Engineered Food Safety Act (referred to in this section 
as the ‘first applicable fiscal year’). 
‘‘(b) PURPOSE OF FEES.— 
‘‘(1) IN GENERAL.—The purposes of fees under 
subsection (a) are as follows: 
‘‘(A) To defray increases in the costs of 
the resources allocated for carrying out section 
409 for the first applicable fiscal year over the 
costs of carrying out such section for the pre-
ceding fiscal year, other than increases that are 
not attributable to the responsibilities of the 
Secretary with respect to genetic food additives. 
‘‘(B) To provide for a program of basic 
and applied research on the safety of genetic 
food additives (to be carried out by the Com-
missioner). The program shall address funda-
mental questions and problems that arise re-
peatedly during the process of reviewing peti-
tions under section 409(b)(1) with respect to 
genetic food additives, and shall not directly 
support the development of new genetically en-
gineered foods. 
‘‘(2) ALLOCATIONS
BY
SECRETARY.—Of the 
total fee revenues collected under subsection (a) for 
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a fiscal year, the Secretary shall reserve and ex-
pend— 
‘‘(A) 95 percent for the purpose described 
in paragraph (1)(A); and 
‘‘(B) 5 percent for the purpose described 
in paragraph (1)(B). 
‘‘(3) CERTAIN
PROVISIONS
REGARDING
IN-
CREASED ADMINISTRATIVE COSTS.—With respect to 
fees under subsection (a): 
‘‘(A) Increases referred to in paragraph 
(1)(A) include the costs of the Secretary in pro-
viding 
for 
investigations 
under 
section 
409(c)(9)(A). 
‘‘(B) Increases referred to in paragraph 
(1)(A) include increases in costs for an addi-
tional number of full-time equivalent positions 
in the Department of Health and Human Serv-
ices to be engaged in carrying out section 409 
with respect to genetic food additives. 
‘‘(c) TOTAL
FEE
REVENUES; INDIVIDUAL
FEE 
AMOUNTS.—The total fee revenues collected under sub-
section (a) for a fiscal year shall be the amounts appro-
priated under subsection (f)(2) for such fiscal year. Indi-
vidual fees shall be assessed by the Secretary on the basis 
of an estimate by the Secretary of the amount necessary 
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to ensure that the sum of the fees collected for such fiscal 
year equals the amount so appropriated. In assessing the 
individual fees, the Secretary shall by regulation provide 
for the assessment of reduced fee amounts for entities that 
are small businesses, or nonprofit private entities, as de-
fined by the Secretary for purposes of this section. 
‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary 
shall grant a waiver from or a reduction of a fee assessed 
under subsection (a) if the Secretary finds that the fee 
to be paid will exceed the anticipated present and future 
costs incurred by the Secretary in carrying out the pur-
poses described in subsection (b) (which finding may be 
made by the Secretary using standard costs). 
‘‘(e) ASSESSMENT OF FEES.— 
‘‘(1) LIMITATION.—Fees may not be assessed 
under subsection (a) for a fiscal year beginning after 
the first applicable fiscal year unless the amount ap-
propriated for salaries and expenses of the Food and 
Drug Administration for such fiscal year is equal to 
or greater than the amount appropriated for salaries 
and expenses of the Food and Drug Administration 
for the first applicable fiscal year multiplied by the 
adjustment factor applicable to the fiscal year in-
volved, except that in making determinations under 
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this paragraph for the fiscal years involved there 
shall be excluded— 
‘‘(A) the amounts appropriated under sub-
section (f)(2) for the fiscal years involved; and 
‘‘(B) the amounts appropriated under sec-
tions 736(g), 738(h), 740(g), and 741(g) for 
such fiscal years. 
‘‘(2) AUTHORITY.—If under paragraph (1) the 
Secretary does not have authority to assess fees 
under subsection (a) during a portion of a fiscal 
year, but does at a later date in such fiscal year 
have such authority, the Secretary, notwithstanding 
the due date under such subsection for fees, may as-
sess and collect such fees at any time in such fiscal 
year, without any modification in the rate of the 
fees. 
‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees collected for a fiscal 
year pursuant to subsection (a) shall be credited to 
the appropriation account for salaries and expenses 
of the Food and Drug Administration and shall be 
available in accordance with appropriation Acts until 
expended without fiscal year limitation. Such sums 
as may be necessary may be transferred from the 
Food and Drug Administration salaries and ex-
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