www.checkbiotech.org ; www.raupp.info ; www.czu.cz

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, March 2007.

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
[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
[www.aphis.usda.gov].