Federal Register Vol. 82, No.49,

This rule is issued under Marketing Agreement No. 125 and Order No. 966, both as amended (7 CFR part 966), regulating the handling of tomatoes grown in Florida, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, Florida tomato handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable Florida tomatoes beginning on August 1, 2016, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule increases the assessment rate established for the Committee for the 2016-17 and subsequent fiscal periods from $0.03 to $0.035 per 25-pound carton of tomatoes.

The Florida tomato marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers of Florida tomatoes. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2015-16 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on August 16, 2016, and unanimously recommended 2016-17 expenditures of $1,494,600 and an assessment rate of $0.035 per 25-pound carton of tomatoes. In comparison, last year's budgeted expenditures were $1,513,177. The assessment rate of $0.035 is $0.005 higher than the rate currently in effect. At the current assessment rate, assessment income would equal only $990,000, an amount insufficient to cover the Committee's anticipated expenditures of $1,494,600. The Committee considered the proposed expenses and recommended increasing the assessment rate.

The major expenditures recommended by the Committee for the 2016-17 year include $450,000 for salaries, $400,000 for research, and $400,000 for education and promotion. Budgeted expenses for these items in 2015-16 were $435,377, $400,000, and $400,000, respectively.

The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of Florida tomatoes. Florida tomato shipments for the 2016-17 year are estimated at 33 million 25-pound cartons, which should provide $1,155,000 in assessment income. Income derived from handler assessments, along with interest income, block grants, and funds from the Committee's authorized reserve, should be adequate to cover budgeted expenses. Funds in the reserve (approximately $999,361) will be kept within the maximum permitted by the order of no more than approximately one fiscal period's expenses as stated in § 966.44.

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2016-17 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 100 producers of tomatoes in the production area and approximately 80 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

Based on industry and Committee data, the average annual price for fresh Florida tomatoes during the 2015-16 season was approximately $11.27 per 25-pound carton, and total fresh shipments were approximately 28.2 million cartons. Using the average price and shipment information, number of handlers, and assuming a normal distribution, the majority of handlers have average annual receipts below $7,500,000. In addition, based on production data, an estimated grower price of $6.25, and the total number of Florida tomato growers, the average annual grower revenue is above $750,000. Thus, a majority of the handlers of Florida tomatoes may be classified as small entities while a majority of the producers may be classified as large entities.

This rule increases the assessment rate established for the Committee and collected from handlers for the 2016-17 and subsequent fiscal periods from $0.03 to $0.035 per 25-pound carton of tomatoes. The Committee unanimously recommended 2016-17 expenditures of $1,494,600 and an assessment rate of $0.035 per 25-pound carton handled. The assessment rate of $0.035 is $.005 higher than the 2015-16 rate. The quantity of assessable tomatoes for the 2016-17 season is estimated at 33 million 25-pound cartons. Thus, the $0.035 rate should provide $1,155,000 in assessment income. Income derived from handler assessments, along with funds from interest income, MAP funds, and block grants, should provide sufficient funds to meet this year's anticipated expenses.

The major expenditures recommended by the Committee for the 2016-17 year include $450,000 for salaries, $400,000 for research, and $400,000 for education and promotion. Budgeted expenses for these items in 2015-16 were $435,377, $400,000, and $400,000, respectively.

At the current assessment rate, assessment income would equal only $990,000, an amount insufficient to cover the Committee's anticipated expenditures of $1,494,600. The Committee considered the proposed expenses and recommended increasing the assessment rate.

Prior to arriving at this budget and assessment rate, the Committee considered information from various sources, such as the Committee's Executive Subcommittee, Research Subcommittee, and Education and Promotion Subcommittee. Alternative expenditure levels were discussed by these groups, based upon the relative value of various activities to the tomato industry. The Committee determined that 2016-17 expenditures of $1,494,600 were appropriate, and the recommended assessment rate, along with funds from interest income, block grants, and funds from reserves, should be adequate to cover budgeted expenses.

A review of historical information and preliminary information pertaining to the upcoming crop year indicates that the average grower price for the 2016-17 season could be approximately $6.50 per 25-pound carton of tomatoes. Therefore, the estimated assessment revenue for the 2016-17 crop year as a percentage of total grower revenue could be approximately 0.5 percent.

This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, these costs are offset by the benefits derived by the operation of the marketing order. In addition, the Committee's meeting was widely publicized throughout the Florida tomato industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the August 16, 2016, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178 Vegetable and Specialty Crops. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

This rule imposes no additional reporting or recordkeeping requirements on either small or large Florida tomato handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

A proposed rule concerning this action was published in the Federal Register on November 23, 2016 (81 FR 84507). Copies of the proposed rule were also mailed or sent via facsimile to all Florida tomato handlers. Finally, the proposal was made available through the internet by USDA and the Office of the Federal Register. A 15-day comment period ending December 8, 2016, was provided for interested persons to respond to the proposal. One comment was received. The commenter opposes the assessment rate and stated the government should not raise the assessment. The marketing order for Florida tomatoes was established at the request of the industry and is locally administered by the Committee, which is made up of growers nominated by their peers. The Committee requires funds to operate the program. The current assessment rate will not provide sufficient funds to cover anticipated expenses and the Committee voted unanimously to increase the assessment rate. Accordingly, no changes will be made to the rule as proposed, based on the comment received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it is also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because handlers are already receiving 2016-17 crop tomatoes from growers. The crop year began August 1, 2016, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable Florida tomatoes handled during such fiscal period. Also, the Committee incurs expenses on a continuing basis. Further, handlers are aware of this rule, which was unanimously recommended at a public meeting, and a 15-day comment period was provided for in the proposed rule.

For the reasons set forth in the preamble, 7 CFR part 966 is amended as follows:

FHFA is amending its FOIA regulation at 12 CFR part 1202 to incorporate changes made to the FOIA, 5 U.S.C. 552, by the FOIA Improvement Act of 2016, Public Law 114-185, 130 Stat. 538 (June 30, 2016) (Act). The primary changes to the FOIA made by the Act include codifying the foreseeable harm standard when making a determination whether to release agency records under Exemption 5; notifying requesters of the availability of dispute resolutions services at various times throughout the FOIA process; providing a minimum of 90 days for requesters to file an administrative appeal; incorporating the new statutory restrictions on charging fees in certain circumstances, and reflecting recent developments in the case law.

FHFA invites comments on all aspects of the interim final rule and will take all relevant comments into consideration before issuing the final regulation. All submissions received must include the agency name or Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted without change on the FHFA Internet Web site, http://www.fhfa.gov, and will include any personal information provided, such as name, address (mailing and email), and telephone numbers. In addition, copies of all comments received will be available for public inspection on business days between the hours of 10 a.m. and 3 p.m. at the Federal Housing Finance Agency, 400 Seventh Street SW., Eighth Floor, Washington, DC 20219. To make an appointment to inspect comments, please call the Office of General Counsel at (202) 649-3804.

FHFA has concluded that good cause exists, under 5 U.S.C. 553(b)(B) and (d)(3), to waive the notice-and-comment and delayed effective date requirements of the Administrative Procedure Act and to proceed with this interim final rule. The amendments to part 1202 primarily address how FHFA will implement the changes made under the Act, make clarifying and general updates to the existing regulation, and add two appendices indicating where to send FOIA requests and appeals to FHFA and FHFA Office of Inspector General, but do not fundamentally alter or change the regulation's nature or scope. Further, in light of the significant need for immediate guidance regarding the changes made under the Act, FHFA has determined that notice-and-comment rulemaking is impracticable and contrary to public policy.

Nevertheless, FHFA is providing the public with a 60-day period following publication of the interim final rule to submit comments. Any comments received will be considered prior to issuing a final regulation.

The Housing and Economic Recovery Act of 2008 (HERA), Public Law 110-289, 122 Stat. 2654, amended the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act) (12 U.S.C. 4501 et seq.) and the Federal Home Loan Bank Act (12 U.S.C. 1421 et seq.) to establish FHFA as an independent agency of the Federal Government to ensure that the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation, and the Federal Home Loan Banks (collectively, the regulated entities) are capitalized adequately; foster liquid, efficient, competitive and resilient national housing finance markets; operate in a safe and sound manner; comply with the Safety and Soundness Act and all rules, regulations, guidelines and orders issued under the Safety and Soundness Act, and the regulated entities' respective authorizing statutes; carry out their missions through activities consistent with the aforementioned authorities; and the activities and operations of the regulated entities are consistent with the public interest.

In 2011, FHFA issued a final FOIA regulation at 12 CFR part 1202 that provided the procedures and guidelines under which FHFA would implement the FOIA, and added provisions to include its newly created component, the Office of Inspector General (FHFA-OIG). This interim final rule amends the existing FOIA regulation at part 1202 to implement the changes made by the Act, remove individual component procedures from the body of the regulation adding them to the newly created appendices, as well as to make clarifying technical amendments.

This section is amended to include new and revised terms. It is also amended to conform to recent decisions of the D.C. Circuit Court of Appeals addressing two FOIA Fee categories: “educational institution” and “representative of the news media.” See Cause of Action v. FTC, 799 F.3d 1108 (D.C. Cir. 2015; and Sack v. DOD, 823 F.3d 687 (D.C. Cir. 2016). In Cause of Action, 799 F.3d at 1125, the court held that a representative of the news media need not work for an entity that is “organized and operated” to publish or broadcast news. Therefore, the definition of “representative of the news media” is amended to remove the “organized and operated” requirement. The definition of “educational institution” is amended to reflect the holding in Sack, 823 F.3d at 688, which held that students who make FOIA requests in furtherance of their coursework or other school-sponsored activities may qualify under this requester category. The amended definition now states that a requester under this category need only to show that the request is made in connection with his or her role at the educational institution.

Paragraph (b) is amended to reflect the changes made to the FOIA by the Act, regarding proactive disclosures of records by making them available for public inspection and copying in FHFA's electronic reading room.

Paragraph (a) is amended to reflect the changes made to the FOIA by the Act regarding adding the foreseeable harm standard to the statute. This amendment informs the public how FHFA will use the foreseeable harm standard when determining whether or not to disclose requested information.

Paragraph (a) is amended to reflect the addition of two appendices with information on where to file FOIA requests and appeals for each FHFA component (FHFA-Headquarters and FHFA-OIG).

Paragraph (b) is amended to include a standard for how FHFA will determine the cut-off date for FOIA searches. Also, as required by the Act, paragraph (g)(2) is amended to make available FHFA's FOIA Public Liaison whenever a request is placed in the complex track. Lastly, paragraph (g)(3) is amended to add an explanation on how, why and when FHFA will aggregate a request.

As required by the Act, paragraph (b) is amended to extend the time to file an administrative appeal to 90 days after an adverse determination. Paragraph (g) is also amended to include a requirement that FHFA notify requesters of the availability of assistance from FHFA's FOIA Public Liaison and the Office of Government Information Services when providing requesters with a response to their requests.

Paragraph (c) is amended to update FHFA's fee schedule. Specifically, a detailed formula on how FHFA's fee schedule is calculated has been added. Going forward fees will be based on this formula and will be published and updated, as required, on FHFA's Web site. Also, as required by the Act, paragraph (j), which discusses restrictions on charging fees when the FOIA's time limits are not met, is amended to reflect changes made by the Act. These changes reflect that agencies may not charge search fees (or duplication fees for representatives of the news media and educational/non-commercial scientific institution requesters) when the agency fails to comply with the FOIA's time limits. The restriction on charging fees is excused and the agency may charge fees as usual when it satisfies one of three exceptions as detailed at 5 U.S.C. 552(a)(4)(A)(vii)(II).

These appendices are new and have been added to describe each FHFA component. Each appendix provides specific information regarding that component to notify the public where to submit a FOIA request for records held or maintained at each component and where to file an appeal.

This interim final rule does not contain any information collection requirement that requires the approval of OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires that a regulation that has a significant economic impact on a substantial number of small entities, small businesses, or small organizations must include an initial regulatory flexibility analysis describing the regulation's impact on small entities. Such an analysis need not be undertaken if the agency has certified that the regulation does not have a significant economic impact on a substantial number of small entities (5 U.S.C. 605(b)). FHFA has considered the impact of this interim final rule under the Regulatory Flexibility Act. FHFA certifies that the regulation is not likely to have a significant economic impact on a substantial number of small business entities because the regulation is applicable only to the internal operations and legal obligations of FHFA.

Background

On January 08, 2016, Stemme AG submitted an application for type validation of the Stemme S12 in accordance with the Technical Implementation Procedures for Airworthiness and Environmental Certification Between the FAA and the European Aviation Safety Agency (EASA), Revision 5, dated September 15, 2015. The Stemme S12 is a two-seat, self-launching, powered glider with a liquid cooled, turbocharged engine mounted in the center fuselage, an indirect drive shaft, and a fully-foldable, variable-pitch composite propeller in the nose. It is constructed from glass and carbon fiber reinforced composites, features a conventional T-type tailplane, and has a retractable main landing gear. The glider has a maximum weight of 1,984 pounds (900 kilograms) and may be equipped with an optional dual-axis autopilot system. EASA type certificated the Stemme S12 under Type Certificate Number (No.) EASA.A.054 on March 11, 2016. The associated EASA Type Certificate Data Sheet (TCDS) No. EASA.A.054 defined the certification basis Stemme AG submitted to the FAA for review and acceptance.

The applicable requirements for glider certification in the United States can be found in FAA Advisory Circular (AC) 21.17-2A, “Type Certification—Fixed-Wing Gliders (Sailplanes), Including Powered Gliders,” dated February 10, 1993. AC 21.17-2A has been the basis for certification of gliders and powered gliders in the United States for many years. AC 21.17-2A states that applicants may utilize the Joint Aviation Requirements (JAR)-22, “Sailplanes and Powered Sailplanes”, or another accepted airworthiness criteria, or a combination of both, as the accepted means for showing compliance for glider type certification.

The applicant Certification Basis is based on EASA Certification Specification (CS)-22, “Sailplanes and Powered Sailplanes”, initial issue, dated November 14, 2003. In addition to CS-22 requirements, the applicant will comply with other requirements from the certification basis referenced in EASA TCDS No. EASA.A.054, including special conditions and equivalent safety findings.

Notice of proposed airworthiness design criteria for the Stemme AG Stemme S12 powered glider was published in the Federal Register on November 30, 2016 (81 FR 86296). No comments were received, therefore these airworthiness design criteria are adopted as proposed.

Accordingly, pursuant to the authority delegated to me by the Administrator, the following airworthiness design criteria under the special class provision of 14 CFR 21.17(b) as part of the type certification basis for the Stemme AG Stemme S12 power glider:

1. 14 CFR part 21, effective February 1, 1965, including amendments 21-1 through 21-93 as applicable.

2. EASA CS-22, initial issue, dated November 14, 2003.

3. EASA Special Condition No. SC-A.22.1.01, “Increase in maximum mass for sailplanes and powered sailplanes.”

4. “Preliminary Standard for the Substantiation of Indirect Drive Shafts in Power Plants of Powered Sailplanes Certified to JAR-22” (with a modification for the Stemme AG model Stemme S 10), Luftfahrt-Bundesamt (LBA) document number (no.) I231-87, issued August 05, 1988.

5. Installation of a Dual-Axis Autopilot System, including—

• EASA CS-VLA (Very Light Aeroplanes) 1309, “Equipment, systems, and installations”; initial issue, dated November 14, 2003; and

• EASA CS-23.1329, “Automatic pilot system”, amendment 3, dated July 20, 2012.

6. Drop Testing for Retractable Landing Gear (EASA equivalent safety findings) to include CS-VLA 725, “Limit drop tests”; CS-VLA 726, “Ground load dynamic tests”; and CS-VLA 727, “Reserve energy absorption”; initial issue dated November 14, 2003.

7. “Standards for Structural Substantiation of Sailplane and Powered Sailplane Parts Consisting of Glass or Carbon Fiber Reinforced Plastics”, LBA document no. I4-FVK/91, issued July 1991.

8. “Guideline for the analysis of the electrical system for powered sailplanes”, LBA document no. I334-MS 92, issued September 15, 1992.

9. The following kinds of operation are allowed: VFR-Day.

10. Date of application for FAA Type Certificate: January 08, 2016.

Discussion

On February 8, 2017, we issued Emergency AD 2017-04-51, which requires inspecting, wrapping, and replacing the DV. This emergency AD was sent previously to all known U.S. owners and operators of these Safran Helicopter Engines, S.A., Arriel 1A1, 1A2, 1B, 1C, 1C1, 1C2, 1D, 1D1, 1E2, 1K1, 1S, and 1S1 turboshaft engines. This action was prompted by reports of fuel leaks originating from the DV on certain Arriel engines. This condition, if not corrected, could result in engine compartment fire, in-flight shutdown, and damage to the helicopter.

We reviewed Safran Helicopter Engines Alert Mandatory Service Bulletin A292 73 0851, Version A, dated January 31, 2017. The MSB describes procedures for inspecting, wrapping, and replacing the DV. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires inspecting, wrapping, and replacing the DV.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the compliance requirements are within 10 flight hours or 7 days. Therefore, we find that notice and opportunity for prior public comment are impracticable and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2017-0115 and Directorate Identifier 2017-NE-04-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

We estimate that this AD affects 70 engines installed on helicopters of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

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

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

PBGC's regulations on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulations are also published on PBGC's Web site (http://www.pbgc.gov).

The interest assumptions in Appendix B to part 4044 are used to value benefits for allocation purposes under ERISA section 4044. PBGC uses the interest assumptions in Appendix B to part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the asset allocation regulation are updated quarterly; assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for April 2017 and updates the asset allocation interest assumptions for the second quarter (April through June) of 2017.

The second quarter 2017 interest assumptions under the allocation regulation will be 2.15 percent for the first 20 years following the valuation date and 2.60 percent thereafter. In comparison with the interest assumptions in effect for the first quarter of 2017, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), an increase of 0.28 percent in the select rate, and an increase of 0.23 percent in the ultimate rate (the final rate).

The April 2017 interest assumptions under the benefit payments regulation will be 1.00 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for March 2017, these interest assumptions represent a decrease of 0.25 percent in the immediate rate and no changes in i1, i2, or i3.

PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the valuation and payment of benefits under plans with valuation dates during April 2017, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows:

The owner of the bridge, the Connecticut Department of Transportation, requested a temporary deviation in order to facilitate maintenance of the bridge including installation of timber ties, miter rail replacement, and steel repairs.

The Metro-North Bridge across the Mianus River, mile 1.0 at Greenwich, Connecticut is a single-leaf bascule railroad bridge offering mariners a vertical clearance of 20 feet at mean high water and 27 feet at mean low water in the closed position. The existing drawbridge operating regulations are listed at 33 CFR 117.209.

The temporary deviation will allow the owner of the Metro-North Bridge to close the span for openings each week beginning 8 a.m. Monday through 4 p.m. Friday from March 27, 2017 to May 8, 2017. The span will open on signal from 4 p.m. Friday through 8 a.m. Monday, provided 24 hours advance notice is given. The regular operating schedule for the span will be restored April 8, 2017 through April 11, 2017 in order to accommodate a previously scheduled boating event.

Vessels able to pass through the bridge in the closed position may do at anytime. The bridge will be able to open for emergencies. There is no alternate route for vessels to pass.

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

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

The Virginia Department of Transportation, who owns and operates the Berkley (U.S. 460/S.R. 337) Bridge across the Elizabeth River, mile 0.4, at Norfolk, VA, has requested a temporary deviation from the current operating regulation set out in 33 CFR 117.1007(b), to facilitate testing of the emergency drive motor on both spans of the bridge.

Under this temporary deviation, the bridge will remain in the closed-to-navigation position from 2 a.m. to 9 a.m. on April 9, 2017. The drawbridge has two spans, each with double-leaf bascule draws, and both spans have a vertical clearance in the closed-to-navigation position of 48 feet above mean high water.

The Berkley Bridge is used by recreational vessels, tug and barge traffic, fishing vessels, and small commercial vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

Vessels able to pass through the bridges in the closed position may do so at anytime. The bridge spans will not be able to open in case of an emergency and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local Notice and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

Multnomah County requested the Broadway Bridge be authorized to open half the span in single leaf mode. The Broadway Bridge crosses the Willamette River at mile 11.7, and provides 90 feet of vertical clearance above Columbia River Datum 0.0 while in the closed-to-navigation position, and provides 125 feet of horizontal clearance with half the span open. This bridge operates in accordance with 33 CFR 117.897. This deviation allows the double bascule span of the Broadway Bridge across the Willamette River, mile 11.7, to operate the bridge in single leaf mode to marine traffic. This deviation allows the bridge to operate the double bascule span one side at a time, single leaf, to install and test new equipment. The deviation period to open the east span only will cover the following dates: From 7 p.m. on May 26, 2017 to 7 a.m. on May 27, 2017; from 7 p.m. on May 27, 2017 to 7 a.m. on May 28, 2017; from 7 p.m. on June 2, 2017 to 7 a.m. on June 3, 2017; from 7 p.m. on June 3, 2017 to 7 a.m. on June 4, 2017; from 6 a.m. on June 15, 2017 to 6 a.m. on July 20, 2017. The deviation period to open the west span only will cover the following dates: From 7 p.m. on July 28, 2017 to 7 a.m. on July 29, 2017; from 7 p.m. on July 29, 2017 to 7 a.m. on July 30, 2017; from 7 p.m. on August 4, 2017 to 7 a.m. on August 5, 2017; from 7 p.m. on August 5, 2017 to 7 a.m. on August 6, 2017; from 6 a.m. on August 16, 2017 to 6 a.m. on September 20, 2017. The bridge shall operate in accordance to 33 CFR 117.897 at all other times. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. We have coordinated with the majority of known waterway users and there were no objections to this schedule.

Vessels able to pass through the bridge in the closed positions may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

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

Multnomah County requested for the Broadway Bridge to remain closed to vessel traffic to facilitate the safe, uninterrupted roadway passage of participants in the Portland Race for the Roses event. The Broadway Bridge crosses the Willamette River at mile 11.7, and provides 90 feet of vertical clearance above Columbia River Datum 0.0 while in the closed-to-navigation position. This bridge operates in accordance with 33 CFR 117.897. This deviation allows the bascule span of the Broadway Bridge across the Willamette River, mile 11.7, to remain in the closed-to-navigation position, and need not open for maritime traffic from 7 a.m. to 12 noon. on April 2, 2017. The bridge shall operate in accordance to 33 CFR 117.897 at all other times. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. We have coordinated with the majority of known waterway users and there were no objections to this schedule.

Vessels able to pass through the bridge in the closed positions may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

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

The Smith Point Bridge, mile 6.1, across Narrow Bay, has a vertical clearance of 18 feet at mean high water and 19 feet at mean low water in the closed position. The existing drawbridge operating regulations are listed at 33 CFR 117.799(d).

The temporary deviation will allow the Smith Point Bridge to remain closed from 7 a.m. through 9 a.m. on August 13, 2017. The waterway is used primarily by seasonal recreational vessels and occasional tug/barge traffic. Coordination with waterway users has indicated no objections to the proposed short-term closure of the draw.

Vessels able to pass through the bridge in the closed positions may do so at anytime. The bridge will be able to open for emergencies. There is no alternate route for vessels to pass.

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0540 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 15, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0540, by one of the following methods:

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

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

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

EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6), of 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for residues of streptomycin, expressed as only streptomycin ((4S,4aR,5S,5aR,6S,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide), in or on fruit, citrus, group 10-10 at 2 parts per million (ppm), and the dried pulp of these commodities at 6 ppm. These time-limited tolerances expire on December 31, 2019.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The Florida Department of Agriculture and Consumer Services (FDACS) asserted that an emergency situation exists in accordance with the criteria for approval of an emergency exemption, and requested the use of streptomycin (and oxytetracycline, addressed in a separate document) in citrus to suppress the Candidatus Liberibacter asiaticus (CLas) bacterium that causes Huanglongbing (HLB) also known as citrus greening. HLB is a newly-introduced disease, vectored by the invasive insect, the Asian citrus psyllid, and is the most serious disease of citrus worldwide. This disease has rapidly spread throughout Florida's citrus production area, causing severe losses with an overall decrease in production of more than 60% primarily due to HLB. Significant losses have occurred, many producers have gone out of business, and FDACS asserts that the long-term economic viability of the citrus industry in Florida is threatened by this disease. Currently there is no cure. The bacteria reside in the phloem (the circulatory system of the tree), disrupting circulation of water and nutrients, which ultimately leads to death of the tree. FDACS states that use of streptomycin, along with other management measures, may suppress HLB symptoms, and prolong the productive life of infected trees, allowing citrus producers to remain in business while researchers continue to explore and evaluate new treatments for the disease.

After having reviewed the submission, EPA determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption are met. EPA has authorized a specific exemption under FIFRA section 18 for the use of streptomycin on citrus to suppress the CLas bacterium that causes HLB disease in Florida.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of streptomycin in or on citrus fruit commodities. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-limited tolerances expire on December 31, 2019, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on citrus fruit commodities after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed levels that were authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether streptomycin meets FIFRA's registration requirements for use on citrus fruit or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these time-limited tolerance decisions serve as bases for registrations of streptomycin by a State for special local needs under FIFRA section 24(c). Nor do these tolerances by themselves serve as the authority for persons in any State other than Florida to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for streptomycin, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption use and the time-limited tolerances for residues of streptomycin on fruit, citrus, group 10-10 at 2 ppm, and the dried pulp of these commodities at 6 ppm. EPA's assessment of exposures and risks associated with establishing the time-limited tolerances follows.

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

A summary of the toxicological endpoints for streptomycin used for human risk assessment is shown in Table 1 of this unit.

The complete human risk assessment for this action can be found at http://www.regulations.gov in the document “Streptomycin. Section 18 Emergency Exemption for Citrus Grown in Florida” in the docket for ID number EPA-HQ-OPP-2016-0450.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to streptomycin, EPA considered exposure under the time-limited tolerances established by this action as well as all existing streptomycin tolerances in 40 CFR 180.245. EPA assessed dietary exposures from streptomycin in food as follows:

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

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the 2003-2008 US Department of Agriculture (USDA) National Health and Nutrition Examination Survey (NHANES). For residue levels in food, EPA assumed tolerance level residues for all registered uses plus the new tolerances of 2 ppm in citrus fruit and 6 ppm in the dried pulp of these commodities. In addition, default processing factors were used for all processed commodities, except citrus juice, oil, and tomato puree since concentration was not observed in these commodities. One hundred percent crop treated (PCT) was assumed for all commodities. EPA's exposure assessment included tolerance level residues in livestock commodities owing to use of streptomycin as an animal drug as well. No anticipated residue or PCT refinements were used.

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

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for streptomycin. Tolerance level residues and 100% CT were assumed for all food commodities.

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

Potential residues resulting in surface water and groundwater were modeled based upon registered and new uses. The estimated drinking water concentrations (EDWCs) for ground water were higher than for surface water, and thus were used for estimating exposure from drinking water consumption, as the most conservative (worst case) estimate. Based on the Pesticide Root Zone Model, Ground Water, the EDWC in groundwater (the highest modeled value) for streptomycin for acute exposures is estimated to be 932 parts per billion (ppb), and for chronic exposures (non-cancer) is estimated at 760 ppb. No acute assessment was required as discussed earlier in this document. The modeled estimate of drinking water concentration for chronic exposure was directly entered into the dietary exposure model used to estimate chronic risks presented by potential residues in food and drinking water.

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

Streptomycin is currently registered for uses on residential gardens and trees which could result in residential exposures. EPA considered residential exposures from these uses and determined the following: Since there is no dermal hazard identified for streptomycin, residential dermal exposures were not assessed. Non-dietary incidental ingestion and inhalation from post-application residential exposures are assumed to be negligible, based upon the use scenarios and chemical properties of streptomycin. However, residential handler inhalation exposures may occur based on the use sites, equipment, and in particular, the lack of personal protective equipment (PPE) requirements on certain product labels for residential uses. Risk was therefore evaluated from short- and intermediate-term inhalation exposures for residential (non-professional) handlers/applicators. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found streptomycin to share a common mechanism of toxicity with any other substances, and streptomycin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that streptomycin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. There were no teratogenic effects noted in a rabbit developmental study at the high dose of 10 mg/kg/day. Although children born to mothers treated with streptomycin injections have sometimes had hearing loss, no teratogenic effects have been attributed to streptomycin treatment. The injected dose at which these effects occurred in humans is equivalent to approximately 150 times higher than the NOAEL from the rabbit study and approximately 30,000 times higher than the dose that produced the reduced body weight endpoint used in establishing the chronic RfD. Additionally, none of the available toxicity data for streptomycin indicate any pre- or post-natal susceptibility. Therefore there are no residual concerns, EPA is confident that the chronic RfD is sufficiently protective for teratogenic effects, and the Food Quality Protection Act (FQPA) safety factor was reduced to 1X.

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

i. The toxicity database for streptomycin is complete. An extensive database exists from drug use of streptomycin in humans and animals and all guideline toxicity data requirements for streptomycin have been waived. The toxicity of streptomycin was assessed using toxicity reviews provided by the FDA and from the published literature on drug use. Because the dose selected for risk assessment from agricultural use is based upon a toxicity endpoint (decreased body weight in test animals) that occurs at a much lower oral dose than the injected dose at which prenatal hearing effects occurred in humans, there are no residual concerns and the FQPA safety factor is reduced to 1X.

ii. The extensive database in animals and humans does not demonstrate any potential for streptomycin to cause either peripheral or central nervous system toxicity and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no direct evidence of sensitivity/susceptibility in the developing or young animal. No teratogenic effects were observed in the rabbit. As noted previously, children born to mothers treated with streptomycin injections have sometimes had hearing loss but no teratogenic effects have been attributed to direct streptomycin treatment. Chosen points of departure are expected to be protective of any possible hearing loss effects.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed assuming 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to streptomycin in drinking water. EPA used similarly conservative assumptions to consider potential for post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by streptomycin.

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

1. Acute risk. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, streptomycin is not expected to pose an acute risk.

2. Chronic risk. Based on the explanation in the unit regarding residential use patterns, chronic residential exposures to residues of streptomycin are not expected.

Therefore chronic aggregate risk was assessed considering only dietary exposures from potential residues in food and drinking water. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to streptomycin from potential residues in food and drinking water will not result in risks of concern (i.e., are <100% of the cPAD) for all population groups considered. The population group with the greatest dietary exposure is Infants ≤1 year old, with 90% of the cPAD occupied by chronic dietary exposure. Estimates for chronic dietary exposure contributed by residues in food occupy ≤32% of the cPAD for all population subgroups, indicating that the main contribution to dietary exposure is from potential residues in drinking water. The most conservative assumptions were made in the drinking water analysis, which likely resulted in overestimated exposures. Refinements could be made which would likely decrease the EDWCs, thereby further reducing the estimates of exposure and risk from potential residues in drinking water. However, assessment using these unrefined worst-case exposure scenarios provided chronic exposure estimates which would not result in risks of concern (i.e., were <100% of the cPAD).

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposures take into account short and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The dermal route of exposure was not assessed because no dermal hazard exists for streptomycin. Non-dietary incidental ingestion and inhalation from post-application residential exposures are assumed to be negligible, based upon the chemical properties and the use scenarios for streptomycin. Intermediate-term residential exposure is not expected from the residential use patterns registered for streptomycin, and therefore was not assessed. However, short-term inhalation exposures may occur for residential handlers applying streptomycin, and therefore this route of exposure was assessed. For all residential handler scenarios considered, the estimated inhalation exposures did not present risks of concern (i.e., MOEs ≥ EPA's LOC of 100). The lowest calculated MOE was 86,000 from the highest exposure scenario of the handler using hand wand/backpack and no PPE. The adult population group with the highest dietary exposure was adults 20 to 49 years old, with 38% of the cPAD occupied. Therefore, aggregate short- and intermediate-term exposure included dietary (food and water) and inhalation routes from residential handler exposure. Using these two highest-exposure scenarios, the short-term exposure estimate resulted in an MOE of 270, which does not present a risk of concern (MOE ≥ LOC of 100). Although residential exposures to children may occur through incidental oral and inhalation routes during residential application and post-application activities, they are assumed to be negligible and thus were not quantitatively assessed. Therefore, the child aggregate assessment included only contributions from chronic exposure to food and drinking water, which was previously presented in this document, and did not result in risks of concern.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in the streptomycin database, no cancer risk is expected from streptomycin and a cancer risk assessment was not needed.

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

6. Pharmaceutical aggregate risk. Section 408 of the FFDCA requires EPA to consider potential sources of exposure to a pesticide and related substances in addition to the dietary sources expected to result from a pesticide use subject to the tolerance. In order to determine whether to maintain a pesticide tolerance, EPA must “determine that there is a reasonable certainty of no harm.” Under FFDCA section 505, the Food and Drug Administration reviews human drugs for safety and effectiveness and may approve a drug notwithstanding the possibility that some users may experience adverse side effects. EPA does not believe that, for purposes of the section 408 dietary risk assessment, it is compelled to assume that combined exposures to pesticide and pharmaceutical residues that lead to a physiological effect in the user constitutes “harm” under the meaning of section 408 of the FFDCA.

Rather, EPA believes the appropriate way to consider the pharmaceutical use of streptomycin in its risk assessment is to examine the impact that the additional nonoccupational pesticide exposures would have to a pharmaceutical user exposed to a related (or, in some cases, the same) compound. Where the additional pesticide exposure has no more than a minimal impact on the pharmaceutical user, EPA could make a reasonable certainty of no harm finding for the pesticide tolerances of that compound under section 408 of the FFDCA. If the potential impact on the pharmaceutical user as a result of co-exposure from pesticide use is more than minimal, then EPA would not be able to conclude that dietary residues were safe, and would need to discuss with FDA appropriate measures to reduce exposure from one or both sources.

Injected drug doses of streptomycin are approximately 15 mg/kg/day. Because the oral absorption of streptomycin is <1%, this corresponds to an oral equivalent dose of 1,500 mg/kg/day. This oral equivalent dose is over 30,000 times the highest dietary exposure estimate of 0.045 mg/kg/day, the food and water exposure estimate for the highest-exposed population (infants <1 year old). Therefore, dietary exposure from pesticide uses of streptomycin is negligible compared to drug exposure and would not contribute to drug toxicity, so there are no concerns for risks from dietary exposure contribution of streptomycin from pesticide use, in patients receiving streptomycin drug injections. Because the pesticide exposure has no more than a minimal impact on the total dose to a pharmaceutical user, EPA believes that there is a reasonable certainty that the potential dietary pesticide exposure will result in no harm to a user being treated therapeutically with streptomycin.

A. Analytical Enforcement Methodology. An adequate enforcement methodology is available to enforce the tolerance expression. The method uses high performance liquid chromatography with tandem mass spectrometry for detection (HPLC-MS/MS). The method is detailed in “Confirmation of Aminoglycosides by HPLC/MS/MS; United States Department of Agriculture, Food Safety and Inspection Service, Office of Public Health Science SOP No: CLG-AMG1.02,” which may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

B. International Residue Limits. In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established any MRLs for streptomycin in/on citrus fruit commodities.

Therefore, time-limited tolerances are established for residues of streptomycin in or on fruit, citrus, group 10-10, at 2 ppm, and the dried pulp of these commodities at 6 ppm. These tolerances expire on December 31, 2019.

This action establishes tolerances under FFDCA sections 408(e) and 408(l)(6). The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

These regulations, issued under the authority of the MMPA (16 U.S.C. 1361 et seq.), establish a framework for authorizing the take of marine mammals incidental to SCWA's estuary management activities at the mouth of the Russian River in Sonoma County, CA. SCWA plans to manage the naturally-formed barrier beach at the mouth of the Russian River in order to minimize potential for flooding adjacent to the estuary and to enhance habitat for juvenile salmonids, as well as to conduct biological and physical monitoring of the barrier beach and estuary. Breaching of the naturally-formed barrier beach at the mouth of the Russian River requires the use of heavy equipment and increased human presence, and monitoring in the estuary requires the use of small boats.

We received an application from SCWA requesting five-year regulations and authorization to take multiple species of marine mammals. Take is anticipated to occur by Level B harassment incidental to estuary management activities due to disturbance of hauled pinnipeds. The regulations are valid from 2017 to 2022. Please see “Background” below for definitions of harassment.

Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1371(a)(5)(A)) directs 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 for up to five years if, after notice and public comment, the agency makes certain findings and issues regulations that set forth permissible methods of taking pursuant to that activity, as well as monitoring and reporting requirements. Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I provide the legal basis for issuing this final rule containing five-year regulations, and for any subsequent Letters of Authorization. As directed by this legal authority, this final rule contains mitigation, monitoring, and reporting requirements.

The following provides a summary of some of the major provisions within the final rulemaking for SCWA estuary management activities. We have determined that SCWA's adherence to the planned mitigation, monitoring, and reporting measures listed below will achieve the least practicable adverse impact on the affected marine mammals. They include:

• Measures to minimize the number and intensity of incidental takes during sensitive times of year and to minimize the duration of disturbances.

• Measures designed to eliminate startling reactions.

• Eliminating or altering management activities on the beach when pups are present, and setting limits on the frequency and duration of events during pupping season.

Paragraphs 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1371 (a)(5)(A) and (D)) 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.

An 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 September 2, 2016, we received an adequate and complete request from SCWA for authorization to take marine mammals incidental to estuary management activities. On September 20, 2016 (81 FR 64440), we published a notice of receipt of SCWA's application in the Federal Register, requesting comments and information related to the request for 30 days. We did not receive any comments. SCWA provided a revised draft incorporating minor revisions on November 1, 2016.

SCWA plans to manage the naturally-formed barrier beach at the mouth of the Russian River in order to minimize potential for flooding adjacent to the estuary and to enhance habitat for juvenile salmonids, as well as to conduct biological and physical monitoring of the barrier beach and estuary. Flood control-related breaching of the barrier beach at the mouth of the river may include artificial breaches, as well as construction and maintenance of a lagoon outlet channel. The latter activity, an alternative management technique conducted to mitigate impacts of flood control on rearing habitat for Endangered Species Act (ESA)-listed salmonids, occurs only from May 15 through October 15 (hereafter, the “lagoon management period”). Artificial breaching and monitoring activities may occur at any time during the period of validity of the regulations, which are valid for 5 years, from April 21, 2017, through April 20, 2022.

Breaching of the naturally-formed barrier beach at the mouth of the Russian River requires the use of heavy equipment (e.g., bulldozer, excavator) and increased human presence, and monitoring in the estuary requires the use of small boats. As a result, pinnipeds hauled out on the beach or at peripheral haul-outs in the estuary may exhibit behavioral responses that indicate incidental take by Level B harassment under the MMPA. Species known from the haul-out at the mouth of the Russian River or from peripheral haul-outs, and therefore anticipated to be taken incidental to the specified activity, include the harbor seal (Phoca vitulina richardii), California sea lion (Zalophus californianus), and northern elephant seal (Mirounga angustirostris).

Prior to this request for incidental take regulations and a subsequent LOA, we issued seven consecutive incidental harassment authorizations (IHAs) to SCWA for incidental take associated with the same ongoing activities. SCWA was first issued an IHA, valid for a period of one year, effective on April 1, 2010 (75 FR 17382; April 6, 2010), and was subsequently issued one-year IHAs for incidental take associated with the same activities, effective on April 21, 2011 (76 FR 23306; April 26, 2011), April 21, 2012 (77 FR 24471; April 24, 2012), April 21, 2013 (78 FR 23746; April 22, 2013), April 21, 2014 (79 FR 20180; April 11, 2014), April 21, 2015 (80 FR 24237; April 30, 2015), and April 21, 2016 (81 FR 22050; April 14, 2016).

Additional detail regarding the specified activity was provided in our Federal Register notice of proposed rulemaking (81 FR 96415; December 30, 2016) and in past notices cited herein; please see those documents or SCWA's application for more information.

The specified activity involves management of the estuary to prevent flooding while preventing adverse modification to critical habitat for ESA-listed salmonids. Requirements related to the ESA are described in further detail below. During the lagoon management period, this involves construction and maintenance of a lagoon outlet channel that would facilitate formation of a perched lagoon. A perched lagoon, which is an estuary closed to tidal influence in which water surface elevation is above mean high tide, would reduce flooding while maintaining beneficial conditions for juvenile salmonids. Additional breaches of the barrier beach may be conducted for the sole purpose of reducing flood risk. SCWA's activity was described in detail in our notice of proposed authorization prior to the 2011 IHA (76 FR 14924; March 18, 2011); please see that document for a detailed description of SCWA's estuary management activities. Aside from minor additions to SCWA's biological and physical estuary monitoring measures, the specified activity remains the same as that described in the 2011 document.

The specified activity may occur at any time during the five-year period of validity for these regulations (April 21, 2017 through April 20, 2022), although construction and maintenance of a lagoon outlet channel would occur only during the lagoon management period. In addition, there are certain restrictions placed on SCWA during the harbor seal pupping season. These, as well as periodicity and frequency of the specified activities, are described in further detail below.

The estuary is located about 97 kilometers (km) (60 miles (mi)) northwest of San Francisco in Sonoma County, near Jenner, California (see Figure 1 of SCWA's application). The Russian River watershed encompasses 3,847 km2 (1,485 mi2) in Sonoma, Mendocino, and Lake Counties. The mouth of the Russian River is located at Goat Rock State Beach (see Figure 2 of SCWA's application); the estuary extends from the mouth upstream approximately 10 to 11 km (6-7 mi) between Austin Creek and the community of Duncans Mills (Heckel and McIver, 1994).

Within the Russian River watershed, the U.S. Army Corps of Engineers (Corps), SCWA, and the Mendocino County Russian River Flood Control and Water Conservation Improvement District (District) operate and maintain Federal facilities and conduct activities in addition to the estuary management, including flood control, water diversion and storage, instream flow releases, hydroelectric power generation, channel maintenance, and fish hatchery production. As described in the notice of proposed rulemaking, NMFS issued a 2008 Biological Opinion (BiOp) for Water Supply, Flood Control Operations, and Channel Maintenance conducted by the Corps, SCWA, and the District in the Russian River watershed (NMFS, 2008). This BiOp found that the activities—including SCWA's estuary management activities—authorized by the Corps and undertaken by SCWA and the District, if continued in a manner similar to recent historic practices, were likely to jeopardize the continued existence of ESA-listed salmonids and were likely to adversely modify critical habitat. In part, therefore, the BiOp requires SCWA to collaborate with NMFS and modify their estuary water level management in order to reduce marine influence (i.e., high salinity and tidal inflow) and promote a higher water surface elevation in the estuary in order to enhance the quality of rearing habitat for juvenile salmonids. SCWA is also required to monitor the response of water quality, invertebrate production, and salmonids in and near the estuary to water surface elevation management in the estuary-lagoon system.

There are three components to SCWA's ongoing estuary management activities: (1) Lagoon outlet channel management, during the lagoon management period only, required to accomplish the dual purposes of flood risk abatement and maintenance of juvenile salmonid habitat; (2) traditional artificial breaching, with the sole objective of flood risk abatement; and (3) physical and biological monitoring in and near the estuary, required under the terms of the BiOp, to understand response to water surface elevation management in the estuary-lagoon system. The latter category (physical and biological monitoring) includes all ancillary beach and/or estuary monitoring activities and will remain the same as in past years and as described in our 2015 notice of proposed authorization (80 FR 14073; March 18, 2015). Please see the previously referenced Federal Register notice (76 FR 14924; March 18, 2011) for detailed discussion of lagoon outlet channel management, artificial breaching, and other monitoring activities.

We published a notice of proposed rulemaking in the Federal Register on December 30, 2016 (81 FR 96415). During the 30-day comment period, we received a letter from the Marine Mammal Commission (Commission) and comments from two private citizens. The Commission recommends that we issue the requested authorization, subject to inclusion of the proposed mitigation and monitoring measures as described in our notice of proposed rulemaking and the application. All measures proposed in the initial Federal Register notice are included within the final rule. The comments from the two private citizens are described below.

Comment 1: If a project is found to jeopardize a species or adversely modify its critical habitat, NMFS must cease activity until a non-jeopardizing Reasonable and Prudent Alternative (RPA) to the proposed project is in place, in coordination with the Federal action agency and any applicant.

Response: Although this is a general comment not specifically relevant to the proposed rulemaking that was the subject of the public comment period, the commenter's statement is correct. We refer readers to NMFS's 2008 BiOp for details of the relevant ESA section 7 consultation described previously in this document.

Comment 2: It is important to leave our environment and the Russian River estuary as pristine as possible for future generations. Please keep takes allowed from this region to a minimum.

Response: As required by the MMPA, NMFS has prescribed mitigation sufficient to satisfy the MMPA's least practicable adverse impact standard and has determined that the level of incidental taking proposed for authorization meets the MMPA's negligible impact standard.

The marine mammal species that may be harassed incidental to estuary management activities are the harbor seal, California sea lion, and the northern elephant seal. We presented a detailed discussion of the status of these stocks and their occurrence in the action area in the notice of the proposed rulemaking (81 FR 96415; December 30, 2016).

Ongoing monthly harbor seal counts at the Jenner haul-out were begun by J. Mortenson in January 1987, with additional nearby haul-outs added to the counts thereafter. In addition, local resident E. Twohy began daily observations of seals and people at the Jenner haul-out in November 1989. These datasets note whether the mouth at the Jenner haul-out was opened or closed at each observation, as well as various other daily and annual patterns of haul-out usage (Mortenson and Twohy, 1994). Recently, SCWA began regular baseline monitoring of the haul-out as a component of its estuary management activity. In the notice of proposed rulemaking, we presented average daily numbers of seals observed at the mouth of the Russian River from 1993-2005 and from 2009-2015 (see Table 1; 81 FR 96415; December 30, 2016).

We provided a detailed discussion of the potential effects of the specified activity on marine mammals in the notice of the proposed rulemaking (81 FR 96415; December 30, 2016). A summary of anticipated effects is provided below.

A significant body of monitoring data exists for pinnipeds at the mouth of the Russian River. In addition, pinnipeds have co-existed with regular estuary management activity for decades, as well as with regular human use activity at the beach, and are likely habituated to human presence and activity. Nevertheless, SCWA's estuary management activities have the potential to disturb pinnipeds present on the beach or at peripheral haul-outs in the estuary. During breaching operations, past monitoring has revealed that some or all of the seals present typically move or flush from the beach in response to the presence of crew and equipment, although some may remain hauled-out. No stampeding of seals—a potentially dangerous occurrence in which large numbers of animals succumb to mass panic and rush away from a stimulus—has been documented since SCWA developed protocols to prevent such events in 1999. While it is likely impossible to conduct required estuary management activities without provoking some response in hauled-out animals, precautionary mitigation measures, described later in this document, ensure that animals are gradually apprised of human approach. Under these conditions, seals typically exhibit a continuum of responses, beginning with alert movements (e.g., raising the head), which may then escalate to movement away from the stimulus and possible flushing into the water. Flushed seals typically re-occupy the haul-out within minutes to hours of the stimulus. In addition, eight other haul-outs exist nearby that may accommodate flushed seals. In the absence of appropriate mitigation measures, it is possible that pinnipeds could be subject to injury, serious injury, or mortality, likely through stampeding or abandonment of pups.

California sea lions and northern elephant seals, which have been noted only infrequently in the action area, have been observed as being less sensitive to stimulus than harbor seals during monitoring at numerous other sites. For example, monitoring of pinniped disturbance as a result of abalone research in the Channel Islands showed that, while harbor seals flushed at a rate of 69 percent, California sea lions flushed at a rate of only 21 percent. The rate for elephant seals was 0.1 percent (VanBlaricom, 2010). In the event that either of these species is present during management activities, they would be expected to display a minimal reaction to maintenance activities—less than that expected of harbor seals.

Although the Jenner haul-out is not known as a primary pupping beach, pups have been observed during the pupping season; therefore, we have evaluated the potential for injury, serious injury, or mortality to pups. There is a lack of published data regarding pupping at the mouth of the Russian River, but SCWA monitors have observed pups on the beach. No births were observed during recent monitoring, but may be inferred based on signs indicating pupping (e.g., blood spots on the sand, birds consuming possible placental remains). Pup injury or mortality would be most likely to occur in the event of extended separation of a mother and pup, or trampling in a mass movement. As discussed previously, no such movements have been recorded since development of appropriate protocols in 1999. Any California sea lions or northern elephant seals present would be independent juveniles or adults; therefore, analysis of impacts on pups is not relevant for those species.

Similarly, the period of mother-pup bonding, critical time needed to ensure pup survival and maximize pup health, is not expected to be impacted by estuary management activities. Harbor seal pups are extremely precocious, swimming and diving immediately after birth and throughout the lactation period, unlike most other phocids which normally enter the sea only after weaning (Lawson and Renouf, 1985; Cottrell et al., 2002; Burns et al., 2005). Lawson and Renouf (1987) investigated harbor seal mother-pup bonding in response to natural and anthropogenic disturbance. In summary, they found that the most critical bonding time is within minutes after birth. Although pupping season is defined as March 15-June 30, the peak of pupping season is typically concluded by mid-May, when the lagoon management period begins. As such, it is expected that most mother-pup bonding would likely be concluded as well. The number of management events during the months of March and April has been relatively low in the past, and the breaching activities occur in a single day over several hours. In addition, mitigation measures described later in this document further reduce the likelihood of any impacts to pups, whether through injury or mortality or interruption of mother-pup bonding.

In summary, and based on extensive monitoring data, we believe that impacts to hauled-out pinnipeds during estuary management activities would be behavioral harassment of limited duration (i.e., less than one day) and limited intensity (i.e., temporary flushing at most). Stampeding, and therefore injury or mortality, is not expected—nor has it been documented—in the years since appropriate protocols were established (see “Mitigation” for more details). Further, the continued, and increasingly heavy (see SCWA's monitoring reports), use of the haul-out despite decades of breaching events indicates that abandonment of the haul-out is unlikely.

We provided a detailed discussion of the potential effects of this action on marine mammal habitat in the notice of the proposed IHA (81 FR 96415; December 30, 2016). SCWA's estuary management activities will result in temporary physical alteration of the Jenner haul-out. With barrier beach closure, seal usage of the beach haul-out declines, and the three nearby river haul-outs may not be available for usage due to rising water surface elevations. Breaching of the barrier beach, subsequent to the temporary habitat disturbance, will likely increase suitability and availability of habitat for pinnipeds. Biological and water quality monitoring will not physically alter pinniped habitat.

In summary, there will be temporary physical alteration of the beach. However, natural opening and closure of the beach results in the same impacts to habitat. Therefore, seals are likely adapted to this cycle. In addition, the increase in rearing habitat quality has the goal of increasing salmonid abundance, ultimately providing more food for seals present within the action area. Thus, any impacts to marine mammal habitat are not expected to cause significant or long-term consequences for individual marine mammals or their populations.

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).”

In accordance with the regulations implemented by this final rule, we plan to issue an LOA to SCWA to take harbor seals, California sea lions, and northern elephant seals, by Level B harassment only, incidental to estuary management activities. These activities, involving increased human presence and the use of heavy equipment and support vehicles, are expected to harass pinnipeds present at the haul-out through disturbance. In addition, monitoring activities prescribed in the BiOp may harass additional animals at the Jenner haul-out and at the three haul-outs located in the estuary (Penny Logs, Patty's Rock, and Chalanchawi). Estimates of the number of harbor seals, California sea lions, and northern elephant seals that may be harassed by the planned activities is based upon the number of potential events associated with Russian River estuary management activities and the average number of individuals of each species that are present during conditions appropriate to the activity. Monitoring effort at the mouth of the Russian River has shown that the number of seals utilizing the haul-out declines during bar-closed conditions. Methodology of take estimation was discussed in detail in our notice of proposed rulemaking (81 FR 96415; December 30, 2016). Table 1 details the total number of estimated takes for harbor seals.

California sea lions and northern elephant seals are occasional visitors to the estuary. Based on limited information regarding occurrence of these species at the mouth of the Russian River estuary, we assume there is the potential to encounter one animal of each species per month throughout the year. Lagoon outlet channel activities could potentially occur over six months of the year, artificial breaching activities over eight months, topographic surveys year-round, and biological and physical monitoring in the estuary over eight months. Therefore, we assume that up to 34 incidents of take could occur per year for both the California sea lion and northern elephant seal. Based on past occurrence records, the take authorization for these two species is likely a precautionary overestimate.

The take numbers described in the preceding text are annual estimates. Therefore, over the course of the 5-year period of validity of the regulations, we will authorize a total of 23,460 incidents of take for harbor seals and 170 such incidents each for the California sea lion and northern elephant seal.

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.” A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, we consider other factors, such as the likely nature of any responses (e.g., intensity, duration), the context of any such responses (e.g., critical reproductive time or location, migration), as well as the number and nature of estimated Level A harassment takes (if any), and effects on habitat. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status.

Consistent with the 1989 preamble for NMFS's implementing regulations (54 FR 40338; September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into these analyses via their impacts on the environmental baseline (e.g., as reflected in the regulatory status of the species, population size and growth rate where known, sources of human-caused mortality).

Although SCWA's estuary management activities may disturb pinnipeds hauled out at the mouth of the Russian River, as well as those hauled out at several locations in the estuary during recurring monitoring activities, impacts are occurring to a small, localized group of animals. While these impacts can occur year-round, they occur sporadically and for limited duration (e.g., a maximum of two consecutive days for water level management events). Seals will likely become alert or, at most, flush into the water in reaction to the presence of crews and equipment on the beach. While disturbance may occur during a sensitive time (during the March 15-June 30 pupping season), mitigation measures have been specifically designed to further minimize harm during this period and eliminate the possibility of pup injury or mother-pup separation.

No injury, serious injury, or mortality is anticipated, nor is the planned action likely to result in long-term impacts such as permanent abandonment of the haul-out. Injury, serious injury, or mortality to pinnipeds would likely result from startling animals inhabiting the haul-out into a mass movement, or from extended mother-pup separation as a result of such movement. Long-term impacts to pinniped usage of the haul-out could result from significantly increased presence of humans and equipment on the beach. To avoid these possibilities, we have worked with SCWA to develop the previously described mitigation measures. These are designed to reduce the possibility of startling pinnipeds, by gradually apprising them of the presence of humans and equipment on the beach, and to reduce the possibility of impacts to pups by eliminating or altering management activities on the beach when pups are present, and by setting limits on the frequency and duration of events during pupping season. During the past 15 years of flood control management, implementation of similar mitigation measures has resulted in no known mass movement or stampede events and no known injury, serious injury, or mortality. Over the course of that time, management events have generally been infrequent and of limited duration.

No pinniped stocks for which incidental take will be authorized are listed as threatened or endangered under the ESA or determined to be strategic or depleted under the MMPA. Recent data suggests that harbor seal populations have reached carrying capacity; populations of California sea lions and northern elephant seals in California are also considered healthy.

In summary, and based on extensive monitoring data, we believe that impacts to hauled-out pinnipeds during estuary management activities would be behavioral harassment of limited duration (i.e., less than one day) and limited intensity (i.e., temporary flushing at most). Stampeding, and therefore injury or mortality, is not expected—nor has it been documented—in the years since appropriate protocols were established (see “Mitigation” for more details). Further, the continued, and increasingly heavy use of the haul-out (see figures in SCWA documents) despite decades of breaching events indicates that abandonment of the haul-out is unlikely. Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the planned monitoring and mitigation measures, we find that the total marine mammal take from SCWA's estuary management activities will have a negligible impact on the affected marine mammal species or stocks.

The number of animals expected to be taken for each species of pinniped can be considered small relative to the population size. There are an estimated 30,968 harbor seals in the California stock, 296,750 California sea lions, and 179,000 northern elephant seals in the California breeding population. Based on extensive monitoring effort specific to the affected haul-out and historical data on the frequency of the specified activity, we plan to authorize annual levels of take, by Level B harassment only, of 4,692 incidents of harassment for harbor seals, 34 incidents of harassment for California sea lions, and 34 incidents of harassment for northern elephant seals, representing 15.2, 0.01, and 0.02 percent of the populations, respectively. However, this represents an overestimate of the number of individuals harassed annually over the duration of the regulations, because these totals represent much smaller numbers of individuals that may be harassed multiple times. Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, we find that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.

In order to issue an incidental take authorization (ITA) 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 adverse 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 subsistence uses.” NMFS's implementing regulations require applicants for ITAs to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).

SCWA will continue the following mitigation measures, as implemented during the previous ITAs, which are designed to minimize impact to affected species and stocks:

• SCWA crews will cautiously approach (e.g., walking slowly with limited arm movement and minimal sound) the haul-out ahead of heavy equipment to minimize the potential for sudden flushes, which may result in a mass movement—a particular concern during pupping season.

• SCWA staff will avoid walking or driving equipment through the seal haul-out.

• Crews on foot will make an effort to be seen by seals from a distance, if possible, rather than appearing suddenly, in order to prevent sudden flushes.

• During breaching events, all monitoring will be conducted from the overlook on the bluff along Highway 1 adjacent to the haul-out in order to minimize potential for harassment.

• A water level management event may not occur for more than two consecutive days unless flooding threats cannot be controlled.

In addition, SCWA will continue the following mitigation measures specific to pupping season (March 15-June 30), as implemented in the previous ITAs:

• SCWA will maintain a one-week no-work period between water level management events (unless flooding is an immediate threat) to allow for an adequate disturbance recovery period. During the no-work period, equipment must be removed from the beach.

• If a pup less than one week old is on the beach where heavy machinery would be used or is on the path used to access the work location, the management action will be delayed until the pup has left the site or until the latest day possible to prevent flooding while still maintaining suitable fish rearing habitat. In the event that a pup remains present on the beach in the presence of flood risk, SCWA will consult with NMFS to determine the appropriate course of action. SCWA will coordinate with the locally established seal monitoring program (Stewards' Seal Watch) to determine if pups less than one week old are on the beach prior to a breaching event.

• Physical and biological monitoring will not be conducted if a pup less than one week old is present at the monitoring site or on a path to the site.

Equipment will be driven slowly on the beach and care will be taken to minimize the number of shut-downs and start-ups when the equipment is on the beach. All work will be completed as efficiently as possible, with the smallest amount of heavy equipment possible, to minimize disturbance of seals at the haul-out. Boats operating near river haul-outs during monitoring will be kept within posted speed limits and driven as far from the haul-outs as safely possible to minimize flushing seals.

We have carefully evaluated SCWA's planned mitigation measures and considered their effectiveness in past implementation to determine whether they are likely to effect the least practicable adverse 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: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals, (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation.

Any mitigation measure(s) we prescribe 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 number (total number or number at biologically important time or location) of individual marine mammals exposed to stimuli expected to result in incidental take (this goal may contribute to goal 1, above, or to reducing takes by behavioral harassment only).

(3) A reduction in the number (total number or number at a biologically important time or location) of times any individual marine mammal would be exposed to stimuli expected to result in incidental take (this goal may contribute to goal 1, above, or to reducing takes by behavioral harassment only).

(4) A reduction in the intensity of exposure to stimuli expected to result in incidental take (this goal may contribute to goal 1, above, or to reducing the severity of behavioral harassment only).

(5) Avoidance or minimization of adverse effects to marine mammal habitat, paying particular attention to the prey base, blockage or limitation of passage to or from biologically important areas, permanent destruction of habitat, or temporary disturbance of habitat during a biologically important time.

(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 SCWA's planned measures and on SCWA's record of management at the mouth of the Russian River including information from monitoring of SCWA's implementation of the mitigation measures as prescribed under the previous ITAs, we have determined that the planned mitigation measures provide the means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an ITA for an activity, section 101(a)(5)(A) 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.

Any monitoring requirement we prescribe should improve our understanding of one or more of the following:

• Occurrence of marine mammal species in action area (e.g., presence, abundance, distribution, density).

• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (e.g., source characterization, propagation, ambient noise); (2) affected species (e.g., life history, dive patterns); (3) co-occurrence of marine mammal species with the action; or (4) biological or behavioral context of exposure (e.g., age, calving, or feeding areas).

• Individual responses to acute stressors, or impacts of chronic exposures (behavioral or physiological).

• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of an individual; or (2) population, species, or stock.

• Effects on marine mammal habitat and resultant impacts to marine mammals.

• Mitigation and monitoring effectiveness.

SCWA submitted a marine mammal monitoring plan as part of the ITA application. It can be found online at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. The plan has been successfully implemented by SCWA under previous ITAs. The purpose of this monitoring plan, which is carried out collaboratively with the Stewards of the Coasts and Redwoods (Stewards) organization, is to detect the response of pinnipeds to estuary management activities at the Russian River estuary. SCWA has designed the plan both to satisfy the requirements of the ITA, and to address the following questions of interest:

1. Under what conditions do pinnipeds haul out at the Russian River estuary mouth at Jenner?

2. How do seals at the Jenner haul-out respond to activities associated with the construction and maintenance of the lagoon outlet channel and artificial breaching activities?

3. Does the number of seals at the Jenner haul-out significantly differ from historic averages with formation of a summer (May 15 to October 15) lagoon in the Russian River estuary?

4. Are seals at the Jenner haul-out displaced to nearby river and coastal haul-outs when the mouth remains closed in the summer?

Baseline Monitoring—Seals at the Jenner haul-out will be counted for four hours every week, with no more than four baseline surveys each month. Two monitoring events each month will occur in the morning, and two will occur in the afternoon, with an effort to schedule a morning survey at low and high tide each month and an afternoon survey at low and high tide each month. This baseline information will provide SCWA with details that may help to plan estuary management activities in the future to minimize pinniped interaction. Survey protocols are as follows: All seals hauled out on the beach are counted every 30 minutes from the overlook on the bluff along Highway 1 adjacent to the haul-out using spotting scopes. Monitoring may conclude for the day if weather conditions affect visibility (e.g., heavy fog in the afternoon). Depending on how the sandbar is formed, seals may haul out in multiple groups at the mouth. At each 30-minute count, the observer indicates where groups of seals are hauled out on the sandbar and provides a total count for each group. If possible, adults and pups are counted separately.

This primary haul-out is where the majority of seals are found and where pupping occurs, and SCWA's planned monitoring will allow continued development in understanding the physical and biological factors that influence seal abundance and behavior at the site. In particular, SCWA notes that the planned frequency of surveys will allow them to be able to observe the influence of physical changes that do not persist for more than ten days, like brief periods of barrier beach closures or other environmental changes, and will allow for assessment of how seals respond to barrier beach closures as well as accurate estimation of the number of harbor seal pups born at Jenner each year.

In addition to the census data, disturbances of the haul-out are recorded. The method for recording disturbances follows those in Mortenson (1996). Disturbances will be recorded on a three-point scale that represents an increasing seal response to the disturbance (Table 2). The time, source, and duration of the disturbance, as well as an estimated distance between the source and haul-out, are recorded. It should be noted that only responses falling into Mortenson's Levels 2 and 3 will be considered as harassment under the MMPA, under the terms of these final regulations.

Weather conditions are recorded at the beginning of each census. These include temperature, Beaufort sea state, precipitation/visibility, and wind speed. Tide levels and estuary water surface elevations are correlated to the monitoring start and end times.

In an effort towards understanding possible relationships between use of the Jenner haul-out and nearby coastal and river haul-outs, several other haul-outs on the coast and in the Russian River estuary are monitored as well (see Figure 1 of SCWA's application). Peripheral site monitoring would occur only in the event of an extended period of lagoon conditions (i.e., barrier beach closed with perched outlet channel for three weeks or more). Abundance at these sites has been observed to be generally very low regardless of river mouth condition. These sites are generally very small physically, and are composed of small rocks or outcrops or logs in the river, and therefore could not accommodate significant displacement from the main beach haul-out. Monitoring of peripheral sites under extended lagoon conditions will allow for possible detection of any changed use patterns.

Estuary Management Event Monitoring, Lagoon Outlet Channel—Should the mouth of the river close during the lagoon management period, SCWA would construct a lagoon outlet channel as required by the BiOp. Activities associated with the initial construction of the outlet channel, as well as the maintenance of the channel that may be required, would be monitored for disturbances to the seals at the Jenner haul-out.

A one-day pre-event channel survey will be made within one to three days prior to constructing the outlet channel. The haul-out will be monitored on the day the outlet channel is constructed and daily for up to the maximum two days allowed for channel excavation activities. Monitoring will also occur on each day that the outlet channel is maintained using heavy equipment for the duration of the lagoon management period. Monitoring of outlet channel construction and maintenance will correspond with that described above in the “Baseline Monitoring” section, with the exception that management activity monitoring duration will be defined by event duration. On the day of the management event, pinniped monitoring will begin at least one hour prior to the crew and equipment accessing the beach work area, and will continue through the duration of the event, until at least one hour after the crew and equipment leave the beach.

In an attempt to understand whether seals from the Jenner haul-out are displaced to coastal and river haul-outs nearby when management events occur, other nearby haul-outs are monitored concurrently with monitoring of outlet channel construction and maintenance activities. This provides an opportunity to qualitatively assess whether these haul-outs are being used by seals displaced from the Jenner haul-out during lagoon outlet channel excavation and maintenance. This monitoring will not provide definitive results regarding displacement to nearby coastal and river haul-outs, as individual seals are not marked or photo-identified, but is useful in tracking general trends in haul-out use during lagoon outlet channel excavation and maintenance. As volunteers are required to monitor these peripheral haul-outs, haul-out locations may need to be prioritized if there are not enough volunteers available. In that case, priority would be assigned to the nearest haul-outs (North Jenner and Odin Cove), followed by the Russian River estuary haul-outs, and finally the more distant coastal haul-outs.

Estuary Management Event Monitoring, Artificial Breaching Events—In accordance with the Russian River BiOp, SCWA may artificially breach the barrier beach outside of the summer lagoon management period, and may conduct a maximum of two such breachings during the lagoon management period, when estuary water surface elevations rise above seven feet. In that case, NMFS may be consulted regarding potential scheduling of an artificial breaching event to open the barrier beach and reduce flooding risk.

Pinniped response to artificial breaching will be monitored at each such event during the period of validity of these regulations. Monitoring methods will follow the census and disturbance monitoring protocols described in the “Baseline Monitoring” section, which were also used for the 1996 to 2000 monitoring events (MSC, 1997, 1998, 1999, 2000; SCWA and MSC, 2001). The exception, as for lagoon management events, is that the duration of monitoring is dependent upon the duration of the event. On the day of the management event, pinniped monitoring begins at least one hour before the crew and equipment accesses the beach work area, and monitoring continues through the duration of the event, until at least one hour after the crew and equipment leave the beach.

For all counts, the following information will be recorded in thirty-minute intervals: (1) Pinniped counts by species; (2) behavior; (3) time, source and duration of any disturbance; (4) estimated distances between source of disturbance and pinnipeds; (5) weather conditions (e.g., temperature, wind); and (5) tide levels and estuary water surface elevation.

Monitoring During Pupping Season—The pupping season is defined as March 15 to June 30. Baseline, lagoon outlet channel, and artificial breaching monitoring during the pupping season will include records of neonate (pups less than one week old) observations. Characteristics of a neonate pup include: Body weight less than 15 kg; thin for their body length; an umbilicus or natal pelage present; wrinkled skin; and awkward or jerky movements on land. SCWA will coordinate with the Stewards' Seal Watch monitoring program (Stewards) to determine if pups less than one week old are on the beach prior to a water level management event.

If, during monitoring, observers sight any pup that might be abandoned, SCWA will contact the NMFS stranding response network immediately, and also will report the incident to NMFS's West Coast Regional Office and Office of Protected Resources within 48 hours. Observers will not approach or move the pup. Potential indications that a pup may be abandoned are: (1) No observed contact with adult seals, (2) no movement of the pup, and (3) the pup's attempts to nurse are rebuffed.

Staffing—Monitoring is conducted by qualified individuals, which may include professional biologists employed by NMFS or SCWA or volunteers trained by the Stewards. All volunteer monitors are required to attend classroom-style training and field site visits to the haul-outs. Training covers the MMPA and conditions of the ITA, SCWA's pinniped monitoring protocols, pinniped species identification, age class identification (including a specific discussion regarding neonates), recording of count and disturbance observations (including completion of datasheets), and use of equipment. Pinniped identification includes the harbor seal, California sea lion, and northern elephant seal, as well as other pinniped species with potential to occur in the area. Generally, SCWA staff and volunteers collect baseline data on Jenner haul-out use during the twice-monthly monitoring events. A schedule for this monitoring will be established with Stewards once volunteers are available for the monitoring effort. SCWA staff monitors lagoon outlet channel excavation and maintenance activities and artificial breaching events at the Jenner haul-out, with assistance from available Stewards volunteers. Stewards volunteers monitor the coastal and river haul-out locations during lagoon outlet channel excavation and maintenance activities.

Training on the MMPA, pinniped identification, and the conditions of the ITA is held for staff and contractors assigned to estuary management activities. The training includes equipment operators, safety crew members, and surveyors. In addition, prior to beginning each water surface elevation management event, the biologist monitoring the event participates in the onsite safety meeting to discuss the location(s) of pinnipeds at the Jenner haul-out that day and methods of avoiding and minimizing disturbances to the haul-out as outlined in the ITA.

SCWA is required to submit an annual report on all activities and marine mammal monitoring results to NMFS within ninety days following the end of the monitoring period. These reports must contain the following information:

• The number of pinnipeds taken, by species and age class (if possible);

• Behavior prior to and during water level management events;

• Start and end time of activity;

• Estimated distances between source and pinnipeds when disturbance occurs;

• Weather conditions (e.g., temperature, wind, etc.);

• Haul-out reoccupation time of any pinnipeds based on post-activity monitoring;

• Tide levels and estuary water surface elevation; and

• Pinniped census from bi-monthly and nearby haul-out monitoring.

The annual report includes descriptions of monitoring methodology, tabulation of estuary management events, summary of monitoring results, and discussion of problems noted and proposed remedial measures.

SCWA must also submit a comprehensive summary report that includes any future application for renewed regulations and Letters of Authorization.

SCWA complied with the mitigation and monitoring required under previous authorizations. Prior Federal Register notices of proposed yearly authorizations have provided summaries of the monitoring results from 2009-2015; please see those documents for more information. Previous monitoring reports are available online at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. We also provided a detailed description of previous monitoring results in the proposed rule for this action (81 FR 96415; December 30, 2016).

The regulations governing the take of marine mammals incidental to SCWA estuary management activities contain an adaptive management component.

The reporting requirements associated with this final rule are designed to provide NMFS with monitoring data from the previous year to allow consideration of whether any changes are appropriate. The use of adaptive management allows NMFS to consider new information from different sources to determine (with input from SCWA regarding practicability) on an annual or biennial basis if mitigation or monitoring measures should be modified (including additions or deletions). Mitigation measures could be modified if new data suggests that such modifications would have a reasonable likelihood of reducing adverse effects to marine mammals and if the measures are practicable.

SCWA's monitoring program (see “Monitoring and Reporting”) will be managed adaptively. Changes to the monitoring program may be adopted if they are reasonably likely to better accomplish the MMPA monitoring goals described previously or may better answer the specific questions associated with SCWA's monitoring plan.

The following are some of the possible sources of applicable data to be considered through the adaptive management process: (1) Results from monitoring reports, as required by MMPA authorizations; (2) results from general marine mammal and sound research; and (3) any information which reveals that marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or subsequent LOAs.

There are no relevant subsistence uses of marine mammals implicated by the specified activity. Therefore, we have determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

No marine mammal species listed under the ESA are expected to be affected by these activities. Therefore, we have determined that section 7 consultation under the ESA is not required.

In compliance with the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.), as implemented by the regulations published by the Council on Environmental Quality (40 CFR parts 1500-1508), and NOAA Administrative Order 216-6, we prepared an Environmental Assessment (EA) to consider the direct, indirect and cumulative effects to the human environment resulting from issuance of the original IHA to SCWA for the specified activities and found that it would not result in any significant impacts to the human environment. We signed a Finding of No Significant Impact (FONSI) on March 30, 2010. We have reviewed SWCA's application for incidental take regulations and an associated LOA for ongoing estuary management activities and the 2016 monitoring report. Based on that review, we have determined that the action follows closely the ITAs issued and implemented in 2010-2016, and does not present any substantial changes, or significant new circumstances or information relevant to environmental concerns which would require a supplement to the 2010 EA or preparation of a new NEPA document. Therefore, we have determined that a new or supplemental EA or Environmental Impact Statement is unnecessary, and we rely on the existing EA and FONSI for this action. The 2010 EA and FONSI for this action are available for review at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm.

Pursuant to the procedures established to implement Executive Order 12866, the Office of Management and Budget has determined that this rule is not significant.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration at the proposed rule stage that this rule will not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis is not required and none has been prepared.

Notwithstanding any other provision of law, no person is required to respond to nor shall a person be subject to a penalty for failure to comply with a collection of information (COI) subject to the requirements of the Paperwork Reduction Act (PRA) unless that COI displays a currently valid OMB control number. These requirements have been approved by OMB under control number 0648-0151 and include applications for regulations, subsequent LOAs, and reports.

For reasons set forth in the preamble, NMFS amends 50 CFR part 217 as follows:

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The B season allowance of the 2017 total allowable catch (TAC) of pollock in Statistical Area 610 of the GOA is 2,232 metric tons (mt) as established by the final 2017 and 2018 harvest specifications for groundfish in the GOA (82 FR 12032, February 27, 2017). In accordance with § 679.20(d)(1)(i), the Regional Administrator has determined that the B season allowance of the 2017 TAC of pollock in Statistical Area 610 of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 2,132 mt and is setting aside the remaining 100 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 610 of the GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Acting Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for pollock in Statistical Area 610 of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 9, 2017.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.