APHIS Describes Its Policy on Low-Level Genetically Engineered Plant Materials
The Animal and Plant Health Inspection Service (APHIS) has issued a notice which describes its policy for responding to low-levels of regulated genetically engineered (GE) plant materials which may occur in commercial seeds or grain.
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(APHIS notes in a press release that this policy is not new, but rather a description of how it currently evaluates and responds to these incidents. In light of continuing international discussions regarding low-level presence, APHIS states that it is taking the opportunity to formally state its approach.)
APHIS Action to Be Determined on a Case-by-Case Basis
APHIS states that its policy is to respond to occurrences of regulated materials in commercial seeds and grain with remedial action that is appropriate to the level of risk and warranted by the facts of each case.
In every such case, APHIS states that it will initiate an inquiry to determine the circumstances surrounding the release, evaluate the risk attendant to the release, and determine what regulatory actions, including remedial and enforcement actions, are required.
According to APHIS, it has authority under the Plant Protection Act (PPA) to take or order remedial measures which include the authority to hold, seize, quarantine, treat, apply other remedial measures to, destroy, or otherwise dispose of regulated materials if it is determined that such measures are necessary to prevent the dissemination of a plant pest within or throughout the U.S. Any remedial action taken would be determined on a case-by-case basis.
APHIS notes that there are two principal situations in which APHIS may determine that action under the PPA is not necessary. Even though remedial measures would not generally be applied in these two situations, applicants field testing these types of plants must be authorized through either notifications or permits and must follow all APHIS requirements. The two principal situations would be (1) when the regulated material is derived from plants that meet all of the criteria to qualify for APHIS' notification process, or (2) if the GE plant is similar to another GE plant that has already been deregulated by APHIS with respect to both plant genotype and any novel protein(s) expressed.
Determination that Mitigation is Unnecessary Does Not Preclude Enforcement
APHIS states if it determines that action is not necessary to mitigate the low-level presence of a regulated material in commerce to protect plant health or the environment, this determination does not preclude enforcement action against a company or individual for violation of APHIS regulations. APHIS will investigate and take appropriate enforcement action whenever regulated materials are detected in commerce.
APHIS notes that any regulatory action it takes will not preclude the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA) from pursuing action under their own authorities, as necessary.
APHIS contact - John Turner (301) 734-8365
APHIS notice (D/N APHIS-2006-0167, FR Pub 03/29/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-1536.pdf
APHIS press release (dated 03/27/07) available at http://www.aphis.usda.gov/newsroom/content/2007/03/llppolicy.shtml.
APHIS fact sheet (dated March 2007) available at http://www.aphis.usda.gov/publications/biotechnology/content/printable_version/fs_llppolicy3-2007.pdf.