Rachel Iadicicco (301) 734-3255
Jerry Redding (202) 720-4623
WASHINGTON, March 27, 2007-- The U.S. Department of Agriculture's Animal and Plant Health Inspection Service is clarifying the existing approach for handling situations in which regulated genetically engineered (GE) plant material becomes mixed at low levels with commercial seeds and grain.
This policy is not new, but rather a description of how APHIS currently evaluates and responds to these incidents. In light of continuing international discussions regarding low-level presence (LLP), APHIS is taking this opportunity to formally state our approach.
One of APHIS' roles is to protect plant health by overseeing the importation, movement and field testing of regulated GE material. A major focus is ensuring appropriate confinement of such material in field tests. Developers must comply with all APHIS regulations and permit conditions to prevent the release of regulated GE material. However, when LLP incidents occur, the agency's policy is to respond with actions appropriate to the level of risk, determined by a scientific assessment and warranted by the facts in each case. APHIS will initiate an inquiry whenever regulated material is mixed with commercial seeds or grain to evaluate any risk, to determine the circumstances surrounding the release and to determine whether remedial and/or enforcement actions may be appropriate.
If APHIS determines that an incident involving regulated GE plant material could pose a risk to plant health or the environment, APHIS will take appropriate remedial steps using its authority under the Plant Protection Act. In cases in which APHIS determines that remedial action is not necessary to mitigate LLP of regulated GE plant material to protect plant health and the environment, APHIS is not precluded from taking enforcement action against a company or individual for violations of APHIS regulations.
A 2002 U.S. Office of Science and Technology Policy Federal Register notice outlined proposed actions to be taken by the three agencies that provide regulatory oversight of the development of GE organisms—APHIS, the U.S. Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA)—aimed at strengthening the controls to prevent low levels of regulated materials from GE plants from occurring in commercial seeds and grain until appropriate safety standards have been met.
APHIS, in 2003, strengthened its field testing requirements for crops that produce pharmaceutical or industrial compounds to ensure that regulated materials from these plants are not found, even at low levels, in commercial seeds and grain. APHIS also initiated a process to
amend its biotechnology regulations in 2004. In 2006, FDA published a Federal Register notice and guidance document for early food safety assessments and EPA published a Federal Register notice clarifying its guidance for field testing of plant-incorporated protectants (pesticides intended to be produced and used in a living plant). This clarification is consistent with those documents.
APHIS oversees the development and introduction (importation, interstate movement and environmental release) of GE organisms. The agency is committed to ensuring safety in the oversight of field tests and other activities involving GE plants. APHIS' approach is to apply precautionary measures to such activities which are commensurate with the risks posed by these crop varieties. This allows for research and development activities to take place, so that potential benefits can be realized, while still protecting agriculture, the environment and the public.
Notice of this policy document is scheduled for publication in the March 29, 2007 Federal Register.
To view the policy, go to the Federal eRulemaking portal at http://www.regulations.gov, select “Animal and Plant Health Inspection Service” from the agency drop-down menu; then click on “Submit.” In the Docket ID column, select APHIS-2006-0167 to view supporting and related materials available electronically. The policy may also be viewed at APHIS' biotechnology regulatory services website at /biotechnology/brs_main.shtml.