From: Walter Epp [for7gen@idiom.com]
Sent: Wednesday, April 04, 2001 2:02 AM
To: fdadockets@oc.fda.gov
Subject: FDA dockets 00N-1396 and 00D-1598

re FDA dockets 00N-1396 and 00D-1598

The FDA proposals are grossly inadequate.

No genetically modified product shall be allowed on the market until it has
undergone
(1) comprehensive multigenerational mammalian health studies, including
assessment of impact on neurological, fetal, reproductive, immunological,
cardiovascular, digestive, and endocrine systems.
and
(2) comprehensive ecological studies, including assessment of effects
on the entire life cycles and interactions of both related and unrelated
species, including a variety of bacteria, fungi, cultivated plants, wild plants,
insects, fish, amphibians, birds, and mammals.
and
(3) comprehensive studies of the stability of the genetic modification in the
modified organism, including at least 7 generations, and for each offspring
that differs from the parent, testing under (1) and (2) above must be done
separately. Artificial genetic constructs are notoriously unstable and prone to
recombination, rearrangement, and silencing. Data on the original organism, no
matter how comprehensive, is irrelevant if subsequent generations have a
different genetic structure and thus potentially different attributes and health
& ecological consequences.
and
(4) comprehensive studies of the modes of horizontal gene transfers to a
variety of viruses (including reactivation of dormant viruses and generation of
new viruses), bacteria, fungi, cultivated plants, wild plants, insects, fish,
amphibians, birds, and mammals.

The studies must be fully paid for by the biotech industry, but conducted by
people who are not connected to or influenced by biotech companies. All data
from all such studies must be made public, including via the internet, and
members of the public must be able to challenge the adequacy of any of the data.


If companies and their CEOs do not agree to fully compensate all economic,
health, and ecological damage without possibility of bankruptcy, then they do
not believe the benefits are worth the risks, so why should we?
This criterion is more relevant than a hundred foot pile of scientific studies.
Any form of escape from liability is a subsidy.

Since the damage could easily exceed the ability of companies to pay, this will
require posting a bond. Since the damage from reproducing genes could last
a million years, the size of this bond would be spectacular.
Anything less constitutes a potentially astronomical subsidy.

When the government builds a building, it requires the contractor to post a bond
to ensure that the building actually gets built on schedule. In this case,
millions dollars are at stake and the consequence to the public of contractor
failure is only loss of money and the inconvenience of delays for a few years.
If government regulation of companies building genetically engineered life forms
is to have any integrity, the bond requirements will be correspondingly greater
by many orders of magnitude, since in this case, the integrity of the fabric of
life is at stake, and the consequences to the public from a population explosion
of mutant reproducing genes potentially includes ecological damage,
impoverishment, and health damage affecting billions of people and economic
damages running into trillions of dollars.

All gross (not net) revenues from genetic engineering shall be held in escrow
until safety has been confirmed over multiple generations. In addition we must
hold parents, subsidiaries, successors, and all other affiliated corporate
entities liable, hold individual principals liable, and hold the entire industry
and their corporate affiliates liable in the event that the guilty company and
people do not have sufficient resources to pay for all damages.

The genetic engineering industry must compensate organic producers for all
costs of testing for genetic contamination and all losses due to genetic drift.


The FDA proposals express concern about the possibility that GE-free labels may
be misleading.
What's far more misleading is to allow GE products to be sold without a label
indicating that no comprehensive health and ecological testing has been done,
or alternatively a label saying "safety unknown".

Actually, many members of the public assume that if a product is on the market
then it has been thoroughly tested for safety, and don't bother to read all the
fine print in the label.  Thus allowing these products on the market without
comprehensive multigenerational health and ecological testing is in and of
itself misleading.

If GE was really so wonderful, makers would be proud and eager to advertise
their products as GE. The fact that they not only oppose labelling for GE
but also want to censor GE-free labels tells us they know there are
problems with GE but want to hide that fact from the consumer.

There must be no restrictions on truthfully labeling products as GE-free.
Any restrictions must be repealed, such as the ones around rBGH that
require saying that there is no difference between products with and without
rBGH, which is now known to be a fraud since there are differences including
increased risk of cancer. If FDA was really interested in stopping misleading
labels, it would never have allowed these rules to go into effect.

From www.psrast.org/bghcpc.htm:
  Date: July 8, 1998.

  As reported in a May 9 article in The Lancet, women with a relatively small
  increase in blood levels of the naturally occurring growth hormone
  Insulin-like Growth Factor I (IGF-1) are up to seven times more likely to
  develop premenopausal breast cancer than women with lower levels. Based on
  those results, the report concluded that the risks of elevated IGF-1 blood
  levels are among the leading known risk factors for breast cancer, and are
  exceeded only by a strong family history or unusual mammographic
  abnormalities. Apart from breast cancer, an accompanying editorial warned
  that elevated IGF-1 levels are also associated with greater than any known
  risk factors for other major cancers, particularly colon and prostate.

  This latest evidence is not unexpected. Higher rates of breast, besides
  colon, cancer have been reported in patients with gigantism (acromegaly)
  who have high IGF-1 blood levels. Other studies have also shown that
  administration of IGF-1 to elderly female primates causes marked breast
  enlargement and proliferation of breast tissue, that IGF-1 is a potent
  stimulator of human breast cells in tissue culture, that it blocks the
  programmed self-destruction of breast cancer cells, and enhances their
  growth and invasiveness.

  These various reports, however, appear surprisingly unaware of the fact
  that the entire U.S. population is now exposed to high levels of IGF-1 in
  dairy products. In February 1995, the Food and Drug Administration approved
  the sale of unlabelled milk from cows injected with Monsanto's genetically
  engineered bovine growth hormone, rBGH, to increase milk production. As
  detailed in a January 1996 report in the prestigious International Journal
  of Health Services, rBGH milk differs from natural milk chemically,
  nutritionally, pharmacologically and immunologically, besides being
  contaminated with pus and antibiotics resulting from mastitis induced by
  the biotech hormone. More critically, rBGH milk is supercharged with high
  levels of abnormally potent IGF-1, up 10 times the levels in natural milk
  and over 10 times more potent. IGF-1 resists pasteurization, digestion by
  stomach enzymes, and is well absorbed across the intestinal wall.

  Still unpublished 1987 Monsanto tests, disclosed by FDA in summary form in
  1990, revealed that statistically significant growth stimulating effects
  were induced in organs of adult rats by feeding IGF-1 at low dose levels
  for only two weeks. Drinking rBGH milk would thus be expected to
  significantly increase IGF-1 blood levels and consequently to increase
  risks of developing breast cancer and promoting its invasiveness.

  SOURCE Cancer Prevention Coalition http://www.preventcancer.com/

For more info on this subject and Monsanto's heavy-handed attempts to
cover it up, see http://www.foxbghsuit.com


The FDA federal register announcement says
   We have reviewed information in the comments received in response
   to the 1992 policy and the 1993 information request as well as the
   comments from the meetings held in 1999.
   These comments did not provide data or other information regarding
   consequences to consumers from eating the foods or any other basis for us to
   find under section 201(n) of the act that such a disclosure was a material
   fact. Many of the comments expressed concern about possible long-term
   consequences from consuming bioengineered foods, but they did not contend
   that any of the bioengineered foods already on the market have adverse health
   effects. The comments were mainly expressions of concern about the unknown.

This claim is so jarringly false and betrays such a profound ignorance of
the public comments that were submitted that it makes one
wonder if FDA is actually reading public comments submitted to it.

Quoting from Steven Druker at the FDA public meeting on genetically engineered
foods, Nov 30, 1999, Panel on Scientific, Safety, and Regulatory Issues:

   FDA is disregarding the well-recognized potential for recombinant DNA
   techniques to produce unexpected toxins and carcinogens in a different
   manner and to a different degree than do conventional methods.  For one
   thing, the foreign genetic material invariably disrupts the region of host
   DNA into which it wedges, and this can adversely alter cellular function.
   Another source of potential problems is the routine practice of fusing
   powerful promoters from viruses or pathogenic bacteria to the transferred
   genes.  This is necessary because genes ordinarily do not express well when
   implanted within a foreign cellular environment. However, besides boosting
   the foreign genes, these promoters can cause overexpression (or even
   suppression) of surrounding native genes. Further, these foreign promoters
   cause the transgenes to act independently of the host organism's intricate
   control mechanisms and to express their products in an essentially
   unregulated manner.  This unregulated flow of foreign substances can upset
   complex biochemical feedback loops.  Moreover, these powerful agents can
   activate metabolic pathways that are ordinarily inactive.

   FDA microbiologist Dr. Louis Pribyl stated: "There is a profound difference
   between the types of unexpected effects from traditional breeding and genetic
   engineering."

   Dr. E.J. Matthews of the FDA's Toxicology Group warned "genetically modified
   plants could ... contain unexpected high concentrations of plant toxicants."

   Also, the head of the FDA's Center for Veterinary Medicine wrote in a
   memorandum to Dr. Maryanski, "CVM"  -- that is the Center for Veterinary
   Medicine -- "believes that animal feeds derived from genetically modified
   plants present unique animal and food safety concerns."

   Dr. Linda Kahl, an FDA compliance officer, protested that the agency was
   "trying to fit a square peg into a round hole by trying to force an ultimate
   conclusion that there is no difference between foods modified by genetic
   engineering and foods modified by traditional breeding practices."  She
   declared, "the processes of genetic engineering and traditional breeding are
   different and, according to the technical experts in the agency, they lead to
   different risks."

Quoting from Dr. Philip Regal, Professor of Ecology, Evolution and Behavior
with the College of Biological Sciences at the University of Minnesota, at the
FDA Public Meeting Biotechnology in the Year 2000 and Beyond, December 13, 1999,
Oakland, California:

   It was a surprise that the pollen from genetically engineered plants was more
   powerful, by 20 to 1, than the pollen from normal plants in pollinating.
   There was a competitive advantage. No one expected that. That was a surprise.
   We know about all sorts of really odd side effects in genetically engineered
   organisms.

   Well, in the case of foods, of course, what we're concerned about is that
   some of these surprises may end up with changing biochemical pathways. These
   are delicately balanced biochemical pathways.

   Again, I want to stress the fact that the rhetoric, the basic rhetoric, is
   dangerous. When we say things about it being no different from traditional
   breeding, it makes the public and the scientific community doubt that the
   people who are dealing with it know how to deal with it. It's really clear to
   me, as a university scientist, when I talk with genetic engineers, when I
   talk with molecular biologists, they cannot talk knowledgeably about the
   risks. That's not part of their training.

Quoting from John Fagan, Chairman and Chief Scientific Officer, Genetic ID, at
the FDA Public Meeting Biotechnology in the Year 2000 and Beyond, December 13,
1999, Oakland, California:

   What we see is that the processes of genetic engineering in fact are more
   likely to create unexpected, unintended side effects than the conventional
   approaches. And this is because you're using approaches that, in fact,
   disrupt the existing genome in a random way. You have insertional mutagenesis
   every time you put a piece of DNA into these things.

   We heard, earlier, that you're putting in one gene; and, therefore, it's not
   a problem. But the problem underlying that is that that's not a surgically
   precise process. You're putting it randomly into the genome. Second of all,
   we don't know how that gene, once it's been put in, is going to interact with
   the other genes, and how the product is going to interact with the other
   biochemicals, biomolecules of that organism.

   So there are levels and levels of complexity, interactions, unpredictability
   that no one, even with a Ph.D. and 30 years of experience in plant science
   and molecular biology, could be able to predict the outcomes of those things.
   Without the ability to predict the outcomes, we need to have a program for
   assessing the outcomes in terms of safety. And that's not -- that's what is
   not in place now.

   Now, what if that tomato had a toxin gene, a metabolic pathway induced
   unexpectedly due to the introduction of a gene? There are tens of thousands
   of metabolites that are produced in any tomato. And we wouldn't have any idea
   which one of those has been altered in its levels, which gene was altered,
   therefore giving rise to that altered thing. And without knowing what it is,
   we can't do the kinds of chemical tests, chemically-based tests, that are now
   recommended by the FDA. We can't choose which test to do. And the basic
   principle in science is that you find what you're looking for. If you don't
   do an assay for the toxin, or other problem that's there, you can't detect
   it. Therefore, what we need is to use biological testing systems, long-term,
   short-term. Not only animal, if we need to do that, but also human. Because,
   in fact, there are no animal models that are appropriate and effective for
   assessing allergenicity. There is not such a model, and there's no chemical
   model that could be used. Therefore, the only way we can assess the
   allergenicity of a novel product of this sort is by doing human testing. If
   we haven't' done that, we haven't assured ourselves that novel allergens
   aren't present.

   The work that was done in the UK with potatoes, a lectin gene was put into
   potatoes. Before that gene was selected for use, years of research had been
   done showing that, when you isolate that protein, that lectin, from its
   natural source, it's not toxic to human beings. Therefore, there should be no
   problem when you put it into a potato. And we were working with a food that
   was not, quote, "toxic" in an acute sense, either. So what they did was to
   put a gene, a "safe gene," into a safe food, and they came up with a product
   that was, in fact, hazardous to rats and, we assume, probably hazardous to
   human beings, too.

   So this illustrates that there's room in the system for unpredicted side
   effects to come up. Given the existence of those, how can we do anything
   other than do testing that's broad enough to assess the full range of
   unpredictable side effects? And, really, the only way to cast a broad enough
   net to do that is to do biological testing, where you're using the organism
   itself, and it's biological processes as the detection system for these
   things. These are challenging experiments to do. They take longer than to do
   a lab test. But without that, we are not protecting the American people.

Quoting from coments of Walter Epp submitted to FDA December 1999:
   If a toxic chemical escapes into the environment, there is a fixed amount of
   toxicity which has a limit to the amount of damage it can do.
   If self-reproducing genes escape, they can have a population explosion and
   irreversibly cause unlimited damage into the indefinite future.
   Regulation to deal with this simple fact of life must obviously be far more
   stringent, comprehensive, and precautionary; whether or not FDA implements it
   will tell us whether it is serving the interests of the public or the
   biotech industry.

For more details on the special risks of genetic engineering, read the book
Genetic Engineering by Mae-Wan Ho, geneticist and biophysicist at Open
University in the UK, and the literature cited in its 53 pages of references.

Walter Epp
281 Jayne #311, Oakland, CA 94610

---
Walter Epp    for7gen@idiom.com