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Federal Register/Vol. 78, No. 217 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices 67169 Brookings Institution event Web site at SUMMARY: Based on new scientific component of these oils. This document http://www.brookings.edu//health/ evidence and the findings of expert addresses PHOs because they are the events. scientific panels, the Food and Drug primary dietary source of industrially- Transcripts: Please be advised that Administration (FDA) has tentatively produced trans fat (Ref. 1). Although all transcripts will not be available. determined that partially hydrogenated refined edible oils contain some trans SUPPLEMENTARY INFORMATION: On July 9, oils (PHOs), which are the primary fat as an unintentional byproduct of 2012, the President signed into law the dietary source of industrially-produced their manufacturing process, trans fats Food and Drug Administration Safety trans fatty acids, or trans fat, are not are an integral component of PHOs and and Innovation Act (FDASIA) (Pub. L. generally recognized as safe (GRAS) for are purposely produced in these oils to 112–144). Title I of FDASIA any use in food based on current affect the properties of the oil and the reauthorizes PDUFA and provides FDA scientific evidence establishing the characteristics of the food to which they with the user fee resources necessary to health risks associated with the are added. maintain an efficient review process for consumption of trans fat, and therefore The current scientific evidence, human drug and biological products. that PHOs are food additives. Although which is discussed in section IV of this The reauthorization of PDUFA includes FDA has not listed the most commonly document, identifies significant health performance goals and procedures for used PHOs, they have been used in food risks caused by the consumption of the Agency that represent FDA’s for many years based on self- trans fat. This evidence includes the commitments during fiscal years 2013– determinations by industry that such opinions of expert panels and the 2005 2017 (PDUFA V). These commitments use is GRAS. If finalized, this would recommendation of the Institute of are fully described in the document mean that food manufacturers would no Medicine (IOM) to limit trans fat entitled ‘‘PDUFA Reauthorization longer be permitted to sell PHOs, either consumption as much as possible while Performance Goals and Procedures directly or as ingredients in another consuming a nutritionally adequate diet, Fiscal Years 2013 Through 2017’’ food product, without prior FDA recognizing that trans fat occurs (PDUFA Goals Letter), available on approval for use as a food additive. naturally in meat and dairy products FDA’s Web site at http://www.fda.gov/ DATES: Submit either electronic or from ruminant animals and that downloads/ForIndustry/UserFees/ written comments and scientific data naturally-occurring trans fat is PrescriptionDrugUserFee/ and information by January 7, 2014. unavoidable in ordinary, nonvegan diets UCM270412.pdf. Section XI of the ADDRESSES: Submit electronic without significant dietary adjustments PDUFA Goals Letter, entitled comments and scientific data and that may introduce undesirable effects ‘‘Enhancement and Modernization of information to http:// (Ref. 2). In addition, according to the the FDA Drug Safety System,’’ includes www.regulations.gov. Submit written Centers for Disease Control and Sentinel as a tool for evaluating drug comments and scientific data and Prevention (CDC), elimination of PHOs safety issues that may require regulatory information to the Division of Dockets from the food supply could prevent action. As part of this enhancement, Management (HFA–305), Food and Drug 10,000 to 20,000 coronary events and FDA committed to hold a public Administration, 5630 Fishers Lane, Rm. 3,000 to 7,000 coronary deaths annually, meeting to engage stakeholders in a 1061, Rockville, MD 20852. All if the marginal benefits of continuing to discussion of current and emerging submissions must include the Agency remove trans fats from food items Sentinel projects and facilitate name and the docket number found in remain constant (Ref. 3). (See stakeholder feedback and input to brackets in the heading of this accompanying economic analysis for determine the feasibility of using document. more information on this estimate.) Given this evidence, we have tentatively Sentinel to evaluate drug safety issues FOR FURTHER INFORMATION CONTACT: that may require regulatory action, e.g., Mical Honigfort, Center for Food Safety determined that there is no longer a labeling changes, PMRs, or PMCs. The and Applied Nutrition (HFS–265), Food consensus among qualified scientific public workshop announced by this and Drug Administration, 5100 Paint experts that PHOs, the primary dietary notice will fulfill this commitment. Branch Pkwy., College Park, MD 20740, source of industrially-produced trans fatty acids, are safe for human Dated: November 5, 2013. 240–402–1278, FAX: 301–436–2972, email: [email protected]. consumption, either directly or as Leslie Kux, ingredients in other food products. Assistant Commissioner for Policy. SUPPLEMENTARY INFORMATION: II. Background [FR Doc. 2013–26855 Filed 11–7–13; 8:45 am] I. Introduction BILLING CODE 4160–01–P In accordance with the process set out A. Hydrogenation Process and Trans in § 170.38(b)(1) (21 CFR 170.38(b)(1)), Fatty Acids Chemical hydrogenation is the DEPARTMENT OF HEALTH AND we are issuing this document process by which hydrogen atoms are HUMAN SERVICES announcing our tentative determination that PHOs are no longer GRAS under added to unsaturated sites on the carbon Food and Drug Administration any condition of use in food and chains of fatty acids, in the presence of therefore are food additives subject to catalysts, thereby reducing the number [Docket No. FDA–2013–N–1317] section 409 of the Federal Food, Drug, of double bonds. ‘‘Partial and Cosmetic Act (FD&C Act) (21 U.S.C. hydrogenation’’ describes an incomplete Tentative Determination Regarding 348). If finalized, this would mean that saturation of the double bonds, in which Partially Hydrogenated Oils; Request food manufacturers would no longer be some double bonds remain but may for Comments and for Scientific Data permitted to sell PHOs, either directly shift to a different position along the and Information or as ingredients in another food carbon chain and alter their AGENCY: Food and Drug Administration, product, without prior FDA approval for configuration from cis to trans. The HHS. use as a food additive. trans arrangement of hydrogen atoms FDA’s evaluation of the GRAS status results in a relatively straight ACTION: Notice; request for comments of PHOs is centered on the trans fatty configuration of the fatty acids and and for scientific data and information. acid (also referred to as ‘‘trans fat’’) increases the melting point, shelf life, VerDate Mar<15>2010 18:08 Nov 07, 2013 Jkt 232001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1 TKELLEY on DSK3SPTVN1PROD with NOTICES 67170 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices and flavor stability of the hydrogenated substance is not GRAS.2 A substance is in part that FDA may, on its own oil. Because of these technical GRAS if it is generally recognized, initiative, propose to determine that a properties, PHOs have been used by the among experts qualified by scientific substance is not GRAS. (See generally food industry in such products as training and experience to evaluate its 36 FR 12093 (June 25, 1971) (issuance margarine, shortening, and baked goods. safety, as having been adequately shown of 21 CFR 121.3, the predecessor of The hydrogenation process can be through scientific procedures (or, in the § 170.38)). Further, as stated previously, controlled to meet the physical or case of a substance used in food prior history of the safe use of a substance in chemical properties needed for a to January 1, 1958, through either food prior to 1958 is not sufficient to specific product application (Ref. 4). If scientific procedures or experience support continued GRAS status if new an oil is allowed to hydrogenate based on common use in food) to be safe evidence demonstrates that there is no completely, the carbon-carbon double under the conditions of its intended use. longer expert consensus that an bonds are mostly eliminated, resulting However, history of use prior to 1958 is ingredient is safe. in a ‘‘fully hydrogenated oil.’’ The trans not sufficient to support continued As noted previously, under section fatty acid content of PHOs can vary from GRAS status if new evidence 201(s) of the FD&C Act, a substance that approximately 10 to 60 percent of the demonstrates that there is no longer a is GRAS for a particular use in food is oil, depending on how the oil is consensus that an ingredient is safe. not a food additive, and may lawfully be manufactured, with an average trans FDA has defined safe as ‘‘a reasonable utilized for that use without Agency fatty acid content of 25 to 45 percent of certainty in the minds of competent review and approval. Currently, a GRAS the oil (Ref. 1). Changes in the pressure, scientists that the substance is not determination is made when the temperature, amount of agitation in the harmful under the intended conditions manufacturer or user of a food substance reaction vessel, type and concentration of use’’ (21 CFR 170.3(i)), and general evaluates the safety of the substance and of catalyst, reaction time, and fat source recognition of safety must be based only the views of qualified experts and will affect the production of trans fatty on the views of qualified experts (21 concludes that the use of the substance acid isomers in PHOs. CFR 170.30(a)). To establish such is GRAS. This approach is commonly As noted, trans fatty acids are also recognition, there must be a consensus referred to as ‘‘GRAS self- formed during the production of non- of expert opinion regarding the safety of determination.’’ Substances that have hydrogenated refined oils (i.e., soybean the use of the substance.
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