Report Title:

GMOs; Pharmaceutical and Industrial Crops

Description:

Regulates production of pharmaceutical crops and industrial crops. Imposes civil penalties for violations.

THE SENATE

S.B. NO.

2132

TWENTY-SECOND LEGISLATURE, 2004

 

STATE OF HAWAII

 


 

A BILL FOR AN ACT

 

relating to genetically engineered crops.

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

SECTION 1. The legislature finds that a pharmaceutical crop or industrial crop are plants that have been genetically engineered to produce a medical or industrial product, including a human or veterinary drug, and a biological, industrial, or research chemical or enzyme.

The legislature further finds that the department of agriculture has issued sixteen permits to allow the cultivation of food crops that are genetically engineered to produce biopharmaceuticals or chemicals that are not approved for human consumption in the State. 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.

The legislature further finds that 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 to those crops, and the level and duration of exposure. Humans, animals, and the environment at large could be at risk from contamination. A major contamination concern is that bioactive nonfood substances, which have not been tested, will contaminate or otherwise adversely affect the general food supply. Substances intended for use as human drugs are especially problematic because they are intended to be biologically active in people.

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 may include liability for contamination episodes, costly food recalls, losses in export markets, reduced prices for a contaminated food or feed crops, and loss of confidence in the safety of Hawaii's food supply among importers and consumers of agricultural commodities from Hawaii. 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.

The legislature finds that while a pro forma zero tolerance standard exists, 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 relaxed regulatory regime. For example, the department of agriculture's regulations aim not for prevention -- which may be unattainable -- but rather for mitigation of the gene flow that results in contamination of food and feed crops with these substances. Some experts in the field are calling for the establishment of tolerances, despite the potential risks involved. Under these circumstances, 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.

SECTION 2. Chapter 142, Hawaii Revised Statutes, is amended by adding a new part to be appropriately designated and to read as follows:

"Part   . Genetically engineered pharmaceutical

and industrial crop safety

142-A Short title. This Act shall be known and may be cited as the Genetically Engineered Pharmaceutical and Industrial Crop Safety Act.

142-B Definitions. As used in this part:

"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 by 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.

"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 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.

"Genetically engineered seed" means a seed that contains or was produced with genetically engineered material. A seed shall be considered to contain genetically engineered material or to have been produced with genetically engineered material if the seed (or the plant from which the seed is derived) has been injected or otherwise treated with 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.

"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.

"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.

142-C Regulation of production of pharmaceutical crops and industrial crops. (a) Growing, raising, or otherwise cultivating a pharmaceutical crop or industrial crop is prohibited in an open air environment and in a food commonly used for human food or domestic animal feed. The department of agriculture shall adopt rules under chapter 91 to enforce these prohibitions. Growing, raising, or otherwise cultivating a pharmaceutical crop or industrial crop shall be prohibited until the rules and tracking system required by this section are in effect.

(b) In order to prevent contamination, the 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.

142-D Civil penalties for violation. (a) The chairperson of the board of agriculture, by written order, may assess a civil penalty against a person who violates a provision of this part, including a rule adopted or order issued under this part. Each violation, and each day during which a violation continues, shall constitute a separate offense.

(b) The maximum amount that may be assessed under this section for any violation is a civil penalty of $1,000,000. In determining the amount of the civil penalty, factors to be considered include the following:

(1) The gravity of the violation;

(2) The degree of culpability;

(3) The size and type of business; and

(4) Any history of prior offenses under such section or other laws administered by the department of agriculture.

(c) A civil penalty under this section shall not be assessed against a person unless the person is given notice and an opportunity for a hearing on the record.

(d) 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, not later than thirty days after the effective date of the order, files a petition for judicial review in the circuit court and simultaneously sends a copy of the petition by certified mail to the department of agriculture.

(e) If a person fails to pay a civil penalty after the order assessing the civil penalty has become final and unappealable, the department shall refer the matter to the attorney general, who shall bring a civil action to recover the amount of the civil penalty. In the collection action, the validity and appropriateness of the order of the department imposing the civil penalty shall not be subject to review."

SECTION 3. In codifying the new sections added by section 2 of this Act, the revisor of statutes shall substitute appropriate section numbers for the letters used in designating the new sections in this Act.

SECTION 4. This Act shall take effect upon its approval.

INTRODUCED BY:

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