Genetically Engineered Pharmaceutical and Industrial Crop Safety Act of 2005 [sic] - 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 the 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.
Authorizes the Secretary of Agriculture 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."
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5267 Introduced in House (IH)]
109th CONGRESS
2d Session
H. R. 5267
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
May 2, 2006
Mr. Kucinich (for himself, Mr. Conyers, Ms. Lee, Mr. Sanders, and Ms.
Waters) 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.
Be it enacted by the Senate and House of Representatives 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 2005''.
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.
<all>
Introduced in House
Introduced in House
Sponsor introductory remarks on measure. (CR E687-688)
Referred to the House Committee on Agriculture.
Referred to the Subcommittee on Conservation, Credit, Rural Development, and Research.
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