I 
108TH CONGRESS 
1ST SESSION H. R. 2917
To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
safety of genetically engineered foods, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 25, 2003
Mr. KUCINICH (for himself, Mr. DEFAZIO, Mr. SANDERS, Ms. LEE, Mr. CON-
YERS, Mr. OLVER, Mr. GEORGE MILLER of California, Mr. HONDA, Mr. 
ACEVEDO-VILA´, Mr. GUTIERREZ, Mr. NADLER, Mr. OWENS, Ms. 
VELA´ZQUEZ, Ms. WATERS, Ms. WATSON, and Ms. WOOLSEY) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to the safety of genetically engineered foods, and 
for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Genetically Engineered 
Food Safety Act’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows:
(1) Genetic engineering is an artificial gene 
transfer process wholly different from traditional 
breeding. 
(2) Genetic engineering can be used to produce 
new versions of virtually all plant and animal foods. 
Thus, within a short time, the food supply could 
consist almost entirely of genetically engineered 
products. 
(3) This conversion from a food supply based 
on traditionally bred organisms to one based on or-
ganisms produced through genetic engineering could 
be one of the most important changes in our food 
supply in this century. 
(4) Genetically engineered foods present new 
issues of safety that have not been adequately stud-
ied. 
(5) The Congress has previously required that 
food additives be analyzed for their safety prior to 
their placement on the market. 
(6) Adding new genes into a food should be 
considered adding a food additive, thus requiring an 
analysis of safety factors. 
(7) Federal agencies have failed to uphold con-
gressional intent of the Food Additives Amendment 
of 1958 by allowing genetically engineered foods to
be marketed, sold and otherwise used without re-
quiring pre-market safety testing addressing their 
unique characteristics. 
(8) The food additive process gives the Food 
and Drug Administration discretion in applying the 
safety factors that are generally recognized as ap-
propriate to evaluate the safety of food and food in-
gredients. 
(9) Given the consensus among the scientific 
community that genetic engineering can potentially 
introduce hazards, such as allergens or toxins, ge-
netically engineered foods need to be evaluated on a 
case-by-case basis and cannot be presumed to be 
generally recognized as safe. 
SEC. 3. FEDERAL DETERMINATION OF SAFETY OF GENETI-
CALLY ENGINEERED FOOD; REGULATION AS 
FOOD ADDITIVE. 
(a) INCLUSION
IN DEFINITION
OF FOOD ADDI-
TIVE.—Section 201 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) is amended—
(1) in paragraph (s), by adding after and below 
subparagraph (6) the following sentence: 
‘‘Such term includes the different genetic constructs, pro-
teins of such constructs, vectors, promoters, marker sys-
tems, and other appropriate terms that are used or cre-
troducing a foreign gene, and changing the positions 
of genes), other than a means consisting exclusively 
of breeding, conjugation, fermentation, hybridiza-
tion, in vitro fertilization, tissue culture, or 
mutagenesis; and 
‘‘(B) an organism made through sexual or asex-
ual reproduction (or both) involving an organism de-
scribed in clause (A), if possessing any of the altered 
molecular or cellular characteristics of the organism 
so described. 
‘‘(4) For purposes of subparagraph (1), a food shall 
be considered to have been produced with a genetically en-
gineered material if the organism from which the food is 
derived has been injected or otherwise treated with a ge-
netically engineered material (except that the use of ma-
nure as a fertilizer for raw agricultural commodities may 
not be construed to mean that such commodities are pro-
duced with a genetically engineered material).’’. 
(b) PETITION TO ESTABLISH SAFETY.—
(1) DATA IN PETITION.—Section 409(b)(2)(E) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 348(b)(2)(E)) is amended by adding at the 
end the following sentence: ‘‘In the case of a genetic 
food additive, such reports shall include all data that 
was collected or developed pursuant to the investiga-
tions, including data that does not support the claim 
of safety for use.’’. 
(2) NOTICES; PUBLIC AVAILABILITY OF INFOR-
MATION.—Section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)) is 
amended—
(A) by striking ‘‘(5)’’ and inserting 
‘‘(5)(A)’’; and 
(B) by adding at the end the following sub-
paragraphs: 
‘‘(B) In the case of a genetic food additive: 
‘‘(i) Promptly after providing the notice under 
subparagraph (A), the Secretary shall make avail-
able to the public all reports and data described in 
paragraph (2)(E) that are contained in the petition 
involved, and all other information in the petition to 
the extent that the information is relevant to a de-
termination of the safety for use of the additive. 
‘‘(ii) Such notice shall state whether any infor-
mation in the petition is not being made available to 
the public because the Secretary has made a deter-
mination that the information does not relate to the 
safety for use of the additive. Any person may peti-
tion the Secretary for a reconsideration of such a de-
termination.
‘‘(C) In the case of genetic food additives: 
‘‘(i) The Secretary shall maintain and make 
available to the public through telecommunications a 
list of petitions that are pending under this sub-
section and a list of petitions for which regulations 
under subsection (c)(1)(A) have been established. 
Such list shall include information on the additives 
involved, including the source of the additives, and 
including any information received by the Secretary 
pursuant to clause (ii). 
‘‘(ii) If a regulation is in effect under sub-
section (c)(1)(A) for a genetic food additive, any 
person who manufactures such additive for commer-
cial use shall submit to the Secretary a notification 
of any knowledge of data that relate to the adverse 
health effects of the additive, when knowledge is ac-
quired by the person after the date on which the 
regulation took effect. If the manufacturer is in pos-
session of the data, the notification shall include the 
data. The Secretary shall by regulation establish the 
scope of the responsibilities of manufacturers under 
this clause, including such limits on the responsibil-
ities as the Secretary determines to be appropriate.’’. 
(3) EFFECTIVE DATE OF REGULATION REGARD-
ING
SAFE
USE; OPPORTUNITY
FOR
PUBLIC
COM-
MENT.—Section 409(c)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(c)(2)) is 
amended—
(A) by striking ‘‘(2)’’ and inserting 
‘‘(2)(A)’’; and 
(B) by adding at the end the following sub-
paragraph: 
‘‘(B)(i) In the case of a genetic food additive, an 
order under paragraph (1)(A) may not be issued regarding 
the petition involved before the expiration of the applicable 
period under clause (ii). During such period, and con-
tinuing until an order under paragraph (1) is issued, the 
Secretary shall provide interested persons an opportunity 
to submit to the Secretary comments on the petition. In 
publishing such notice, the Secretary shall inform the pub-
lic of such opportunity. 
‘‘(ii) For purposes of clause (i), the applicable period 
under this clause regarding a petition is the 30-day period 
beginning on the date on which the Secretary has under 
subparagraph (B)(i) of subsection (b)(5) made informa-
tion available to the public regarding the petition, except 
that, if under subparagraph (B)(ii) of such subsection the 
Secretary finds in favor of a person who files for reconsid-
eration (relating to a determination by the Secretary that 
information does not relate to safety), such 30-day period
is extended by an additional period of 30-days. For pur-
poses of the preceding sentence, a discrete 30-day exten-
sion applies to each such reconsideration for which the 
Secretary finds in favor of the person filing for reconsider-
ation.’’. 
(4) CONSIDERATION OF CERTAIN FACTORS.—
Section 409(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 348(c)) is amended by adding 
at the end the following paragraph: 
‘‘(6) In the case of a genetic food additive, the factors 
considered by the Secretary regarding safety for use shall 
include (but not be limited to) the results of the following 
analyses:
‘‘(A) Allergenicity effects resulting from the 
added proteins, including proteins not found in the 
food supply. 
‘‘(B) Pleiotropic effects. The Secretary shall re-
quire tests to determine the potential for such ef-
fects (using molecular characterization, biochemical 
characterization, mRNA profiling, or other tech-
niques, or as appropriate, combinations of such tech-
niques). 
‘‘(C) Appearance of new toxins or increased lev-
els of existing toxins.
‘‘(D) Changes in the functional characteristics 
of food. 
‘‘(E) Changes in the levels of important nutri-
ents. 
‘‘(F) Changes in the levels of anti-nutrients.’’. 
(5) CERTAIN
TESTS.—Section 409(c) of the 
Federal Food, Drug, and Cosmetic Act, as amended 
by paragraph (4), is amended by adding at the end 
the following paragraph: 
‘‘(7) In the case of genetic food additives: 
‘‘(A) If a genetic food additive is a protein from 
a commonly or severely allergenic food, the Sec-
retary may not establish a regulation under para-
graph (1)(A) if the petition under subsection (b)(1) 
fails to include full reports of investigations that 
used serum or skin tests (or other advanced tech-
niques) on a sensitive population to determine 
whether such additive is commonly or severely aller-
genic. 
‘‘(B)(i) If a genetic food additive is a protein 
that has not undergone the investigations described 
in subparagraph (A), the Secretary may not estab-
lish a regulation under paragraph (1)(A) if the peti-
tion under subsection (b)(1) fails to include full re-
ports of investigations that used the best available
biochemical and physiological protocols to evaluate 
whether it is likely that the protein involved is an al-
lergen. 
‘‘(ii) For purposes of clause (i), the Secretary 
shall by regulation determine the best available bio-
chemical and physiological protocols. In carrying out 
rulemaking under the preceding sentence, the Sec-
retary shall consult with the Director of the Na-
tional Institutes of Health.’’. 
(6) PROHIBITED ADDITIVES.—Section 409(c) of 
the Federal Food, Drug, and Cosmetic Act, as 
amended by paragraph (5), is amended by adding at 
the end the following paragraph: 
‘‘(8) In the case of a genetic food additive, the Sec-
retary may not establish a regulation under paragraph 
(1)(A) if—
‘‘(A) the additive is a protein and a report of 
an investigation finds that the additive is likely to be 
commonly or severely allergenic; 
‘‘(B) the additive is a protein and a report of 
an investigation that uses a protocol described in 
paragraph (7)(B) fails to find with reasonable cer-
tainty that the additive is unlikely to be an allergen; 
or
(c) REGULATION ISSUED ON SECRETARY’S INITIA-
TIVE.—Section 409(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 348(d)) is amended—
(1) by striking ‘‘(d) The Secretary’’ and insert-
ing ‘‘(d)(1) Subject to paragraph (2), the Sec-
retary’’; and 
(2) by adding at the end the following para-
graph: 
‘‘(2) The provisions of subsections (b) and (c) that 
expressly reference genetic food additives apply with re-
spect to a regulation proposed by the Secretary under 
paragraph (1) to the same extent and in the same manner 
as such provisions apply with respect to a petition filed 
under subsection (b)(1).’’.
(d) CIVIL PENALTIES.—Section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend-
ed by adding at the end the following subsection: 
‘‘(h)(1) With respect to a violation of section 301(a), 
301(b), or 301(c) involving the adulteration of food by rea-
son of failure to comply with the provisions of section 409 
that relate to genetic food additives, any person engaging 
in such a violation shall be liable to the United States for 
a civil penalty in an amount not to exceed $100,000 for 
each such violation.
‘‘(2) Paragraphs (3) through (5) of subsection (g) 
apply with respect to a civil penalty under paragraph (1) 
of this subsection to the same extent and in the same man-
ner as such paragraphs (3) through (5) apply with respect 
to a civil penalty under paragraph (1) or (2) of subsection 
(g).’’. 
(e) CITIZEN SUITS.—Chapter III of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) 
is amended by adding at the end the following section: 
‘‘CITIZEN SUITS REGARDING GENETIC FOOD ADDITIVES 
‘‘SEC. 311. (a) IN GENERAL.—Except as provided in 
subsection (c), any person may on his or her behalf com-
mence a civil action in an appropriate district court of the 
United States against—
‘‘(1) a person who is alleged to have engaged in 
a violation of section 301(a), 301(b), or 301(c) in-
volving the adulteration of food by reason of failing 
to comply with the provisions of section 409 that re-
late to genetic food additives; or 
‘‘(2) the Secretary where there is alleged a fail-
ure of the Secretary to perform any act or duty 
under section 409 that relates to such additives and 
is not discretionary. 
‘‘(b) RELIEF.—In a civil action under subsection (a), 
the district court involved may, as the case may be—
‘‘(1) enforce the compliance of a person with 
the applicable provisions referred to paragraph (1) 
of such subsection; or 
‘‘(2) order the Secretary to perform an act or 
duty referred to in paragraph (2) of such subsection. 
‘‘(c) LIMITATIONS.—
‘‘(1) NOTICE
TO
SECRETARY.—A civil action 
may not be commenced under subsection (a)(1) prior 
to 60 days after the plaintiff has provided to the 
Secretary notice of the violation involved. 
‘‘(2) RELATION TO ACTIONS OF SECRETARY.—
A civil action may not be commenced under sub-
section (a)(2) if the Secretary has commenced and 
is diligently prosecuting a civil or criminal action in 
a district court of the United States to enforce com-
pliance with the applicable provisions referred to in 
subsection (a)(1). 
‘‘(d) RIGHT OF SECRETARY TO INTERVENE.—In any 
civil action under subsection (a), the Secretary, if not a 
party, may intervene as a matter of right. 
‘‘(e) AWARD OF COSTS; FILING OF BOND.—In a civil 
action under subsection (a), the district court involved 
may award costs of litigation (including reasonable attor-
ney and expert witness fees) to any party whenever the 
court determines such an award is appropriate. The court
may, if a temporary restraining order or preliminary in-
junction is sought, require the filing of a bond or equiva-
lent security in accordance with the Federal Rules of Civil 
Procedure. 
‘‘(f) SAVINGS PROVISION.—This section does not re-
strict any right that a person (or class of persons) may 
have under any statute or common law to seek enforce-
ment of the provisions referred to subsection (a)(1), or to 
seek any other relief (including relief against the Sec-
retary).’’. 
(f) RULE OF CONSTRUCTION.—With respect to sec-
tion 409 of the Federal Food, Drug, and Cosmetic Act 
as amended by this section, compliance with the provisions 
of such section 409 that relate to genetic food additives 
does not constitute an affirmative defense in any cause 
of action under Federal or State law for personal injury 
resulting in whole or in part from a genetic food additive. 
SEC. 4. USER FEES REGARDING DETERMINATION OF SAFE-
TY OF GENETIC FOOD ADDITIVES. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by inserting after 
section 409 the following section: 
‘‘USER FEES REGARDING SAFETY OF GENETIC FOOD 
ADDITIVES 
‘‘SEC. 409A. (a) IN GENERAL.—In the case of ge-
netic food additives, the Secretary shall in accordance with
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 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 
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
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