Unknown. Final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2015-12-14.xml --- 80 239 Monday, December 14, 2015 Contents Agricultural Marketing Agricultural Marketing Service RULES National Organic Program: Sunset 2015 Amendments to the National List, 77231-77234 2015-31413 PROPOSED RULES Increased Assessment Rates: Pistachios Grown in California, Arizona, and New Mexico, 77277-77279 2015-31371 Agriculture Agriculture Department See Agricultural Marketing Service See Rural Business-Cooperative Service Architectural Architectural and Transportation Barriers Compliance Board NOTICES Meetings, 77315-77316 2015-31403 Army Army Department NOTICES Privacy Act;

Systems of Records, 77330-77333 2015-31350 2015-31352 Broadcasting Broadcasting Board of Governors NOTICES Meetings; Sunshine Act, 77316 2015-31498 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 77329-77330 2015-31420 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 77349-77351 2015-31344 Guideline for Prescribing Opioids for Chronic Pain, 77351-77352 2015-31375 Meetings:

Board of Scientific Counselors, National Center for Injury Prevention and Control, 77352 2015-31367 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 77352-77354 2015-31398 2015-31399 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 77354-77355 2015-31314 Coast Guard Coast Guard RULES Drawbridge Operations:

Hoquiam River, Hoquiam, WA, 77252-77253 2015-31388 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Commodity Futures Commodity Futures Trading Commission NOTICES Meetings; Sunshine Act, 77329 2015-31479 Defense Department Defense Department See Army Department See Navy Department Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Student Assistance General Provisions - Annual Fire Safety Report, 77333-77334 2015-31346 Energy Department Energy Department See Federal Energy Regulatory Commission Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Texas; El Paso Particulate Matter Contingency Measures, 77253-77255 2015-31310 Pesticide Tolerances: Naphthalene Acetates, 77255-77260 2015-31309 Pesticide Tolerances; Exemptions: Polyamide Ester Polymers, 77260-77264 2015-30924 Renewable Fuel Standard Program:

Standards for 2014, 2015, and 2016 and Biomass-Based Diesel Volume for 2017, 77420-77518 2015-30893 PROPOSED RULES Nondiscrimination in Programs or Activities Receiving Federal Assistance from the Environmental Protection Agency, 77284-77289 2015-31050 NOTICES Motor Vehicle Emission Factor Model for Use in the State of California, 77337-77340 2015-31307 Federal Aviation Federal Aviation Administration RULES Class E Airspace; Establishments: Neah Bay, WA, 77234-77235 2015-31274 PROPOSED RULES Airworthiness Directives:

Airbus Airplanes, 77279-77283 2015-31306 Class E Airspace; Amendments: Deer Lodge, MT, 77283-77284 2015-31273 Federal Communications Federal Communications Commission PROPOSED RULES Improving Wireless Emergency Alerts and Community-Initiated Alerting, 77289-77311 2015-31234 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 77340-77341 2015-31318 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 77341-77343 2015-31389 Meetings; Sunshine Act, 77343 2015-31481 Terminations of Receivership: Legacy Bank, Scottsdale, AZ, 77343 2015-31390 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 77343-77344 2015-31544 Federal Emergency Federal Emergency Management Agency NOTICES Changes in Flood Hazard Determinations, 77361-77365 2015-31379 Flood Hazard Determinations, 77356-77361, 77365-77367 2015-31376 2015-31377 2015-31378 Recovery Policy:

Labor Costs - Emergency Work, 77365 2015-31381 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Southern California Edison Co., 77336 2015-31396 Combined Filings, 77334-77335 2015-31391 Environmental Assessments; Availability, etc.: East Tennessee Natural Gas, LLC; Loudon Expansion Project, 77336-77337 2015-31392 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Central Antelope Dry Ranch C LLC, 77335 2015-31395 FTS Master Tenant 1, LLC, 77335 2015-31394 Refund Effective Dates:

Emera Maine, 77337 2015-31393 Federal Motor Federal Motor Carrier Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Motor Carrier Identification Report, 77407-77408 2015-31341 Qualification of Drivers; Exemption Applications: Diabetes Mellitus, 77408-77414 2015-31340 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 77344-77349 2015-31356 Federal Trade Federal Trade Commission RULES Telemarketing Sales Rule, 77520-77561 2015-30761 Fish Fish and Wildlife Service NOTICES Endangered Species:

Recovery Permit Applications, 77367-77368 2015-31424 Food and Drug Food and Drug Administration NOTICES Meetings: Circulatory System Devices Panel of the Medical Devices Advisory Committee, 77355 2015-31372 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 77416 2015-31348 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 77355-77356 2015-31355 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S. Customs and Border Protection Indian Affairs Indian Affairs Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Water Delivery and Electric Service Data for the Operation of Irrigation and Power Projects and Systems, 77371-77372 2015-31343 Liquor Control Statutes: Enterprise Rancheria of Maidu Indians of California, 77369-77371 2015-31313 North Fork Rancheria of Mono Indians of California, 77372-77374 2015-31311 Interior Interior Department See Fish and Wildlife Service See Indian Affairs Bureau See Land Management Bureau See National Park Service International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Aluminum Extrusions from the People's Republic of China, 77325-77329 2015-31425 Citric Acid and Certain Citrate Salts, 77318-77319 2015-31419 Citric Acid and Certain Citrate Salts from the People's Republic of China, 77323-77325 2015-31427 Wooden Bedroom Furniture from the People's Republic of China, 77321-77323 2015-31426 Determinations of Sales at Less Than Fair Value: Certain Steel Nails from the United Arab Emirates, 77316-77317 2015-31429 Meetings: Environmental Technologies Trade Advisory Committee, 77323 2015-31428 Renewable Energy and Energy Efficiency Advisory Committee, 77317-77318 2015-31365 Request for Public Input:

Sectoral Dialogues to Inform Work on Standards Cooperation under the U.S.-India Strategic and Commercial Dialogue, 77319-77321 2015-31430 International Trade Com International Trade Commission NOTICES Complaints: Certain Rack Mountable Power Distribution Units, 77376 2015-31338 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Dental Implants; Correction, 77376-77377 2015-31354 Justice Department Justice Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Furnishing of Samples, 77377 2015-31334 Land Land Management Bureau NOTICES Meetings: Pecos District Resource Advisory Council, New Mexico, 77374 2015-31423 Millenium Millennium Challenge Corporation NOTICES Compacts: Kingdom of Morocco, 77377-77379 2015-31366 National Credit National Credit Union Administration NOTICES Meetings; Sunshine Act, 77379 2015-31502 National Endowment for the Arts National Endowment for the Arts NOTICES Meetings:

Arts Advisory Panel, 77379-77380 2015-31345 National Foundation National Foundation on the Arts and the Humanities See National Endowment for the Arts National Highway National Highway Traffic Safety Administration NOTICES Petitions for Inconsequential Noncompliance: Nitto Tire U.S.A, Inc., 77415-77416 2015-31349 National Labor National Labor Relations Board RULES Rules and Regulations, 77236-77238 2015-31339 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species:

Atlantic Bluefin Tuna Fisheries, 77264-77267 2015-31384 Fisheries of the Exclusive Economic Zone Off Alaska: Reallocation of Pacific Cod in the Central Regulatory Area of the Gulf of Alaska Management Area, 77275-77276 2015-31386 Fisheries off West Coast States: Pacific Coast Groundfish Fishery Management Plan; Trawl Rationalization Program; Midwater Trawl Requirements, 77267-77275 2015-31363 PROPOSED RULES Control Date for the Blueline Tilefish Fishery in Waters North of the Virginia/North Carolina Border, 77312-77313 2015-31364 National Park National Park Service NOTICES Applications:

Right-of-Way across Gates of the Arctic National Preserve, 77375 2015-31422 Continuation of Concession Contracts, 77374-77375 2015-31332 Manhattan Project National Historical Park, 77375-77376 2015-31330 National Science National Science Foundation NOTICES Permit Applications: Antarctic Conservation Act, 77380 2015-31335 2015-31337 Navy Navy Department NOTICES Exclusive Patent Licenses: Lockmasters Inc., 77333 C1--2015--30491 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Facility Operating Licenses:

Davis-Besse Nuclear Power Station, Unit 1, 77380-77381 2015-31418 Meetings; Sunshine Act, 77381-77382 2015-31567 Pension Benefit Pension Benefit Guaranty Corporation NOTICES Exemption from the Bond/Escrow Requirement Relating to the Sale of Assets by an Employer Who Contributes to a Multiemployer Plan: Harrington Air Systems, LLC and J.C. Cannistraro, LLC, 77382-77383 2015-31357 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 77383-77384 2015-31373 2015-31374 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances:

Human Rights Day and Human Rights Week (Proc. 9380), 77563-77566 2015-31582 Rural Business Rural Business-Cooperative Service NOTICES Funding Availability: Rural Energy for America Program, 77314-77315 2015-31325 Guarantee Fee Rates for Guaranteed Loans for Fiscal Year 2016: Maximum Portion of Guarantee Authority Available for Fiscal Year 2016; Annual Renewal Fee for Fiscal Year 2016, 77314 2015-31300 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 77392-77398 2015-31358 2015-31359 2015-31360 2015-31361 2015-31362 Self-Regulatory Organizations; Proposed Rule Changes: C2 Options Exchange, Inc., 77394-77396 2015-31326 Chicago Board Options Exchange, Inc., 77402-77404 2015-31327 NASDAQ OMX PHLX, LLC, 77399-77402 2015-31333 New York Stock Exchange, LLC, 77392-77394 2015-31329 NYSE Arca, Inc., 77384-77392 2015-31328 Social Social Security Administration NOTICES Reporting by State ABLE Programs, 77404 2015-31351 State Department State Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Local U.S. Citizen Skills/Resources Survey, 77405-77406 2015-31382 Request for Entry into Children's Passport Issuance Alert Program, 77405 2015-31383 Surface Transportation Surface Transportation Board PROPOSED RULES Offers of Financial Assistance, 77311-77312 2015-31347 Trade Representative Trade Representative, Office of United States NOTICES Policy Recommendations for Deepening the U.S.-Africa Trade and Investment Relationship; Public Hearings, 77406-77407 2015-31324 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See National Highway Traffic Safety Administration See Surface Transportation Board Treasury Treasury Department See Foreign Assets Control Office RULES Gulf Coast Restoration Trust Fund, 77239-77252 2015-31431 Customs U.S.

Customs and Border Protection NOTICES Customs Brokers User Fee Payment for 2016, 77356 2015-31370 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals; Withdrawal, 77416 2015-31387 Reasonable Charges for Medical Care or Services: Calendar Year Update and National Average Administrative Prescription Drug Charge Update, 77417-77418 2015-31385 Separate Parts In This Issue Part II Environmental Protection Agency, 77420-77518 2015-30893 Part III Federal Trade Commission, 77520-77561 2015-30761 Part IV Presidential Documents, 77563-77566 2015-31582 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 80 239 Monday, December 14, 2015 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-15-0015; NOP-15-07] RIN 0581-AD39 National Organic Program (NOP); Sunset 2015 Amendments to the National List AGENCY:

Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: This final rule addresses recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board

(NOSB)following their October 2014 meeting. These recommendations pertain to the 2015 Sunset Review of substances on the U.S. Department of Agriculture's

(USDA)National List of Allowed and Prohibited Substances (National List). Consistent with the recommendations from the NOSB, this final rule removes two nonorganic agricultural substances from the National List for use in organic handling, fortified cooking wines—marsala wine and sherry wine. This final rule also removes two listings for synthetic substances allowed for use in organic crop production on the National List, streptomycin and tetracycline, as their use exemptions expired on October 21, 2014. DATES: *Effective Date:* This final rule is effective on December 14, 2015. FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2642-So., Ag Stop 0268, Washington, DC 20250-0268. *Telephone:*

(202)720-3252; *Fax:*

(202)205-7808. SUPPLEMENTARY INFORMATION: I. Background The National Organic Program

(NOP)is authorized by the Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501-6522). The USDA Agricultural Marketing Service

(AMS)administers the NOP. Final regulations implementing the NOP, also referred to as the USDA organic regulations, were published December 21, 2000 (65 FR 80548), and became effective on October 21, 2002. Through these regulations, the AMS oversees national standards for the production, handling, and labeling of organically produced agricultural products. Since becoming effective, the USDA organic regulations have been frequently amended, mostly for changes to the National List in 7 CFR 205.601-205.606. This National List identifies the synthetic substances that may be used and the nonsynthetic substances that may not be used in organic production. The National List also identifies synthetic, nonsynthetic nonagricultural, and nonorganic agricultural substances that may be used in organic handling. The OFPA and the USDA organic regulations, as indicated in § 205.105, specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any nonorganic agricultural substance and any nonsynthetic nonagricultural substance used in organic handling appear on the National List. As stipulated by the OFPA, recommendations to propose amendment of the National List are developed by the NOSB, operating under the Federal Advisory Committee Act (5 U.S.C. App. 2 *et seq.* ), to assist in the evaluation of substances to be used or not used in organic production and handling, and to advise the Secretary on the USDA organic regulations. The OFPA also requires a sunset review of all substances included on the National List within five years of their addition to or renewal on the list. If a listed substance is not reviewed by the NOSB and renewed by the USDA within the five year period, its allowance or prohibition on the National List is no longer in effect. Under the authority of the OFPA, the Secretary can amend the National List through rulemaking based upon proposed amendments as recommended by the NOSB. The NOSB's recommendations to continue existing exemptions and prohibitions include consideration of public comments and applicable supporting evidence that express a continued need for the use or prohibition of the substance(s) as required by the OFPA. Recommendations to either continue or discontinue an authorized exempted synthetic substance (7 U.S.C. 6517(c)(1)) are determined by the NOSB's evaluation of technical information, public comments, and supporting evidence that demonstrate that the substance is:

(a)Harmful to human health or the environment;

(b)no longer necessary for organic production due to the availability of alternative wholly nonsynthetic substitute products or practices; or

(c)inconsistent with organic farming and handling practices. This rule removes the expired listings of two substances, streptomycin and tetracycline, as their National List exemptions expired on October 21, 2014. After this expiration date, the use of streptomycin and tetracycline in organic production is prohibited. While USDA accredited certifying agents are enforcing the prohibition of streptomycin and tetracycline, delisting of these substances from the National List reduces the likelihood of noncompliant use by organic producers. Following their October 2014 public meeting, the NOSB submitted their 2015 Sunset Review recommendations to the Secretary. This rule amends the National List to implement two NOSB recommendations to remove the substances, marsala wine and sherry wine, allowed as ingredients in or on processed products labeled as “organic” in § 205.606. The National List exemptions of these substances for use in organic production and handling that were considered by the NOSB during the 2015 Sunset Review process were evaluated according to the evaluation criteria specified on the OFPA (7 U.S.C. 6517-6518). II. Overview of Amendments The following provides an overview of the amendments made to designated sections of the National List regulations: § 205.601 Synthetic Substances Allowed for Use in Organic Crop Production This final rule amends § 205.601 of the National List regulations by removing

(1)the expired substance exemption for streptomycin, for fire blight control in apples and pears only until October 21, 2014, in § 205.601(i)(11), and

(2)the expired substance exemption for tetracycline, for fire blight control in apples and pears only until October 21, 2014, in § 205.601(i)(12). Streptomycin This rule amends § 206.601 of the National List by removing the expired exemption for streptomycin, for fire blight control in apples and pears only until October 21, 2014. In 1995, streptomycin was recommended by the NOSB for addition as a plant disease control to the National List. The NOSB recommendation was accepted by the Secretary and streptomycin was included, as a plant disease control, in the initial final rule establishing the NOP that was published on December 21, 2000 (65 FR 80548). The listing for streptomycin was amended, as recommended by the NOSB, on June 6, 2012 (77 FR 33290) to add an expiration date to the streptomycin annotation: Streptomycin, for fire blight control in apples and pears only until October 21, 2014. This rule removes the listing for streptomycin that expired on October 21, 2014 from § 205.601. Since the prohibition against the use of streptomycin has been effective since October 21, 2014, removal of this exempted substance from the National List has no new regulatory effect. Tetracycline This rule amends § 206.601 of the National List by removing the expired exemption for tetracycline, for fire blight control in apples and pears only until October 21, 2014. Tetracycline was considered by the NOSB at their October 31-November 4, 1995, meeting. The NOSB recommendation was accepted by the Secretary and tetracycline was included, as a plant disease control, in the initial final rule establishing the NOP that was published on December 21, 2000 (65 FR 80548). Subsequently, as recommended by the NOSB, the listing for tetracycline was amended on August 2, 2012 (77 FR 45903) to add an expiration date to the tetracycline annotation: Tetracycline, for fire blight control in apples and pears only until October 21, 2014. This rule removes the exempted listing for tetracycline from § 205.601 that expired on October 21, 2014. Since the prohibition against the use of tetracycline has been effective since October 21, 2014, the removal of this exempted substance from the National List has no new regulatory effect. Sec. 205.606 Nonorganically Produced Agricultural Products Allowed as Ingredients In or On Processed Products Labeled as “Organic” This final rule amends § 205.606 of the National List by removing two substance exemptions listed in § 205.606(g): Fortified cooking wines,

(1)marsala,

(2)sherry. This rule implements two NOSB recommendations from their 2015 Sunset review that were submitted to the Secretary on October 30, 2014. During their 2015 Sunset Review, the NOSB determined that two substance exemptions for marsala wine and sherry wine included on § 205.606 of the National List are no longer necessary for organic handling. Marsala Wine The USDA organic regulations have included an exemption on the National List for fortified cooking wines as an ingredient for use in organic processed products at § 205.606(g) as follows: Fortified cooking wines,

(1)Marsala. In 2007, marsala wine was petitioned for addition to § 205.606 because it was considered a key flavor ingredient that was not commercially available in organic form and quantity. As required by the OFPA, the exemption for marsala wine was considered during the NOSB's 2015 sunset review. During their sunset review deliberation, the NOSB received no public comments supporting the continued need for the use of nonorganic marsala wine in organic processed products. In addition, the NOSB considered evidence that only a few operations use marsala wine as an ingredient in organic processed products. Based upon this information, the NOSB determined that the exemption for marsala wine on § 205.606 is no longer necessary or essential for organic processed products and voted for the removal of marsala wine from the National List, effective on December 14, 2015. Sherry Wine The USDA organic regulations have included an exemption on the National List for fortified cooking wine, sherry wine, as an ingredient for use in organic processed products at § 205.606(g) as follows: Fortified cooking wines,

(2)Sherry. In 2007, sherry wine was petitioned for addition to § 205.606 because it was considered a key flavor ingredient that was not commercially available in organic form or quantity. As required by the OFPA, the exemption for sherry wine was considered during the NOSB's 2015 sunset review. During their sunset review deliberation, the NOSB received no public comments supporting the continued need for the use of nonorganic sherry wine in organic processed products. In addition, the NOSB considered evidence that only a few operations use sherry wine as an ingredient in organic processed products. Based upon this information, the NOSB determined that the exemption for sherry wine as listed on § 205.606 is no longer necessary or essential for organic processed products and voted for the removal of sherry wine from the National List, effective on December 14, 2015. This rule amends § 205.606 by redesignating paragraphs

(h)through

(z)as

(g)through (y), respectively. III. Related Documents Two notices of public meeting with request for comments were published in **Federal Register** on March 10, 2014 (79 FR 13272) and on September 8, 2014 (79 FR 53162) to notify the public that the 2015 sunset review listings discussed in this proposed rule would expire on December 14, 2015, if not reviewed by the NOSB and renewed by the Secretary. The listing for both streptomycin and tetracycline was added to the National List by the final rule (65 FR 80548) published in the **Federal Register** on December 21, 2000. Subsequently, an expiration date of October 21, 2014 was added to the streptomycin and tetracycline annotations on June 6, 2012 (77 FR 33290) and on August 2, 2012 (77 FR 45903). The proposal to address the substances in this final rule was published in the **Federal Register** on July 30, 2015 (80 FR 45499). IV. Statutory and Regulatory Authority OFPA, as amended (7 U.S.C. 6501-6522), authorizes the Secretary to make amendments to the National List based on proposed recommendations developed by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA authorize the NOSB to develop proposed amendments to the National List for submission to the Secretary and establish a petition process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List. The National List petition process is implemented under § 205.607 of the USDA organic regulations. The current petition process was published on January 18, 2007 (72 FR 2167) and can be accessed through the NOP Web site at *http://www.ams.usda.gov/nop* . AMS published a revised sunset review process in the **Federal Register** on September 16, 2013 (78 FR 56811). A. Executive Order 12866 This action has been determined to be not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget. B. Executive Order 12988 Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This final rule is not intended to have a retroactive effect. States and local jurisdictions are preempted under OFPA from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in section 2115(b) of OFPA (7 U.S.C. 6514(b)). States are also preempted under section 2104 through 2108 of OFPA (7 U.S.C. 6503-6507) from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of OFPA. Pursuant to section 2108(b)(2) of OFPA (7 U.S.C. 6507(b)(2)), a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must:

(a)Further the purposes of OFPA,

(b)not be inconsistent with OFPA,

(c)not be discriminatory toward agricultural commodities organically produced in other States, and

(d)not be effective until approved by the Secretary. Pursuant to section 2120(f) of OFPA (7 U.S.C. 6519(f)), this rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-399), nor the authority of the Administrator of EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136-136(y)). Section 2121 of OFPA (7 U.S.C. 6520) provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. OFPA also provides that the U.S. District Court for the district in which a person is located has jurisdiction to review the Secretary's decision. C. Regulatory Flexibility Act The Regulatory Flexibility Act

(RFA)(5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to the action. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. Pursuant to the requirements set forth in the RFA, AMS performed an economic impact analysis on small entities in the final rule published in the **Federal Register** on December 21, 2000 (65 FR 80548). AMS has also considered the economic impact of this action on small entities. The impact on entities affected by this rule would not be significant. The effect of this rule would be to prohibit the use of two nonorganic agricultural products that may be available in organic form for use in organic processed products. AMS concludes that the economic impact of removing the nonorganic agricultural products, marsala wine and sherry wine, would be minimal to small agricultural firms since organic form of these agricultural products or organic forms of alternative agricultural products may be commercially available and, as such, their nonorganic forms are proposed to be removed from the National List under this rule. Accordingly, AMS certifies that this rule will not have a significant economic impact on a substantial number of small entities. Small agricultural service firms, which include producers, handlers, and accredited certifying agents, have been defined by the Small Business Administration

(SBA)(13 CFR 121.201) as those having annual receipts of less than $7,000,000 and small agricultural producers are defined as those having annual receipts of less than $750,000. According to USDA, National Agricultural Statistics Service (NASS), certified organic acreage exceeded 3.5 million acres in 2011. 1 According to NOP's Accreditation and International Activities Division, the number of certified U.S. organic crop and livestock operations totaled over 19,470 in 2014. The list of certified operations is available on the NOP Web site at *http://apps.ams.usda.gov/nop/.* AMS believes that most of these entities would be considered small entities under the criteria established by the SBA. U.S. sales of organic food and non-food have grown from $1 billion in 1990 to $39.1 billion in 2014, an 11.3 percent growth over 2013 sales. 2 In addition, the USDA has 80 accredited certifying agents who provide certification services to producers and handlers. A complete list of names and addresses of accredited certifying agents may be found on the AMS NOP Web site, at *http://www.ams.usda.gov/services/organic-certification/certifying-agents.* AMS believes that most of these accredited certifying agents would be considered small entities under the criteria established by the SBA. Certifying agents reported 27,810 certified operations worldwide in 2014. 1 U.S. Department of Agriculture, National Agricultural Statistics Service. October 2012. 2011 Certified Organic Productions Survey. 2 Organic Trade Association. 2014. Organic Industry Survey. *www.ota.com.* D. Paperwork Reduction Act No additional collection or recordkeeping requirements are imposed on the public by this rule. Accordingly, OMB clearance is not required by section 350(h) of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35, or OMB's implementing regulations at 5 CFR part 1320. E. Executive Order 13175 This rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications. F. Comments Received on Proposed Rule AMS-NOP-15-0015; NOP-15-07 AMS received two comments on proposed rule AMS-NOP-15-0015. Only one comment from a consumer addressed the 2015 Sunset review amendments to remove marsala and sherry wines from the National List. The second comment was from a California apple producer and it addressed removing the expired listings, streptomycin and tetracycline, from the National List. The consumer who commented on removing marsala and sherry wines from the National List agreed with the proposed amendment to prohibit the use of these nonorganic ingredients in foods labeled as organic. During their sunset review of marsala and sherry, the NOSB did not receive comments supporting the continued use of these wines as nonorganic ingredients in organic products. Additionally, since no comments were received opposing the removal of marsala and sherry wines from the National List, AMS is finalizing these amendments as proposed through this final rule. Additionally, the consumer who supported the removal of marsala and sherry wines also added that nonorganic ingredients should not be used in organic foods. AMS has considered this comment. The USDA organic regulations, in § 205.301(b), requires that a raw or processed agricultural product sold, labeled, or represented as “organic” must contain not less than 95 percent organically produced raw or processed agricultural products. Any remaining product ingredients must be organically produced, unless not commercially available in organic form, or must be nonagricultural substances as listed in § 205.605, or nonorganic agricultural products as listed in § 205.606 on the National List. In essence, the USDA organic regulations requires organic producers or organic handlers to maximize organic ingredients before using nonorganic nonagricultural or nonorganic agricultural that are included on the National List. Changes Requested But Not Made The commenter on the proposed removal of expired listings for streptomycin and tetracycline did not agree with this action and did not agree with the prohibition against the use of these antibiotics to control fire blight infestation in apple production. This commenter stated that the prohibition of streptomycin and tetracycline for use in apple production has had a significant impact on organic apple growers in California's central valley. According to this commenter, the alternatives to the use of streptomycin and tetracycline researched in the Pacific Northwest are ineffective in controlling fire blight in California's central valley. The commenter claims the amendment to prohibit the use of these antibiotics to control fire blight created a significant economic advantage for apple growers in the Pacific Northwest. The removal of the expired listings for streptomycin and tetracycline in the proposed rule is essentially a notice of a technical correction since the prohibition on the use of these two substances in organic crop production is already in effect. The final rule that established the effective date of streptomycin's expiration date as listed in § 205.601(i)(11) was published in the **Federal Register** (77 FR 33290) on June 6, 2012. This final rule addressed comments received on the proposed rule to list streptomycin with an expiration date, including comments in support of or in opposition to the expiration date. AMS also addressed comments on commercially viable alternatives, including the efficacy of these alternatives, and addressed additional factors considered by the NOSB during their determination. Since the prohibition against the use of streptomycin has been in effect since October 22, 2014, AMS is finalizing this correction as noted in the proposed rule. Organic producers who have determined that there are no commercially available alternatives to streptomycin in controlling fire blight in apples or pear production for their region can submit a petition ( *http://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition* ) to add streptomycin back onto the National List. The final rule that established the effective date of tetracycline's expiration date as listed in § 205.601(i)(12) was published in the **Federal Register** (77 FR 45903) on August 2, 2012. This final rule addressed comments received on the proposed rule to list tetracycline with an expiration date, including comments in support of or in opposition to the expiration date. AMS also addressed comments on commercially viable alternatives, including the efficacy of these alternatives, and addressed additional factors considered by the NOSB during their determination. Since the prohibition against the use of tetracycline has been in effect since October 22, 20014, AMS is finalizing this correction as noted in the proposed rule. Organic producers who have determined that there are no commercially available alternatives to tetracycline in controlling fire blight in apples or pear production for their region can submit a petition ( *http://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition* ) to add tetracycline back onto the National List. List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agricultural commodities, Imports, Labeling, Livestock, Reporting and recordkeeping requirements, Soil conservation. For the reasons set forth in the preamble, 7 CFR part 205 is amended as follows: PART 205—NATIONAL ORGANIC PROGRAM 1. The authority citation for 7 CFR part 205 continues to read as follows: Authority: 7 U.S.C. 6501-6522. § 205.601 [Amended] 2. Section 205.601 is amended by removing paragraphs (i)(11) and (12). § 205.606 [Amended] 3. Section 205.606 is amended by removing paragraph

(g)and redesignating paragraphs

(h)through

(z)as

(g)through (y). Dated: December 8, 2015. Rex A. Barnes, Associate Administrator, Agricultural Marketing Service. [FR Doc. 2015-31413 Filed 12-11-15; 8:45 am]

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