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 research 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 biopharmaceuticals 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 purposes, 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 pharmaceutical 
        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 
        contamination, a major concern of which is that bioactive 
        nonfood substances, which have not been tested, will 
        contaminate or otherwise adversely affect the food supply. 
        Substances intended for use as human drugs are especially 
        problematic because they are intended 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 episodes, 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 Agriculture and experts in the 
        field acknowledge that contamination of human food and animal 
        feed is inevitable 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 substances. Some experts in the field are 
        calling for establishment 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 engineered 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 molecular or cellular 
        level by means that are not possible under natural conditions 
        or processes (including recombinant DNA and RNA techniques, 
        cell fusion, microencapsulation, macroencapsulation, gene 
        deletion and doubling, introducing a foreign gene, and changing 
        the positions of genes), other than a means consisting 
        exclusively of breeding, conjugation, fermentation, 
        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 engineered material. A seed shall be 
        considered to contain 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 derived) 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 
        produced 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 veterinary 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 genetically 
        engineered plant that is designed to produce industrial 
        products, including industrial and research chemicals and 
        enzymes. The term includes a crop intentionally treated with 
        genetically engineered material that, in turn, produces an 
        industrial substance.

SEC. 4. REGULATION OF PRODUCTION OF PHARMACEUTICAL CROPS AND INDUSTRIAL 
              CROPS.

    (a) Temporary Moratorium Pending Regulations.--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 pharmaceutical crop or industrial crop in an 
open air environment.
    (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 tracking system to regulate the growing, 
handling, transportation, 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 subsections (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 Secretary of Agriculture 
may assess, by written order, a civil penalty against a person that 
violates a provision of section 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 Penalties.--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 penalty, 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 section 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 Secretary 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 Assessment.--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 appropriateness 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 INDUSTRIAL 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.
Genetically Engineered Pharmaceutical and Industrial Crop Safety Act of 2003 - Prohibits: (1) a pharmaceutical crop or industrial crop to be grown, raised, or otherwise cultivated until the final regulations and tracking system required by this Act are in effect; and (2) cultivation of a pharmaceutical crop or industrial crop in an open air environment, or in a food commonly used for human food or domestic animal feed.

Directs: (1) the United States Department of Agriculture to establish a tracking system to regulate the growing, handling, transportation, and disposal of all pharmaceutical and industrial crops and their byproducts to prevent contamination; and (2) the Secretary of Agriculture to issue related regulations.

Authorizes the Secretary to assess civil penalties for violations of such provisions.

Directs the National Academy of Sciences to report on alternative methods to produce pharmaceuticals or industrial chemicals that may be conducted in controlled production facilities without the risk of contamination.

Defines: (1) genetically engineered plant; (2) genetically engineered material; (3) genetically engineered seed; (4) pharmaceutical crop; and (5) industrial crop.
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.