D.C. April 8, 2004 -- CropChoice news -- DTN, 04/07/04:
The nation's two major grain industry organizations
and the Biotechnology Industry Organization (BIO) for
the first time have jointly urged three U.S. regulatory
agencies to expedite the implementation of an overarching,
science-based policy governing incidental, trace amounts
- or so-called "adventitious presence" - of
biotechnology-enhanced events in raw and processed grains
and oilseeds, as well as food and feed, according to
a press release.
The National Grain and Feed Association (NGFA), North
American Export Grain Association (NAEGA), BIO and 17
State and Regional Grain and Feed Associations affiliated
with the NGFA said implementation of such a policy for
biotech-enhanced commodities is "enormously important"
and a "vital" precursor to the United States'
providing international leadership to develop a harmonized
global approach on the issue.
The organizations' joint statement was precipitated
by a request for comment from the U.S. Department of
Agriculture's Animal and Plant Health Inspection Service
(APHIS) on whether it should establish a separate component
within its regulatory system to address the adventitious
presence of biotech-enhanced commodities that have not
yet received full regulatory approval for food or feed.
APHIS also sought input on whether it should exempt
"low-level" occurrences of such biotech-enhanced
events in commercial crops, food, feed or seed.
The NGFA, NAEGA, BIO and the other organizations urged
APHIS to work with the Environmental Protection Agency
(EPA) and the Food and Drug Administration (FDA) in
developing a unified policy approach governing the adventitious
presence of biotech events that have been reviewed for
food, feed and environmental safety, but have not completed
the full regulatory-approval process.
In so doing, the groups called on the three federal
agencies to adopt a policy proposed by the White House
Office of Science and Technology in August 2002.
"Such a policy must be solidly grounded in science,
involve all agencies with regulatory responsibilities
for biotechnology, and not compromise the safety of
the U.S. food and feed supply or the environment,"
the groups said.
The organizations also insisted that such an early
safety assessment policy maintain stringent regulatory
safeguards and be restricted to those biotech events
(specific gene sequences) for which the sponsors seek
regulatory approval for use in the general commodity
stream for food and feed use.
Biotech-enhanced plants intended for pharmaceutical
or industrial uses would not be covered by this policy
unless they are deregulated for general commodity use
in food and feed. Under the U.S. government's current
"coordinated framework" for regulating agricultural
biotech-enhanced events, APHIS is responsible for issuing
permits for field trials of biotech-enhanced plants,
and grants "non-regulated status" to biotech
crops if the agency determines they do not pose an adverse
risk to other plants, wildlife or the environment.
Meanwhile, FDA determines whether biotech-enhanced
foods, feed and feed ingredients are safe for human
and animal consumption.
EPA registers biotech-enhanced events that express
their own pesticides and determines whether such products
pose unreasonable adverse effects upon the environment.
The NGFA, NAEGA, BIO and other groups noted that trace
amounts of biotech-enhanced events in commodity crops
that have not completed the regulatory review process
can result from a plant's natural physiology (pollen
flow) or inadvertent mixing during harvest and transportation.
But they noted that the U.S. regulatory system imposes
a zero tolerance on the presence of such unapproved
biotech-enhanced events in food and feed, regardless
of the risk level.