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National Academy of Sciences:
Genetically Modified Animals May Pose Environmental Risks

JILL CARROLL and ANTONIO REGALADO / Wall Street Journal 21aug02

[SF Chronicle, NAS Press Release, and NY Times articles below]

WASHINGTON -- The National Academy of Sciences struck a cautionary note in a new report on genetically modified animals, warning that they could pose environmental risks that the government might not be equipped to evaluate.

The report, requested by the Food and Drug Administration, will have significant sway with the various regulatory bodies that have a hand in overseeing the animals that are just now coming out of laboratories to help farmers improve breeding stock and produce new drugs.

The report also questions whether the agency has the legal authority to deal with wider environmental risks posed by so-called transgenic animals, suggesting the government's current regulatory framework is inadequate.

"This report clearly shows that the technology is moving so fast that it definitely poses some challenges to the regulatory system," said Michael Fernandez, scientific director of the Pew Initiative on Food and Biotechnology, an independent information clearinghouse based here.

The report said animals also could pose food-safety risks and animal-welfare concerns. But the NAS committee said the main problem lies in figuring out how the animals might affect the environment.

The report specifically cited work being done with a fast-growing salmon, a genetically modified species that is likely to be the first to be commercially developed for human consumption, if approved. The report raised concerns that the salmon might escape from their marine breeding pens and breed with natural stocks, reducing the number of wild species, or disrupt the predator-prey relationship because they might grow larger than normal. The FDA previously has indicated such animals would be subject to the same regulations that govern new-animal antibiotics or growth hormones.

Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at the FDA, which reviews transgenic animals, said the agency will use the report to create an "optimal" policy for evaluating the animals and consult other agencies such as the Fish and Wildlife Service and Environmental Protection Agency for advice.

"We continue to be in touch with these regulatory agencies," he said. "We have developed a working relationship with the other agencies."

Dr. Sundlof also said the agency will continue to bar cloned animals from the food supply pending further research.

mindfully.org note:
The sterilization of salmon is
an indicator of the risk involved.
Sterilization of all released fish is
not possible. In real life conditions,
some will get lose.

See Trojan gene hypothesis

The salmon's developer, Aqua Bounty Farms Inc. of Waltham, Mass., says it would create salmon that, if approved, would all be sterilized females to prevent them from mixing with wild stock should they escape from their ocean net pens, something considered inevitable by most experts.

The animals put "forward a new and novel risk," said Joseph Mendelson, legal director at the Center for Food Safety, an environmental advocacy group. "We need a system in place that looks long and hard" at them.

Another issue of concern is cloning. Already, several companies are cloning prize bulls or dairy cattle for as little as $20,000. Last summer, the FDA told these companies not to allow the animals into the food chain. Dr. Sundlof said the agency is continuing that policy pending further research.

The NAS committee noted that it wasn't charged with looking at the benefits of genetically modified animals and that all new technologies pose some risks.


Scientists seek more control over bioengineered beasts 

TOM ABATE / SF Chronicle 21aug02

Report warns of risks to gene pool, humans' health

Warning that bioengineered animals could escape into the wild and muddy the gene pool, a new scientific report calls for more oversight of the entire field, including assessments of whether biotech meat or dairy products might cause allergies if eaten.

The report released Tuesday by the National Research Council offers the first comprehensive look at the potential environmental and health risks of using gene-splicing and cloning to create animals that could not have been bred through traditional means.

The National Research Council report was requested by the U.S. Food and Drug Administration, which is fashioning new rules to govern the many ways in which corporate and academic scientists are redesigning animals.

Some firms hope to create fish that grow faster or cattle that have an extra copy of the genes that make meat lean. Drug companies are bioengineering cows to produce medicines in their milk. A Dutch scientist hopes to use flies in a similar fashion. Other scientists are modifying pigs to, one day, transplant their hearts into human patients. A Canadian firm is growing superstrong spider silk in goats.

Looking at this range of activities, the report questioned whether federal rulemakers were up to the task.

"The current regulatory framework might not be adequate to address unique problems and characteristics associated with animal biotechnologies," the report said.

SENATE CONSIDERS SEAFOOD LABEL

Meanwhile, one biotech firm's bid to sell a fast-growing salmon has already provoked a legislative reaction in Sacramento.

The state Senate could vote as early as today on a bill that would require California stores to label genetically engineered seafood -- even though Aqua Bounty of Massachusetts says its biotech salmon is still about a year away from final FDA review.

Although it trod controversial ground, the National Research Council report drew praise from proponents and opponents of biotechnology.

"We were quite pleased to see the NRC report," said Joseph McGonigle, vice president of Aqua Bounty. "It clearly identifies the scientific areas of risk and leaves aside the wild claims."

For instance, although the council's top concern was that "highly mobile" biotech animals, like the salmon, might escape, McGonigle said the panel noted that they would need an evolutionary advantage to hurt wild fish -- a caveat that he said cleared his firm's sexually sterilized salmon.

Joseph Mendelson, legal director for the Center for Food Safety in Washington, D.C., and a leading opponent of biotech agriculture, also took comfort from the study.

"With all the issues the report raises, the FDA clearly has to act now to create mandatory safety and environmental reviews," he said.

Joy Mench, a professor of animal welfare at UC Davis and one of the 12 scientists on the panel, said it was up to the FDA and other federal agencies to beef up the rules and systems to manage this burgeoning effort to bioengineer animals.

"This report raises issues that people are going to have to look at and make risk-based recommendations," Mench said.

MAJOR POINTS OF REPORT

Among the key findings:

Cats, goats, fish and other animals that can easily go feral pose the greatest risk of escaping and cross-breeding with unforeseen consequences for the genetic future of these species.

Current rules seem to completely overlook efforts to bioengineer insects, which would be particularly difficult to quarantine or capture if problems arose.

The panel found moderate concern that animals bioengineered for food purposes might produce proteins that would cause allergies or other reactions and said this "will have to be assessed."

The study found no evidence that food from cloned animals was any different from the classic variety but noted an absence of comparative studies.

The panel noted "the theoretical possibility" that bioengineering pigs for use as transplant donors could lead to the creation of a new infectious agent that might spread through the human population.

CAN'T MAKE EXACT ASSESSMENTS

Mench said the panelists found it difficult to make blanket statements about the safety of eating bioengineered animal products because there are so many different approaches.

"This is all so new that we don't have the data yet to make precise risk assessments," Mench said.

Meanwhile, academic and commercial scientists pushing the biotech envelope are running up against regulatory roadblocks.

At UC Davis, animal scientist James Murray is raising genetically engineered goats to test techniques he hopes to introduce in dairy cows. When the goats reach the end of their research life, he destroys them because the FDA doesn't want them turned into food.

"We want to know what the FDA is going to require to put these animals in the food chain," he said. "They should be eaten. There is no reason not to."

E-mail Tom Abate at tabate@sfchronicle.com .

 


Potential Environmental Problems With Animal Biotech Raise Some Concerns; No Evidence Cloned Animals Are Unsafe to Eat, But Data Still Lacking

NAS Press Release 20aug02

WASHINGTON -- The possibility of certain genetically engineered fish and other animals escaping and potentially introducing engineered genes into wild populations tops the list of concerns associated with advances in animal biotechnology, says a new report [available for reading online] from the National Academies' National Research Council. On the other hand, no evidence yet exists that products from cloned livestock are unsafe for human consumption, although the committee that wrote the report found it difficult to identify concerns without additional information about food composition, which could be collected using available analytical tests.

The report was requested by the Food and Drug Administration as it prepares to rule on the safety of certain animal-biotechnology products, particularly cloned cattle. The committee was asked only to identify science-based concerns; it was not asked to identify potential benefits from animal biotechnology or to make policy recommendations.

"As is the case with any new technology, it is almost impossible to state that there is no concern, and in certain areas of animal biotechnology we did identify some legitimate ones," said committee chair John G. Vandenbergh, professor of zoology, North Carolina State University, Raleigh. "By identifying these concerns, we hope we can help this technology be applied as safely as possible without denying the public its potential benefits."

The committee said the greatest concern is the ability of certain genetically engineered organisms to escape and reproduce in the natural environment. Genetically engineered insects, shellfish, fish, and other animals that can easily escape, that are highly mobile, and that become feral easily are of particular concern, especially if they are more successful at reproduction than their natural counterparts. For example, it is possible that if transgenic salmon with genes engineered to accelerate growth were released into the natural environment, they could compete more successfully for food and mates than wild salmon.

By creating transgenic animals with genes from another species, or by removing or "turning off" genes, animals can be produced to grow bigger and more rapidly, or possess traits beneficial to humans, such as meat with more protein and less fat, eggs with less cholesterol, milk containing pharmaceutical products, or even tissues and organs suitable for human transplantation. And through somatic cell nuclear transfer -- the technique used to clone Dolly the sheep -- scientists can create an almost identical copy of an adult animal with desirable traits. The owners of a few hundred cows cloned this way in the United States have been asked by FDA to hold off selling the cows' milk and meat, or breeding them, pending regulatory approval.

In transgenic animals developed for human consumption, there is a low probability that a few new proteins expressed when genes are inserted from another species may trigger allergic or hypersensitive reactions in a small, but unknown, percentage of people. The potential for allergenicity is difficult to gauge, however, since it can only be detected once a person is exposed and experiences a reaction. While a reaction will be recognizable, as it is with well-known allergens like peanuts and shellfish, the uncertainty surrounding new proteins and potential impact on consumers who may be allergic is serious enough to elicit a moderate level of concern, according to the committee.

Animals genetically engineered to produce non-food products, such as cows that produce drugs in their milk, are not intended to enter the food supply. But the committee said there are grounds for concern that adequate controls be in place to ensure restrictions on the use of carcasses from such animals. In at least one instance, meat from the carcasses of such animals was used to make a food product.

The applications of biotechnology may someday reduce the number of animals needed for food and fiber production, but they also can have adverse effects on the welfare of animals, the committee noted. For example, calves and lambs produced through in vitro fertilization or cloning tend to have higher birth weights and longer gestation periods, which leads to difficult births often requiring caesarian sections. In addition, some of the biotechnology techniques in use today are extremely inefficient at producing fetuses that survive. Of the transgenic animals that do survive, many do not express the inserted gene properly, often resulting in anatomical, physiological, or behavioral abnormalities. There is also a concern that proteins designed to produce a pharmaceutical product in the animal's milk may find their way to other parts of the animal's body, possibly causing adverse effects.

Although the committee was not asked to make any policy recommendations, it suggested that the current regulatory framework may not be adequate given that the responsibilities of federal agencies for regulating animal biotechnology are unclear in some respects.

The study was sponsored by the Food and Drug Administration. The National Research Council is the principal operating arm of the National Academy of Sciences and the National Academy of Engineering. It is a private, nonprofit institution that provides science and technology advice under a congressional charter. A committee roster follows. Read the full text of Animal Biotechnology: Science-Based Concerns for free on the Web, as well as more than 1,800 other publications from the National Academies. Printed copies are available for purchase from the National Academy Press Web site or by calling (202) 334-3313 or 1-800-624-6242. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

NATIONAL RESEARCH COUNCIL Division on Earth and Life Studies Board on Agriculture and Natural Resources

Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology

John G. Vandenbergh (chair) Professor of Zoology North Carolina State University Raleigh

Alwynelle Self Ahl USDA Fellow Center for the Integrated Study of Food, Animal, and Plant Systems Tuskegee University Tuskegee, Ala.

John M. Coffin* American Cancer Society Research Professor of Molecular Biology and Microbiology School of Medicine Tufts University, and Director HIV Drug Resistance Program National Cancer Institute Frederick, Md.

Willard H. Eyestone Research Associate Professor Department of Large Animal Clinical Sciences Virginia-Maryland Regional College of Veterinary Medicine Blacksburg

Eric M. Hallerman Associate Professor Department of Fisheries and Wildlife Sciences Virginia Polytechnic Institute and State University Blacksburg, Va.

Tung-Ching Lee Distinguished Professor of Food Science and Nutrition Cook College Rutgers University New Brunswick, N.J.

Joy A. Mench Professor Animal Science Department University of California Davis

William M. Muir Professor of Breeding and Genetics Department of Animal Sciences, and Director High Definition Genomics Center Purdue University West Lafayette, Ill.

R. Michael Roberts* Curator's Professor of Animal Science and Biochemistry University of Missouri Columbia

Theodore H. Schettler Science Director Science and Environmental Health Network Boston

Lawrence B. Schook Professor of Comparative Genomics Department of Animal Sciences and Veterinary Pathobiology University of Illinois Urbana-Champaign

Michael R. Taylor Senior Fellow and Director Center for Risk Management Resources for the Future Washington, D.C.

RESEARCH COUNCIL STAFF

Kim Waddell Study Director

* Member, National Academy of Sciences


Animal Biotechnology: Science-Based Concerns

National Research Council
Public Briefing August 21, 2002
Opening Statement by
John G. Vandenbergh
Professor of Zoology, North Carolina State University, Raleigh and Chair, Committee on Defining Science-Based Concerns Associated With Products of Animal Biotechnology



Good morning.
On behalf of the National Academies, I would like to welcome those of you in the room as well as those of you listening on the Web. I am pleased to be here with some of my fellow committee members to release the findings of our new report, Animal Biotechnology: Science-Based Concerns.

Research on genetic engineering has led to an increase in the development of a substantial variety of food and agricultural goods as well as pharmaceutical and other products that promote human health. The federal regulatory system for genetically engineered animals and their products has been subject to increasing attention and discussion among research scientists and policy-makers, as well as the public. In 2001, the Food and Drug Administration's Center for Veterinary Medicine recognized that it was an opportune time to ask the National Research Council to identify the science-based risks and concerns associated with animal biotechnology prior to any regulatory review of the food and environmental safety of these products. Specifically, we were charged to:

One, develop a listing of risk issues in the areas of food safety, environmental safety, and animal safety. Two, provide criteria for selection of risk issues that should be considered most important and that need to be addressed or managed. And three, identify and justify risk issues that were considered but not identified as important.

Although future policy decisions regarding the use of animal biotechnology will no doubt take into consideration the potential benefits as well as the potential risks, the committee was not asked to examine benefits. Nor was it asked to make policy recommendations. Because it was difficult to compare environmental, food-safety, and animal welfare risks, the committee instead attempted to prioritize concerns within each main area.

The primary criterion for selection of concerns that emerged from committee discussions in each of these areas is based on the judgment of the immediacy and potential severity of the risk based on scientific information. We also categorized risks by examining the products and their potential differences with similar products derived from conventional practices.

This report is "a snapshot in time," with the technology continuing to rapidly advance. In fact, some major advances were reported during the brief period in which this report was being prepared. We sense that animal biotechnology will evolve at a similar rate to that occurring with plant biotechnology. Because this technology is new, however, we were often challenged by the paucity of data that might have provided stronger insights into the relative risks for the techniques and applications being discussed.

The technologies that were examined include: introduction of new genes, modification of genes, and propagation by nuclear transfer of nearly identical copies of an animal, what's termed "cloning." These technologies make it possible to create animals with useful novel properties for dairy, meat, or fiber production, for environmental control of waste production, and for production of useful products for biomedical purposes.

Although many of the details of the techniques described will no doubt soon become outdated and replaced by new ones not yet considered, some general issues will remain. In particular, there will probably always be concerns regarding the use of unnecessary genes in DNA constructs used for generation of engineered animals. There will also be concerns about the use of vectors with the potential to be mobilized or to otherwise contribute sequences to other organisms, and the effects of the technology on the welfare of the engineered animals themselves.

The principles for assessing the safety of food from genetically engineered animals are qualitatively the same as for non-engineered animals, but animals genetically engineered for non-food products, such as pharmaceuticals, might present additional concerns relating to the nature of the products that they produce. For example, female animals might be genetically engineered to produce non-food products in their milk or eggs, but the males produced through this process or the unused females might be considered for entry into the food supply. The safety of food products that are derived from animals engineered for non-food purposes might present a concern if the non-food product is found in parts of the animal that may be sold.

The genetic engineering of animals intended for use as food will involve the expression of new proteins in animals; hence the safety, including the potential allergenicity, of introducing new proteins into the food supply might be a concern. The probability that particular novel gene products might trigger such responses in some consumers is thought to be low, but because of the potentially significant impacts on individuals who may be sensitive, we viewed allergenicity as a moderate level of food safety concern. A lower level of food safety concern exists that transgenically derived proteins used to enhance a trait such as growth or disease resistance could retain their bioactivity after consumption. Products that might induce toxicity were of least concern because they would likely be identified by current food safety assessment procedures.

Animal biotechnology may produce foods with changed nutritional attributes. These products might include eggs that are lower in cholesterol or meat with enhanced vitamin content and lower fat. If these changed products were labeled in order to appeal to targeted consumers and identifiable to those who might have medical or other reasons to avoid such foods, they would be of low concern.

The cloning of animals from somatic cells is a new and rapidly changing technology. This made it difficult to draw conclusions regarding the safety of milk, meat, or other products from animals that are themselves somatic cell clones. The key scientific issue was whether and to what degree the genomic reprogramming that occurs with somatic cell cloning results in gene expression that raises food safety concerns. There are currently no data to indicate whether abnormalities in patterns of gene expression persist in adult clones and are associated with food safety risks. Nor are there substantial analytical data comparing the composition of meat and milk products of somatic cell clones, their offspring, and conventionally bred animals. Somatic cell cloned cattle reportedly are physiologically, immunologically, and behaviorally normal. They also exhibit puberty at the expected age, with high rates of conception upon artificial insemination. We felt that it was difficult to identify concerns without additional data regarding food product composition, which could be gathered using available analytical tests. There is no current evidence that food products derived from adult somatic cell clones or their progeny present a food safety concern.

We also considered potential risks associated with the cloning technologies of embryo splitting, and nuclear transfer using embryonic cells, which is an older, different technique than somatic cell nuclear transfer. Based on current scientific understanding, products of clones produced through embryo splitting and nuclear transfer using embryonic cells were regarded as posing a low level of food safety concern. Nevertheless, the committee believes that an evaluation of the composition of food products derived from cloned animals using available procedures would be prudent to minimize any remaining food safety concerns. The products of offspring of cloned animals were regarded as posing no food safety concern because they are the result of natural matings.

The committee considered environmental issues to be a significant science-based concern associated with animal biotechnology, in large part due to the uncertainty inherent in identifying environmental problems early on and the difficulty of remediation once a problem has been identified. We focused our attention on engineered animals that are intended to remain in confinement but escape or are inadvertently released into natural environments. This could result in the transgene spreading through reproduction with wild individuals of the same species. The likelihood of a transgenic animal becoming established in the environment and the level of concern regarding such a likelihood is dependent on two factors: its ability to escape and disperse in diverse communities, and its survival and reproductive success in that environment. Our greatest concerns were with species that become feral easily, are highly mobile, and have a history of causing extensive community damage. They include insects, shellfish, fish, and mice and rats. At the other end of the spectrum, less mobile and highly domesticated animals that do not become feral easily, such as domestic chickens, cattle, and sheep, present the least concern. Also transgenic animals produced for human medical benefits, such as xenotransplantation and pharmaceutical production, have little chance of becoming established in the environment. The impacts of any short- or long-term environmental harms from genetically engineered animals are dependent on the stability and resilience of the communities that would absorb these individuals. Those that are most stable will sustain the least harm, while those that are the least stable will sustain the greatest harm.

When we looked at the modification of animals for biomedical purposes, we identified several areas of concern, particularly with the transplantation of animal tissue and organs into humans, which is known as xenotransplantation. Xenotransplantation has inherent risks, among them the possibility of novel infectious disease. It is not expected that humans will consume animals engineered to produce non-food products, but the committee has a concern regarding the adequacy of controls in place to ensure restriction on the use of carcasses from such animals. Entry of surplus animals into the food chain poses a concern because of the possibility of people being exposed to transgenes and their expressed products.

The effects of genetic manipulation on animal health and welfare are of significant public concern. Our committee considered the following facets of animal welfare in discussing transgenic and cloning technologies: their potential to cause pain, physical, and psychological distress; behavioral abnormality; physiological abnormality; and/or health problems - and conversely their potential to alleviate or reduce these problems. For example, a number of species of hoofed animals produced by in vitro culture or nuclear cell transfer methods, whether or not they carry a transgene, tend to have higher birth weights and longer gestation times than offspring produced by artificial insemination. Because of this, difficult calvings can be a problem and might require special husbandry or veterinary procedures such as caesarian sections. Additional health and welfare problems requiring special attention include respiratory distress, lack of suckling reflex, and a variety of pathological conditions.

The techniques in use for the production of transgenic animals are inefficient. Unexpected phenotypic effects, especially on anatomical, physiological, or behavioral traits of genetically engineered animals can occur. Work with knockout and cloned mice has demonstrated, in some instances, elevated levels of aggression and impairment of learning and motor skills, suggesting additional studies of cloned livestock are warranted. An important animal welfare concern related to xenotransplantation is the management and housing of pigs intended for use as organ source animals. The pigs are maintained in sterile, often isolated environments to minimize transmission of disease to human recipients, but this environment might result in abnormal behavioral development.

Although our charge was limited to addressing science-based concerns about animal biotechnology, the committee also took account of policy and institutional concerns. We noted that many factors influence the nature of scientific research and that the interpretation of data and technologies often have impacts on social, political, economic, religious, and spiritual conditions or values which, in turn, might impact health and the environment.

New technologies, such as biotechnology, are often characterized by a variety of uncertainties resulting in unexpected outcomes. Uncertainty also relates to the difficulty of placing the potential impacts into the policy context within which proposed biotechnologies will be addressed.

The current regulatory framework might not be adequate to address unique problems and characteristics associated with animal biotechnologies. The responsibilities of federal agencies for regulating animal biotechnology are unclear. In addition to the potential lack of clarity about regulatory responsibilities and data collection requirements, we also had a concern about the legal and technical capacity of the agencies to address potential hazards, particularly in the environmental area.

My colleagues and I will now take your questions. Please step to a microphone, and whether you are here or submitting a question via e-mail, please identify yourself and your organization. Thank you.


Panel Urges Caution in Producing Gene-Altered Animals 

WARREN E. LEARY / NY Times 22aug02

WASHINGTON, Aug. 20 Although there is no evidence that cows, sheep and other animals reproduced through cloning are unsafe to eat, more caution is needed on animals engineered to contain genes from other species, a panel of scientists said today.

The National Research Council committee, asked by the Food and Drug Administration to examine the safety concerns of applying biotechnology to animal products used for food, said it had reservations about food from some gene-altered animals. However, the committee said, there also appear to be many benefits if the technology is applied and regulated carefully.

"We were asked to focus on safety concerns, but we don't want to inhibit the progress of biotechnology, because of its many potential benefits," said Dr. John G. Vandenbergh of North Carolina State University, chairman of the panel. "We are saying, If you use this technology, do it in a safe manner."

The 12-member committee of scientists, doctors and other experts said its biggest concern about the new technology was the potential of certain genetically engineered organisms to escape and reproduce in the natural environment. Modified insects, fish, shellfish and other animals could easily escape and threaten their natural counterparts. For example, the panel said, gene-altered salmon given the ability to grow at an accelerated rate might compete more successfully for food and mates than natural varieties, causing wild salmon to die out.

The food and drug agency asked for the review as it prepared to rule on the safety of selling food products from animals manipulated through biotechnology, particularly cloned cattle. With techniques similar to those used to clone Dolly the sheep, scientists can create almost an identical copy of an adult animal with certain desirable traits. Owners of hundreds of cows cloned this way want to sell milk or meat from them but have been warned to wait for regulatory approval.

The panel said it found no data indicating the products of cloned animals were unsafe, nor did it identify a way something was likely to go wrong to make such cloned animals the source of unsafe food.

But the committee said it had reservations about food from transgenic animals, those that are changed by adding genes of other species or by having existing genes removed or deactivated. Such animals could produce meat with less fat or more protein, eggs with less cholesterol, or milk that contains drugs or vaccines that could fight disease.

One potential risk of food from transgenic animals is that some new proteins produced because of adding genes from other species might prompt hypersensitive or allergic reactions in a few people. The panel said that predicting such allergic potential was hard, and that some adverse reactions might not show up until products were on the market.

Dr. Vandenbergh said in an interview that people accepted a certain level of risk in everyday life, but that risks from foods needed to be kept as low as possible. Between 1 percent and 2 percent of adults, and 5 percent of children, have allergies, he said.

"There are a number of things that have an extremely low probability of risk, but if they occur, the consequences can be serious, as with an allergic reaction," he said.

The committee said that animals engineered to produce nonfood products, like drugs in their milk, should not enter the food supply. However, it said, it is unclear whether adequate controls are in place to ensure that carcasses from such animals do not yield food.

The National Research Council, a part of the National Academy of Sciences, was asked to look only at scientific concerns about biotechnology and food, and not for policy recommendations. But the committee said that regulation of the technology now spanned several federal agencies, and that this arrangement might not be adequate.

The committee said in its report that it had "concern about the legal and technical capacity of the agencies to address potential hazards, particularly in the environmental area."

Michael R. Taylor, a committee member and senior fellow with Resources for the Future, a study group based in Washington, said the panel was not criticizing a particular agency but saying that Congress and other policy makers should give regulators the tools they needed to deal with nontraditional technology that crossed traditional agency lines. "Does the F.D.A., for instance, have adequate authority to deal with issues such as the environmental consequences of a transgenic fish getting out?" Mr. Taylor asked.

Joseph Mendelson, the legal director for the Center for Food Safety, which has criticized genetically modified food, said regulatory uncertainty was enough in itself to keep these foods off the market.

"There are still serious issues concerning safety and regulation that should keep these things from endangering human health and the environment," Mr. Mendelson said.

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