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6-Regulation: Plugging the holes in biotech food safety

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

TITLE:  Plugging The Holes in Biotech Food Safety
        FDA Needs Authority To Assure Safety Of GE Foods, Says Report
SOURCE: Center for Science in the Public Interest, USA, Press Release
DATE:   Jan 7, 2003

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Plugging The Holes in Biotech Food Safety
FDA Needs Authority To Assure Safety Of GE Foods, Says Report

The Food and Drug Administration (FDA) lacks both the authority and the 
information to adequately evaluate the safety of genetically engineered 
(GE) foods, according to the nonprofit Center for Science in the Public 
Interest (CSPI). A new report from the group says that while the few GE 
food crops now on the market appear to be safe, the FDA is ill-equipped to 
assure the safety of future foods that will be engineered in increasingly 
complex ways.

Currently, biotechnology companies are encouraged - but not required - to 
submit safety-testing data to the FDA for its review. CSPI's examination of 
14 such submissions obtained under the Freedom of Information Act found 
that companies sometimes refused FDA requests for more information. 
Monsanto, CIBA-Geigy (now Syngenta), and Dow AgroSciences, for instance, 
each declined to provide requested scientific data to the FDA about strains 
of genetically engineered insect-resistant corn.

"The voluntary notification process by which the FDA reviews safety data 
for new crops allows biotechnology companies to safely ignore FDA requests 
for more information," said Doug Gurian-Sherman, science director of CSPI's 
biotechnology project and the report's author. "Without a legally mandated 
approval process, the FDA can only review whatever data that a company lets 
it review."

The report also found technical shortcomings in the safety data provided by 
biotech companies, as well as some obvious errors that the FDA failed to 
detect. Submissions from Exelixis (formerly Agitrope) about GE delayed-
ripening tomatoes and cantaloupe, for example, contained erroneous and 
unsupported conclusions that went unremarked upon by the FDA. The CSPI 
report also found that one GE developer used inadequate methodology to test 
for allergens, and that others failed to evaluate toxicants and anti-
nutrients. Errors like those might have been caught by observers outside 
the government, says Gurian-Sherman, had the process not been secret.

The first recommendation in the CSPI report is to replace the voluntary 
notification system with a mandatory pre-market approval system that 
requires biotechnology companies to submit much more detailed testing 
information and obtain FDA approval before marketing the product. 
Legislation that would do exactly that was introduced last fall by Senator 
Dick Durbin (D-IL), who is expected to reintroduce the bill this year.

Even without legislation, says CSPI, the FDA can take steps to give 
consumers greater confidence that the GE foods the agency reviews are safe. 
Most basically, the FDA should develop detailed safety testing guidelines 
for biotech developers.

"We found that biotech companies weren't always performing the right tests 
to look for potentially dangerous compounds, including allergens, and that 
there was a great deal of unevenness among different developers' 
submissions," said Gurian-Sherman. "But the FDA isn't giving companies 
enough guidance about what tests companies should conduct, or how much data 
companies should provide."

GE crops have the potential to provide enormous benefits to both consumers 
and the environment, according to CSPI's report. But the group warns that 
the technology's life span would be short if dangerous biotech products 
were to show up on supermarket shelves.

"The public will - and should - only have confidence in GE foods if the 
government formally approves them as safe after a thorough and transparent 
review," said Gurian-Sherman. "The biotech industry itself should be 
clamoring for that kind of a process."

On Tuesday, Gurian-Sherman will present CSPI's concerns at a meeting of a 
committee of the National Academy of Sciences (NAS) that is reviewing some 
of the food-safety aspects of GE crops. "I hope the NAS committee will 
provide the FDA and industry with specific advice on the kinds of tests 
that should be done," Gurian-Sherman said.

[download report at]

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

TITLE:  FDA Policies for Gene-Altered Foods Faulted in Report
SOURCE: The Washington Post, USA, by Justin Gillis
DATE:   Jan 7, 2003

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FDA Policies for Gene-Altered Foods Faulted in Report

Excessive levels of harmful compounds could show up in genetically 
engineered foods because the government has failed to put strong safeguards 
in place to catch them, a consumer group says in a report scheduled for 
release today.

The Center for Science in the Public Interest (CSPI), a Washington group 
known for a moderate stance on the use of genetic engineering to alter food 
plants, contends that the Food and Drug Administration, the primary federal 
agency responsible for food safety, missed "obvious errors" in reviewing 
some gene-altered crops. Although crops now on the market appear to be safe 
to eat, the group said the FDA's procedures are so full of holes that 
continued safety cannot be ensured as companies press to bring many more 
genetically engineered plants to market.

"The companies don't provide enough data to prove these foods are safe," 
said Gregory A. Jaffe, director of biotechnology issues at the center. "And 
FDA's review process doesn't give you a lot of comfort that they've looked 
at it closely and challenged the companies."

Laura Tarantino, deputy director of food-additive safety at the FDA, 
rejected the group's contentions, saying companies have provided all the 
data on their crops that the agency deemed important. She said FDA staffers 
were well aware of the possibility that genetic engineering could increase 
levels of harmful compounds in food. She called this a "very hypothetical 
risk" and said she did not believe it had happened with any crop now on the 
market. She added, however, that the FDA was studying whether it should 
make changes in the way it reviews such foods as more move toward 

The food-processing industry also rejected the report's conclusions, saying 
the current regulatory setup gives the FDA maximum "flexibility" to ensure 
that foods are safe.

The center's report is designed to influence an unfolding public debate 
about the way the nation regulates genetically altered crops. At the 
request of the FDA and other federal agencies, a panel of the National 
Academy of Sciences, meeting today in Washington, is studying whether such 
crops could have unintended consequences for human nutrition.

Much of the concern centers on "anti-nutrients," or harmful compounds 
common in many food crops. Typically such compounds are present only at 
minuscule levels. But when crops are genetically altered there is at least 
a theoretical risk that the level of anti-nutrients could increase, making 
consumption of that plant more harmful. The FDA has failed to establish 
firm procedures requiring companies to test for such harmful changes, the 
report said.

The center said the FDA's review process is an outgrowth of the nation's 
lax approach to dealing with genetically altered crops. Congress has never 
passed a law to regulate plants or animals created through genetic 
engineering, and, as a result, federal agencies have had to stretch old 
laws, written for other purposes, to create a patchwork system of rules.

Some gene-altered food plants, particularly if they contain foreign genes 
to help them fight bugs, fall under regulations requiring their creators to 
get mandatory approval from the Environmental Protection Agency before 
going to market. But others fall solely under the FDA's food-safety 
jurisdiction, and that agency has adopted only voluntary procedures for 
companies to follow in assuring the public their products are safe.

The food industry likes this voluntary system. Environmental groups, 
suspicious of all genetic manipulation of plants or animals, have long 
decried it. CSPI is one of the few consumer-oriented groups that supports 
genetic manipulation in principle but argues that the voluntary system must 
be scrapped.

For the report, CSPI reviewers studied about a quarter of all the cases 
where gene-altered plants have come before the FDA for review. In many 
instances, the report said, the FDA requested information on the 
nutritional composition of a plant that industry failed to provide. In 
three of 14 cases, CSPI reviewers found "obvious errors" in FDA analyses of 
certain food crops. For instance, certain scientific papers -- cited to 
prove that human exposure to a particular foreign protein in gene-altered 
tomatoes and cantaloupes was safe -- don't actually prove anything of the 
sort, the center said. "Had FDA conducted thorough reviews, the errors 
would have been easily detected," the report said.

Tarantino of the FDA said she had not seen the CSPI report and could not 
respond to the claim. But there is routine give-and-take between the FDA 
and companies about the quality of scientific evidence, she added, and the 
agency will not bless crops for commercialization until it is satisfied.

CSPI called for a tighter system involving mandatory review of new products 
and a detailed statistical analysis of risks -- in essence, a version of 
the rigorous drug-approval process for which the FDA is widely respected.

Timothy Willard, a spokesman for the National Food Processors Association, 
said the food industry would support some changes, including making some 
type of FDA review mandatory. But he noted that no company has opted out of 
the current voluntary process, which has worked to date.

                                  PART III
-------------------------------- GENET-news --------------------------------

TITLE:  FDA cannot ensure safety of biotech foods - US group
SOURCE: Reuters, by Randy Fabi
DATE:   Jan 9, 2003

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FDA cannot ensure safety of biotech foods - US group

WASHINGTON - The Food and Drug Administration cannot guarantee the safety 
of genetically modified foods because it is unable to obtain all scientific 
data from biotech companies, a consumer group said.

The Center for Science in the Public Interest said companies like Monsanto 
Co., Syngenta AG and Dow Chemical Co.'s Dow AgroSciences all declined to 
provide requested scientific data to the FDA about strains of genetically 
engineered insect-resistant corn.

U.S. biotech companies are encouraged, but not required, to submit food 
safety testing data to federal regulators for review. When the FDA 
requested additional information, biotech companies complied only half the 
time, according to an analysis of FDA data by the advocacy group.

"With a legally mandated approval process, the FDA can only review whatever 
data that a company lets it review," said Doug Gurian-Sherman, the group's 
science director and author of the report.

The Center for Science in the Public Interest, which supports biotech 
crops, said gene-spliced foods currently being marketed appeared to be safe 
for consumers. However, it said the FDA was "ill-equipped" to assure the 
safety of more complex biotech foods in the future.

FDA officials were not immediately available for comment.


The Biotechnology Industry Organization, which represents companies such as 
Monsanto, Syngenta and Dow Chemical, said its members submit all necessary 
scientific data requested by the FDA.

Lisa Dry, the trade group's spokeswoman, said if certain information was 
not given, the FDA has the power to not allow the marketing of a biotech 

"The FDA has all the authority necessary to collect information from 
manufacturers and to ensure consumers the food supply is safe," she said.

The industry does support some changes in the regulatory system to ease 
consumer concerns, including requiring companies submit more detailed 
testing information.

The United States is the world's largest producer of crops that are 
genetically modified to make them resistant to pests, or to withstand 
herbicides used to kill nearby weeds.

Some U.S. trading partners, especially from Europe and southern Africa, 
have imposed strict rules on genetically modified crops due to concerns 
that they may be toxic and cause allergies. The United States strongly 
disputes these claims.

The FDA's stamp of approval on biotech foods are key to consumer 
acceptance, both advocates and critics say.

The report also found gaps in the scientific data provided to the FDA by 
biotech companies.

"We found that biotech companies weren't always performing the right tests 
to look for potentially dangerous compounds, including allergens," Gurian-
Sherman said.

The center's concerns were presented this week before a panel of the 
National Academy of Sciences, which is studying the unintended health 
effects of biotech foods. The panel's conclusions will be presented to the 
FDA and the U.S. Agriculture Department.

The Center for Science in the Public Interest recommended the FDA require 
biotech companies submit more detailed testing information and obtain 
federal approval before marketing their product.

Sen. Dick Durbin, an Illinois Democrat, is expected to introduce 
legislation later this year that would give the FDA this authority, the 
consumer group said.

Concerns about biotech foods grabbed headlines two years ago when banned 
StarLink corn was found to have entered the U.S. food chain, sparking 
massive recalls of hundreds of corn products from grocery store shelves 
across the country.

Last month, the variety was found in a U.S. corn shipment bound for Japan's 
food supply.


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