U.S. Not Prepared To Monitor Approved Biotech

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http://ens-news.com/ens/apr2003/2003-04-25-10.asp U.S. Not Prepared To Monitor

Approved Biotech

WASHINGTON, DC, April 25, 2003 (ENS) - The U.S. government's oversight of

biotech crops once they have been approved is inadequate and has potential

vulnerabilities, according to a new report from the Pew Initiative on Food and

Biotechnology, a non profit research organization.

The post market oversight of biotech crops, also known as genetically modified,

is intended to ensure compliance with restrictions that agencies might impose to

protect public health and the environment.

The current regulatory oversight system, write the authors of " Post-Market

Oversight of Biotech Foods: Is the System Prepared? " is poorly equipped to carry

out this mandate.

" Our report raises questions about the future preparedness of the post market

oversight program to achieve its traditional objectives, including the

enforcement of regulatory restrictions and the detection and correction of

unanticipated health or environmental problems, " said Michael Taylor, the

report's key author and senior fellow at Resources for the Future.

Post market oversight Taylor explained, includes requiring buffer zones between

genetically modified and conventional crops to detect and address any

unanticipated health or environmental problems that could occur after a biotech

product is planted in fields or enters the marketplace. Some 75 percent of

soybeans grown in the United States are already genetically modified. (Photo

courtesy U.S. Department of Agriculture (USDA))The report finds that biotech

crops are regulated through a patchwork of laws - three federal agencies use at

least 10 different laws and a range of regulations and guidelines to address

biotechnology products.

Each of the laws currently used was developed before the advent of biotechnology

products and reflects widely different regulatory approaches and procedures,

explained Taylor and coauthor Jody Tick, also with Resources for the Future.

The reports finds, for example, that the U.S. Department of Agriculture's Animal

and Plant Health Inspection Service (APHIS), which oversees biotech plantings,

does not have the authority under current regulations to impose conditions on

the use of biotech crops once they have been approved for for large scale

planting.

In addition, APHIS cannot require biotech developers to monitor those crops'

impact on the environment post-approval.

The U.S. Environmental Protection Agency (EPA)is responsible for regulations

that manage the environmental impact of pesticides, including those incorporated

into biotech crops, but agricultural interests are not legally bound to meeting

the EPA's standards, according to the report.

The agency can only impose conditions on biotech companies, which are supposed

to monitor how farmers use their products.

" There are no official EPA standards for what constitutes an adequate degree of

compliance or government audits of how well farmers are complying, " the authors

wrote.

And they say the U.S. Food and Drug Administration (FDA) has no affirmative post

market inspection or compliance program for biotech foods, even though it has

for other categories of food and drug products it regulates. Proponents of

biotech crops say widespread acceptance can reduce pesticide use, but many

environmentalists are not yet convinced it is a good trade off. (Photo by Tim

McCabe courtesy USDA)This calls into question whether the FDA has the detection

methods it needs, the capacity to conduct large volume sampling and testing, and

adequate legal tools, such as the authority, to examine food industry records.

The importance of post market oversight has been heightened by two high profile

events with biotech corn.

In 2000, StarLink, a variety of biotech corn approved only for use in animal

feed, accidentally ended up in the human food supply. It resulted in the recall

of more than 300 food products and costing farmers, food processors and the

grain industry millions of dollars in lost profit.

The second event occurred in November 2002, when it was discovered that corn

genetically modified and grown by ProdiGene to produce a protein that serves as

a pig vaccine, contaminated some 500,000 bushels of soybeans grown in Nebraska.

The soybeans were grown in a field that had previously been used by ProdiGene to

grow the biopharm corn. When the corn crop failed, ProdiGene plowed it under and

planted food grade soybeans.

The soybeans were intercepted before they could reach the human or animal food

supply, and USDA officials said this demonstrated that adequate safeguards are

in place. But others are less than convinced and the believe the concern over

biopharm crops warrants greater regulatory oversight. Environmentalists and

some public health groups have concerns about the potential contamination of

other crops from biotech varieties. (Photo courtesy USDA) " Although the agencies

with oversight for biotech crops have shown substantial resilience and capacity

to react to significant problems, there are some serious questions about whether

the current regulatory regime is prepared for what lies ahead, " said Michael

Rodemeyer, executive director of the Pew Initiative.

" Plant biotechnology holds promises for products with strong consumer benefits,

such as allergen free crops or plant made drugs that help solve unmet medical

needs, but these new applications also call into question whether the

government's post-market oversight can ensure compliance as well as maintain

consumer confidence, which is essential to the well-being of this industry. "

The debate over genetically modified, or biotech, crops has grown in recent

months, as the United States and the European Union (EU) are engaged in a very

public dispute over the safety of biotech foods. The U.S. government, in

particular Bush administration officials, are keen to allow more biotech crops,

but many others are wary of the potential health, environmental and economic

impacts of biotechnology.

The EU has refused to grant import licenses for biotech food for the past four

years because many Europeans are worried about possible health and environmental

risks.

EU officials are not slated to decide on any new policies affecting biotech

foods until October.

The United States produces some two-thirds of the world's GM crops and U.S.

officials estimate the EU ban has cost its agricultural industry hundreds of

millions, including some $300 million a year in corn sales alone.

They contend the ban is negatively affecting global trade, slowing development

of new GM crops and contributing to famine in developing countries. Some 34

percent of U.S. corn is genetically modified, as is some 71 percent of U.S.

cotton and 75 percent of U.S. soybeans.

With biotech crops now common in the United States and the Bush administration's

eagerness to promote biotechnology, including biopharm crops, oversight of

approved biotechnology producsts is emerging as a very real issue, said Taylor.

" The time is ripe to address these issues, " he said, " before a crisis occurs. "

 

 

 

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