View Rule

Statement of Need: APHIS currently regulates the introduction (movement into the United States or interstate, or release into the environment) of genetically engineered organisms that may present a plant pest risk under 7 CFR part 340, "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests." APHIS is evaluating its regulatory program to determine if there is a need to revise its regulations in light of our current knowledge and experience and advances in science and technology.

Summary of the Legal Basis: The primary authority is provided by the Plant Protection Act, which authorizes the Secretary of Agriculture to prohibit or restrict the importation, entry, and movement in interstate commerce any plant, plant product, biological control organism, noxious weed, or other article if necessary to prevent the introduction into or dissemination within the United States of any plant pest or noxious weed. Such articles may include genetically engineered products.

Alternatives: A draft environmental impact statement (DEIS) prepared for this action evaluates all of the regulatory alternatives under consideration by the Agency. Some key alternatives considered include whether APHIS should broaden the scope of the regulations to reflect its authority over noxious weeds and biological control organisms; whether and how to revise the regulations to make the Agency’s use of risk-based categories–where genetically engineered organisms are classified according to risk and familiarity so that oversight and confinement vary by category–more refined, more explicit and more transparent to the industry and the public and what criteria should be used to establish risk-based categories; how to manage genetically engineered organisms that present only minor unresolved risks that can be mitigated effectively, and what factors should be considered in establishing appropriate mitigations; whether new or additional regulatory mechanisms are needed to ensure that genetically engineered organisms producing pharmaceutical or industrial compounds are subject to requirements and oversight commensurate with the potential risks; for organisms that might be commercialized but that do not meet the criteria for deregulation, whether a new type of permitting system would be more appropriate in terms of efficiency and effectiveness than the current system; whether APHIS should establish a new regulatory approach to address incidents of low-level presence of genetically engineered plant material; whether APHIS should establish a new regulatory mechanism to allow for imports of commodities for nonpropagative use, that is, for food, feed, or processing, in cases where these commodities might not have been deregulated in the United States; and whether to expand its current exemption from interstate movement restrictions additional well-studied, low-risk, genetically engineered research organisms.

Anticipated Costs and Benefits: To be determined.

Risks: While APHIS has always used a risk-based approach in regulating genetically engineered organisms, there is a trend toward more highly varied organisms. For example, genetic engineering technology has advanced to the point where organisms can be developed that produce novel proteins and other substances with biological activity or industrial utility. We have initiated this rulemaking because APHIS recognizes that the regulatory process may need greater flexibility and rigor to more appropriately regulate the increasing variety of organisms.