[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67169-67175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1317]


Tentative Determination Regarding Partially Hydrogenated Oils; 
Request for Comments and for Scientific Data and Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and for scientific data and 
information.

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SUMMARY: Based on new scientific evidence and the findings of expert 
scientific panels, the Food and Drug Administration (FDA) has 
tentatively determined that partially hydrogenated oils (PHOs), which 
are the primary dietary source of industrially-produced trans fatty 
acids, or trans fat, are not generally recognized as safe (GRAS) for 
any use in food based on current scientific evidence establishing the 
health risks associated with the consumption of trans fat, and 
therefore that PHOs are food additives. Although FDA has not listed the 
most commonly used PHOs, they have been used in food for many years 
based on self-determinations by industry that such use is GRAS. If 
finalized, this would mean that food manufacturers would no longer be 
permitted to sell PHOs, either directly or as ingredients in another 
food product, without prior FDA approval for use as a food additive.

DATES: Submit either electronic or written comments and scientific data 
and information by January 7, 2014.

ADDRESSES: Submit electronic comments and scientific data and 
information to http://www.regulations.gov. Submit written comments and 
scientific data and information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All submissions must include the Agency name and 
the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Mical Honigfort, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1278, FAX: 
301-436-2972, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Introduction

    In accordance with the process set out in Sec.  170.38(b)(1) (21 
CFR 170.38(b)(1)), we are issuing this document announcing our 
tentative determination that PHOs are no longer GRAS under any 
condition of use in food and therefore are food additives subject to 
section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 348). If finalized, this would mean that food manufacturers 
would no longer be permitted to sell PHOs, either directly or as 
ingredients in another food product, without prior FDA approval for use 
as a food additive.
    FDA's evaluation of the GRAS status of PHOs is centered on the 
trans fatty acid (also referred to as ``trans fat'') component of these 
oils. This document addresses PHOs because they are the primary dietary 
source of industrially-produced trans fat (Ref. 1). Although all 
refined edible oils contain some trans fat as an unintentional 
byproduct of their manufacturing process, trans fats are an integral 
component of PHOs and are purposely produced in these oils to affect 
the properties of the oil and the characteristics of the food to which 
they are added.
    The current scientific evidence, which is discussed in section IV 
of this document, identifies significant health risks caused by the 
consumption of trans fat. This evidence includes the opinions of expert 
panels and the 2005 recommendation of the Institute of Medicine (IOM) 
to limit trans fat consumption as much as possible while consuming a 
nutritionally adequate diet, recognizing that trans fat occurs 
naturally in meat and dairy products from ruminant animals and that 
naturally-occurring trans fat is unavoidable in ordinary, nonvegan 
diets without significant dietary adjustments that may introduce 
undesirable effects (Ref. 2). In addition, according to the Centers for 
Disease Control and Prevention (CDC), elimination of PHOs from the food 
supply could prevent 10,000 to 20,000 coronary events and 3,000 to 
7,000 coronary deaths annually, if the marginal benefits of continuing 
to remove trans fats from food items remain constant (Ref. 3). (See 
accompanying economic analysis for more information on this estimate.) 
Given this evidence, we have tentatively determined that there is no 
longer a consensus among qualified scientific experts that PHOs, the 
primary dietary source of industrially-produced trans fatty acids, are 
safe for human consumption, either directly or as ingredients in other 
food products.

II. Background

A. Hydrogenation Process and Trans Fatty Acids

    Chemical hydrogenation is the process by which hydrogen atoms are 
added to unsaturated sites on the carbon chains of fatty acids, in the 
presence of catalysts, thereby reducing the number of double bonds. 
``Partial hydrogenation'' describes an incomplete saturation of the 
double bonds, in which some double bonds remain but may shift to a 
different position along the carbon chain and alter their configuration 
from cis to trans. The trans arrangement of hydrogen atoms results in a 
relatively straight configuration of the fatty acids and increases the 
melting point, shelf life,

[[Page 67170]]

and flavor stability of the hydrogenated oil. Because of these 
technical properties, PHOs have been used by the food industry in such 
products as margarine, shortening, and baked goods. The hydrogenation 
process can be controlled to meet the physical or chemical properties 
needed for a specific product application (Ref. 4). If an oil is 
allowed to hydrogenate completely, the carbon-carbon double bonds are 
mostly eliminated, resulting in a ``fully hydrogenated oil.'' The trans 
fatty acid content of PHOs can vary from approximately 10 to 60 percent 
of the oil, depending on how the oil is manufactured, with an average 
trans fatty acid content of 25 to 45 percent of the oil (Ref. 1). 
Changes in the pressure, temperature, amount of agitation in the 
reaction vessel, type and concentration of catalyst, reaction time, and 
fat source will affect the production of trans fatty acid isomers in 
PHOs.
    As noted, trans fatty acids are also formed during the production 
of non-hydrogenated refined oils (i.e., soybean and cottonseed oils) as 
a result of the cis to trans isomerization induced by high temperatures 
used during processing, such as deodorization (Ref. 5). The 
concentration of trans fatty acids in non-hydrogenated refined oils is 
typically below 2 percent (Ref. 6). Low levels (below 2 percent) of 
trans fatty acids may also be found in fully hydrogenated oils due to 
incomplete hydrogenation (Ref. 7). Theoretically, a fully hydrogenated 
oil would be fully saturated and would not contain any trans fatty 
acids. However, no hydrogenation process is 100 percent efficient. In 
addition, the trans fatty isomer content of an edible oil can be 
controlled by blending different oils or through processing of mixed 
fatty acids (Ref. 4).\1\
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    \1\ Hydrogenation also occurs in the digestive tract of ruminant 
animals and results in the formation of some trans isomers in the 
fat components of dairy and meat products from these animals. These 
isomers usually make up only a small percent (typically around 3 
percent) of the total fatty acids of such products (Ref. 5). This 
document is limited to PHOs and does not address the trans fat 
component of meat and dairy products from ruminant animals.
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B. The GRAS Standard

    Section 409 of the FD&C Act provides that a food additive is unsafe 
unless it is used in accordance with certain conditions set forth in 
that section. ``Food additive'' is defined by section 201(s) of the 
FD&C Act (21 U.S.C. 321(s)) as any substance the intended use of which 
results or may reasonably be expected to result in its becoming a 
component or otherwise affecting the characteristics of any food, if 
such substance is not GRAS.\2\ A substance is GRAS if it is generally 
recognized, among experts qualified by scientific training and 
experience to evaluate its safety, as having been adequately shown 
through scientific procedures (or, in the case of a substance used in 
food prior to January 1, 1958, through either scientific procedures or 
experience based on common use in food) to be safe under the conditions 
of its intended use. However, history of use prior to 1958 is not 
sufficient to support continued GRAS status if new evidence 
demonstrates that there is no longer a consensus that an ingredient is 
safe.
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    \2\ Certain other substances that may become components of food 
are also excluded from the statutory definition of food additive, 
including pesticide chemicals and their residues, new animal drugs, 
color additives, and dietary ingredients in dietary supplements (21 
U.S.C. 321(s)(1) through (s)(6)).
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    FDA has defined safe as ``a reasonable certainty in the minds of 
competent scientists that the substance is not harmful under the 
intended conditions of use'' (21 CFR 170.3(i)), and general recognition 
of safety must be based only on the views of qualified experts (21 CFR 
170.30(a)). To establish such recognition, there must be a consensus of 
expert opinion regarding the safety of the use of the substance. (See, 
e.g., United States v. Western Serum Co., Inc., 666 F.2d 335, 338 (9th 
Cir. 1982) (citing Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 
609, 629-32 (1973)). Unanimity among experts regarding safety of a 
substance is not required. (See, e.g., United States v. Articles of 
Drug * * * 5,906 boxes, 745 F.2d 105, 119 n. 22 (1st Cir. 1984); United 
States v. Articles of Food and Drug (Coli-Trol 80), 518 F.2d 743, 746 
(5th Cir. 1975) (``What is required is not unanimous recognition but 
general recognition.'')). However, the existence of a severe conflict 
among experts regarding the safety of the use of a substance precludes 
a finding of general recognition (See, e.g., Premo Pharmaceutical 
Laboratories v. United States, 629 F.2d 795, 803 (2d Cir. 1980)).
    Importantly, the GRAS status of a specific use of a particular 
substance in food is time-dependent. That is, as new scientific data 
and information develop about a substance or the understanding of the 
consequences of consumption of a substance evolves, expert opinion 
regarding the safety of a substance for a particular use may change 
such that there is no longer a consensus that the specific use is safe. 
The fact that the status of a substance under section 201(s) of the 
FD&C Act may evolve over time is the underlying basis for FDA's 
regulation at Sec.  170.38, which provides in part that FDA may, on its 
own initiative, propose to determine that a substance is not GRAS. (See 
generally 36 FR 12093 (June 25, 1971) (issuance of 21 CFR 121.3, the 
predecessor of Sec.  170.38)). Further, as stated previously, history 
of the safe use of a substance in food prior to 1958 is not sufficient 
to support continued GRAS status if new evidence demonstrates that 
there is no longer expert consensus that an ingredient is safe.
    As noted previously, under section 201(s) of the FD&C Act, a 
substance that is GRAS for a particular use in food is not a food 
additive, and may lawfully be utilized for that use without Agency 
review and approval. Currently, a GRAS determination is made when the 
manufacturer or user of a food substance evaluates the safety of the 
substance and the views of qualified experts and concludes that the use 
of the substance is GRAS. This approach is commonly referred to as 
``GRAS self-determination.'' Substances that have been self-determined 
as GRAS are not comprehensively listed or otherwise publicly 
identified.
    Other substances that are GRAS may be identified in FDA regulations 
in one of two ways. Following the passage of the 1958 Food Additives 
Amendment, FDA established in its regulations a list of food substances 
that, when used as indicated, are considered GRAS. This list (commonly 
referred to as the ``GRAS list'') now appears at 21 CFR part 182. 
Thereafter, in 1972, we established the GRAS affirmation process 
through which we affirmed, through notice and comment rulemaking, the 
GRAS status of particular uses of certain substances in food.\3\ 
Regulations affirming the GRAS status of certain substances appear at 
21 CFR parts 184 and 186.\4\
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    \3\ As a general matter, FDA no longer lists GRAS substances in 
its regulations because, in April 1997, we proposed to establish a 
voluntary notification program for GRAS, which does not involve 
rulemaking (62 FR 18938, April 17, 1997). At the time of the 
proposal, FDA initiated a pilot of the GRAS notification program, 
which continues to function. A firm may voluntarily submit 
information on a GRAS self-determination to FDA for review through 
the GRAS notification program, but is not required to do so.
    \4\ For a more detailed discussion of the history of GRAS, see 
62 FR 18938 at 18939 and 18940.
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C. Status of PHOs

    PHOs, which are the primary dietary source of industrially-produced 
trans fat (Ref. 1), have a long history of use as food ingredients. The 
partial hydrogenation process was developed in the 1930s and has been 
in widespread commercial use since the 1940s. Two common PHOs currently 
used by the food industry are partially

[[Page 67171]]

hydrogenated soybean oil and partially hydrogenated cottonseed oil, 
neither of which is listed as GRAS in FDA's regulations. However, these 
and other commonly used PHOs (e.g., partially hydrogenated coconut oil 
and palm oil) have been considered GRAS (through a GRAS self-
determination) by the food industry for use in food at levels 
consistent with good manufacturing practice based on a history of use 
prior to 1958. We are not aware that either FDA or the United States 
Department of Agriculture (USDA) granted any explicit prior sanction or 
approval for any use of PHOs in food prior to the 1958 Food Additives 
Amendment to the FD&C Act.
    In contrast, the partially hydrogenated versions of low erucic acid 
rapeseed oil (LEAR oil; 21 CFR 184.1555(c)(2)) and menhaden oil (21 CFR 
184.1472(b)) are affirmed by regulation as GRAS for use in food. 
Partially hydrogenated LEAR oil was affirmed as GRAS for use in food 
(50 FR 3745; January 28, 1985) through scientific procedures. Partially 
hydrogenated menhaden oil was affirmed as GRAS for use in food (54 FR 
38219; September 15, 1989) on the basis that the oil is chemically and 
biologically comparable to commonly used partially hydrogenated 
vegetable oils such as corn and soybean oils. Partially hydrogenated 
LEAR and menhaden oils are not currently widely used by the food 
industry.\5\
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    \5\ The non-hydrogenated version of LEAR oil (also known as 
canola oil) is widely used in foods, and non-hydrogenated menhaden 
oil is currently used in a limited number of products, primarily to 
increase the omega-3 fatty acid content of the food. Like other non-
hydrogenated refined oils, non-hydrogenated LEAR and menhaden oils, 
which are also affirmed by FDA as GRAS for use in food, are not 
significant dietary sources of trans fat.
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    Although none of the food standards of identity in FDA's 
regulations explicitly refers to PHOs, the nature of some of the 
products for which there are standards of identity is such that PHOs 
historically have been used in their manufacture in conformance with 
those standards (e.g., shortening in bread, rolls, and buns (21 CFR 
136.110(c)(5)), French dressing (21 CFR 169.115), mayonnaise (21 CFR 
169.140), and margarine (21 CFR 166.110)). However, no food standard of 
identity requires the use of PHOs and, therefore, industry's ability to 
comply with any standard would not be prevented by a change in the 
regulatory status of PHOs.

D. Labeling of Trans Fat

    As an initial step to address the negative health effects of trans 
fat consumption in the United States, we issued a proposed rule in the 
Federal Register of November 17, 1999 (64 FR 62746) entitled ``Food 
Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content 
Claims, and Health Claims'' (the November 1999 proposal), in which we 
proposed that trans fat content be provided in nutrition labeling to 
help consumers determine how each food product contributes to their 
overall dietary intake of trans fat. Our proposal was supported by 
findings from intervention and observational studies that evaluated the 
evidence that dietary trans fatty acids influence blood lipid levels in 
humans and increase their risk of coronary heart disease (CHD) (64 FR 
62746 at 62750). In the November 1999 proposal, we discussed research 
that showed that diets containing trans fatty acids resulted in 
increased serum low-density lipoprotein cholesterol (LDL-C), a major 
risk factor for CHD (64 FR at 62746 at 62749 through 62754). In the 
Federal Register of July 11, 2003 (68 FR 41434), we issued a final rule 
(the July 2003 final rule) amending our nutrition labeling regulations 
to require declaration of the trans fatty acid content of food in the 
nutrition label of conventional foods and dietary supplements (21 CFR 
101.9(c)(2)(ii)). This requirement was effective January 1, 2006.\6\ In 
the July 2003 final rule (68 FR 41434 at 41457), the Agency noted that 
the IOM/National Academy of Sciences (IOM/NAS) report about trans fat 
(Ref. 2) did not make quantitative recommendations for establishing a 
Daily Reference Value (DRV) for trans fat. The IOM/NAS report 
recommended that the intake of trans fat be as low as possible while 
maintaining a nutritionally balanced diet and did not provide a daily 
reference intake (DRI) for trans fat or information that the Agency 
needs to establish a DRV for nutrition labeling purposes. Therefore, in 
the absence of a scientific basis or recommendation for trans fat 
consumption by an authoritative body, FDA did not establish a DRV for 
trans fat, and therefore, the July 2003 final rule did not require 
listing of Percent of Daily Value (% DV) for trans fat on product 
labels.
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    \6\ The regulation requires the declaration of the amount of 
trans fat in a product, on a separate line directly below the 
statement for saturated fat; the declaration must express the amount 
of trans fat as grams per serving to the nearest 0.5 g increment 
below 5 g and to the nearest gram increment above 5 g. If a serving 
contains less than 0.5 g, the trans fat content may be declared as 
zero. The regulation also provides that, in certain circumstances, 
the statement ``Not a significant source of trans fat'' may be used 
instead of a declaration of trans fat content. The regulation 
defines the number of grams of trans fat in a serving as the sum of 
all unsaturated fatty acids that contain one or more isolated (i.e., 
nonconjugated) double bonds in a trans configuration. If FDA makes a 
final determination that PHOs are not GRAS, no amount of PHOs would 
be permitted in food products without prior FDA approval for use as 
a food additive.
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III. Current Dietary Intake of Trans Fat From PHOs

    In the July 2003 final rule, we estimated that mean adult (aged 20 
years or more) intake of trans fat from products containing PHOs was 
4.6 grams per day (g/d) (2.0 percent of energy based on a 2,000 calorie 
diet) (68 FR 41434 at 41470).\7\ We also estimated that total trans fat 
intake from products containing PHOs and from animal products 
containing trans fat (1.2 g/d) was 5.8 g/d for adults (2.6 percent of 
caloric energy). Based on food composition data collected in 2009 and 
2010, we updated our intake estimate of trans fat from products 
containing PHOs. Our analysis showed that many food products have been 
reformulated to eliminate or to substantially reduce the amount of 
industrially-produced trans fatty acids (Ref. 8). However, as discussed 
further in this section, certain population groups still consume high 
levels of trans fatty acids, primarily through consumption of food 
products containing PHOs.
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    \7\ (4.6 g//d x 9 kcal/g x 100)/2,000 kcal/d = 2.0% of energy.
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    In 2010, we prepared an estimate of the intake of industrially-
produced trans fat using available food consumption data (2003-2006 
National Health and Nutrition Examination Survey (NHANES)), market 
share information, and trans fat levels based on label declaration data 
and analytical data for products that were identified as containing 
PHOs (Ref. 8). We estimated the 2010 mean trans fat intake for the U.S. 
population aged 2 years or more \8\ who consumed one or more of the 
processed foods identified as containing PHOs \9\ to be 1.3 grams per 
person per day (g/p/d) (0.6 percent of caloric energy). For high-level 
consumers (represented by the 90th percentile), we estimated the intake 
to be 2.6 g/p/d (1.2 percent of caloric energy) for the U.S. population 
aged 2 years or more. Based on this estimate, the mean dietary intake 
of industrially-produced trans fat has decreased significantly since 
our estimate in the July 2003 final rule.

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Additionally, scientists at the CDC recently studied the change in 
levels of four major trans fatty acids in the blood of U.S. non-
Hispanic white adults from 2000 to 2009, and reported a 58 percent 
average decrease during that timeframe (Ref. 9).
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    \8\ While we did not calculate a mean intake for ages 20 years 
or more, based on the similarity in the intakes calculated for 
children aged 2-5 years, teenage boys, and persons aged 2 years or 
more (Ref. 8), we believe there would not be a significant 
difference between the intake estimated for persons ages 2 years or 
more and that for persons ages 20 years or more.
    \9\ The current estimate indicated that approximately 100 
percent of the population consumed one or more of the foods under 
consideration. This is due to the wide variety of foods that contain 
trans fat from PHOs.
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    The data that we collected show that many foods (e.g., frozen 
potato products, most frozen breaded products) have been reformulated 
to remove PHOs. However, a number of foods made with PHOs remain on the 
market. These products fall into one of two categories: Foods for which 
consumers have alternatives containing lower levels of trans fat (e.g., 
cookies, baked goods, microwave popcorn, frozen pizza, frozen pies, 
shortening) and foods for which consumers have limited or no choice of 
an alternative containing a lower level of trans fat (e.g., ready-to-
use frostings, stick margarine).
    In 2010, we also prepared an estimate for a high-intake scenario by 
assuming that trans fat was present at the highest level observed for 
all foods within a particular food category based on label surveys or 
analytical data. For this scenario, we estimated the mean intake to be 
2.7 g/p/d (1.2 percent of energy) and the 90th percentile intake to be 
5.4 g/p/d (2.4 percent of energy) for the U.S. population aged 2 years 
or more.
    In 2012, using label survey data, we updated the 2010 intake 
estimate of trans fats from PHOs for those food categories that were 
identified as major contributors to the dietary intake of trans fat, as 
well as for those categories where we have noted progress in 
reformulation. For this most recent estimate, we calculated the mean 
intake to be 1.0 g/p/d (0.5 percent of energy) and the 90th percentile 
intake to be 2.0 g/p/d (1.0 percent of energy) for the U.S. population 
aged 2 years or more (Ref. 10). We also prepared an estimate for a 
high-intake scenario by assuming that trans fat was present at the 
highest level observed for all foods within a particular food category 
based on the label survey. For this scenario, we estimated the mean 
intake to be 2.1 g/p/d (1.0 percent of energy) and the 90th percentile 
intake to be 4.2 g/p/d (1.9 percent of energy) for the U.S. population 
aged 2 years or more.
    We do not consider this to be a significant change in the overall 
dietary intake of trans fat since 2010. However, it suggests a 
continued downward trend in the dietary intake of trans fat. 
Specifically, there was a decrease observed in the intake of trans fat 
in the refrigerated dough, savory snacks, and frozen pizza categories, 
consistent with the lower levels of trans fat observed in our label 
survey.
    Although trans fat intake has decreased overall since our 2003 
trans fat intake estimate, individuals with certain dietary habits may 
still consume high levels of trans fat from certain brands or certain 
types of food products (e.g., refrigerated biscuits, ready-to-use 
frostings, certain brands of frozen pizzas, and certain brands of 
microwave popcorn), which could contain several grams trans fat per 
serving. As noted previously, for those consumers who consistently 
choose these products, the daily intake of added trans fat is 
approximately twice as high as that for the consumer who does not 
choose only the foods containing the highest levels of trans fat within 
a particular category (2.1 g/p/d vs. 1.0 g/p/d).

IV. Safety

    In the November 1999 proposed rule, we concluded that dietary trans 
fatty acids have adverse effects on blood cholesterol measures that are 
predictive of CHD risk, specifically LDL-C levels (64 FR 62746 at 
62754). We took final action in the July 2003 final rule based on our 
evaluation of comments received and on scientific evidence 
demonstrating that the consumption of trans fatty acids increases LDL-
C, one of the major risk factors for CHD. The July 2003 final rule 
cited authoritative reports that recommended limiting intake of trans 
fat to reduce CHD risk, such as the Dietary Guidelines for Americans, 
2000 (Ref. 11), the American Heart Association Guidelines (Ref. 12), 
the 2002 IOM/NAS report (Ref. 2), as well as additional studies that 
had been published since the November 1999 proposal (68 FR 41434 at 
41444). In particular, the 2002 IOM/NAS report recognized the positive 
linear trend between trans fat intake, LDL-C concentration, and heart 
disease, concluded that ``trans fatty acids are not essential and 
provide no known benefit to human health,'' and recommended that 
``trans fatty acid consumption be kept as low as possible while 
consuming a nutritionally adequate diet.'' The report did not recommend 
an upper limit for trans fat because it concluded that any incremental 
increase in trans fat consumption increases the risk of CHD.
    FDA has summarized findings reported in the literature since the 
publication of the July 2003 final rule (Refs. 13, 14). Since 2003, 
both controlled trials and observational human studies published on 
trans fatty acid consumption have consistently confirmed the adverse 
effects of trans fatty acid consumption on intermediary risk factors 
(e.g., serum lipoproteins) and the increased risk of CHD (Ref. 13). 
Expert review panels from the IOM/NAS in 2005 (Ref. 2), the American 
Heart Association (Refs. 15, 16), the American Dietetic Association 
(Ref. 17), the World Health Organization (Ref. 18), the Dietary 
Guidelines Advisory Committee (Refs. 19, 20), and the FDA Food Advisory 
Committee Nutrition Subcommittee (Ref. 21) agree that trans fat-
mediated changes in lipid metabolism, pro-inflammatory effects, and 
endothelial dysfunction lead to dose-dependent increases in CHD events 
in humans. These expert panels all concluded that there is no threshold 
intake level for industrially-produced trans fat that would not 
increase an individual's risk of CHD, or adverse effects on risk 
factors for CHD. Moreover, the panels also agree that trans fatty acids 
have a stronger effect on the risk of CHD than saturated fatty acids.
    This significant recent evidence demonstrating the increased risk 
of CHD from consumption of any amount of trans fat means that 
consumption of PHOs, the primary dietary source of trans fat, also 
leads to increased LDL-C levels and an increased risk of CHD. These 
demonstrated effects support a determination that the consumption of 
PHOs could be harmful (i.e., increased risk for CHD) under any 
condition of use in food. Accordingly, we tentatively determine that 
this evidence erodes any basis to support the GRAS status of these 
oils, and therefore that there is no longer a consensus among qualified 
scientific experts that PHOs, the primary dietary source of 
industrially-produced trans fatty acids, are safe under any condition 
of use in food.
    We note that, in addition to an increased risk of CHD, trans fat 
consumption (and, accordingly, consumption of food products containing 
PHOs) has also been connected to a number of other adverse effects on 
health. Some studies suggest that trans fat consumption may worsen 
insulin resistance, especially in those who are predisposed to the 
condition (e.g., preexisting insulin resistance, greater adiposity, or 
lower physical activity levels) (Refs. 22, 23). Trans fat may also 
increase diabetes risk (Refs. 22-26) although this association requires 
further confirmation. In addition, there is some evidence that fetuses 
and breastfeeding infants of mothers who regularly consume trans fat 
may be at higher risk for impaired growth (which may be due to 
inhibition of the synthesis of essential polyunsaturated fatty acids 
that are needed for their growth and development) (Refs. 27-31). 
Scientific evidence also shows that, in addition to

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increasing LDL-C, trans fat intake lowers serum high-density 
lipoprotein cholesterol (HDL-C), a protective form of serum cholesterol 
(Refs. 32-39).

V. Other Activities Relating to PHO Consumption

    Over the past 5 years, several municipalities, states, and other 
countries have taken action to reduce the use of PHOs in food. While 
these actions pertain generally to all products containing trans fat, 
because PHOs are the primary dietary source of trans fat, their 
immediate effect is primarily on food products containing PHOs. For 
example, the Danish government passed legislation in 2003 that 
restricted the use of industrially-produced trans fat to a maximum of 2 
percent of fats and oils used in all processed food products. These 
required limitations on dietary trans fat have nearly eliminated trans 
fat from commercial sources such that industrially-produced trans fat 
is no longer a significant source of intake of trans fat in Denmark 
(Refs. 40-42). Also, in 2007, Canada set voluntary trans fat reduction 
targets of no more than 2 percent trans fat in the fat content of 
vegetable oils and spreadable margarine and no more than 5 percent in 
all other foods (Ref. 43). Health Canada monitored the industry's 
actions by analyzing products and reviewing nutrition labels. Canada's 
monitoring data showed that nutrition labeling regulations are an 
effective motivator for industry and that many manufacturers reduced 
the trans fat content of foods to meet the voluntary limit of 5 percent 
total fat as trans fat, especially because the monitoring data were 
posted on Health Canada's Web site. However, Health Canada noted that 
some sectors (i.e., bakery products, desserts, and cookies) face 
challenges in reducing the trans fat content of their products (Ref. 
44).
    In the United States, some jurisdictions such as the State of 
California (California Health and Safety Code, Section 114377), New 
York City (New York City Health Code, Section 81.08), the City of 
Baltimore (Baltimore City Health Code Section 6-507), and Montgomery 
County, MD (County Council for Montgomery County Maryland, Resolution 
No. 16-134, 2007) have imposed restrictions on the use of trans fat 
ingredients in food service establishments. Generally, these 
regulations do not permit food service establishments to sell or 
distribute foods, and in some cases, use ingredients, containing 
greater than 0.5 g trans fat per serving. In New York City, by 2008 an 
estimated 98 percent of restaurants were not using ingredients 
containing industrially-produced trans fat, compared with 50 percent in 
2005 (Ref. 45).
    We have also received two citizen petitions regarding the safety of 
PHOs. In 2004, FDA received a citizen petition from the Center for 
Science in the Public Interest (CSPI) requesting that we revoke the 
GRAS status of PHOs, and consequently declare that all of these oils 
are food additives. The petition also asks FDA to revoke the safe 
conditions of use for partially hydrogenated products that are 
currently considered food additives,\10\ to prohibit the use of 
partially hydrogenated vegetable oils that are prior sanctioned (FDA is 
not aware of any), and to initiate a program to encourage manufacturers 
and restaurants to switch to more healthy oils. The petition excluded 
trans fat that occurs naturally in meat from ruminant animals and dairy 
fats, and that forms during the production of non-hydrogenated oils. It 
also does not include fully hydrogenated oils, which contain negligible 
amounts of trans fat, and PHOs that may be produced by new technologies 
that result in negligible amounts of trans fat in the final product. 
CSPI's petition states that trans fat promotes CHD by increasing LDL-C 
and also by lowering HDL-C, and therefore has greater adverse effects 
on serum lipids (and possibly CHD) than saturated fats. CSPI also 
states that, beyond its adverse effects on serum lipids, trans fat may 
promote heart disease in additional ways. Based on these findings, CSPI 
asserts that PHOs can no longer be considered GRAS.\11\
---------------------------------------------------------------------------

    \10\ The petition from CSPI provided, as an example, partially 
hydrogenated methyl ester of rosin, which is approved as a food 
additive for use as a synthetic flavoring substance (32 FR 7946, 
June 2, 1967; 21 CFR 172.515) and as a masticatory substance in 
chewing gum base (29 FR 13894, October 8, 1964; 21 CFR 172.615). 
Partially hydrogenated methyl ester of rosin is not a PHO; 
accordingly, this document does not address this substance.
    \11\ The CSPI petition may be accessed at http://www.regulations.gov and is identified as Docket No. FDA-2004-P-0279.
---------------------------------------------------------------------------

    In 2009, we received a citizen petition from Dr. Fred Kummerow 
requesting that we ban partially hydrogenated fat from the American 
diet. Dr. Kummerow cited studies linking the intake of industrially-
produced trans fatty acids to the prevalence of CHD in the United 
States. The petition also asserts that trans fat may be passed to 
infants via breast milk and that the daily intake of trans fat related 
to the health of children has been ignored since children do not 
exhibit overt heart disease. Dr. Kummerow further states that 
inflammation in the arteries is believed to be a risk factor in CHD and 
studies have shown that trans fatty acids elicit an inflammatory 
response.\12\
---------------------------------------------------------------------------

    \12\ The petition from Dr. Kummerow may be accessed at http://www.regulations.gov and is identified as Docket No. FDA-2009-P-0382.
---------------------------------------------------------------------------

VI. Tentative Determination

    As discussed previously, for a substance to be GRAS, there must be 
a consensus among qualified experts that the substance is safe under 
the intended conditions of use. In accordance with the process in FDA's 
regulations in Sec.  170.38, the Agency on its own initiative or on the 
petition of any interested person, under 21 CFR part 10, may publish a 
notice in the Federal Register determining that a substance is not GRAS 
and is a food additive subject to section 409 of the FD&C Act. In 
accordance with this process, we will normally allow a period of 60 
days during which any interested person may file comments, and we will 
evaluate all comments received (Sec.  170.38(b)). If we conclude that 
there is a lack of convincing evidence that the substance is GRAS or is 
otherwise exempt from the definition of a food additive in section 
201(s) of the FD&C Act, we will publish a notice thereof in the Federal 
Register.
    Based on current scientific evidence discussed in section IV of 
this document regarding the health risks associated with the 
consumption of trans fat, opinions of expert panels, as well as the 
IOM's recommendation to limit trans fat consumption as much as 
possible, we have tentatively determined that there is not a consensus 
that PHOs, the primary dietary source of industrially-produced trans 
fatty acids, are safe for use in food. The fact that a substance was 
commonly used in food prior to 1958 is not sufficient to support 
continued GRAS status if there is no longer a scientific consensus that 
the substance is safe for the intended use in food.
    FDA has prepared a memorandum attempting to estimate the potential 
costs and benefits associated with removing PHOs from the food supply 
(Ref. 46). Where possible we have used publicly available information 
to make these estimates; however, in many cases we have very limited 
data to support our rough estimates. We estimate the initial costs of 
removing PHOs from the food supply to be about $8 billion, although 
those costs may not be borne all in one year if FDA provides a multi-
year compliance period; we seek comment on that idea as part of this 
notice. We estimate the 20-year net present value of costs to be 
between $12 and $14 billion, where the upper and lower estimates are 
calculated at 3 and

[[Page 67174]]

7 percent discount rates. Using the same method, we estimate benefits 
between $117 and $242 billion. Our memorandum is part of the 
administrative record and can be found on http://www.regulations.gov as 
Reference 46 to this document. As discussed in the memorandum, our 
analysis focused on processed foods and food prepared at home. There 
may, however, be additional costs to small businesses associated with 
removing PHOs from food. Our intent is not to create an undue burden on 
these entities. Therefore, we are specifically requesting comment on 
the costs to small businesses and any special considerations that might 
be made in order to minimize the burden on these entities. We request 
comment on what types of special considerations for small business 
would be possible if FDA makes a final determination that PHOs are not 
GRAS.

VII. Request for Comments and for Scientific Data and Information

    We are seeking comments and additional scientific data and 
information related to this action and, in particular, we request 
comment on the following:
    1. Should FDA finalize its tentative determination that PHOs are no 
longer GRAS?
    2. Are there data to support other possible approaches to 
addressing the use of PHOs in food, such as by setting a specification 
for trans fat levels in food?
    3. How long would it take producers to reformulate food products to 
eliminate PHOs from the food supply? Are there likely to be differences 
in reformulation time for certain foods or for certain types of 
businesses?
    4. If FDA makes a final determination that PHOs are not GRAS and 
does not otherwise authorize their use in food, FDA intends to provide 
for a compliance date that would be adequate for producers to 
reformulate any products as necessary and that would minimize market 
disruption. We welcome comments on what would be an adequate time 
period for compliance.
    5. Are there any special considerations that could be made to 
reduce the burden on small businesses that would result from removal of 
PHOs from foods, such as additional time for reformulation? Would those 
considerations be consistent with a final determination that PHOs are 
not GRAS?
    6. Are there other challenges regarding the removal of PHOs from 
foods? Are there products that may not be able to be reformulated? If 
so, what sorts of products and what challenges are faced?
    7. Is there any knowledge of an applicable prior sanction for the 
use of PHOs in food?
    We anticipate that some interested persons may wish to provide FDA 
with certain comments, research, data, and information that they 
consider to be trade secret or confidential commercial information 
(CCI) that would be exempt under Exemption 4 of the Freedom of 
Information Act (5 U.S.C. 552). You may claim information that you 
submit to FDA as CCI or trade secret by clearly marking both the 
document and the specific information as ``confidential.'' Information 
so marked will not be disclosed except in accordance with the Freedom 
of Information Act and FDA's disclosure regulations (21 CFR part 20). 
For electronic submissions to http://www.regulations.gov indicate in 
the ``comments'' box of the appropriate docket that your submission 
contains confidential information. You must also submit a copy of the 
comment that does not contain the information claimed as confidential 
for inclusion in the public version of the official record. Information 
not marked confidential will be included in the public version of the 
official record without prior notice.

VIII. Comments

    Interested persons may submit either electronic comments and 
scientific data and information to http://www.regulations.gov or 
written comments and scientific data and information to the Division of 
Dockets Management (see ADDRESSES). It is only necessary to send one 
set of comments. Identify comments with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

IX. References

    We have placed the following references on display in the Division 
of Dockets Management (see ADDRESSES). You may see them between 9 a.m. 
and 4 p.m., Monday through Friday. FDA has verified the Web site 
addresses, but FDA is not responsible for any subsequent changes to the 
Web sites after this document publishes in the Federal Register.

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Existing Oils and Fats Used in Products With Reduced Trans-Fatty 
Acid Content,'' Journal of the American Dietetic Association, 
106:867-877, 2006.
2. IOM/NAS, ``Dietary Reference Intakes for Energy Carbohydrate, 
Fat, Fatty Acids, Cholesterol, and Amino Acids (Macronutrients),'' 
chapters 8 and 11, National Academies Press, Washington DC, 2002/
2005 (Internet address: http://www.nap.edu).
3. Dietz, W. H. and K. S. Scanlon, ``Eliminating the Use of 
Partially Hydrogenated Oil in Food Production and Preparation,'' 
Journal of the American Medical Association, 108: 143-144, 2012.
4. Institute of Shortening and Edible Oils, Food Fats and Oils, 9th 
ed., Washington DC, p. 9, 2006 (Internet address: http://www.iseo.org/httpdocs/Publications/FoodFatsOils2006.pdf).
5. Kodali, D. R. and G. R. List, Eds., Trans Fats Alternatives, AOCS 
Press, Champaign, IL, pp. 4, 2005.
6. Kodali, D. R. and G. R. List, Eds., Trans Fats Alternatives, AOCS 
Press, Champaign, IL, p. 34-35, 2005.
7. United States Department of Agriculture (USDA) National Nutrition 
Database for Standard Reference, Release 23, 2010 (Internet address: 
http://www.ars.usda.gov/Services/docs.htm?docid=8964).
8. Doell, D., D. Folmer, H. Lee, et al., ``Updated Estimate of Trans 
Fat Intake by the U.S. Population,'' Food Additives and 
Contaminants: Part A: Chemistry, Analysis, Control, Exposure and 
Risk Assessment, 29: 861-874, 2012.
9. Vesper, H.W., H.C. Kulper, L.B. Mirel, et al., ``Research Letter: 
Levels of Plasma trans-Fatty Acids in Non-Hispanic White Adults in 
the United States in 2000 and 2009,'' Journal of the American 
Medical Association, 307: 562-563, 2012.
10. Memorandum from D. Doell and M. Honigfort to Division of 
Petition Review, August 26, 2013.
11. USDA and Department of Health and Human Services (HHS), Dietary 
Guidelines for Americans, 2000, 5th ed., pp. 28-30, Washington, DC: 
U.S. Government Printing Office, January 2000.
12. Krauss, R.M., R.H. Eckel, B. Howard, et al., ``American Heart 
Association Guidelines, Revision 2000: A Statement for Healthcare 
Professionals from the Nutrition Committee of the American Heart 
Association,'' Circulation, 102: 2296-2311, 2000.
13. Memorandum from J. Park to M. Honigfort, August 10, 2005.
14. Memorandum from J. Park to M. Honigfort, August 19, 2010.
15. American Heart Association, http://www.heart.org/HEARTORG/GettingHealthy/FatsAndOils/Fats101/Trans-Fats_UCM_301120_Article.jsp.
16. Eckel, R.H., S. Borra, A.H. Lichtenstein, et al., 
``Understanding the Complexity of Trans Fatty Acid Reduction in the 
American Diet,'' Circulation, 115:2231-2246, 2007.
17. Kris-Etherton, P. M., S. Innis, ``Position of the American 
Dietetic Association and Dietitians of Canada: Dietary Fatty 
Acids,'' Journal of the American Dietetic

[[Page 67175]]

Association, pp. 1599-1611, 2007.
18. World Health Organization, ``Diet, Nutrition, and the Prevention 
of Chronic Disease,'' Technical Series Report 916, pp. 81-85, 
Geneva, 2003.
19. USDA and HHS, Dietary Guidelines for Americans, 2005, 6th ed., 
pp. 29 through 34, Washington, DC: U.S. Government Printing Office, 
January 2005.
20. USDA and HHS, Dietary Guidelines for Americans, 2010, 7th ed., 
pp. 24-27, Washington, DC: U.S. Government Printing Office, December 
2010.
21. HHS/FDA/Center for Food Safety and Applied Nutrition Advisory 
Committee/Nutrition Subcommittee Meeting, Total Fat and Trans Fat, 
April 27-28, 2004.
22. Lefevre, M., J. C. Lovejoy, S. R. Smith, J. P. DeLany, et al., 
``Comparison of the Acute Response to Meals Enriched With cis- or 
trans-Fatty Acids on Glucose and Lipids in Overweight Individuals 
With Differing FABP2 Genotypes,'' Metabolism, 54:1652-1658, 2005.
23. Micha, R., D. Mozaffarian, ``Trans Fatty Acids: Effects on 
Cardiometabolic Health and Implications for Policy,'' 
Prostaglandins, Leukotrienes and Essential Fatty Acids, 79:147-152, 
2008.
24. Teegala, S. M., W. C. Willett, D. Mozaffarian, ``Consumption and 
Health Effects of Trans Fatty Acids: A Review,'' Journal of AOAC 
International, 92:1250-1257, 2009.
25. Riserus, U., ``Trans Fatty Acids and Insulin Resistance,'' 
Atherosclerosis Supplements, 7:37-39, 2006.
26. Kavanagh, K., K. L. Jones, J. Sawyer, K. Kelley, et al., ``Trans 
Fat Diet Increases Abdominal Obesity Changes in Insulin Sensitivity 
in Monkeys,'' Obesity, 15:1675-1684, 2007.
27. Morrison, J. A., C. J. Glueck, P. Wang, ``Dietary Trans Fatty 
Acid Intake is Associated with Increased Fetal Loss,'' Fertility and 
Sterility, 90:385-390, 2008.
28. Van Eijsden, M., G. Hornstra, M. F. van der Waal, T. G. M. 
Vrijkotte, et al., ``Maternal n-3, n-6, and Trans Fatty Acid Profile 
Early in Pregnancy and Term Birth Weight: A Prospective Cohort 
Study,'' The American Journal of Clinical Nutrition, 87:887-895, 
2008.
29. Innis, S., ``Fatty Acids and Early Human Development,'' Early 
Human Development, 83:761-766, 2007.
30. Hornstra, G., M. van Eijsden, C. Dirix, G. Bonsel, ``Trans Fatty 
Acids and Birth Outcome: Some First Results of the MEFAB and ABCD 
Cohorts,'' Atherosclerosis Supplements, 7:21-23, 2006.
31. Innis, S. ``Trans Fatty Intakes During Pregnancy, Infancy and 
Early Childhood,'' Atherosclerosis Supplements, 7:17-20, 2006.
32. Brouwer, I. A., A. J. Wanders, M. B. Katan, ``Effect of Animal 
and Industrial Trans Fatty Acids on HDL and LDL Cholesterol Levels 
in Humans--A Quantitative Review,'' PLoS One, 5(3):e9434, 2010.
33. Mozaffarian, D., R. Clarke, ``Quantitative Effects on 
Cardiovascular Risk Factors and Coronary Heart Disease Risk of 
Replacing Partially Hydrogenated Vegetable Oils With Other Fats and 
Oils,'' European Journal of Clinical Nutrition, 63:S22-S33, 2009.
34. Chardigny, J.-M., F. Destaillats, C. Malpuech-Brugere, J. Molin, 
et al., ``Do Trans Fatty Acids From Industrially Produced Sources 
and From Natural Sources Have the Same Effect on Cardiovascular 
Disease Risk Factors in Healthy Subjects? Results of the Trans Fatty 
Acids Collaboration (TRANSFACT) Study,'' The American Journal of 
Clinical Nutrition, 87:558-566, 2008.
35. Mensink, R. P., P. L. Zock, A. D. Kester, et al., ``Effects of 
Dietary Fatty Acids and Carbohydrates on the Ratio of Serum Total to 
HDL Cholesterol and on Serum Lipids and Apolipoproteins: A Meta-
Analysis of 60 Controlled Trials,'' The American Journal of Clinical 
Nutrition, 77:1146-55, 2003.
36. Ascherio, A., ``Trans Fatty Acids and Blood Lipids,'' 
Atherosclerosis Supplements, 7:25-27, 2006.
37. Mozaffarian, D., M. B., Katan, A. Asherio, M. J. Stampfer, et 
al., ``Trans Fatty Acids and Cardiovascular Disease,'' The New 
England Journal of Medicine, 354:1601-1613, 2006.
38. Denke, M. A., ``Dietary Fats, Fatty Acids, and Their Effects on 
Lipoproteins,'' Current Atherosclerosis Reports, 8:466-471, 2006.
39. Vega-Lopez, S., L. M. Ausman, S. M. Jalbert, A. T. Erkilla, et 
al., ``Palm and Partially Hydrogenated Soybean Oils Adversely Alter 
Lipoprotein Profiles Compared with Soybean and Canola Oils in 
Moderately Hyperlipidemic Subjects,'' The American Journal of 
Clinical Nutrition, 84:54-62, 2006.
40. Leth, T., H. G. Jensen, A. A. Mikkelsen, A. Bysted, ``The Effect 
of the Regulation on Trans Fatty Acid Content in Danish Food,'' 
Atherosclerosis Supplements, 7(2):53-56, 2006.
41. Stender, S., J. Dyerberg, A. Bysted, T. Leth, et al., ``A Trans 
World Journey,'' Atherosclerosis Supplements, 7:47-52, 2006.
42. Bysted A., A. E. Mikkelsen, T. Leth, ``Substitution of Trans 
Fatty Acids in Foods on the Danish Market,'' European Journal of 
Lipid Science and Technology, 111:574-583, 2009.
43. Health Canada, ``Trans Fat'' (Internet address: http://www.hc-sc.gc.ca/fn-an/nutrition/gras-trans-fats/index-eng.php).
44. Health Canada, ``Fourth Set of Monitoring Data--Trans Fat 
Monitoring Program'' (Internet address: http://www.hc-sc.gc.ca/fn-an/nutrition/gras-trans-fats/tfa-age_four-data_quatr-donn-eng.php).
45. Angell, S. Y., L. D. Silver, G. P. Goldstein, C. M. Johnson, et 
al., ``Cholesterol Control Beyond the Clinic: New York City's Trans 
Fat Restriction,'' Annals of Internal Medicine, 151:129-134, 2009.
46. Memorandum from R. Bruns to M. Honigfort, November 5, 2013.

    Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26854 Filed 11-7-13; 8:45 am]
BILLING CODE 4160-01-P