Fedoroff Letter to EPA raises serious concerns over EPA blundering

Sixty members of the U.S. National Academy of Sciences, comprising many of America’s most eminent biological scientists, and including Nobel Laureates Dr. James Watson and Dr. Gunter Blobel, have written to the US Environmental Protection Agency expressing  their concerns about recent EPA moves to change biotech crop regulations.

Professor Nina Fedoroff of the Pennsylvania State University is the lead protest letter signatory.

The biotech crop regulation changes mooted by the EPA were announced March 2011 in the Federal Register here (pdf).

Scientist co-signatories on the Fedoroff Letter say that the EPA is going down a troublesome path that is not based on science, and which will frustrate and delay innovations needed to provide farmers with better cropping methods.  Because of the delays and unneeded extra cost burdens such a  policy shift would create, it would surely undermine global food security.

The text of Fedoroff Letter is provided below (see here for the full original letter).

The EPA has made a rather cryptic and stiff reply to the Fedoroff Letter, and their formulaic response provides, as yet,  no clue that the scientist’s worries are not fully justified.

Nina Fedoroff has (together with Robert Haselkorn,and Bruce M. Chassy) written a very readable  editorial about this issue in the FASEB biology journal:
EPA’s Proposed Biotech Policy Turns a Deaf Ear to Science” (pdf). This great FASEB editorial fully explains the nature of the problem that is brewing with the current EPA policy direction.

The take home message from FASEB is worth repeating:
Such expanded regulation would serve only to increase costs, hinder research, undermine the long-term viability of public university research programs, and limit product development from the private sector. The proposed actions would threaten our ability to produce high quality food at an affordable price and to feed a growing population.
They would also weaken the competitive advantage of U.S. public research programs in the global research arena, all with no increase in safety for consumers, farmers, or the environment — indeed, the contrary would be the case in many instances.
The academic community is committed to ensuring that the environmental and food safety benefits of biotechnology-derived plants continue to accrue, and it is essential that all agencies respect the scientific basis for regulation and division of regulatory responsibilities established by the Coordinated Framework. It is critical that regulations focus on scientifically demonstrated hazards, rather than being driven by issues of perception or political expediency. Therefore, we urge that the pending EPA regulatory actions be reconsidered and the rule-making proposal be limited to requirements for substances that have traditionally been regulated by the EPA, such as PIPs, and then only to those requirements that are fully justified on the basis of sound science.

Readers of Biofortified should start bending the ears of congressional representatives — and get the  EPA’s attention by every available communication channel — to make sure this potentially serious misadventure does not happen.

Text of the Fedoroff Letter:
July 5th ,  2011
The Honorable Lisa P. Jackson Administrator
Environmental Protection Agency Ariel Rios Building
1200 Pennsylvania Avenue, N.W. Washington, DC 20460
Dear Administrator Jackson:

We, the undersigned members of the National Academy of Sciences, write today to voice our concern over the latest proposal from the U.S. Environmental Protection Agency (EPA) to further expand its regulatory coverage over transgenic crops in a way that cannot be justified on the basis of either scientific evidence or experience gained over the past several decades, both of which support the conclusion that molecular modification techniques are no more dangerous than any modification technique now in use. The increased regulatory burdens that would result from this expansion would impose steep barriers to scientific innovation and product development across all sectors of our economy and would not only fail to enhance safety, but would likely prolong reliance on less safe and obsolete practices.

Twenty-five years ago, on June 26, 1986, the Office of Science and Technology Policy (O$TP) put forth a policy statement that created a “Coordinated Framework for the Regulation of Biotechnology” in the United States. At the time the Coordinated Framework was articulated, a degree of caution seemed reasonable, while seeking to achieve “a balance between regulation adequate to ensure health and environmental safety while maintaining sufficient regulatory flexibility to avoid impeding the growth of an infant industry”. At that time it was acknowledged that the framework should be “expected to evolve in accord with the experiences of the industry and the agencies, and, thus, modifications may need to be made”.

Since then, extensive research, coupled with years of experience, led to the conclusion that there is no scientific basis to single out plants produced by transgene insertion for a special regulati•ry review, nor to distinguish these products from others on the basis of the process used to create them. There is now abundant evidence that the most appropriate regulatory approach would be to require review only of truly novel traits introduced into plants without regard to the methods used for their introduction. Yet the regulatory apparatus in the U.S. has increasingly moved in the opposite direction towards ever greater regulation and increased data requirements for transgenic plants, despite the abundant accumulation of data attesting to their safety.

The scientific community has a strong interest in keeping regulations science-based and Commensurate with the risk of the products at issue. This past March, EPA announced in the Federal Register a draft proposed rule to codify data requirements for plant incorporated protectants (PIPS). This draft was forwarded by EPA to the U.S. Department of Agriculture (USDA), Department of Health and Human Services and Congress for review in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act.

Based on initial reviews of that draft proposal and recent EPA actions associated with biotechnology-derived crops, it is clear that the Agency is departing from a science-based regulatory process, walking down a path towards one based on the controversial European “precautionary principle” that goes beyond codifying data requirements for substances regulated as PIPs for the past 15 years.

We are particularly troubled by proposals to expand EPA’s current oversight into areas such as virus resistance and weediness that have been adequately addressed by USDA since 1986. Already, EPA has expanded its oversight into virus resistance, which previously had been the purview of USDA’s Animal and Plant Health Inspection Service (APHIS) and which EPA prudently proposed in 1994 to exempt from its regulations. With the draft proposed rules, EPA would further expand its regulations and data demands to other areas historically covered by USDA-APHIS without the slightest justification based on either data or experience.

It is most troubling that EPA is also proposing to increase its regulation to cover matters which are still not deemed to be threats even after years of study, such as potential gene transfer from plants to soil microorganisms. In other actions, EPA has expressed its right to regulate plants engineered for altered growth (e.g., by suppression of ethylene production), the same way it regulates synthetic plant growth regulators. The Agency does so based on a generous interpretation of the enabling legislation, despite the absence of any scientifically credible hazard.

Such an expansion in regulatory purview would reverse long established and highly successful policy under the Coordinated Framework. Such a shift would (1) create a duplicative regulatory system for very low risk products delivering substantial, demonstrated environmental benefits; (2) increase costs, reduce efficiency and prolong the review timelines thereby discouraging innovation; (3) dramatically increase the hurdles already facing academic institutions and companies attempting to improve so-called minor use or specialty crops through modern biotechnology; and (4) adversely impact trade in safe and wholesome commodities produced by U.S. growers because of the stigma attached to anything characterized as a “pesticide” — a regulatory label for DNA that is unique to the U.S. — and with no concomitant increase in product safety. In addition, any expansion in regulatory oversight not resulting from documented risk could have global ramifications, as policymakers in other countries routinely consider U.S. policymakers as leaders in the regulation of crops derived from biotechnology.

Indeed, it is astonishing that EPA would attempt such an expansion of its regulatory activity in this sphere. We now have more than 25 years of experience with biotechnology-derived crop plants. None of the hypothetical risks articulated at the dawn of this era has been realized and caused new environmental problems. On the contrary, billions upon billions of meals derived from these crops have been eaten by humans and livestock around the world with no ill effects. Moreover, environmental impacts of production agriculture and the carbon footprint of agriculture have been significantly reduced through the use of transgenic crops. At the same time, farmers have benefited economically, socially, and through improved health. These indisputable results make a compelling case that existing regulatory burdens should be reduced and refocused. There is absolutely no justification in either scientific data or experience for the regulatory expansion proposed by EPA.

Over the last two decades, advances in sequencing and genomic analysis have revealed that biotechnology is more precise and less disruptive to the genome than traditional plant breeding. In point of fact, recent genomic, proteomic and metabolomic comparisons of varieties bred through conventional and transgenic methods demonstrate that transgenic plants with incorporated novel traits more closely resemble the parental variety than do new varieties of the same plant produced by more traditional breeding or mutagenesis techniques. These findings confirm that transgene insertion is not inherently risky nor does it present new and greater hazards than conventional plant breeding.

In conclusion, recent EPA actions signal an intent to expand the Agency’s regulatory oversight into products regulated by USDA for over two decades and to products for which there has never been a justification for regulation. These actions are not only inconsistent with regulatory directives mandated by the current Administration, they also erode the integrity of the Coordinated Framework. Such expanded regulation would serve only to increase costs, hinder research, undermine the long-term viability of public university research programs, and limit product development from the private sector. The proposed actions would threaten our ability to produce high quality food at an affordable price and feed a growing population. They would also weaken the competitive advantage of U.S. public research programs in the global research arena, all with no increase in safety for consumers, farmers, or the environment — indeed, the contrary would be the case in many instances.

The academic community is committed to ensuring that the environmental and food safety benefits of biotechnology-derived plants continue to accrue, and it is essential that all agencies respect the scientific basis for regulation and division of regulatory responsibilities established by the Coordinated Framework. It is critical that regulations focus on scientifically demonstrated hazards, rather than being driven by issues of perception or political expediency. Therefore, Administrator Jackson, we urge you to reconsider the pending EPA regulatory actions and limit the rulemaking proposal to requirements for substances that have traditionally been regulated by EPA as PIPs, and then to only those requirements that are fully justified on the basis of safety and sound science.

I sign this letter on behalf of the more than 60 members of the U.S. National Academy of Sciences listed below. The list includes many of America’ most eminent biological scientists, including Nobel Laureates Dr. James Watson and Dr. Gunter Blobel.

Sincerely,
Dr. Nina V. Fedoroff
Member, National Academy of Sciences
2006 National Medal of Science Laureate
Science and Technology Adviser to the. Secretary of State and to the Administrator of USAID, 2007-10
Evan Pugh Professor, Pennsylvania State University
Huck institutes of the Life Sciences
211 Wartik
State College, PA 16801
nvflPpsu.edu

Other Fedoroff Letter Signatories:
Richard Amasino
Professor, Department of Biochemistry University of Wisconsin-Madison
Madison, WI
Charles J. Arntzen
Regents’ Professor and Florence Ely Nelson Presidential Chair The Biodesign Institute at Arizona State University
Tempe, AZ
Frederick M Ausubel
Professor of Genetics
Harvard Medical School and Massachusetts General Hospital Boston, MA
Jeffrey Bennetzen
Giles Professor and Head of the Department of Genetics University of Georgia
Athens, GA
Andrew A. Benson
Professor of Biology Emeritus
Scripps Institution of Oceanography University of California – San Diego San Diego, CA
Gunter Blobel, MD
Professor of Cell Biology The Rockefeller University New York, NY
David Botstein
Lewis-Sigler Institute for Integrative Genomics Princeton University
Princeton, NJ
John S. Boyer
E. I. du Pont Professor of Biochemistry/Biophysics Emeritus Univ. of Delaware
Newark, DE
Steven Briggs
Distinguished Professor of Cell and Developmental Biology University of California —San Diego
Donald Brown
Staff Member, Director Emeritus Carnegie Institution for Science Baltimore, MD
Bob Buchanan
Professor
University of California — Berkeley Berkeley, CA
Vicki Chandler
Regent’s Professor Emeritus University of Arizona
Tucson, AZ
Joanne Chory
Professor, The Salk Institute
Director, Plant Biology Laboratory Investigator, Howard Hughes Medical Institute San Diego, CA
Rodney Croteau
Regents’ Professor
Institute of Biological Chemistry Washington State University Pullman, WA
Eric Davidson
Norman Chandler Professor of Cell Biology California Institute of Technology
Pasadena, CA
David Dilcher
Professor Emeritus Department of Biology Indiana University
Bloomington, IN
John E. Dowling
Gund Professor of Neurosciences Harvard University
Cambridge, MA
Dr. Stephen J. Elledge Professor of Genetics Department of Genetics Harvard Medical School Boston, MA
Stanley Fields
Professor
University of Washington Seattle, WA
Michael Freeling
Professor of Genetics
University of California — Berkeley Berkeley, CA
Dr. Elisabeth Gantt
Distinguished University Professor, Emerita Dept. Cell Biology and Molecular Genetics University of Maryland
College Park, MD
Martin Gellert
Bethesda, MD
Dr. Laurie H. Glimcher
Irene Heinz Given Professor of Immunology Professor of Medicine, Harvard Medical School Harvard School of Public Health
Boston, MA
Robert Goldberg
Distinguished Professor of Molecular, Cell, and Developmental Biology University of California – Los Angeles (UCLA)
Los Angeles, CA
Bruce D. Hammock
Distinguished Professor of Entomology UCD &
Cancer Center UCD Medical Center
Director, NIEHS-UCD Superfund Basic Research Program University of California- Davis
Davis, CA
Robert Haselkorn
Fanny L. Pritzker Distinguished Service Professor of Molecular Genetics & Cell Biology The University of Chicago
Chicago, IL
J. Woodland Hastings
Paul C. Mangelsdorf Professor of Natural Sciences Department of Molecular and Cellular Biology Harvard University
Cambridge, MA
Donald R. Helinski
Professor Emeritus
Division of Biological Sciences University of California – San Diego San Diego, CA
Peter M. Howley, M.D.
Shattuck Professor of Pathological Anatomy Harvard Medical School
Boston, MA
Andre Jagendorf
Liberty Hyde Bailey Professor Emeritus Cornell University
Ithaca, NY
Cynthia Kenyon
Professor, Department of Biochemistry and Biophysics University of California — San Francisco
San Francisco, CA
Judith Kimble
Vilas Professor, University of Wisconsin-Madison Investigator, Howard Hughes Medical Institute Madison, WI
Marc Kirschner
John Enders University Professor Chair, Department of Systems Biology Harvard University
Boston, MA
Todd R. Klaenhammer
Distinguished University Professor & William Neal Reynolds Professor North Carolina State University
Raleigh, NC
Andrew H. Knoll
Fischer Professor of Natural History Harvard University
Cambridge, MA
J. Clark Lagarias, Ph.D.
Professor of Biochemistry University of California — Davis Davis, CA
Steve Lindow
Professor of Plant Pathology University of California – Berkeley Berkeley, CA
Susan Lindquist
Professor of Biology, Massachusetts Institute of Technology
Investigator, Howard Hughes Medical Institute and Whitehead Institute for Biomedical Research Boston, MA
Richard Losick
The Biological Laboratories Harvard University
Cambridge, MA
Anthony P. Mahowald, Ph. D.
Louis Block Professor Emeritus
Department of Molecular Genetics and Cell Biology The University of Chicago
Chicago, IL
Steven McKnight
Professor and Chairman
Department of Biochemistry
UT Southwestern Medical Center Dallas, TX
John Mekalanos, Ph.D.
Professor and Chair, Department of Microbiology and Molecular Genetics Harvard Medical School
Boston, MA
June B. Nasrallah
B McClintock Professorship Cornell University
Ithaca, NY
Eugene Nester
Professor Emeritus
University of Washington Seattle, WA
Eldon H. Newcomb
Folke Skoog Professor Emeritus Department of Botany
University of Wisconsin – Madison Madison, WI
Jeffrey Palmer
Dr. Jeffrey D. Palmer, Distinguished Professor of Biology and Class of ’55 Professor
Indiana University
Bloomington, IN
John T. Potts, Jr., MD
Jackson Distinguished Professor of Clinical Medicine Director of Research and Physician-in-Chief Emeritus Harvard Medical School, Massachusetts General Hospital Boston, MA
Peter H. Raven
President Emeritus
Missouri Botanical Garden St. Louis, MO
Michael Rosbash
Investigator Howard Hughes Medical Institute Professor of Biology at Brandeis University Waltham, MA
David D. Sabatini, M.D., Ph.D. Frederick L. Ehrman Professor Department of Cell Biology NYU School of Medicine
New York, NY
Matthew Scott
Professor
Stanford University School of Medicine Palo Alto, CA
Ron Sederoff
Distinguished University Professor
Edwin F. Conger Professor in the Department of Forestry and Environmental Resources North Carolina State University
Raleigh, NC
Jonathan Seidman
Henrietta and Frederick Bugher Professor of Cardiovascular Genetics Department of Genetics
Harvard Medical School
Boston, MA
Philip A. Sharp
Institute Professor, Dept. of Biology Massachusetts Institute of Technology Cambridge, MA
Chris Somerville
Philomathia Professor of Alternative Energy Director, Energy Biosciences Institute University of California – Berkeley,
Berkeley, CA
Allan Spradling
Director, Department of Embryology Carnegie Institution for Science Washington, DC
Brian Staskawicz
Professor and Chair of Plant and Microbial Biology University of California – Berkeley
Berkeley, CA
Kevin Struhl
David Wesley Gaiser Professor
Dept. Biological Chemistry and Molecular Pharmacology
Harvard Medical School
Boston, MA
Clifford J Tabin
George Jacob and Jacqueline Hazel Leder Professor and Chair Department of Genetics
Harvard Medical School
Boston, MA
Michael Thomashow
University Distinguished Professor & Director, MSU-DOE Plant Research Lab Michigan State University
East Lansing, MI
Inder Verma
Irwin and Joan Jacobs Chair in Exemplary Life Science American Cancer Society Professor of Molecular Biology The Salk Institute, Laboratory of Genetics
La Jolla, CA
James D. Watson
Chancellor Emeritus
Cold Spring Harbor Laboratory Cold Spring Harbor, NY
Diter von Wettsteinu
R.A.Nilan Distinguished Professor
Department of Crop and Soil Sciences & School of Molecular Biosciences Washington State University
Pullman, WA
William B. Wood
Distinguished Professor, Emeritus University of Colorado, Boulder Boulder, CO
Patricia Zambryski
Professor, Department of Plant and Microbial Biology University of California – Berkeley
Berkeley, CA
Federal Register Document:
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 152, 158, and 174
[EPA–HQ–OPP–2009–0499; FRL–8863–5] RIN 2070–AJ27
Pesticides; Data Requirements for  Plant-Incorporated Protectants (PIPs) and Certain Exemptions for PIPs
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David Tribe is an applied geneticist, teaching graduate/undergrad courses in food science, food safety, biotechnology and microbiology at the University of Melbourne.