[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Rules and Regulations]
[Pages 23358-23359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10714]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

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


Final Determination Regarding Partially Hydrogenated Oils

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; declaratory order; extension of compliance date.

-----------------------------------------------------------------------

SUMMARY: Based on the available scientific evidence and the findings of 
expert scientific panels, the Food and Drug Administration (FDA or we) 
made a final determination that there is no longer a consensus among 
qualified experts that partially hydrogenated oils (PHOs), which are 
the primary dietary source of industrially produced trans fatty acids 
(IP-TFA), are generally recognized as safe (GRAS) for any use in human 
food. In a declaratory order announcing our final determination, we set 
a compliance date of June 18, 2018. We are now extending the compliance 
date for certain uses of PHOs.

DATES: Compliance dates: See sections II and III of this document.

FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1309, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 17, 2015 (80 FR 34650), we issued a 
final determination that there is no longer a consensus among qualified 
experts that PHOs are GRAS for any use in human food. Because PHOs are 
the primary dietary source of IP-TFA, FDA's evaluation of the GRAS 
status of PHOs centered on the trans fatty acid component of these fats 
and oils. We based our determination on available scientific evidence 
and the findings of expert scientific panels establishing the health 
risks associated with the consumption of trans fat. FDA's determination 
identified significant human health risks, namely an increased risk of 
coronary heart disease, associated with the consumption of trans fat 
(78 FR 67169 at 67172; 80 FR 34650 at 34659).
    The order established a 3-year compliance date, to June 18, 2018, 
to allow time for food manufacturers using PHOs to identify suitable 
replacement ingredients for PHOs and to reformulate and modify labeling 
of affected products. The 3-year compliance date was also intended to 
allow time for submission and review and, if applicable requirements 
were met, approval of food additive petitions for uses of PHOs for 
which industry or other interested individuals believe that safe 
conditions of use may be prescribed. Finally, this compliance date was 
also intended to give manufacturers time to exhaust existing 
inventories and give distributors and retailers time to distribute 
products with PHOs (80 FR 34650 at 34669). We based the compliance date 
on the information available, including comments on the proposed order 
(80 FR 34650 at 34668 to 34669).
    In the 2015 final order, we stated that food that is adulterated 
may be subject to seizure and distributors, manufacturers, and other 
parties responsible for such food may be subject to injunction. We also 
reminded distributors and other members of the food industry that they 
have an obligation to ensure that the food they manufacture, 
distribute, sell, or otherwise market complies with the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (80 FR 34650 at 34655).
    In the Federal Register of October 28, 2015 (80 FR 65978), we 
published a document announcing that we had filed a food additive 
petition submitted by the Grocery Manufacturers Association (GMA) 
seeking approval for certain uses of PHOs in or on select foods. We 
initially filed the food additive petition on October 1, 2015. GMA 
subsequently amended their food additive petition, and it was re-filed 
on March 7, 2017. The amended food additive petition requested that the 
food additive regulations be amended to provide for the safe use of 
PHOs in certain food applications. Elsewhere in this issue of the 
Federal Register, we have published a document announcing our denial of 
this food additive petition.
    For purposes of this document extending the compliance date for 
certain uses of PHOs, we refer to the specified uses of PHOs in GMA's 
food additive petition as the ``petitioned uses'' and all other uses of 
PHOs not authorized by FDA as ``non-petitioned uses.'' We refer to 
``manufacturing'' in this document as making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food, including food crops or ingredients. See 21 CFR 
1.227.
    On March 23, 2018, the Consolidated Appropriations Act, 2018, (Pub. 
L. 115-141) was enacted into law. Section 738 of the Consolidated 
Appropriations Act, 2018, provided that no PHOs, as defined in our 
declaratory order, shall be deemed unsafe within the meaning of section 
409(a) of the FD&C Act (21 U.S.C. 348(a)) and no food that is 
introduced or delivered for introduction into interstate commerce that 
bears or contains a partially hydrogenated oil shall be deemed 
adulterated under sections 402(a)(1) or (a)(2)(C)(i) of the FD&C Act 
(21 U.S.C. 342(a)(1) or (a)(2)(C)(i)) by virtue of bearing or 
containing a partially hydrogenated oil, until June 18, 2018.

II. Extension of the Compliance Date for Certain Uses

    We have been informed by a number of trade associations 
representing many segments of the food industry that they have replaced 
the PHO uses that are not covered by the food additive petition (the 
non-petitioned uses) and thus will be able to stop using PHOs by the 
June 18, 2018, compliance date (Ref. 1). However, the trade 
associations also

[[Page 23359]]

have informed us that, due to shelf lives ranging from 3 to 24 months, 
a variety of products containing non-petitioned uses of PHOs will be in 
distribution on, and for some time after, the compliance date in the 
final order (Ref. 1). In addition, the trade associations have informed 
us that, if we deny the food additive petition, they will need 
additional time beyond June 18, 2018, to remove and replace the 
petitioned uses and deplete the product in distribution (Refs. 1 and 
2). FDA has considered these requests as well as the health benefits of 
removing the uses of PHOs in food manufacturing and is revising the 
compliance date for certain uses.

A. Non-Petitioned Uses

    Foods manufactured after June 18, 2018 with non-petitioned uses of 
PHOs may be subject to enforcement action by FDA. Based on the recent 
industry information, FDA understands additional time is needed for 
products manufactured (domestically and internationally) before June 
18, 2018, to work their way through distribution. Therefore, we are 
extending the compliance date of food products that were manufactured 
before June 18, 2018, with non-petitioned uses of PHO. The new 
compliance date for these products is January 1, 2020. After January 1, 
2020, such foods may be subject to enforcement action by FDA. FDA 
believes an 18-month extension is appropriate given the range of shelf 
lives brought to our attention and the 3-year original compliance date.

B. Petitioned Uses

    In light of our denial of GMA's food additive petition, we 
acknowledge that the food industry needs additional time to identify 
suitable replacement substances for the petitioned uses of PHOs and 
that the food industry may not have done so for the petitioned uses 
while the petition was under our review. Industry has indicated that 12 
months could be a reasonable timeframe for reformulation activities 
(Ref 1). Therefore, we are extending the compliance date to June 18, 
2019, for the manufacturing of food with the petitioned uses of PHOs. 
Food manufactured with the petitioned uses after June 18, 2019, may be 
subject to enforcement action by FDA.
    The petitioned uses are as follows:
     PHO, or a blend of PHOs, used as a solvent or carrier, or 
a component thereof, for flavoring agents, flavor enhancers, and 
coloring agents intended for food use, provided the PHOs in the solvent 
or carrier contribute no more than 150 parts per million (ppm) (150 
milligrams per kilogram (mg/kg)) IP-TFA to the finished food as 
consumed;
     PHO, or a blend of PHOs, used as a processing aid, or a 
component thereof, provided the PHOs in the processing aid contribute 
no more than 50 ppm (50 mg/kg) IP-TFA to the finished food as consumed;
     PHO, or a blend of PHOs, used as a pan release agent for 
baked goods at levels up to 0.2 grams/100 grams (0.2 g/100 g) in pan 
release spray oils, provided the PHO contributes no more than 0.14 g 
IP-TFA/100 g spray oil.
    The petitioned uses excluded dietary supplements. The physical and 
technical effects of the petitioned uses of PHOs were specified as: 
Release agents, either alone or in combination with other components 
(Sec.  170.3(o)(18) (21 CFR 170.3(o)(18))); processing aids or 
components thereof (Sec.  170.3(o)(24)); and as solvents, carriers, and 
vehicles for fat soluble coloring agents, flavoring agents, and flavor 
enhancers (Sec.  170.3(o)(27)).
    In addition, for food manufactured with the petitioned uses before 
June 18, 2019, we are extending the compliance date to January 1, 2021. 
This time frame will allow manufacturers, distributors, and retailers 
to exhaust product inventory of foods made with the petitioned uses 
before the manufacturing compliance date. All foods containing 
unauthorized uses of PHOs after January 1, 2021, may be subject to FDA 
enforcement action.

III. Compliance Dates

    For convenience, we are summarizing the extended compliance dates 
as follows:

------------------------------------------------------------------------
                                     Original       Extended  compliance
         Product uses            compliance date            date
------------------------------------------------------------------------
                           Non-Petitioned Uses
------------------------------------------------------------------------
Manufacturing of food with non- June 18, 2018....  Not Extended.
 petitioned uses of PHOs.
Foods manufactured with non-    June 18, 2018....  January 1, 2020.
 petitioned uses of PHOs
 before June 18, 2018.
------------------------------------------------------------------------
                            Petitioned Uses *
------------------------------------------------------------------------
Manufacturing of food with the  June 18, 2018....  June 18, 2019.
 petitioned uses of PHOs.
Foods manufactured with the     June 18, 2018....  January 1, 2021.
 petitioned uses of PHOs
 before June 18, 2019.
------------------------------------------------------------------------
* Petitioned uses exclude use in dietary supplements and are limited to:
 PHO, or a blend of PHOs, used as a pan release agent for baked
  goods at levels up to 0.2 grams/100 grams (0.2 g/100 g) in pan release
  spray oils, provided the PHO contributes no more than 0.14 g IP-TFA/
  100 g spray oil;
 PHO, or a blend of PHOs, used as a solvent or carrier, or a
  component thereof, as defined in Sec.   170.3(o)(27), for flavoring
  agents, flavor enhancers, and coloring agents intended for food use,
  provided the PHOs in the solvent or carrier contribute no more than
  150 parts per million (ppm) (150 milligrams per kilogram (mg/kg)) IP-
  TFA to the finished food as consumed; and
 PHO, or a blend of PHOs, used as a processing aid, or a
  component thereof, as defined in Sec.   170.3(o)(24) and 21 CFR
  101.100(a)(3)(ii), provided the PHOs in the processing aid contribute
  no more than 50 ppm (50 mg/kg) IP-TFA to the finished food as
  consumed.

IV. References

    The following references are on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Letter from the American Bakers Association, et al., to Dr. Scott 
Gottlieb, Commissioner, Food and Drug Administration (April 30, 
2018) (sent by electronic mail).
2. Letter from Leon H. Bruner, DVM, Ph.D., Senior Vice President, 
Science and Regulatory Affairs and Chief Science Officer, Grocery 
Manufacturers Association, to Dr. Scott Gottlieb, Commissioner, Food 
and Drug Administration (April 27, 2018).

    Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10714 Filed 5-18-18; 8:45 am]
 BILLING CODE 4164-01-P