Position Statement
Genetically Modified Organisms

Background

Since 1992, the Federal Drug Administration (FDA) has approved the
introduction of several genetically modified organisms (GMOs) into the
agricultural supply of the United States. The FDA has concluded that
genetic modification of plants, animals, and microorganisms does not
represent a significant change from traditional breeding techniques.

Contrary to the opinion of the FDA, the creation of novel plant and
animal gene combinations utilizing biotechnology is unprecedented in the
known history of species interactions on this planet. By definition, the
taxonomic unit called "species" is the level at which genetic exchange
occurs. Current biotechnological applications now regularly create novel
genetic combinations across the level of kingdom. Such changes to
genomes never occur outside of the laboratory.

The introduction of genetically modified organisms has significant
unavoidable adverse environmental impacts as defined under both the
National Environmental Policy Act (NEPA) and the California
Environmental Quality Act (CEQA). Possible impacts to native species
include:

1)      The introduction of new genotypes into native plant populations by
cross-pollination among analogous species. Agricultural species in the
Santa Cruz area that have native analogues include wild strawberry
(Fragaria sp.) and Douglas fir (Pseudotsuga menziesii).
2)      Negative impacts to fauna associated with plant species, such as
pollinators.
3)      Development of new weeds among species that no longer experience
herbivory due to poisons (such as Bt toxin) introduced into plants.
4)      Development of herbicide resistant weeds.
5)      Increased use of herbicides on genetically modified plant varieties
(such as Round-up Ready soybeans).

Several scientific studies have documented the dangers of GMOs.
However, there has been no formal environmental review of the ecological
effects of GMOs in the environment. Such review is required under both
NEPA and CEQA.

Position

It is the position of the Santa Cruz County Chapter of the California
Native Plant Society that the introduction of genetically modified
species should be halted immediately until a full environmental review
has been conducted by the appropriate federal and state agencies.
Appropriate federal and state agencies should perform reviews on
individual releases and on the broad issue of releases (i.e. a
programmatic EIS). The programmatic EIS should include a contingency
plan that addresses unexpected/unforeseen negative consequences of the
release of GMOs.

Adopted by the Board by Unanimous Vote on 1/10/00

________________________________________________________

Department Of Health And Human Services,
Food and Drug Administration
Dockets Management Branch (HFA-305),
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

RE: Docket No. 99N-4282
13 January 2000
To Whom It May Concern,

This letter is in response to the notice of Public Meetings entitled
Biotechnology in the Year 2000 and Beyond listed in the Federal Register
on October 25, 1999 (Volume 64, Number 205, Page 57470-57472). This
issue is referred to in the Federal Register as Docket Number 99N-4282.
As I was unable to attend any of the public hearings, I request that my
written comments be included as a part of the public record on this
topic. I also request that I be included in any mailing lists maintained
by FDA concerning Genetically Modified Organisms (GMOs).

On behalf of the over 300 members of the Santa Cruz County Chapter of
the California Native Plant Society (CNPS), I am writing to express our
concerns over the decision by FDA to allow the release of GMOs into the
environment. The California Native Plant Society is a scientific society
dedicated to research, education, and protection of California's native
flora.

The failure by FDA to recognize the historically unprecedented changes
that are being made to plants, animals, and microorganisms at a
molecular level has led to the largest and most unpredictable scientific
experiment ever instituted by our species. Because FDA has failed to
adequately assess the risks associated with the introduction of
genetically modified organisms into the environment, FDA is in violation
of the National Environmental Policy Act (NEPA). For this reason, the
Santa Cruz County Chapter of CNPS requests that FDA immediately halt all
introduction of new species varieties that are derived from
non-traditional breeding techniques until a full Environmental Impact
Statement (EIS) is finalized in accordance with NEPA that evaluates the
ecological impacts of biotechnological changes to plant and animal
species

The Statement of Policy: Foods Derived From New Plant Varieties
published in the Federal Register May 29, 1992 (Vol. 57, No. 104, pages
22984 - 23005)[Referred to in this letter as FR 5/29/92 and incorporated
by reference] is based on the false assumption that genetically modified
organisms are analogous to varieties bred by traditional breeding
techniques. Page 22984 states "Under this policy, foods …. developed by
the new methods of genetic modification are regulated …. utilizing an
approach identical in principle to that applied to foods developed by
traditional plant breeding."  In fact, most of the FDA educational
material published about the genetic modification of organisms refers to
biotechnology as being simply an extension of traditional breeding
methods. (Safety Assurance of Foods Derived by Modern Biotechnology in
the United States, U. S. Food and Drug Administration, Center for Food
Safety and Applied Nutrition, July 1996
http://vm.cfsan.fda.gov/~lrd/biojap96.html, incorporated by reference;
and Genetic Engineering Fast Forwarding To Future Foods, revised
February 1998, http://www.fda.gov/bbs/topics/CONSUMER/geneng.html,
incorporated by reference).

Contrary to the FDA opinion, the creation of novel plant, animal, and
microorganism gene combinations utilizing biotechnology is unprecedented
in the known history of species interactions on this planet. By
definition, the taxonomic unit called "species" is the level at which
genetic exchange occurs. There are several examples of successful
hybridization within the taxonomic level of  "genera", but I know of no
successful genetic exchange above the level of "family". Even if such
exchanges occur (such as due to viruses), they are extremely rare.
Current biotechnological applications now regularly create novel genetic
combinations across the highest level of organisms, kingdom. Such an
exchange of genotypes would never occur in nature. Only in the highly
unnatural setting of a molecular biology laboratory can such changes
occur readily.

The Santa Cruz County Chapter of CNPS recognizes the following potential
significant environmental effects from the introduction of GMOs into the
environment.

1) The introduction of new genotypes into native plant populations by
cross-pollination among analogous species.
There is a strong case for the potential that genetically modified (GM)
food crops will pollute native plants in the event that they are planted
in areas where native analogues are found. For instance, FDA has
approved several varieties of genetically modified corn in the last
several years. The species from which agricultural corn was hybridized
has a range that extends from the southwestern United States to South
America. When GM crops are planted near these native species, there is a
high risk that transference of genetic material will occur, which can be
considered pollution of the native genetic stock. Yet, there are no
safeguards in the system to forestall this negative environmental
impact. (see The Ecological Risks of Engineered Crops - Comprehensive
look at the potential risks of genetically engineered crops, including
recommendations on how the federal government can evaluate and mitigate
those risks,  Jane Rissler and Margaret Mellon, MIT Press, 1996. 192
pp.) [incorporated by reference]

2) Negative impacts to fauna associated with plant species, such as
pollinators.
The potential for transgenic plants to negatively impact non-target
species has been scientifically documented. The May 1999 issue of the
renowned journal Nature contained an article that indicated that the
pollen from transgenic corn had a significant negative impact on the
growth and survival of monarch butterflies. This issue alone provides an
ecological impact significant enough to warrant review of FDAs policy
under NEPA. (See J.E. Losey, et. al., "Transgenic pollen harms monarch
larvae," Nature 399:214, May, 1999; and The Royal Society, "Genetically
Modified Plants for food use", 1998,
http://www/royalsoc.ac.uk/st_pol40.htm)[both articles incorporated by
reference]

3) Development of new weeds among species that no longer experience
herbivory due to poisons (such as Bt toxin) introduced into plants.
Herbivory by insects may be an important mechanism in keeping some
species from becoming invasive. However, the introduction of genes that
confer resistance to insects (such as Bt toxin) may allow some plant
species to develop resistance to herbivory, causing them to become
weeds. This is true not only of particular crop species themselves, but
also the native analogues of crop species found in the natural
environment with which transgenic species might cross-pollinate. (While
many of the articles referenced in this letter discuss the likelihood of
genetic pollution due to cross-pollination, I know of no article that
looks at the effects of decreased herbivory on plant invasiveness.)

4) Development of herbicide resistant weeds.
A related issue is the development of herbicide resistant weeds through
the transference of genetic material. For instance, it is conceivable
that the Monsanto Corporation would one day develop a "Roundupâ ready
radish". Here in Santa Cruz County, wild radish is considered an
invasive exotic species that is a threat to native ecosystems. One of
the methods utilized by habitat restorationists to control wild radish
is using Roundupâ. However, if the gene which confers the "Round-up
ready" trait were to be transferred to wild radish, the weed could
conceivably become impossible to control without the use of even more
poisonous herbicides.
(T.R. Mikkelsen et. al., "The risk of crop transgene spread", Nature
380: 31, 1996,; A.F Raybould, A.J. Gray, "Will hybrids of genetically
modified crops invade natural ecosystems?", Trends in Ecology and
Evolution, 9: 85 - 89, 1994) )[both articles incorporated by reference]
 

5) Increased use of herbicides on genetically modified plant varieties
Herbicides represent a risk not only to environmental health but to
human health as well. Even Glyphosate (the active ingredient in
Roundupâ) is poisonous at sufficient levels. The surfactant found in
Roundupâ is even more toxic to animals that the active ingredient. The
approval, by FDA, of GMOs that are "Roundupâ ready" means that even more
herbicide will be applied in agricultural systems. This would have many
significant environmental impacts on natural ecosystems found adjacent
to agricultural systems. (See Union of Concerned Scientists, Fact sheet:
Risks of Genetic Engineering,
http://www.ucsusa.org/biotechnology/index.html ; Royal Society, 1998,
referenced in #2 above) [incorporated by reference]
 

Because the FDA has used FR 5/29/92 to define GMOs as being
qualitatively the same as species produced by traditional breeding
techniques, FDA has failed to recognize the serious negative
environmental impacts that may occur as GMOs are released into the
environment. However, as is clearly stated above, there are in fact
several significant environmental impacts, both possible and proven,
associated with biotechnology. Since FDA has taken it upon itself to be
the proper federal agency to approve the release of GMOs, it is the role
of FDA to guarantee that the proper analysis is performed in relation to
the action of approving these novel species.

NEPA requires federal agencies to analyze and disclose the environmental
impacts on all projects, prior to making a decision on how to implement
a project. 40 CFR 1501.4 dictates the process that determines whether a
full EIS or an Environmental Assessment is required, or whether a
Finding of No Significant Impact (FONSI) is sufficient.  Given the
number and severity of significant environmental impacts associated with
the introduction of GMOs into the environment, a full EIS is warranted
in this case. Although FDA has allowed the release of several species of
GMOs into the environment, to date no documentation as required under
NEPA has been developed for public comment. For this reason, FDA is out
of compliance with NEPA in regards to GMOs.

Therefore, it is the position of the Santa Cruz County Chapter of the
California Native Plant Society that the introduction of genetically
modified species should be halted immediately until a full environmental
review has been conducted by the appropriate federal agencies.
Appropriate federal agencies should perform reviews on individual
releases and on the broad issue of releases (i.e. a programmatic EIS).
The programmatic EIS should include a contingency plan that addresses
unexpected/unforeseen negative consequences of the release of GMOs.

Thank you for considering my comments.
 
 
 

Joe Rigney
Co-chair, Conservation Committee
California Native Plant Society, Santa Cruz County Chapter
PO Box 8098
Santa Cruz, CA 95061

Cc:
President Bill Clinton, United States President
Senator Barbara Boxer, United States Senate
Senator Diane Feinstein, United States Senate
Representative Sam Farr, United States House of Representatives
Representative Tom Campbell, United States House of Representatives
Governor Gray Davis, California Governor
Senator Bruce McPhersen, California State Senate
Assemblyman Fred Keeley, California State Assembly
Mardi Wormhoudt, Santa Cruz County Board of Supervisors
Jeff Almquist, Santa Cruz County Board of Supervisors
Jan Beutz, Santa Cruz County Board of Supervisors
Tim Fitzmaurice, Santa Cruz City Council
Kieth Sugar, Santa Cruz City Mayor
United States Environmental Protection Agency