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. CONYERS, 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 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.
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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Genetically Engineered 

5 Pharmaceutical and Industrial Crop Safety Act of 2003’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

8 (1) A pharmaceutical crop or industrial crop is 

9 a plant that has been genetically engineered to 

10 produce a medical or industrial product, including a 

11 human or veterinary drug, biologic, industrial, or re12 search chemical, or enzyme. 

13 (2) The Department of Agriculture has issued 

14 ‘‘split approval’’ permits to allow the cultivation of 

15 10 food crops genetically engineered to produce bio16 pharmaceuticals or chemicals that are not approved 

17 for human consumption. As of January 1, 2003, 

18 more than 300 field trials have been conducted in 

19 the United States. In nearly 70 percent of these 

20 tests, corn has been the crop used, but other crops 

21 tested include soybean, tobacco, rice, alfalfa, barley, 

22 rapeseed (canola), wheat, tomato, safflower, and 

23 sugercane. 

24 (3) Many of the novel substances produced in 

25 pharmaceutical crops and industrial crops exhibit 
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1 high levels of biological activity and are intended to 

2 be used for particular medical or industrial pur3 poses, under very controlled circumstances. None of 

4 these substances is intended to be incorporated in 

5 food or to be spread into the environment. 

6 (4) The magnitude of the risks posed by phar7 maceutical crops and industrial crops depends on 

8 many factors, including the chemicals involved, the 

9 organisms or environments exposed, and the level 

10 and duration of the exposure. Humans, animals, and 

11 the environment at large could be at risk from con12 tamination, a major concern of which is that bio13 active nonfood substances, which have not been test14 ed, will contaminate or otherwise adversely affect the 

15 food supply. Substances intended for use as human 

16 drugs are especially problematic because they are in17 tended to be biologically active in people. 

18 (5) Pharmaceutical crops and industrial crops 

19 also pose substantial liability and other economic 

20 risks to farmers, grain handlers, food companies, 

21 and other persons in the food and feed supply chain. 

22 These risks include liability for contamination epi23 sodes, costly food recalls, losses in export markets, 

24 reduced prices for a contaminated food or feed crop, 

25 and loss of confidence in the safety of the American 
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1 food supply among foreign importers and consumers 

2 of American agricultural commodities. 

3 (6) These risks necessitate a zero tolerance 

4 standard for the presence of pharmaceutical crops 

5 and industrial crops and their byproducts in crops 

6 used to produce human food or animal feed. 

7 (7) While there presently exists a pro forma 

8 zero tolerance standard, the Department of Agri9 culture and experts in the field acknowledge that 

10 contamination of human food and animal feed is in11 evitable due to the inherent imprecision of biological 

12 and agricultural systems, as well as the laxity of the 

13 regulatory regime. This is illustrated, for example, in 

14 the Department of Agriculture’s regulations, which 

15 aim not for prevention (recognized as unattainable), 

16 but rather mitigation of the gene flow that results 

17 in contamination of food/feed crops with these sub18 stances. Some experts in the field are calling for es19 tablishment of tolerances, despite the potential risks 

20 involved. 

21 (8) Therefore, appropriate regulatory controls, 

22 as established by this Act, are urgently needed to 

23 ensure that pharmaceutical crops and industrial 

24 crops and their byproducts do not enter human food 

25 or animal feed crops at any level. 
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1 SEC. 3. DEFINITIONS. 

2 In this Act: 

3 (1) The term ‘‘genetically engineered plant’’ 

4 means a plant that contains a genetically engineered 

5 material or was produced from a genetically engi6 neered seed. A plant shall be considered to contain 

7 a genetically engineered material if the plant has 

8 been injected or otherwise treated with a genetically 

9 engineered material (except that the use of manure 

10 as a fertilizer for the plant may not be construed to 

11 mean that the plant is produced with a genetically 

12 engineered material). 

13 (2) The term ‘‘genetically engineered material’’ 

14 means material that has been altered at the molec15 ular or cellular level by means that are not possible 

16 under natural conditions or processes (including re17 combinant DNA and RNA techniques, cell fusion, 

18 microencapsulation, macroencapsulation, gene dele19 tion and doubling, introducing a foreign gene, and 

20 changing the positions of genes), other than a means 

21 consisting exclusively of breeding, conjugation, fer22 mentation, hybridization, in vitro fertilization, tissue 

23 culture, or mutagenesis. 

24 (3) The term ‘‘genetically engineered seed’’ 

25 means a seed that contains a genetically engineered 

26 material or was produced with a genetically engi-
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1 neered material. A seed shall be considered to con2 tain a genetically engineered material or to have 

3 been produced with a genetically engineered material 

4 if the seed (or the plant from which the seed is de5 rived) has been injected or otherwise treated with a 

6 genetically engineered material (except that the use 

7 of manure as a fertilizer for the plant may not be 

8 construed to mean that any resulting seeds are pro9 duced with a genetically engineered material). 

10 (4) The term ‘‘pharmaceutical crop’’ means a 

11 genetically engineered plant that is designed to 

12 produce medical products, including human and vet13 erinary drugs and biologics. The term includes a 

14 crop intentionally treated with genetically engineered 

15 material that, in turn, produces a medical substance. 

16 (5) The term ‘‘industrial crop’’ means a geneti17 cally engineered plant that is designed to produce in18 dustrial products, including industrial and research 

19 chemicals and enzymes. The term includes a crop in20 tentionally treated with genetically engineered mate21 rial that, in turn, produces an industrial substance. 

22 SEC. 4. REGULATION OF PRODUCTION OF PHARMA23 CEUTICAL CROPS AND INDUSTRIAL CROPS. 

24 (a) TEMPORARY MORATORIUM PENDING REGULA25 TIONS.—No pharmaceutical crop or industrial crop may 
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1 be grown, raised, or otherwise cultivated until the final 

2 regulations and tracking system required by this section 

3 are in effect. 

4 (b) PROHIBITION ON OPEN-AIR CULTIVATION.—No 

5 person may grow, raise or otherwise cultivate a pharma6 ceutical crop or industrial crop in an open air environ7 ment. 

8 (c) PROHIBITION ON USE OF COMMON HUMAN

9 FOODS OR ANIMAL FEEDS.—No person may grow, raise, 

10 or otherwise cultivate a pharmaceutical crop or industrial 

11 crop in a food commonly used for human food or domestic 

12 animal feed. 

13 (d) BIOTECH TRACKING SYSTEM.—The United 

14 States Department of Agriculture shall establish a track15 ing system to regulate the growing, handling, transpor16 tation, and disposal of all pharmaceutical and industrial 

17 crops and their byproducts to prevent contamination. 

18 (e) REGULATIONS.—The Secretary of Agriculture 

19 shall issue regulations—

20 (1) to enforce the prohibitions imposed by sub21 sections (b) and (c); 

22 (2) to designate the common foods whose use as 

23 a source of a pharmaceutical crop or industrial crop 

24 is prohibited by subsection (c); and 
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1 (3) to establish the tracking system required by 

2 subsection (d). 

3 SEC. 5. CIVIL PENALTIES FOR VIOLATION. 

4 (a) AUTHORITY TO ACCESS PENALTIES.—The Sec5 retary of Agriculture may assess, by written order, a civil 

6 penalty against a person that violates a provision of sec7 tion 5, including a regulation promulgated or order issued 

8 under such section. Each violation, and each day during 

9 which a violation continues, shall be a separate offense. 

10 (b) AMOUNT AND FACTORS IN ACCESSING PEN11 ALTIES.—The maximum amount that may be accessed 

12 under this section for a violation may not exceed 

13 $1,000,000. In determining the amount of the civil pen14 alty, the Secretary shall take into account—

15 (1) the gravity of the violation; 

16 (2) the degree of culpability; 

17 (3) the size and type of the business; and 

18 (4) any history of prior offenses under such sec19 tion or other laws administered by the Secretary. 

20 (c) NOTICE AND OPPORTUNITY FOR HEARING.—The 

21 Secretary shall not assess a civil penalty under this section 

22 against a person unless the company is given notice and 

23 opportunity for a hearing on the record before the Sec24 retary in accordance with sections 554 and 556 of title 

25 5, United States Code. 
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1 (d) JUDICIAL REVIEW.—(1) An order assessing a 

2 civil penalty against a person under subsection (a) may 

3 be reviewed only in accordance with this subsection. The 

4 order shall be final and conclusive unless the person—

5 (A) not later than 30 days after the effective 

6 date of the order, files a petition for judicial review 

7 in the United States court of appeals for the circuit 

8 in which the person resides or has its principal place 

9 of business or in the United States Court of Appeals 

10 for the District of Columbia; and 

11 (B) simultaneously sends a copy of the petition 

12 by certified mail to the Secretary. 

13 (2) The Secretary shall promptly file in the court a 

14 certified copy of the record on which the violation was 

15 found and the civil penalty assessed. 

16 (e) COLLECTION ACTION FOR FAILURE TO PAY AS17 SESSMENT.—If a person fails to pay a civil penalty after 

18 the order assessing the civil penalty has become final and 

19 unappealable, the Secretary shall refer the matter to the 

20 Attorney General, who shall bring a civil action to recover 

21 the amount of the civil penalty in United States district 

22 court. In the collection action, the validity and appro23 priateness of the order of the Secretary imposing the civil 

24 penalty shall not be subject to review. 
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1 SEC. 6. REPORT TO CONGRESS ON ALTERNATIVE METHODS 

2 TO PRODUCE PHARMACEUTICAL AND INDUS3 TRIAL CROPS. 

4 The National Academy of Sciences shall submit to 

5 Congress a report that explores alternative methods to 

6 produce pharmaceuticals or industrial chemicals that have 

7 the advantage of being conducted in controlled production 

8 facilities and do not present the risk of contamination.

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