83 FR 23358 - Final Determination Regarding Partially Hydrogenated Oils
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 98 (May 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 98 (May 21, 2018)
| Page Range | 23358-23359 | |
| FR Document | 2018-10714 |
[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)] [Rules and Regulations] [Pages 23358-23359] From the Federal Register Online [www.thefederalregister.org] [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
![23358 Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Rules and Regulations
the service information listed in this human food. In a declaratory order distributors and other members of the
paragraph under 5 U.S.C. 552(a) and 1 CFR announcing our final determination, we food industry that they have an
part 51. set a compliance date of June 18, 2018. obligation to ensure that the food they
(2) You must use this service information manufacture, distribute, sell, or
We are now extending the compliance
as applicable to do the actions required by
this AD, unless the AD specifies otherwise. date for certain uses of PHOs. otherwise market complies with the
(i) Sikorsky S–76 Helicopter Alert Service DATES: Compliance dates: See sections II Federal Food, Drug, and Cosmetic Act
Bulletin ASB 76–73–8, Revision A, dated and III of this document. (FD&C Act) (80 FR 34650 at 34655).
December 4, 2015. FOR FURTHER INFORMATION CONTACT:
In the Federal Register of October 28,
(ii) Sikorsky Maintenance Manual, SA Ellen Anderson, Center for Food Safety 2015 (80 FR 65978), we published a
4047–76C–2, Temporary Revision No. 73–07,
and Applied Nutrition (HFS–265), Food document announcing that we had filed
dated August 17, 2016. a food additive petition submitted by
(iii) Sikorsky Maintenance Manual, SA and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402– the Grocery Manufacturers Association
4047–76C–2, Temporary Revision No. 73–08, (GMA) seeking approval for certain uses
dated September 20, 2017. 1309, email: ellen.anderson@
fda.hhs.gov. of PHOs in or on select foods. We
(3) For Sikorsky service information
identified in this AD, contact Sikorsky initially filed the food additive petition
SUPPLEMENTARY INFORMATION: on October 1, 2015. GMA subsequently
Aircraft Corporation, Customer Service
Engineering, 124 Quarry Road, Trumbull, CT I. Background amended their food additive petition,
06611; telephone 1–800-Winged-S or 203– and it was re-filed on March 7, 2017.
416–4299; email wcs_cust_service_eng.gr-
In the Federal Register of June 17, The amended food additive petition
sik@lmco.com. 2015 (80 FR 34650), we issued a final requested that the food additive
(4) You may view this service information determination that there is no longer a regulations be amended to provide for
at FAA, Office of the Regional Counsel, consensus among qualified experts that the safe use of PHOs in certain food
Southwest Region, 10101 Hillwood Pkwy, PHOs are GRAS for any use in human applications. Elsewhere in this issue of
Room 6N–321, Fort Worth, TX 76177. For food. Because PHOs are the primary the Federal Register, we have published
information on the availability of this dietary source of IP–TFA, FDA’s
material at the FAA, call (817) 222–5110. a document announcing our denial of
evaluation of the GRAS status of PHOs this food additive petition.
(5) You may view this service information centered on the trans fatty acid
that is incorporated by reference at the For purposes of this document
National Archives and Records
component of these fats and oils. We extending the compliance date for
Administration (NARA). For information on based our determination on available certain uses of PHOs, we refer to the
the availability of this material at NARA, call scientific evidence and the findings of specified uses of PHOs in GMA’s food
(202) 741–6030, or go to: http:// expert scientific panels establishing the additive petition as the ‘‘petitioned
www.archives.gov/federal-register/cfr/ibr- health risks associated with the uses’’ and all other uses of PHOs not
locations.html. consumption of trans fat. FDA’s authorized by FDA as ‘‘non-petitioned
Issued in Fort Worth, Texas, on May 9, determination identified significant uses.’’ We refer to ‘‘manufacturing’’ in
2018. human health risks, namely an this document as making food from one
Lance T. Gant, increased risk of coronary heart disease, or more ingredients, or synthesizing,
Director, Compliance & Airworthiness associated with the consumption of preparing, treating, modifying or
Division, Aircraft Certification Service. trans fat (78 FR 67169 at 67172; 80 FR manipulating food, including food crops
[FR Doc. 2018–10581 Filed 5–18–18; 8:45 am] 34650 at 34659). or ingredients. See 21 CFR 1.227.
The order established a 3-year On March 23, 2018, the Consolidated
BILLING CODE 4910–13–P
compliance date, to June 18, 2018, to Appropriations Act, 2018, (Pub. L. 115–
allow time for food manufacturers using 141) was enacted into law. Section 738
PHOs to identify suitable replacement of the Consolidated Appropriations Act,
DEPARTMENT OF HEALTH AND ingredients for PHOs and to reformulate 2018, provided that no PHOs, as defined
HUMAN SERVICES and modify labeling of affected in our declaratory order, shall be
Food and Drug Administration products. The 3-year compliance date deemed unsafe within the meaning of
was also intended to allow time for section 409(a) of the FD&C Act (21
21 CFR Part 172 submission and review and, if U.S.C. 348(a)) and no food that is
applicable requirements were met, introduced or delivered for introduction
[Docket No. FDA–2013–N–1317] approval of food additive petitions for into interstate commerce that bears or
uses of PHOs for which industry or contains a partially hydrogenated oil
Final Determination Regarding other interested individuals believe that shall be deemed adulterated under
Partially Hydrogenated Oils safe conditions of use may be sections 402(a)(1) or (a)(2)(C)(i) of the
AGENCY: Food and Drug Administration, prescribed. Finally, this compliance FD&C Act (21 U.S.C. 342(a)(1) or
HHS. date was also intended to give (a)(2)(C)(i)) by virtue of bearing or
ACTION: Notification; declaratory order; manufacturers time to exhaust existing containing a partially hydrogenated oil,
extension of compliance date. inventories and give distributors and until June 18, 2018.
retailers time to distribute products with
SUMMARY: Based on the available PHOs (80 FR 34650 at 34669). We based II. Extension of the Compliance Date for
scientific evidence and the findings of the compliance date on the information Certain Uses
expert scientific panels, the Food and available, including comments on the We have been informed by a number
Drug Administration (FDA or we) made proposed order (80 FR 34650 at 34668 of trade associations representing many
sradovich on DSK3GMQ082PROD with RULES
a final determination that there is no to 34669). segments of the food industry that they
longer a consensus among qualified In the 2015 final order, we stated that have replaced the PHO uses that are not
experts that partially hydrogenated oils food that is adulterated may be subject covered by the food additive petition
(PHOs), which are the primary dietary to seizure and distributors, (the non-petitioned uses) and thus will
source of industrially produced trans manufacturers, and other parties be able to stop using PHOs by the June
fatty acids (IP–TFA), are generally responsible for such food may be subject 18, 2018, compliance date (Ref. 1).
recognized as safe (GRAS) for any use in to injunction. We also reminded However, the trade associations also
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![Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Rules and Regulations 23359
have informed us that, due to shelf lives appropriate given the range of shelf 50 ppm (50 mg/kg) IP–TFA to the
ranging from 3 to 24 months, a variety lives brought to our attention and the 3- finished food as consumed;
of products containing non-petitioned year original compliance date. • PHO, or a blend of PHOs, used as
uses of PHOs will be in distribution on, a pan release agent for baked goods at
B. Petitioned Uses
and for some time after, the compliance levels up to 0.2 grams/100 grams (0.2 g/
date in the final order (Ref. 1). In In light of our denial of GMA’s food 100 g) in pan release spray oils,
addition, the trade associations have additive petition, we acknowledge that provided the PHO contributes no more
informed us that, if we deny the food the food industry needs additional time than 0.14 g IP–TFA/100 g spray oil.
additive petition, they will need to identify suitable replacement The petitioned uses excluded dietary
additional time beyond June 18, 2018, to substances for the petitioned uses of supplements. The physical and
remove and replace the petitioned uses PHOs and that the food industry may technical effects of the petitioned uses
and deplete the product in distribution not have done so for the petitioned uses of PHOs were specified as: Release
(Refs. 1 and 2). FDA has considered while the petition was under our agents, either alone or in combination
these requests as well as the health review. Industry has indicated that 12 with other components (§ 170.3(o)(18)
benefits of removing the uses of PHOs months could be a reasonable timeframe (21 CFR 170.3(o)(18))); processing aids
in food manufacturing and is revising for reformulation activities (Ref 1). or components thereof (§ 170.3(o)(24));
the compliance date for certain uses. Therefore, we are extending the and as solvents, carriers, and vehicles
compliance date to June 18, 2019, for for fat soluble coloring agents, flavoring
A. Non-Petitioned Uses the manufacturing of food with the agents, and flavor enhancers
Foods manufactured after June 18, petitioned uses of PHOs. Food (§ 170.3(o)(27)).
2018 with non-petitioned uses of PHOs manufactured with the petitioned uses In addition, for food manufactured
may be subject to enforcement action by after June 18, 2019, may be subject to with the petitioned uses before June 18,
FDA. Based on the recent industry enforcement action by FDA. 2019, we are extending the compliance
information, FDA understands The petitioned uses are as follows: date to January 1, 2021. This time frame
additional time is needed for products • PHO, or a blend of PHOs, used as will allow manufacturers, distributors,
manufactured (domestically and a solvent or carrier, or a component and retailers to exhaust product
internationally) before June 18, 2018, to thereof, for flavoring agents, flavor inventory of foods made with the
work their way through distribution. enhancers, and coloring agents intended petitioned uses before the
Therefore, we are extending the for food use, provided the PHOs in the manufacturing compliance date. All
compliance date of food products that solvent or carrier contribute no more foods containing unauthorized uses of
were manufactured before June 18, than 150 parts per million (ppm) (150 PHOs after January 1, 2021, may be
2018, with non-petitioned uses of PHO. milligrams per kilogram (mg/kg)) IP– subject to FDA enforcement action.
The new compliance date for these TFA to the finished food as consumed;
products is January 1, 2020. After • PHO, or a blend of PHOs, used as III. Compliance Dates
January 1, 2020, such foods may be a processing aid, or a component For convenience, we are summarizing
subject to enforcement action by FDA. thereof, provided the PHOs in the the extended compliance dates as
FDA believes an 18-month extension is processing aid contribute no more than follows:
Extended
Product uses Original compliance date compliance date
Non-Petitioned Uses
Manufacturing of food with non-petitioned uses of PHOs ......................................... June 18, 2018 ......................................... Not Extended.
Foods manufactured with non-petitioned uses of PHOs before June 18, 2018 ........ June 18, 2018 ......................................... January 1, 2020.
Petitioned Uses *
Manufacturing of food with the petitioned uses of PHOs .......................................... June 18, 2018 ......................................... June 18, 2019.
Foods manufactured with the petitioned uses of PHOs before June 18, 2019 ......... June 18, 2018 ......................................... January 1, 2021.
* 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), pro-
vided 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 1. Letter from the American Bakers Dated: May 15, 2018.
Association, et al., to Dr. Scott Gottlieb, Leslie Kux,
The following references are on Commissioner, Food and Drug
Associate Commissioner for Policy.
display in the Dockets Management Administration (April 30, 2018) (sent by
[FR Doc. 2018–10714 Filed 5–18–18; 8:45 am]
sradovich on DSK3GMQ082PROD with RULES
Staff (HFA–305), Food and Drug electronic mail).
Administration, 5630 Fishers Lane, Rm. 2. Letter from Leon H. Bruner, DVM, Ph.D., BILLING CODE 4164–01–P
Senior Vice President, Science and
1061, Rockville, MD 20852, and are
Regulatory Affairs and Chief Science
available for viewing by interested Officer, Grocery Manufacturers
persons between 9 a.m. and 4 p.m., Association, to Dr. Scott Gottlieb,
Monday through Friday. Commissioner, Food and Drug
Administration (April 27, 2018).
VerDate Sep<11>2014 15:54 May 18, 2018 Jkt 244001 PO 00000 Frm 00011 Fmt 4700 Sfmt 9990 E:\FR\FM\21MYR1.SGM 21MYR1](https://thefederalregister.org/doc/83_FR_23456/page/2.svg)
Document Created: 2018-11-02 11:07:21
Document Modified: 2018-11-02 11:07:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification; declaratory order; extension of compliance date. | |
| Dates | Compliance dates: See sections II and III of this document. | |
| 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] | |
| FR Citation | 83 FR 23358 |
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