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Federal Register/Vol. 80, No. 116/Wednesday, June 17, 2015 34650 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices Seven PREIS grantees have requested Objectives and Need for Assistance, Single-source program expansion supplemental funding awards. Their Approach, and Budget and Budget supplement awards are made to the applications were assessed by a review Justification. The applications were following PREIS grantees: panel for completeness and assessed to have scored within a responsiveness in the categories of fundable range. Supplement award Grantee organization City State amount Child and Family Resources, Inc. ......................................................... Tucson ........................................... AZ $32,314 Children’s Hospital of Los Angeles ....................................................... Los Angeles ................................... CA 115,898 Cicatelli Associates Inc. ......................................................................... New York ....................................... NY 130,000 Demoiselle2Femme ............................................................................... Chicago ......................................... IL 55,959 Education Development Center, Inc. ..................................................... Newton .......................................... MA 55,560 Teen Outreach Pregnancy Services ..................................................... Tucson ........................................... AZ 29,000 The Village for Families & Children, Inc ................................................ Hartford ......................................... CT 33,235 Statutory Authority: Section 2953 of the 240–402–1278, email: mical.honigfort@ source of industrially-produced trans Patient Protection and Affordable Care Act of fda.hhs.gov. fatty acids (Ref. 1). As explained in the 2010, Pub. L. 111–148, added Section 513 to SUPPLEMENTARY INFORMATION: tentative determination (78 FR 67169), Title V of the Social Security Act, codified all refined edible oils contain some at 42 U.S.C. 713, authorizing the Personal Table of Contents Responsibility Education Program. trans fat as an unintentional byproduct I. Background of their manufacturing process; Mary M. Wayland, II. Definitions and Scope, and Related however, unlike other edible oils, trans Senior Grants Policy Specialist, Division of Comments With FDA Responses fats are an integral component of PHOs Grants Policy, Office of Administration. III. Discussion of Legal Issues, and Related and are purposely produced in these [FR Doc. 2015–14839 Filed 6–16–15; 8:45 am] Comments With FDA Responses oils to affect the properties of the oils A. GRAS BILLING CODE 4184–37–P and the characteristics of the food to B. Prior Sanctions C. Procedural Requirements which they are added. In addition, the trans fat content of PHOs is significantly DEPARTMENT OF HEALTH AND IV. Discussion of Scientific Issues, and Related Comments With FDA Responses greater than the amount in other edible HUMAN SERVICES A. Intake Assessment oils. Non-hydrogenated refined oils may B. Safety contain trans fatty acids as a result of Food and Drug Administration V. Citizen Petitions high-temperature processing, at levels [Docket No. FDA–2013–N–1317] VI. Environmental Impact typically below 2 percent (Ref. 2). Low VII. Economic Analysis levels (below 2 percent) may also be Final Determination Regarding VIII. Compliance Date and Related Comments found in fully hydrogenated oils (FHOs) Partially Hydrogenated Oils With FDA Responses IX. Conclusion and Order due to incomplete hydrogenation (Ref. AGENCY: Food and Drug Administration, X. References 3). Small amounts (typically around 3 HHS. percent) may be found in the fat I. Background ACTION: Notice; declaratory order. component of dairy and meat products In accordance with the process set out from ruminant animals (Ref. 4). SUMMARY: Based on the available in § 170.38(b)(1) (21 CFR 170.38(b)(1)), FDA’s tentative determination scientific evidence and the findings of we issued a notice on November 8, 2013 identified the significant human health expert scientific panels, the Food and (the November 2013 notice, 78 FR risks associated with the consumption Drug Administration (FDA or we) has 67169), announcing our tentative of trans fat (78 FR 67169 at 67171). The made a final determination that there is determination that, based on currently tentative determination was based on no longer a consensus among qualified available scientific information, PHOs evidence including results from a experts that partially hydrogenated oils are no longer GRAS under any number of controlled feeding studies on (PHOs), which are the primary dietary condition of use in human food and trans fatty acid consumption in humans source of industrially-produced trans therefore are food additives subject to (Refs. 5 and 6), findings from long-term fatty acids (IP–TFA) are generally section 409 of the Federal Food, Drug, prospective epidemiological studies recognized as safe (GRAS) for any use in and Cosmetic Act (the FD&C Act) (21 (Refs. 5 and 6), and the opinions of human food. This action responds, in U.S.C. 348). expert panels (Refs. 7, 8, 9, 10, 11, 12, part, to citizen petitions we received, FDA’s evaluation of the GRAS status 13, and 14). The latter included the and we base our determination on of PHOs centers on the trans fatty acid 2005 recommendation of the Institute of available scientific evidence and the (TFA, also referred to as ‘‘trans fat’’) Medicine (IOM) to limit trans fat findings of expert scientific panels component of these oils. Although we consumption as much as possible while establishing the health risks associated primarily use the word ‘‘oil’’ when consuming a nutritionally adequate diet, with the consumption of trans fat. discussing PHOs in this document, recognizing that trans fat occurs DATES: Compliance date: Affected partially hydrogenated fats (such as naturally in meat and dairy products persons must comply no later than June partially hydrogenated lard), are from ruminant animals and that 18, 2018. included within the definition of PHOs naturally-occurring trans fat is FOR FURTHER INFORMATION CONTACT: (discussed in section II) and therefore unavoidable in ordinary, non-vegan Mical Honigfort, Center for Food Safety within the scope of this order, and diets without significant dietary and Applied Nutrition (HFS–265), Food references to ‘‘oil’’ in this document adjustments that may introduce and Drug Administration, 5100 Paint should be read in most cases to include undesirable effects (Ref. 7). In addition, Branch Pkwy., College Park, MD 20740, fats. PHOs are the primary dietary in the tentative determination FDA cited VerDate Sep<11>2014 18:47 Jun 16, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34651 a peer reviewed, published estimate of governments. Most comments generally When a fat or oil is hydrogenated, the deaths and coronary events that would supported the tentative determination or degree of hydrogenation can be tailored be prevented annually in the United supported aspects of it. FDA also to obtain the desired properties for the States from elimination of remaining received numerous comments stating application. FHOs are produced by uses of PHOs from the food supply (Ref. that although they agreed with FDA’s allowing the hydrogenation process to 15). Given all this evidence, we efforts to further reduce trans fat in the proceed to complete or near complete tentatively determined that there is no food supply, they disagreed with our saturation to obtain a more solid fat. In longer a consensus among qualified tentative determination regarding the practice, the reaction does not proceed experts that PHOs, the primary dietary GRAS status of PHOs. Of the comments to 100 percent completion, even when source of IP–TFA, are safe for human that objected to the tentative producing FHOs, and some degree of consumption, either directly or as determination, many disagreed with unsaturation unavoidably remains in ingredients in other food products. FDA’s scientific analysis and offered the final fat or oil. Non-hydrogenated PHOs have a long history of use as alternative approaches to address trans refined fats and oils generally contain food ingredients. The two most common fat in the food supply. Some comments trans fatty acids as an unavoidable PHOs currently used by the food addressed issues outside the scope of impurity as a result of high-temperature industry, partially hydrogenated the tentative determination (such as processing, at levels typically below 2 soybean oil and partially hydrogenated disruptions to trade, taxation of foods, percent (Ref. 2). The IV of a fat or oil cottonseed oil, are not listed as GRAS or and requests for bans on other is not a direct measure of the TFA as approved food additives in FDA’s substances) and were not considered. content, but is a measure of the degree regulations. However, these and other We reviewed all comments that were of unsaturation. Thus, in a fat or oil that commonly used PHOs (e.g., partially submitted to the docket before arriving has been hydrogenated, a low degree of hydrogenated coconut oil and partially at the decision outlined in this order. unsaturation (i.e., a low IV number) will hydrogenated palm oil) have been We have arranged comments and our correlate to a low level of TFA. FHOs considered GRAS by the food industry responses
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