‘‘(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-
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. 
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‘‘(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 
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. 5. EMBARGO AUTHORITY. 
(a) EMBARGO.— 
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(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 de-
tained’’ and inserting the following: ‘‘If, 
during an inspection conducted under sec-
tion 704, an officer or employee of the De-
partment has reason to believe that a food 
or device is in violation of this Act, such 
officer or employee may order the food or 
device 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’’ each place such term appears 
and inserting ‘‘food or device’’; 
(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.’’. 
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(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)— 
(i) by striking ‘‘device’’ the first place 
such term appears and inserting ‘‘food or 
device’’; and 
(ii) by striking ‘‘the device’’ and in-
serting ‘‘such food or device’’; and 
(B) in section 304(g)(2), by striking ‘‘de-
vice’’ each place such term 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 Act, 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-
metic Act, the Food and Drug Administration shall dis-
close all necessary information without regard to business 
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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. 6. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY UN-
REGULATED MARKETED ADDITIVES. 
(a) RULEMAKING; EFFECTIVE DATE.—Not later 
than one year after the date of the enactment of this Act, 
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 3, and criteria for 
carrying out section 409A of such Act (as added by section 
4). Such amendments take effect upon the expiration of 
the 30-day period beginning on the date on which the Sec-
retary promulgates the final rule under the preceding sen-
tence, 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 
made by section (3)) that in the United States was 
in commercial use in food as of the day before the 
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