Ariz. Admin. Code § 3-4-901

Current through Register Vol. 30, No. 50, December 13, 2024

Section R3-4-901 - Genetically Engineered Organisms and Products

A. Definitions. In addition to the definitions provided in A.R.S. § 3-101, the following shall apply:

1. "Associate Director" means the Associate Director of the Plant Services Division of the Arizona Department of Agriculture.

2. "Genetically engineered" means the genetic modification of organisms by recombinant DNA techniques, including genetic combinations resulting in novel organisms or genetic combinations that would not naturally occur.

3. "Organisms" means any active, infective, or dormant stage or life form of any entity characterized as living, including vertebrate and invertebrate animals, plants, bacteria, fungi, mycoplasms, mycoplasma-like organisms, as well as entities such as viroid, viruses, or any entity characterized as living related to the foregoing.

4. "Permit" means an application which has been approved by USDA and the Department.

5. "Permit application" means an application filed with USDA, which may be supplemented with requirements from the Department, for the introduction of genetically engineered organisms and products, as provided by 7 CFR 340, revised June 16, 1987. The material incorporated herein by reference is on file with the Office of the Secretary of State and does not include any later amendments or editions of the incorporated matter.

6. "Product" means plant reproductive parts including pollen, seeds, and fruit, spores, or eggs.

7. "USDA" means the United States Department of Agriculture, Animal and Plant Health Inspection Service, Plant Protection and Quarantine (USDA, APHIS, PPQ).

B. Permit applications. A genetically engineered organism or product shall not be introduced into Arizona, sold, offered for sale, or distributed for release into Arizona's environment unless a permit issued pursuant to the application has been issued by USDA, or the Department has been notified by the USDA that the genetically engineered organisms or product is eligible under the notification procedure, as prescribed by 7 CFR § 340.3, revised August 6, 2007, or it has been determined by the USDA to be of nonregulated status, as prescribed by 7 CFR 340.6, revised May 1997. The material incorporated herein by reference is on file with the Office of the Secretary of State and does not include any later amendments or editions of the incorporated matter.

1. Applicants for the release or use of genetically engineered organisms or products shall follow all permit application procedures required by USDA.

2. In addition to USDA's requirements, permit applications shall demonstrate to the Department that:

a. Genetically engineered organisms or products shall be handled in such a manner so that no genetically engineered organism or product accidentally escapes into Arizona's environment.

b. All permit applicants shall comply with Arizona quarantine rules regulating the plants, pests, or organisms being introduced into Arizona.

3. The Department may, if it deems necessary to protect agriculture, public health, or the environment from potential adverse effects from the introduction of a specific genetically engineered organism or product:

a. Place restrictions on the number and location of organisms or products released, method of release, training of persons involved with the release of organisms or products, disposal of organisms or products, and other conditions of use;

b. Require measures to limit dispersal of released organisms or spread of inserted genes or gene products;

c. Require monitoring of the abundance and dispersal of the released organism or inserted genes or gene products;

d. Request the USDA to deny, suspend, modify, or revoke the permit for failure to comply with this rule.

e. Request the USDA to suspend the permit if it is determined that an adverse effect is occurring or is likely to occur because of a release authorized by such permit.

4. To the extent possible, the Department shall accept for review and base its decision on the data submitted with the federal application. However, the Department may request additional information from the applicant to assess the risks to animals and plants, including risks of vector transmissions of genetically engineered organisms or products.

5. The Associate Director shall review the application recommendations with the Director who shall, within the time period prescribed on each USDA application, approve, conditionally approve, or deny the permit.

6. The Director shall return the completed application with the resolution to USDA for final action.

Ariz. Admin. Code § R3-4-901

Adopted effective November 22, 1993 (Supp. 93-4). Amended by final rulemaking at 25 A.A.R. 3357, effective 1/4/2020.