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-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. The 
sums transferred shall be available solely for the 
purposes described in paragraph (1) of subsection 
(b), and the sums are subject to allocations under 
paragraph (2) of such subsection. 
‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(A) FIRST FISCAL YEAR.—For the first 
applicable fiscal year— 
‘‘(i) there is authorized to be appro-
priated for fees under subsection (a) an 
amount equal to the amount of increase 
determined under subsection (b)(1)(A) by 
the Secretary (which amount shall be pub-
lished in the Federal Register); and 
‘‘(ii) in addition, there is authorized to 
be appropriated for fees under subsection 
(a) an amount determined by the Secretary 
to be necessary to carry out the purpose 
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described in subsection (b)(1)(B) (which 
amount shall be so published). 
‘‘(B) SUBSEQUENT
FISCAL
YEARS.—For 
each of the four fiscal years following the first 
applicable fiscal year— 
‘‘(i) there is authorized to be appro-
priated for fees under subsection (a) an 
amount equal to the amount that applied 
under subparagraph (A)(i) for the first ap-
plicable fiscal year, except that such 
amount shall be adjusted under paragraph 
(3)(A) for the fiscal year involved; and 
‘‘(ii) in addition, there is authorized to 
be appropriated for fees under subsection 
(a) an amount equal to the amount that 
applied under subparagraph (A)(ii) for the 
first applicable fiscal year, except that such 
amount shall be adjusted under paragraph 
(3)(B) for the fiscal year involved. 
‘‘(3) ADJUSTMENTS.— 
‘‘(A) AGENCY COST OF RESOURCES.—For 
each fiscal year other than the first applicable 
fiscal year, the amount that applied under para-
graph (2)(A)(i) for the first applicable fiscal 
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year shall be multiplied by the adjustment fac-
tor (as defined in subsection (i)). 
‘‘(B) RESEARCH PROGRAM.—For each fis-
cal year other than the first applicable fiscal 
year, the amount that applied under paragraph 
(2)(A)(ii) for the first applicable fiscal year 
shall be adjusted by the Secretary (and as ad-
justed shall be published in the Federal Reg-
ister) to reflect the greater of— 
‘‘(i) the total percentage change that 
occurred during the preceding fiscal year 
in the Consumer Price Index for all urban 
consumers (all items; U.S. city average); or 
‘‘(ii) the total percentage change for 
such fiscal year in basic pay under the 
General Schedule in accordance with sec-
tion 5332 of title 5, United States Code, 
as adjusted by any locality-based com-
parability payment pursuant to section 
5304 of such title for Federal employees 
stationed in the District of Columbia. 
‘‘(4) OFFSET.—Any amount of fees collected 
for a fiscal year under subsection (a) that exceeds 
the amount of fees specified in appropriation Acts 
for such fiscal year shall be credited to the appro-
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priation account of the Food and Drug Administra-
tion as provided in paragraph (1), and shall be sub-
tracted from the amount of fees that would other-
wise be authorized to be collected under this section 
pursuant to appropriation Acts for a subsequent fis-
cal year. 
‘‘(g) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 days after it is due, 
such fee shall be treated as a claim of the United States 
Government subject to subchapter II of chapter 37 of title 
31, United States Code. 
‘‘(h) CONSTRUCTION.—This section may not be con-
strued as requiring that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employers, and advisory committees not 
engaged in carrying out section 409 with respect to ge-
netic food additives be reduced to offset the number of 
officers, employees, and advisory committees so engaged. 
‘‘(i) DEFINITION
OF ADJUSTMENT FACTOR.—For 
purposes of this section, the term ‘adjustment factor’ ap-
plicable to a fiscal year is the lower of— 
‘‘(1) the Consumer Price Index for all urban 
consumers (all items; United States city average) for 
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April of the preceding fiscal year divided by such 
Index for April of the first applicable fiscal year; or 
‘‘(2) the total of discretionary budget authority 
provided for programs in categories other than the 
defense category for the immediately preceding fiscal 
year (as reported in the Office of Management and 
Budget sequestration preview report, if available, re-
quired under section 254(c) of the Balanced Budget 
and Emergency Deficit Control Act of 1985) divided 
by such budget authority for the first applicable fis-
cal year (as reported in the Office of Management 
and Budget final sequestration report submitted for 
such year). 
For purposes of this subsection, the terms ‘budget author-
ity’ and ‘category’ have the meaning given such terms in 
the Balanced Budget and Emergency Deficit Control Act 
of 1985.’’. 
SEC. 205. EMBARGO AUTHORITY. 
(a) EMBARGO.— 
(1) 
TEMPORARY
DETENTION.—Section 
304(g)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 334(g)(1)) is amended— 
(A) in the first sentence— 
(i) by striking ‘‘If during’’ and all 
that follows through ‘‘order the device or 
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tobacco product detained’’ and inserting 
the following: ‘‘If, during an inspection 
conducted under section 704, an officer or 
employee of the Department has reason to 
believe that a food, device, or tobacco prod-
uct is in violation of this Act, such officer 
or employee may order the food, device, or 
tobacco product detained’’; and 
(ii) by striking ‘‘he may authorize’’ 
and inserting ‘‘the Secretary may author-
ize’’; 
(B) in the second and third sentences, by 
striking ‘‘device or tobacco product’’ each place 
it appears and inserting ‘‘food, device, or to-
bacco product’’; 
(C) by striking the fourth and fifth sen-
tences; and 
(D) by adding at the end the following sen-
tence: ‘‘A detention order under this paragraph 
shall be considered final agency action.’’. 
(2) CONFORMING AMENDMENTS.—Chapter III 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331 et seq.) is amended— 
(A) in section 301(r)— 
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(i) by striking ‘‘device or tobacco 
product’’ the first place such term appears 
and inserting ‘‘food, device, or tobacco 
product’’; and 
(ii) by striking ‘‘the device or tobacco 
product’’ and inserting ‘‘such food, device, 
or tobacco product’’; and 
(B) in section 304(g)(2)— 
(i) in subparagraph (A), by striking 
‘‘device or tobacco product’’ and inserting 
‘‘food, device, or tobacco product’’; and 
(ii) in subparagraph (B), by striking 
‘‘device’’ each place it appears and insert-
ing ‘‘food or device’’. 
(b) DATE CERTAIN
FOR PROPOSED
AND FINAL 
RULES.—Within six months of the date of the enactment 
of this title, the Secretary of Health and Human Services 
shall propose a revision to the regulations in effect on such 
date under section 304(g) of the Federal Food, Drug, and 
Cosmetic Act to include food. Within three months of the 
date such proposed revision is published in the Federal 
Register, the Secretary shall issue a final revision of such 
regulations. 
(c) CONFIDENTIALITY.—For any food embargoed, 
seized, or recalled under the Federal Food, Drug, and Cos-
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metic Act, the Food and Drug Administration shall dis-
close all necessary information without regard to business 
confidentiality, if such disclosure is necessary to fully em-
bargo, seize, or recall any adulterated food. 
(d) FOOD RETAILER REGISTRATION.—All food re-
tailers shall register with the Food and Drug Administra-
tion for the purpose of expediting recalls, embargoes, and 
seizures under the Federal Food, Drug, and Cosmetic Act. 
SEC. 206. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY 
UNREGULATED MARKETED ADDITIVES. 
(a) RULEMAKING; EFFECTIVE DATE.—Not later 
than one year after the date of the enactment of this title, 
the Secretary of Health and Human Services shall by reg-
ulation establish criteria for carrying out section 409 of 
the Federal Food, Drug, and Cosmetic Act in accordance 
with the amendments made by section 203, and criteria 
for carrying out section 409A of such Act (as added by 
section 204). Such amendments take effect upon the expi-
ration of the 30-day period beginning on the date on which 
the Secretary promulgates the final rule under the pre-
ceding sentence, subject to subsection (b). 
(b) PREVIOUSLY UNREGULATED MARKETED ADDI-
TIVES.— 
(1) IN GENERAL.—In the case of a genetic food 
additive (as defined pursuant to the amendments 
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made by section 203) that in the United States was 
in commercial use in food as of the day before the 
date on which the final rule under subsection (a) is 
promulgated, the amendments made by this title 
apply to the additive upon the expiration of the two- 
year period beginning on the date on which the final 
rule is promulgated, subject to paragraph (2). 
(2) USER
FEES.—With respect to a genetic 
food additive described in paragraph (1), such para-
graph does not waive the applicability of section 
409A of the Federal Food, Drug, and Cosmetic Act 
to a petition under section 409(b)(1) of such Act 
that is filed before the expiration of the two-year pe-
riod described in such paragraph. 
Æ 
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