Incorporation by Reference of the Food Chemicals Codex, 7Th Edition
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Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations 71457 that there is specific, objective support small entities will have an estimated By the Commission. for the burden estimates associated with cost of $60 in Year 1 and no further Nathaniel J. Davis, Sr., the information requirements. ongoing costs. These figures are based Deputy Secretary. 62. Interested persons may obtain on information collection costs plus [FR Doc. 2013–28626 Filed 11–27–13; 8:45 am] information on the reporting additional costs for compliance. The BILLING CODE 6717–01–P requirements by contacting the Federal Commission does not consider this to be Energy Regulatory Commission, Office a significant economic impact for small of the Executive Director, 888 First entities because it should not represent DEPARTMENT OF HEALTH AND Street NE., Washington, DC 20426 a significant percentage of the small HUMAN SERVICES [Attention: Ellen Brown, email: Data entities’ operating budgets. The [email protected], phone: (202) 502– Food and Drug Administration 8663, fax: (202) 273–0873]. Commission solicited comments concerning is proposed Regulatory IV. Environmental Analysis Flexibility Act certification and did not 21 CFR Parts 172, 173, 178, and 180 63. The Commission is required to receive any comments. Accordingly, the [Docket No. FDA–2010–F–0320] prepare an Environmental Assessment Commission certifies that this Final or an Environmental Impact Statement Rule will not have a significant Food Additive Regulations; for any action that may have a economic impact on a substantial Incorporation by Reference of the significant adverse effect on the human number of small entities. Food Chemicals Codex, 7th Edition environment.54 The Commission has VI. Document Availability AGENCY: Food and Drug Administration, categorically excluded certain actions HHS. from this requirement as not having a 66. In addition to publishing the full ACTION: Final rule. significant effect on the human text of this document in the Federal environment. Included in the exclusion Register, the Commission provides all SUMMARY: The Food and Drug are rules that are clarifying, corrective, interested persons an opportunity to Administration (FDA or we) is or procedural or that do not view and/or print the contents of this amending select food additive substantially change the effect of the regulations that incorporate by reference 55 document via the Internet through the regulations being amended. The food-grade specifications from prior actions directed herein fall within this Commission’s Home Page (http:// www.ferc.gov) and in the Commission’s editions of the Food Chemicals Codex categorical exclusion in the (FCC) to incorporate by reference food- Commission’s regulations. Public Reference Room during normal business hours (8:30 a.m. to 5:00 p.m. grade specifications from the FCC 7th V. Regulatory Flexibility Act Eastern time) at 888 First Street NE., Edition (FCC 7). We are taking this 64. The Regulatory Flexibility Act of Room 2A, Washington, DC 20426. action in response to a petition filed by 1980 (RFA) 56 generally requires a the United States Pharmacopeial 67. From the Commission’s Home Convention (U.S.P. or petitioner). description and analysis of proposed Page on the Internet, this information is rules that will have significant DATES: This rule is effective November available on eLibrary. The full text of 29, 2013. See the ‘‘Objections’’ heading economic impact on a substantial this document is available on eLibrary number of small entities. As discussed of the SUPPLEMENTARY INFORMATION in PDF and Microsoft Word format for above, regional Reliability Standard section for information on the filing of viewing, printing, and/or downloading. BAL–002–WECC–2 applies to 36 objections. Submit either electronic or registered balancing authorities and To access this document in eLibrary, written objections and requests for a reserve sharing groups in the NERC type the docket number excluding the hearing by December 30, 2013. The Compliance Registry. Comparison of the last three digits of this document in the Director of the Office of the Federal NERC Compliance Registry with data docket number field. Register approves the incorporation by submitted to the Energy Information 68. User assistance is available for reference of certain publications listed Administration on Form EIA–861 eLibrary and the Commission’s Web site in the rule as of November 29, 2013. indicates that, of the 36 registered during normal business hours from the ADDRESSES: You may submit either balancing authorities and reserve Commission’s Online Support at (202) electronic or written objections and sharing groups, two may qualify as 502–6652 (toll free at 1–866–208–3676) requests for a hearing, identified by small entities.57 or email at [email protected], Docket No. FDA–2010–F–0320, by any 65. The Commission estimates that, or the Public Reference Room at (202) of the following methods: on average, each of the two affected 502–8371, TTY (202) 502–8659. Email Electronic Submissions the Public Reference Room at 54 Regulations Implementing the National Submit electronic objections in the [email protected]. Environmental Policy Act of 1969, Order No. 486, following way: 52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs., • Regulations Preambles 1986–1990 ¶ 30,783 (1987). VII. Effective Date and Congressional Federal eRulemaking Portal: http:// 55 18 CFR 380.4(a)(2)(ii). Notification www.regulations.gov. Follow the 56 5 U.S.C. 601–612. instructions for submitting comments. 57 69. These regulations are effective The RFA definition of ‘‘small entity’’ refers to Written Submissions the definition provided in the Small Business Act January 28, 2014. The Commission has (SBA), which defines a ‘‘small business concern’’ as determined, with the concurrence of the Submit written objections in the a business that is independently owned and Administrator of the Office of following ways: operated and that is not dominant in its field of • operation. See 15 U.S.C. 632. According to the Information and Regulatory Affairs of Mail/Hand delivery/Courier (for Small Business Administration, an electric utility is OMB, that this rule is not a ‘‘major rule’’ paper or CD–ROM submissions): defined as ‘‘small’’ if, including its affiliates, it is as defined in section 351 of the Small Division of Dockets Management (HFA– primarily engaged in the generation, transmission, and/or distribution of electric energy for sale and Business Regulatory Enforcement 305), Food and Drug Administration, its total electric output for the preceding fiscal year Fairness Act of 1996. 5630 Fishers Lane, Rm. 1061, Rockville, did not exceed 4 million megawatt hours. MD 20852. VerDate Mar<15>2010 20:31 Nov 27, 2013 Jkt 232001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\29NOR1.SGM 29NOR1 sroberts on DSK5SPTVN1PROD with RULES 71458 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations Instructions: All submissions received public review and comment on U.S.P.’s III, IV, or V to industry or the public. must include the Agency name and Web site. U.S.P. scientists and its Food (Under 5 U.S.C. 552(a) and 1 CFR Docket No. FDA–2010–F–0320 for this Ingredients Expert Committee review 51.7(a)(4), a publication that is to be rulemaking. All objections received may these data and, if necessary, conduct incorporated by reference must be be posted without change to http:// laboratory tests. Once approved by the ‘‘reasonably available’’ to and capable of www.regulations.gov, including any Food Ingredients Expert Committee, being used by persons affected by the personal information provided. For new or updated monographs are publication.) Second, the petitioner detailed instructions on submitting published in the next edition or maintained that updating the references objections, see the ‘‘Objections’’ heading Supplement to the FCC. to older editions of the FCC to FCC 7 of the SUPPLEMENTARY INFORMATION The petitioner initially requested may avoid confusion, inconsistency, section of this document. amendments to 39 existing references to and lack of uniformity in the quality of Docket: For access to the docket to older editions of the FCC in parts 172, food additives and ingredients read background documents or 173, 178, and 180 to incorporate by manufactured and sold. Third, the objections received, go to http:// reference the specifications contained in petitioner noted that, in many cases, the www.regulations.gov and insert the FCC 7. The petitioner explained that of editions of the FCC prior to FCC 7 may docket number, found in brackets in the the regulations it has requested to be employ outdated analytical heading of this document, into the updated, 15 regulations refer to the third methodologies and equipment that do ‘‘Search’’ box and follow the prompts edition of the FCC (FCC III, published not reflect current scientific practices, and/or go to the Division of Dockets in 1981); 18 regulations refer to the and which may be difficult to obtain. Management, 5630 Fishers Lane, Rm. fourth edition of the FCC (FCC IV, We note that, subsequent to our 1061, Rockville, MD 20852. published in 1996); 4 regulations refer analysis of FCC 7, the U.S.P. published to the fifth edition of the FCC (FCC V, the eighth edition of the FCC (FCC 8) in FOR FURTHER INFORMATION CONTACT: published in 2004); and 2 regulations March 2012. Initiating a review of FCC Mical Honigfort, Center for Food Safety refer to the sixth edition of the FCC 8 at this time would delay issuance of and Applied Nutrition (HFS–265), Food (FCC 6, published in 2008). (The IOM this final rule. To avoid a delay in and Drug Administration, 5100 Paint used roman numerals when referring to updating the references to the FCC in Branch Pkwy., College Park, MD 20740– editions of the FCC, e.g., FCC III and our food additive regulations, we are 3835, 240–402–1278.