3-Food: U.S. National Academy of Sciences calls for extended foodsafety assessments for "novel foods"

[GENET <coordination@genet-info.org>]

-------------------------------- GENET-news -------------------------------

TITLE:  Composition of Altered Food Products, Not Method Used to Create
        Them, Should Be Basis for Federal Safety Assessment
SOURCE: The National Academy of Sciences, USA
        http://www4.nationalacademies.org/news.nsf/isbn/0309092094?
        OpenDocument
DATE:   27 Jul 2004 

------------------- archive: http://www.genet-info.org/ -------------------


---------------------------------------------------------------------------
   "Unexpected changes are more apt to occur if genetic material is
    transferred between distantly related species. Genetic engineering is
    more likely to cause unintended changes than some techniques, such as
    simple selection, but less likely to do so than other currently used
    methods, such as those that use radiation or chemicals. Because all
    methods can cause these changes, the committee concluded that attempts
    to assess food safety based solely on the method of breeding are
    'scientifically unjustified.' "
---------------------------------------------------------------------------


Composition of Altered Food Products, Not Method Used to Create Them,
Should Be Basis for Federal Safety Assessment

WASHINGTON -- Federal agencies should assess the safety of genetically
altered foods -- whether produced by genetic engineering or by other
techniques, such as conventional breeding for desirable traits -- on a
case-by-case basis to determine whether unintended changes in their
composition could adversely affect human health, says a new report from
the National Academies' National Research Council and Institute of
Medicine. The scope of each safety evaluation should not be based solely
on the technique used to alter the food, said the committee that wrote
the report, because even traditional methods such as cross-breeding can
cause unexpected changes. Instead, greater scrutiny should be given to
foods containing new compounds or unusual amounts of naturally occurring
substances, regardless of the method used to create them.

"All evidence to date indicates that any breeding technique that alters a
plant or animal -- whether by genetic engineering or other methods -- has
the potential to create unintended changes in the quality or amounts of
food components that could harm health," said committee chair Bettie Sue
Masters, Robert A. Welch Foundation Distinguished Professor in Chemistry,
University of Texas Health Science Center, San Antonio. "The possible
impact of such compositional changes should be examined on a case-by-case
basis to determine whether and how much further evaluation is needed."

The report uses the term "genetic modification" to describe the broad
array of breeding techniques -- ranging from traditional cross-breeding
to genetic engineering to the use of chemicals or radiation -- used to
alter plant and animal traits that can be inherited from one generation
to the next. "Genetic engineering" refers to a specific type of
alteration that uses molecular biology techniques to delete genes or to
transfer genes for particular qualities from one species to another. For
example, plant breeders have engineered crops to resist pests by
inserting a protein from a soil bacterium, and efforts are under way to
develop foods with enhanced nutritional content.

Adverse health effects from genetic engineering have not been documented
in the human population, but the technique is new and concerns about its
safety remain. The U.S. Department of Agriculture, the Food and Drug
Administration, and the U.S. Environmental Protection Agency commissioned
the National Academies to assess the potential for adverse health effects
from genetically engineered foods compared with foods altered in other
ways, and to provide guidance on how to identify and evaluate the
likelihood of those effects.

Genetic engineering is not an inherently hazardous process, the report
says, but the resulting food, along with foods created from other methods
of genetic modification, should be examined to determine if the inserted
genes produce toxins or allergens. Unexpected changes are more apt to
occur if genetic material is transferred between distantly related
species. Genetic engineering is more likely to cause unintended changes
than some techniques, such as simple selection, but less likely to do so
than other currently used methods, such as those that use radiation or
chemicals. Because all methods can cause these changes, the committee
concluded that attempts to assess food safety based solely on the method
of breeding are "scientifically unjustified."

Instead, foods modified by any method that changes genetic composition
should, when warranted by their individual characteristics, be evaluated
on a case-by-case basis before their commercial release. The report
offers a framework to guide federal agencies in selecting the route of
safety assessment. A new genetically modified food whose composition is
very similar to a commonly used conventional version may warrant little
or no additional safety evaluation. But if an unknown substance has been
detected in a food, a more detailed analysis should be conducted to
determine whether an allergen or toxin may be present. Likewise, foods
with nutrient levels that fall outside the normal range should be
assessed for their potential impact on consumers' diets and health.

Scientists' current ability to predict whether such changes will cause
adverse health effects is limited, and more research is needed in this
area, the committee cautioned. In some cases, evaluation should continue
after products are on the market -- especially for foods with new
substances or unusual nutrient profiles -- to assess and validate how
well pre-market evaluations are working. Barriers to this type of
surveillance exist, however. For example, currently there is no way to
track altered foods in the marketplace or identify consumers who have
used them. The committee urged the agencies to improve their ability to
detect consumer trends in purchasing genetically modified foods, and to
enable the traceability of these foods. Also, better epidemiological and
survey tools should be developed that can detect changes in the
population's health that may be caused by these foods.

The committee was also asked to examine safety issues related to foods
from cloned animals. Safety evaluation of foods from these animals should
also focus on the product itself rather than the process used to create
it, said the committee, which recommended that the evaluations compare
foods from cloned animals with those from noncloned animals. At present,
there is no evidence that foods from cloned animals pose an increased
risk to consumers. However, cloned animals that are engineered to produce
pharmaceuticals should be kept from entering the food chain, the
committee stated.

The report was sponsored by the U.S. Department of Agriculture, the Food
and Drug Administration of the U.S. Department of Health and Human
Services, and the U.S. Environmental Protection Agency. The National
Research Council and Institute of Medicine are private, nonprofit
institutions that provide science and health policy advice under a
congressional charter. The Research Council is the principal operating
arm of the National Academy of Sciences and the National Academy of
Engineering. A committee roster follows.

Copies of Safety of Genetically Engineered Foods: Approaches to Assessing
Unintended Health Effects are available from the National Academies
Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://
www.nap.edu. The cost of the report is $35.00 (prepaid) plus shipping
charges of $4.50 for the first copy and $.95 for each additional copy.
Reporters may obtain a copy from the Office of News and Public
Information (contacts listed above).

[ This news release and the report are available at http://national-
academies.org ]

Contacts: William Kearney, Director of Media Relations 
Sara Frueh, Assistant Editor
Chris Dobbins, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail <news@nas.edu>

*****

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

and

INSTITUTE OF MEDICINE
Food and Nutrition Board

Committee on Identifying and Assessing Unintended Effects of Genetically
Engineered Foods on Human Health

Bettie Sue Masters, Ph.D. (chair) Robert A. Welch Foundation
Distinguished Professor in Chemistry Department of Biochemistry
University of Texas Health Science Center San Antonio

Fuller W. Bazer, Ph.D. Associate Vice Chancellor and Associate Director
Texas Agricultural Station, and Executive Associate Dean College of
Agriculture Texas A&M University College Station

Shirley A.A. Beresford, Ph.D. Professor Department of Epidemiology
University of Washington Seattle

Dean DellaPenna, Ph.D. Professor Department of Biochemistry and Molecular
Biology Michigan State University East Lansing

Terry D. Etherton, Ph.D. Distinguished Professor of Animal Nutrition and
Head Department of Dairy and Animal Science Pennsylvania State University
University Park

Cutberto Garza, M.D., Ph.D. Professor Division of Nutritional Sciences
Cornell University Ithaca, N.Y.

Lynn Goldman, M.D., M.P.H. Professor of Occupational and Environmental
Health Bloomberg School of Public Health Johns Hopkins University Baltimore

Sidney Green, Ph.D.* Graduate Professor of Pharmacology Department of
Pharmacology College of Medicine Howard University Washington, D.C.

Jesse F. Gregory III, Ph.D. Professor Department of Food Science and
Human Nutrition University of Florida Gainesville

Jennifer Hillard Former National Vice President of Issues and Policy
Consumer's Association of Canada Winnipeg, Manitoba

Alan G. McHughen, Ph.D. Biotechnology Specialist Department of Botany and
Plant Sciences University of California Riverside

Sanford A. Miller, Ph.D. Senior Fellow and Adjunct Professor Center for
Food and Nutrition Policy Virginia Polytechnic Institute and State
University Alexandria

Steve L. Taylor, Ph.D. Maxcy Distinguished Professor and Head Department
of Food Science and Technology University of Nebraska Lincoln

Timothy Zacharewski, Ph.D. Associate Professor Department of Biochemistry
and Molecular Biology Michigan State University East Lansing

STAFF

Ann Yaktine, Ph.D. Senior Program Officer

 * Committee member until April 2003


                                  PART II
-------------------------------- GENET-news -------------------------------

TITLE:  Report: Biotech Proposals Should Be Eyed
SOURCE: The Associated Press / New York Times, USA
        http://www.nytimes.com/aponline/national/AP-Biotech-Crops.html
DATE:   27 Jul 2004 

------------------- archive: http://www.genet-info.org/ -------------------


Report: Biotech Proposals Should Be Eyed

WASHINGTON (AP) -- Federal regulators should look more closely at the
potential health effects of some genetically modified plants before they
can be grown as commercial crops, a scientific advisory panel said Tuesday.

It also said regulators should check for potential food safety problems
after people eat the products.

The report by a committee of the National Research Council and Institute
of Medicine said regulators should target tighter scrutiny at genetically
engineered varieties that have greater levels of biological differences
from current plants.

The analyses also should look more closely at conventionally developed
plants if there are indications that naturally occurring chemicals in the
conventional plants could have unintended health effects, the report said.

Some chemicals in plants can create allergic reactions or otherwise make
some people sick. To prevent such problems, the study recommended a case-
by-case approach to the applications based on compounds in conventional
as well as biotech plants, rather than the current focus on biotech
varieties. The report said, however, that biotech plants would probably
have greater risk.

The compounds to be examined could be new ones not normally in the
plants, as well as naturally occurring ones that are above or below
healthful levels, the report said.

To help regulators make their approval decisions, a database should be
developed to list the levels of certain compounds, including healthful
substances such as proteins and dangerous ones such as allergens, the
report said.

The report also said the government should develop better ways to see if
genetically modified foods cause health problems. Among these could be
systems to trace foods with greatly altered levels of those compounds
through the food supply, and to check populations to see if there are
health problems among people who eat the foods.

However, the primary focus should be on the preapproval process, "and we
would hope that, for the most part, there wouldn't be a great deal of
postmarket tracking," said the committee chairwoman, Bettie Sue Masters,
a professor of chemistry at the University of Texas Health Science Center
in San Antonio.

The report said that genetic engineering of food crops, although
relatively new, appears to be a safe technology and that there is no
evidence it has harmed health. Committee members emphasized that current
biotech crops have gone through extensive safety checks.

Current biotech crops do not need the tracing or re-examination, said
Dean DellaPenna, a professor of biochemistry and molecular biology at
Michigan State University. The committee's job was to evaluate what could
be done for new applications, he said. "What we are talking about is from
this point going forward," he said.

The committee did not intend for researchers to identify every one of the
thousands of compounds in plants, but to focus on the "handful" that
might cause problems, DellaPenna said.

The committee did not consider the cost of implementing its
recommendations, DellaPenna said. "We are proposing what we think would
be ideal recommendations, and it is certainly up to the agencies and
Congress to determine how they go forward."

The report was done for the Food and Drug Administration, the Agriculture
Department and the Environmental Protection Agency, which oversee biotech
crop applications.

Michael Phillips, vice president of agricultural science and regulatory
policy at the Biotechnology Industry Organization, a biotech trade group,
said the report should "lay to rest the few naysayers who continue to
question the safety of these crops."

Consumer advocates said the report also supported their positions. "The
report clearly and correctly states that biotech foods could have
unintended consequences," said Gregory Jaffe, biotechnology project
director of the Center for Science in the Public Interest.

The National Research Council and the Institute of Medicine are arms of
the National Academy of Sciences, a private, congressionally chartered
organization that advises the government on scientific and technical matters.


                                  PART III
-------------------------------- GENET-news -------------------------------

TITLE:  Panel Sees No Unique Risk From Genetic Engineering
SOURCE: The New York Times, USA, by Andrew Pollack
        http://www.nytimes.com/2004/07/28/science/28study.html
DATE:   28 Jul 2004 

------------------- archive: http://www.genet-info.org/ -------------------


Panel Sees No Unique Risk From Genetic Engineering 

Genetically engineered crops do not pose health risks that cannot also
arise from crops created by other techniques, including conventional
breeding, the National Academy of Sciences said in a report issued yesterday.

The conclusion backs the basic approach now underlying government
oversight of biotech foods, that special food safety regulations are not
needed just because foods are genetically engineered.

Nevertheless, the report said that genetic engineering and other
techniques used to create novel crops could result in unintended, harmful
changes to the composition of food, and that scrutiny of such crops
should be tightened before they go to market.

"The most important message from this report is that it's the product
that matters, not the system you are using to produce it," Jennifer
Hillard, a consumer advocate from Canada who was on the committee that
wrote the report, said in a telephone news conference. Committee members
said the genetically engineered foods already on the market are safe.

The study, "Safety of Genetically Engineered Foods: Approaches to
Assessing Unintended Health Effects," is somewhat vague on how
regulations should change, but rather deals more with the science needed
to determine whether food from genetically engineered crops and animals
might be harmful.

It does not, for instance, explicitly recommend mandatory reviews of new
genetically engineered foods by the Food and Drug Administration. It says
that assessments should be made on a case-by-case basis. Right now,
companies that create such crops voluntarily consult with the F.D.A.

The report suggests that in some cases, surveillance might be needed
after a food gets to the market to check for possible health effects,
something not done now. It also calls for some information on the
composition of genetically modified foods to be made public rather than
kept proprietary.

Both sides in the polarized debate about genetically engineered foods
found things to like and not like in the report.

"They've clearly identified that there are significant problems with our
technological ability to both identify changes that might happen in G.E.
crops as well as to evaluate what those changes might mean," said Doug
Gurian-Sherman, a senior scientist at the Center for Food Safety in
Washington, which opposes biotech crops.

But backers of biotech were heartened by the report's determination that
the risks of biotech foods are not unique. Michael Phillips, vice
president of agricultural science and regulatory policy of the
Biotechnology Industry Organization, said in a statement that the report
"should lay to rest the few naysayers who continue to question the safety
of these crops."

The report was commissioned by the three agencies that regulate
genetically engineered crops: the F.D.A, the Department of Agriculture
and the Environmental Protection Agency. It was produced by a committee
of mostly academic scientists led by Bettie Sue Masters, of the
department of biochemistry at the University of Texas Health Science
Center in San Antonio.

Genetic engineering involves the transfer of a specific gene from one
organism to another. Cross-breeding, by contrast, involves the mixing of
thousands of genes, most unknown. Another breeding technique is to
bombard plants with radiation or expose them to chemicals to induce
hundreds of random mutations in hopes of finding one that will confer a
desirable trait.

The report said that genetic engineering was more likely to cause
unintended effects than the other techniques used to develop plants
except for the mutation-inducing technique.

Right now, crops produced by techniques other than genetic engineering go
through virtually no regulatory scrutiny.




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