Guest guest Posted January 7, 2003 Report Share Posted January 7, 2003 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. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.