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.
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.
“This
‘zero-tolerance’ policy exposes grain handlers, food
processors and feed manufacturers to the risk that any
presence in general commodity crops of biotech-enhanced
events that have not been approved for food and feed under
the U.S. regulatory process could render such crops
adulterated and subject to seizure under federal law,” the
groups said. Such risks are even more complex for
agricultural exporters, which confront a lag time in biotech
approvals by foreign governments, they said. Further, the
groups subsequently noted that this policy is inconsistent
with other food regulations that have established thresholds
for trace amounts of unexpected materials.
The NGFA, NAEGA,
BIO and other organizations said that once such a policy is
established, the U.S. government “must vigorously promote
global adoption” of compatible regulatory systems that meet
the same standards for being science-based and transparent.
“A U.S. policy on adventitious presence is a key element in
a much-needed comprehensive and harmonized global approval
system for regulation of agricultural products of modern
biotechnology,” the groups said.
Associations
affiliated with the NGFA that signed the joint statement
were the Agribusiness Association of Iowa, Grain and Feed
Association of Illinois, Grain Elevator and Processing
Society, Indiana Grain and Feed Association, Kansas Grain
and Feed Association, Michigan Agri-Business Association,
Minnesota Grain and Feed Association, Missouri Ag Industries
Council Inc., Montana Grain Elevator Association, Nebraska
Grain and Feed Association, North Dakota Grain Dealers
Association, Ohio Agribusiness Association, Oklahoma Grain
and Feed Association, South Dakota Grain and Feed
Association, Tennessee Feed and Grain Association, Texas
Grain and Feed Association and Wisconsin Agri-Service
Association. Also signing was the Iowa Seed Association and
the Montana Agricultural Business Association.
The NGFA,
established in 1896, consists of 1,000 grain, feed,
processing, exporting and other grain-related companies that
operate about 5,000 facilities that handle more than
two-thirds of all U.S. grains and oilseeds. The NGFA’s
membership encompasses all sectors of the industry,
including country, terminal and export elevators; feed
manufacturers; cash grain and feed merchants; end users of
grain and grain products, including processors, flour
millers, and livestock and poultry integrators; commodity
futures brokers and commission merchants; and allied
industries. The NGFA also consists of 35 affiliated state
and regional grain and feed associations,
as well as two
international affiliated associations. The NGFA has a
strategic alliance with the Grain Elevator and Processing
Society and the Pet Food Institute. The NGFA and NAEGA are
co-located and have a joint operating and services
agreement.
NAEGA, established in 1912,
is a not-for-profit trade association comprised of private
and publicly owned companies and farmer-owned cooperatives
involved in and providing services to the bulk grain and
oilseed exporting industry. NAEGA member companies ship
practically all of the bulk grains and oilseeds exported
each year from the United States.
BIO represents
more than 1,000 biotechnology companies, academic
institutions, state biotechnology centers and related
organizations in all 50 U.S. states and 33 other nations.
BIO members are involved in the research and development of
health-care, agricultural, industrial and environmental
biotechnology products.