activities, and displacement. Behavioral responses to sound are highly variable and context-specific and reactions, if any, depend on species, state of maturity, experience, current activity, reproductive state, auditory sensitivity, time of day, and many other factors (Richardson et al., 1995; Wartzok et al., 2003; Southall et al., 2007).

Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzok et al., 2003). Animals are most likely to habituate to sounds that are predictable and unvarying. The opposite process is sensitization, when an unpleasant experience leads to subsequent responses, often in the form of avoidance, at a lower level of exposure. Behavioral state may affect the type of response as well. For example, animals that are resting may show greater behavioral change in response to disturbing sound levels than animals that are highly motivated to remain in an area for feeding (Richardson et al., 1995; NRC, 2003; Wartzok et al., 2003).

Controlled experiments with captive marine mammals showed pronounced behavioral reactions, including avoidance of loud sound sources (Ridgway et al., 1997; Finneran et al., 2000). Observed responses of wild marine mammals to loud pulsed sound sources (typically seismic guns or acoustic harassment devices, but also including pile driving) have been varied but often consist of avoidance behavior or other behavioral changes suggesting discomfort (Morton and Symonds, 2002; Thorson and Reyff, 2006; see also Gordon et al., 2004; Wartzok et al., 2003; Nowacek et al., 2007). Responses to continuous sound, such as vibratory pile installation, have not been documented as well as responses to pulsed sounds.

With both types of pile driving, it is likely that the onset of pile driving could result in temporary, short term changes in an animal's typical behavior and/or avoidance of the affected area. These behavioral changes may include (Richardson et al., 1995): Changing durations of surfacing and dives; number of blows per surfacing; moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where sound sources are located; and/or flight responses (e.g., pinnipeds flushing into water from haul-outs or rookeries). Pinnipeds may increase their haul-out time, possibly to avoid in-water disturbance (Thorson and Reyff, 2006).

The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification could be expected to be biologically significant if the change affects growth, survival, or reproduction. Significant behavioral modifications that could potentially lead to effects on growth, survival, or reproduction include:

• Drastic changes in diving/surfacing patterns (such as those thought to cause beaked whale stranding due to exposure to military mid-frequency tactical sonar);

• Habitat abandonment due to loss of desirable acoustic environment; and

• Cessation of feeding or social interaction.

The onset of behavioral disturbance from anthropogenic sound depends on both external factors (characteristics of sound sources and their paths) and the specific characteristics of the receiving animals (hearing, motivation, experience, demography) and is difficult to predict (Southall et al., 2007).

Auditory Masking—Natural and artificial sounds can disrupt behavior by masking, or interfering with, a marine mammal's ability to hear other sounds. Masking occurs when the receipt of a sound is interfered with by another coincident sound at similar frequencies and at similar or higher levels. Chronic exposure to excessive, though not high-intensity, sound could cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions. Masking can interfere with detection of acoustic signals such as communication calls, echolocation sounds, and environmental sounds important to marine mammals. Therefore, under certain circumstances, marine mammals whose acoustical sensors or environment are being severely masked could also be impaired from maximizing their performance fitness in survival and reproduction. If the coincident (masking) sound were anthropogenic, it could be potentially harassing if it disrupted hearing-related behavior. It is important to distinguish TTS and PTS, which persist after the sound exposure, from masking, which occurs only during the sound exposure. Because masking (without resulting in TS) is not associated with abnormal physiological function, it is not considered a physiological effect, but rather a potential behavioral effect.

Masking occurs at the frequency band which the animals utilize so the frequency range of the potentially masking sound is important in determining any potential behavioral impacts. Because sound generated from in-water vibratory pile driving is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds made by porpoises. However, lower frequency man-made sounds are more likely to affect detection of communication calls and other potentially important natural sounds such as surf and prey sound. It may also affect communication signals when they occur near the sound band and thus reduce the communication space of animals (Clark et al., 2009) and cause increased stress levels (Foote et al., 2004; Holt et al., 2009).

Masking has the potential to impact species at the population or community levels as well as at individual levels. Masking affects both senders and receivers of the signals and can potentially have long-term chronic effects on marine mammal species and populations. Recent research suggests that low frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, and that most of these increases are from distant shipping (Hildebrand, 2009). All anthropogenic sound sources, such as those from vessel traffic, pile driving, and dredging activities, contribute to the elevated ambient sound levels, thus intensifying masking.

Vibratory pile driving is relatively short-term, with rapid oscillations occurring for 10 to 30 minutes per installed pile. It is possible that vibratory pile driving resulting from this proposed action may mask acoustic signals important to the behavior and survival of marine mammal species, but the short-term duration and limited affected area would result in insignificant impacts from masking. Any masking event that could possibly rise to Level B harassment under the MMPA would occur concurrently within the zones of behavioral harassment already estimated for vibratory pile driving, and which have already been taken into account in the exposure analysis.

Acoustic Effects, Airborne—Marine mammals that occur in the project area could be exposed to airborne sounds associated with pile driving that have the potential to cause harassment, depending on their distance from pile driving activities. Airborne pile driving sound would have less impact on cetaceans than pinnipeds because sound from atmospheric sources does not transmit well underwater (Richardson et al., 1995); thus, airborne sound would only be an issue for pinnipeds either hauled-out or looking with heads above water in the project area. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled-out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon their habitat and move further from the source. Studies by Blackwell et al. (2002) and Moulton et al. (2005) indicate a tolerance or lack of response to unweighted airborne sounds as high as 112 dB peak and 96 dB rms.

Besides being susceptible to vessel strikes, cetacean and pinniped responses to vessels may result in behavioral changes, including greater variability in the dive, surfacing, and respiration patterns; changes in vocalizations; and changes in swimming speed or direction (NRC 2003). There will be a temporary and localized increase in vessel traffic during construction. A maximum of three work barges will be present at any time during the in-water and over water work. The barges will be located in close proximity to each other near the construction site.

The primary potential impacts to marine mammal habitat are associated with elevated sound levels produced by vibratory and impact pile driving and removal in the area. However, other potential impacts to the surrounding habitat from physical disturbance are also possible.

Potential Pile Driving Effects on Prey—Construction activities would produce continuous (i.e., vibratory pile driving) sounds. Fish react to sounds that are especially strong and/or intermittent low-frequency sounds. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. Hastings and Popper (2005) identified several studies that suggest fish may relocate to avoid certain areas of sound energy. Additional studies have documented effects of pile driving on fish, although several are based on studies in support of large, multiyear bridge construction projects (e.g., Scholik and Yan, 2001, 2002; Popper and Hastings, 2009). Sound pulses at received levels of 160 dB may cause subtle changes in fish behavior. SPLs of 180 dB may cause noticeable changes in behavior (Pearson et al., 1992; Skalski et al., 1992). SPLs of sufficient strength have been known to cause injury to fish and fish mortality. The most likely impact to fish from pile driving activities at the project area would be temporary behavioral avoidance of the area. The duration of fish avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution, and behavior is anticipated. Additionally, NMFS developed a Biological Opinion in 2011 which indicated that no adverse effects were anticipated for critical habitat of prey species for marine mammals. In general, impacts to marine mammal prey species are expected to be minor and temporary due to the short timeframe for the project.

Effects to Foraging Habitat—Pile installation may temporarily increase turbidity resulting from suspended sediments. Any increases would be temporary, localized, and minimal. The Corps must comply with state water quality standards during these operations by limiting the extent of turbidity to the immediate project area. In general, turbidity associated with pile installation is localized to about a 25-ft (7.62 m) radius around the pile (Everitt et al., 1980). Cetaceans are not expected to be close enough to the project pile driving areas to experience effects of turbidity, and any pinnipeds will be transiting the terminal area and could avoid localized areas of turbidity. Therefore, the impact from increased turbidity levels is expected to be discountable to marine mammals. Furthermore, pile driving and removal at the project site will not obstruct movements or migration of marine mammals.

Natural tidal currents and flow patterns in MCR waters routinely disturb sediments. High volume tidal events can result in hydraulic forces that re-suspend benthic sediments, temporarily elevating turbidity locally. Any temporary increase in turbidity as a result of the proposed action is not anticipated to measurably exceed levels caused by these normal, natural periods.

In order to issue an LOA under section 101(a)(5)(A) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, “and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking” for certain subsistence uses.

For the proposed mitigation measures, the Corps listed the following protocols to be implemented during its proposed jetty rehabilitation program at MCR.

The Corps will conduct briefings between construction supervisors and crews, the marine mammal monitoring team, and Corps staff prior to the start of all pile driving activity in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

All pile driving and removal activities will be conducted only using a vibratory hammer.

The shutdown zone will include all areas where the underwater SPLs are anticipated to equal or exceed the Level A (injury) criteria for marine mammals (180 dB isopleth for cetaceans; 190 dB isopleth for pinnipeds). The shutdown zone will always be a minimum of 66 ft (20 m) to prevent injury from physical interaction of marine mammals with construction equipment. The Level B harassment zone would extend 4.6 mi (7.4 km) from the sound source. The Level A and B harassment thresholds are depicted in Table 4 found later in the Estimated Take by Incidental Harassment section.

For in-water heavy machinery work other than pile driving (using, e.g., standard barges, tug boats, barge-mounted excavators, or clamshell equipment used to place or remove material), if a marine mammal comes within 66 ft (20 m), operations shall cease and vessels shall reduce speed to the minimum level required to maintain steerage and safe working conditions. This type of work could include the following activities: (1) Movement of the barge to the pile location or (2) positioning of the pile on the substrate via a crane (i.e., stabbing the pile).

If the shutdown zone is obscured by fog or poor lighting conditions, pile driving will not be initiated until the entire shutdown zone is visible.

A monitoring plan will be implemented as described in Sections 13 and 16 of the Application. This plan includes shutdown zones and specific procedures in the event a mammal is encountered.

If a marine mammal approaches or enters the injury zone during pile driving, work will be halted and delayed until either the animal's voluntary departure has been visually confirmed beyond the disturbance zone, or 15 minutes for pinnipeds or 30 minutes for cetaceans have passed without re-detection of the animal.

Marine Mammal Observers (MMO) will scan the waters for 30 minutes before and during all pile driving. If any species for which take is not authorized are observed within the area of potential sound effects during or 30 minutes before pile driving, the observer(s) will immediately notify the on-site supervisor or inspector, and require that pile driving either not initiate or temporarily cease until the animals have moved outside of the area of potential sound effects.

Work would occur only during daylight hours, when visual monitoring of marine mammals can be conducted. In order to minimize impact to Southern Resident killer whales, in-water work will not be conducted during their primary feeding season extending from October 1 until May 1. Installation could occur from May 1 through September 30 each year.

If between May 1 and July 1 any killer whales are observed within the area of zone of influence (ZOI), comprising the Level A and Level B thresholds, the Corps will immediately shut down all pile installation, removal, or maintenance activities. Operations will either remain shutdown or will not be initiated until all killer whales have moved outside of the area of the ZOI. In order to avoid take of endangered Southern Resident killer whales, which may be indistinguishable from transient whales, after July 1 until September 30 all killer whales will be assumed to be transients. No shutdown is required for killer whales observed after July 1 until September 30 in the Level B harassment zone, but animals must be recorded as Level B takes in the approved monitoring forms.

NMFS has carefully evaluated the applicant's proposed mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of affecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:

• The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals;

• The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and

• The practicability of the measure for applicant implementation,

Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

1. Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal);

2. A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only);

3. A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only);

4. A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only);

5. Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time; and

6. For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an Incidental Take Authorization (ITA) for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. The Corps submitted information regarding marine mammal monitoring to be conducted during pile driving and removal operations as part of the proposed rule application. That information can be found in sections 13 and 16 of the application. The monitoring measures may be modified or supplemented based on comments or new information received from the public during the public comment period.

Monitoring measures proposed by the applicant or prescribed by NMFS should contribute to or accomplish one or more of the following top-level goals:

1. An increase in our understanding of the likely occurrence of marine mammal species in the vicinity of the action, i.e., presence, abundance, distribution, and/or density of species.

2. An increase in our understanding of the nature, scope, or context of the likely exposure of marine mammal species to any of the potential stressor(s) associated with the action (e.g., sound or visual stimuli), through better understanding of one or more of the following: The action itself and its environment (e.g., sound source characterization, propagation, and ambient noise levels); the affected species (e.g., life history or dive pattern); the likely co-occurrence of marine mammal species with the action (in whole or part) associated with specific adverse effects; and/or the likely biological or behavioral context of exposure to the stressor for the marine mammal (e.g., age class of exposed animals or known pupping, calving or feeding areas).

3. An increase in our understanding of how individual marine mammals respond (behaviorally or physiologically) to the specific stressors associated with the action (in specific contexts, where possible, e.g., at what distance or received level).

4. An increase in our understanding of how anticipated individual responses, to individual stressors or anticipated combinations of stressors, may impact either: The long-term fitness and survival of an individual; or the population, species, or stock (e.g., through effects on annual rates of recruitment or survival).

5. An increase in our understanding of how the activity affects marine mammal habitat, such as through effects on prey sources or acoustic habitat (e.g., through characterization of longer-term contributions of multiple sound sources to rising ambient noise levels and assessment of the potential chronic effects on marine mammals).

6. An increase in understanding of the impacts of the activity on marine mammals in combination with the impacts of other anthropogenic activities or natural factors occurring in the region.

7. An increase in our understanding of the effectiveness of mitigation and monitoring measures.

8. An increase in the probability of detecting marine mammals (through improved technology or methodology), both specifically within the safety zone (thus allowing for more effective implementation of the mitigation) and in general, to better achieve the above goals.

The Corps will employ one or two vessels to monitor shutdown and disturbance zones for pile-driving and removal activities at the North Jetty and South Jetty offloading facilities. Section 16 of the Application indicates roughly where these vessels will be located. These vessels will be traversing across the delineated disturbance zones associated with the site at which active pile driving is occurring.

• Visual monitoring will be conducted by qualified, trained MMOs. Visual monitoring will be implemented during all pile installation activities at all jetties. An observer must meet the qualifications stated in the application, have prior training and experience conducting marine mammal monitoring or surveys, and have the ability to identify marine mammal species and describe relevant behaviors that may occur in proximity to in-water construction activities.

• MMOs must be approved in advanced by NMFS.

• Trained MMOs will be placed at the best vantage points practicable (e.g., at the pile location on construction barges, on shore, or aboard vessels, etc. as noted in the figures) to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. Likely shore-based MMO locations are described in section 16 of the Application.

• During pedestrian surveys, personnel will avoid as much as possible direct approach towards pinnipeds that are hauled out. If it is absolutely necessary to make movements towards pinnipeds, approach in a slow and steady manner to reduce the behavioral harassment to the animals as much as possible.

• Use a hand-held or boat-mounted GPS device and rangefinder to verify the required monitoring distance from the project site. MMOs will use range finders to determine distance to marine mammals, boats, buoys, and construction equipment.

• MMOs will be equipped with camera and video capable of recording any necessary take information, including data required in the event of an unauthorized Level A take.

• Scan the waters within the area of potential sound effects using high-quality binoculars (e.g., Zeiss 10x42, or similar) or spotting scopes (20-60 zoom or equivalent), and by making visual observations.

• MMOs shall be equipped with radios or cell phones for maintaining immediate contact with other observers, Corps engineers, and personnel operating pile equipment.

• Monitoring would be conducted before, during, and after pile driving and removal activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven. Observations made outside the shutdown zone will not result in shutdown; that pile segment would be completed without cessation, unless the animal approaches or enters the shutdown zone, at which point all pile driving activities would be halted. Monitoring will take place from 30 minutes prior to initiation through 30 minutes post-completion of pile driving activities. Pile driving activities include the time to remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than 30 minutes.

A hydroacoustic monitoring plan shall be employed using an appropriate method reviewed and approved by NMFS to ensure that the harassment isopleths are not extending past the initial distances established.

We require that observers use approved data forms. Among other pieces of information, the Corps will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, the Corps will attempt to distinguish between the number of individual animals taken and the number of incidents of take. We require that, at a minimum, the following information be collected on the sighting forms:

• Date and time that monitored activity begins or ends;

• Construction activities occurring during each observation period;

• Weather parameters (e.g., percent cover, visibility);

• Water conditions (e.g., sea state, tide state);

• Species, numbers, and, if possible, sex and age class of marine mammals;

• Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;

• Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;

• Locations of all marine mammal observations; and

• Other human activity in the area.

The Corps would submit an annual report to NMFS's Permits and Conservation Division within 90 days of the end of every operating season (October 1) during the five-year authorization period. The annual report would detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. If no comments are received from NMFS within 30 days, the draft final report will become final. If comments are received, a final report must be submitted up to 30 days after receipt of comments. Reports shall contain the following information:

• Summaries of monitoring effort (e.g., total hours, total distances, and marine mammal distribution through the study period, accounting for sea state and other factors affecting visibility and detectability of marine mammals);

• Analyses of the effects of various factors influencing detectability of marine mammals (e.g., sea state, number of observers, and fog/glare);

• Species composition, occurrence, and distribution of marine mammal sightings, including date, numbers, age/size/gender categories (if determinable), and group sizes;

• Observed behavioral responses to pile driving including bearing and direction of travel and distance from pile driving activity; and

• Results of hydroacoustic monitoring program.

In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the LOA (if issued), such as an injury (Level A harassment), serious injury or mortality (e.g., ship-strike, gear interaction, and/or entanglement), the Corps would immediately cease the specified activities and immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the West Coast Regional Stranding Coordinator. The report would include the following information:

• Time, date, and location (latitude/longitude) of the incident;

• Name and type of vessel involved (if applicable);

• Vessel's speed during and leading up to the incident (if applicable);

• Description of the incident;

• Status of all sound source used in the 24 hours preceding the incident;

• Water depth;

• Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

• Description of all marine mammal observations in the 24 hours preceding the incident;

• Species identification or description of the animal(s) involved;

• Fate of the animal(s); and

• Photographs or video footage of the animal(s) (if equipment is available).

Activities would not resume until NMFS is able to review the circumstances of the prohibited take. NMFS would work with the Corps to determine necessary actions to minimize the likelihood of further prohibited take and ensure MMPA compliance. The Corps would not be able to resume their activities until notified by NMFS via letter, email, or telephone.

In the event that the Corps discovers an injured or dead marine mammal, and the lead MMO determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition as described in the next paragraph), the Corps would immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the West Coast Regional Stranding Coordinator.

The report would include the same information identified in the section above. Activities would be able to continue while NMFS reviews the circumstances of the incident. NMFS would work with the Corps to determine whether modifications in the activities are appropriate.

In the event that the Corps discovers an injured or dead marine mammal, and the lead MMO determines that the injury or death is not associated with or related to the activities authorized in the LOA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), the Corps would report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the NMFS West Coast Stranding Hotline or West Coast Regional Stranding Coordinator, within 24 hours of the discovery. The Corps would provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. Pile driving activities would be permitted to continue.

Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: “. . . any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

All anticipated takes would be by Level B harassment resulting from vibratory pile driving and removal and may result in temporary changes in behavior. Injurious or lethal takes are not expected due to the expected source levels and sound source characteristics associated with the activity, and the proposed mitigation and monitoring measures are expected to further minimize the possibility of such take.

If a marine mammal responds to a stimulus by changing its behavior (e.g., through relatively minor changes in locomotion direction/speed or vocalization behavior), the response may or may not constitute taking at the individual level, and is unlikely to affect the stock or the species as a whole. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on animals or on the stock or species could potentially be significant (e.g., Lusseau and Bejder 2007; Weilgart 2007). Given the many uncertainties in predicting the quantity and types of impacts of sound on marine mammals, it is common practice to estimate how many animals are likely to be present within a particular distance of a given activity, or exposed to a particular level of sound, and to use those values to estimate take.

Upland work can generate airborne sound and create visual disturbance that could potentially result in disturbance to marine mammals (specifically, pinnipeds) that are hauled out or at the water's surface with heads above the water. Because there are regular haul-outs in close proximity to South Jetty, we believe that incidents of incidental take may occur. Furthermore, the Corps will also be conducting pedestrian surveys on each of the jetties during the summer lasting about two days for each survey. During the life of this proposed action, about six days of surveys over three seasons would occur at the South Jetty, which is the only jetty survey with the potential to impact pinnipeds.

The Corps requested authorization for the incidental taking of small numbers of killer whale, gray whale, humpback whale, harbor porpoise, Steller sea lion, California sea lion, and harbor seal near the MCR project area that may result from vibratory pile driving and removal during construction activities associated with the rehabilitation of the Jetty system at the MCR. In order to estimate the potential incidents of take that may occur incidental to the specified activity, we must first estimate the extent of the sound field that may be produced by the activity and then consider that in combination with information about marine mammal density or abundance in the project area. We first provide information on applicable sound thresholds for determining effects to marine mammals before describing the information used in estimating the sound fields, the available marine mammal density or abundance information, and the method of estimating potential incidences of take.

We use generic sound exposure thresholds to determine when an activity that produces sound might result in impacts to a marine mammal such that a take by harassment might occur. These thresholds below (Table 3) are used to estimate when harassment may occur (i.e., when an animal is exposed to levels equal to or exceeding the relevant criterion). NMFS is working to revise these acoustic guidelines; for more information on that process, please visit www.nmfs.noaa.gov/pr/acoustics/guidelines.htm.

Underwater Sound Propagation Formula—Pile driving generates underwater noise that can potentially result in disturbance to marine mammals in the project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:

This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20*log[range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10*log[range]). A practical spreading value of fifteen is often used under conditions where water increases with depth as the receiver moves away from the shoreline, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions. Practical spreading loss ((15*log[range]) with a 4.5 dB reduction in sound level for each doubling of distance is assumed here.

The Corps does not have information or modeling results related to pile installation activities. However, some features of the proposed action are similar to those recently proposed by the Navy, the Washington State Department of Transportation (WSDOT), and other entities which were issued IHA/LOAs. For these reasons, NMFS considered some of the results from previous, representative monitoring efforts. Though the MCR navigation channel is a major commercial thoroughfare, there are no ports or piers in the immediate proximity of the jetties, as the seas are too dangerous. The locations and settings of the MCR jetties are far more dynamic than a naval pier setting in the Puget Sound, the substrate is mostly sand, and the natural background noise is likely to be much higher with the large, breaking wave sets, dynamic currents, and high winds. The Corps project is also in the immediate proximity of the open ocean, with less opportunity for sound attenuation by land.

NMFS considered representative results from underwater monitoring for concrete, steel, and wood piles that were installed via both impact and vibratory hammers in water depths from 5 to 15 meters (Illingworth and Rodkin 2007, WSDOT 2011 cited in Naval Base Kitsap 2014, Navy 2014, and NMFS 2011b). Transmission loss and propagation estimates are affected by the size and depth of the piles, the type of hammer and installation method, frequency, temperature, sea conditions, currents, source and receiver depth, water depth, water chemistry, and bottom composition and topography. NMFS reviewed several documents that included relevant monitoring results for radial distances and proxy sound levels encompassed by underwater pile driving noise. These distances for vibratory driving for 24-in steel piles were summarized previously in Table 16 in the Application.

Because no site-specific, in-water noise attenuation data is available, the practical spreading model described and used by NMFS was used to determine transmission loss and the distances at which impact and vibratory pile driving or removal source levels are expected to attenuate down to the pertinent acoustic thresholds. The underwater practical spreading model is provided below:

NMFS used representative sound levels from different studies to determine appropriate proxy sound levels and to model estimated distances until pertinent thresholds (R1 and dB at R1). Studies which met the following parameters were considered: Pile materials comprised of wood, concrete, and steel pipe piles; pile sizes from 24- to 30-inches diameter, and pile driver type of either vibratory and impact hammers. These types and sizes of piles were considered in order to evaluate a representative range of sound levels that may result from the proposed action. In some cases, becausee there was little or no data specific to 24-inch piles, NMFS analyzed 30-inch piles as the next larger pile size with available data. The Corps will include a maximum pile size of 24-inches as a constraint in its construction contracts, though it will consult with NMFS regarding the originally proposed size.

Results of the practical spreading model provided the distance of the radii that were used to establish a ZOI or area affected by the noise criteria. At the MCR, the channel is about 3 miles across between the South and North Jetty. These jetties, as well as Jetty A, could attenuate noise, but the flanking sides on two of the jetties are open ocean, and Jetty A is slightly further interior in the estuary. Clatsop Spit, Cape Disappointment, Hammond Point, as well as the Sand Islands, are also land features that would attenuate noise. Therefore, as a conservative estimate, NMFS is using (and showing on ZOI maps) the maximum distance and area but has indicated jetty attenuation in the ZOI area maps (See Figures 18, 19, 20, and 21 in the Application).

NMFS selected proxy values for impact installation methods and calculated distances to acoustic thresholds for comparison and contextual purposes. NMFS ultimately relied most heavily on the proxy values developed by the Navy (2014).

For vibratory pile driving source level installation, NMFS proposes to use a figure of 163 dB re 1 μPa rms at 10 m. The proxy value of 163 dB re 1 μPa rms at 10 m is greater than the 24-inch pipe pile proxy and equal to the sheet pile values proposed by Navy (2014) at 161 dB re 1 μPa rms and 163 dB re 1 μPa rms, respectively, and is also higher than the Friday Harbor Ferry sample (162 dB re 1 μPa rms) (Navy 2014 and Laughlin 2010a cited in Washington State Ferries 2013, respectively). NMFS also proposes 163 dB re 1 μPa rms to represent sheet pile installation, which registered higher than the pipe pile levels in the proxy study. Given the comparative differences between the substrate and context used in the Navy study relative to the MCR, 163 dB re 1 μPa rms is a very conservative evaluation level. Results are listed in Tables 4, 5, 6, and 7.

The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires each regional fishery management council to submit any fishery management plan or amendment to any plan to NMFS for review and approval, partial approval, or disapproval. The Magnuson-Stevens Act also requires that NMFS, upon receiving a plan or plan amendment, publish an announcement in the Federal Register notifying the public that the plan or plan amendment is available for review and comment.

The FMP being revised by Amendment 45 was prepared by the Council and implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Act.

Amendment 40 to the FMP separated the Federal recreational red snapper sector as a way to provide the basis for increased flexibility in future management as well as minimize the chance for recreational quota overruns, which could jeopardize the rebuilding of the red snapper stock (80 FR 22422, April 22, 2015). Amendment 40 established sector separation by defining distinct private angling and Federal for-hire (charter vessel and headboat) components within the recreational sector of those who fish for red snapper, allocated red snapper resources between the components, and established component-specific accountability measures through the use of component annual catch targets to project recreational fishing season lengths. Amendment 40 defined the Federal for-hire component as including operators of vessels with Federal charter vessel/headboat permits for Gulf reef fish and their angler clients. The private angling component was defined as including anglers fishing from private vessels and state-permitted for-hire vessels.

Amendment 40 also applied a 3-year sunset provision for the regulations implemented through its final rule. The sunset provision maintained the measures for sector separation through the end of the 2017 fishing year, on December 31, 2017. The 3-year sunset provision was included to provide an incentive for the Council to continue to evaluate alternative management measures or programs for the recreational sector. Unless modified, after the 2017 fishing year, on January 1, 2018, the management measures implemented through Amendment 40 will expire and the recreational sector will be managed as a single entity. The Council is currently working to develop and approve other amendments to address the management of the charter and headboat fishing within the Federal for-hire component (Amendments 41 and 42 to the FMP, respectively). The development of these amendments is taking longer than the Council anticipated, and if approved by NMFS, would likely not be effective until after the sector separation provisions expire on December 31, 2017. Therefore, the Council determined there was a need to extend the sunset provision for an additional 5 years past the original sunset date.

Amendment 45 would extend the 3-year sunset provision for the separation of the Federal for-hire and private angling recreational components for Gulf red snapper and associated management measures for an additional 5 years. If implemented, this would extend Gulf recreational red snapper sector separation through the end of the 2022 fishing year, on December 31, 2022, rather than the current sunset date of December 31, 2017. Beginning on January 1, 2023, the red snapper recreational sector would be managed as a single entity without the separate Federal for-hire and private angling components. The Council would need to take further action for these recreational components and management measures to extend beyond the 5-year extension proposed in Amendment 45.

A proposed rule that would implement Amendment 45 has been drafted. In accordance with the Magnuson-Stevens Act, NMFS is evaluating Amendment 45 to determine whether it is consistent with the FMP, the Magnuson-Stevens Act, and other applicable law. If the determination is affirmative, NMFS will publish the proposed rule in the Federal Register for public review and comment.

The Council has submitted Amendment 45 for Secretarial review, approval, and implementation. Comments on Amendment 45 must be received by October 24, 2016. Comments received during the respective comment periods, whether specifically directed to the amendment or the proposed rule, will be considered by NMFS in its decision to approve, partially approve, or disapprove Amendment 45. All comments received by NMFS on the amendment or the proposed rule during their respective comment periods will be addressed in the final rule.