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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3252 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3252
To make technical corrections to amendments made by the FDA Food Safety
Modernization Act to allow the Food and Drug Administration to assess
and collect food-related reinspection fees and recall fees, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
November 20, 2025
Mr. Durbin (for himself, Mr. Blumenthal, and Mr. Markey) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To make technical corrections to amendments made by the FDA Food Safety
Modernization Act to allow the Food and Drug Administration to assess
and collect food-related reinspection fees and recall fees, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FSMA Fee Technical Corrections
Act''.
SEC. 2. FOOD-RELATED FEES.
(a) In General.--Paragraph (2) of section 743(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-31(b)) is amended to read
as follows:
``(2) Fee methodology; fee amounts.--
``(A) In general.--Subject to adjustments made by
the Secretary in accordance with subparagraph (B), fees
established for a fiscal year--
``(i) under subsection (a)(1)(A) shall be
in the amount equal to $15,000, multiplied, for
fiscal year 2026 and each subsequent fiscal
year, by the adjustment factor described in
subsection (c)(3);
``(ii) under subsection (a)(1)(B) shall be
in the amount equal to $15,000, multiplied, for
fiscal year 2026 and each subsequent fiscal
year, by the adjustment factor described in
subsection (c)(3);
``(iii) under subsection (a)(1)(C) shall be
based on the Secretary's estimate of 100
percent of the costs of the activities
described in such subsection for such fiscal
year; and
``(iv) under subsection (a)(1)(D) shall be
in the amount equal to $15,000, multiplied, for
fiscal year 2026 and each subsequent fiscal
year, by the adjustment factor described in
subsection (c)(3).
``(B) Other considerations.--
``(i) Fee adjustment for small
businesses.--
``(I) In general.--In the case of a
facility or importer that, at the time
of the reinspection or recall order, is
a small business as defined in
subsection (a)(2)(E), the amount of the
fee under subparagraph (A), (B), or (D)
of subsection (a)(1), for a fiscal
year, shall be adjusted to be equal to
\1/3\ of the amount of the fee
calculated under clause (i), (ii), or
(iv) of subparagraph (A), as
applicable, for such fiscal year.
``(II) Publication of schedule.--
The schedule of such adjusted fee
amounts shall be published annually
with the user fee notice under
subsection (e).
``(III) Guidance.--Not later than
270 days after the date of enactment of
the FSMA Fee Technical Corrections Act,
the Secretary shall publish guidance to
describe how a food facility or
importer may request a fee reduction
under this clause, which shall be
issued for immediate implementation to
facilitate timely fee reductions, as
applicable.
``(ii) Voluntary qualified importer
program.--In establishing the fee amounts under
subparagraph (A)(iii) for a fiscal year, the
Secretary shall provide for the number of
importers who have submitted to the Secretary a
notice under section 806(c) informing the
Secretary of the intent of such importer to
participate in the program under section 806 in
such fiscal year.
``(iii) Crediting of carryover fees.--In
establishing the fee amounts under subparagraph
(A) for a fiscal year, the Secretary shall
provide for the crediting toward fee revenue of
estimated carryover fee collections from the
previous fiscal year if the Secretary
overestimated the amount of fees needed to
carry out activities described in paragraph (3)
for such previous year, and shall account for
any adjustment of fees under clause (i).''.
(b) Use of Fees.--Paragraph (3) of section 743(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-31(b)) is amended to read
as follows:
``(3) Use of fees.--
``(A) Oversight of facilities and importers.--Fees
collected pursuant to subparagraphs (A), (B), and (D)
of subsection (a)(1) shall be available solely for the
costs of oversight of foreign and domestic facilities
and importers.
``(B) Voluntary qualified importer program.--Fees
collected pursuant to subparagraph (C) of subsection
(a)(1) shall be available solely for the costs of the
voluntary qualified importer program under section
806.''.
(c) Limitation on Amount.--Section 743(c)(4)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-31(c)(4)(A)) is amended--
(1) in clause (i), by striking ``$20,000,000'' and
inserting ``$25,000,000''; and
(2) in clause (ii), by striking ``$25,000,000'' and
inserting ``$30,000,000''.
(d) Definition of Reinspection.--Section 743(a)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-31(a)(2)) is amended--
(1) by amending subparagraph (A) to read as follows:
``(A) the term `reinspection' means--
``(i) with respect to domestic and foreign
facilities, 1 or more inspections conducted
under section 704 subsequent to an inspection
conducted under such provision which identified
noncompliance resulting in a classification of
`official action indicated', specifically to
determine whether compliance has been achieved
to the Secretary's satisfaction; and
``(ii) with respect to importers, 1 or more
inspections conducted under the foreign
supplier verification program under section 805
subsequent to an inspection conducted under
such provision which identified noncompliance
resulting in a classification of `official
action indicated', specifically to determine
whether compliance has been achieved to the
Secretary's satisfaction;'';
(2) in subparagraph (B)(ii), by striking ``; and'' and
inserting a semicolon;
(3) in subparagraph (C), by striking the period and
inserting a semicolon; and
(4) by adding at the end the following:
``(D) the term `importer' means an importer of
human or animal food that is subject to the foreign
supplier verification program requirements under
section 805; and
``(E) the term `small business' means--
``(i) with respect to a domestic or foreign
facility, a business (including any
subsidiaries or affiliates) employing fewer
than 500 full-time equivalent employees;
``(ii) with respect to an importer of human
food, an importer (including any subsidiaries
and affiliates) averaging less than $1,000,000
per year, adjusted for inflation, during the 3-
year period preceding the applicable calendar
year, in sales of human food combined with the
United States market value of human food
imported, manufactured, processed, packed, or
held without sale (such as food imported for a
fee); and
``(iii) with respect to an importer of
animal food, an importer (including any
subsidiaries and affiliates) averaging less
than $2,500,000 per year, adjusted for
inflation, during the 3-year period preceding
the applicable calendar year, in sales of
animal food combined with the United States
market value of animal food imported,
manufactured, processed, packed, or held
without sale (such as food imported for a
fee).''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8277-8278)
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