Unknown. Confirmation of regulations
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--- schema: federal-register doc_type: fedreg source_file: FR-2015-05-06.xml --- 80 87 Wednesday, May 6, 2015 Contents Agricultural Marketing Agricultural Marketing Service RULES National Organic Program Regulations: Section 610 Review, 25897-25901 2015-10446 PROPOSED RULES United States Antitrust Laws, Immunity, and Liability under Marketing Order Programs, 25969-25970 2015-10447 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Farm Service Agency See Food Safety and Inspection Service See National Institute of Food and Agriculture See Natural Resources Conservation Service See Rural Utilities Service RULES Final Affordability Determination Energy Efficiency Standards, 25901-25924 2015-10380 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 25995 2015-10529 Animal Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: User Fee Regulations, 25995-25996 2015-10531 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26051-26056 2015-10541 2015-10542 2015-10543 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Programs:
Changes to the Requirements for Part D Prescribers, 25958-25966 2015-10545 Commerce Commerce Department See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration Defense Department Defense Department See Engineers Corps See Navy Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26008-26010 2015-10509 2015-10510 2015-10513 Education Department Education Department NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Migrant Student Information Exchange, 26011-26012 2015-10514 Meetings: The Historically Black Colleges and Universities Capital Financing Advisory Board, 26012 2015-10596 Employee Benefits Employee Benefits Security Administration NOTICES Meetings: Advisory Council on Employee Welfare and Pension Benefit Plans, 26094-26095 2015-10369 Energy Department Energy Department See Federal Energy Regulatory Commission Engineers Engineers Corps NOTICES Environmental Impact Statements;
Availability, etc.: Gray's Beach Restoration Project, Waikiki, Island of Oahu, HI; Withdrawal, 26010 2015-10618 Environmental Protection Environmental Protection Agency RULES Pesticide Tolerances: Fenazaquin, 25953-25958 2015-10375 Tolerance Requirements; Exemptions: 1-Octanol, 25950-25953 2015-10364 Bacillus thuringiensis Cry1A.105 Protein in Soybean, 25946-25950 2015-10624 Defensin Proteins derived from spinach in Citrus Plants, 25943-25946 2015-10486 NOTICES California State Nonroad Engine Pollution Control Standards:
Small Off-Road Engines, 26041-26046 2015-10610 Spark Ignition Marine Engine and Boat Regulations, 26032-26041 2015-10632 Pesticide Product Registrations: Applications for New Active Ingredients, 26031-26032 2015-10368 Applications for New Uses, 26030-26031 2015-10483 Preliminary Designation of Certain Stormwater Discharges in the State of New Mexico, 26030 2015-10617 Farm Service Farm Service Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Request for Aerial Photography, 25996-25997 2015-10606 Federal Communications Federal Communications Commission PROPOSED RULES 911 Call-Forwarding Requirements for Non-Service-Initialized Phones, 25977-25989 2015-10472 Modernizing Common Carrier Rules, 25989-25994 2015-10470 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26046-26048 2015-10602 2015-10603 Meetings: Technological Advisory Council, 26048 2015-10370 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: National Fire Department Census, 26071-26072 2015-10525 Flood Hazard Determinations, 26074 2015-10536 Flood Hazard Determinations; Changes, 26070-26071, 26074-26084 2015-10532 2015-10533 2015-10534 2015-10535 Flood Hazard Determinations; Proposals, 26066-26070, 26072-26074 2015-10522 2015-10524 2015-10537 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Pacific Gas and Electric Co., 26012-26013, 26017-26018, 26022 2015-10562 2015-10564 2015-10573 TransCanada Hydro Northeast, Inc., 26021-26022 2015-10574 Combined Filings, 26026-26029 2015-10568 2015-10576 Environmental Assessments;
Availability, etc.: National Fuel Gas Supply Corp. and Empire Pipeline, Inc.; Northern Access 2016 Project, 26015-26017 2015-10557 Rockies Express Pipeline LLC REX Zone 3 Capacity Enhancement Project, 26024-26026 2015-10558 Sacramento Municipal Utility District Upper American River Hydroelectric Project, 26018 2015-10563 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: 65HK 8me LLC, 26022-26023 2015-10561 67RK 8me LLC, 26019 2015-10560 Arrow Energy RRH, LLC, 26014-26015 2015-10572 Kiyoshi Technologies, LLC, 26014 2015-10571 License Terminations:
Willow Creek Hydro, LLC, 26023-26024 2015-10566 License Transfer Applications: Trafalgar Power, Inc.; Ampersand Forestport Hydro, LLC, 26029-26030 2015-10565 Petitions for Declaratory Orders: Chevron U.S.A. Inc., 26024 2015-10570 Requests under Blanket Authorizations: Northern Natural Gas Co.; Staff Protests; Withdrawal, 26019-26020 2015-10569 Restricted Service Lists: Minneapolis Lease Housing Associates IV, LP, Minnesota A-Mill Artist Lofts Hydroelectric Project, 26014 2015-10567 Staff Attendances, 26018-26019 2015-10577 Technical Conferences PJM Interconnection, LLC;
Comment Requests, 26020-26021 2015-10559 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 26048-26049 2015-10611 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualification of Drivers; Exemption Applications: Diabetes Mellitus, 26133-26139 2015-10608 Vision, 26131-26133, 26139-26142 2015-10604 2015-10605 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26050-26051 2015-10600 Changes in Bank Control:
Acquisitions of Shares of a Bank or Bank Holding Company, 26049 2015-10589 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 26049-26050 2015-10591 Proposals to Engage in or to Acquire Companies Engaged in Permissible Nonbanking Activities, 26049 2015-10590 Federal Trade Federal Trade Commission RULES Rules of Practice, 25940-25943 2015-10517 Fish Fish and Wildlife Service RULES Boating Infrastructure Grant Program, 26150-26174 2015-09961 NOTICES Environmental Impact Statements;
Availability, etc.: Rocky Mountain Arsenal National Wildlife Refuge, Commerce City, CO, Comprehensive Conservation Plan, 26084-26086 2015-10326 Food and Drug Food and Drug Administration NOTICES Guidance: Administrative Applications and the Phased Review Process, 26062-26063 2015-10480 Bioequivalence Recommendations for Clozapine Orally Disintegrating Tablets/Oral, 26063-26064 2015-10478 Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices, 26061-26062 2015-10482 Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications, 26057-26058 2015-10539 Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, 26058-26059 2015-10479 Withdrawal of Guidance Published Before December 31, 2013, 26059-26061 2015-10477 Food Safety Food Safety and Inspection Service NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Consumer Complaint Monitoring System and the Food Safety Mobile Questionnaire, 25997-25998 2015-10607 Foreign Claims Foreign Claims Settlement Commission NOTICES Meetings; Sunshine Act, 26094 2015-11037 General Services General Services Administration PROPOSED RULES General Services Administration Acquisition Regulations: Transactional Data Reporting; Extension of Time for Comments, 25994 2015-10637 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Federal Emergency Management Agency See Transportation Security Administration Housing Housing and Urban Development Department RULES Final Affordability Determination - Energy Efficiency Standards, 25901-25924 2015-10380 Interior Interior Department See Fish and Wildlife Service See National Park Service See Surface Mining Reclamation and Enforcement Office Internal Revenue Internal Revenue Service PROPOSED RULES Qualifying Income from Activities of Publicly Traded Partnerships with Respect to Minerals or Natural Resources, 25970-25977 2015-10592 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 26144-26147 2015-10594 2015-10597 2015-10598 2015-10599 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Circular Welded Non-Alloy Steel Pipe from Mexico, 26003-26004 2015-10623 Large Power Transformers from the Republic of Korea, 26001-26003 2015-10512 Meetings: Renewable Energy and Energy Efficiency Advisory Committee, 26001 2015-10527 International Trade Com International Trade Commission NOTICES Investigations;
Determinations, Modifications, and Rulings, etc.: Television Sets, Television Receivers, Television Tuners, and Components Thereof, 26091-26094 2015-10520 Justice Department Justice Department See Foreign Claims Settlement Commission Labor Department Labor Department See Employee Benefits Security Administration See Occupational Safety and Health Administration National Archives National Archives and Records Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26099 2015-10495 National Credit National Credit Union Administration RULES Chartering and Field of Membership Manual, 25924-25931 2015-10548 Corporate Credit Unions, 25932-25939 2015-10546 National Highway National Highway Traffic Safety Administration NOTICES Buy America Waivers, 26142-26143 2015-10609 National Institute Food National Institute of Food and Agriculture NOTICES Applications:
Veterinary Medicine Loan Repayment Program, 25998-25999 2015-10287 National Institute National Institute of Standards and Technology NOTICES Exclusive Patent Licenses, 26004 2015-10497 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 26064-26065 2015-10496 National Institute of Diabetes and Digestive and Kidney Diseases, 26065 2015-10540 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic:
South Atlantic Gray Triggerfish; Commercial Accountability Measure and Closure, 25966-25967 2015-10595 Fisheries of the Economic Exclusive Zone Off Alaska: Groundfish Fishery by Non-Rockfish Program Catcher Vessels Using Trawl Gear in the Western and Central Regulatory Area of the Gulf of Alaska, 25967-25968 2015-10601 NOTICES NOAA RESTORE Act Science Program Science Plan, 26004-26007 2015-10453 National Park National Park Service NOTICES Environmental Impact Statements; Availability, etc.:
General Management Plan/Wilderness Study, Hawaii Volcanoes National Park, HI, 26086-26089 2015-10528 National Register of Historic Places: Pending Nominations and Related Actions, 26089 2015-10530 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26099-26100 2015-10500 Meetings; Sunshine Act, 26099 2015-10961 National Telecommunications National Telecommunications and Information Administration NOTICES Meetings:
Broadband Opportunity Council Webinar, 26007-26008 2015-10580 National Resources Natural Resources Conservation Service NOTICES Proposed Changes to the National Handbook of Conservation Practices, 25999-26001 2015-10476 Navy Navy Department NOTICES Meetings: U.S. Naval Academy Board of Visitors, 26010-26011 2015-10556 Secretarial Authorization for Navy Department Member to Serve on Board of Directors, Navy-Marine Corps Relief Society, 26011 2015-10578 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Combined Licenses:
Nuclear Innovation North America LLC; South Texas Project, Units 3 and 4, 26104-26105 2015-10492 Exemptions: Duke Energy Florida, Inc., Crystal River Nuclear Generating Plant, Unit 3, 26100-26104 2015-10494 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Expansions of Recognition as a Nationally Recognized Testing Laboratory: Nemko-CCL, 26097-26098 2015-10549 TUV Rheinland of North America, Inc., 26095-26096 2015-10550 TUV SUD America, Inc., 26096-26097 2015-10551 Overseas Overseas Private Investment Corporation NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 26105 2015-10547 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: National Small Business Week (Proc. 9270), 26175-26178 2015-11103 Public Service Recognition Week (Proc. 9271), 26179-26180 2015-11109 Rural Utilities Rural Utilities Service NOTICES Meetings: Broadband Opportunity Council Webinar, 26007-26008 2015-10580 Science Technology Science and Technology Policy Office NOTICES Requests for Information:
Sustained Assessment Process of the U.S. National Climate Assessment, 26105-26106 2015-10352 Securities Securities and Exchange Commission NOTICES Applications: Starboard Investment Trust and Foliometrix, LLC, 26121-26124 2015-10511 Syntax, LLC and Syntax ETF Trust, 26106-26114 2015-10586 TCW Direct Lending, LLC, et al., 26114-26118 2015-10585 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 26124-26127 2015-10505 New York Stock Exchange, LLC, 26118-26121 2015-10503 Options Clearing Corp., 26127-26130 2015-10504 Small Business Small Business Administration NOTICES Disaster Declarations:
New York, 26130 2015-10523 Virginia, 26131 2015-10521 Meetings: Audit and Financial Management Advisory Committee, 26131 2015-10518 Surrender of Licenses: EGL NatWest Equity Partners USA, LP, 26131 2015-10519 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26089-26091 2015-10582 2015-10587 Surface Transportation Surface Transportation Board NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Notifications of Trails Act Agreement and Substitute Sponsorship, 26143-26144 2015-10544 Transportation Department Transportation Department See Federal Motor Carrier Safety Administration See National Highway Traffic Safety Administration See Surface Transportation Board Security Transportation Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Department of Homeland Security Traveler Redress Inquiry Program, 26084 2015-10526 Treasury Treasury Department See Internal Revenue Service NOTICES Final Policy and Procedures for Implementation of the National Environment Policy Act, 26147 2015-10593 Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 26150-26174 2015-09961 Part III Presidential Documents, 26175-26180 2015-11103 2015-11109 Reader Aids Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, 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 87 Wednesday, May 6, 2015 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Docket Numbers AMS-NOP-11-0005; AMS-NOP-11-01] National Organic Program Regulations; Section 610 Review AGENCY:
Agricultural Marketing Service, USDA. ACTION: Confirmation of regulations. SUMMARY: This document summarizes the findings of a USDA Agricultural Marketing Service
(AMS)review of the National Organic Program
(NOP)which is implemented under the Organic Food Production Act (OFPA). The review criteria are stipulated by the Regulatory Flexibility Act (RFA), in section 610. Based upon this review, the AMS has determined that the USDA organic regulations meet the objectives of the OFPA and should continue. Since becoming effective on the October 21, 2002, there have been multiple amendments to the USDA organic regulations. Most of these amendments were additions to or deletions from the National List of Allowed and Prohibited Substances (National List). DATES: Effective May 6, 2015. FOR FURTHER INFORMATION CONTACT: Interested persons may obtain a copy of the review. Requests for a copy of the review should be sent to Jennifer Tucker, Ph.D., Acting Director, Standards Division, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2648-S., Ag Stop 0268, Washington, DC 20250-0268. Telephone:
(202)720-3252, Fax.
(202)205-7808 or email: *Jennifer.Tucker@ams.usda.gov,* or by accessing the Web site at *http://www.ams.usda.gov/nop.* SUPPLEMENTARY INFORMATION: The National Organic Program
(NOP)is authorized by the Organic Foods Protection Act
(OFPA)of 1990, as amended (7 U.S.C. 6501-6522). The USDA Agricultural Marketing Service
(AMS)administers the NOP. Final regulations implementing the NOP 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. The OFPA authorizes the certification and inspection of crop, wild crop, livestock, or handling operations that label, market or represent agricultural products as organic. The OFPA also provides authorization for the NOP to accredit state and private certifying agents to certify organic crop, wild crop, livestock, or handling operations to the USDA organic regulations in the United States and internationally. Since becoming fully effective in 2002, the USDA organic regulations have been frequently amended. Most of these amendments were changes to the National List of Allowed and Prohibited Substances (National List) in 7 CFR 205.601-205.606. This National List identifies the synthetic substances that may be used and the nonsynthetic (natural) 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 NOP regulations, 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 and any nonsynthetic nonagricultural substance used in organic handling appear on the National List. Recommendations to amend the National List are developed by the National Organic Standards Board (NOSB), a 15-member advisory board composed of four organic farmers; two organic handlers; one retailer; three experts in environmental protection and resource conservation; three consumer or public interest group members; one expert in toxicology, ecology, or biochemistry and; one certifying agent representative. The NOSB is organized under the Federal Advisory Committee Act (5 U.S.C. App. 2 *et seq.* ) to assist in the development of standards for substances to be used or not used in organic production and handling, and to advise the Secretary on any other sections of the USDA organic regulations. NOSB members are nominated by the organic community and selected by the Secretary. The OFPA also requires a review of all substances on the National List within 5 years of their addition or renewal. If a substance is not reviewed by the NOSB and renewed through rulemaking by the USDA within the five year period, its allowance or prohibition on the National List is no longer in effect (7 U.S.C. 6517(e)). As of January 2, 2014, there are 27,108 producer and handler operations certified to the USDA organic regulations. Some of these certified operations are certified as “grower groups,” certified as a single entity, but consisting of groups of ten to thousands of small organic producers. The USDA organic regulations, as authorized by the OFPA, are implemented and applied uniformly and are designed to benefit all entities, regardless of size. On March 24, 2006, the AMS published in the **Federal Register** (71 FR 14827), its schedule to review certain regulations, including the NOP, under criteria contained in section 610 of the RFA (5 U.S.C. 601-612). Because many AMS regulations impact small entities, AMS decided, as a matter of policy, to periodically review certain regulations, irrespective of whether specific regulations meet the threshold requirement for mandatory review established by the RFA. A Notice of Regulatory Flexibility Act: Section 610 Review of the USDA organic regulations was published in the **Federal Register** on February 25, 2011 (76 FR 10527). This notice indicated AMS would implement specific criteria contained in section 610 of the RFA during the review of the USDA organic regulations that have a significant effect on a substantial number of small entities to determine whether any effect can be decreased or minimized. The purpose of the review is for AMS to determine whether the USDA organic regulations should be continued without change, amended or rescinded, consistent with the objectives of OFPA, to minimize impact on small entities. The review considered these factors:
(1)The continued need for the regulations;
(2)the nature of complaints or comments received from the public concerning the regulations;
(3)the complexity of the regulations;
(4)the extent to which the regulations overlap, duplicate, or conflict with other Federal rules, and, to the extent feasible, with State and local government rules; and
(5)the length of time since the regulations have been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations. The notice invited the general public and interested parties to submit written comments on the impact of the regulations on small business. In response to this notice, the NOP received written comments from five organic producers (two crop, one wild crop, and two livestock), three accredited certifying agents, three handlers (an ingredient supplier, a retailer, and a beverage association), two consumers, and an organic business consultant, for a total of fourteen comments. Of the fourteen comments received, eight commenters specifically addressed the need for the regulations to continue, and not be terminated or rescinded. Five additional commenters proposed amendments or made recommendations about issues for the NOP to consider. One commenter stated that certification of organic products was unfair because of time commitment and expense. This commenter alternatively proposed that conventional operations should be certified to assess inputs used on these operations. Nine commenters described their concerns with the program or described concerns regarding the regulations. Eight commenters specifically addressed the complexity of the regulations either by indicating that the complexity of the regulations can be problematic at times, or that a significant level of complexity is needed to ensure organic product integrity. There were five comments on whether the regulations overlap, duplicate, or conflict with other Federal, State or Local government regulation. Four commenters specifically addressed the RFA section 610 review criteria regarding impacts on small entities as a result of changes in technology, economic conditions, or other factors that may have impacted an area affected by the regulations since the regulations became effective on October 21, 2002. One commenter, a certifying agent, addressed all of the factors considered in the RFA section 610 review of the USDA organic regulations. Most of the commenters addressed three out of five of the review factors. Comments are categorically grouped and discussed below. Comments from organic producers supported continuation of the regulations, but some did include concerns with the program or included proposed amendments for improving it. An organic seed producer expressed support for the continuation of the regulations, but suggested that NOP has not adequately enforced the requirement for the use of organic seed when commercially available as required by 7 CFR 205.204(a). This commenter also suggested that some certifying agents may be routinely allowing the use of non-organic seed, even though high quality organic seed is available in commercial quality and quantity. The commenter requested increased enforcement of the organic seed regulation requirements to ensure organic seed is being utilized by organic producers. In response to comments received at public meetings, the NOSB provided the NOP with recommendations that outlined concepts and procedures for determining commercial availability of organic seeds and planting stock. In response, the NOP published final guidance NOP 5029: Seeds, Annual Seedlings, and Planting Stock in Organic Crop Production, in the NOP Program Handbook on February 28, 2013. 1 This guidance describes practices for certified operations to use to obtain all organic seeds, annual seedlings, and planting stock in support of their organic production. The guidance also describes the responsibilities of organic operations and certifying agents for sourcing organic seeds and planting stock and emphasizes the utilization of organic seed is a requirement of the regulations. 1 NOP final guidance, instructions, and policy memos can be found in the NOP Program Handbook, available on the NOP Web site at: *http://www.ams.usda.gov/NOPProgramHandbook.* A certified organic fruit producer commented on being prevented from using an organic label claim on his organic fruit alcohol product because of added sulfites. The commenter stated that because of the restriction with added sulfites limited for use with only organic grapes, a “made with organic. . .” claim could not be used on the product label. On October 31, 2011, the NOP published Policy Memo 10-2: Sulfur Dioxide in wine made with organic fruit, in the Program Handbook. 2 This policy memo stipulates that added sulfites, as sulfur dioxide, can only be used in organic wine made from organic grapes as specified on the National List in § 205.605(b). The allowance for sulfur dioxide on the National List limits the use of sulfur dioxide to only wine made with organic grapes and can only be labeled as “made with organic grapes.” Changing the allowance of sulfur dioxide in organic wine can be considered through submission of a National List petition to amend the annotation, and subsequent rulemaking to amend the regulations. As per 7 CFR 205.607 of the USDA organic regulations, any person may submit a petition to change or amend the National List according to petition procedures published on January 18, 2007 (72 FR 2167). 3 2 *Ibid.* 3 Notice of Guidelines on Procedures for Submitting National List Petitions, January 18, 2007, available on the NOP Web site: *http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateN&navID=NationalOrganicProgram&leftNav=NationalOrganicProgram&page=NOPFilingaPetition&description=Filing%20a%20Petition* . An organic wild crop producer supported continuation of the regulations, concluding there is an ongoing need for Federal regulation and oversight of the term “organic” as it applies to all products being produced and handled organically. The commenter also stated accredited certifying agents should ensure that organic livestock producers are providing organic livestock with organic feed ingredients. The commenter specifically mentioned organic wild harvested kelp. The commenter claimed ensuring the feeding of organic kelp would enhance his organization's opportunity to develop and maintain additional certified organic wild crop harvesting sites for kelp, and would support the growth of the business. On February 28, 2013, the NOP published guidance document NOP 5057: The Use of Kelp in Organic Livestock Feed. 4 This guidance establishes that kelp may be certified organic as a wild crop under 7 CFR 205.207 and must be certified organic if used as an ingredient in livestock feed per § 205.237. The guidance applies to all NOP certifying agents that certify kelp and certified organic operations that feed kelp to organic livestock. 4 NOP 5057: The Use of Kelp in Organic Livestock Feed, available in the NOP Program Handbook on the NOP Web site at: *http://www.ams.usda.gov/NOPProgramHandbook.* A small livestock producer requested the program increase the $5,000 exemption limit for organic certification. There is an exemption from certification for organic producers and handlers who sell less than $5,000 in organic agricultural products per year (7 U.S.C. 6505; 7 CFR 205.101(a)). The livestock producer pointed out that the OFPA was passed in 1990, and the $5,000 limit has been subject to inflation since 1990. This commenter proposed that the small operation exemption be raised to $10,000 or $20,000. Since the $5,000 exemption from certification is a specific OFPA requirement, an increase in the exemption amount must be enacted through Congress and cannot be amended through the regulatory process. A veterinarian, who also is an organic egg producer, supports the NOP, stating there is a good system of certifiers and inspectors in place. However, this commenter expressed concern with changes in poultry health care practices and living condition standards being advocated by some organizations. The comments addressed issues on poultry access to pasture, animal behavior, bird stocking rate, age of bird, and temporary confinement. According to the commenter, changes in the organic standards on these issues should be based upon scientific merit, and not on human desires and social interactions. During NOSB deliberations, the NOSB considered technical information on livestock practice standards. In 2009 and 2011, the NOSB forwarded several recommendations on establishing more specific animal welfare requirements. These recommendations addressed issues on animal handling and transport and animal welfare, including stocking rates and livestock health care. The NOP is currently evaluating these recommendations to determine how to effectively process these recommendations through rulemaking. Three accredited certifying agents provided comments in support of continuation of the regulations. A small accredited certifying agent commented on the burden of the expense of the periodic USDA-required accreditation audits on small organic certifiers and requested that audit fees should be scaled upon the size of the certifier. The two larger certifying agents also commented on the paperwork burden on operations seeking certification or continuing with certification. One certifying agent affirmed the need for regulations as critical to assure integrity and maintain consumer confidence in the organic industry. However, comments received from clients regarding the regulations were mostly concerned with the amount of paperwork required for recordkeeping, which some considered to be excessive and burdensome. This certifying agent stated there is a need to streamline paperwork and recordkeeping requirements for all organic operations. Another certifying agent also addressed the burden faced by certified operations, specifically organic dairy operations complying with pasture practice standards. This commenter stated that the pasture practice standards rule (75 FR 7154) was not needed, was excessively complex, would cause significant adverse effects for many small farms, and would be difficult for certifying agents to effectively implement. The NOP is aware of the commenter's concerns and notes that the pasture practice standards were developed over a period of five years with input of multiple stakeholders. There were a significant number of oral and written responses submitted during public comment periods associated with the development of this rule. The majority of commenters, including many dairy operations, supported the addition of detailed pasture practice standards. During NOP trainings for accredited certifying agents conducted in 2012 and 2013, the NOP received statements from certifying agents on farmers reporting that they are spending too much of their time completing program forms and maintaining program records. As required in 7 CFR 205.103, recordkeeping is essential to ensure organic operations are implementing required organic practice standards. The NOP has considered how to minimize the regulatory burden when implementing the regulations. As a result, the NOP began implementing an initiative in 2013 to identify and remove barriers to certification, to streamline the certification process, to focus enforcement activities, and to work with organic producers and handlers to correct small issues before they become larger issues. When developing this initiative, the NOP outlined five objectives:
(1)Develop efficient processes by eliminating bureaucratic processes that do not contribute to organic integrity;
(2)streamline recordkeeping requirements to ensure that required records support organic integrity and are not a barrier for farms and businesses to maintain organic compliance;
(3)apply common sense to an operation's organic system plans that clearly capture organic practices;
(4)implement fair and focused enforcement; and
(5)maintain or improve organic integrity by focusing on factors that impact organic integrity. The NOP continues to work with certifying agents to implement these objectives with regard to the recordkeeping and reporting requirements for certifying agents and organic producers and handlers. Three organic handlers commented on the RFA Section 610 review. An ingredient processor submitted a comment requesting clarification on why non-organic ethanol is not permitted in the U.S. for use in processing organic products. The processor stated that their product, processed with ethanol, was marketed with an organic label in the European Union (EU), where ethanol is allowed for organic processing in the EU regulations. In the U.S., ethanol is available in certified organic, natural, and synthetic forms. The use of certified organic ethanol would be permitted in the production of the processor's product under the USDA organic regulations. Non-organic ethanol is allowed for use in organic crop and livestock production as a sanitizer. Non-organic ethanol cannot be used in organic processing under the USDA organic regulations since it is not included on the National List in either 7 CFR 205.605 or 7 CFR 205.606. Use of non-organic ethanol in organic processing requires amendment of the National List through the petition process to include non-organic ethanol on the National List, and subsequent rulemaking. A beverage association comment disagreed with Alcohol, Tobacco Tax, and Trade Bureau
(TTB)labeling requirements for wine that requires approval for changes to a vintage year on an organic wine label that was previously approved. This requirement is outside of the scope of the USDA organic regulations. The TTB reviews and approves wine labels, including any requirements for changing the vintage year. Under a Memorandum of Understanding between AMS and TTB, the TTB receives, reviews, and approves or rejects labeling applications for alcohol products bearing an organic claim. TTB has informed the NOP of their change in the TTB list of the allowable revisions that may be made to an approved label without the need for resubmission contained on the TTB Application for and certification of label/bottle approval. TTB removed the caveat that the change in vintage dates did not apply to organic products. A comment from an organic co-operative retailer supported the continued need for the regulations. The commenter gave a description of the positive impacts of the complexity of the regulation on their business, and emphasized that the regulations do not overlap, duplicate, or conflict with other Federal, state or local rules for the operation. A comment from a consumer claimed that certification requirements for organic operations are unfair because nonorganic operations are not required to disclose to the public the uses of harmful substances. All food products in the normal stream of commerce are subject to Federal, state, and local laws and regulatory requirements that contribute to maintaining food safety and restrict or prohibit the use of harmful substances. Another consumer comment expressed support for continuation of the regulations. This commenter chooses organic products to assure that the food is raised humanely and without synthetic ingredients. However, the commenter also expressed concern that the regulations may be more burdensome to small dairy operations. As noted in prior discussion, the NOP started an initiative on 2013 to reduce the regulatory burden on organic operations. An organic agricultural business expressed strong support for continuation of the regulations. This commenter stated that the regulations need to be routinely amended since organic production is based upon a concept of continual improvement, and the regulation should adhere to this principle. Such amendments should take into account innovations and improvements by organic practitioners. The commenter proposed several amendments to the regulations, some of these proposed amendments were identified as opportunities to decrease regulatory complexity and reduce regulatory burden without sacrificing organic integrity or compromise consumer confidence. A summary of these proposed amendments include: • The NOP should prohibit blending of organic and non-organic forms of the same ingredient in “made with organic” products. On May 2, 2014, the NOP published final guidance NOP 5032: Products in the “made with Organic * * * Labeling Category to address this issue. 5 This guidance describes requirements for products in the “made with organic (specified ingredients or food group(s))” category. This guidance clarifies product composition, labeling claims, use of organic and nonorganic forms of the same ingredient, percentage of organic ingredient statements, and ingredients or food groups in the “made with organic * * *” claim. 5 NOP 5032: Products in the “made with Organic * * * Labeling Category, available in the NOP Program Handbook on the NOP Web site at: *http://www.ams.usda.gov/NOPProgramHandbook.* • The regulations should allow the use of non-synthetic substances allowed for use in crop production to control pest infestation in post-harvest handling pest control when preventive practices are ineffective. On April 25, 2014, the NOP published draft guidance, NOP 5023: Substances Used in Post-Harvest Handling of Organic Products. 6 This draft guidance describes substances that may be used in post-harvest handling of organic products. The guidance clarifies:
(1)What substances may be used;
(2)the difference between post-harvest handling of raw agricultural crops and further processing; and
(3)the provisions for facility pest management. 6 Draft Guidance NOP 5023: Substances Used in Post-Harvest Handling of Organic Products. NOP draft guidance can be found on the NOP Web site at: *http://www.ams.usda.gov/NOPDraftGuidance.* • The NOP should amend 7 CFR 205.237(a) to allow commercial availability to be applied to minor agricultural ingredients fed to organic livestock to alleviate burden on small organic livestock producers. On February 28, 2013, the NOP published NOP 5030, Evaluating Allowed Ingredients and Sources of Vitamins and Minerals For Organic Livestock Feed. 7 This guidance clarifies the agricultural, nonsynthetic, and synthetic ingredients permitted in organic livestock feed and also addresses the feed supplements and feed additives that must be reviewed for compliance with regulations. Under the USDA organic regulations, organic producers must provide livestock feed pursuant to 7 CFR 205.237. Section 205.237 states that agricultural ingredients included in the ingredients list for livestock feed products must be organically produced. 7 NOP 5030: Evaluating Allowed Ingredients and Sources of Vitamins and Minerals For Organic Livestock Feed, available in the NOP Program Handbook on the NOP Web site at: *http://www.ams.usda.gov/NOPProgramHandbook.* • The NOP should amend the National List petition procedures and processes as they are complicated, costly, lengthy, arbitrary, and may not provide due process to the petitioners. In May 2014, the NOP in collaboration with the NOSB initiated a process to revise National List petition procedures in an effort to make the petition submission procedures clearer for petitioners. The revised procedures will clarify how to submit complete petitions, explain to petitioners what to expect in the petition process, and make the review process for the NOSB clearer and more consistent. • The NOP should increase collaboration between NOP and other government agencies with authority related to organic agricultural production. Historically, NOP has established and maintained collaborative interactions with the U.S. Food and Drug Administration
(FDA)on organic food processing and handling and livestock healthcare products and feed ingredients; with the U.S. Environmental Protection Agency
(EPA)on pest control ingredients and applications; with TTB on labeling of organic alcohol beverages; and with the Federal Trade Commission on product labeling. As part of these interactions, NOP continues to collaborate regarding agricultural products that fall within the scope of organic certification. • The NOP should alter restrictions on the use of plastic mulch (§ 205.601(b)(2)(ii)) so that biodegradable plastic mulch could remain on the soil beyond harvest or end of the growing season. The commenter indicated there is no listing for mulch made from biodegradable plastic on the National List, and a petition would have to be submitted to add this new material. In August 2013, the NOP published proposed rule (78 FR 52100), based upon NOSB recommendations, which would add a new definition for biodegradable biobased mulch film to 7 CFR 205.2 and add biodegradable biobased mulch film to the National List in 7 CFR 205.601 for use in organic crop production. 8 8 National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops and Processing); Proposed rule; Available on the NOP Web site: *http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5104847* Upon the completion of the RFA Section 610 review of the USDA organic regulations, AMS has determined that there is no critical need to amend the regulations. Since becoming effective on the October 21, 2002, there have been multiple amendments of the regulations, mostly to the National List. Some of these amendments have reduced the burden on small operations, while some amendments, that have served to protect organic integrity and support consumer confidence, may have increased the burden on small operations. Based on the findings from the review, AMS has determined that the NOP is not overly complex and does not significantly overlap, or conflict with other regulations. Based upon the review, AMS has determined that the NOP should continue. The USDA organic regulations are dynamic in nature and the NOP continues to collaborate with the NOSB and the organic community on rulemaking and development of guidance documents, such as recently published rulemaking on pesticide residue testing, and published guidance on composting, wild crop harvesting, handling unpackaged organic goods, and the list of permitted substances for crops. Authority: 7 U.S.C. 6501-6522. Dated: April 30, 2015. Rex A. Barnes, Associate Administrator, Agricultural Marketing Service. [FR Doc. 2015-10446 Filed 5-5-15; 8:45 am]
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15 references not yet in our index
- 7 CFR 205
- 7 USC 6501-6522
- 7 CFR 205.601-205
- 5 USC 601-612
- 7 CFR 205.204(a)
- 7 CFR 205.607
- 7 CFR 205.207
- 7 CFR 205.101(a)
- 7 CFR 205.103
- 7 CFR 205.605
- 7 CFR 205.606
- 7 CFR 205.237(a)
- 7 CFR 205.237
- 7 CFR 205.2
- 7 CFR 205.601
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Cite7 USC 6501-6522
Cite7 CFR 205.601-205
Cite5 USC 601-612
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