[pf] Fwd: Debate 2000'1205 a: EPA Starlink Press Release: Preliminary dismissal

by David A

18 December 2000 17:33 UTC

Starlink:


-----Original Message-----
From:    David Appell appell@nasw.org
Sent:    Sun, 17 Dec 2000 21:06:36 -0500
To:      davidnh@visto.com
Subject: [Fwd: Debate 2000'1205 a: EPA Starlink Press Release: Preliminary 
dismissal of the case on grounds of small amounts found in human food chain due 
to the Aventis withdrawal of all relevant products.]



___________________________________________________________________________
Visit http://www.visto.com/info, your free web-based communications center.
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Dear friends,

thanks to the always well and early informed news networks Agbioview and AGNET,
the EPA circulates here preliminary report on the Starlink 'event'.

For all other paragraphs please read the full document, nothing contradicts 
the conclusions
given below in a summary.

The concerns can be minimized, but not dismissed totally. There is need for 
more monitoring.
These judgements are based on the fact that due to the extremely LOW AMOUNT 
of the Bt protein
Cry9C the risk is negligable. But this also means that ONLY  a thorough 
risk assessment on
the allerginicity will reveal the data whether the protein can be approved 
for general human
consumption in higher quantities. Which also means that the risk assessment 
could
result into a zero solution.

Klaus


the full report either on:

http://www.epa.gov/scipoly/sap/2000/november/one.pdf

or

ftp://debate:friends@sgiserv.unibe.ch/home/debate/starlink.pdf


+++++++++++++++++++++++++++++++++++++++++


Summary
The Panel concluded that the StarLink™ corn Cry9C Bt-pesticidal protein 
should be
classified as having low probability to sensitize some individuals to Cry9C 
protein. Because no
single factor is completely predictive of allergenicity and no records of 
Cry9C human
sensitization exist as yet, there can be no final proof that Cry9C is or is 
not a food allergen.
However, the apparent low level of Cry9C protein entering the human diet 
make it a low
likelihood that StarLink™ corn has resulted in sensitization of some 
individuals to the Cry9C
protein. The Panel believes that there would be an enhanced risk if the 
amount of Cry9C in the
food supply would increase by orders of magnitude, whereas lowering the 
levels makes
sensitization less probable.


NOTICE
This report has been written as part of the activities of the Federal 
Insecticide, Fungicide,
and Rodenticide Act (FIFRA), Scientific Advisory Panel (SAP). This report 
has not been
reviewed for approval by the United States Environmental Protection Agency 
(Agency) and,
hence, the contents of this report do not necessarily represent the views 
and policies of the
Agency, nor of other agencies in the Executive Branch of the Federal 
government, nor does
mention of trade names or commercial products constitute a recommendation 
for use.
The FIFRA SAP was established under the provisions of FIFRA, as amended by 
the Food
Quality Protection Act (FQPA) of 1996, to provide advice, information, and 
recommendations to
the Agency Administrator on pesticides and pesticide-related issues 
regarding the impact of
regulatory actions on health and the environment. The Panel serves as the 
primary scientific peer
review mechanism of the EPA, Office of Pesticide Programs (OPP) and is 
structured to provide
balanced expert assessment of pesticide and pesticide-related matters 
facing the Agency. Food
Quality Protection Act Science Review Board members serve the FIFRA SAP on 
an ad-hoc basis
to assist in reviews conducted by the FIFRA SAP. Further information about 
FIFRA SAP
reports and activities can be obtained from its web site at 
http://www.epa.gov/scipoly/sap/ or the
OPP Docket at (703) 305-5805. Interested persons are invited to contact 
Larry Dorsey, SAP
Executive Secretary, via e-mail at dorsey.larry@.epa.gov.


SAP Report No. 2000-06, December 1, 2000
REPORT:
FIFRA Scientific Advisory Panel Meeting,
November 28, 2000, held at the Holiday Inn Rosslyn Hotel,
Arlington, Virginia
Session I - A Set of Scientific Issues Being Considered by
the Environmental Protection Agency Regarding:
Assessment of Scientific Information Concerning
StarLink Corn
Mr. Paul Lewis Stephen Roberts, Ph.D.
Designated Federal Official FIFRA SAP Session Chair
FIFRA Scientific Advisory Panel FIFRA Scientific Advisory Panel
Date:_______________________ Date:_______________________



Imprint, authors:
Federal Insecticide, Fungicide, and Rodenticide Act
Scientific Advisory Panel Meeting
November 28, 2000
Assessment of Scientific Information Concerning StarLink™ Corn
PARTICIPANTS
FIFRA SAP Session Chair
Stephen Roberts, Ph.D., Center for Environmental and Human Health, 
University of Florida,
Gainesville, FL
FIFRA Scientific Advisory Panel
Charles Capen, D.V.M., Department of Veterinary Medicine, Ohio State 
University, Columbus,
OH
FQPA Science Review Board Members
Ricki Helm, Ph.D., Arkansas Children’s Hospital, Little Rock, AK
R. Carl Hoseney, Ph.D., R and R Research, Manhattan, KS
Charles Hurburgh, Ph.D., Iowa State University, Agricultural and Biosystems 
Engineering
Department, Ames, IA
Barry Jacobsen, Ph.D., Montana State University, Department of Plant 
Sciences and Plant
Pathology, Bozeman, MT
Phil Kenkel, Ph.D., University of Tennessee, Department of Agricultural 
Economics,
Knoxville, TN
David Lineback, Ph.D., Joint Institute of Food Safety and Applied 
Nutrition, University of
Maryland, College Park, MD
David MacIntosh, Ph.D.,University of Georgia, Department of Environmental 
Health,
206 Environmental Health Building, Athens, GA
Dirk Maier, Ph.D., Purdue University, Department of Agricultural and 
Biological Engineering,
West Lafayette, IN
Dean Metcalfe, M.D., NIAID/Laboratory of Allergic Diseases, Bethesda, MD
Hubert P.J.M. Noteborn, Ph.D., State Institute for Quality Control of 
Agricultural Products
The Netherlands,6700 AE Wageningen
Nu-may Ruby Reed, Ph.D., Cal/EPA, Department of Pesticide Regulation, 
Sacramento, CA
Marc Rothenberg, M.D. Ph.D., Children’s Hospital Medical Center, Division 
of Pulmonary
Medicine, Allergy/Immunology, Cincinnati, OH
Hugh Sampson, M.D., Mt Sinai/NYU Medical Center, Department of Pediatrics, 
New York, NY
10029


Federal Insecticide, Fungicide, and Rodenticide Act
Scientific Advisory Panel Meeting
November 28, 2000
Assessment of Scientific Information Concerning StarLink™ Corn
PARTICIPANTS
FIFRA SAP Session Chair
Stephen Roberts, Ph.D., Center for Environmental and Human Health, 
University of Florida,
Gainesville, FL
FIFRA Scientific Advisory Panel
Charles Capen, D.V.M., Department of Veterinary Medicine, Ohio State 
University, Columbus,
OH
FQPA Science Review Board Members
Ricki Helm, Ph.D., Arkansas Children’s Hospital, Little Rock, AK
R. Carl Hoseney, Ph.D., R and R Research, Manhattan, KS
Charles Hurburgh, Ph.D., Iowa State University, Agricultural and Biosystems 
Engineering
Department, Ames, IA
Barry Jacobsen, Ph.D., Montana State University, Department of Plant 
Sciences and Plant
Pathology, Bozeman, MT
Phil Kenkel, Ph.D., University of Tennessee, Department of Agricultural 
Economics,
Knoxville, TN
David Lineback, Ph.D., Joint Institute of Food Safety and Applied 
Nutrition, University of
Maryland, College Park, MD
David MacIntosh, Ph.D.,University of Georgia, Department of Environmental 
Health,
206 Environmental Health Building, Athens, GA
Dirk Maier, Ph.D., Purdue University, Department of Agricultural and 
Biological Engineering,
West Lafayette, IN
Dean Metcalfe, M.D., NIAID/Laboratory of Allergic Diseases, Bethesda, MD
Hubert P.J.M. Noteborn, Ph.D., State Institute for Quality Control of 
Agricultural Products
The Netherlands,6700 AE Wageningen
Nu-may Ruby Reed, Ph.D., Cal/EPA, Department of Pesticide Regulation, 
Sacramento, CA
Marc Rothenberg, M.D. Ph.D., Children’s Hospital Medical Center, Division 
of Pulmonary
Medicine, Allergy/Immunology, Cincinnati, OH
Hugh Sampson, M.D., Mt Sinai/NYU Medical Center, Department of Pediatrics, 
New York, NY
10029

Designated Federal Official
Mr. Paul Lewis, FIFRA Scientific Advisory Panel, Office of Science 
Coordination and Policy,
Office of Prevention, Pesticides and Toxic Substances, Environmental 
Protection Agency,
Washington, DC
PUBLIC COMMENTERS
Oral statements were made by:
Rhona Applebaum, Ph.D., on behalf of the Alliance for Better Foods
I. Leonard Bernstein, Ph.D., on behalf of the University of Cincinnati
James BeMiller, Ph.D., on behalf of the Corn Refiners Association
Mr. William Bogot and Mr. Clint Krislov, on behalf of Krislov and Associates
Mr. Larry Bohlen, on behalf of Friends of the Earth
Anne Bridges, Ph.D., on behalf of the American Association of Cereal Chemists
Gary Burleson, Ph.D., on behalf of Burleson Research Technologies
Edmund Crouch, Ph.D., on behalf of Cambridge Environmental Inc.
Mr. W.J. Duensing, on behalf of the North American Millers Association
Mr. Bill Freese, a private citizen
Mr. Steven Gill, on behalf of the United States Department of Agriculture
Ms. Barbara Glenn, on behalf of the Federation of Animal Science Societies
Rebecca Goldburg, Ph.D., on behalf of Environmental Defense
Michael Hansen, Ph.D., on behalf of Consumers Union
Susan Harlander, Ph.D., on behalf of Bionational Consultants
Mr. Arvid Hawk, on behalf of the National Grain and Feed Association
Jason Hlywka, Ph.D., on behalf of Cantox Health Sciences International
Ms. Diana Jackson, on behalf of the Alliance for Bio-Integrity
Ms. Susan Keith, on behalf of the National Corn Growers Association
James Lamb, Ph.D., on behalf of BBL Sciences
Mr. Joseph Mendelson, on behalf of the Center for Food Safety
Ms. Anne Munoz-Furlong, on behalf of the Food Allergy Network
Earl Nestmann, Ph.D., on behalf of the Grocery Manufacturers of America
Ms. Katherine Ozer, on behalf of the National Family Farm Coalition
Barbara Petersen, Ph.D., on behalf of Novigen Sciences and Larry 
Somerville, Ph.D. on behalf of
Aventis CropScience, USA LP
Michael Phillips, Ph.D., on behalf of the Biotechnology Industry Organization
Leah Porter, Ph.D., on behalf of the American Crop Protection Association
Ms. Elizabeth Rice-Arnold, on behalf of the Institute of Science, 
Technology and Public Policy
Jane Rissler, Ph.D., on behalf of the Union of Concerned Scientists
Lloyd Rooney, Ph.D., on behalf of Texas A&M University
Mr. David Senter, on behalf of the American Corn Growers Association
Ms. Margaret Wittenberg, on behalf of Whole Foods Market
Larry Williams, Ph.D., on behalf of Duke University Medical Center
Jupiter Yeung, Ph.D., on behalf of the National Food Processors Association


Written statements were received from:
Alliance for Bio-Integrity
American Association of Cereal Chemists
American Crop Protection Association
Aventis CorpScience
Mr. Bill Freese
Biorational Consultants, Inc
Blasland, Bouck & Lee, Inc.
BRT, Inc.
Cambridge Environmental, Inc.
Consumer Policy Institute/Consumer Union
Corn Refiners Association
Texas A&M University
Federation of Animal Science Societies
Biotechnology Industry Organization
Environmental Defense
Greenpeace
Harvard Center for Risk Analysis
International Consumers for Civil Society
Medallion Laboratories
Monsanto
National Coalition Against the Misuse of Pesticides
National Corn Growers Association
National Food Processors Association.
National Grain and Feed Association
North American Millers Association
Science for Organizations
United States Department of Agriculture
University of Nebraska
University of Illinois


CHARGE
Allergenicity
1. Based on your review of the currently available data, how would you 
assess the likelihood
(high, medium, or low) that the Cry9C protein is a food allergen? Please 
explain the basis for
that conclusion.
Sensitization
2. Assuming the Cry9C protein has the potential to act as a human allergen 
and taking into
account the limited duration (four years) and amount of exposure (no 
StarLink™ corn produced
after 2000) to Cry9C in the food supply, how would you assess the 
likelihood (high, medium, or
low) that the use of StarLink™ corn in making processed food has resulted 
in the sensitization of
some individuals to the Cry9C protein? Please explain the basis for that 
conclusion. What
difference would it make if the amount in the food supply is one or two 
orders of magnitude
lower or higher?
3. The submission from Aventis CropSciences contends that “[i]t is unlikely 
that a protein, which
is present at low levels in the diet, would become an allergen. . . . 
Allergic responses are not
induced by . . . minor components, but are specific for a few usually 
highly expressed proteins.”
(Submission, p.21) Aventis contends that Cry9C represents less than 0.0129% 
of the corn
protein, and therefore that it is very unlikely to become a food allergen. 
Please comment on the
scientific basis for this approach to evaluating the potential 
allergenicity of a protein.
4. Please comment on the relevance of the Bernstein, et al. study on dermal 
and inhalation
sensitization to microbial Bacillus thuringiensis pesticide products to 
sensitization and
allergenicity of the Cry9C protein in food.
5. Please comment on the CDC and FDA analysis of reports from individuals 
who claim to have
experienced adverse effects after consuming food that might have been made 
from StarLink™
corn?





¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦¦

Prof. Dr. Klaus Ammann
Director Botanical Garden,
University of Bern
Altenbergrain 21
CH - 3013 Bern, Switzerland
Tel. +41 31 631 49 37
Fax +41 31 631 49 93
Mobile +41 79 429 70 62
klaus.ammann@ips.unibe.ch