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RESOLUTION POSTED ON WEB SITE

 

The new 108th U.S. Congress begins on Tuesday. However, we don't expect

the Genetically Engineered Food Right to Know Act to get introduced for

at least a couple months. So this is the perfect time to focus on

getting a " resolution " supporting national labeling legislation passed

by your local city or county council.

 

Passing these resolutions are a key step in The Campaign's new " All

Politics Are Local Politics " drive. Our new web site features

step-by-step instructions on what to do to get a resolution passed by

your city or county government at:

http://www.thecampaign.org/cities.php

 

NATIONAL ACADEMY OF SCIENCES MEETING

 

The National Academy of Sciences (NAS) is having a meeting in

Washington, DC, January 6 - 8, 2003, titled " Unintended Health Effects

of Genetically Engineered Foods. " This is the second meeting of an 18

month project titled " Process to Identify Hazards and Assess the

Unintended Effects of Genetically Engineered Foods on Human Health. "

 

This NAS project started on February 15, 2002 and is scheduled to run 18

months. A final report will be issued at the end of the project.

 

Posted below are two articles that discuss the meeting and criticism of

current FDA policy on biotech foods from the Center for Science in the

Public Interest (CSPI). The first article is from the Washington Post

titled " FDA Policies for Gene-Altered Foods Faulted in Report. " The

second article from United Press International is titled " Safety of

transgenic animals doubted. "

 

CSPI will be releasing a report on Tuesday challenging the effectiveness

of current FDA policy on genetically engineered foods.

 

Gregory A. Jaffe, director of biotechnology issues at CSPI states, " The

companies don't provide enough data to prove these foods are safe and

FDA's review process doesn't give you a lot of comfort that they've

looked at it closely and challenged the companies. "

 

We are glad to see CSPI getting more aggressive in challenging the FDA

on genetically engineered foods than they have in the past. Apparently

CSPI has now become more critical of FDA policy since they recently

reviewed the FDA's review of genetically engineered foods and found it

" so full of holes that continued safety cannot be ensured... "

 

If you want to read the agenda of the NAS meeting, here is a link that

will autodirect you to their web site:

http://www.thecampaign.org/nas010603.htm

 

The two articles below will provide a lot of information about the

regulation of genetically engineered foods in the United States and what

the FDA has on their agenda in the coming months.

 

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. "

 

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

 

FDA Policies for Gene-Altered Foods Faulted in Report

 

By Justin Gillis

Washington Post Staff Writer

Tuesday, January 7, 2003; Page A05

 

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 commercialization.

 

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.

 

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

 

Safety of transgenic animals doubted

Steve Mitchell

UPI Medical Correspondent

 

Published January 6, 2003

 

WASHINGTON, Jan. 6 (UPI) -- Genetically engineered animals -- which

could be in food markets by next year -- could pose hazards to human

health and the environment, experts told United Press International

Monday.

 

The comments came as a panel of scientists convened by the government

kicked off a three-day meeting to discuss the health risks of

genetically modified plants and animals.

 

" We don't know as much as we'd like to about potential unexpected

changes that can occur in animals with genetic engineering, " said

Douglas Gurian-Sherman, science director for the biotechnology project

at the Center for Science in the Public Interest in Washington.

 

A panel convened by the National Academy of Sciences began their second

meeting Monday to discuss methods for identifying unintended health

effects of genetically engineered foods.

 

The panel will address issues related to both genetically modified

plants and animals. The first meeting was held in September and

panelists expect to issue a report on their conclusions in 2004 to help

the Food and Drug Administration and other agencies determine how to

regulate these products.

 

FDA representatives will make a presentation at the NAS meeting, in

which they will report the agency has decided to classify genetically

engineered or transgenic animals as drugs for regulatory purposes. This

has the benefit of requiring a mandatory safety review for these animals

-- for genetically modified plants, the safety review is voluntary.

 

" But the problem is the process is completely secret, " Gurian-Sherman

said. " It doesn't allow public input or comment " and the public will not

be told which transgenic animals the agency is reviewing.

 

A report issued by a different NAS panel in August concluded transgenic

animals probably were safe to eat but recommended further research

before finally declaring them totally safe for humans.

 

Although no genetically engineered animals have been approved by the FDA

for human consumption in the United States, several are being developed.

In addition, Cuba has approved a strain of tilapia fish genetically

engineered to grow rapidly and a genetically engineered carp might be

approved in China.

 

The species closest to market in America is a salmon that has been

genetically modified to produce more growth hormone, which causes it to

grow more rapidly than non-modified fish. The salmon producer, Aqua

Bounty Farms of Waltham, Mass., said it currently is completing safety

studies and the fish appears to be no different than normal salmon.

 

" We have no reason to believe there is anything unusual occurring in

these fish, " Aqua Bounty spokesman Joe McGonigle told UPI. He noted all

the safety studies " will eventually ... go up on our Web site, among

other places " to make them available to the public. The company plans to

file for FDA approval in the latter half of this year, which could make

the transgenic salmon available to consumers in 2004.

 

Robert Schwartz, a cell biologist at the Baylor College of Medicine and

co-founder of Advisys, a company in The Woodlands, Texas, that is

involved in improving the growth of livestock, agreed transgenic animals

are safe for consumption.

 

" There's no evidence of toxicity " of genetically engineered animals,

said Schwartz, who will also make a presentation at the NAS meeting.

 

However, he noted there are no standards for testing the safety of these

animals. The FDA should establish criteria for how these tests should be

conducted, which would help assure the public these animals are safe, he

said.

 

Schwartz's company is working on a pig with a gene for a protein called

insulin-like growth factor that increases the animal's weight. Other

transgenic animals being developed include cattle with antibacterial

genes to make their milk safer.

 

" It is highly doubtful " that any of these animals are toxic to humans

" but there would have to be testing, some sort of standards ... to prove

it, " Schwartz said, adding better education of what these products can

do and informing consumers on packaging the product comes from a

genetically modified animal also would be helpful.

 

The Center for Food Safety in Washington, which filed a legal petition

with the FDA and other governmental agencies to keep the transgenic fish

from coming to market, also has concerns about the health risks posed to

humans consuming the fish. The FDA needs to establish " a real process of

looking at the human health impacts of the fish, " said Joseph Mendelson,

the center's legal director.

 

Elevated levels of growth hormones could create risks or unintended

effects, such as allergies in some people, Mendelson said. There are

also humane issues to consider because the fish are being created merely

to improve industry efficiency, he said.

 

So far the FDA has not responded to the legal petition, which the Center

filed along with 75 other environmental and consumer groups, Mendelson

said, but they have received 50,000 public comments in support of the

petition.

 

Another problem is the environmental impact of transgenic animals,

Gurian-Sherman said. Indeed, the NAS report in August concluded the

impact of these animals escaping into the environment was the most

worrisome because there was no way to predict what might happen or to

reverse such a situation if it turns out to have disastrous

consequences.

 

" Studies show that potentially a genetically engineered salmon, if it

escapes, could cause extinction of endangered salmon species, "

Gurian-Sherman said.

 

The FDA review process requires companies to assess the environmental

impact these animals could have, but there are some barriers to putting

that into practice, Gurian-Sherman said. " It is not clear how much

authority the FDA has to do a thorough environmental analysis and there

is also a lot of concern that they don't have the expertise because they

don't usually do that kind of analysis, " he said.

 

Aqua Bounty's McGonigle said his company still is working with the FDA

to determine how to do an environmental impact assessment of the salmon.

That study has not yet begun, he said.

 

The FDA did not return repeated phone calls from UPI seeking comment by

presstime.

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