"science-based" regulation by FDA, EPA, USDA

From: Twittman@aol.com
Date: Sat Feb 26 2000 - 14:21:50 EST


Hi Sanet Folks,
  Stanislaus J. Dundon who is the Coordinator, Soul of Agriculture Project in
Davis, California has asked me for help preparing for an address to the
agbiotech community on March 6th. I wonder if any of you might be able to
give him a few ideas or sources of information? His email address is
sjdundon@davis.com . Below is the text from a letter he wrote to me and many
of the sustainable ag folks here in California.

Thank you,
Thomas Wittman

>> I am dismayed that elements within the biotech industry are not only
letting intemperate remarks about "junk science" escape from their mouths
but that some are making deliberate efforts to attack serious scientific
work.
    Nevertheless, as an ethicist who is asked to teach something or other, I
have to assume I am speaking to someone who wants to do the right thing.
Police are needed for the others, not ethicists.
    So what I am appealling for from all who receive this letter is help in
making my case pursuasive as I speak to well intentioned members of the
agbiotech community on March 6th. I have focuses on one item and that is
that the main hope of agbiotech both to do good and to be trusted by the
public in that effort is a proper use of incomplete science in doing their
applied work and in communicating it to the public. If everyone's "science"
[i.e. scientific work which is far from complete] is regarded as so
partisan as to be unworthy of serious response, the companies themselves
will have no hope of regaining public trust.
    The agbiotech community makes frequent reference to the "science-based"
regulation by FDA, EPA, USDA to which their products are subjected. This is
a good move on their part because their private "science" will be as little
trusted as they are without the some objective review. The liberal policy
of the EPA, under FIFRA, to allow the companies or their contracted labs do
their safety testing but allowing the EPA to review the work, and also to
have the animal feeding slides stored in a public repository for
examination by competent pathologists (Tracor-Jitco, I believe) was a kind
of openness. But the studies themselves were treated as proprietary
information since they were so immensely expensive and could be used by
rival manufacturers if fully public.
    However there is no such agreed upon way for the public to know what kind
of science is being done or has been done privately or by the agencies
noted above. In order for me to make the point that this has to change, I
need the best evidence about the actual facts about which there is such
radical disagreement. This is what I know so far.

FDA has had 40 voluntary consultations. FDA is doing no "required" testing
of GMOs on its own, but retains a vague right to call for tests if some
suspicion of allergic potential shows up.

FDA claims that other tests dealing with novel field crops are required by
the USDA. My information is that no such tests are REQUIRED, and few
breeders do tests beyond what is commerically relevant to continued sales
(yield, pest resistance, appearance). Intricate testing of comparable
nutrient status are not required of conventional breeders and both the FDA
and, to a lesser extent, USDA claim that nothing should be required of GMO
novelties than of convention novelties.

USDA: I don't know what they routinely do which could be called a
scientific safety test. They sponsor yield tests for new varieties and some
have been done. Round-up Ready Soys on a gross basis look o.k. But Monsanto
will not make isogenetic matched pairs of seeds (same pedigree except for
the GM gene) available for field testing. USDA does not have the power to
demand it.

EPA: Bt-expressing crops are being treated as pesticides and are getting
some of the scientific review which EPA traditionally required. I
personally believe that EPA needs to review the literature already
reporting the health and environmental risks of glyphosate more seriously

This is not a whole lot and a call for more work would seem to be in
everyones favor. Some of the companies are beginning to talk to critics and
be more open. Monsanto needs to come along with them.

Who can tell me where to go to get hard data on government required testing
of GMOs? URLs, please if possible, also note my toll free number below.

I insert below the conclusion of my talk as planned.
    For those of you who know me in my role as national Coordinator of the
Soul of Agriculture Project, I would like you to see this talk to the
industry as part of my duties. The reason is the following. Family farmers
(managers or owners) in asking for the support of many constituencies
implicitly (and explicitly, if Soul of Ag is successful) promises to
consumers and environmentalists that they will do all in their power to
produce healthy food in a sustainable manner which will not damage nature
in its beauty and variety in any avoidable way, nor will they sponsor a
form of agriculture which will make food or farming less accessible to the
poor of the world. Family farmers will not be able to make that promise if
they have no reliable scientific knowledge about the nutritional, toxicity,
and environmental impacts of the crops they grow. In our meetings many
farmers have already supported labelling, but due to the likelihood of
uncontrollable outcrossing many have expressed concern that labelling may
become meaningless. We need more than labelling, we need detailed
knowledge, not sweeping assurances, to be able to make the promise
indicated above (See www.soulofag.org)
    BIOTECHNOLOGY COMMUNICATIONS WORKSHOP, UC DAVIS
                MAR. 6, 2000
(Concluding remarks of Stan Dundon on the Ethics and Values at Risk
in the communication practices in biotechnology)

Based on what I have laid out above, it appears clear that the applied
biotechnology community considers the restoration of public trust in the
safety of their products and the scientific soundness of their processes to
be a high priority.
    I am in agreement with this goal and wish to further emphasize the common
sense certitude that the elements which can restore trust are threefold:
1.) Trustworthy policies and actions
2.) Confirmation of that trustworthiness by independent, competent reviewers.
3.) Cultivation of open communication with reasonable critics.

I have taken you time this morning to try to make clear how much harm could
be done to all of the three elements if the requirements of good
"science-in-the-making" are not met by all stake-holders. One of my major
claims is that a "harmful side effect" of the recent communication
practices is so serious that it could, if not avoided, destroy all three
elements. That side effect is the creation in the public mind of an
"anti-science conviction." This conviction would take the form of a belief
that there is no such thing as incomplete scientific work which deserves
serious consideration by policy makers or the public/consumers.

To safeguard the three elements noted and based on my earlier remarks I
suggest the following tasks. [Since I am talking to developers and users of
biotechnology I will not explicitly lay out the similar tasks which your
critics might take on.]

I.) Trustworthy policies and actions: Make sure your scientists and
technical staffs feel free to discuss with each other and managers any
cautionary information or opinion which their work and experience suggest
as important. In collaborative projects with academic scientists, openly
cultivate the discussion of the distinct problems which genetic engineering
may pose for farmer, environmental and consumer concerns. Do not fail to
consider the poorest of the poor farmers and consumers in this discussion.

II.) Confirmation of that trustworthiness by independent, competent
reviewers.
        As current biotech community communications make clear this
confirmation
is seen as critical. One does not win trust by simply asking for it.
Continual appeal to the "science-based" regulatory actions of the FDA, EPA,
and USDA shows how common-sense this need for reviewers is. Be extremely
careful, then, in not using carelessly the name of these agencies or of the
"science" they use, collect or practice. Go to the source, get documented
lists of the scientific tests which any of these agencies have done,
required, overseen and have made available for public review. Make sure
that any FIFRA-type constraints on this public review are not so severe as
to make "science" into a candidate for "pseudo-science". [Secrecy is one of
the prime signs of pseudo-science.]
    Advocate and, if necessary, publicly funded independent scientific work in
universities or in the three government agencies on any issue of
significant public or scientific concern. Do not oppose too quickly calls
for a regulation calling for regular safety and efficacy testing of your
novel products.

III. Cultivation of open communication with reasonable critics
    This cultivation has been resumed by some of your community and is
critical for the work of science. Do not dismiss critics' work as
junk-science, but show where it is wrong in detail, if it is. Face their
arguments and respond with serious scientific work of your own. Do not
engage in sweeping statements which ignore detailed objections by critics.
Don't claim to be infallible, nobody is, and nobody believes industry is
either. Only the patient and non-hasty working of the filtering process of
the scientific community will produce truly solid conclusions. [See Henry
Bauer's book "Scientific Literacy and the Myth of the Scientific Method"]

REMEMBER IF YOU DESTROY THE REPUTATION OF SCIENCE YOU WILL HAVE NO WAY OF
REGAINING PUBLIC TRUST.

Stanislaus J. Dundon
Coordinator, Soul of Agriculture Project
P.O. Box 72084, Davis CA. 95617
Home Phone 530-756-9679 Toll Free 1-888-393-4047, pin 3903
Office (Community Alliance with Family Farmers, CAFF) 530-756-8518 ext 31
Fax 530-756-7857. Toll Free to Dundon at CAFF 1-888-393-4047, pin 7183, ext
31

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