Final Determination Regarding Partially Hydrogenated Oils, 23358-23359 [2018-10714]

Download as PDF 23358 Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Rules and Regulations the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise. (i) Sikorsky S–76 Helicopter Alert Service Bulletin ASB 76–73–8, Revision A, dated December 4, 2015. (ii) Sikorsky Maintenance Manual, SA 4047–76C–2, Temporary Revision No. 73–07, dated August 17, 2016. (iii) Sikorsky Maintenance Manual, SA 4047–76C–2, Temporary Revision No. 73–08, dated September 20, 2017. (3) For Sikorsky service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1–800-Winged-S or 203– 416–4299; email wcs_cust_service_eng.grsik@lmco.com. (4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N–321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222–5110. (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741–6030, or go to: https:// www.archives.gov/federal-register/cfr/ibrlocations.html. Issued in Fort Worth, Texas, on May 9, 2018. Lance T. Gant, Director, Compliance & Airworthiness Division, Aircraft Certification Service. [FR Doc. 2018–10581 Filed 5–18–18; 8:45 am] BILLING CODE 4910–13–P 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. Notification; declaratory order; extension of compliance date. ACTION: 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 sradovich on DSK3GMQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 15:54 May 18, 2018 Jkt 244001 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: ellen.anderson@ fda.hhs.gov. 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 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 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 E:\FR\FM\21MYR1.SGM 21MYR1 23359 Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Rules and Regulations 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 3year 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 (§ 170.3(o)(18) (21 CFR 170.3(o)(18))); processing aids or components thereof (§ 170.3(o)(24)); and as solvents, carriers, and vehicles for fat soluble coloring agents, flavoring agents, and flavor enhancers (§ 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 compliance date Product uses Extended compliance date June 18, 2018 ......................................... June 18, 2018 ......................................... Not Extended. January 1, 2020. June 18, 2018 ......................................... June 18, 2018 ......................................... June 18, 2019. January 1, 2021. Non-Petitioned Uses Manufacturing of food with non-petitioned uses of PHOs ......................................... Foods manufactured with non-petitioned uses of PHOs before June 18, 2018 ........ Petitioned Uses * Manufacturing of food with the petitioned uses of PHOs .......................................... Foods manufactured with the 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 § 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 § 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. sradovich on DSK3GMQ082PROD with RULES 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. VerDate Sep<11>2014 15:54 May 18, 2018 Jkt 244001 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). PO 00000 Frm 00011 Fmt 4700 Sfmt 9990 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 E:\FR\FM\21MYR1.SGM 21MYR1

Agencies

[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]


=======================================================================
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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
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