I 
111TH CONGRESS 
2D SESSION 
H. R. 5578 
To prohibit the open-air cultivation of genetically engineered pharmaceutical 
and industrial crops, to prohibit the use of common human food or 
animal feed as the host plant for a genetically engineered pharmaceutical 
or industrial chemical, to establish a tracking system to regulate the 
growing, handling, transportation, and disposal of pharmaceutical and 
industrial crops and their byproducts to prevent human, animal, and 
general environmental exposure to genetically engineered pharmaceutical 
and industrial crops and their byproducts, to amend the Federal Food, 
Drug, and Cosmetic Act with respect to the safety of genetically engi-
neered foods, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 23, 2010 
Mr. KUCINICH (for himself, Mr. DEFAZIO, Mr. FRANK of Massachusetts, Mr. 
GRIJALVA, Mr. STARK, and Ms. WOOLSEY) introduced the following bill; 
which was referred to the Committee on Agriculture, and in addition to 
the Committee on Energy and Commerce, for a period to be subsequently 
determined by the Speaker, in each case for consideration of such provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To prohibit the open-air cultivation of genetically engineered 
pharmaceutical and industrial crops, to prohibit the use 
of common human food or animal feed as the host plant 
for a genetically engineered pharmaceutical or industrial 
chemical, to establish a tracking system to regulate the 
growing, handling, transportation, and disposal of phar-
maceutical and industrial crops and their byproducts to 
prevent human, animal, and general environmental expo-
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sure to genetically engineered pharmaceutical and indus-
trial crops and their byproducts, 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; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Genetically Engineered Safety Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
TITLE I—GENETICALLY ENGINEERED PHARMACEUTICAL AND 
INDUSTRIAL CROP SAFETY 
Sec. 101. Short title. 
Sec. 102. Findings. 
Sec. 103. Definitions. 
Sec. 104. Regulation of production of pharmaceutical crops and industrial 
crops. 
Sec. 105. Civil penalties for violation. 
Sec. 106. Report to Congress on alternative methods to produce pharmaceutical 
and industrial crops. 
TITLE II—GENETICALLY ENGINEERED FOOD SAFETY 
Sec. 201. Short title. 
Sec. 202. Findings. 
Sec. 203. Federal determination of safety of genetically engineered food; regula-
tion as food additive. 
Sec. 204. User fees regarding determination of safety of genetic food additives. 
Sec. 205. Embargo authority. 
Sec. 206. Rulemaking; effective date; previously unregulated marketed addi-
tives. 
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TITLE 
I—GENETICALLY 
ENGI-
NEERED 
PHARMACEUTICAL 
AND INDUSTRIAL CROP SAFE-
TY 
SEC. 101. SHORT TITLE. 
This title may be cited as the ‘‘Genetically Engi-
neered Pharmaceutical and Industrial Crop Safety Act of 
2010’’. 
SEC. 102. FINDINGS. 
Congress finds the following: 
(1) A pharmaceutical crop or industrial crop is 
a plant that has been genetically engineered to 
produce a medical or industrial product, including a 
human or veterinary drug, biologic, industrial, or re-
search chemical, or enzyme. 
(2) The Department of Agriculture has issued 
‘‘split approval’’ permits to allow the cultivation of 
10 food crops genetically engineered to produce bio-
pharmaceuticals or chemicals that are not approved 
for human consumption. As of January 1, 2003, 
more than 300 field trials have been conducted in 
the United States. In nearly 70 percent of these 
tests, corn has been the crop used, but other crops 
tested include soybean, tobacco, rice, alfalfa, barley, 
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rapeseed (canola), wheat, tomato, safflower, and 
sugercane. 
(3) Many of the novel substances produced in 
pharmaceutical crops and industrial crops exhibit 
high levels of biological activity and are intended to 
be used for particular medical or industrial pur-
poses, under very controlled circumstances. None of 
these substances is intended to be incorporated in 
food or to be spread into the environment. 
(4) The magnitude of the risks posed by phar-
maceutical crops and industrial crops depends on 
many factors, including the chemicals involved, the 
organisms or environments exposed, and the level 
and duration of the exposure. Humans, animals, and 
the environment at large could be at risk from con-
tamination, a major concern of which is that bio-
active nonfood substances, which have not been test-
ed, will contaminate or otherwise adversely affect the 
food supply. Substances intended for use as human 
drugs are especially problematic because they are in-
tended to be biologically active in people. 
(5) Pharmaceutical crops and industrial crops 
also pose substantial liability and other economic 
risks to farmers, grain handlers, food companies, 
and other persons in the food and feed supply chain. 
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These risks include liability for contamination epi-
sodes, costly food recalls, losses in export markets, 
reduced prices for a contaminated food or feed crop, 
and loss of confidence in the safety of the American 
food supply among foreign importers and consumers 
of American agricultural commodities. 
(6) These risks necessitate a zero tolerance 
standard for the presence of pharmaceutical crops 
and industrial crops and their byproducts in crops 
used to produce human food or animal feed. 
(7) While there presently exists a pro forma 
zero tolerance standard, the Department of Agri-
culture and experts in the field acknowledge that 
contamination of human food and animal feed is in-
evitable due to the inherent imprecision of biological 
and agricultural systems, as well as the laxity of the 
regulatory regime. This is illustrated, for example, in 
the Department of Agriculture’s regulations, which 
aim not for prevention (recognized as unattainable), 
but rather mitigation of the gene flow that results 
in contamination of food/feed crops with these sub-
stances. Some experts in the field are calling for es-
tablishment of tolerances, despite the potential risks 
involved. 
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(8) Therefore, appropriate regulatory controls, 
as established by this title, are urgently needed to 
ensure that pharmaceutical crops and industrial 
crops and their byproducts do not enter human food 
or animal feed crops at any level. 
SEC. 103. DEFINITIONS. 
In this title: 
(1) The term ‘‘genetically engineered plant’’ 
means a plant that contains a genetically engineered 
material or was produced from a genetically engi-
neered seed. A plant shall be considered to contain 
a genetically engineered material if the plant has 
been injected or otherwise treated with a genetically 
engineered material (except that the use of manure 
as a fertilizer for the plant may not be construed to 
mean that the plant is produced with a genetically 
engineered material). 
(2) The term ‘‘genetically engineered material’’ 
means material that has been altered at the molec-
ular or cellular level by means that are not possible 
under natural conditions or processes (including re-
combinant DNA and RNA techniques, cell fusion, 
microencapsulation, macroencapsulation, gene dele-
tion and doubling, introducing a foreign gene, and 
changing the positions of genes), other than a means 
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consisting exclusively of breeding, conjugation, fer-
mentation, hybridization, in vitro fertilization, tissue 
culture, or mutagenesis. 
(3) The term ‘‘genetically engineered seed’’ 
means a seed that contains a genetically engineered 
material or was produced with a genetically engi-
neered material. A seed shall be considered to con-
tain a genetically engineered material or to have 
been produced with a genetically engineered material 
if the seed (or the plant from which the seed is de-
rived) has been injected or otherwise treated with a 
genetically engineered material (except that the use 
of manure as a fertilizer for the plant may not be 
construed to mean that any resulting seeds are pro-
duced with a genetically engineered material). 
(4) The term ‘‘pharmaceutical crop’’ means a 
genetically engineered plant that is designed to 
produce medical products, including human and vet-
erinary drugs and biologics. The term includes a 
crop intentionally treated with genetically engineered 
material that, in turn, produces a medical substance. 
(5) The term ‘‘industrial crop’’ means a geneti-
cally engineered plant that is designed to produce in-
dustrial products, including industrial and research 
chemicals and enzymes. The term includes a crop in-
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tentionally treated with genetically engineered mate-
rial that, in turn, produces an industrial substance. 
SEC. 104. REGULATION OF PRODUCTION OF PHARMA-
CEUTICAL CROPS AND INDUSTRIAL CROPS. 
(a) TEMPORARY MORATORIUM PENDING REGULA-
TIONS.—No pharmaceutical crop or industrial crop may 
be grown, raised, or otherwise cultivated until the final 
regulations and tracking system required by this section 
are in effect. 
(b) PROHIBITION ON OPEN-AIR CULTIVATION.—No 
person may grow, raise or otherwise cultivate a pharma-
ceutical crop or industrial crop in an open air environ-
ment. 
(c) PROHIBITION
ON USE
OF COMMON HUMAN 
FOODS OR ANIMAL FEEDS.—No person may grow, raise, 
or otherwise cultivate a pharmaceutical crop or industrial 
crop in a food commonly used for human food or domestic 
animal feed. 
(d) BIOTECH
TRACKING
SYSTEM.—The United 
States Department of Agriculture shall establish a track-
ing system to regulate the growing, handling, transpor-
tation, and disposal of all pharmaceutical and industrial 
crops and their byproducts to prevent contamination. 
(e) REGULATIONS.—The Secretary of Agriculture 
shall issue regulations— 
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(1) to enforce the prohibitions imposed by sub-
sections (b) and (c); 
(2) to designate the common foods whose use as 
a source of a pharmaceutical crop or industrial crop 
is prohibited by subsection (c); and 
(3) to establish the tracking system required by 
subsection (d). 
SEC. 105. CIVIL PENALTIES FOR VIOLATION. 
(a) AUTHORITY TO ACCESS PENALTIES.—The Sec-
retary of Agriculture may assess, by written order, a civil 
penalty against a person that violates a provision of sec-
tion 105, including a regulation promulgated or order 
issued under such section. Each violation, and each day 
during which a violation continues, shall be a separate of-
fense. 
(b) AMOUNT
AND FACTORS
IN ACCESSING PEN-
ALTIES.—The maximum amount that may be accessed 
under this section for a violation may not exceed 
$1,000,000. In determining the amount of the civil pen-
alty, the Secretary shall take into account— 
(1) the gravity of the violation; 
(2) the degree of culpability; 
(3) the size and type of the business; and 
(4) any history of prior offenses under such sec-
tion or other laws administered by the Secretary. 
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(c) NOTICE AND OPPORTUNITY FOR HEARING.—The 
Secretary shall not assess a civil penalty under this section 
against a person unless the company is given notice and 
opportunity for a hearing on the record before the Sec-
retary in accordance with sections 554 and 556 of title 
5, United States Code. 
(d) JUDICIAL REVIEW.—(1) An order assessing a 
civil penalty against a person under subsection (a) may 
be reviewed only in accordance with this subsection. The 
order shall be final and conclusive unless the person— 
(A) not later than 30 days after the effective 
date of the order, files a petition for judicial review 
in the United States court of appeals for the circuit 
in which the person resides or has its principal place 
of business or in the United States Court of Appeals 
for the District of Columbia; and 
(B) simultaneously sends a copy of the petition 
by certified mail to the Secretary. 
(2) The Secretary shall promptly file in the court a 
certified copy of the record on which the violation was 
found and the civil penalty assessed. 
(e) COLLECTION ACTION FOR FAILURE TO PAY AS-
SESSMENT.—If a person fails to pay a civil penalty after 
the order assessing the civil penalty has become final and 
unappealable, the Secretary shall refer the matter to the 
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Attorney General, who shall bring a civil action to recover 
the amount of the civil penalty in United States district 
court. In the collection action, the validity and appro-
priateness of the order of the Secretary imposing the civil 
penalty shall not be subject to review. 
SEC. 106. REPORT TO CONGRESS ON ALTERNATIVE METH-
ODS TO PRODUCE PHARMACEUTICAL AND IN-
DUSTRIAL CROPS. 
The National Academy of Sciences shall submit to 
Congress a report that explores alternative methods to 
produce pharmaceuticals or industrial chemicals that have 
the advantage of being conducted in controlled production 
facilities and do not present the risk of contamination. 
TITLE II—GENETICALLY 
ENGINEERED FOOD SAFETY 
SEC. 201. SHORT TITLE. 
This title may be cited as the ‘‘Genetically Engi-
neered Food Safety Act’’. 
SEC. 202. 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. 
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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 
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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. 203. FEDERAL DETERMINATION OF SAFETY OF GE-
NETICALLY 
ENGINEERED 
FOOD; 
REGULA-
TION 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-
ated as a result of the creation of a genetically engineered 
food (as defined in paragraph (ss)), other than a genetic 
construct, protein, vector, promoter, or marker system or 
other appropriate term for which an application under sec-
tion 505 or 512 has been filed. For purposes of this Act, 
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the term ‘genetic food additive’ means a genetic construct, 
protein, vector, promoter, or marker system or other ap-
propriate term that is so included.’’; and 
(2) by adding at the end the following: 
‘‘(ss)(1) The term ‘genetically engineered food’ means 
food that contains or was produced with a genetically engi-
neered material. 
‘‘(2) The term ‘genetically engineered material’ 
means material derived from any part of a genetically en-
gineered organism, without regard to whether the altered 
molecular or cellular characteristics of the organism are 
detectable in the material. 
‘‘(3) The term ‘genetically engineered organism’ 
means— 
‘‘(A) an organism that has been altered at the 
molecular or cellular level by means that are not 
possible under natural conditions or processes (in-
cluding but not limited to recombinant DNA and 
RNA techniques, cell fusion, microencapsulation, 
macroencapsulation, gene deletion and doubling, in-
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 
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‘‘(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) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 348(b)(2)) is amended by adding after and 
below subparagraph (E) 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 investigations, 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, 
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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-
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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— 
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(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 
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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. 
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‘‘(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. 
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‘‘(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) effective June 1, 2006, a selective marker 
is used with respect to the additive, the selective 
marker will remain in the food involved when the 
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food is marketed, and the selective marker inhibits 
the function of one or more antibiotics.’’. 
(7) ADDITIONAL PROVISIONS.—Section 409(c) 
of the Federal Food, Drug, and Cosmetic Act, as 
amended by paragraph (6), is amended by adding at 
the end the following paragraph: 
‘‘(9)(A) In determining the safety for use of genetic 
food additives, the Secretary may (directly or through con-
tract) conduct investigations of such additives for pur-
poses of supplementing the information provided to the 
Secretary pursuant to petitions under subsection (b)(1). 
‘‘(B) To provide the Congress with a periodic inde-
pendent, external review of the Secretary’s formulation of 
the approval process under paragraph (1)(A) that relates 
to genetic food additives, the Secretary shall enter into 
an agreement with the Institute of Medicine. Such agree-
ment shall provide that, if the Institute of Medicine has 
any concerns regarding the approval process, the Institute 
of Medicine will submit to the Congress a report describ-
ing such concerns.’’. 
(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— 
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(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 (5) through (7) of subsection (f) 
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 (5) through (7) apply with respect 
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to a civil penalty under paragraph (1), (2), (3), (4), or 
(9) of subsection (f).’’. 
(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: 
‘‘SEC. 311. CITIZEN SUITS REGARDING GENETIC FOOD AD-
DITIVES. 
‘‘(a) IN GENERAL.—Except as provided in subsection 
(c), any person may on his or her behalf commence 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 
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‘‘(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-
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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. 204. USER FEES REGARDING DETERMINATION OF 
SAFETY 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: 
‘‘SEC. 409A. USER FEES REGARDING SAFETY OF GENETIC 
FOOD ADDITIVES. 
‘‘(a) IN GENERAL.—In the case of genetic food addi-
tives, the Secretary shall in accordance with this section 
assess and collect a fee on each petition that is filed under 
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section 409(b)(1). The fee shall be collected from the per-
son who submits the petition, is due upon submission of 
the petition, and shall be assessed in an amount deter-
mined under subsection (c). This section applies as of the 
first fiscal year that begins after the date of promulgation 
of the final rule required in section 206 of the Genetically 
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 
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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. 
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‘‘(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 
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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-
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 
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