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6-Regulation: U.S. report on lack of GE food oversight



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                                  PART I
-------------------------------- GENET-news --------------------------------

TITLE:  Post-market oversight of biotech foods
        Is the system prepared?
SOURCE: Pew Initiative on Food and Biotechnology, USA
        http://pewagbiotech.org/research/postmarket/
DATE:   April 2003

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Post-market oversight of biotech foods
Is the system prepared?

The September 2000 discovery of StarLink corn in taco shells caught the
public and much of the American food system by surprise. StarLink was one of
several varieties of corn that had been genetically modified to produce its own
insecticide. The U.S. Environmental Protection Agency (EPA) had approved
StarLink only for animal feed because tests had suggested that the specific
insecticidal protein in the genetically modified corn might be a human allergen.
StarLink was therefore not approved for use in human food.

The discovery of StarLink where it was not supposed to be caused a public
uproar. The group that first reported it, Genetically Engineered Food Alert,
used the finding to argue for stronger government regulation of biotech crops
and foods. The food industry recalled foods containing StarLink from the
market out of concern about the possible impact of StarLink on the safety and
public acceptance of their products. Corn traders faced disruption of their
export markets. And commentators suggested the U.S. regulatory system had failed
by not preventing the problem from occurring in the first place. A chronology
of the StarLink case is provided in Appendix A.

The government also acted, declaring StarLink’s presence in human food
unlawful, working with the food industry to accomplish the necessary recalls and
attempting to calm grain markets and the concerns of foreign trading partners.
In addition, EPA announced that it would no longer approve the registration
of pesticidal traits in genetically modified plants if the plants were not
also approved for human food use. This action would appear to preclude future
StarLink-type episodes by ensuring that all pesticide-producing
genetically-modified crops on the market would be approved as safe for humans to eat.

Such a perspective on the StarLink incident, however, would be far too
simple. StarLink may prove to be a one-time experience—and it has not been linked
conclusively to any adverse effects—but its importance extends well beyond
the specific facts. StarLink put a public spotlight on the regulatory system
for biotech food. It raised questions about how the system works today and
whether it is prepared for the challenges it will face in the future. These
challenges were underscored again recently with a “near miss”: material from a
variety of corn engineered to produce an animal vaccine, made by a company named
ProdiGene, turned up in soybeans destined for the food supply. Fortunately,
the corn was detected by government inspectors in time to keep it out of the
food supply.

This report addresses a subset of the questions about biotechnology
regulation. This report is one of several reports on aspects of the U.S. regulatory
system for biotechnology prepared by the Pew Initiative on Food and
Biotechnology. Much of the public debate about biotechnology prior to StarLink focused
on whether, and under what circumstances, biotech products should enter the
environment and marketplace: what standards, testing, and review procedures
should be required prior to biotech crops being planted and biotech foods sold?
This report addresses issues that arise after the products enter the
environment or the marketplace—when the crop is in the field, commodities are in
commerce, and foods are being prepared and marketed to consumers:

Is the regulatory system prepared to ensure compliance with use restrictions
or other conditions imposed by regulators to protect health or the
environment?

More broadly, what is the appropriate degree of control over biotech foods
and crops after they enter the environment or the marketplace?

What role can and should the government play in achieving this control?

How do the postrelease and postmarket oversight issues posed by biotech
crops and foods compare with those posed by conventionally produced ones?

This report is intended to inform the public, policymakers, and other
interested parties in the biotechnology debate. The report identifies issues and
provides factual background and analysis, rather than offering policy
recommendations. There are no “right” answers or single solutions to the issues
presented. The issues involve subjective values and a range of competing
considerations and interests that should be sorted out in public processes.

The Pew Initiative on Food and Biotechnology commissioned Resources for the
Future (RFF) to prepare this report. We would like to acknowledge authors
Michael R. Taylor and Jody S. Tick, of RFF for their collaboration and
thoughtful examination of these issues.

We hope that our analysis contributes to an informed debate and, in the end,
to good public policy. This report, like all of our projects, is made
possible through a grant from The Pew Charitable Trusts to the University of
Richmond. The opinions expressed in this report are those of the authors and do not
necessarily reflect the views of The Pew Charitable Trusts.


Michael Rodemeyer
Executive Director
Pew Initiative on Food and Biotechnology
April 2003


For download:
Executive Summary 
Complete Report


                                  PART II
-------------------------------- GENET-news --------------------------------

TITLE:  Little Oversight of Altered Crops 
        Beyond the Farm, U.S. Lacks System to Track Engineered Food, Report
Says
SOURCE: The Washington Post, USA, by Justin Gillis
        http://www.washingtonpost.com/wp-dyn/articles/A34921-2003Apr24.html
DATE:   Apr 25, 2003

------------------ archive: http://www.gene.ch/genet.html ------------------


Little Oversight of Altered Crops 
Beyond the Farm, U.S. Lacks System to Track Engineered Food, Report Says

The government has no effective system of overseeing genetically altered
crops after they go to market, a regulatory gap that could pose acute problems
as more such crops are commercialized, according to a new report.

Two government agencies, the Food and Drug Administration and the
Agriculture Department, don't even attempt to enforce rules on gene-altered crops after
they're commercialized, and may lack sufficient legal authority to do so,
said the report, commissioned by the Pew Initiative on Food and Biotechnology.

The third agency that regulates such crops, the Environmental Protection
Agency, has legal authority to set rules that apply after commercialization but
has established no effective means of enforcing them, the report found.

A crop regulated by EPA and subject, in theory, to broad planting and
harvesting restrictions was the cause of the biggest failure yet in crop
biotechnology, the report noted. StarLink corn was supposed to be approved for use only
as animal feed, but farmers and seed companies failed to honor government
restrictions, and the corn wound up in a wide variety of products on U.S.
grocery shelves, forcing recalls in 2000.

That problem was caught not by a government surveillance program, since none
exists, but by an environmental coalition buying corn products off the
shelves of Safeway and having them tested.

The StarLink episode could be a harbinger as more genetically altered
products, including crops designed to grow pharmaceuticals and industrial
chemicals, are brought to market, said the report, released yesterday.

The report was prepared for the Pew Initiative, a Washington think tank set
up to foster public discussion of genetic engineering, by Michael Taylor and
Jody Tick, analysts at Resources for the Future, a group known for
researching environmental questions.

Taylor emphasized in an interview that weak oversight has not resulted in
major health or safety problems. Even the StarLink debacle, which cost food and
biotechnology companies hundreds of millions of dollars, is not known to
have harmed anyone. Moreover, he said, a broad government monitoring program
could be costly and complicated, and its purpose would be to guard against harms
that are somewhat theoretical, so more public discussion is needed on
whether such an effort would be worth the trouble.

If the public concludes that it wants more effective monitoring, Taylor
said, probably the only way to get it would be to pass a law in Congress, since
federal agencies have already stretched the intent of old laws in their
attempts to oversee the engineered crops.

Government agencies often lack the ability to test for the presence of
altered genes in food, the Pew report said.

And there's evidence to suggest the minimal restrictions that government
agencies are imposing are often ignored. For instance, the EPA requires that
farmers follow certain planting guidelines with insect-resistant crops, but it
leaves enforcement in the hands of the companies selling the seed. Anonymous
farmer surveys done by others suggest that compliance with those rules may be
as low as 60 percent in some regions of the country, the report said. The
government is not inspecting farms to verify compliance.

"Looking ahead, there's some things that we normally look to government
regulation to do that aren't being done," Taylor said. "The question is, do they
need to be done for this technology?"

Spokesmen at the Agriculture Department, the FDA and the EPA emphasized
yesterday that they review biotech crops carefully before they are brought to
market, demanding food-safety studies and other data, but they acknowledged that
under current practice, it's largely up to individual farmers and companies
to obey government rules after a crop is commercialized.

The regulators emphasized that any time they become aware of a problem, they
can take action, as in the StarLink case. EPA spokesman David Deegan noted
the agency has changed its rules to prevent any case exactly like StarLink
from happening again.

The agencies are already studying the question of whether more aggressive
monitoring of crops after they reach the marketplace -- regulators call it
"post-market surveillance" -- is warranted, now or in the future.

"We certainly welcome this new contribution to a discussion that has been
ongoing," said Cindy Smith, chief biotechnology regulator at the Agriculture
Department. Added James H. Maryanski, biotech coordinator at the FDA: "It's
very important to us to maintain the integrity of the food supply. It's also
important to make sure we don't inhibit a new industry if it's not necessary."

The biotechnology industry has strongly opposed legislation to tighten
restrictions on gene-altered crops, declaring the current system adequate. The
report yesterday annoyed the Biotechnology Industry Organization, a Washington
trade group, which said in a prepared statement that the Pew initiative
"appears to be in search of a reason for existence by commissioning a report on a
nonissue." The group added, "There are zero cases of any proven health issues
associated with the food products of biotechnology."



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