this section assess and collect a fee on each petition that
is filed under section 409(b)(1). The fee shall be collected
from the person who submits the petition, is due upon sub-
mission of the petition, and shall be assessed in an amount
determined under subsection (c). This section applies as
of the first fiscal year that begins after the date of promul-
gation of the final rule required in section 6 of the Geneti-
cally Engineered Food Safety Act (referred to in this sec-
tion 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
a fiscal year, the Secretary shall reserve and
expend—
‘‘(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
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
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-
tion 736(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-
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
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
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-
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
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.—
(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.’’.
(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
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
date on which the final rule under subsection (a) is
promulgated, the amendments made by this Act
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