MOFGA - Genetic Engineering News

Testimony of the Maine Organic Farmers and Gardeners Association
In Support of L.D. 902
"An Act to Require the Labeling of Certain Genetically Engineered Foods"
March 29, 2001

MOFGA is a non-profit organization with over 3,400 members, who include farmers, gardeners, and consumers dedicated to ensuring the availability of healthful food, to sustainable rural economies and to protection of the environment. Over seven years ago, MOFGA was instrumental in proposing the first mandatory GE labeling legislation in the nation, and thereafter was represented on the Maine Commission to Study Genetic Engineering and Biotechnology, created by the Maine legislature and appointed by the governor.

The Maine Commission’s charge was to examine the adequacy of federal regulation to address the environmental and health issues presenting by genetic engineering technologies. The broad-based Commission’s final report issued in March, 1996 reported a consensus identifying three inadequacies in the current system of biotech oversight: lack of federal mandatory labeling for genetically engineered foods, lack of an effective system of mandatory pre-market notification, and lack of an effective system of federal legislation to assess the risks of environmental release of genetically engineered fish.

To date, the FDA has failed to correct these basic deficiencies. In the face of the failure of the federal government to mandate labeling, it is necessary for the states to step into the void.

Two developments occurred in the past year to underscore the urgency of moving on labeling of genetically engineered foods. The first is the publication of a study by the prestigious National Academy of Sciences entitled "Genetically Modified Pest-Protected Plants: Science and Regulation" [April, 2000: www.nap.edu/html/gmpp/]

While the report cautiously states that "the committee is not aware of any evidence that foods on the market are unsafe to eat as a result of genetic modification," the report acknowledges that "there is the potential...for adverse health effects." The report clearly demonstrates that tests of both health and environmental impacts have to date been insufficient to reach a scientific determination of safety. The report is replete with strong recommendations for further research to address health and environmental impacts, including:

--- "the development of improved methods for identifying potential allergens in [GE] plants"

--- "monitoring for pleiotropic [secondary] changes in plant physiology and biochemistry during the development of [GE] plants"

--- "long term toxicity testing..."

--- "determine the impacts of specific [GE] crops on nontarget organisms."

--- "assess gene flow and its potential consequences."

--- "monitor ecological impacts of [GE] crops on a long term basis to ensure the detection of impacts that may not be predicted from tests conducted during the regulatory approval process."

The National Academy of Sciences study makes it clear that the development of genetically engineered food is an experiment in progress.

The second development is the issuance, on January 17, 2001, of a proposed regulation for premarket notification of GE foods by the FDA, and of a proposed "guidance" on labeling of GE foods. [www.fda.gov/OHRMS/DOCKETS/98fr/011801a.htm; http://vm.cfsan.fda.gov/~dms/biolabgu.html] These documents bear careful study. Their internal contradictions are astonishing.

The FDA "reiterates its view…that transferred genetic material can be presumed to be GRAS [Generally Recognized As Safe] [a category previously reserved for foods that had a long history of safe human consumption] and "is not altering its view…that there is unlikely to be a safety question sufficient to question the presumed GRAS status…" Accordingly, the FDA is not mandating safety testing for new GE foods.

However, the FDA goes on for the first time to formally concede that "because [genetic engineering] can introduce genetic material from a much wider range of sources than previously possible, there is a greater likelihood that the modified food will contain substances that are significantly different from, or are present in food at a significantly higher level than, counterpart substances historically consumed in food." The FDA also concedes that allergenicity is a bigger issue with GE foods: "because genes code for proteins, and virtually all allergens are proteins…by increasing the range of potential proteins that can be introduced into food over that possible by traditional breeding, there is an increased potential for introducing an allergen into a food developed using rDNA technology." Finally, the FDA notes that the future directions of biotechnology suggest the potential for more, not fewer, of these troublesome issues: "FDA expects that with the increased introduction of multiple genes [as opposed to current single gene inserts], unintended effects may become more common."

We find these three admissions refreshingly groundbreaking in candor. They quite naturally follow upon the disclosure, in litigation, of internal FDA documents in which top level FDA scientists questioned industry’s arguments that there will be no unintended consequences from GE foods, noting that "time and time again, there is no data to back up their contention." [quoted in "Biotechnology Food: From the Lab to a Debacle," New York Times, January 25, 2001 (http://partners.nytimes.com/2001/01/25/business/25FOOD)] However, the FDA’s response to these issues -- concerns that consumer activists have been raising for years -- is woefully inadequate. Mandatory premarket notification is clearly a step in the right direction. But "notification" is not at all the same as "regulation" or "registration," as we have with new pesticides, or pharmaceuticals. After receiving notification of a new biotech food, the Commission does not have to confirm, approve, or in anyway put its stamp of approval affirmatively on the company’s decision to market the product. All it has to say is that, based on its evaluation of the premarket notice, "the agency has no questions, at this time, regarding [the manufacturer’s] view that the bioengineered food is as safe as comparable food…" This is appallingly flimsy assurance, for all of our tax dollars, especially given the admitted risks presented by this new technology.

In sum, both the National Academy of Sciences report and the FDA’s own recent admissions about the added risks of genetically engineered food strongly support the view that consumers have a right to make a choice not to assume those risks when they put food on their dinner tables. The time for mandatory labeling is now.

Sharon S. Tisher
Chair, MOFGA Public Policy Committee


Info Events the MOF&G Online Technical Services Crop Certification Organic Food		Testimony of the Maine Organic Farmers and Gardeners Association In Support of L.D. 902 "An Act to Require the Labeling of Certain Genetically Engineered Foods" March 29, 2001 MOFGA is a non-profit organization with over 3,400 members, who include farmers, gardeners, and consumers dedicated to ensuring the availability of healthful food, to sustainable rural economies and to protection of the environment. Over seven years ago, MOFGA was instrumental in proposing the first mandatory GE labeling legislation in the nation, and thereafter was represented on the Maine Commission to Study Genetic Engineering and Biotechnology, created by the Maine legislature and appointed by the governor. The Maine Commission’s charge was to examine the adequacy of federal regulation to address the environmental and health issues presenting by genetic engineering technologies. The broad-based Commission’s final report issued in March, 1996 reported a consensus identifying three inadequacies in the current system of biotech oversight: lack of federal mandatory labeling for genetically engineered foods, lack of an effective system of mandatory pre-market notification, and lack of an effective system of federal legislation to assess the risks of environmental release of genetically engineered fish. To date, the FDA has failed to correct these basic deficiencies. In the face of the failure of the federal government to mandate labeling, it is necessary for the states to step into the void. Two developments occurred in the past year to underscore the urgency of moving on labeling of genetically engineered foods. The first is the publication of a study by the prestigious National Academy of Sciences entitled "Genetically Modified Pest-Protected Plants: Science and Regulation" [April, 2000: www.nap.edu/html/gmpp/] While the report cautiously states that "the committee is not aware of any evidence that foods on the market are unsafe to eat as a result of genetic modification," the report acknowledges that "there is the potential...for adverse health effects." The report clearly demonstrates that tests of both health and environmental impacts have to date been insufficient to reach a scientific determination of safety. The report is replete with strong recommendations for further research to address health and environmental impacts, including: --- "the development of improved methods for identifying potential allergens in [GE] plants" --- "monitoring for pleiotropic [secondary] changes in plant physiology and biochemistry during the development of [GE] plants" --- "long term toxicity testing..." --- "determine the impacts of specific [GE] crops on nontarget organisms." --- "assess gene flow and its potential consequences." --- "monitor ecological impacts of [GE] crops on a long term basis to ensure the detection of impacts that may not be predicted from tests conducted during the regulatory approval process." The National Academy of Sciences study makes it clear that the development of genetically engineered food is an experiment in progress. The second development is the issuance, on January 17, 2001, of a proposed regulation for premarket notification of GE foods by the FDA, and of a proposed "guidance" on labeling of GE foods. [www.fda.gov/OHRMS/DOCKETS/98fr/011801a.htm; http://vm.cfsan.fda.gov/~dms/biolabgu.html] These documents bear careful study. Their internal contradictions are astonishing. The FDA "reiterates its view…that transferred genetic material can be presumed to be GRAS [Generally Recognized As Safe] [a category previously reserved for foods that had a long history of safe human consumption] and "is not altering its view…that there is unlikely to be a safety question sufficient to question the presumed GRAS status…" Accordingly, the FDA is not mandating safety testing for new GE foods. However, the FDA goes on for the first time to formally concede that "because [genetic engineering] can introduce genetic material from a much wider range of sources than previously possible, there is a greater likelihood that the modified food will contain substances that are significantly different from, or are present in food at a significantly higher level than, counterpart substances historically consumed in food." The FDA also concedes that allergenicity is a bigger issue with GE foods: "because genes code for proteins, and virtually all allergens are proteins…by increasing the range of potential proteins that can be introduced into food over that possible by traditional breeding, there is an increased potential for introducing an allergen into a food developed using rDNA technology." Finally, the FDA notes that the future directions of biotechnology suggest the potential for more, not fewer, of these troublesome issues: "FDA expects that with the increased introduction of multiple genes [as opposed to current single gene inserts], unintended effects may become more common." We find these three admissions refreshingly groundbreaking in candor. They quite naturally follow upon the disclosure, in litigation, of internal FDA documents in which top level FDA scientists questioned industry’s arguments that there will be no unintended consequences from GE foods, noting that "time and time again, there is no data to back up their contention." [quoted in "Biotechnology Food: From the Lab to a Debacle," New York Times, January 25, 2001 (http://partners.nytimes.com/2001/01/25/business/25FOOD)] However, the FDA’s response to these issues -- concerns that consumer activists have been raising for years -- is woefully inadequate. Mandatory premarket notification is clearly a step in the right direction. But "notification" is not at all the same as "regulation" or "registration," as we have with new pesticides, or pharmaceuticals. After receiving notification of a new biotech food, the Commission does not have to confirm, approve, or in anyway put its stamp of approval affirmatively on the company’s decision to market the product. All it has to say is that, based on its evaluation of the premarket notice, "the agency has no questions, at this time, regarding [the manufacturer’s] view that the bioengineered food is as safe as comparable food…" This is appallingly flimsy assurance, for all of our tax dollars, especially given the admitted risks presented by this new technology. In sum, both the National Academy of Sciences report and the FDA’s own recent admissions about the added risks of genetically engineered food strongly support the view that consumers have a right to make a choice not to assume those risks when they put food on their dinner tables. The time for mandatory labeling is now. Sharon S. Tisher Chair, MOFGA Public Policy Committee