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[SANET-MG] USDA policy pollution by design
It would be truly remarkable if USDA tries to actually apply the policy.
I wonder how this policy will help to encourage export of US food crops?
USDA press Release
USDA CLARIFIES POLICY ON LOW-LEVEL PRESENCE OF GENETICALLY ENGINEERED
MATERIAL
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
http://www.aphis.usda.gov/biotechnology/brs_main.shtml.
#
Note to Reporters: USDA news releases, program announcements and media
advisories are available on the Internet. Go to the APHIS news release
page at http://www.aphis.usda.gov/lpa/newsroom. Also, anyone with an
e-mail address can sign up to receive APHIS press releases
automatically. Send an e-mail message to
lyris@mdrdlyriss10.aphis.usda.gov and leave the subject blank. In the
message, type
subscribe press_releases.
APHIS considers six safety-related criteria when
determining a GE plant material’s potential to pose
a risk to plant health or the environment. The
criteria are:
1. The plant is not a Federal noxious weed or
considered a weed in the area of introduction.
2. The introduced genetic material must remain
inside the living cell and replicate only with the
plant DNA.
3. The introduced genetic material’s function is
known and does not create a plant disease.
4. The introduced genetic material does not create
an infectious entity or unintended toxins, or
produce products intended for pharmaceutical
or industrial use.
5. The introduced genetic material does not
cause the creation of a new plant virus.
6. The plant does not contain genes from animal
or human pathogens, or contain coding
sequences whose products are known agents
of diseases in humans or nontarget animals
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