I 
108TH CONGRESS 
1ST SESSION H. R. 2921
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, 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. 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 Agriculture 
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-
sure to genetically engineered pharmaceutical and indus-
trial crops and their byproducts, 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 
Pharmaceutical and Industrial Crop Safety Act of 2003’’. 
SEC. 2. 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, 
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. 
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. 
(8) Therefore, appropriate regulatory controls, 
as established by this Act, 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. 3. DEFINITIONS. 
In this Act: 
(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 
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-
tentionally treated with genetically engineered mate-
rial that, in turn, produces an industrial substance. 
SEC. 
4. 
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—
(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. 5. 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 5, including a regulation promulgated or order issued 
under such section. Each violation, and each day during 
which a violation continues, shall be a separate offense. 
(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. 
(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 
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. 6. REPORT TO CONGRESS ON ALTERNATIVE METHODS 
TO PRODUCE PHARMACEUTICAL AND INDUS-
TRIAL 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.
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