Federal Register Vol. 82, No.100,

In an interim rule 1 effective June 16, 2016, and published in the Federal Register on June 16, 2016 (81 FR 39175-39176, Docket No. APHIS-2015-0097), we amended the Asian longhorned beetle (ALB) regulations in 7 CFR 301.51 by removing plants of the genus Celtis, which we have determined not to be a host plant of ALB, from the list of regulated articles. This action relieved restrictions on the movement of Celtis spp. plants from areas quarantined for ALB.

Comments on the interim rule were required to be received on or before August 15, 2016. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule without change.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866. Because this rule is waived, it does not trigger the requirements of Executive Order 13771.

This rule is issued under section 8e of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” Section 8e provides that whenever certain commodities are regulated under Federal marketing orders, imports of those commodities into the United States are prohibited unless they meet the same or comparable grade, size, quality, and/or maturity requirements as those in effect for the domestically produced commodities. The Act also authorizes USDA to perform inspections and other related functions (such as commodity sampling) on those imported commodities and to certify whether these requirements have been met.

Parts 944, 980, and 999 of title 7 of the Code of Federal Regulations (CFR) specify inspection, certification, and reporting requirements for imported commodities regulated under 8e. These parts also list the imported commodities that may be exempt from grade, size, quality, and/or maturity requirements when imported for specific purposes (such as processing, donation to charitable organizations, or livestock feed). Additionally, these parts specify the form importers must use to report to USDA and the U.S. Customs and Border Protection (CBP) imports of commodities exempt from 8e regulations.

USDA is issuing this rule in conformance with Executive Orders 12866, 13771, 13563, and 13175.

This rule continues in effect an interim rule clarifying change to part 980, the vegetable import regulations. The interim rule moved the procedure for filing an exempt commodity form for tomatoes destined for noncommercial outlets for experimental purposes from § 980.212 of the tomato import regulations to § 980.501 of the vegetable safeguard procedures import regulations. This change removed reference to a form that does not exist for imports and made the safeguard regulations consistent for all imported vegetables that are exempt from 8e regulations.

This rule also continues in effect the change to § 999.600 of the pistachio import regulations that removed the reference to a paper-based notification of entry process, known in the industry as the “stamp and fax” process. This paper-based process was replaced by an electronic filing requirement that was developed to comply with the International Trade Data System (ITDS) and was specified within the USDA's Agricultural Marketing Service (AMS) Specialty Crops Inspection Division's regulations in an interim rule published in the Federal Register on December 21, 2016 (81 FR 93571). Removing this outdated information streamlines the regulations and provides consistency among the specialty crop import regulations.

This rule also continues in effect other minor administrative changes to §§ 944.401, 999.1, and 999.600 of the fruit and specialty crop import regulations. These changes, which include updating agency and program names and removing or updating other information that was duplicative or out of date, helps ensure the import regulations contain accurate information and align with the ITDS objective of streamlining import processes for the trade.

AMS has determined that these changes to the fruit, vegetable, and specialty crop import regulations meet CBP's requirements for ITDS by shifting an exempt-tomato reporting requirement to the proper safeguard procedures section of the vegetable import regulations. These regulations were revised in 2015 to provide an electronic filing option; streamline an entry notification process for imported pistachios; and remove or revise duplicative or outdated information. These changes help reduce the burden on America's import trade without compromising AMS' ability to ensure compliance with its import regulations.

In an interim rule published in the Federal Register on December 5, 2016, and effective on December 8, 2016 (81 FR 87409, Doc. No. AMS-SC-164-0083, SC16-944/980/999-1 IR), clarifying changes were made to part 980 by moving the exempt-use reporting requirements for tomatoes destined for noncommercial outlets for experimental purposes from § 980.212 (tomato import regulations) to § 980.501 (safeguard procedures section for imported vegetables).

In addition, § 999.600(d) of the pistachio import regulations was revised to remove the paper-based “stamp and fax” process, which has been replaced by an electronic process that importers now use to notify AMS of an initial request for inspection.

Finally, several administrative changes were made to various sections in parts 944 and 999 (the fruit and specialty crop import regulations, respectively). First, the USDA agency and program names were updated, where needed. Second, §§ 944.401(e) (olives) and 999.1(c)(1) (dates) were changed by simplifying the language regarding the requirement that importers provide USDA inspectors with identifying information about each lot being inspected. Finally, § 999.1(e) (dates) was updated by removing a paragraph titled “importation,” because it contained redundant and incomplete information about filing inspection or exemption documents with CBP.

This rule does not meet the definition of a significant regulatory action contained in section 3(f) of Executive Order 12866, and is not subject to review by the Office of Management and Budget (OMB). Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017). Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this action 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.

Small agricultural service firms, which includes importers, are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000 (13 CFR 121.201).

Based on 2015 reporting, USDA estimates that there were two importers and two receivers of tomatoes that were exempt from 8e requirements. Although USDA does not have access to data about the business sizes of these importers and receivers, it is likely that the majority may be classified as large entities.

This rule continues in effect the action that moved the requirements for reporting imported tomatoes destined for noncommercial outlets for experimental purposes, which are exempt from 8e regulations, from the tomato import regulations to the safeguard section of the vegetable import regulations. This change to the regulations did not revise the procedures currently used by importers and receivers of exempt tomatoes; instead, it shifted the outdated requirements contained in § 980.212 to the more appropriate safeguard procedures section in § 980.501. Most importers and receivers already file FV-6 forms electronically with AMS, while some paper forms are still submitted to AMS. In 2015, AMS estimates it received five electronic FV-6 forms and no paper FV-6 forms for approximately 14,900 pounds of exempt tomatoes.

As part of the full implementation of ITDS, importers and receivers report exempt shipments through CBP's Automated Commercial Environment (ACE) system and AMS' Compliance and Enforcement Management System (CEMS). CEMS was developed by AMS to replace AMS' Marketing Order Online System (MOLS), an online system that was used from its implementation in 2008 until it was replaced by CEMS in 2016. An affirmation of interim rule as final rule was published in the Federal Register on June 25, 2015, (80 FR 36465) that provided for the electronic submission of FV-6 forms, a practice that has existed since MOLS was implemented in 2008 but was not reflected in the regulations. This action imposes no additional burden on importers and receivers of exempt tomatoes.

Regarding alternatives to this action, AMS determined that these changes to the regulations were needed to comply with ITDS requirements. Moving an outdated, paper-based exempt form-filing requirement from the import tomato regulations to the safeguard section of the vegetable import regulations standardized the regulations and properly provided for the current requirement of filing a paper or electronic form FV-6, which benefits importers and receivers who import these exempt tomatoes. In addition, changing the pistachio regulations by removing the paper-based “stamp and fax” requirement streamlined the regulations and reduced the burden on the trade. The other administrative changes made in the interim rule provided the import trade with accurate information.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection requirements for the form FV-6 (for commodities exempt from 8e requirements) have been previously approved by OMB and assigned OMB No. 0581-0167 (Specific Commodities Imported into United States Exempt From Import Regulations). No changes in the requirements for the FV-6 form as a result of this action are necessary. The shift of the requirements for exempt-use filings from the tomato import regulations to the safeguard section for imported vegetables was administrative in nature and did not change the practice that has existed for many years. Should any changes to form FV-6 become necessary in the future, they would be submitted to OMB for approval.

This rule will not impose any additional reporting or recordkeeping requirements on either small or large importers or receivers of commodities exempt from 8e regulations. As with all import regulations, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

Further, importers are already familiar with the long-existing process and requirement to file FV-6 forms for commodities exempt from 8e regulations. Also, the import trade is fully aware of the ITDS initiative, which is designed to streamline and automate the filing of import shipment data.

Comments on the interim rule were required to be received on or before February 3, 2017. No comments were received. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule, without change.

To view the interim rule, go to: https://www.regulations.gov/document?D=AMS-SC-16-0083-0001.

This action also affirms information contained in the interim rule concerning Executive Orders 12866, 12988, 13175, and 13563; the Paperwork Reduction Act (44 U.S.C. Chapter 35); and the E-Gov Act (44 U.S.C. 101).

After consideration of all relevant material presented, it is found that finalizing the interim rule, without change, as published in the Federal Register (81 FR 87409, December 5, 2016) will tend to effectuate the declared policy of the Act.

This final rule is issued under Marketing Order No. 985 (7 CFR part 985), as amended, regulating the handling of spearmint oil produced in the Far West (Washington, Idaho, Oregon, and designated parts of Nevada and Utah), 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 final rule in conformance with Executive Orders 12866, 13771, 13563, and 13175. This rule does not meet the definition of a significant regulatory action contained in section 3(f) of Executive Order 12866, and is not subject to review by the Office of Management and Budget (OMB). Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule is not intended to have retroactive effect. Under the order now in effect, salable quantities and allotment percentages may be established for classes of spearmint oil produced in the Far West. This final rule will establish the quantity of spearmint oil produced in the Far West, by class, which handlers may purchase from, or handle on behalf of, producers during the 2017-2018 marketing year, which begins on June 1, 2017.

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. A 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.

The Far West Spearmint Oil Administrative Committee (Committee) meets annually in the fall to adopt a marketing policy for the ensuing marketing year or years. In determining such marketing policy, the Committee considers a number of factors, including, but not limited to, the current and projected supply, estimated future demand, production costs, and producer prices for all classes of spearmint oil. Input from spearmint oil handlers and producers regarding prospective marketing conditions for the upcoming year is considered as well.

If the Committee's marketing policy considerations indicate a need for regulating the quantity of any or all classes of spearmint oil marketed, the Committee subsequently recommends to USDA the establishment of a salable quantity and allotment percentage for such class or classes of oil in the forthcoming marketing year. Recommendations for volume regulation are intended to ensure that market requirements for Far West spearmint oil are satisfied and orderly marketing conditions are maintained.

The salable quantity represents the total amount of each class of spearmint oil that handlers may purchase from, or handle on behalf of, producers during the marketing year. The allotment percentage is the percentage used to calculate each producer's prorated share of the salable quantity. It is derived by dividing the salable quantity for each class of spearmint oil by the total of all producers' allotment bases for the same class of oil. Each producer's annual allotment of salable spearmint oil is calculated by multiplying their respective total allotment base by the allotment percentage for each class of spearmint oil. A producer's allotment base is their quantified share of the spearmint oil market based on a statistical representation of past spearmint oil production, with accommodation for reasonable, normal adjustments to such base as prescribed by the Committee and approved by USDA.

Salable quantities and allotment percentages are established at levels intended to fulfill market requirements and to maintain orderly marketing conditions. Committee recommendations for volume regulation are made well in advance of the period in which the regulations are to be effective, thereby allowing producers the chance to adjust their production decisions accordingly.

Pursuant to authority in §§ 985.50, 985.51, and 985.52 of the order, the full eight-member Committee met on October 19, 2016, and recommended salable quantities and allotment percentages for both classes of oil for the 2017-2018 marketing year. By a vote of 6-2, the Committee recommended the establishment of a salable quantity and allotment percentage for Scotch spearmint oil of 774,645 pounds and 36 percent, respectively. The two Committee members that voted in opposition to the recommendation both supported volume regulation, but at higher levels than were proposed. They felt that a nearly 20 percent year-over-year reduction in the salable quantity and allotment percentage for Scotch spearmint oil was too severe.

For Native spearmint oil, with a unanimous vote (7-0, with the public member abstaining), the Committee recommended the establishment of a salable quantity and allotment percentage of 1,075,051 pounds and 44 percent, respectively. Pursuant to § 985.29(a), seven members of the Committee constitute a quorum and six concurring votes are required to pass a motion.

This final rule establishes the amount of Scotch and Native spearmint oil that handlers may purchase from, or handle on behalf of, producers during the 2017-2018 marketing year, which begins on June 1, 2017. Salable quantities and allotment percentages have been placed into effect each season since the order's inception in 1980.

As noted above, the Committee recommended a salable quantity of Scotch spearmint oil of 774,645 pounds and an allotment percentage of 36 percent for the upcoming 2017-2018 marketing year. To arrive at these recommendations, the Committee utilized 2017-2018 sales estimates for Scotch spearmint oil, as provided by several of the industry handlers, historical and current Scotch spearmint oil production, inventory statistics, and international market data obtained from consultants for the spearmint oil industry.

The trade demand estimate for Far West Scotch spearmint oil was revised during the 2016-2017 marketing year from an initial estimate of 900,000 pounds to the current estimate of 950,000 pounds. Trade demand is expected to decrease from the 950,000 pounds anticipated in the 2016-2017 marketing year to 925,000 pounds in the 2017-2018 marketing year. Industry reports indicate that the decreased trade demand estimate is the result of decreased consumer demand for spearmint-flavored products, especially chewing gum in China and India, as fruit flavors are becoming preferential to consumers. In addition, better than expected production of spearmint oil in competing markets, most notably Canada and the U.S. Midwest, have also factored into the Committee's assessment of the market.

Production of Far West Scotch spearmint oil declined from 1,229,258 pounds in 2015 to an estimated 1,113,346 pounds in 2016. Production over the last three seasons has exceeded sales, leading to a gradual build in the salable carry-in of Scotch spearmint oil. Scotch spearmint oil held in the reserve pool, which was completely depleted at the beginning of the 2014-2015 marketing year, has also been gradually increasing over the past three years.

Carry-in represents the amount of salable spearmint oil produced, but not marketed, in a previous year or years that is available for sale in the current year under a previous year's annual allotment. Under volume regulation, spearmint oil that is designated as salable continues to be available to the market until it is sold and may be marketed at any time at the discretion of the owner. Spearmint oil held in reserve, however, is spearmint oil that has been produced in excess of a producer's marketing year allotment that can only be released into the market under certain circumstances.

Salable carry-in is the primary measure of excess spearmint oil supply under the order as it represents overproduction in prior years that is currently available to the market without restriction. Spearmint oil held in the reserve pool is a lesser indicator of excess supply, as it is spearmint oil that is not available to the market in the current marketing year without an increase in the salable quantity and allotment percentage.

The Committee estimates that there will be 174,507 pounds of salable carry-in of Scotch spearmint oil on June 1, 2017. If correct, this figure would be up 8,739 pounds from the 165,768 pounds carried in the previous year on June 1, 2016. The Committee estimates that salable carry-in will decrease to 24,152 pounds at the beginning of the 2018-2019 marketing year, if current market conditions and projections are maintained.

This anticipated level of carry-in (24,152 pounds) would be below the quantity that the Committee considers favorable (generally 150,000 pounds). However, the Committee believes that this lower salable carry-in is manageable given the strong production of spearmint in the current marketing year and the quantity of Scotch spearmint oil held in the reserve pool that could be released into the market if the industry experiences an unexpected increase in demand.

The Committee reported that there was 15,937 pounds of Scotch spearmint oil held in the reserve pool as of May 31, 2016. The Committee expects the reserve pool to increase to 204,691 pounds by May 31, 2017. This quantity of reserve oil should be an adequate buffer to supply the market if necessary.

The Committee estimates the total available supply of Scotch oil for the 2017-2018 marketing year to be 949,152 pounds (174,507 pounds of estimated carry-in plus 774,645 pounds of recommended salable quantity). The 2017-2018 Scotch spearmint oil salable quantity of 774,645 pounds recommended by the Committee represents a decrease of 184,066 pounds from the salable quantity established the previous marketing year (958,711 pounds).

The Committee estimates the 2017-2018 marketing year trade demand for Scotch spearmint oil at 925,000 pounds. As stated previously, the Committee expects that there will be 174,507 pounds of available carry-in of Scotch spearmint oil on June 1, 2017. That carry-in, when combined with the recommended 2017-2018 marketing year salable quantity of 774,645 pounds, will result in a total supply of 949,152 pounds of Scotch spearmint oil for the 2017-2018 marketing year. This quantity of Scotch spearmint oil is expected to fully satisfy estimated market demand of 925,000 pounds and is estimated to leave 24,152 pounds as carry-out from the 2017-2018 marketing year to be used as carry-in for the 2018-2019 marketing year.

The Committee's stated intent in the use of marketing order volume regulation provisions for Scotch spearmint oil is to keep adequate supplies available to meet market needs and maintain orderly marketing conditions. The recommended salable quantity of Scotch spearmint oil for the upcoming marketing year is less than the salable quantity established for the previous year. Even so, the Committee expects that the market will be fully supplied for the 2017-2018 marketing year.

The Committee believes that the recommended salable quantity will adequately meet demand, as well as result in a reasonable carry-in for the following year. The Committee developed its recommendation for the Scotch spearmint oil salable quantity and allotment percentage for the 2017-2018 marketing year based on the information discussed above, as well as the computational data outlined below.

(A) Estimated carry-in of Scotch spearmint oil on June 1, 2017: 174,507 pounds. This figure is the difference between the revised 2016-2017 marketing year total available supply of 1,124,507 pounds and the revised 2016-2017 marketing year estimated trade demand of 950,000 pounds.

(B) Estimated trade demand of Scotch spearmint oil for the 2017-2018 marketing year: 925,000 pounds. This figure was established at the Committee meeting held on October 19, 2016. The average estimated trade demand derived from six production area producer meetings held prior to the main meeting on October 19, 2016, was 960,400, which is 8,000 pounds more than the average of trade demand estimates submitted by handlers (952,400 pounds). Far West Scotch spearmint oil sales have averaged 1,021,786 pounds per year over the last three years, and 987,639 pounds over the last five years. Given the anticipated market conditions for the coming year, the Committee decided it was prudent to anticipate the lower trade demand at 925,000 pounds. Should the initially established volume regulation levels prove insufficient to adequately supply the market, the Committee has the authority to recommend intra-seasonal increases, as were undertaken in the 2014-2015 marketing year, and several other previous marketing years.

(C) Salable quantity of Scotch spearmint oil required from the 2017-2018 marketing year production: 750,493 pounds. This figure is the difference between the estimated 2017-2018 marketing year trade demand (925,000 pounds) and the estimated carry-in on June 1, 2017 (174,507 pounds). This salable quantity represents the minimum amount of Scotch spearmint oil that may be needed to satisfy estimated demand for the coming year.

(D) Total estimated allotment base of Scotch spearmint oil for the 2017-2018 marketing year: 2,151,792 pounds. This figure represents a one-percent increase over the 2016-2017 total allotment base of 2,130,487 pounds as prescribed by the order under § 985.53(d)(1). The one-percent increase equals 21,305 pounds of Scotch spearmint oil. This total estimated allotment base is generally revised each year on June 1 due to producer base being lost because of the bona fide effort production provisions of § 985.53(e). The adjustment is usually minimal.

(E) Computed Scotch spearmint oil allotment percentage for the 2017-2018 marketing year: 34.9 percent. This percentage is computed by dividing the minimum required salable quantity (750,493 pounds) by the total estimated allotment base (2,151,792 pounds).

(F) Recommended Scotch spearmint oil allotment percentage for the 2017-2018 marketing year: 36 percent. This is the Committee's recommendation and is based on the computed allotment percentage (34.9 percent), and input from producers and handlers at the October 19, 2016, meeting. The recommended 36 percent allotment percentage reflects the Committee's belief that the computed percentage (34.9 percent) may not adequately supply the potential 2017-2018 Scotch spearmint oil market demand.

(G) Recommended Scotch spearmint oil salable quantity for the 2017-2018 marketing year: 774,645 pounds. This figure is the product of the recommended salable allotment percentage (36 percent) and the total estimated allotment base (2,151,792 pounds) for the 2017-2018 marketing year.

(H) Estimated total available supply of Scotch spearmint oil for the 2017-2018 marketing year: 949,152 pounds. This figure is the sum of the 2017-2018 recommended salable quantity (774,645 pounds) and the estimated carry-in on June 1, 2017 (174,507 pounds).

The Committee also recommended a 2017-2018 Native spearmint oil salable quantity of 1,075,051 pounds and an allotment percentage of 44 percent at the October 19, 2016, meeting. These figures represent a decrease of 134,495 pounds and 6 percent, respectively, from the salable quantity and allotment percentage established for the previous marketing year. To formulate this recommendation, the Committee utilized Native spearmint oil sales estimates for the 2017-2018 marketing year, as provided by several of the industry's handlers, as well as historical and current Native spearmint oil market statistics.

The Committee estimates that there will be 1,094,659 pounds of Native spearmint oil in the reserve pool on June 1, 2017. This figure, which is the excess Native spearmint oil production held in reserve by producers, is 499,305 pounds higher than the reserve pool held by producers on June 1, 2016. This would be the highest reserve pool level since 2004. Reserve pool levels of Native spearmint oil had been slowly moving toward the level that the Committee believes is optimal for the industry prior to the increases experienced in 2015 and 2016. The large year over year increase in Native spearmint oil held in reserve (84 percent) is the result of substantially increased production and only moderately increased industry trade demand.

Far West Native spearmint oil production was estimated at 1,510,936 pounds in 2015, compared to 1,694,684 pounds estimated for 2016. Although total estimated acres of Native spearmint production decreased by 164 acres, yield per acre has risen from 145.8 in 2015 to 166.2 pounds per acre this year. Conversely, sales of Native spearmint oil, which were increasing at about a 4 percent rate from 2009 to 2014, dropped by 12 percent for the 2015-2016 marketing year.

Despite Committee statistics that indicate a sharp drop for Far West Native spearmint oil sales from the previous marketing year (2015-2016), monthly sales, to date, for the 2016-2017 marketing year have been moderately stronger. The Committee expects this trend to continue, even as imports of spearmint oil are also rising. Canada more than doubled its shipments of spearmint oil into the U.S. market from 2014 to 2015, and Chinese shipments are up 14 percent over the same period. While it is a common practice for buyers to mix U.S. and foreign-produced oils to create a final product with a certain flavor profile, the greatest percentage of oil in those blends continues to be from the Far West. The Committee and the industry expect that practice to continue into the future.

One exception to the rising trend in spearmint oil imports, India has reduced shipments over the last two years. Recent reports used by the Committee indicate that spearmint oil produced in India is improving in quality, yet decreasing in acreage. Indian spearmint oil is increasingly regarded as an alternative to high quality, Far West Native spearmint oil, but production problems have limited its importation into the U.S. market. As a result, imports from India, while still in demand, decreased in the past year. However, spearmint oil from India may return as a major threat to the Far West Native spearmint oil industry's domestic market share in the future.

One of the factors considered by the Committee when it estimated trade demand was that sales of mint products, both domestically and abroad, have slowed down. This is largely the result of slowing economies in Europe and Asia. In addition, demand is expected to be impacted by the purchasing patterns of end users. Over the last several years, end users may have been building reserve stocks of Far West oil when prices were low as a hedge against future price increases. End users of spearmint oil are expected to continue to rely on Far West production as their main source of high quality Native spearmint oil, but demand may be at lower quantities moving forward in response to the current market factors. However, Committee members remain optimistic that demand will rise again in the long term.

As such, spearmint oil handlers, who regularly help predict trade demand for Far West Native spearmint oil, estimate demand to range between 1,300,000 and 1,400,000 pounds (with an average of 1,320,000 pounds) for the 2017-2018 marketing year. This estimate is the same as the estimate for the previous marketing year. The Committee used the handlers' input when it estimated the 2017-2018 marketing year Native spearmint oil trade demand to be 1,250,000 pounds. This figure is 25,000 pounds less than the figure used in the previous marketing year and approximately 75,000 pounds below the 3-year average sales figure (1,324,560 pounds).

The estimated carry-in of 189,820 pounds of Native spearmint oil on June 1, 2017, in conjunction with the Committee recommended salable quantity of 1,075,051 pounds, results in an estimated total available supply of 1,264,871 pounds of Native spearmint oil during the 2017-2018 marketing year. With estimated trade demand of 1,250,000 pounds for the 2017-2018 marketing year, the Committee projects that 14,871 pounds of Native spearmint oil will be carried into the 2018-2019 marketing year, a reduction of 174,909 pounds from the estimated 2017-2018 marketing year carry-in. The Committee estimates that there will be 1,094,659 pounds of Native spearmint oil held in the reserve pool at the beginning of the 2017-2018 marketing year. Should the industry experience an unexpected increase in trade demand during the 2017-2018 marketing year, Native spearmint oil in the reserve pool could be released to satisfy that demand.

The Committee's stated intent in the use of marketing order volume regulation provisions for Native spearmint oil is to keep adequate supplies available to meet market needs while maintaining orderly marketing conditions. With that in mind, the Committee developed its recommendation for the Native spearmint oil salable quantity and allotment percentage for the 2017-2018 marketing year based on the information discussed above, as well as the data outlined below.

(A) Estimated carry-in of Native spearmint oil on June 1, 2017: 189,820 pounds. This figure is the difference between the revised 2016-2017 marketing year total available supply of 1,430,820 pounds and the revised 2016-2017 marketing year estimated trade demand of 1,241,000 pounds.

(B) Estimated trade demand of Native spearmint oil for the 2017-2018 marketing year: 1,250,000 pounds. This estimate was established by the Committee and is based on input from producers at six Native spearmint oil production area meetings held in mid-October 2016, as well as estimates provided by handlers and other meeting participants at the October 19, 2016, main meeting. This figure represents a decrease of 25,000 pounds from the previous year's estimate. The average estimated trade demand for Native spearmint oil from the six production area grower's meetings was 1,287,500 pounds, whereas the handlers' estimates ranged from 1,300,000 to 1,400,000 pounds. The average of Far West Native spearmint oil sales over the last three years is 1,324,560 pounds. However, the quantity marketed over the most recent full marketing year, 2015-2016, was 1,241,140 pounds. The Committee chose to be conservative in the establishment of its trade demand estimate for the 2017-2018 marketing year to avoid oversupplying the market in the face of increasing production.

(C) Salable quantity of Native spearmint oil required from the 2017-2018 marketing year production: 1,060,180 pounds. This figure is the difference between the estimated 2017-2018 marketing year estimated trade demand (1,250,000 pounds) and the estimated carry-in on June 1, 2017 (189,820 pounds). This is the minimum amount of Native spearmint oil that the Committee believes will be required to meet the anticipated 2017-2018 marketing year trade demand.

(D) Total estimated allotment base of Native spearmint oil for the 2017-2018 marketing year: 2,443,297 pounds. This figure represents a one-percent increase over the 2016-2017 total allotment base of 2,419,106 pounds as prescribed by the order in § 985.53(d)(1). The one-percent increase equals 24,191 pounds of Native spearmint oil. This estimate is generally revised each year on June 1 due to producer base being lost because of the bona fide effort production provisions of § 985.53(e). The revision is usually minimal.

(E) Computed Native spearmint oil allotment percentage for the 2017-2018 marketing year: 43.4 percent. This percentage is calculated by dividing the required salable quantity (1,060,180 pounds) by the total estimated allotment base (2,443,297 pounds) for the 2017-2018 marketing year.

(F) Recommended Native spearmint oil allotment percentage for the 2017-2018 marketing year: 44 percent. This is the Committee's recommendation based on the computed allotment percentage (43.4 percent), the average of the computed allotment percentage figures from the six production area meetings (46.7 percent), and input from producers and handlers at the October 19, 2016, meeting. The recommended 44 percent allotment percentage is also based on the Committee's belief that the computed percentage (43.4 percent) may not adequately supply the potential market for Native spearmint oil in the 2017-2018 marketing year.

(G) Recommended Native spearmint oil 2017-2018 marketing year salable quantity: 1,075,051 pounds. This figure is the product of the recommended allotment percentage (44 percent) and the total estimated allotment base (2,443,297 pounds).

(H) Estimated available supply of Native spearmint oil for the 2017-2018 marketing year: 1,264,871 pounds. This figure is the sum of the 2017-2018 recommended salable quantity (1,075,051 pounds) and the estimated carry-in on June 1, 2017 (189,820 pounds).

Under volume regulation, the salable quantity is the total quantity of each class of spearmint oil that handlers may purchase from, or handle on behalf of, producers during a marketing year. Each producer is allotted a share of the salable quantity by applying the allotment percentage to the producer's allotment base for the applicable class of spearmint oil.

The Committee's recommended Scotch and Native spearmint oil salable quantities and allotment percentages of 774,645 pounds and 36 percent, and 1,075,051 pounds and 44 percent, respectively, are based on the goal of maintaining market stability. The Committee anticipates that this goal will be achieved by matching the available supply of each class of spearmint oil to the estimated demand of each, thus avoiding extreme fluctuations in inventories and prices.

The salable quantities established by this final rule are not expected to cause a shortage of spearmint oil supplies. Any unanticipated or additional market demand for spearmint oil which may develop during the marketing year could be satisfied by an intra-seasonal increase in the salable quantity. The order contains a provision in § 985.51 for intra-seasonal increases to allow the Committee the flexibility to respond quickly to changing market conditions.

Under volume regulation, producers who produce more than their annual allotments during the marketing year may transfer such excess spearmint oil to producers who have produced less than their annual allotment. In addition, on December 1 of each year, producers that have not transferred their excess spearmint oil to other producers must place their excess spearmint oil production into the reserve pool to be released in the future in accordance with market needs and under the Committee's direction.

This regulation is similar to regulations issued in prior seasons. The average initial allotment percentage for the five most recent marketing years for both Scotch and Native spearmint oil is 52.6 percent.

In conjunction with the issuance of this final rule, USDA has reviewed the Committee's marketing policy statement for the 2017-2018 marketing year. The Committee's marketing policy statement, a requirement whenever the Committee recommends volume regulation, fully meets the intent of § 985.51(b) of the order.

During its discussion of potential 2017-2018 salable quantities and allotment percentages, the Committee considered: (1) The estimated quantity of salable oil of each class held by producers and handlers; (2) the estimated demand for each class of oil; (3) the prospective production of each class of oil; (4) the total of allotment bases of each class of oil for the current marketing year and the estimated total of allotment bases of each class for the ensuing marketing year; (5) the quantity of reserve oil, by class, in storage; (6) producer prices of oil, including prices for each class of oil; and (7) general market conditions for each class of oil, including whether the estimated season average price to producers is likely to exceed parity. Conformity with USDA's “Guidelines for Fruit, Vegetable, and Specialty Crop Marketing Orders” (http://www.ams.usda.gov/publications/content/1982-guidelines-fruit-vegetable-marketing-orders) has also been reviewed and confirmed.

The establishment of these salable quantities and allotment percentages allows for anticipated market needs. In determining anticipated market needs, the Committee considered historical sales, as well as changes and trends in production and demand. This rule also provides producers with information on the amount of spearmint oil that should be produced for the 2017 production season in order to meet anticipated market demand.

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 action 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 eight spearmint oil handlers subject to regulation under the order, approximately 41 producers of Scotch spearmint oil, and approximately 94 producers of Native spearmint oil in the regulated production area. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).

Based on the SBA's definition of small entities, the Committee estimates that two of the eight handlers regulated by the order could be considered small entities. Most of the handlers are large corporations involved in the international trading of essential oils and the products of essential oils. In addition, the Committee estimates that 12 of the 41 Scotch spearmint oil producers, and 31 of the 94 Native spearmint oil producers could be classified as small entities under the SBA definition. Thus, a majority of handlers and producers of Far West spearmint oil may not be classified as small entities.

This final rule establishes the quantity of spearmint oil produced in the Far West, by class, which handlers may purchase from, or handle on behalf of, producers during the 2017-2018 marketing year. The Committee recommended this rule to help maintain stability in the spearmint oil market by matching supply to estimated demand, thereby avoiding extreme fluctuations in supplies and prices. Establishing quantities that may be purchased or handled during the marketing year through volume regulations allows producers to coordinate their spearmint oil production with the expected market demand. Authority for this action is provided in §§ 985.50, 985.51, and 985.52 of the order.

The Far West spearmint oil industry is characterized by producers whose farming operations generally involve more than one commodity, and whose income from farming operations is not exclusively dependent on the production of spearmint oil. A typical spearmint oil producing operation has enough acreage for rotation such that the total acreage required to produce the crop is about one-third spearmint and two-thirds rotational crops. Thus, the typical spearmint oil producer has to have considerably more acreage than is planted to spearmint during any given season. Crop rotation is an essential cultural practice in the production of spearmint oil for purposes of weed, insect, and disease control. To remain economically viable with the added costs associated with spearmint oil production, a majority of spearmint oil producing farms fall into the SBA category of large businesses.

Small spearmint oil producers generally are not as extensively diversified as larger ones and, as such, are more at risk from market fluctuations. Such small producers generally need to market their entire annual production of spearmint oil and are not financially able to hold spearmint oil for sale in future years. In addition, small producers generally do not have a large assortment of other crops to cushion seasons with poor spearmint oil returns.

Conversely, large diversified producers have the potential to endure one or more seasons of poor spearmint oil markets because income from alternate crops could support their operation for a period of time. Reasonable assurance of a stable price and market provides all producing entities with the ability to maintain proper cash flow and to meet annual expenses.

Costs to producers and handlers, large and small, resulting from this rule are expected to be offset by the benefits derived from a more stable market and increased returns. The benefits of this rule are expected to be equally available to all producers and handlers regardless of their size.

Instability in the spearmint oil sub-sector of the mint industry is much more likely to originate on the supply side than the demand side. Fluctuations in yield and acreage planted from season to season tend to be larger than fluctuations in the amount purchased by handlers. Historically, demand for spearmint oil tends to change slowly from year to year.

Demand for spearmint oil at the farm level is derived from retail demand for spearmint-flavored products such as chewing gum, toothpaste, and mouthwash. The manufacturers of these products are by far the largest users of spearmint oil. However, spearmint flavoring is generally a very minor component of the products in which it is used, so changes in the raw product price have little impact on the retail prices for those goods.

In 2013, 2014, and 2015, the Committee set salable percentages at levels that resulted in most, if not all, of the spearmint oil production being made available to the market. This was in response to the increased demand for spearmint oil from the Far West due to increased utilization by end users and the reduced supply of spearmint oil coming from other production areas, both domestic and foreign.

Although there is still strong demand for spearmint oil, competing areas (mainly Canada) have experienced better than expected production in 2015 and 2016, and will create some marketing pressure for spearmint oil from the Far West. In addition, the slowing of international markets for spearmint-flavored products has negatively impacted the demand for domestically produced spearmint oil. Thus, the lower salable quantities and allotment percentages recommended by the Committee for the 2017-2018 marketing year are intended to be responsive to the changing environment of the spearmint oil market.

In the late 1990s, the Committee recommended higher than normal salable quantities and allotment percentages in hopes of gaining market share. This approach did not work. In the following years, the salable quantities and allotment percentages were established at lower levels in order to reduce the excess spearmint oil production and resulting build-up of inventory. In order to avoid a similar scenario moving forward, the Committee, relying heavily on the information provided to them by spearmint oil handlers during the October 19, 2016, meeting, ultimately recommended reducing the 2017-2018 marketing year salable quantities and allotment percentages from the previous year to better align the available supply with market demand.

The Committee reported that recent producer prices for spearmint oil are $16.50 to $18.00 per pound. Average producer prices for all types of spearmint oil for the production years 2013-2015 at $18.79, $19.21, and $18.32 per pound, respectively. These are computed price averages for Washington, Oregon, and Idaho combined, based on USDA's National Agricultural Statistics Service (NASS) data.

Spearmint oil production tends to be cyclical. Prior to the inception of the marketing order in 1980, extreme variability in producer prices was common. For example, the season average producer price for Washington Native spearmint oil in 1971 was $3.00 per pound. By 1975, the producer price had risen to $11.00 per pound, an increase of over 260 percent in just four years. Such fluctuations were not unusual in the spearmint oil industry in the years leading up to the promulgation of the order. For most producers, this was an untenable situation. Years of relatively high spearmint oil production, with demand remaining relatively stable, led to periods in which large producer stocks of unsold spearmint oil depressed producer prices. Shortages and high prices followed in subsequent years, as producers responded to price signals by cutting back production.

After establishment of the order, the supply and price variability in the spearmint oil market moderated. During the 25-year period from 1982 to 2006, the season average producer price for Native spearmint oil ranged from a high of $11.10 to a low of $9.00 per pound, or a difference of 23 percent. No change in producer price from one year to the next during this period was more than $1.00 per pound. This is a remarkable record of price stability. From 2006 to 2008, when production contracts tied to input costs were prevalent in the industry, the annual average Native spearmint oil producer price jumped by $3.80 per pound. During this time period, prices for fuel, fertilizer, and labor increased dramatically, resulting in higher contracted producer prices, and a resulting concurrent increase in the overall season average producer price for the industry.

The significant variability of the spearmint oil market is illustrated by the fact that the coefficient of variation, or CV (a standard measure of variability), of Far West spearmint oil producer prices for the period 1980-2015 (when the marketing order was in effect) is 0.24, compared to 0.36 for the decade prior to the promulgation of the order (1970-79) and 0.49 for the prior 20-year period (1960-79). The coefficient of variation, as presented herein, was calculated by USDA from information provided by the Committee and NASS. This analysis provides an indication of the price stabilizing impact of the marketing order as higher CV values correspond to greater variability.

According to information compiled by the Committee, the lowest level of production in a marketing year since the establishment of the order was about 47 percent of the 36-year average (1.96 million pounds from 1980 through 2015) and the largest crop was approximately 157 percent of the 36-year average. A key consequence is that, in years of oversupply and low prices, the season average producer price of spearmint oil is below the average cost of production (as measured by the Washington State University Cooperative Extension Service).

The wide fluctuations in supply and prices that result from the cyclical nature of the spearmint oil industry, which were even more pronounced before the creation of the order, can create liquidity problems for some producers. The order was designed to reduce the price impacts of the cyclical swings in production. However, producers have been less able to weather these cycles in recent years because of increases to production costs. While prices for spearmint oil have been relatively steady, the cost of production has increased to the extent that plans to plant spearmint may be postponed or vacated indefinitely. Producers may also be enticed by the prices of alternative crops and their lower cost of production.

In an effort to stabilize prices, the spearmint oil industry uses the volume regulation mechanisms authorized under the order. This authority allows the Committee to recommend a salable quantity and allotment percentage for each class of oil for the upcoming marketing year. The salable quantity for each class of oil is the total volume of spearmint oil produced in a marketing year that producers may sell during that same marketing year. The allotment percentage for each class of spearmint oil is derived by dividing the salable quantity by the total allotment base.

Each producer is then issued an annual allotment certificate, in pounds, for the applicable class of oil. This is calculated by multiplying the producer's allotment base by the applicable allotment percentage. This is the amount of oil of each applicable class that the producer can market under the order.

By December 1 of each year, the Committee identifies any oil that individual producers have produced above the volume specified on annual allotment certificates. Prior to December 1, such excess oil can be transferred to another producer to fill a deficiency in that producer's annual allotment as provided for in § 985.156(a).

The order allows limited quantities of excess oil to be sold by one producer to another producer to fill production deficiencies during a marketing year. A deficiency occurs when on-farm production is less than a producer's annual allotment. When a producer has a deficiency, the producer may utilize their own reserve pool oil to fill that deficiency, or excess production (production of spearmint oil in excess of the producer's annual allotment) from another producer may also be secured to fill the deficiency. As mentioned previously, all of these provisions need to be exercised prior to December 1 of each year.

Excess spearmint oil not transferred to another producer to fill a deficiency is held in storage and, on December 1, is added to the reserve pool administered by the Committee pursuant to § 985.157. The Committee maintains the reserve pool for each class of spearmint oil. Once spearmint oil is placed in the reserve pool, such spearmint oil cannot enter the market during that marketing year unless USDA approves a Committee recommendation to increase the salable quantity and allotment percentage for a certain class of oil, subsequently making a portion of the reserve pool of that class of spearmint oil available to the market. Without an increase in the salable quantity and allotment percentage, spearmint oil placed in the reserve pool cannot be removed from the reserve pool and marketed in the marketing year in which it is initially placed in the reserve pool. However, producers may dispose of reserve spearmint oil from their own production, and held in their own account, under certain provisions in subsequent marketing years under the supervision of the Committee.

While the Committee administers the reserve pool of spearmint oil, ownership and physical possession of spearmint oil held in reserve does not transfer to the Committee. The Committee accounts for, and controls the release of, reserve spearmint oil, but does not take title to, nor dispose of, any such oil of its own accord or for its own benefit. Producers, at their sole discretion, make the decisions regarding the disposition of oil held in the reserve pool under any one of three possible mechanisms.

Section 985.57(b) details the conditions under which a producer may dispose of their reserve pool spearmint oil. First, producers may utilize reserve oil from their own production to fill intra-seasonal increases in the allotment percentage and salable quantity. Second, producers may fill an ensuing year's annual allotment from spearmint oil held in the reserve pool. Lastly, producers may exchange salable oil of the same class and quantity of reserve oil from their own production to rotate stock, so long as the Committee is properly notified and the oil is properly identified.

In any given year, the total available supply of spearmint oil is composed of current production plus salable carryover stocks from the previous crop. The Committee seeks to maintain market stability by balancing supply and demand, and to close the marketing year with an appropriate level of salable spearmint oil to carry over into the subsequent marketing year. If the industry has production in excess of the salable quantity, the reserve pool absorbs the surplus quantity of spearmint oil, thereby withholding it from the market, unless such oil is needed to fill unanticipated intra-seasonal increases in demand. In this way, excess spearmint oil is not allowed to oversupply the market and create price instability. Likewise, if production is insufficient in any given year to fully supply the market with spearmint oil, the reserve pool oil can be released to satisfy the market demand until production can be increased.

Therefore, under its provisions, the order may attempt to stabilize prices by (1) regulating supply and establishing reserves in high production years, thus minimizing the price-depressing effect that excess producer stocks have on unsold spearmint oil, and (2) ensuring that stocks are available in short supply years when prices would otherwise increase dramatically. Reserve pool stocks, which increase in high production years, are drawn down in years where the crop is short.

An econometric model generated by USDA was used to assess the impact that volume regulation has on the prices producers receive for their commodity. Without volume regulation, spearmint oil markets would likely be over-supplied. This could result in low producer prices and a large volume of oil stored and carried over to the next crop year. The model estimates how much lower producer prices would likely be in the absence of volume regulation.

The Committee estimated trade demand for the 2017-2018 marketing year for both classes of oil at 2,175,000 pounds, and that the expected combined salable carry-in will be 364,327 pounds. This results in a combined required salable quantity of 1,810,673 pounds (2,175,000 pounds of total trade demand less 364,327 pounds of total carry-in) for the 2017-2018 marketing year. Under volume regulation, total sales of spearmint oil by producers for the 2017-2018 marketing year will be held to 2,214,023 pounds (the recommended salable quantity for both classes of spearmint oil of 1,849,696 pounds plus 364,327 pounds of carry-in). This total available supply of 2,214,023 pounds should be more than adequate to supply the 2,175,000 pounds of anticipated total trade demand for spearmint oil. In addition, as of June 1, 2016, the total reserve pool for both classes of spearmint oil stood at 611,291 pounds. Furthermore, that quantity is expected to rise over the course of the 2016-2017 marketing year. Should trade demand increase unexpectedly during the 2017-2018 marketing year, reserve pool spearmint oil could be released into the market to supply that increase in demand.

The recommended allotment percentages, upon which 2017-2018 producer allotments are based, are 36 percent for Scotch spearmint oil and 44 percent for Native spearmint oil. Without volume regulation, producers would not be held to these allotment levels, and could produce and sell an unrestricted quantity of spearmint oil. The USDA econometric model estimated that the season average producer price per pound (from both classes of spearmint oil) would decline about $2.45 per pound as a result of the higher quantities of spearmint oil that would be produced and marketed without volume regulation. The surplus situation for the spearmint oil market that would exist without volume regulation in 2017-2018 also would likely dampen prospects for improved producer prices in future years because of the buildup in stocks.

The use of volume regulation allows the industry to fully supply spearmint oil markets while avoiding the negative consequences of over-supplying these markets. The use of volume regulation is believed to have little or no effect on consumer prices of products containing spearmint oil and would not result in fewer retail sales of such products.

The Committee discussed alternatives to the recommendations contained in this rule for both classes of spearmint oil. The Committee discussed and rejected the idea of not regulating any volume for both classes of spearmint oil because of the severe price-depressing effects that would likely occur without volume regulation. The alternative to establish salable quantities and allotment percentages at the 2016-2017 marketing year's levels was discussed, but not put to any motion, for both classes of oil. The Committee also discussed and considered salable quantities and allotment percentages that were above and below the levels that were ultimately recommended for Scotch spearmint oil. Ultimately, the action taken by the Committee was to decrease the salable quantities and allotment percentages for both Class 1 and Class 3 spearmint oil from the current 2016-2017 marketing year levels.

As noted earlier, the Committee's recommendation to establish salable quantities and allotment percentages for both classes of spearmint oil was made after careful consideration of all available information including: (1) The estimated quantity of salable oil of each class held by producers and handlers; (2) the estimated demand for each class of oil; (3) the prospective production of each class of oil; (4) the total of allotment bases of each class of oil for the current marketing year and the estimated total of allotment bases of each class for the ensuing marketing year; (5) the quantity of reserve oil, by class, in storage; (6) producer prices of oil, including prices for each class of oil; and (7) general market conditions for each class of oil, including whether the estimated season average price to producers is likely to exceed parity.

Based on its review, the Committee believes that the salable quantities and allotment percentages recommended will achieve the objectives sought. The Committee also believes that, should there be no volume regulation in effect for the upcoming marketing year, the Far West spearmint oil industry would return to the pronounced cyclical price patterns that occurred prior to the promulgation of the order. As previously stated, annual salable quantities and allotment percentages have been issued for both classes of spearmint oil since the order's inception. The salable quantities and allotment percentages established herein are expected to facilitate the goal of maintaining orderly marketing conditions for Far West spearmint oil for the 2017-2018 and future marketing years.

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 OMB and assigned OMB No. 0581-0178, Vegetable and Specialty Crops. No changes are necessary in those requirements as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.

This final rule establishes the salable quantities and allotment percentages for Class 1 (Scotch) spearmint oil and Class 3 (Native) spearmint oil produced in the Far West during the 2017-2018 marketing year. Accordingly, this action will not impose any additional reporting or recordkeeping requirements on either small or large spearmint oil producers or 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 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.

In addition, the Committee's meeting was widely publicized throughout the spearmint oil industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the October 19, 2016, meeting was a public meeting and all entities, both large and small, were able to express views on the issues presented.

A proposed rule concerning this action was published in the Federal Register on March 31, 2017 (82 FR 16001). A copy of the rule was provided to Committee staff, who in turn made it available to all Far West spearmint oil producers, handlers, and interested persons. Finally, the rule was made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending May 1, 2017, was provided to allow interested persons to respond to the proposal. No comments were 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 matter presented, including the information and recommendations 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.

It is further found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register (5 U.S.C. 553) because the 2017-2018 marketing year starts on June 1, 2017, and handlers will need to begin purchasing the spearmint oil allotted under this rulemaking. Further, handlers are aware of this rule, which was recommended at a public meeting. Finally, a 30-day comment period was provided for in the proposed rule, and no comments were received.

For the reasons set forth in the preamble, 7 CFR part 985 is amended as follows:

Good Cause for Immediate Adoption Without Prior Notice

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.) authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without seeking comment prior to the rulemaking.

Section 553(d)(3) of the Administrative Procedure Act requires that agencies publish a rule not less than 30 days before its effective date, except as otherwise provided by the agency for good cause found and published with the rule.

This technical amendment corrects an erroneous cross-reference in § 5.71(a)(6). This correction will not impose any additional restrictions on the persons affected by these regulations. Furthermore, any additional delay in making the regulations correct would be contrary to the public interest because it would allow an error in the FAA's regulations to persist for a longer period of time. Accordingly, the FAA finds that (i) public comment on these standards prior to promulgation is unnecessary, and (ii) good cause exists to make this rule effective in less than 30 days.

In the final rule titled Safety Management System for Domestic, Flag and Supplemental Operations Certificate Holders, published on January 8, 2015 (80 FR1308), the FAA required air carriers operating under part 121 to develop and implement a safety management system (SMS) to improve the safety of its aviation-related activities. This rule is found in title 14 of the Code of Federal Regulations, part 5. Part 5 consists of six subparts: Subparts A through F.

Section 5.71(a)(6) requires a certificate holder to develop and maintain processes and systems to monitor potential non-compliance with safety risk controls developed through the safety risk management process. The safety risk management process is set out in Subpart C of part 5, but § 5.71(a)(6) erroneously cross-references Subpart B of part 5. Accordingly, this amendment corrects the cross-reference in § 5.71(a)(6) to refer to Subpart C of part 5.

The technical amendment corrects § 5.71(a)(6) so that it references Subpart C instead of Subpart B of part 5.

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295 airplanes. The NPRM published in the Federal Register on February 28, 2017 (82 FR 12074) (“the NPRM”). The NPRM was prompted by a reported inability to extend the external handle of the emergency door from its recess due to a jammed spring mechanism. The NPRM proposed to require a one-time functional check of each emergency door handle, and corrective actions if necessary. We are issuing this AD to detect and correct jamming of the door spring mechanism, which could lead to the inability to push out the emergency door external handle from its position normally aligned with the door skin. This condition could result in the inability to open the emergency door from outside during an emergency.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2016-0051, dated March 11, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0123.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We reviewed the following Airbus Defense and Space service information.

• Airbus Defense and Space Alert Operators Transmission AOT-CN235-52-0001, dated September 4, 2014.

• Airbus Defense and Space Alert Operators Transmission AOT-C295-52-0001, dated September 4, 2014.

The service information describes procedures for a one-time functional check of each emergency door handle and corrective actions if necessary. These documents are distinct since they apply to different airplane models. 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 estimate that this AD affects 27 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

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.

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Embraer S.A. Model EMB-120, -120ER, -120FC, -120QC, and -120RT airplanes. The NPRM published in the Federal Register on December 21, 2016 (81 FR 93647). The NPRM was prompted by changes to the airworthiness limitations, which add life-limited landing gear parts not previously identified. The NPRM proposed to require revising the maintenance or inspection program, as applicable, to incorporate new airworthiness limitations that add life limits for previously unidentified landing gear parts. We are issuing this AD to prevent life-limited landing gear parts from being used beyond their safe-life limits, which could lead to collapse of the landing gear.

The Agência Nacional de Aviação Civil (ANAC), which is the aviation authority for Brazil, has issued Brazilian Airworthiness Directive 2016-07-02, dated July 27, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Embraer S.A. Model EMB-120, -120ER, -120FC, -120QC, and -120RT airplanes. The MCAI states:

This AD requires revising the maintenance or inspection program, as applicable, to incorporate new airworthiness limitations that add life limits for previously unidentified landing gear parts. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9507.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We reviewed the following Embraer service information:

• EMB-120 Brasilia Maintenance Review Board (MRB) Report, Temporary Revision 28-1, dated May 17, 2016. This service information adds life-limited landing gear parts not previously identified to the airworthiness limitations section.

• Alert Service Bulletin 120-32-A543, dated July 11, 2016. This service information provides procedures for replacement of affected parts.

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 estimate that this AD affects 70 airplanes 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.

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to DG Flugzeugbau GmbH Model DG-500MB gliders. The NPRM was published in the Federal Register on March 2, 2017 (82 FR 12312). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We reviewed Solo Kleinmotoren GmbH Technische Mitteilung (English translation: Service Bulletin), Nr. 4600-6, Ausgabe 1 (English translation: Issue 1), dated November 16, 2016. The service information describes procedures for a software update that provides new settings to the engine control unit (ECU) to lower the load on the bearings of the crankshaft. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of the AD.

We estimate that this AD will affect 3 products of U.S. registry. We also estimate that it would take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $510, or $170 per product.

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.

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0158; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2014-16-19, Amendment 39-17943 (79 FR 49449, August 21, 2014) (“AD 2014-16-19”). AD 2014-16-19 applied to all Airbus Model A330-200 Freighter, -200, and -300 series airplanes. The NPRM published in the Federal Register on January 4, 2017 (82 FR 734). The NPRM was prompted by the issuance of more restrictive fuel airworthiness limitations. The NPRM proposed to require revision of the maintenance or inspection program, as applicable, to include new fuel airworthiness limitations. The NPRM also proposed to remove certain airplanes from the applicability of AD 2014-16-19. We are issuing this AD to prevent the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2016-0065, dated April 5, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A330-200 Freighter series airplanes, Model A330-200 series airplanes, Model A330-300 series airplanes; and Model A340-200 series airplanes, Model A340-300 series airplanes, Model A340-500 series airplanes, and Model A340-600 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9524.

We gave the public the opportunity to participate in developing this AD. We considered the comment received. The Air Line Pilots Association, International expressed support for the NPRM.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

Airbus has issued Airbus A330 Airworthiness Limitations Section (ALS) Part 5—Fuel Airworthiness Limitations (FAL), Revision 01, dated October 28, 2015. These airworthiness limitations introduce more restrictive fuel airworthiness limitations. 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 estimate that this AD affects 104 airplanes of U.S. registry.

The actions required by AD 2014-16-19, and retained in this AD, take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that are required by AD 2014-16-19 is $85 per product.

We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $8,840, or $85 per product.

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.

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 787-8 and 787-9 airplanes. The NPRM published in the Federal Register on September 15, 2016 (81 FR 63433). The NPRM was prompted by a report indicating that a portion of the sealant above the engine pylon between the wing skin and the vapor barrier might have been omitted. The NPRM proposed to require an inspection for missing sealant in the seam on the outside and inside of the engine struts, and corrective actions if necessary. We are issuing this AD to detect and correct missing sealant above the engine pylon between the wing skin and the vapor barrier, which can create an unintended leak path for fuel, potentially draining onto the aft fairing heat shield above the engine and onto hot engine parts or brakes, which could lead to a major ground fire.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Boeing and United Airlines (UAL) expressed support for the NPRM.

UAL requested that we revise the proposed AD to refer to Issue 002 of Boeing Alert Service Bulletin B787-81205-SB570029-00. UAL stated that it disagrees with the finish requirement being an RC task. UAL pointed out that there is already an airworthiness limitation (AWL)/Critical Design Configuration Control Limitations (CDCCL) task, 51-AWL-01, for a paint requirement on the wing, resulting in a redundant AD requirement. UAL explained that Boeing plans to revise the service information to remove the requirement for applying finish over the newly applied sealant as a required for compliance (RC) task.

We do not agree with UAL's request to revise this AD. When we incorporate service information by reference, we refer to approved or published service information. At the time of this action, Issue 002 of Boeing Alert Service Bulletin B78781205-SB570029-00 is not approved or published. We do not consider that delaying this action until after the release of a service bulletin revision is warranted. Boeing Alert Service Bulletin B787-81205-SB570029-00, Issue 001, dated February 23, 2016, provides instructions that adequately address the missing sealant above the engine pylon between the wing skin and the vapor barrier, and provides the necessary steps to restore the finish disturbed by the required work.

In addition, although UAL stated that Boeing plans to eliminate the RC designation for the finish restoration steps, Boeing has not received agreement from the FAA that such a proposal would be approved. The proper restoration of the finish, and particularly the thickness of the entire set of finish layers, is safety critical for the reasons stated in the related AWL. We do not view the AD requirement for finish restoration to be redundant relative to the AWL. The AWL requires that, following maintenance, alteration, and repair activity, the finish must be restored to the specifications contained in the AWL. We, therefore, expect the data used for any maintenance, alteration, or repair activity that disturbs that finish (in this case Boeing Alert Service Bulletin B787-81205-SB570029-00, Issue 001, dated February 23, 2016) to contain instructions that result in restoration of the finish to the standard contained in the AWL. For these reasons, we do not agree with elimination of the RC designation for the referenced steps.

We also do not agree that an operator can develop their own alternative finish restoration procedures without FAA or Boeing Commercial Airplanes Organization Designation Authorization (ODA) engineering review and approval of an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (h) of this AD. We have not changed this AD in this regard.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We reviewed Boeing Alert Service Bulletin B787-81205-SB570029-00, Issue 001, dated February 23, 2016. The service information describes procedures for doing an inspection for missing sealant in the seam on the outside and inside of the engine struts, and installing missing sealant. 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 estimate that this AD affects 32 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

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

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

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

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

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

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

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc. Model DHC-8-400 series airplanes. The NPRM published in the Federal Register on December 16, 2016 (81 FR 91058) (“the NPRM”). The NPRM was prompted by reports of interruptions in the airstair door operation. The NPRM proposed to require repetitive inspections and modification of the handrail hardware. We are issuing this AD to ensure the ability to evacuate passengers through the airstair door in the event of an emergency.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2015-02, dated January 27, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or ”the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model DHC-8-400, -401, and -402 airplanes. The MCAI states:

Required actions include applicable corrective actions (replacing or removing brackets, installing lanyards, adjusting pins, and adjusting affected parts of the assembly). You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9438.

We gave the public the opportunity to participate in developing this AD. We considered the comment received. The Air Line Pilots Association, International supported the NPRM.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

Bombardier, Inc. issued Service Bulletin 84-52-79, Revision C, dated February 2, 2016. This service information describes procedures for a general visual inspection to detect deformities and cracks of the forward and aft handle holder brackets on the airstair handrail; a detailed visual inspection of the forward and aft pin retainer brackets for the condition of the lanyards and the pins; a check for unobstructed movement of the pin retainer brackets; and rework of the airstair door handrail to prevent damage to the bulkhead and to prevent the door from jamming once the handrails are stowed. 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 estimate that this AD affects 82 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 737-300, -400, and 0500 series airplanes. The NPRM published in the Federal Register on August 30, 2016 (81 FR 59541) (“the NPRM”). The NPRM was prompted by an evaluation by the DAH indicating that the fuselage skin is subject to WFD. The NPRM proposed to require modification of the lap joint, including related investigative actions and corrective actions if necessary. The NPRM also proposed to require repetitive post-modification inspections for cracking of the skin at critical fastener rows, and corrective actions if necessary. We are issuing this AD to detect and correct cracks at the lap joint skin that could link up and result in rapid decompression and loss of structural integrity of the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Boeing requested that we remove certain references to AD 2015-16-08, Amendment 39-18233 (80 FR 51450, August 25, 2015) (“AD 2015-16-08”). Boeing pointed out that paragraphs (i), (j), and (k) of AD 2015-16-08 refer to a location (S-4R, Station (STA) 908-STA 1016) that is outside of the area affected by the modification specified in paragraph (g) of the proposed AD (S-4L and S-4R, STA 360-STA 908).

We agree with the commenter. Specifically, paragraphs (g) and (h) of AD 2015-16-08 apply to the modification area specified in this AD, but paragraphs (i), (j), and (k) of AD 2015-16-08 do not. Therefore, we have revised paragraph (k) of this AD to remove reference to paragraphs (i), (j), and (k) of AD 2015-16-08.

Aviation Partners Boeing stated that accomplishing the supplemental type certificate (STC) ST01219SE does not affect the actions specified in the NPRM.

We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) of this AD and added paragraph (c)(2) to this AD to state that installation of STC ST01219SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

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

We reviewed Boeing Alert Service Bulletin 737-53A1343, dated March 25, 2016. The service information describes procedures for modification of the lap joint, including related investigative actions and corrective actions if necessary. The service information also describes procedures for post-modification inspections for cracking of the skin at critical fastener rows, and corrective actions if necessary. 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 estimate that this AD affects 115 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

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

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

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

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

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

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

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

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

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

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

Discussion

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A300 series airplanes; and Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). The SNPRM published in the Federal Register on November 10, 2016 (81 FR 78944) (“the SNPRM”). We preceded the SNPRM with a notice of proposed rulemaking (NPRM) that published in the Federal Register on February 13, 2015 (80 FR 7992) (“the NPRM”). The NPRM proposed to require repetitive inspections for cracking of the FR 40 forward fittings for airplanes previously repaired. The NPRM was prompted by reports indicating that, on airplanes that received a certain repair following crack findings, cracks can re-initiate. The SNPRM proposed to require repetitive rototest, ultrasonic, high frequency eddy current, special detailed, and liquid penetrant inspections, as applicable, of the center wing FR 40 lower outboard radius for cracking, and related investigative and corrective actions if necessary. The SNPRM also proposed to add airplanes to the applicability. We are issuing this AD to detect and correct cracking on the FR 40 forward fittings, which could result in reduced structural integrity of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0232R1, dated December 16, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 series airplanes; and Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). The MCAI states:

Required actions include repetitive rototest, ultrasonic, high frequency eddy current, special detailed, and liquid penetrant inspections, as applicable, of the center wing FR 40 lower outboard radius for cracking, and related investigative and corrective actions if necessary.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-0084.

We gave the public the opportunity to participate in developing this AD. We received no comments on the SNPRM or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the SNPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM.

We reviewed the following service information:

• Airbus Service Bulletin A300-57-6117, dated May 28, 2015.

• Airbus Service Bulletin A300-57-0261, dated June 11, 2015.

The service information describes procedures for repetitive ultrasonic, rototest, high frequency eddy current, special detailed, and liquid penetrant inspections, and related investigative and corrective actions. These documents are distinct since they apply to different airplane models. 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 estimate that this AD affects 29 airplanes of U.S. registry.

We estimate the following costs to comply with this AD.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Piper Aircraft, Inc. Models PA-31, PA-31-300, PA-31-325, and PA-31-350 airplanes. The NPRM published in the Federal Register on January 3, 2017 (82 FR 48). The NPRM was prompted by reports of fatigue cracking in the FS 332.00 bulkhead common to the horizontal stabilizer front spar attachment on Piper Aircraft, Inc. PA-31 airplanes. Cracks in the bulkhead could compromise the structural component's capability to carry flight loads, increasing the potential to overload and fail adjacent structure. The NPRM proposed to provide an optional modification if no cracks are found that will greatly reduce the likelihood of the specified cracks. We are issuing this AD to detect and repair cracks in the bulkhead that could lead to structural failure and result in loss of control.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Joe M. Miller, Chief Inspector for Warbelow's Air Ventures, Inc. in Fairbanks, Alaska, stated they have complied with the proposed requirement on 3 airplanes and find that it takes 2 mechanics about 6 hours each (12 man-hours) to accomplish just the inspection phase. The commenter states that to better access the affected areas it is easier to remove both horizontal stabilizers. In total, it takes a crew of 2 about 4 days (64 man-hours) to accomplish the complete process from inspection to return to service.

We partially agree. We agree with revising the labor estimates for both the inspection and modification because of the additional operator data. Also, we will ensure the access time is included in both the inspection and modification estimates. Because the original time estimate was provided by another experienced operator, we will update the estimate to reflect an average of the two reported times. We disagree with using a combined estimate of 64 hours because the inspection and modification are estimated separately. We will make the following changes to the AD based on this comment:

• Update the inspection labor estimate from 1 hour to 12 hours; and

• Update the modification labor estimate from 26 to 45 hours.

Joe M. Miller, Chief Inspector, Warbelow's Air Ventures, Inc., Fairbanks, Alaska, asked that we provide reference to those airplanes that have previously complied with Service Bulletin 1289A and installed kit 88578-001 Rev B. The commenter stated the NPRM only addresses the initial inspection and modification of FS 332 and does not address airplanes that have previously complied with Piper MSB 1289A by inspection and subsequent installation of the Piper Kit 88578-001 Rev B.

We do not agree because paragraph (f) of the AD addresses this situation with the phrase “unless already done.”

We have not changed the AD based on this comment.

Roger Braun asked that we extend the initial compliance time because his impression is that the cracks were found solely on one very high-time (20,000 hour plus) airplane, and he perceives 3,000 hours time-in-service (TIS) as too early to start the inspection intervals based on the finding.

We do not agree because the airplane design is intended to provide a service life that is crack-free. When cracks are found in service, a management program is put in place (reference Advisory Circular 91-82). It is true that the crack was found on an airplane with over 20,000 hours. The compliance time for the management program is based on the known failure time but must include safety and statistical reduction factors (reference Advisory Circular 23-13). Starting inspections at 3,000 hours TIS ensures any cracks that form will be found early enough to prevent an unsafe condition. While it may appear excessive, the compliance time is set to meet the design intent of a crack-free operation.

We have not changed the AD based on this comment.

Roger Braun asked that we allow for a visual inspection instead of a penetrant inspection because the parts involve a simple visual inspection. The commenter suggested that 10x glass would suffice instead of stripping paint and doing a dye-penetrant inspection. Then, a penetrant could be used if any cracks are suspected.

We do not agree because the cleaning and penetrant method has higher detection reliability than a purely visual method. The reliability of the inspection method is tied to the compliance time for the repetitive inspection and deferral of the permanent modification. Once the AD is published, the commenter may request an alternative method of compliance (AMOC) for the visual inspection method. The request, including all substantiating data, may be submitted following 14 CFR 39.19 as specified in paragraph (i)(1) of this AD.

We have not changed the AD based on this comment.

Tim Glubaskas, Director of Maintenance, Warbelow's Air Ventures, asked for a clarification on whether installation of the kit terminates the repetitive inspections.

That kit installation is terminating action for the repetitive inspection. This is addressed in paragraph (g)(3)(i) of this AD when the kit is used as a repair for cracks and in paragraph (g)(4) of this AD when the kit is used as a modification with no cracks.

We have not changed the AD based on this comment.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

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

We reviewed Piper Aircraft, Inc. Service Bulletin No. 1289A, dated October 26, 2016. The service information describes procedures for the repetitive inspections, necessary repairs, and the optional modification of the bulkhead. 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 estimate that this AD affects 955 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary repairs/replacements that would be required based on the results of the inspection. We have no way of determining the number of airplanes that might need these repairs/replacements:

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

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

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

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

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

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

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

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

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

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-0114; Directorate Identifier 2017-NE-03-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 with FAA personnel concerning this AD.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2017-0071, dated April 26, 2017 (referred to hereinafter as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0114.

RR has issued Alert NMSB RB.211-72-AH976, Revision 2, dated March 16, 2017. The Alert NMSB describes procedures for FPI of the CIC that have RR Repair FRSC005 applied to them. 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.

This product has been approved by the aviation authority of the United Kingdom, and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This AD requires one-time FPI of each affected CIC and, depending on findings, accomplishment of a repair.

No domestic operators use this product. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

We estimate that this AD affects 0 engines installed on airplanes 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.

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

For the reasons discussed above, I certify this AD:

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

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

(3) Will not affect intrastate aviation in Alaska 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:

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to supersede AD 2011-17-09, Amendment 39-16773 (76 FR 53305, August 26, 2011) (“AD 2011-17-09”); and AD 2012-25-12, Amendment 39-17293 (77 FR 75825, December 26, 2012) (“AD 2012-25-12”). AD 2011-17-09 applied to all Airbus Model A330-200, -200 Freighter, and -300 series airplanes. AD 2012-25-12 applied to all Airbus Model A330-200 and -300 series airplanes. The SNPRM published in the Federal Register on December 16, 2016 (81 FR 91062). We preceded the SNPRM with a notice of proposed rulemaking (NPRM) that published in the Federal Register on January 13, 2016 (81 FR 1570). The NPRM was prompted by a determination that more restrictive instructions and/or airworthiness limitations should be incorporated into the maintenance or inspection program, as applicable. The NPRM proposed to require revising the maintenance or inspection program, as applicable, to incorporate new or revised airworthiness limitation requirements. The SNPRM proposed to require revising the maintenance or inspection program, as applicable, to incorporate more restrictive instructions and/or airworthiness limitations that the manufacturer has recently issued. We are issuing this AD to detect and correct fatigue cracking, accidental damage, or corrosion in principal structural elements, and possible failure of certain life limited parts, which could result in reduced structural integrity of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive, 2014-0009, dated January 8, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and Model A340-200, -300, -500, and -600 series airplanes. The MCAI states:

The unsafe condition is fatigue cracking, accidental damage, or corrosion in certain principal structural elements, and possible failure of certain life limited parts, which could result in reduced structural integrity of the airplane. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-8428.

We gave the public the opportunity to participate in developing this AD. We received no comments on the SNPRM or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the SNPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM.

Airbus has issued Airbus A330 ALS Part 1, SL-ALI, Revision 08, dated April 11, 2016. Messier-Bugatti-Dowty has issued Service Letter A33-34 A20, Revision 7, including Appendixes A through F, dated July 20, 2012. This service information describes SL-ALI for the landing gear. This service information is distinct since it was issued by two different manufacturers for different purposes.

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 estimate that this AD affects 82 airplanes of U.S. registry.

The actions that are required by AD 2011-17-09, and retained in this AD, take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that are required by AD 2011-17-09 is $85 per product.

The actions that are required by AD 2012-25-12, and retained in this AD, take about 16 work-hours, at an average labor rate of $85 per work-hour, with required parts cost of about $255,000 per MLG bogie beam. Based on these figures, the estimated cost of the actions that are required by AD 2012-25-12 is up to $256,360 per MLG bogie beam.

We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $6,970, or $85 per product.

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.

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A330-223F, -223, -321, -322, and -323 airplanes. The NPRM published in the Federal Register on August 30, 2016 (81 FR 59535). The NPRM was prompted by fatigue load analysis that determined the need for reduced inspection intervals (for torque checks required by AD 2013-14-04, Amendment 39-17509 (78 FR 68352, November 14, 2013) (“AD 2013-14-04”)) and updated torque values of the bolts. The NPRM proposed to require repetitive torque checks to determine if there are any loose or broken forward engine mount bolts, and, if necessary, replacement of all four forward engine mount bolts and associated nuts, inspection of the forward mount assembly, and repair. We are issuing this AD to detect and correct loose and broken bolts, which could lead to engine detachment in flight and damage to the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-0214, dated October 19, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A330-223F, -223, -321, -322, and -323 airplanes. The MCAI states:

Corrective actions include repetitive torque checks to determine if there are any loose or broken forward engine mount bolts on both engines, and, if necessary, replacement of all four forward engine mount bolts and associated nuts, inspection of the forward mount assembly, and repair. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8849.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

American Airlines (AA) requested that we correct the reference to the FAA AD in paragraph (g)(1) of the proposed AD, which incorrectly identified AD 2013-13-05. The correct AD number for this terminating action is 2013-14-04.

We agree and have revised paragraph (g)(1) of this AD accordingly.

AA requested that we clarify the compliance time for airplanes with an average flight time (AFT) of more than 132 minutes for the second cycle interval (1,851-2,700 flight cycles). AA proposed that we revise the second row of table 1 to paragraph (g) of the proposed AD by referring to the specified compliance times since accomplishing actions in AD 2013-14-04.

We agree that clarification is necessary. The compliance times for the initial and repetitive torque checks required by AD 2013-14-04 are identified in table 1 to paragraph (g)(1) of this AD (table 1 to paragraph (g) of the proposed AD). The compliance times include specified flight cycles since the last torque check specified in Pratt & Whitney Alert Service Bulletin PW4G-100-A71-32, which operators might have accomplished to comply with AD 2013-14-04. Paragraph (g)(1) of this AD requires that the next torque check be done in accordance with Airbus Service Bulletin A330-71-3028, Revision 02, dated August 31, 2015 (“A330-71-3028, R02”). Accomplishment of the torque check required by paragraph (g)(1) of this AD terminates the requirements of AD 2013-14-04. We have not changed this AD regarding this issue.

Paragraph (h) of the proposed AD stated that accomplishment of the actions specified by paragraph (g) of the proposed AD “constitutes compliance with” the requirements specified in paragraph (g) of AD 2006-16-05. AA requested that we revise paragraph (h) of the proposed AD to specifically state that the new AD would also “terminate” the inspection specified in AD 2006-16-05.

We agree with the commenter. We have revised paragraph (h) of this AD to state that accomplishment of the actions required by paragraph (g) of this AD terminates the requirements of paragraph (g) of AD 2006-16-05.

AA requested that we revise paragraph (j) of the proposed AD to specifically allow early compliance with the AD upon its release and prior to the effective date of the AD, using Airbus Service Bulletin A330-71-3028, R02. AA stated that this would allow operators to immediately begin using the higher torque values specified in Airbus Service Bulletin A330-71-3028, R02. AA stated that as written, the AD would not allow operators to immediately use the higher torque values specified in Airbus Service Bulletin A330-71-3028, R02, because AD 2013-14-04 specifies the use of Airbus Service Bulletin A330-71-3028, Revision 01, dated February 12, 2012, which contains lower torque values. AA stated that this would preclude the need for a request for an alternative method of compliance (AMOC) against AD 2013-14-04 to allow the use of the higher torque values, and that this change would streamline the compliance revision process.

We acknowledge the request and agree that clarification is necessary. Because AD 2013-14-04 requires using Airbus Service Bulletin A330-71-3028, Revision 01, dated February 12, 2012, operators need approval to use Airbus Service Bulletin A330-71-3028, R02, as an AMOC for the requirements of AD 2013-14-04. We have issued global AMOC ANM-116-17-243, dated April 4, 2017, approving the use of Airbus Service Bulletin A330-71-3028, R02, for compliance with the requirements of AD 2013-14-04. Therefore, no changes to this AD are necessary regarding this issue.

Delta Air Lines (Delta) requested that we revise the statement in paragraph (g)(2) of the proposed AD to remove the requirement to obtain FAA, EASA, or Airbus Design Organization Approval (DOA) approval for any instance where Airbus Service Bulletin A330-71-3028, R02, specifies contacting Airbus. Delta requested that we instead require these approvals only for damage that exceeds the allowable limits in the airplane maintenance manual (AMM); component maintenance manual (CMM); or cleaning, instruction and repair (CIR) manual. Delta stated that Airbus Service Bulletin A330-71-3028, R02, specifies contacting Airbus any time a bolt is found out of tolerance regardless whether any damage is found. As such, this would effectively require FAA, EASA, or Airbus DOA approval any time a bolt is found with a torque out of limits, even if there is no damage to the forward mount assembly, or if the damage is within the AMM, CMM, or CIR allowable limits. Delta agreed with the required approvals, but only when there is damage that exceeds those limits. Delta stated that this change would limit the number of AMOC requests, and reduce airplane out-of-service times while maintaining the acceptable level of safety.

We disagree with the commenter's request to change the corrective action requirement in paragraph (g)(2) of this AD. The requirements of this AD correspond with those specified in the MCAI. The MCAI refers to Airbus Service Bulletin A330-71-3028, R02, which specifies that when any bolt is found with a torque out of limits, corrective actions must be done. We have determined that these actions are necessary to address the identified unsafe condition. However, under the provisions of paragraph (k)(1) of this AD, we will consider requests for approval of alternative corrective actions if sufficient data are submitted to substantiate that the alternative actions would provide an acceptable level of safety. We have not changed this AD regarding this issue.

Delta stated that paragraph (g)(2) of the proposed AD, which applies to the airplane (not the engine mount), would require repair before further flight. Delta interpreted this to mean the proposed AD would require repair of the forward engine mount before the airplane could return to flight. Delta requested that we revise the proposed AD to include a statement that explicitly allows replacement of damaged engine mounts, allowing the airplane to return to service as quickly as possible.

We partially agree with the commenter's request. We agree that replacement of an affected forward engine mount might be allowed as a corrective action and that a different compliance time may be acceptable. We have revised paragraph (g)(2) of this AD by replacing the proposed requirement to repair before further flight with the requirement to contact the FAA, EASA, or Airbus's EASA DOA before further flight to obtain applicable corrective action instructions approved by the FAA, EASA, or Airbus's EASA DOA, and to do applicable corrective actions within the compliance time specified in those instructions.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

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

Airbus has issued Service Bulletin A330-71-3028, Revision 02, dated August 31, 2015. The service information describes procedures for repetitive torque checks for loose or broken forward engine mount bolts on both engines, replacement of all four forward engine mount bolts and associated nuts, and inspection of the forward mount assembly. 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 estimate that this AD affects 41 airplanes of U.S. registry.

We also estimate that it would take about 3 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $6,747 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $287,082, or $7,002 per product.

In addition, we estimate that any necessary follow-on actions would take about 1 work-hour and require parts costing $6,747, for a cost of $6,832 per product. We have no way of determining the number of aircraft that might need these actions.

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A321 series airplanes. The NPRM published in the Federal Register on December 2, 2016 (81 FR 86975). The NPRM was prompted by a determination from fatigue testing on the Model A321 airframe that cracks could develop on holes at certain fuselage frame locations. The NPRM proposed to require repetitive inspections for cracking on holes at certain fuselage frame locations, and repairs if necessary. We are issuing this AD to detect and correct cracking at certain hole locations in the fuselage frame, which could result in reduced structural integrity of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2016-0106, dated June 6, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Airbus Model A321 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9431.

We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM and the FAA's response.

Delta Airlines (DAL) requested that we revise the NPRM to permit use of later approved revisions of service information as we have done in previous alternative methods of compliance (AMOCs). DAL stated that Airbus service bulletins are EASA approved, and through the bi-lateral agreement with the European Union, these subsequent service bulletin revisions should be allowed to be used by U.S. operators without seeking an AMOC. DAL also explained that having the ability to utilize future service bulletin revisions without seeking an AMOC is more efficient and preserves the required level of safety.

We do not agree with DAL's request. While we acknowledge that we allow the use of later approved revisions of service information in AMOCs, we may not allow use of “later FAA-approved revisions” in an AD when referring to the service document. Doing so violates Office of the Federal Register (OFR) regulations for approval of materials “incorporated by reference,” as specified in 1 CFR 51.1(f).

In general terms, we are required by the OFR regulations to either publish the service document contents as part of the actual AD language; or submit the service document to the OFR for approval as “referenced” material, in which case we may only refer to such material in the text of an AD. The AD may refer to the service document only if the OFR approved it for “incorporation by reference.” See 1 CFR part 51.

To allow operators to use later revisions of the referenced document (issued after publication of the AD), either we must revise the AD to reference specific later revisions, or operators must request approval to use later revisions as an AMOC under the provisions of paragraph (i)(1) of this AD. We have not changed this AD in this regard.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

Airbus has issued Service Bulletin A320-53-1315, dated January 13, 2016; and Service Bulletin A320-53-1316, dated January 13, 2016. This service information describes procedures for doing a special detailed inspection for cracking at the tooling holes on frame 35.2A between stringer 22 and stringer 23, and repairs. These documents are distinct since they apply to different sides of the airplane. 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 estimate that this AD affects 175 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Slingsby Aviation Ltd. Models T67M260 and T67M260-T3A airplanes. That NPRM was published in the Federal Register on February 7, 2017 (82 FR 9537), and proposed to supersede AD 2015-11-01, Amendment 39-18164 (80 FR 30136, May 27, 2015) (“AD 2015-11-01”).

Since we issued AD 2015-11-01, new service information was issued to revise the inspection instructions and to add a new initial inspection period after replacement of the brake master cylinder pivot pins.

The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states that:

The MCAI can be found in the AD docket on the Internet at: https://www.regulations.gov/document?D=FAA-2017-0048-0002.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

Slingsby Aviation Ltd. trading as Marshall Aerospace and Defence Group has issued Marshall Aerospace and Defence Group Service Bulletin SBM 200, Revision 2, dated December 2015. The service bulletin describes procedures for inspection of the brake master cylinder pivot pin. 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 estimate that this AD will affect 3 products of U.S. registry. We also estimate that it would take about 6 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $50 per product.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $1,680, or $560 per product.

In addition, we estimate that any necessary follow-on actions would take about .5 work-hour and require parts costing $100, for a cost of $142.50 per product. We have no way of determining the number of products that may need these actions.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0048; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.

The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me by the Administrator, part 95 of the Federal Aviation Regulations (14 CFR part 95) is amended as follows effective at 0901 UTC, June 22, 2017.

Sonoma-Marin Area Rail Transit has requested a temporary change to the operation of the Northwestern Pacific (Haystack Landing) railroad bridge, mile 12.4, over Petaluma River, at Haystack Landing (Petaluma), CA. The drawbridge navigation span provides a vertical clearance of 3 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.187(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 7 a.m. on May 31, 2017 to 3 p.m. on June 1, 2017, to allow the bridge owner to perform necessary bridge maintenance and change the gear reducer fluid. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not 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 waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so 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. Table of Abbreviations BNM Broadcast Notice to Mariners CFR Code of Federal Regulations COTP Captain of the Port Upper Mississippi River DHS Department of Homeland Security FR Federal Register LNM Local Notice to Mariners NPRM Notice of proposed rulemaking §  Section UMR Upper Mississippi River U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not receive the application until February 23, 2017. After full review of the details for the planned and locally advertised displays, the Coast Guard determined action is needed to protect people and property from the safety hazards associated with the fireworks display on the Upper Mississippi River (UMR) near St. Louis, MO. It is impracticable to publish an NPRM because we must establish this safety zone by May 28, 2017. As such, it is impracticable to publish an NPRM because we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of the rule is contrary to the public interest as it would delay the effectiveness of the temporary safety zone needed to respond to potential related safety hazards associated with the fireworks display.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP has determined that potential hazards associated with the fireworks display will be a safety concern before, during, and after the display. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.

This rule establishes a safety zone from 8:30 p.m. on May 28, 2017 through 10 p.m. on May 29, 2017. This rule will be enforced from 8.30 p.m. to 10 p.m. on May 28, 2017, unless the fireworks display is postponed because of adverse weather, in which case this rule will be enforced from 8.30 p.m. to 10 p.m. on May 29, 2017. The safety zone will cover all navigable waters between miles 180 and 180.5 on the UMR in St. Louis, MO. Any changes to the planned schedule will be communicated to mariners using Broadcast Notice to Mariners (BNM) and Local Notice to Mariners (LNM). The safety zone is intended to ensure the safety of vessels and these navigable waters before, during and after the fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. These rules have not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, they have not been reviewed by the Office of Management and Budget.

This temporary final rule establishes a safety zone impacting a one-half mile area on the UMR for a limited time period of one hour and a half. During the enforcement period, vessels are prohibited from entering into or remaining within the safety zone unless specifically authorized by the COTP or other designated representative. Based on the location, limited safety zone area, and short duration of the enforcement period, this rule does not pose a significant regulatory impact. Additionally, notice of the safety zone or any changes in the planned schedule will be made via BNM and LNM. Permission to enter this safety zone must be requested from the COTP or other designated representative.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A. above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding these rules. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting two hours that will prohibit entry from mile 180 to 180.5 on the UMR. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Record of Environmental Consideration are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard will enforce the Safety Zones; Annual Events in the Captain of the Port Buffalo Zone listed in 33 CFR 165.939 for the following event:

(1) Bay Swim, Erie, PA; The safety zone listed in 33 CFR 165.939(a)(33) will be enforced from 8:45 a.m. to 11:45 a.m. on June 17, 2017.

Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring within the safety zone during an enforcement period is prohibited unless authorized by the Captain of the Port Buffalo or his designated representative. Those seeking permission to enter the safety zone may request permission from the Captain of Port Buffalo via channel 16, VHF-FM. Vessels and persons granted permission to enter the safety zone shall obey the directions of the Captain of the Port Buffalo or his designated representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course.

This notice of enforcement is issued under authority of 33 CFR 165.939 and 5 U.S.C. 552 (a). In addition to this notice of enforcement in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via Broadcast Notice to Mariners or Local Notice to Mariners. If the Captain of the Port Buffalo determines that the safety zone need not be enforced for the full duration stated in this notice he or she may use a Broadcast Notice to Mariners to grant general permission to enter the respective safety zone.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On September 25, 2015, EPA published a final conditional approval for NHDES's November 15, 2012 SIP revision. See 80 FR 57722. That conditional approval identified three provisions required under Federal PSD and NNSR program regulations that were not included in the State's November 15, 2012 SIP submittal.

On December 16, 2015 and July 8, 2016, EPA published final conditional approvals of several of New Hampshire's infrastructure SIP revisions, i.e., those for the 2008 ozone NAAQS, the 2008 lead NAAQS, the 2010 NO2 NAAQS, the 2010 SO2 NAAQS, the 1997 PM2.5 NAAQS and the 2006 PM2.5 NAAQS. These conditional approvals identified one of the same provisions that was not included in the State's November 15, 2012 SIP submittal, i.e., notice of major source permits to affected states and Indian Governing bodies. See 80 FR 78135 and 81 FR 44542.

Under section 110(k)(4) of the CAA, EPA may conditionally approve a plan based on a commitment from the State to adopt specific enforceable measures by a date certain no later than one year from the effective date of final conditional approval. If the EPA subsequently determines that the State has met its commitment, EPA publishes a document in the Federal Register notifying the public that EPA is converting the conditional approval to a full approval.

However, if the State fails to meet its commitment in a timely manner, then the conditional approval automatically converts to a disapproval by operation of law without further action required by EPA. If that were to occur, EPA would then notify the State by letter. At that time, the conditionally approved SIP revisions would not be part of the State's approved SIP. EPA subsequently would publish a document in the Federal Register notifying the public that the conditional approval automatically converted to a disapproval.

EPA's September 25, 2015 conditional approval required the NHDES to submit revised regulations that address three separate provisions of EPA's PSD and NNSR program regulations that were not included in the State's November 15, 2012 SIP submittal. To address the conditional approval, on October 26, 2016, the NHDES submitted regulatory provisions for approval into the State's SIP. The three provisions include the following:

• 40 CFR 51.165(a)(5)(i), which notifies any owner or operator that approval to construct shall not relieve them of the responsibility to comply fully with applicable provisions of the plan and any other requirements under local, State or Federal law;

• 40 CFR 51.165(a)(6) and (7), which require additional record keeping and other requirements applicable at major stationary sources for projects that are not major modifications based on the required actual-to-projected actual test, but which have a “reasonable possibility” of resulting in a significant emission increase; and

• 40 CFR 51.166(q)(2)(iv), which requires notice of a draft PSD permit to be sent to, among other entities, state air agencies and Indian Governing bodies whose lands may be affected by emissions from the permitted source. Only the references to “state air agencies” and “Indian Governing bodies” were missing from New Hampshire's regulatory provision.

With respect to the issue noted previously relating to the State's obligation to provide notice to states and Indian governing bodies, EPA's December 16, 2015 conditional approval and July 8, 2016 conditional approval, applicable to the State's infrastructure SIPs (identified earlier in this action), both required the NHDES to address the requirements of CAA sections 110(a)(2)(C), (D) and (J) as they relate to the NHDES's obligation to send notice of draft PSD permits to other state air agencies and Indian Governing bodies whose lands may be affected by emissions from the permitted source, as required under 40 CFR 51.166(q)(2)(iv). The NHDES regulatory provisions submitted to EPA on October 26, 2016 also properly addressed these infrastructure SIP conditional approvals.

As noted previously, on October 26, 2016, the NHDES submitted to EPA the three provisions identified in the September 25, 2015 conditional approval. EPA reviewed the three provisions and found they met the terms of the September 25, 2015 conditional approval. Accordingly, EPA is converting the September 25, 2015 conditional approval to a full approval. Also, as noted previously, because the October 26, 2016 submittal included provisions that met the terms of the December 16, 2015 and July 8, 2016 infrastructure conditional approvals, EPA is also converting the December 16, 2015 and July 8, 2016 conditional approvals to full approvals.

EPA provided an analysis of its approval of the three regulatory provisions in question in a technical support document (TSD), which is included in the docket and administrative record for this action.

NHDES's October 26, 2016 submittal also contained revisions to Env-A 618.01 and Env-A 619, for the purpose of updating to July 1, 2016 the incorporation by reference date used in the New Hampshire's regulations implementing 40 CFR 51.165 and 40 CFR 52.21. New Hampshire also requested in its October 26, 2016 SIP submittal that EPA remove from the New Hampshire SIP sections Env-A 619.03(c)(2) and (c)(3). By removing sections Env-A 619.03(c)(2) and (c)(3), New Hampshire's SIP-approved definitions of “allowable emissions” and “potential to emit” are now identical to EPA's definitions of those terms in 40 CFR 52.21 (as of July 1, 2016). The changes to these two definitions satisfies CAA section 110(l) because simply including the notion of federal enforceability into these definitions will not interfere with any applicable requirement concerning attainment of a NAAQS or reasonable further progress (as defined by the CAA) or any other applicable CAA requirement. Additionally, the State's October 26, 2016 submittal included a change to Env-A 619.07(d) so that the State regulations now correctly identify the proper citation for the public notice requirements relating to PSD permits.

On January 31, 2017, New Hampshire submitted SIP revisions to Env-A 621, Permit Notice and Hearing Procedures: Temporary Permits and Permits to Operate. Env-A 621 establishes the public notice requirements for the State's NNSR, PSD and minor NSR permit programs, and replaces the current SIP-approved public notice requirements under Env-A 205, Public Notice and Hearing Procedures. The SIP revisions include provisions that render New Hampshire's PSD program's public notice requirements consistent with the Federal SIP-approved PSD program's public notice requirements under 40 CFR 51.166(q). The SIP revisions also render New Hampshire's NNSR permit program's public notice requirements consistent with the public notice requirements under 40 CFR 51.166(q), even though the applicable Federal rules only require SIP-approved NNSR permit programs to meet the less prescriptive air permit program public notice requirements under 40 CFR 51.161. Since the public notice requirements under 40 CFR 51.166(q) are more comprehensive than 40 CFR 51.161, New Hampshire's revisions to the public notice requirements of its NNSR permit programs are fully approvable. Finally, New Hampshire's revisions to the public notice requirements applicable to its minor NSR permit program are consistent with 40 CFR 51.161. The minor NSR permit program consists of those federal permit rules that apply to new or modified emission units with emission increases below the PSD and NNSR program applicability threshold levels. Since the provisions of Env-A 621 are replacing and thus supersede the current SIP-approved public notice requirements under Env-A 205, Public Notice and Hearing Procedures, NHDES requested that EPA remove Env-A 205 from the SIP.

EPA has provided an analysis of these amendments in the TSD document which is included in the docket and administrative record for this action.

On January 18, 2017, the NHDES submitted to EPA a SIP revision requesting the withdrawal of Env-A 700 Permit Fee system from the New Hampshire SIP. EPA is approving this revision on the grounds that it is consistent with the CAA Amendments of 1990 at section 110(a)(2)(L). That section of the CAA requires SIPs to contain permit fee programs which sufficiently cover the cost of SIP-approved major source permitting programs, i.e., NNSR and PSD. Section 110(a)(2)(L) further states that the SIP requirement for a permit fee system may be superseded if a state's fee program under subchapter V of the CAA Amendments (colloquially referred to as the title V operating permit program) is applicable to the same sources and is approved by the Administrator. New Hampshire's title V operating permit program received interim approval in 1996 and full approval in 2001. In EPA's proposed interim approval, we stated that “. . .New Hampshire has demonstrated that the state is collecting sufficient permit fees to meet EPA's [title V operating permitting program requirements].” See 61 FR 42225 (August 14, 1996). Furthermore, New Hampshire's title V operating permit program covers the same sources as the SIP-approved major source permitting programs.

On November 17, 2015, NHDES submitted to EPA as a SIP revision its “Amendment to New Hampshire [sic] 2008 Ozone 8-hour and 2010 Nitrogen Dioxide 1-hour NAAQS Infrastructure SIPs to Address the Good Neighbor Requirements of Clean Air Act Section 110(a)(2)(D)(i)(I).” EPA approved this submittal with respect to the 2008 ozone NAAQS on October 13, 2016 (81 FR 70631). Our evaluation of the submittal with respect to the 2010 NO2 standard is discussed later in this preamble.

Section 110(a)(2)(D)(i)(I) of the CAA, known as the “good neighbor provision,” requires each state to include “adequate provisions” in its SIP prohibiting “any source or other type of emissions activity within the State from emitting any air pollutant in amounts which will contribute significantly to nonattainment in, or interfere with maintenance by, any other State with respect to any [national ambient air quality standard].” 42 U.S.C. 7410(a)(2)(D)(i)(I). New Hampshire was required to address these provisions for the 2010 NO2 NAAQS.

New Hampshire's infrastructure SIP submission to address the good neighbor requirements of CAA section 110(a)(2)(D)(i)(I) notes that on January 20, 2012, EPA designated all areas of the country as “unclassifiable/attainment” for the 2010 NO2 NAAQS. EPA did this because design values (DVs) for the 2008-2010 period at all monitored sites met the NAAQS. Measurements from 2013-2015 indicate continued attainment of the 2010 NO2 NAAQS throughout the country. New Hampshire currently operates one NO2 monitor located in Londonderry. The DV is based on the 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations. The 98th percentile in 2014 and 2015 were 25.3 and 22.7 parts per billion (ppb), respectively. (The State has insufficient data to determine the DV for the entire period from 2013 through 2015 due to the lack of data capture in 2013.) The values from 2014 and 2015, however, are significantly less than the national ambient air quality standard for NO2, which is 100 ppb. However, the absence of a violating ambient air quality monitor within the State is insufficient by itself to demonstrate that New Hampshire has met its interstate transport obligation. While the DV may help to assist in characterizing air quality within New Hampshire, section 110(a)(2)(D)(i)(I) specifically addresses the effects that sources within New Hampshire have on air quality in neighboring states. Therefore, an evaluation and analysis of DV's in neighboring states is appropriate.

Table I contains the highest NO2 design values for the three states neighboring New Hampshire, i.e., Maine, Vermont, and Massachusetts.

As shown by the Table 1 chart in this preamble, the highest NO2 design value in each neighboring state is significantly less than the NO2 NAAQS. As a result, EPA finds that sources or emissions activity from within New Hampshire will not interfere with other states' ability to attain and maintain the 2010 NO2 NAAQS.

The New Hampshire submittal notes that New Hampshire nitrogen oxides (NOX) emissions have been declining, with total statewide NOX emissions dropping from 69,836 tons in 2002 to 37,292 tons in 2011. In 2014, statewide NOX emissions were 36,014 tons. Our review of NOX emissions data from New Hampshire sources, which New Hampshire has entered into the EPA National Emissions Inventory database, confirms this emission data. In light of the analysis, EPA is approving New Hampshire's infrastructure submittal for the 2010 NO2 NAAQS as it pertains to section 110(a)(2)(D)(i)(I) of the CAA.

EPA is approving the PSD and NNSR permitting program provisions included in NHDES's October 22, 2016 SIP submittal and is converting the September 25, 2015 conditional approval to a full approval. EPA is also converting the December 16, 2015 and July 8, 2016 conditional approvals relating to New Hampshire's infrastructure SIPs1 for the 2008 ozone, 2008 Lead, 2010 SO2, 2010 NO2, 1997 PM2.5, and the 2006 PM2.5 NAAQS, to a full approval.

EPA is approving into the New Hampshire SIP Env-A 621, Permit Notice and Hearing Procedures: Temporary permits and Permits to Operate submitted on January 31, 2017. In addition, since the provisions under Env-A 621 supersede the current SIP-approved public hearing provisions under Env-A 205 Public Notice and Hearing Procedures, EPA is removing Env-A 205 in its entirety from the SIP. Because the requirements of Env-621 are no less stringent that the requirements of Env-A 205, this SIP revision also meets section 110(l) of the CAA.

EPA is approving NHDES's January 18, 2017 submittal requesting withdrawal of Env-A 700 Permit Fee System from the New Hampshire SIP. EPA finds that the New Hampshire SIP revision is consistent with the requirements of section 110(a)(2)(L) of the CAA, as described earlier in this action. EPA is therefore removing Env-A 700 in its entirety from the SIP in light of the State's title V operating permit program fee requirements.

EPA is approving NHDES's November 17, 2015 submittal that addresses the infrastructure SIP requirements under Section 110(a)(2)(D)(i)(I) for the 2010 NO2 NAAQS. The analysis provided in the submittal shows that: (1) NO2 concentrations in New Hampshire are significantly below the 2010 NO2 NAAQS; (2) NOX emissions within New Hampshire continue to decrease over time; and (3) sources of NOX emissions, or other types of emissions activity, in New Hampshire do not contribute significantly to nonattainment in, or interfere with maintenance by, any other State with respect to the NO2 NAAQS.

EPA is publishing these actions without prior proposal because the Agency views these as noncontroversial amendments and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revisions should relevant adverse comments be filed. This rule will be effective July 24, 2017 without further notice unless the Agency receives relevant adverse comments by June 26, 2017.

If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on the proposed rule. All parties interested in commenting on the proposed rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on July 24, 2017 and no further action will be taken on the proposed rule. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of New Hampshire's Env-A 618, Env-A 619.03, Env-A 619.07, and Env-A 621 (except for Env-A 621.10) and the removal of Env-A 205 and Env-A 700 described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov, and/or at the EPA Region 1 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

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

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

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

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

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

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

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

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

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

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 24, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

In final rule FR Doc. 2017-09028, published in the issue of Friday, May 5, 2017 (82 FR 21123), make the following correction:

On page 21123, in the third column, remove amendatory instruction 2.

Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0112 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 July 24, 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-2016-0112, by one of the following methods:

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

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

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

In the Federal Register of April 25, 2016 (81 FR 24044) (FRL-9944-86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8447) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide, flazasulfuron (N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(trifluoromethyl)-2-pyridinesulfonamide), in or on olive at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

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

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

The risk assessment for flazasulfuron is based on a well-characterized and complete toxicology database. After oral administration to rats, more than 84% of the dose of flazasulfuron was excreted within 72 hours, mostly as parent compound. Urinary elimination accounted for about 80-90% of the dose and fecal elimination for about 10-20%. Females tended to eliminate more in the urine, and slightly more rapidly, than males. Tissue distribution was rapid but incomplete. While levels in tissue were generally low, the tissues with highest concentrations were the blood, liver, and muscle.

The liver was the main target organ of flazasulfuron in most species tested, with effects ranging from non-adverse liver hypertrophy to more severe histopathological findings like inflammatory cell infiltration, hepatocellular necrosis and swelling, and bile duct proliferation. Rats also showed kidney toxicity (nephropathy) after chronic exposure. No adverse effects were observed in most short and intermediate duration (≤90 days) studies; only reduced body weight gain and non-adverse liver effects (increased weight and hepatocellular hypertrophy) were observed in some of the subchronic toxicity studies.

Developmental toxicity was observed in rats and abortions in rabbits; however, findings in rats were not consistent across strains. A small increase in the incidence of intraventricular septal defect was observed in Wistar rats but not in Sprague-Dawley rats. Significant decreases in mean fetal body weight were observed in both rat strains at the limit dose. In these same studies in the rat, the maternal animals showed no adverse effects. A high incidence of abortion and decreased food consumption, but no specific fetal effects, were observed in rabbits. While the developmental studies indicate there is offspring susceptibility in rats, both rat studies provide clear no-observed-adverse-effect levels (NOAELs) for the adverse fetal effects. Furthermore, the points of departure (PODs) used for risk assessment are lower than doses associated with fetal effects; therefore, the assessments are protective of the observed offspring effects.

No increase in tumor incidence was seen in rats or mice. Flazasulfuron is not genotoxic. There was no evidence of neurotoxicity in the database. The acute toxicity data indicate that flazasulfuron has low acute oral, dermal, and inhalation toxicity. It was not found to be a skin irritant, but was a moderate eye irritant. Flazasulfuron was not a dermal sensitizer. Flazasulfuron is classified as “not likely to be carcinogenic in humans” based on the lack of carcinogenic effects in the rat and mouse carcinogenicity studies, and lack of a mutagenicity concern.

Specific information on the studies received and the nature of the adverse effects caused by flazasulfuron as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document titled “Flazasulfuron. Aggregate Human Health Risk Assessment for the Proposed New Use on Olives” at page 23 in docket ID number EPA-HQ-OPP-2016-0112.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological POD and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for flazasulfuron used for human risk assessment is discussed in Unit II. B. of the final rule published in the Federal Register of September 5, 2014 (79 FR 52985) (FRL-9915-32).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to flazasulfuron, EPA considered exposure under the petitioned-for tolerances as well as all existing flazasulfuron tolerances in 40 CFR 180.655. EPA assessed dietary exposures from flazasulfuron in food as follows:

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

Such effects were identified for flazasulfuron. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) under the Continuing Survey of Food Intake by Individuals (CSFII) and the CDC under the National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WEIA) 2003-2008. The acute dietary exposure analyses incorporate tolerance-level residues of the currently registered and proposed crops combined with 100% crop treated (%CT) to determine the exposure and risk estimates. Residues of flazasulfuron were all <Level of Quantification (LOQ) (<0.01 ppm) in/on olive fruit and olive oil; therefore, processing factors could not be calculated. An acceptable method was used for residue quantitation, and adequate data were submitted to support sample storage intervals and conditions. In the crop field trials, all residues of parent flazasulfuron in olive were nondetectable. Since all residues were <LOQ, residue decline could not be assessed. Acceptable metabolism studies on grapes, sugarcane, and tomatoes are available. Residues of flazasulfuron were not detected in the tomato study and were only detected as a trace or minor component in the grape and sugarcane studies. Therefore, the processing factors were set at 1 in the dietary exposure assessment.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WEIA 2003-2008. The chronic dietary exposure analyses incorporate tolerance-level residues of the currently registered and proposed crops combined with 100%CT to determine the exposure and risk estimates. Processing factors were set at 1 in the dietary exposure assessment.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that flazasulfuron 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 flazasulfuron. Tolerance level residues and/or 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 flazasulfuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of flazasulfuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticide Root Zone Model Ground Water (PRZM GW) for ground water and the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) for surface water, the estimated drinking water concentrations (EDWCs) of flazasulfuron for acute exposures are estimated to be 26.9 parts per billion (ppb) for surface water and 90.8 ppb for ground water.

For chronic exposures for non-cancer assessments EDWCs are estimated to be 4.67 ppb for surface water and 55.6 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

For acute dietary risk assessment, the water concentration value of 90.8 ppb was used to assess the contribution to drinking water.

For chronic dietary risk assessment, the water concentration of value 55.6 ppb was used to assess the contribution to drinking water.

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

Flazasulfuron is currently registered for use on turf that could result in residential exposures. Residential exposure may occur by the dermal, oral, and inhalation routes of exposures. Flazasulfuron does not pose a dermal hazard; therefore, only inhalation (handler exposure for adults) and oral (post-application incidental oral for children) were assessed. Non-occupational exposures to flazasulfuron are expected to be for short-term durations only. The recommended residential exposure for use in the adult aggregate assessment reflects inhalation exposure from applications to turf via backpack or manually pressurized handwand. The recommended residential exposure for use in the children 1 to <2 years old aggregate assessment reflects hand-to-mouth exposures from post-application exposure to turf treatments. A turf transferable residues (TTR) study is not required for flazasulfuron at this time since there was no dermal hazard identified and the hand-to-mouth MOE is greater than 1,000 based on default values for the fraction of application rate available for transfer after a turf application. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

In 2016, EPA's Office of Pesticide Programs released a guidance document entitled, “Pesticide Cumulative Risk Assessment: Framework for Screening Analysis” https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. This document provides guidance on how to screen groups of pesticides for cumulative evaluation using a two-step approach beginning with the evaluation of available toxicological information and if necessary, followed by a risk-based screening approach. This framework supplements the existing guidance documents for establishing common mechanism groups (CMGs) and conducting cumulative risk assessments (CRA). The Agency has utilized this framework for flazasulfuron and determined that although flazasulfuron shares some chemical and/or toxicological characteristics (e.g., chemical structure or apical endpoint) with other pesticides, the toxicological database does not support a testable hypothesis for a common mechanism of action. No further data is required to determine that no common mechanism of toxicity exists for flazasulfuron and other pesticides and no further cumulative evaluation is necessary for flazasulfuron.

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

2. Prenatal and postnatal sensitivity. The available data indicate that flazasulfuron produced developmental effects in the rabbit (increased abortions), and reproductive effects in the rat (decreased pup body weight), only at maternally/parentally toxic dose levels, and these developmental/offspring effects were not more severe than maternal/parental effects (increased abortions the rabbit, increased nephropathy and decreased pup body weight in the rat). While developmental effects (increased incidence of interventricular septal defect and reduced fetal weights) were seen in rats in the absence of maternal toxicity, an indication of quantitative and qualitative susceptibility, clear NOAELs and LOAELs have been established for these adverse fetal effects. Furthermore, the PODs used for risk assessment are lower than doses associated with these developmental effects. Therefore, the assessments are protective of the observed offspring effects, and the Agency has no concerns for quantitative or qualitative susceptibility.

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

i. The toxicity database for flazasulfuron is complete.

ii. An acute neurotoxicity study was conducted with flazasulfuron at dose levels up to 2,000 mg/kg. Mean motor activity measurements at dose levels of 1,000 and 2,000 mg/kg for males and females were statistically significantly decreased from the respective control groups five hours post-dosing. Animals were less active with more resting time than controls. The effect was reversed by the next scheduled observation (Day 7). Neurohistopathologic evaluation did not demonstrate any test material related neurotoxic lesions following the examination of tissues from the central and peripheral nervous systems of high dose and control animals. The NOAEL was 50 mg/kg. A subchronic neurotoxicity study was conducted with flazasulfuron at up to 732 mg/kg bw/day in the diet for 90 days. No biologically relevant neurotoxic effects were observed at the dose levels tested. The available neurotoxicity battery, therefore, did not raise concern for neurotoxicity. Similarly, the subchronic and chronic data in the database did not show any adverse effects that could be considered as neurotoxicity.

iii. While there is evidence of increased qualitative and quantitative susceptibility in the young based on rat malformations and decreased fetal weight in two rat developmental toxicity studies, the FQPA Safety Factor is reduced to 1X and is protective of the observed offspring susceptibility because there are clear NOAELs for the developmental effects in the two rat studies developmental toxicity studies and the PODs selected for risk assessment are protective of those effects.

iv. There are no residual uncertainties identified in the exposure databases. The exposure databases are complete or are estimated based on data that reasonably account for potential exposures. The acute and chronic dietary food exposure assessment were conservatively based on tolerance-level residues on the currently registered and proposed crops, 100% CT assumptions, and conservative ground water drinking water modeling estimates. The Agency does not believe that the non-dietary residential exposures are underestimated because they are also based on conservative assumptions. All of the exposure estimates are based on conservative assumptions and are not likely to result in underestimated risk.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to flazasulfuron will occupy 3.1% of the aPAD for infants less than one-year old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to flazasulfuron from food and water will utilize 23% of the cPAD for infants less than one-year old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of flazasulfuron is not expected.

3. Short- and intermediate-term aggregate risk. There is potential short-term aggregate exposure to flazasulfuron via the dietary pathway (which is considered background exposure) and the residential pathway (which is considered the primary pathway). Since intermediate-term residential exposures are not likely to occur, intermediate-term aggregate risks were not assessed. Since there is no dermal endpoint, the short-term aggregate exposure assessment for adults includes dietary (food and drinking water) and inhalation handler exposures and results in an aggregate MOE of 1,600. The short-term aggregate exposure assessment for children 1-2 years old includes dietary (food and drinking water) and post-application hand-to-mouth exposure from treated turf and results in an aggregate MOE of 810. Because EPA's level of concern for flazasulfuron is a MOE of 100 or below, these MOEs are not of concern.

4. Aggregate cancer risk for U.S. population. A cancer aggregate risk assessment was not conducted because there was no evidence of carcinogenicity to humans based on lack of carcinogenic effects in the rat and mouse carcinogenicity studies.

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

An adequate enforcement method is available. The method uses high performance liquid chromatography/tandem mass spectrometry with multiple reaction monitoring (HPLC/MS-MS/MRM). The LOQ is 0.01 ppm.

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

The Codex has not established a MRL for flazasulfuron.

Therefore, tolerances are established for residues of flazasulfuron, herbicide, in or on olive at 0.01 ppm.

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

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

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

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0029 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 July 24, 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-2016-0029, by one of the following methods:

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

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

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

In the Federal Registers of March 16, 2016 (81 FR 14030) (FRL-9942-86); May 19, 2016 (81 FR 31581) (FRL-9946-02); and August 12, 2016 (81 FR 53379) (FRL-9949-53) EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 6F8442, PP 5F8429, and PP 6E8466) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366-5569. The petitions requested that 40 CFR 180.632 be amended by establishing tolerances for residues of the miticide/insecticide fenazaquin, 4-[2-[4-(1,1-dimethylethyl)phenyl]ethoxy]quinazoline, in or on hops at 30 parts per million (ppm) (PP 6F8442); nuts, tree, group 14-12 at 0.02 ppm (PP 5F8429); pineapple at 0.2 ppm (PP 6E8466); and tea at 9 ppm (PP 6E8466). The petitions also requested that the existing tolerance for almond at 0.2 ppm be removed upon establishment of the above tolerance for nut, tree group 14-12. Those documents referenced summaries of the petitions prepared by Gowan Company, the registrant, which are available in the docket, http://www.regulations.gov. Comments were received on the Notices of Filing. EPA's response to these comments is discussed in Unit IV.C.

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

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

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

The most consistently observed effects of fenazaquin exposure across species, sexes, and treatment durations were decreases in body weight, food consumption, and food efficiency. These effects were consistent with the commonly observed effects for compounds that disrupt mitochondrial electron transport system. Fenazaquin is a member of this class of chemicals.

Fenazaquin did not produce developmental effects in rats and rabbits with prenatal exposure. It also did not cause reproductive effects, although it produced decreased body weight in the offspring at a dose where maternal body reduction also occurred in the reproduction study. The available data did not demonstrate clear neurotoxicity, immunotoxicity, or genotoxicity. The data in the immunotoxicity study showed an increased incidence of ataxia/hypo-activity with gavage dosing, but the effects were judged to be resulting from general malaise. Fenazaquin is also classified as not likely to be carcinogenic to humans, based on a lack of treatment-related cancer effects in two carcinogenicity studies.

Specific information on the studies received and the nature of the adverse effects caused by fenazaquin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Fenazaquin (044501); Human Health Risk Assessment in Support of Proposed Uses on tree nuts, group 14-12, and Hops, Dried Cones” in pp. 11-17 in docket ID number EPA-HQ-OPP-2016-0029.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for fenazaquin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of May 6, 2015 (80 FR 25953) (FRL-9925-97).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fenazaquin, EPA considered exposure under the petitioned-for tolerances as well as all existing fenazaquin tolerances in 40 CFR 180.632. EPA assessed dietary exposures from fenazaquin in food as follows:

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

Such effects were identified for fenazaquin. In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance level residues, default processing factors, and 100 percent crop treated (PCT) for all proposed and registered uses.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used DEEM-FCID, Version 3.16 software with 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance level residues, default processing factors, and 100 PCT for all proposed and registered uses.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fenazaquin 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 or PCT information in the dietary assessment for fenazaquin. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. In drinking water, the residues of concern are fenazaquin (parent) and two metabolites: Metabolite M29 or 2-(4-{2-[(2-hydroxyquinazolin-4-yl)oxy]ethyl}phenyl)-2-methylpropanoic acid and its tautomer 2-methyl-2-(4-{2-[(2-oxo-1,2-dihydroquinazolin-4-yl)oxy]ethyl}phenyl)propanoic acid; and Metabolite 1 or 4-[2-(4-tert-butyl-phenyl)-ethoxy]-quinazolin-2-ol and its tautomer 4-[2-(4-tert-butylphenyl)ethoxy]quinazolin-2(1H)-one. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for fenazaquin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fenazaquin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticide in Water Calculator (PWC version 1.52), the estimated drinking water concentrations (EDWCs) of fenazaquin and its metabolites of concern for acute exposures are estimated to be 23.8 parts per billion (ppb) for surface water and 1.112 ppb for ground water, for chronic exposures for non-cancer assessments are estimated to be 3.19 ppb for surface water and 0.891 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 23.8 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 3.19 ppb was used to assess the contribution to drinking water.

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

Fenazaquin is currently registered for the following uses that could result in residential exposures: Ornamental plants. There is a potential for exposure associated with handler (i.e., mixing, loading and applying), as well as post-application exposure from the use of fenazaquin on ornamental plants. However, for residential exposure associated with handlers, all registered fenazaquin product labels with residential use sites (e.g., ornamental plants) require that handlers wear specific clothing (e.g., long-sleeve shirt/long pants/chemical resistant gloves) and/or use personal protective equipment (PPE). Therefore, the Agency has made the assumption that these products are not for homeowner use, and has not conducted a quantitative residential handler assessment.

With respect to the potential residential post-application exposure from the use of fenazaquin on ornamental plants, since there is (1) no adverse systemic hazard via the dermal route of exposure; (2) inhalation exposures are typically negligible in outdoor settings; and (3) there is no incidental oral exposure expected from fenazaquin use on ornamental plants, a residential post-application assessment is unnecessary. Furthermore, since the extent to which young children engage in activities associated with these areas or utilize these areas for prolonged periods of play is low, significant non-dietary ingestion exposure is not expected.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

Unlike other pesticides, for which EPA followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fenazaquin and any other substances, and fenazaquin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that fenazaquin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

2. Prenatal and postnatal sensitivity. Susceptibility/sensitivity in the developing animals was evaluated in developmental toxicity studies in rats and rabbits as well as a reproduction and fertility study in rats. The data showed no evidence of increased sensitivity/susceptibility in the developing fetuses or young animals. Clear NOAELs and LOAELs are available for all the parental and offspring effects.

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

i. The toxicity database for fenazaquin is complete.

ii. The available data do not provide evidence that fenazaquin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

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

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fenazaquin in drinking water. These assessments will not underestimate the exposure and risks posed by fenazaquin.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fenazaquin will occupy 11% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fenazaquin from food and water will utilize 9.6% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure, when the additional uses for hops, dried cones and nuts, tree, group 14-12 are considered. The chronic exposure will increase to 9.9% of the cPAD for children 1-2 years old, when tea and pineapple are also assessed (See “Fenazaquin, Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to Support Use of the Insecticide (Without Section 3 Registration) on Imported Tea and Imported Pineapple” in docket ID number EPA-HQ-OPP-2016-0029). Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fenazaquin is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there is no dermal endpoint and no potential short-term residential inhalation or incidental oral exposure to fenazaquin, a short-term risk is not expected.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there is no dermal endpoint and no potential intermediate-term inhalation or oral residential exposure to fenazaquin, an intermediate-term risk is not expected.

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

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

Adequate enforcement methodology, high-performance liquid chromatography with positive ion electrospray ionization with tandem mass spectrometric detection (LC-MS/MS), is available to enforce the tolerance expression. However, for tea, residues were analyzed using gas chromatography with mass spectrometry (GC-MS) in selected ion monitoring mode.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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

The Codex has not established MRLs for fenazaquin in/on hop, dried cones; nuts, tree, group 14-12; pineapple; or tea, dried.

The majority of comments submitted to this docket concerned chemicals or actions not associated with the fenazaquin petitions. One comment was submitted by the Center for Biological Diversity (CBD) in response to the Notice of Filing for PP 6F8442 and PP 5F8429 and was primarily concerned about environmental risks and Agency compliance with any relevant obligations under the Endangered Species Act. This comment is not relevant to the Agency's evaluation of safety of the fenazaquin tolerances; section 408 of the FFDCA focuses on potential harms to human health, not effects on the environment.

The three remaining comments were anonymous public comments submitted in response to the Notice of Filing, which stated, in part, to “Deny this petition. It is harmful and is a toxic chemical”; “there is insufficient information on all facets of hazard from this toxic chemical”; and “We, as Americans, do not need or want any more EPA regulations.” The Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops; however, these comments provide no supporting information upon which to evaluate the safety of pesticide. The existing legal framework provided by section 408 of the FFDCA states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. The Agency has evaluated the available information and determined that these tolerances are safe.

Therefore, tolerances are established for residues of fenazaquin, including its metabolites and degradates, in or on hop, dried cones at 30 ppm; nuts, tree, group 14-12 at 0.02 ppm; pineapple at 0.20 ppm; and tea, dried at 9.0 ppm. In addition, the Agency is removing the separate tolerance for almonds as it is unnecessary because almond is a commodity covered by the crop group tolerances for nuts, tree, group 14-12.

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

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

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

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0143 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 July 24, 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-2016-0143, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of August 29, 2016 (81 FR 59165) (FRL-9950-22), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5E8433) by Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.654 be amended by establishing tolerances for residues of the fungicide isopyrazam, in or on cucurbit crop subgroup 9A at 0.3 parts per million (ppm); pepper, bell at 0.6 ppm; and tomato at 0.5 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA is establishing a lower tolerance than was requested for pepper, bell and is revising the commodity terminology for vegetable, cucurbit, subgroup 9A. The reasons for these changes are explained in Unit IV.C.

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

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

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

Subchronic and chronic oral toxicity studies in the rat, mouse, rabbit and dog demonstrate that the primary target organ for isopyrazam is the liver (increased organ weight and centrilobular hepatocyte hypertrophy). Liver toxicity is usually accompanied by reductions in bodyweight and food consumption. Isopyrazam did not cause reproductive toxicity. Effects seen in the offspring (decreased bodyweight during lactation and increase liver weight at weaning) in the rat reproduction study occurred at the same doses that cause general toxicity in the parents. Developmental effects described as small eyes and/or microphthalmia were observed in both the Himalayan and New Zealand rabbit strains. However, in the Himalayan strain, the intraocular abnormalities occur in the absence of maternal toxicity while in the New Zealand strain, the ocular abnormalities occurred at doses that were maternally toxic. Developmental effects observed in the rat (increased post-implantation loss, reduced fetal weight, and a non- or incomplete ossification or retardation of ossification) occurred at doses that also produced maternal toxicity (mortality, decreased body weights, body weight gains, and food consumption, increased liver weights and microscopic findings in the liver).

No evidence of specific neurotoxicity was seen in acute and subchronic oral neurotoxicity studies in rats. Clinical signs seen in two subchronic dog studies (side-to-side head wobble, ataxia, reduced stability) are consistent with neurotoxic effects. However, detailed and specific neuropathological analyses were not conducted for the dog studies (i.e., functional observational battery, motor activity, detailed histopathology with special stains). Consequently, there is uncertainty regarding whether the effects seen in the dog studies are in fact signs of neurotoxicity. However, clear no observed adverse effect levels (NOAELs)/lowest adverse effect levels (LOAELs) were established for both subchronic dog studies. The point of departure selected for the acute dietary assessment is based on clinical signs seen on day 2 in one of four males in the subchronic dog study. This study provides the lowest NOAEL in the database (most sensitive endpoint) for a single dose effect. The dose used for the chronic dietary risk assessment is eight times lower than the dose at which clinical effects were seen at four weeks in the second subchronic dog study.

There is no evidence of immunotoxicity based on a 28-day dietary immunotoxicity study in mice. The LOAEL for immunotoxicity was not identified and the NOAEL for immunotoxicity was 1,356 milligrams/kilograms (mg/kg).

Isopyrazam is classified as “Likely to be Carcinogenic to Humans” based on increased incidence of uterine endometrial adenocarcinomas and liver hepatocellular adenomas in female rats and increased incidence of thyroid follicular cell adenomas and/or carcinomas in male rats. Isopyrazam is not carcinogenic in the mouse. There is no evidence of genotoxicity, mutagenicity, or clastogenicity in the in vivo and in vitro studies. There are no structural relationships with other known carcinogens. A linear low-dose approach (Q1*) was used to extrapolate experimental animal tumor data for the quantification of human cancer risk.

Isopyrazam is of low acute toxicity by the oral, dermal, and inhalation routes and is not a skin or eye irritant.

Specific information on the studies received and the nature of the adverse effects caused by isopyrazam as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Isopyrazam: Human Health Risk Assessment for the Establishment of Tolerances with No U.S. Registrations in/on Cucurbit Vegetables Crop Subgroup 9A, Bell Pepper and Tomato Imported from Belgium, Greece, Italy, Spain and the United Kingdom” in docket ID number EPA-HQ-OPP-2016-0143.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for isopyrazam used for human risk assessment is discussed in Table 1 of the final rule published in the Federal Register of December 27, 2013 (78 FR 78740) (FRL-9903-53).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isopyrazam, EPA considered exposure under the petitioned-for tolerances as well as all existing isopyrazam tolerances in 40 CFR 180.654. EPA assessed dietary exposures from isopyrazam in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for isopyrazam. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, maximum residues from field trials conducted at the maximum use rates were used to estimate isopyrazam residues of concern and 100 percent crop treated (PCT) assumptions were used. Dietary Exposure Evaluation Model (DEEM) default processing factors were used for all processed commodities including dried apple (8.0), apple juice/cider (1.3), dried banana/plantain (3.9), peanut butter (1.89), dried tomato (14.3), tomato juice (1.5), tomato paste (5.4), and tomato puree (3.3). In the absence of peanut processing data, the maximum theoretical concentration factor was used for peanut oil (2.8).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA used the average residues from field trials conducted at the maximum use rates were used to estimate isopyrazam and the same processing factors and PCT assumptions as in the acute dietary exposure analysis.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that isopyrazam should be classified as “Likely to be Carcinogenic to Humans” and a linear approach has been used to quantify cancer risk. In evaluating the cancer risk, EPA used the same residue levels, processing factors and PCT assumptions as in the chronic dietary exposure analysis.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use PCT information in the dietary assessment for isopyrazam. Maximum or average residue levels from field trials conducted at the maximum use rates were assumed for all food commodities.

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

2. Dietary exposure from drinking water. An assessment of residues in drinking water is not needed for isopyrazam because there is no drinking water exposure for isopyrazam uses, which are all non-domestic.

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

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found isopyrazam to share a common mechanism of toxicity with any other substances, and isopyrazam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isopyrazam does not have a common mechanism of toxicity with other substances. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

2. Prenatal and postnatal sensitivity. There are no residual uncertainties for pre- and/or postnatal susceptibility even though qualitative susceptibility was observed in the range-finding developmental studies in rabbits. Developmental effects (eye abnormalities) were observed in the absence of maternal toxicity in two range finding developmental toxicity studies in the Himalayan rabbit. However, the eye effects were only observed at relatively high doses (200-400 mg/kg/day) with clear NOAELs/LOAELs established for the developmental effects. Developmental effects observed in the rat (increased post-implantation loss, reduced fetal weight and non-or incomplete ossification or retardation of ossification) occurred only at doses that also produced maternal toxicity (mortality, decreased body weights, body weight gains, and food consumption). There was no evidence of increased susceptibility in a 2-generation reproduction study following pre- or postnatal exposure to isopyrazam. There was also no evidence of neuropathology or abnormalities in the development of the fetal nervous system from the available toxicity studies conducted with isopyrazam. Clear NOAELs/LOAELs were established for the developmental effects observed in rats and rabbits as well as for the offspring effects (increased liver weights) seen in the 2-generation reproduction study and a dose-response relationship for the effects of concern is well characterized. The dose used for the acute dietary risk assessment (30 mg/kg/day), based on effects seen in the subchronic dog study, is protective of the developmental effects seen in rats (44.5 mg/kg/day) and rabbits (200 mg/kg/day). Based on these considerations, there are no residual uncertainties for pre- and/or postnatal susceptibility.

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

i. The toxicity database for isopyrazam is complete.

ii. As discussed in Unit III.A, there is no indication that isopyrazam is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.

iii. As discussed in Unit III.D.2, there are no residual uncertainties for pre-and/or post-natal susceptibility.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and maximum or average residue levels from field trials conducted at the maximum use rates. There are no currently registered or proposed occupational or residential uses of isopyrazam in the U.S. and adequate residue data are available. These assessments will not underestimate the exposure and risks posed by isopyrazam.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to isopyrazam at the 95th percentile will occupy 4.7% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isopyrazam from food will utilize 5.0% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for isopyrazam.

3. Short- and intermediate-term risk. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure (which includes both food and water and is considered to be a background exposure level). Isopyrazam is not registered in the United States. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD, no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for isopyrazam.

4. Aggregate cancer risk for U.S. population. Using the exposure assumptions discussed in this unit for cancer exposure, the cancer dietary risk estimate for the U.S. population is 3 × 10−6. EPA generally considers cancer risks (expressed as the probability of an increased cancer case) in the range of 1 in 1 million (or 1 × 10−6) or less to be negligible. The precision that can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the logarithmic scale; for example, risks falling between 3 × 10−7 and 3 × 10−6 are expressed as risks in the range of 10−6. Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark level of concern of the range of 10−6 until the calculated risk exceeds approximately 3 × 10−6. This is particularly the case where some conservatism is maintained in the exposure assessment. For isopyrazam, EPA's exposure assessment assumes average residues of concern from field trials reflecting the maximum use rates, default processing factors, the maximum theoretical concentration for residues in peanut oil, and 100 PCT, which is highly conservative. Accordingly, EPA has concluded the cancer risk from exposure to isopyrazam falls within the range of 10−6 and is thus negligible.

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

Adequate enforcement methodology (GRM006.01B) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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

The Codex has not established MRLs for isopyrazam in or on vegetable, cucurbit, subgroup 9A; pepper, bell; and tomato.

Based on the residue levels observed in the field trial studies, EPA is establishing a tolerance of 0.50 ppm in or on pepper, bell in lieu of the 0.6 ppm as requested by the petitioner. The tolerance requested for Cucurbit Crop Group 9A is also being established as Vegetable, cucurbit, subgroup 9A, which is the standard commodity description for these commodities. The petitioned-for tolerances for residues of isopyrazam in/on cucurbit crop group 9A (0.3 ppm) and tomato (0.5 ppm) are set at 0.30 ppm and 0.50 ppm, respectively, consistent with the current practices for setting tolerances.

Therefore, tolerances are established for residues of isopyrazam, (3-(difluoromethyl)-1-methyl-N-[1,2,3,4-tetrahydro-9-(1-methylethyl)-1,4-methano-naphthalen-5-yl]-1H-pyrazole-4-carboxamide), determined as the sum of its syn-isomer (3-(difluoromethyl)-1-methyl-N-[(1RS, 4SR, 9RS)-1,2,3,4-tetrahydro-9-(1-methylethyl)-1,4-methanonaphthalen-5-yl]-1H-pyrazole-4-carboxamide) and anti-isomer (3-(difluoromethyl)-1-methyl-N-[(1RS, 4SR, 9SR)-1,2,3,4-tetrahydro-9-(1-methylethyl)-1,4-methano-naphthalen-5-yl]-1H-pyrazole-4-carboxamide), in or on vegetable, cucurbit, subgroup 9A at 0.30 ppm; pepper, bell at 0.50 ppm; and tomato at 0.50 ppm.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. FEMA has determined that the community suspension(s) included in this rule is a non-discretionary action and therefore the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) does not apply.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR part 64 is amended as follows:

Background

Black sea bass are jointly managed by the Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission as part of the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP). Specifications in these fisheries include various catch and landing subdivisions, such as the commercial and recreational sector annual catch limits (ACLs), annual catch targets (ACTs), and sector-specific landing limits (i.e., the commercial fishery quota and recreational harvest limit).

On December 28, 2015, NMFS published a final rule implementing the Council's recommended 2016-2018 specifications for the black sea bass fishery (80 FR 80689). The Council intended to reconsider the specifications set for fishing year 2017 following completion of the next black sea bass benchmark assessment in late 2016/early 2017.

As detailed in the proposed rule (82 FR 17964; April 14, 2017), the peer-reviewed assessment indicates that the black sea bass stock north of Cape Hatteras is not overfished and overfishing is not occurring. The spawning stock biomass in 2015 (the terminal year of the assessment) was estimated to be 2.3 times higher than the target and the fishing mortality rate was 25 percent below the overfishing threshold. Additional information on the assessment and the Council's recommendation are provided in the proposed rule and not repeated here. This final rule implements the Council's recommended black sea bass specifications for the 2017 fishing year and updates projected specifications for 2018. By providing projected specifications for 2018, NMFS hopes to assist fishery participants in planning ahead. This rule also removes the commercial fishery accountability measure (AM) previously implemented to the 2017 fishing year (81 FR 93842; December 22, 2016). Final 2018 specifications will be published in the Federal Register before the start of the 2018 fishing year (January 1, 2018) following the Council's review.

NMFS will consider any needed changes to the 2017 recreational management measures (i.e., minimum fish size, per-angler possession limits, and fishing seasons) for black sea bass through a separate action before summer 2017.

This rule implements the revised 2017 and projected 2018 acceptable biological catch (ABC) and commercial and recreational catch limits (Table 1), as outlined in the proposed rule.

The revised 2017 specifications represent a 53-percent increase from the previously implemented 2017 commercial quota, and a 52-percent increase in the 2017 recreational harvest limit.