Dear Mr. Caton:

Thank you for responding to the concerns outlined in my previous email. 
However, I would like to clarify several points.

1.) I am Ms. McCullum not Mr. McCullum

2.) Dr. Harry Kuiper is a HIGHLY respected scientist in the field of food 
safety evaluation - not only in Europe but in the US as well. I suggest you 
talk to experts in food toxicology to find out more about
Dr. Kuiper before making a blanket statement about a respected scientist 
you know nothing about.

3.) Dr. Fagan is also a well-respected scientist who has expressed concerns 
around GE foods (please see his biosketch below).

4.) About whether or not FDA is reconsidering its regulatory policy on the 
safety evaluation of GE foods, I suggest you consult the Federal Register - 
the placed where government agencies publish proposed hearings and/or 
rulings. BOTH Scientific/Safety Issues and Public Information Issues (e.g., 
labeling) are being considered under the reevaluation of regulatory policy 
on GE foods. Each of these issues was addressed at the 3 public hearings, 
with two separate panels of experts. How do I know? I was there! Here are 
examples of questions the scientific/safety panel was asked to address:

What newly emerging scientific information related to the safety of foods 
derived from bioengineered plants is there, if any? Are there specific 
tests which, if conducted on such foods, would provide increased assurance 
of safety for man or animals consuming these foods?

What types of food products derived from bioengineered plants are planned 
for the future? Will these foods raise food safety issues that would 
require different approaches to safety testing and agency oversight? If so, 
what are these approaches?


5.) I suggest you contact Dr. Marion Nestle (PhD in Molecular Biology) who 
is the current Chair of the Food and Nutrition Department at New York 
University. She was on one of the expert panels at the FDA public hearing 
in Chicago, and has served on the government committee that approved rBST 
(as well as others). Her email address is: marion.nestle@nyu.edu

6.) To date, I have only been able to find 6 published studies in 
peer-reviewed journals that evaluate the safety of GE foods. 4 = no 
effects; 2 = effects. Are 6 short-term studies sufficient to provide 
conclusive evidence of the long-term safety of these foods? I have provided 
a summary of each studied evaluated, along with a reference for each. I am 
not anti-science or anti-technology but I do think that using caution and 
common sense is needed. If negative effects are found to occur much later, 
they are not reversible and cannot be simply 'taken off' the market like 
other products previously approved but only later found to have 
life-threatening effects (e.g., the weight loss drug Redux).

Thanks again for your consideration,

Chris

Summary of feeding studies on GE foods

>>>>  1.) Bt spores fed to chicken quails (no problem)
>>>>  2.) Bt spores administered to rats via trachea (health problems)
>>>>  3.) Gt soya fed to rats, chicken, cattle, and catfish (no problem)
>>>>  4.) Gt soya fed to mice by gavage (no problem)
>>>>  5.) Lecitin potatoes fed to rats (health problems)
>>>>  6.) Bt corn fed to chickens (no problem)

>>1. Tsai-San-Fu. Liao-Jiunn-Wang. Wang-Shun-Cheng. Safety evaluation of 
>>Bacillus Thuringiensis var. israelensis for Japanese quail by oral 
>>administration. Journal of the Chinese Society of Veterinary Science. 22 
>>(5). 1996, 340-347 LG Chinese (CH); Non-English (XE)
>>
>>2. Tsai-San-Fu. Liao-Jiunn-Wang. Wang-Shun-Cheng. Clearance and effects 
>>of intratracheal instillation to spores of Bacillus thuringiensis or 
>>Metarhizium anisopliae in rats. Journal of the Chinese Society of 
>>Veterninary Science. 23 (6), 1997, 515-522 LG Chinese (CH): Non-English (XE)
>>
>>3. Hammond, BG, Vicini, JL, Hartnell, GF, et. al. The feeding value of 
>>soybeans fed to rats, chickens, catfish, and dairy cattle is not altered 
>>by genetic incorporation of glyphosate. Journal of Nutrition 
>>1996,126(3):717-727.
>>
>>4. Harrison, LA, Bailey, MR, Naylor, MW, et al.  The expressed protein in 
>>glyphosate-tolerant soybean, 5-enolpyruvylshikimate-3-phosphate snythase 
>>from Agrobacterium sp. strain CP4, is rapidly digested in vitro and is 
>>not toxic to acutely gavaged mice. Journal of Nutrition 1996, 126(3):728-740.
>>
>>5. Ewen, S. and A. Pusztai. Effects of diets containing genetically 
>>modified potatoes expressing Galanthus nivalis lectin on rat small 
>>intestine. Lancet 1999; 354:1353-1354.
>>
>>6. Brake, J. Vlachos, D. Evaluation of Transgenic Event 176 Bt corn in 
>>Broiler Chickens. Poultry Science, 1998, 77:648-656.
BIOSKETCH

John Fagan
Dr. John Fagan has spent more than 25 years using cutting edge molecular
genetic techniques in cancer research. He earned a B.S. (cum laude with
distinction in chemistry) from the University of Washington and a Ph.D. in
biochemistry and molecular biology from Cornell University. He then spent 7
years doing research in molecular biology at the National Institutes of
Health, first as a postdoctoral fellow, and subsequently leading his own
research group from 1980 to 1984. In 1984, Dr. Fagan moved his research
laboratory from the National Institutes of Health to Maharishi University
of Management, where he is now Professor of Molecular Biology and
Biochemistry, Chairman of the Department of Chemistry, Co-director of the
Physiology and Molecular and Cell Biology Ph.D. Program, and Dean of the
Graduate School.
As Professor of Molecular Biology, Dr. Fagan has received more than $2.5
million in grants from the National Cancer Institute of the National
Institutes of Health. These grants supported research whose long-term goal
was to identify cancer susceptibility genes and to understand how
carcinogens and environmental pollutants, such as dioxin, influence gene
expression. He has authored more than 30 technical articles on these
topics, which have been published in internationally recognized,
peer-reviewed journals, including Molecular and Cellular Biology, The
Journal of Biological Chemistry, The Journal of Molecular Biology, and
Biochemistry. From 1991 to 1995 Dr. Fagan was the recipient of a Research
Career Development Award from the National Cancer Institute, which is given
to enhance the research development of promising scientists.
In recent years Dr. Fagan has become increasingly concerned regarding the
approach currently being taken in applying genetic engineering in food
production and agriculture, and regarding the health and ethical dangers
linked to germ-line genetic engineering in humans. In November of 1994, he
publicly took an ethical stand urging biomedical and agricultural
scientists to take safer, more productive research directions, and, in
medicine, to focus more on prevention and less on high-tech therapeutics.
He underscored these warnings by returning a $613,882 grant to the National
Institutes of Health and withdrawing grant applications worth another $1.25
million. These would have further supported research that could have
contributed indirectly to the development of germ-line genetic engineering
in humans. He has now redirected his own research to study natural health
promotion and disease prevention strategies, to develop new methods for
assessing food safety and purity, and to develop and evaluate sustainable
approaches in agriculture.
Dr. Fagan has taken an active role working with governmental agencies, and
governmental and commercial laboratories in the US, Europe and elsewhere
around the globe to develop, implement, and validate analytical procedures
for genetically engineered foods and for monitoring the presence of
genetically engineered organisms in the environment. In this role he has
made use of his decades of research experience in molecular biology to
develop highly sensitive and accurate methods for detecting and
quantitating genetically engineered foods and ingredients. He has also
founded Genetic ID, the first company to offer analytical services for
genetically engineered foods and agricultural products globally. Genetic ID
also licenses these technologies to laboratories in many countries around
the world. Dr. Fagan is currently the Chairman and Chief Scientific Officer
of Genetic ID.
Dr. Fagan serves as a scientific consultant on health and environmental
issues, and as an editorial advisor and reviewer for scientific journals.
He has also served on committees for the peer-review of federal
government-sponsored research grants.He is a frequent speaker at international
scientific and professional conferences, to organizations with interests in 
food,
the environment, agriculture, and health, as well as to students and civic 
groups,
and to international organizations. Topics include, not only the health and
environmental impacts, but also the social, cultural, economic, ethical,
and human rights implications of applying genetic engineering in
agriculture, food production, and medicine. Dr. Fagan also speaks on his
other area of current research, in which he uses rigorous biomedical
approaches to evaluate preventive and natural approaches in health care.
The current focus of Dr. Fagan's work is to stimulate dialogue regarding
national and international policy and regulations regarding use of genetic
engineering in agriculture and the food industry. Current discussion
focuses on two issues: (a) the consumers right to have choice in the
marketplace as to whether they purchase genetically engineered foods, and
(b) the need to establish more rigorous standards regarding safety and
environmental assessment of genetically engineered foods. During the last
two years this work has taken Dr. Fagan to Australia, Austria, Belgium,
Brazil, Croatia, Denmark, Finland, France, Germany, Indonesia, Ireland,
Italy, Netherlands, Northern Ireland, Norway, Sweden, Switzerland, and the
United Kingdom, as well as Japan, Canada, and the United States. During
these visits Dr. Fagan has met with legislators, government
representatives, the food and agricultural industries, the press, consumer
representatives, the public, and leaders in the scientific community. He
has also made presentations to national and international regulatory
bodies, such as committees of the Codex Alimentarius Commission and the
Convention on Biological Diversity. This work has had direct impact on
national and international policy on genetically modified foods.