Unknown. Interim rule with request for comments

5,795 words·~26 min read·/register/2012/09/27/2012-23748

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2012-09-27.xml --- 77 188 Thursday, September 27, 2012 Contents Agricultural Marketing Agricultural Marketing Service RULES National Organic Program (NOP); Sunset Review

(2012)for Nutrient Vitamins and Minerals, 59287-59291 2012-23748 Agriculture Agriculture Department See Agricultural Marketing Service See Food Safety and Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2012-23795 59372-59373 2012-23797 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Privacy Act; Systems of Records, 59386-59388 2012-23756 Children Children and Families Administration RULES State Plan Approval and Grant Procedures; CFR Correction, 59339 2012-23893 Coast Guard Coast Guard NOTICES Findings of Equivalence: Alternate Pressure Relief Valve Settings on Certain Vessels Carrying Liquefied Gases in Bulk, 59408-59409 2012-23772 Commerce Commerce Department See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 59373 2012-23761 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 59452-59453 2012-23745 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 59389 2012-23966 Defense Acquisition Defense Acquisition Regulations System RULES Acquisitions of Commercial Items; CFR Correction, 59339 2012-23917 Contracting by Negotiation; CFR Correction, 59343-59344 2012-23944 Contractor Qualifications; CFR Corrections, 59339 2012-23905 Patents, Data, and Copyrights; CFR Correction, 59339 2012-23925 Publicizing Contract Actions; CFR Correction, 59339 2012-23901 Defense Department Defense Department See Defense Acquisition Regulations System Education Department Education Department RULES Federal Student Aid Programs, 59311-59318 2012-23831 Employee Benefits Employee Benefits Security Administration NOTICES Meetings: Advisory Council on Employee Welfare and Pension Benefit Plans, 59420 2012-23744 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pell Grants and the Payment of Unemployment Benefits to Individuals in Approved Training, 59420-59421 2012-23810 Energy Department Energy Department See Federal Energy Regulatory Commission Environmental Protection Environmental Protection Agency RULES Approvals and Promulgations of Implementation Plans: North Carolina; Approval of Rocky Mount Supplemental Motor Vehicle Emissions Budget Update, 59335-59338 2012-23716 Revisions to Nevada State Implementation Plan; Stationary Source Permits, 59321-59335 2012-23121 National Oil and Hazardous Substances Pollution Contingency Plan National Priorities List, 59338-59339 2012-23819 Regulation of Fuels and Fuel Additives: 2013 Biomass-Based Diesel Renewable Fuel Volume, 59458-59485 2012-23344 PROPOSED RULES Approvals and Promulgations of Implementation Plans: North Carolina; Approval of Rocky Mount Supplemental Motor Vehicle Emissions Budget Update, 59356-59357 2012-23717 NOTICES Meetings: SFIREG EQI Working Committee, 59396 2012-23824 Executive Office of the President See Presidential Documents Export Import Export-Import Bank NOTICES Application for Final Commitment for a Long-term Loan or Financial Guarantee in Excess of $100 million; 25 Day Comment Period, 59396-59397 2012-23781 Economic Impact Policy, 59397 2012-23866 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Registration of Mortgage Loan Originators, 3064-0171, 59397-59398 2012-23780 Federal Energy Federal Energy Regulatory Commission PROPOSED RULES Revisions to Page 700 of FERC Form No. 6, 59348-59354 2012-23807 NOTICES Applications: Hawks Nest Hydro, LLC, 59389-59390 2012-23805 Combined Filings, 59390-59391 2012-23785 2012-23786 Complaints: Delta Air Lines, Inc., et. al, v. Buckey Pipe Line Company, L.P., 59391 2012-23787 Environmental Assessments; Availability, etc.: Transcontinental Gas Pipe Line Company, LLC, Brandywine Creek Replacement Project, 59391-59393 2012-23803 Meetings: Jordan Cove Energy Project LP, Jordan Cove Energy Project LP, 59393-59394 2012-23808 Preliminary Permit Applications: Wills Creek Hydro, LLC, 59394-59395 2012-23802 Proposed Study Plan and the Revised Study Plan for the Susitna-Watana; Correction, 59395 2012-23809 Records Governing Off-the-Record Communications, 59395 2012-23784 Revised Restricted Service List for Programmatic Agreements: Grand River Dam Authority, Oklahoma Salina Pumped Storage Project, 59395-59396 2012-23804 Federal Financial Federal Financial Institutions Examination Council NOTICES Appraisal Subcommittee; Proposed Policy Statements, 59398-59399 2012-23782 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualifications of Drivers: Exemption Applications; Diabetes Mellitus, 59447-59451 2012-23759 2012-23760 Federal Trade Federal Trade Commission RULES Rules of Practice, 59294-59311 2012-23691 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants: 12-Month Finding on a Petition To List Spring Mountains Acastus Checkerspot Butterfly as an Endangered or Threatened Species, 59357-59371 2012-23739 Endangered Status for Grotto Sculpin and Designation of Critical Habitat, 59488-59515 2012-23742 Mount Charleston Blue Butterfly as Endangered and Five Blue Butterflies as Threatened Due to Similarity of Appearance, 59518-59540 2012-23747 NOTICES Comprehensive Conservation Plans: Great Bay National Wildlife Refuge, Rockingham County, NH, 59412-59414 2012-23799 Enhancements of Survival Permits; Safe Harbor Agreements: Marys River Ranch, Elko County, NV, 59414-59415 2012-23783 Food and Drug Food and Drug Administration NOTICES Determination That ENDURON (methyclothiazide) Tablets and Six Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 59403-59404 2012-23779 Public Workshops: Food Defense, 59404-59405 2012-23778 Food Safety Food Safety and Inspection Service RULES Additional Changes to the Schedule of Operations Regulations, 59291-59294 2012-23682 Foreign Trade Foreign-Trade Zones Board NOTICES Applications for Reorganization Under Alternative Site Framework: Foreign-Trade Zone 72, Indianapolis, IN, 59373-59374 2012-23827 Withdrawal of Production Notification: Brightpoint North America LP, Foreign-Trade Zone 126, Reno, NV, 59374 2012-23823 General Services General Services Administration NOTICES Meetings: Presidents Management Advisory Board, 59399 2012-23750 Health and Human Health and Human Services Department See Children and Families Administration See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 59399-59402 2012-23773 2012-23774 2012-23776 Supplemental Fundings for Cooperative Agreements: New Mexico Department of Health, Office of Border Health; Arizona Department of Health Services, Office of Border Health, etc., 59402-59403 2012-23722 Homeland Homeland Security Department See Coast Guard See U.S. Citizenship and Immigration Services See U.S. Customs and Border Protection NOTICES Meetings: Homeland Security Science and Technology Advisory Committee, 59407-59408 2012-23821 Industry Industry and Security Bureau NOTICES Meetings: Emerging Technology And Research Advisory Committee, 59374 2012-23754 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 59453-59456 2012-23724 2012-23725 2012-23727 2012-23728 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Comment Request for Form 8281, 59456 2012-23737 International Trade Adm International Trade Administration NOTICES Antidumping Duty Administrative Reviews; Results, Extensions, Amendments, etc.: Certain Small Diameter Carbon and Alloy Seamless Standard, Line and Pressure Pipe Under 4.5 Inches From Japan, 59374-59375 2012-23835 Sodium Hexametaphosphate From the People's Republic of China, 59375-59377 2012-23832 Antidumping Duty Orders; Sunset Reviews; Results, Extensions, Amendments, etc.: Solid Agricultural Grade Ammonium Nitrate From Ukraine, 59377 2012-23828 Labor Department Labor Department See Employee Benefits Security Administration See Employment and Training Administration See Veterans Employment and Training Service NOTICES 2012 Update to Department of Labor's List of Goods From Countries Produced by Child Labor or Forced Labor, 59417-59418 2012-23402 Initial Determinations Revising List of Products Requiring Federal Contractor Certifications: Forced/Indentured Child Labor Pursuant to Executive Order 13126, 59418-59420 2012-23395 Land Land Management Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 59415-59416 2012-23811 Meetings: Front Range Resource Advisory Council, 59416 2012-23796 NASA National Aeronautics and Space Administration RULES Cross Waivers of Liability Clauses, 59339-59343 2012-23715 National Credit National Credit Union Administration PROPOSED RULES Payday-Alternative Loans, 59346-59348 2012-23718 National Institute National Institutes of Health NOTICES Meetings: National Cancer Institute, 59406 2012-23753 National Institute on Alcohol Abuse and Alcoholism, 59405-59406 2012-23752 National Institute on Deafness and Other Communication Disorders, 59405 2012-23751 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: 2012 Commercial Accountability Measure and Closure for South Atlantic Vermilion Snapper, 59344 2012-23815 NOTICES Takes of Marine Mammals Incidental to Specified Activities: Seabird and Pinniped Research Activities in Central California, 2012-2013, 59377-59386 2012-23820 National Park National Park Service NOTICES Meetings: National Park System Advisory Board, 59416-59417 2012-23812 Nuclear Regulatory Nuclear Regulatory Commission PROPOSED RULES Environmental Qualifications of Electrical Equipment, 59345-59346 2012-23792 Presidential Documents Presidential Documents PROCLAMATIONS Chimney Rock National Monument; Establishment (Proc. 8868), 59275-59281 2012-23863 Special Observances: National Historically Black Colleges and Universities Week (Proc. 8869), 59283-59284 2012-23868 National Hunting and Fishing Day (Proc. 8870), 59285-59286 2012-23872 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., 59425-59427 2012-23765 Chicago Board Options Exchange, Inc., 59444-59446 2012-23764 EDGA Exchange, Inc, 59441-59442 2012-23768 EDGX Exchange, Inc., 59429-59431 2012-23769 Municipal Securities Rulemaking Board, 59427-59429 2012-23767 NYSE MKT LLC, 59423-59425, 59442-59444 2012-23763 2012-23766 Options Clearing Corp., 59431-59439 2012-23816 The NASDAQ Stock Market LLC, 59439-59441 2012-23798 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 59447 2012-23735 Interest Rates, 59447 2012-23732 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 59406-59407 2012-23788 Fiscal Year 2012 Funding Opportunity, 59407 2012-23817 Surface Transportation Surface Transportation Board NOTICES Abandonment Exemptions: Pickens Railway Co., Pickens County, SC, 59451-59452 2012-23757 Transportation Department Transportation Department See Federal Motor Carrier Safety Administration See Surface Transportation Board Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application to Register Permanent Residence or Adjust Status, Form I-485 and Supplements A, C, and E, 59409-59410 2012-23814 National Interest Waivers, Supplemental Evidence to I-140 and I-485, 59410-59411 2012-23813 Customs U.S. Customs and Border Protection NOTICES Quarterly IRS Interest Rates Used in Calculating Interest: Overdue Accounts and Refunds on Customs Duties, 59411-59412 2012-23822 Veteran Affairs Veterans Affairs Department RULES Removal of 30-Day Residency Requirement for Per Diem Payments, 59318-59320 2012-23775 PROPOSED RULES Removal of 30-Day Residency Requirement for Per Diem Payments, 59354-59356 2012-23777 Veterans Employment Veterans Employment and Training Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Vocational Rehabilitation and Employment Tracking Report, etc., 59421-59423 2012-23836 Separate Parts In This Issue Part II Environmental Protection Agency, 59458-59485 2012-23344 Part III Interior Department, Fish and Wildlife Service, 59488-59515 2012-23742 Part IV Interior Department, Fish and Wildlife Service, 59518-59540 2012-23747 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. 77 188 Thursday, September 27, 2012 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-10-0083; NOP-10-09IR] RIN 0581-AD17 National Organic Program (NOP); Sunset Review

(2012)for Nutrient Vitamins and Minerals AGENCY: Agricultural Marketing Service, USDA. ACTION: Interim rule with request for comments. SUMMARY: This interim rule addresses a recommendation submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board

(NOSB)on April 29, 2011. This recommendation pertains to the 2012 Sunset Review for the exemption

(use)of nutrient vitamins and minerals in organic handling on U.S. Department of Agriculture's

(USDA)National List of Allowed and Prohibited Substances (National List). On January 12, 2012, AMS published a proposed rule on the 2012 Sunset Review which proposed to continue the exemption

(use)for nutrient vitamins and minerals on the National List for 5 years after its October 21, 2012 sunset date. The proposed rule also proposed to correct an inaccurate cross reference to U.S. Food and Drug Administration

(FDA)regulations in the listing for vitamins and minerals on the National List. AMS continues to review the public comments on the proposed rule and assess the extent of impacts on the industry that could result from correcting the cross reference to FDA regulations. Therefore, due to the impending sunset of the allowance for nutrients vitamins and minerals from the National List on October 21, 2012, and based on the NOSB recommendation, this interim rule renews, without change, the exemption

(use)for nutrient vitamins and minerals on the National List. This interim rule provides for the continued use of nutrients vitamins and minerals in organic products until the agency completes the January 12, 2012, rulemaking. DATES: *Effective Date:* This interim rule becomes effective October 21, 2012. All comments received by December 26, 2012 will be considered prior to the issuance of a final rule. ADDRESSES: Interested persons may submit written comments on this interim rule using the following addresses: • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • *Mail:* Toni Strother, Agricultural Marketing Specialist, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2646-So., Ag Stop 0268, Washington, DC 20250. *Instructions:* All submissions received must include the docket number AMS-NOP-10-0083; NOP-10-09IR, and/or Regulatory Information Number

(RIN)0581-AD17 for this rulemaking. All comments received will be posted without change to *http://www.regulations.gov.* *Docket:* For access to the docket to read background documents or comments received, go to *http://www.regulations.gov.* Comments submitted in response to this interim rule will also be available for viewing in person at USDA-AMS, National Organic Program, 1400 Independence Ave. SW., Room 2646-South Building, Washington, DC, from 9 a.m. to 12 noon and from 1 p.m. to 4 p.m., Monday through Friday, (except official Federal holidays). Persons wanting to visit the USDA South Building to view comments received in response to this proposed rule are requested to make an appointment in advance by calling

(202)720-3252. FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, Standards Division, Telephone:

(202)720-3252; Fax:

(202)205-7808. SUPPLEMENTARY INFORMATION: I. Background The Organic Foods Production Act of 1990

(OFPA)(7 U.S.C. 6501-6522), authorizes the establishment of the National List. The National List identifies synthetic substances that are exempted (allowed) in organic production and nonsynthetic substances that are prohibited in organic crop and livestock production. The National List also identifies nonagricultural nonsynthetic, nonagricultural synthetic and nonorganic agricultural substances that may be used in organic handling. The exemptions and prohibitions granted under the OFPA are required to be reviewed every 5 years by the National Organic Standards Board (NOSB). The Secretary has authority under the OFPA to renew such exemptions and prohibitions. If the substances are not reviewed by the NOSB within 5 years of their inclusion on the National List and addressed by the Secretary, then their authorized use or prohibition expires under OFPA's sunset provision. On March 26, 2010, the National Organic Program

(NOP)published an Advance Notice of Proposed Rulemaking

(ANPR)to announce the pending sunset of substances on the National List and opened the public comment process on whether existing exemptions for specified synthetic and nonsynthetic substances in organic handling should be continued (75 FR 14500). 1 The ANPR indicated that the exemption for the use of nutrient vitamins and minerals as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s))” would expire after October 21, 2012, if the listing was not renewed. The public comment period lasted 60 days. Comments were received from organic handlers, ingredient suppliers and trade associations. Comments received supported the continued listing of nutrient vitamins and minerals in organic handling. The written comments can be retrieved at *http://www.regulations.gov* by searching for the document ID number: AMS-NOP-09-0074. The NOP provided the NOSB with these public comments to consider in their deliberations on the status of nutrient vitamins and minerals in organic products after the 2012 sunset date. 1 The Sunset 2012 ANPR also pertained to the exemptions for synthetic substances and prohibitions for nonsynthetic substances used in crop and livestock production. At their April 2011 public meeting, the NOSB approved a recommendation to renew the listing for nutrient vitamins and minerals after its October 21, 2012 sunset date. Their recommendation stated that the listing should be renewed as codified at 7 CFR 205.605(b): “Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality Guidelines for Foods”. 2 In addition to the ANPR for Sunset 2012 published on March 26, 2010, the NOSB received additional public comment concerning the pending sunset of this listing in response to three **Federal Register** notices announcing meetings of the NOSB and its planned deliberations on recommendations involving Sunset 2012 substances. The notices were published in the **Federal Register** as follows: March 17, 2010 (75 FR 12723), September 20, 2010 (75 FR 57194), and March 4, 2011 (76 FR 12013). The NOSB received further written and oral testimony concerning nutrient vitamins and minerals at all three of these public business meetings which occurred in Woodland, CA on April 26-29, 2010, in Madison, WI on October 25-28, 2010, and in Seattle, WA on April 26-29, 2011. The written comments can be retrieved via *http://www.regulations.gov* by searching for the document ID numbers: AMS-NOP-10-0021 (May 2010 meeting); AMS-NOP-10-0068 (October 2010 meeting); and AMS-NOP-11-05 (April 2011 meeting). The oral comments were recorded in the meeting transcripts available on the NOP Web site, *http://www.ams.usda.gov/nop.* 2 NOSB, 2011, Formal Recommendation by the National Organic Standards Board

(NOSB)to the National Organic Program (NOP), Nutrient Vitamins and Minerals Sunset, available at *http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091724.* During their April 2011 deliberations on the renewal of nutrients vitamins and minerals, the NOSB explained that the Food and Drug Administration

(FDA)had recently provided a response to the NOP regarding the reference to 21 CFR 104.20 in the current annotation for nutrient vitamins and minerals on the National List. 3 The reference to 21 CFR 104.20 refers to the fortification policy for food under the FDA's jurisdiction. The NOP had requested the information from FDA to consider whether changes to the annotation were necessary to correct an inaccurate cross reference to FDA policy and to clarify what synthetic substances are allowed as vitamins and minerals in products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” The fortification policy at 21 CFR 104.20 provides for the rational addition of essential nutrients to food for human consumption. FDA considers only “essential nutrients” to be within the scope of its fortification policy at 21 CFR 104.20. The nutrients which FDA has determined to be essential are enumerated in 21 CFR 101.9(c)(8)(iv) with corresponding Reference Daily Intakes (RDIs), and 21 CFR 101.9(c)(9), which includes potassium and its corresponding Daily Reference Value (DRV). FDA stated that substances such as omega-3 and omega-6 fatty acids, inositol, choline, carnitine, and taurine are not essential nutrients listed under 101.9(c)(8)(iv) and are, therefore, not within the scope of FDA's fortification policy at 21 CFR 104.20. The FDA also clarified that infant formula is not within the scope of the fortification policy; the requirements in 21 CFR part 107 pertain to required and essential nutrients for infant formula and include minimum and maximum amounts for those nutrients. 3 FDA Response to NOP—Questions and Answers Regarding Nutrient Fortification of Foods. April 14, 2011. Available at *http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090415* . Based on this information, the NOSB signaled its intent to issue another recommendation for an annotation change to the listing for nutrients vitamins and minerals at their November 2011 public meeting. However, since NOP intended to take action to amend the listing through a proposed rule, the NOSB opted to remove proposing a recommendation for an annotation change on nutrient vitamins and minerals from their November 2011 meeting agenda. On January 12, 2012, AMS published a proposed rule on the 2012 Sunset Review for nutrient vitamins and minerals (77 FR 1980). The rule proposed to address the April 2011 NOSB recommendation and to revise the cross reference to FDA regulations to specify that only vitamins and minerals which are declared essential for food in 21 CFR 101.9 and vitamins and minerals that are required for infant formula in 21 CFR 107.10 and 107.100, may be used in organic products. As a result, under the proposal, any ingredient not specified by these cross references to FDA regulations would be excluded from use in organic products and would need to be petitioned to the NOSB for separate exemptions on the National List. Examples of affected ingredients which would need separate exemptions on the National List include docosahexanoic acid

(DHA)algal oil, arachidonic acid

(ARA)single-cell oil, taurine, inositol, choline, ascorbyl palmitate, synthetic beta-carotene, L-carnitine, lycopene, nucleotides, lutein, and L-methionine. Further, AMS would need to conduct separate rulemaking to codify the exemptions based on NOSB recommendations for any petitioned substances. A detailed discussion of the proposal, including further discussion of the examples of ingredients that would be affected and an initial assessment of the impacts of correcting the cross references to FDA regulations, is available in the proposed rule (77 FR 1980). The proposed rule provided a 60 day comment period, which closed on March 12, 2012. Comments were specifically requested on:

(i)The actual economic impacts of the proposed action;

(ii)the adequacy of the estimated impact of the proposed action on small entities; and

(iii)the length of the proposed compliance date. AMS received 26 written comments in response to the proposed rule. The written comments can be retrieved via *www.regulations.gov* by searching for the document ID number: AMS-NOP-10-0083. Persons wanting to visit the USDA South Building to view comments in response to the proposed rule are requested to make an appointment in advance by calling

(202)720-3252. AMS continues to assess the public comments on the proposed rule and evaluate the impact of clarifying the cross reference to FDA regulations. Given that the current allowance for nutrient vitamins and minerals is due to sunset (“expire”) from the National List on October 21, 2012, AMS is issuing this interim rule with request for comments to provide continuity to the organic industry and avoid widespread disruption that would result if the allowance for vitamins and minerals were to sunset. For example, if the current allowance for vitamins and minerals was to sunset, Vitamins A and D, used to fortify fluid milk, and B-vitamins, used in bread and cereal to replace vitamins lost during processing, could no longer be added to organic products. AMS believes that renewing the current listing for nutrient vitamins and minerals on the National List is the most appropriate action at this time. When AMS published the proposed rule in January 2012, the agency requested comments on the adequacy of the economic analysis that was presented and the two year compliance date that was proposed. AMS received limited public comment on the impacts of correcting the cross reference to FDA regulations. The NOSB has made final recommendations to AMS on four petitioned substances, petitions for eight substances remain outstanding. A summary of the status of these petitions is provided in Table 1. Table 1—Status of National List Petitions for Affected Ingredients a Ingredient Petition submitted to NOSB NOSB recommendation Docosahexanoic Acid

(DHA)algal oil b Yes NOSB recommended the addition to § 205.605(a): DHA algal oil, not hexane extracted; other ingredients that are agricultural must be organic. Arachidonic Acid

(ARA)single-cell oil b Yes NOSB recommended the addition to § 205.605(a): Arachidonic Acid

(ARA)from fungal oil, not hexane extracted; other ingredients that are agricultural must be organic. Inositol Yes NOSB recommended the addition to § 205.605(b): CAS #87-89-8 (myo-inositol) and 6917-35-7 (non-specific isomer) for use in infant formula and medical nutritional enteral products labeled organic or made with organic (specified ingredients or food group(s)). Choline (two separate petitions for infant formula and infant food, and all other foods) Yes NOSB recommended the addition to § 205.605(b): Choline chloride (CAS #67-48-1) and Choline bitartrate (CAS #87-67-2) for use in infant formula and medical nutritional enteral products labeled organic or made with organic (specified ingredients or food group(s)). Ascorbyl Palmitate Yes NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. c Beta-carotene d Yes NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. L-carnitine Yes NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. Lycopene Yes NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. Lutein Yes NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. L-Methionine Yes NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. Nucleotides Yes NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. Taurine Yes NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. Amino Acids for pet food Yes NOSB Livestock Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. a Petitions are available on the NOP Web site in the petitioned substances database: *http://www.ams.usda.gov/NOPNationalList* . b Some of the DHA and ARA used in organic products is derived from fish oil, currently provided for in section 205.606 of the National List, rather than algal and microbial sources. c All NOSB subcommittee proposals are available online at *http://www.ams.usda.gov/NOSBCommitteeRecommendations* . Information for the October 15-18, 2012 NOSB public meeting is available online at *http://www.ams.usda.gov/NOSBMeetings* . d The beta-carotene petition is for the synthetic form. Beta-carotene extract color is currently listed in section 205.606 as a nonorganically produced agricultural ingredient allowed in products labeled “organic” when an organic version is not commercially available. Once the NOSB completes its review and has issued recommendations on all petitioned nutrients, the public will be able to more fully comment on the implications of correcting the FDA cross reference as proposed. For this reason, we are requesting comments through this interim rule. After consideration of comments submitted to both the proposed rule and this interim rule, AMS intends to issue a final rule that will address the proposed correction to the listing for nutrient vitamins and minerals on the National List. As previously noted, AMS would need to conduct separate rulemaking to codify the exemptions based on recommendations by the NOSB for any petitioned substance. Therefore, consistent with the April 2011 NOSB recommendation, this interim rule continues the allowance for nutrient vitamins and minerals at section 205.605(b) as follows: “Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality Guidelines for Foods.” This action enables the industry to continue with the status quo until additional public comments are received and a final rule is published. This action avoids the widespread disruption to the organic market that would occur if the allowance for any synthetic vitamins and minerals were to sunset (“expire”) from the National List on October 21, 2012. II. Statutory and Regulatory Authority The OFPA authorizes the Secretary to make amendments to the National List based on proposed amendments 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 section 205.607 of the NOP regulations. The current petition process (72 FR 2167, January 18, 2007) can be accessed through the NOP Web site at *http://www.ams.usda.gov.* A. Executive Order 12866 This action has been determined 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 interim rule is not intended to have a retroactive effect. States and local jurisdictions are preempted under the 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 the OFPA (7 U.S.C. 6514(b)). States are also preempted by the OFPA (7 U.S.C. 6503 through 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 the OFPA. Pursuant to the 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 the OFPA,

(b)not be inconsistent with the 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 the OFPA (7 U.S.C. 6519(f)), this interim 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 (FIFRA) (7 U.S.C. 136-136(y)). The 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. The 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 final 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 such actions in order that small business will not be unduly or disproportionately burdened. 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 interim rule on small entities. The effect of this rule would be to allow the continued use of nutrients vitamins and minerals in organic handling. AMS concludes that the economic impact of continuing this allowance for nutrient vitamins and minerals in organic handling would avoid market disruption and would be beneficial to small agricultural service firms. Therefore, AMS certifies that this rule would 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. Based on USDA data from the Economic Research Service (ERS), the total acreage of certified organic land grew from 1.8 million acres in 2000 to 4.8 million acres in 2008, of which approximately 2.2 million acres was pasture and rangeland. 4 The number of certified organic producers in the U.S. has more than doubled in that time period rising from approximately 7,000 in 2000 to nearly 17,700 by the end of 2011. 5 ERS, based upon the list of certified operations maintained by the NOP, estimated the number of certified handling operations was 3,225 in 2007. AMS believes that most of these entities would be considered small entities under the criteria established by the SBA. 4 U.S. Department of Agriculture, Economic Research Service. 2008. *U.S. Organic Agriculture, 1992-2008,* data set, available at *www.ers.usda.gov/data/organicERS.* The number of U.S. organic operations at the end of 2011 is from data compiled by the National Organic Program, *http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097523.* 5 *Ibid.* The increasing production capacity for organic agricultural products parallels growth trends in sales of organic products. Since implementation of the NOP, the organic industry has experienced consecutive years of growth demonstrated by increasing sales to consumers. In 2011, U.S. retail sales of organic food and beverages totaled over $29.2 billion. 6 The pace of double-digit sales growth that persisted from 2002-2008 has dipped, but the 7.7 percent growth recorded from 2009-2010, and the 9.4 percent growth recorded from 2010-2011, marked increases from previous years. The top grossing organic food categories in terms of sales for 2011 are fruits and vegetables (40.5%), dairy (14.6%) and packaged/prepared foods, which includes baby formula and baby food (13.6%). Sales of dry breakfast goods, which includes cereals, grew 6.2% in the year 2011, exceeding $1 billion. Organic frozen prepared foods account for the highest sales within the packaged/prepared foods category. Nutrient vitamins and minerals are used to fortify products in the dairy, packaged/prepared foods, and breakfast goods product categories. 6 Organic Trade Association, 2012. *2012 Organic Industry Survey.* Brattleboro, VT. In addition, USDA has 91 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/nop.* AMS believes that most of these accredited certifying agents would be considered small entities under the criteria established by the SBA. D. Paperwork Reduction Act No additional collection or recordkeeping requirements are imposed on the public by this interim rule. Accordingly, OMB clearance is not required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35. E. Executive Order 13175 This interim 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. Effective Date This interim rule reflects a recommendation submitted to the Secretary by the NOSB for the purpose of fulfilling the requirements of 7 U.S.C. 6517(e) of the OFPA. Section 7 U.S.C. 6517(e) requires the NOSB to review each substance on the National List within 5 years of its publication. Pursuant to 5 U.S.C. 553, it is found and determined upon good cause that it is impracticable and contrary to the public interest to give preliminary notice prior to putting this rule into effect in order to ensure the continued use of nutrients vitamins and minerals in organic products after October 21, 2012, and avoid widespread disruption to the organic market. Accordingly, this rule shall be effective on October 21, 2012. List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agriculture, Animals, Archives and records, Imports, Labeling, Organically produced products, Plants, Reporting and recordkeeping requirements, Seals and insignia, Soil conservation. The authority citation for 7 CFR part 205 continues to read as follows: Authority: 7 U.S.C. 6501-6522. Dated: September 21, 2012. David R. Shipman, Administrator, Agricultural Marketing Service. [FR Doc. 2012-23748 Filed 9-26-12; 8:45 am]

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