Washington, DC
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 (click
HERE).
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
http://www.aphis.usda.gov/biotechnology/brs_main.shtml. |
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