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 (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 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,

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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 , 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. (See, e.g., been self-determined as GRAS are not and cottonseed oils) as a result of the cis United States v. Western Serum Co., comprehensively listed or otherwise to trans isomerization induced by high Inc., 666 F.2d 335, 338 (9th Cir. 1982) publicly identified. temperatures used during processing, (citing Weinberger v. Hynson, Westcott Other substances that are GRAS may such as deodorization (Ref. 5). The & Dunning, 412 U.S. 609, 629–32 be identified in FDA regulations in one concentration of trans fatty acids in (1973)). Unanimity among experts of two ways. Following the passage of non-hydrogenated refined oils is regarding safety of a substance is not the 1958 Food Additives Amendment, typically below 2 percent (Ref. 6). Low required. (See, e.g., United States v. FDA established in its regulations a list levels (below 2 percent) of trans fatty Articles of Drug * * * 5,906 boxes, 745 of food substances that, when used as acids may also be found in fully F.2d 105, 119 n. 22 (1st Cir. 1984); indicated, are considered GRAS. This hydrogenated oils due to incomplete United States v. Articles of Food and list (commonly referred to as the ‘‘GRAS hydrogenation (Ref. 7). Theoretically, a Drug (Coli-Trol 80), 518 F.2d 743, 746 list’’) now appears at 21 CFR part 182. fully hydrogenated oil would be fully (5th Cir. 1975) (‘‘What is required is not Thereafter, in 1972, we established the saturated and would not contain any unanimous recognition but general GRAS affirmation process through trans fatty acids. However, no recognition.’’)). However, the existence which we affirmed, through notice and hydrogenation process is 100 percent of a severe conflict among experts comment rulemaking, the GRAS status efficient. In addition, the trans fatty regarding the safety of the use of a of particular uses of certain substances isomer content of an edible oil can be substance precludes a finding of general in food.3 Regulations affirming the controlled by blending different oils or recognition (See, e.g., Premo GRAS status of certain substances through processing of mixed fatty acids Pharmaceutical Laboratories v. United appear at 21 CFR parts 184 and 186.4 (Ref. 4).1 States, 629 F.2d 795, 803 (2d Cir. 1980)). Importantly, the GRAS status of a C. Status of PHOs B. The GRAS Standard specific use of a particular substance in PHOs, which are the primary dietary Section 409 of the FD&C Act provides food is time-dependent. That is, as new source of industrially-produced trans fat that a food additive is unsafe unless it scientific data and information develop (Ref. 1), have a long history of use as is used in accordance with certain about a substance or the understanding food ingredients. The partial conditions set forth in that section. of the consequences of consumption of hydrogenation process was developed ‘‘Food additive’’ is defined by section a substance evolves, expert opinion in the 1930s and has been in 201(s) of the FD&C Act (21 U.S.C. regarding the safety of a substance for a widespread commercial use since the 321(s)) as any substance the intended particular use may change such that 1940s. Two common PHOs currently use of which results or may reasonably there is no longer a consensus that the used by the food industry are partially be expected to result in its becoming a specific use is safe. The fact that the component or otherwise affecting the status of a substance under section 3 As a general matter, FDA no longer lists GRAS characteristics of any food, if such 201(s) of the FD&C Act may evolve over substances in its regulations because, in April 1997, time is the underlying basis for FDA’s we proposed to establish a voluntary notification 1 program for GRAS, which does not involve Hydrogenation also occurs in the digestive tract regulation at § 170.38, which provides of ruminant animals and results in the formation of rulemaking (62 FR 18938, April 17, 1997). At the some trans isomers in the fat components of dairy time of the proposal, FDA initiated a pilot of the and meat products from these animals. These 2 Certain other substances that may become GRAS notification program, which continues to isomers usually make up only a small percent components of food are also excluded from the function. A firm may voluntarily submit (typically around 3 percent) of the total fatty acids statutory definition of food additive, including information on a GRAS self-determination to FDA of such products (Ref. 5). This document is limited pesticide chemicals and their residues, new animal for review through the GRAS notification program, to PHOs and does not address the trans fat drugs, color additives, and dietary ingredients in but is not required to do so. component of meat and dairy products from dietary supplements (21 U.S.C. 321(s)(1) through 4 For a more detailed discussion of the history of ruminant animals. (s)(6)). GRAS, see 62 FR 18938 at 18939 and 18940.

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hydrogenated soybean oil and partially 62746) entitled ‘‘Food Labeling: Trans Daily Value (% DV) for trans fat on hydrogenated cottonseed oil, neither of Fatty Acids in Nutrition Labeling, product labels. which is listed as GRAS in FDA’s Nutrient Content Claims, and Health III. Current Dietary Intake of Trans Fat regulations. However, these and other Claims’’ (the November 1999 proposal), From PHOs commonly used PHOs (e.g., partially in which we proposed that trans fat hydrogenated coconut oil and palm oil) content be provided in nutrition In the July 2003 final rule, we have been considered GRAS (through a labeling to help consumers determine estimated that mean adult (aged 20 GRAS self-determination) by the food how each food product contributes to years or more) intake of trans fat from industry for use in food at levels their overall dietary intake of trans fat. products containing PHOs was 4.6 consistent with good manufacturing Our proposal was supported by findings grams per day (g/d) (2.0 percent of practice based on a history of use prior from intervention and observational energy based on a 2,000 calorie diet) (68 to 1958. We are not aware that either studies that evaluated the evidence that FR 41434 at 41470).7 We also estimated FDA or the United States Department of dietary trans fatty acids influence blood that total trans fat intake from products Agriculture (USDA) granted any explicit levels in humans and increase containing PHOs and from animal prior sanction or approval for any use of their risk of coronary heart disease products containing trans fat (1.2 g/d) PHOs in food prior to the 1958 Food (CHD) (64 FR 62746 at 62750). In the was 5.8 g/d for adults (2.6 percent of Additives Amendment to the FD&C Act. November 1999 proposal, we discussed caloric energy). Based on food In contrast, the partially hydrogenated research that showed that diets composition data collected in 2009 and versions of low erucic acid rapeseed oil containing trans fatty acids resulted in 2010, we updated our intake estimate of (LEAR oil; 21 CFR 184.1555(c)(2)) and increased serum low-density lipoprotein trans fat from products containing menhaden oil (21 CFR 184.1472(b)) are (LDL–C), a major risk factor PHOs. Our analysis showed that many affirmed by regulation as GRAS for use for CHD (64 FR at 62746 at 62749 food products have been reformulated to in food. Partially hydrogenated LEAR through 62754). In the Federal Register eliminate or to substantially reduce the oil was affirmed as GRAS for use in food of July 11, 2003 (68 FR 41434), we amount of industrially-produced trans (50 FR 3745; January 28, 1985) through issued a final rule (the July 2003 final fatty acids (Ref. 8). However, as scientific procedures. Partially rule) amending our nutrition labeling discussed further in this section, certain hydrogenated menhaden oil was regulations to require declaration of the population groups still consume high affirmed as GRAS for use in food (54 FR trans fatty acid content of food in the levels of trans fatty acids, primarily 38219; September 15, 1989) on the basis nutrition label of conventional foods through consumption of food products that the oil is chemically and and dietary supplements (21 CFR containing PHOs. biologically comparable to commonly 101.9(c)(2)(ii)). This requirement was In 2010, we prepared an estimate of 6 used partially hydrogenated vegetable effective January 1, 2006. In the July the intake of industrially-produced oils such as corn and soybean oils. 2003 final rule (68 FR 41434 at 41457), trans fat using available food Partially hydrogenated LEAR and the Agency noted that the IOM/National consumption data (2003–2006 National menhaden oils are not currently widely Academy of Sciences (IOM/NAS) report Health and Nutrition Examination used by the food industry.5 about trans fat (Ref. 2) did not make Survey (NHANES)), market share Although none of the food standards quantitative recommendations for information, and trans fat levels based of identity in FDA’s regulations establishing a Daily Reference Value on label declaration data and analytical explicitly refers to PHOs, the nature of (DRV) for trans fat. The IOM/NAS report data for products that were identified as some of the products for which there are recommended that the intake of trans fat containing PHOs (Ref. 8). We estimated standards of identity is such that PHOs be as low as possible while maintaining the 2010 mean trans fat intake for the historically have been used in their a nutritionally balanced diet and did not U.S. population aged 2 years or more 8 manufacture in conformance with those provide a daily reference intake (DRI) who consumed one or more of the standards (e.g., shortening in bread, for trans fat or information that the processed foods identified as containing rolls, and buns (21 CFR 136.110(c)(5)), Agency needs to establish a DRV for PHOs 9 to be 1.3 grams per person per French dressing (21 CFR 169.115), nutrition labeling purposes. Therefore, day (g/p/d) (0.6 percent of caloric in the absence of a scientific basis or mayonnaise (21 CFR 169.140), and energy). For high-level consumers recommendation for trans fat margarine (21 CFR 166.110)). However, (represented by the 90th percentile), we consumption by an authoritative body, no food standard of identity requires the estimated the intake to be 2.6 g/p/d (1.2 FDA did not establish a DRV for trans use of PHOs and, therefore, industry’s percent of caloric energy) for the U.S. fat, and therefore, the July 2003 final ability to comply with any standard population aged 2 years or more. Based rule did not require listing of Percent of would not be prevented by a change in on this estimate, the mean dietary intake of industrially-produced trans fat has the regulatory status of PHOs. 6 The regulation requires the declaration of the decreased significantly since our D. Labeling of Trans Fat amount of trans fat in a product, on a separate line directly below the statement for saturated fat; the estimate in the July 2003 final rule. As an initial step to address the declaration must express the amount of trans fat as grams per serving to the nearest 0.5 g increment 7 (4.6 g//d × 9 kcal/g × 100)/2,000 kcal/d = 2.0% negative health effects of trans fat below 5 g and to the nearest gram increment above consumption in the United States, we of energy. 5 g. If a serving contains less than 0.5 g, the trans 8 fat content may be declared as zero. The regulation While we did not calculate a mean intake for issued a proposed rule in the Federal ages 20 years or more, based on the similarity in Register of November 17, 1999 (64 FR also provides that, in certain circumstances, the statement ‘‘Not a significant source of trans fat’’ the intakes calculated for children aged 2–5 years, may be used instead of a declaration of trans fat teenage boys, and persons aged 2 years or more 5 The non-hydrogenated version of LEAR oil (also content. The regulation defines the number of (Ref. 8), we believe there would not be a significant known as canola oil) is widely used in foods, and grams of trans fat in a serving as the sum of all difference between the intake estimated for persons non-hydrogenated menhaden oil is currently used unsaturated fatty acids that contain one or more ages 2 years or more and that for persons ages 20 in a limited number of products, primarily to isolated (i.e., nonconjugated) double bonds in a years or more. increase the omega-3 fatty acid content of the food. trans configuration. If FDA makes a final 9 The current estimate indicated that Like other non-hydrogenated refined oils, non- determination that PHOs are not GRAS, no amount approximately 100 percent of the population hydrogenated LEAR and menhaden oils, which are of PHOs would be permitted in food products consumed one or more of the foods under also affirmed by FDA as GRAS for use in food, are without prior FDA approval for use as a food consideration. This is due to the wide variety of not significant dietary sources of trans fat. additive. foods that contain trans fat from PHOs.

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Additionally, scientists at the CDC Although trans fat intake has Expert review panels from the IOM/ recently studied the change in levels of decreased overall since our 2003 trans NAS in 2005 (Ref. 2), the American four major trans fatty acids in the blood fat intake estimate, individuals with Heart Association (Refs. 15, 16), the of U.S. non-Hispanic white adults from certain dietary habits may still consume American Dietetic Association (Ref. 17), 2000 to 2009, and reported a 58 percent high levels of trans fat from certain the World Health Organization (Ref. 18), average decrease during that timeframe brands or certain types of food products the Dietary Guidelines Advisory (Ref. 9). (e.g., refrigerated biscuits, ready-to-use Committee (Refs. 19, 20), and the FDA The data that we collected show that frostings, certain brands of frozen Food Advisory Committee Nutrition many foods (e.g., frozen potato pizzas, and certain brands of microwave Subcommittee (Ref. 21) agree that trans products, most frozen breaded products) popcorn), which could contain several fat-mediated changes in lipid have been reformulated to remove grams trans fat per serving. As noted metabolism, pro-inflammatory effects, PHOs. However, a number of foods previously, for those consumers who and endothelial dysfunction lead to made with PHOs remain on the market. consistently choose these products, the dose-dependent increases in CHD These products fall into one of two daily intake of added trans fat is events in humans. These expert panels categories: Foods for which consumers approximately twice as high as that for all concluded that there is no threshold have alternatives containing lower the consumer who does not choose only intake level for industrially-produced levels of trans fat (e.g., cookies, baked the foods containing the highest levels trans fat that would not increase an goods, microwave popcorn, frozen of trans fat within a particular category individual’s risk of CHD, or adverse pizza, frozen pies, shortening) and foods (2.1 g/p/d vs. 1.0 g/p/d). effects on risk factors for CHD. for which consumers have limited or no Moreover, the panels also agree that IV. Safety choice of an alternative containing a trans fatty acids have a stronger effect lower level of trans fat (e.g., ready-to- In the November 1999 proposed rule, on the risk of CHD than saturated fatty use frostings, stick margarine). we concluded that dietary trans fatty acids. In 2010, we also prepared an estimate acids have adverse effects on blood This significant recent evidence for a high-intake scenario by assuming cholesterol measures that are predictive demonstrating the increased risk of CHD that trans fat was present at the highest of CHD risk, specifically LDL–C levels from consumption of any amount of level observed for all foods within a (64 FR 62746 at 62754). We took final trans fat means that consumption of particular food category based on label action in the July 2003 final rule based PHOs, the primary dietary source of surveys or analytical data. For this on our evaluation of comments received trans fat, also leads to increased LDL– scenario, we estimated the mean intake and on scientific evidence C levels and an increased risk of CHD. to be 2.7 g/p/d (1.2 percent of energy) demonstrating that the consumption of These demonstrated effects support a and the 90th percentile intake to be 5.4 trans fatty acids increases LDL–C, one of determination that the consumption of g/p/d (2.4 percent of energy) for the U.S. the major risk factors for CHD. The July PHOs could be harmful (i.e., increased population aged 2 years or more. 2003 final rule cited authoritative risk for CHD) under any condition of In 2012, using label survey data, we reports that recommended limiting use in food. Accordingly, we tentatively updated the 2010 intake estimate of intake of trans fat to reduce CHD risk, determine that this evidence erodes any trans fats from PHOs for those food such as the Dietary Guidelines for basis to support the GRAS status of categories that were identified as major Americans, 2000 (Ref. 11), the American these oils, and therefore that there is no contributors to the dietary intake of Heart Association Guidelines (Ref. 12), longer a consensus among qualified trans fat, as well as for those categories the 2002 IOM/NAS report (Ref. 2), as scientific experts that PHOs, the where we have noted progress in well as additional studies that had been primary dietary source of industrially- reformulation. For this most recent published since the November 1999 produced trans fatty acids, are safe estimate, we calculated the mean intake proposal (68 FR 41434 at 41444). In under any condition of use in food. to be 1.0 g/p/d (0.5 percent of energy) particular, the 2002 IOM/NAS report We note that, in addition to an and the 90th percentile intake to be 2.0 recognized the positive linear trend increased risk of CHD, trans fat g/p/d (1.0 percent of energy) for the U.S. between trans fat intake, LDL–C consumption (and, accordingly, population aged 2 years or more (Ref. concentration, and heart disease, consumption of food products 10). We also prepared an estimate for a concluded that ‘‘trans fatty acids are not containing PHOs) has also been high-intake scenario by assuming that essential and provide no known benefit connected to a number of other adverse trans fat was present at the highest level to human health,’’ and recommended effects on health. Some studies suggest observed for all foods within a that ‘‘trans fatty acid consumption be that trans fat consumption may worsen particular food category based on the kept as low as possible while insulin resistance, especially in those label survey. For this scenario, we consuming a nutritionally adequate who are predisposed to the condition estimated the mean intake to be 2.1 g/ diet.’’ The report did not recommend an (e.g., preexisting insulin resistance, p/d (1.0 percent of energy) and the 90th upper limit for trans fat because it greater adiposity, or lower physical percentile intake to be 4.2 g/p/d (1.9 concluded that any incremental increase activity levels) (Refs. 22, 23). Trans fat percent of energy) for the U.S. in trans fat consumption increases the may also increase diabetes risk (Refs. population aged 2 years or more. risk of CHD. 22–26) although this association We do not consider this to be a FDA has summarized findings requires further confirmation. In significant change in the overall dietary reported in the literature since the addition, there is some evidence that intake of trans fat since 2010. However, publication of the July 2003 final rule fetuses and breastfeeding infants of it suggests a continued downward trend (Refs. 13, 14). Since 2003, both mothers who regularly consume trans in the dietary intake of trans fat. controlled trials and observational fat may be at higher risk for impaired Specifically, there was a decrease human studies published on trans fatty growth (which may be due to inhibition observed in the intake of trans fat in the acid consumption have consistently of the synthesis of essential refrigerated dough, savory snacks, and confirmed the adverse effects of trans polyunsaturated fatty acids that are frozen pizza categories, consistent with fatty acid consumption on intermediary needed for their growth and the lower levels of trans fat observed in risk factors (e.g., serum lipoproteins) development) (Refs. 27–31). Scientific our label survey. and the increased risk of CHD (Ref. 13). evidence also shows that, in addition to

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increasing LDL–C, trans fat intake containing industrially-produced trans have shown that trans fatty acids elicit lowers serum high-density lipoprotein fat, compared with 50 percent in 2005 an inflammatory response.12 cholesterol (HDL–C), a protective form (Ref. 45). VI. Tentative Determination of serum cholesterol (Refs. 32–39). We have also received two citizen petitions regarding the safety of PHOs. As discussed previously, for a V. Other Activities Relating to PHO In 2004, FDA received a citizen petition substance to be GRAS, there must be a Consumption from the Center for Science in the consensus among qualified experts that Over the past 5 years, several Public Interest (CSPI) requesting that we the substance is safe under the intended municipalities, states, and other revoke the GRAS status of PHOs, and conditions of use. In accordance with countries have taken action to reduce consequently declare that all of these the process in FDA’s regulations in the use of PHOs in food. While these oils are food additives. The petition also § 170.38, the Agency on its own actions pertain generally to all products asks FDA to revoke the safe conditions initiative or on the petition of any containing trans fat, because PHOs are of use for partially hydrogenated interested person, under 21 CFR part 10, the primary dietary source of trans fat, products that are currently considered may publish a notice in the Federal their immediate effect is primarily on food additives,10 to prohibit the use of Register determining that a substance is food products containing PHOs. For partially hydrogenated vegetable oils not GRAS and is a food additive subject example, the Danish government passed that are prior sanctioned (FDA is not to section 409 of the FD&C Act. In legislation in 2003 that restricted the aware of any), and to initiate a program accordance with this process, we will use of industrially-produced trans fat to to encourage manufacturers and normally allow a period of 60 days a maximum of 2 percent of fats and oils restaurants to switch to more healthy during which any interested person may used in all processed food products. oils. The petition excluded trans fat that file comments, and we will evaluate all These required limitations on dietary occurs naturally in meat from ruminant comments received (§ 170.38(b)). If we trans fat have nearly eliminated trans fat animals and dairy fats, and that forms conclude that there is a lack of from commercial sources such that during the production of non- convincing evidence that the substance industrially-produced trans fat is no hydrogenated oils. It also does not is GRAS or is otherwise exempt from longer a significant source of intake of include fully hydrogenated oils, which the definition of a food additive in trans fat in Denmark (Refs. 40–42). Also, contain negligible amounts of trans fat, section 201(s) of the FD&C Act, we will in 2007, Canada set voluntary trans fat and PHOs that may be produced by new publish a notice thereof in the Federal reduction targets of no more than 2 technologies that result in negligible Register. percent trans fat in the fat content of amounts of trans fat in the final product. Based on current scientific evidence vegetable oils and spreadable margarine CSPI’s petition states that trans fat discussed in section IV of this document and no more than 5 percent in all other promotes CHD by increasing LDL–C and regarding the health risks associated foods (Ref. 43). Health Canada also by lowering HDL–C, and therefore with the consumption of trans fat, monitored the industry’s actions by has greater adverse effects on serum opinions of expert panels, as well as the analyzing products and reviewing (and possibly CHD) than IOM’s recommendation to limit trans fat nutrition labels. Canada’s monitoring saturated fats. CSPI also states that, consumption as much as possible, we data showed that nutrition labeling beyond its adverse effects on serum have tentatively determined that there is regulations are an effective motivator for lipids, trans fat may promote heart not a consensus that PHOs, the primary industry and that many manufacturers disease in additional ways. Based on dietary source of industrially-produced reduced the trans fat content of foods to these findings, CSPI asserts that PHOs trans fatty acids, are safe for use in food. meet the voluntary limit of 5 percent can no longer be considered GRAS.11 The fact that a substance was commonly total fat as trans fat, especially because In 2009, we received a citizen petition used in food prior to 1958 is not the monitoring data were posted on from Dr. Fred Kummerow requesting sufficient to support continued GRAS Health Canada’s Web site. However, that we ban partially hydrogenated fat status if there is no longer a scientific Health Canada noted that some sectors from the American diet. Dr. Kummerow consensus that the substance is safe for (i.e., bakery products, desserts, and cited studies linking the intake of the intended use in food. cookies) face challenges in reducing the industrially-produced trans fatty acids FDA has prepared a memorandum trans fat content of their products (Ref. to the prevalence of CHD in the United attempting to estimate the potential 44). States. The petition also asserts that costs and benefits associated with In the United States, some trans fat may be passed to infants via removing PHOs from the food supply jurisdictions such as the State of breast milk and that the daily intake of (Ref. 46). Where possible we have used California (California Health and Safety trans fat related to the health of children publicly available information to make Code, Section 114377), New York City has been ignored since children do not these estimates; however, in many cases (New York City Health Code, Section exhibit overt heart disease. Dr. we have very limited data to support 81.08), the City of Baltimore (Baltimore Kummerow further states that our rough estimates. We estimate the City Health Code Section 6–507), and inflammation in the arteries is believed initial costs of removing PHOs from the Montgomery County, MD (County to be a risk factor in CHD and studies food supply to be about $8 billion, Council for Montgomery County although those costs may not be borne Maryland, Resolution No. 16–134, 2007) 10 The petition from CSPI provided, as an all in one year if FDA provides a multi- have imposed restrictions on the use of example, partially hydrogenated methyl ester of year compliance period; we seek rosin, which is approved as a food additive for use trans fat ingredients in food service comment on that idea as part of this establishments. Generally, these as a synthetic flavoring substance (32 FR 7946, June 2, 1967; 21 CFR 172.515) and as a masticatory notice. We estimate the 20-year net regulations do not permit food service substance in chewing gum base (29 FR 13894, present value of costs to be between $12 establishments to sell or distribute October 8, 1964; 21 CFR 172.615). Partially and $14 billion, where the upper and hydrogenated methyl ester of rosin is not a PHO; foods, and in some cases, use lower estimates are calculated at 3 and ingredients, containing greater than 0.5 accordingly, this document does not address this substance. g trans fat per serving. In New York 11 The CSPI petition may be accessed at http:// 12 The petition from Dr. Kummerow may be City, by 2008 an estimated 98 percent of www.regulations.gov and is identified as Docket No. accessed at http://www.regulations.gov and is restaurants were not using ingredients FDA–2004–P–0279. identified as Docket No. FDA–2009–P–0382.

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7 percent discount rates. Using the same sorts of products and what challenges 106:867–877, 2006. method, we estimate benefits between are faced? 2. IOM/NAS, ‘‘Dietary Reference Intakes for $117 and $242 billion. Our 7. Is there any knowledge of an Energy Carbohydrate, Fat, Fatty Acids, memorandum is part of the applicable prior sanction for the use of Cholesterol, and Amino Acids (Macronutrients),’’ chapters 8 and 11, administrative record and can be found PHOs in food? We anticipate that some interested National Academies Press, Washington on http://www.regulations.gov as DC, 2002/2005 (Internet address: http:// Reference 46 to this document. As persons may wish to provide FDA with www.nap.edu). discussed in the memorandum, our certain comments, research, data, and 3. Dietz, W. H. and K. S. Scanlon, analysis focused on processed foods and information that they consider to be ‘‘Eliminating the Use of Partially food prepared at home. There may, trade secret or confidential commercial Hydrogenated Oil in Food Production however, be additional costs to small information (CCI) that would be exempt and Preparation,’’ Journal of the businesses associated with removing under Exemption 4 of the Freedom of American Medical Association, 108: 143–144, 2012. PHOs from food. Our intent is not to Information Act (5 U.S.C. 552). You may claim information that you submit to 4. Institute of Shortening and Edible Oils, create an undue burden on these Food Fats and Oils, 9th ed., Washington entities. Therefore, we are specifically FDA as CCI or trade secret by clearly DC, p. 9, 2006 (Internet address: http:// requesting comment on the costs to marking both the document and the www.iseo.org/httpdocs/Publications/ small businesses and any special specific information as ‘‘confidential.’’ FoodFatsOils2006.pdf). considerations that might be made in Information so marked will not be 5. Kodali, D. R. and G. R. List, Eds., Trans order to minimize the burden on these disclosed except in accordance with the Fats Alternatives, AOCS Press, entities. We request comment on what Freedom of Information Act and FDA’s Champaign, IL, pp. 4, 2005. 6. Kodali, D. R. and G. R. List, Eds., Trans types of special considerations for small disclosure regulations (21 CFR part 20). For electronic submissions to http:// Fats Alternatives, AOCS Press, business would be possible if FDA Champaign, IL, p. 34–35, 2005. makes a final determination that PHOs www.regulations.gov indicate in the 7. United States Department of Agriculture are not GRAS. ‘‘comments’’ box of the appropriate (USDA) National Nutrition Database for docket that your submission contains Standard Reference, Release 23, 2010 VII. Request for Comments and for confidential information. You must also (Internet address: http:// Scientific Data and Information submit a copy of the comment that does www.ars.usda.gov/Services/ We are seeking comments and not contain the information claimed as docs.htm?docid=8964). additional scientific data and confidential for inclusion in the public 8. Doell, D., D. Folmer, H. Lee, et al., information related to this action and, in version of the official record. ‘‘Updated Estimate of Trans Fat Intake Information not marked confidential by the U.S. Population,’’ Food Additives particular, we request comment on the and Contaminants: Part A: Chemistry, following: will be included in the public version Analysis, Control, Exposure and Risk 1. Should FDA finalize its tentative of the official record without prior Assessment, 29: 861–874, 2012. determination that PHOs are no longer notice. 9. Vesper, H.W., H.C. Kulper, L.B. Mirel, et GRAS? VIII. Comments al., ‘‘Research Letter: Levels of Plasma 2. Are there data to support other trans-Fatty Acids in Non-Hispanic White possible approaches to addressing the Interested persons may submit either Adults in the United States in 2000 and use of PHOs in food, such as by setting electronic comments and scientific data 2009,’’ Journal of the American Medical and information to http:// Association, 307: 562–563, 2012. a specification for trans fat levels in 10. Memorandum from D. Doell and M. food? www.regulations.gov or written comments and scientific data and Honigfort to Division of Petition Review, 3. How long would it take producers information to the Division of Dockets August 26, 2013. to reformulate food products to 11. USDA and Department of Health and Management (see ADDRESSES). It is only eliminate PHOs from the food supply? Human Services (HHS), Dietary necessary to send one set of comments. Are there likely to be differences in Guidelines for Americans, 2000, 5th ed., Identify comments with the docket reformulation time for certain foods or pp. 28–30, Washington, DC: U.S. number found in brackets in the for certain types of businesses? Government Printing Office, January heading of this document. Received 2000. 4. If FDA makes a final determination comments may be seen in the Division 12. Krauss, R.M., R.H. Eckel, B. Howard, et that PHOs are not GRAS and does not of Dockets Management between 9 a.m. al., ‘‘American Heart Association otherwise authorize their use in food, and 4 p.m., Monday through Friday, and Guidelines, Revision 2000: A Statement FDA intends to provide for a will be posted to the docket at http:// for Healthcare Professionals from the compliance date that would be adequate Nutrition Committee of the American www.regulations.gov. for producers to reformulate any Heart Association,’’ Circulation, 102: products as necessary and that would IX. References 2296–2311, 2000. 13. Memorandum from J. Park to M. minimize market disruption. We We have placed the following welcome comments on what would be Honigfort, August 10, 2005. references on display in the Division of 14. Memorandum from J. Park to M. an adequate time period for compliance. Dockets Management (see ADDRESSES). Honigfort, August 19, 2010. 5. Are there any special You may see them between 9 a.m. and 15. American Heart Association, considerations that could be made to 4 p.m., Monday through Friday. FDA http://www.heart.org/HEARTORG/ reduce the burden on small businesses has verified the Web site addresses, but GettingHealthy/FatsAndOils/Fats101/ _ _ _ that would result from removal of PHOs FDA is not responsible for any Trans-Fats UCM 301120 Article.jsp. from foods, such as additional time for subsequent changes to the Web sites 16. Eckel, R.H., S. Borra, A.H. Lichtenstein, reformulation? Would those et al., ‘‘Understanding the Complexity of after this document publishes in the Trans Fatty Acid Reduction in the considerations be consistent with a final Federal Register. determination that PHOs are not GRAS? American Diet,’’ Circulation, 115:2231– 1. Tarrago-Trani, M., K. M. Philips, L. E. 2246, 2007. 6. Are there other challenges Lemar, et al.,’’New and Existing Oils and 17. Kris-Etherton, P. M., S. Innis, ‘‘Position regarding the removal of PHOs from Fats Used in Products With Reduced of the American Dietetic Association and foods? Are there products that may not Trans-Fatty Acid Content,’’ Journal of Dietitians of Canada: Dietary Fatty be able to be reformulated? If so, what the American Dietetic Association, Acids,’’ Journal of the American Dietetic

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Association, pp. 1599–1611, 2007. Vegetable Oils With Other Fats and DEPARTMENT OF HEALTH AND 18. World Health Organization, ‘‘Diet, Oils,’’ European Journal of Clinical HUMAN SERVICES Nutrition, and the Prevention of Chronic Nutrition, 63:S22–S33, 2009. Disease,’’ Technical Series Report 916, 34. Chardigny, J.-M., F. Destaillats, C. National Institutes of Health pp. 81–85, Geneva, 2003. Malpuech-Brugere, J. Molin, et al., ‘‘Do 19. USDA and HHS, Dietary Guidelines for Trans Fatty Acids From Industrially Proposed Collection; 60-Day Comment Americans, 2005, 6th ed., pp. 29 through Produced Sources and From Natural Request: Incident HIV/Hepatitis B Virus 34, Washington, DC: U.S. Government Sources Have the Same Effect on Printing Office, January 2005. Cardiovascular Disease Risk Factors in Infections in South African Blood 20. USDA and HHS, Dietary Guidelines for Healthy Subjects? Results of the Trans Donors: Behavioral Risk Factors, Americans, 2010, 7th ed., pp. 24–27, Fatty Acids Collaboration (TRANSFACT) Genotypes and Biological Washington, DC: U.S. Government Study,’’ The American Journal of Characterization of Early Infection Printing Office, December 2010. Clinical Nutrition, 87:558–566, 2008. 21. HHS/FDA/Center for Food Safety and 35. Mensink, R. P., P. L. Zock, A. D. Kester, Summary: In compliance with the Applied Nutrition Advisory Committee/ et al., ‘‘Effects of Dietary Fatty Acids and requirement of Section 3506(c) (2) (A) of Nutrition Subcommittee Meeting, Total Carbohydrates on the Ratio of Serum the Paperwork Reduction Act of 1995, Fat and Trans Fat, April 27–28, 2004. Total to HDL Cholesterol and on Serum for opportunity for public comment on 22. Lefevre, M., J. C. Lovejoy, S. R. Smith, J. Lipids and Apolipoproteins: A Meta- proposed data collection projects, the P. DeLany, et al., ‘‘Comparison of the Analysis of 60 Controlled Trials,’’ The National Heart, Lung, and Blood Acute Response to Meals Enriched With American Journal of Clinical Nutrition, cis- or trans-Fatty Acids on Glucose and 77:1146–55, 2003. Institute (NHLBI), the National Lipids in Overweight Individuals With 36. Ascherio, A., ‘‘Trans Fatty Acids and Institutes of Health (NIH), will publish Differing FABP2 Genotypes,’’ Blood Lipids,’’ periodic summaries of proposed Metabolism, 54:1652–1658, 2005. Supplements, 7:25–27, 2006. projects to the Office of Management 23. Micha, R., D. Mozaffarian, ‘‘Trans Fatty 37. Mozaffarian, D., M. B., Katan, A. Asherio, and Budget (OMB) for review and Acids: Effects on Cardiometabolic Health M. J. Stampfer, et al., ‘‘Trans Fatty Acids approval. and Implications for Policy,’’ and Cardiovascular Disease,’’ The New Written comments and/or suggestions Prostaglandins, Leukotrienes and England Journal of Medicine, 354:1601– from the public and affected agencies Essential Fatty Acids, 79:147–152, 2008. 1613, 2006. are invited on one or more of the 38. Denke, M. A., ‘‘Dietary Fats, Fatty Acids, 24. Teegala, S. M., W. C. Willett, D. following points: (1) Whether the Mozaffarian, ‘‘Consumption and Health and Their Effects on Lipoproteins,’’ Effects of Trans Fatty Acids: A Review,’’ Current Atherosclerosis Reports, 8:466– proposed collection of information is Journal of AOAC International, 92:1250– 471, 2006. necessary for the proper performance of 1257, 2009. 39. Vega-Lopez, S., L. M. Ausman, S. M. the function of the agency, including 25. Riserus, U., ‘‘Trans Fatty Acids and Jalbert, A. T. Erkilla, et al., ‘‘Palm and whether the information will have Insulin Resistance,’’ Atherosclerosis Partially Hydrogenated Soybean Oils practical utility; (2) The accuracy of the Supplements, 7:37–39, 2006. Adversely Alter Lipoprotein Profiles agency’s estimate of the burden of the 26. Kavanagh, K., K. L. Jones, J. Sawyer, K. Compared with Soybean and Canola Oils proposed collection of information, Kelley, et al., ‘‘Trans Fat Diet Increases in Moderately Hyperlipidemic Subjects,’’ The American Journal of Clinical including the validity of the Abdominal Obesity Changes in Insulin methodology and assumptions used; (3) Sensitivity in Monkeys,’’ Obesity, Nutrition, 84:54–62, 2006. 15:1675–1684, 2007. 40. Leth, T., H. G. Jensen, A. A. Mikkelsen, Ways to enhance the quality, utility, and 27. Morrison, J. A., C. J. Glueck, P. Wang, A. Bysted, ‘‘The Effect of the Regulation clarity of the information to be ‘‘Dietary Trans Fatty Acid Intake is on Trans Fatty Acid Content in Danish collected; and (4) Ways to minimize the Associated with Increased Fetal Loss,’’ Food,’’ Atherosclerosis Supplements, burden of the collection of information Fertility and Sterility, 90:385–390, 2008. 7(2):53–56, 2006. on those who are to respond, including 28. Van Eijsden, M., G. Hornstra, M. F. van 41. Stender, S., J. Dyerberg, A. Bysted, T. the use of appropriate automated, Leth, et al., ‘‘A Trans World Journey,’’ der Waal, T. G. M. Vrijkotte, et al., electronic, mechanical, or other ‘‘Maternal n-3, n-6, and Trans Fatty Acid Atherosclerosis Supplements, 7:47–52, 2006. technological collection techniques or Profile Early in Pregnancy and Term other forms of information technology. Birth Weight: A Prospective Cohort 42. Bysted A., A. E. Mikkelsen, T. Leth, Study,’’ The American Journal of ‘‘Substitution of Trans Fatty Acids in To Submit Comments and For Further Clinical Nutrition, 87:887–895, 2008. Foods on the Danish Market,’’ European Information: To obtain a copy of the 29. Innis, S., ‘‘Fatty Acids and Early Human Journal of Lipid Science and Technology, data collection plans and instruments, Development,’’ Early Human 111:574–583, 2009. submit comments in writing, or request Development, 83:761–766, 2007. 43. Health Canada, ‘‘Trans Fat’’ (Internet more information on the proposed 30. Hornstra, G., M. van Eijsden, C. Dirix, G. address: http://www.hc-sc.gc.ca/fn-an/ project, contact: Simone Glynn, MD, nutrition/gras-trans-fats/index-eng.php). Bonsel, ‘‘Trans Fatty Acids and Birth Project Officer/ICD Contact, Two Outcome: Some First Results of the 44. Health Canada, ‘‘Fourth Set of Monitoring Data—Trans Fat Monitoring Program’’ Rockledge Center, Suite 9142, 6701 MEFAB and ABCD Cohorts,’’ Rockledge Drive, Bethesda, MD 20892, Atherosclerosis Supplements, 7:21–23, (Internet address: http://www.hc- sc.gc.ca/fn-an/nutrition/gras-trans-fats/ or call 301–435–0065, or Email your 2006. _ _ 31. Innis, S. ‘‘Trans Fatty Intakes During tfa-age four-data quatr-donn-eng.php). request, including your address to: Pregnancy, Infancy and Early 45. Angell, S. Y., L. D. Silver, G. P. Goldstein, [email protected]. Formal requests Childhood,’’ Atherosclerosis C. M. Johnson, et al., ‘‘Cholesterol for additional plans and instruments Supplements, 7:17–20, 2006. Control Beyond the Clinic: New York must be requested in writing. 32. Brouwer, I. A., A. J. Wanders, M. B. City’s Trans Fat Restriction,’’ Annals of Comments Due Date: Comments Internal Medicine, 151:129–134, 2009. Katan, ‘‘Effect of Animal and Industrial regarding this information collection are Trans Fatty Acids on HDL and LDL 46. Memorandum from R. Bruns to M. Honigfort, November 5, 2013. best assured of having their full effect if Cholesterol Levels in Humans—A received within 60 days of the date of Quantitative Review,’’ PLoS One, Dated: November 5, 2013. this publication. 5(3):e9434, 2010. Leslie Kux, 33. Mozaffarian, D., R. Clarke, ‘‘Quantitative Proposed Collection: Incident HIV/ Assistant Commissioner for Policy. Effects on Cardiovascular Risk Factors Hepatitis B virus (HBV) infections in and Coronary Heart Disease Risk of [FR Doc. 2013–26854 Filed 11–7–13; 8:45 am] South African blood donors: Behavioral Replacing Partially Hydrogenated BILLING CODE 4160–01–P risk factors, genotypes and biological

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