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B-335722 Nov 17, 2023 1 (2023-11-17)

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            G   $    U.S. GOVERNMENT ACCOUNTABILITY OFFICE
441 G St. N.W.
Washington, DC 20548


B-335722


November  17, 2023

The Honorable Bernard Sanders
Chairman
The Honorable Bill Cassidy
Ranking Member
Committee  on Health, Education, Labor, and Pensions
United States Senate

The Honorable Cathy McMorris Rodgers
Chair
The Honorable Frank Pallone, Jr.
Ranking Member
Committee  on Energy and Commerce
House  of Representatives

Subject: Department of Health and Human Services, Food and Drug Administration:
         Revocation of Uses of Partially Hydrogenated Oils in Foods

Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule
promulgated by the Department of Health and Human Services, Food and Drug Administration
(FDA) titled Revocation of Uses of Partially Hydrogenated Oils in Foods (RIN: 0910-A115).
We  received the rule on October 31, 2023. It was published in the Federal Register as a direct
final rule on August 9, 2023. 88 Fed. Reg. 53764. The stated effective date is December 22,
2023.

According to FDA, it is amending its regulations that provide for the use of partially
hydrogenated oils (PHOs) in food in light of its determination that PHOs are no longer generally
recognized as safe (GRAS). FDA  stated that the rule removes PHOs as an optional ingredient
in the standards of identity for peanut butter and canned tuna. FDA also stated that it is revising
its regulations affirming food substances as GRAS pertaining to menhaden oil and rapeseed oil
to no longer include partially hydrogenated forms of these oils and deletes the regulation
affirming hydrogenated fish oil as GRAS as an indirect food substance. FDA stated further that
they are also revoking prior sanctions (i.e., pre-1958 authorization of certain uses) for the use of
PHOs  in margarine, shortening, and bread, rolls, and buns based on its conclusion that these
uses of PHOs may  be injurious to health. Finally, FDA stated that it is issuing these
amendments   directly as a final rule because they are noncontroversial given the public health
risks associated with PHOs and the increasing use of PHO alternatives, and it anticipates no
significant adverse comments because PHOs were declared no longer GRAS for any use in
human  food in 2015.

The Congressional Review Act (CRA) requires a 60-day delay in the effective date of a major
rule from the date of publication in the Federal Register or receipt of the rule by Congress,
whichever is later. 5 U.S.C. § 801(a)(3)(A). This direct final rule was published in the Federal

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