Post-Market Oversight of Biotech Foods

[Guest guest]

The Pew Initiative on Food and Biotechnology issued a report last Thursday

on the "Post-Market Oversight of Biotech Foods."

 

The 128-page report raises significant concerns about the system in

place to regulate genetically engineered foods. The Associated Press

article below titled "Research group says better biotech regulation

needed" will provide further details.

 

There are several points to keep in mind when reading the article below,

the executive summary or the complete report.

 

First, while the Pew Initiative on Food and Biotechnology represents

itself as having a neutral position on genetically engineered foods,

many people feel they often draw conclusions that are favorable to the

biotech industry in spite of evidence to the contrary.

 

Second, one of the two authors of this report, Michael R. Taylor, was

formerly Vice President for Public Policy at Monsanto and Deputy

Commissioner for Policy at the Food and Drug Administration. So the fact

that this report is critical at all of the regulatory system is

significant considering Michael Taylor's background.

 

Third, the statement in the Associated Press article below by James

Maryanski, biotech coordinator at the Food and Drug Administration, is

very misleading. Maryanski states, "We feel confident that once we

complete our review and approval, that those foods are safe." But what

Maryanski fails to point out is that biotech companies are not required

to have their genetically engineered foods reviewed and approved by the

FDA. As a matter of fact, with few exceptions, the biotech companies are

not even required to tell the FDA they are bringing new biotech products

to market, let alone have them reviewed and approved.

 

Fourth, keep in mind that it was not the FDA, the USDA or the EPA that

discovered StarLink corn, unapproved for human consumption, had

contaminated the human food supply. Larry Bohlen of Friends of the Earth

was responsible for making the StarLink contamination discovery after he

sent some products containing corn to Genetic ID for testing. If Larry

had not had this testing done, millions of Americans could still be

eating StarLink corn. And many of these people could be experiencing

allergic reactions, not knowing why their health had taken a downward

turn.

 

The bottom line is that with the lack of regulatory oversight in the

United States, biotech crops are an accident waiting to happen. Problems

have occurred in the past and the likelihood is good that accidents will

happen again in the future unless the regulatory system changes.

 

Here is a link to the 22-page executive summary:

http://pewagbiotech.org/research/postmarket/PostMarketExecSum.pdf

 

Here is a link to the entire 128-page report:

http://pewagbiotech.org/research/postmarket/PostMarket.pdf

 

Craig Winters

Executive Director

The Campaign to Label Genetically Engineered Foods

 

The Campaign

PO Box 55699

Seattle, WA 98155

Tel: 425-771-4049

Fax: 603-825-5841

E-mail: label

Web Site: http://www.thecampaign.org

 

Mission Statement: "To create a national grassroots consumer campaign

for the purpose of lobbying Congress and the President to pass

legislation that will require the labeling of genetically engineered

foods in the United States."

 

***************************************************************

 

Research group says better biotech regulation needed

 

SAN FRANCISCO (AP) -Federal regulators aren't equipped to monitor the

effects of approved genetically engineered products on human health and

the environment, a nonpartisan research group warned Thursday.

 

The Pew Initiative on Food and Biotechnology said there's no evidence

that genetically engineered products have caused harm. But Pew warns

that the regulatory system will be further challenged because more

genetically engineered products are expected to be approved in the near

future and there's scant oversight once products reach the market.

 

The Washington, D.C.-based group's 128-page report concluded there are

``unresolved questions about the government's proper role in addressing

issues that arise after products are in the marketplace.''

 

Soy, corn, canola and cotton are the only four approved biotechnology

crops grown widely in the United States. But thousands of experimental

crops are being grown, including plants engineered with human genes to

produce medicines.

 

The Pew report pointed to two recent biotech mishaps as cause for

concern.

 

In 2000, it was discovered that StarLink corn, an engineered product not

approved for human consumption, was mixed with regular corn in a number

of cases.

 

Last year, Prodigene Inc. was caught mixing corn genetically engineered

to be a drug with soy beans meant for the food supply.

 

``Our analysis casts doubt on the preparedness of the current postmarket

oversight program to achieve its traditional objectives, including the

enforcement of regulatory restrictions and the detection and correction

of unanticipated health or environmental problems,'' Michael Taylor and

Jody Tick wrote in the report.

 

Federal regulators concede that most of their biotechnology oversight

occurs before products are approved for market. They argue that their

pre-approval review is rigorous and, once approved, a product is

presumed safe.

 

``We feel confident that once we complete our review and approval, that

those foods are safe,'' said James Maryanski, biotech coordinator at the

Food and Drug Administration. ``That continues to be our assessment.''

 

Maryanski said no health problems have been associated with biotech

food. He also said the FDA continues to examine its biotechnology review

process, especially as it relates to plants genetically engineered to

grow pharmaceuticals.

 

At the Agriculture Department, which regulates all biotech crops grown

in the United States, officials said they are in the middle of an

extensive analysis of how to monitor engineered plants. A National

Academies of Sciences committee already has raised similar concerns

voiced in the Pew report, said the USDA's top biotech regulator, Cathy

Smith.

 

``We continue to evolve our regulations,'' Smith said.

 

While some biotechnology critics argued Thursday that the Pew report

didn't criticize regulators enough, the lobbying outfit for the

biotechnology industry said proper regulation is already in place.

 

``The report raises a non-issue,'' said Lisa Dry, a spokeswoman for the

Biotechnology Industry Organization. ``The federal agencies have all the

statutory authority they need and they give these products stringent

scrutiny before they go to market.''

 

Dry also said regulators have the power to recall approved products that

may be found to be harmful.

 

Posted on Fri, Apr. 25, 2003

 

On the Net:

 

Pew report: http://pewagbiotech.org/research/postmarket/

 

FDA: http://www.fda.gov

 

USDA: http://www.usda.gov

 

BIO: http://www.bio.org/foodag/