"System Failure: Abort and Retry"
Statement of Mark Lipson
Policy Program Director
Organic Farming and Research Foundation
Food and Drug Administration, Public Hearing on "Biotechnology in the Year
2000 and Beyond"
December 13, 1999
[Federal Register Docket# 99N-4282]
The Organic Farming Research Foundation is a producer-directed organization
dedicated to the improvement and adoption of organic farming methods. As
analysts of U.S. policy for food and agricultural issues, we appreciate the
opportunity to comment on FDA's policies and performance regarding
We are not categorically opposed to every use of "bioengineering" in
agriculture, but OFRF believes that the federal government has fundamentally
failed to provide an adequate regulatory regime for transgenic technologies
and products. In particular, the division of responsibilities among FDA,
and USDA ensures that there is no comprehensive, public interest oversight
governing the release of transgenic organisms into the environment and the
food supply. The environmental, agricultural, food safety and food security
issues cannot be considered in isolation from each other, and sound public
policy cannot be formulated or implemented in such a fragmented system.
Furthermore, under the existing regulatory framework there is no definite
point of accountability for the consequences of this regulatory failure.
There is nobody ultimately in charge except the biotechnology industry
itself. The Administration should immediately begin the process of
new, comprehensive regulatory process, with extensive participation from
consumers, farmers and the public interest community. Unless and until a
regulatory system is in place, a moratorium on all transgenic food and
agricultural applications should be imposed.
Regarding the six specific issues posed by FDA in its Federal Register
for this meeting, we have the following comments.
- [Has FDA's consultation process achieved its intended purpose? Based on
experience to date, should this regulatory approach ``sunset,'' continue in
its current state, be made mandatory, or otherwise be revised?] FDA's
so-called "consultation process" has failed to assure public safety and it
has helped to undermine confidence in the products of U.S. agriculture. The
process should be scrapped immediately and reformulated in the context of a
new, unified regulatory system.
- [What newly emerging scientific information related to the safety of
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?]
There is substantial new information related to the safety of
foods, as well as old information that the agency has apparently ignored.
New information includes emerging knowledge of the massive and ubiquitous
effects from transgenic plants in the agricultural environment and livestock
physiology. These effects may indeed have important implications for food
safety and they have not been recognized by any U.S. regulatory agency.
Mandatory pre-market safety testing must be based on the actual transgenic
product, as used in the real world and as consumed by real people and
animals. In addition to the requirement for real-world pre-market testing,
there must be much more rigorous controls on the transparency and
of the testing that is done.
- [What types of food products derived from bioengineered plants are
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
The powerful and uncertain qualities of current and planned transgenic food
"events" demand a complete overhaul of the governmental approach to safety
testing and agency oversight, as we have stated.
"Public Information Issues:"
- [Should FDA's policy requiring labeling for significant changes,
changes in nutrients or the introduction of allergens, be maintained or
modified? Should FDA maintain or revise its policy that the name of the new
food be changed when the common or usual name for the traditional
no longer applies? Have these policies regarding the labeling of these foods
served the public?]
FDA's labeling policy has failed to serve the public interest. The failure
to require labeling is imposing unacceptable costs and risks on the farmers
and manufacturers who do not wish to have anything to do with transgenic
foods. We are bearing the demand of consumers to know what is in their
food. The public has a right to require labeling of transgenic content in
their foods, and the government must implement this in a way that
unequivocally places the costs and liabilities on the patent-holders and
- [Should additional information be made available to the public about
derived from bioengineered plants? If so, what information? Who should be
responsible for communicating such information?]
All data and background information related to safety, efficacy, use and
in the environment of transgenic food products and ingredients must be
provided by the product developers and made available to the public. In
addition, FDA must go out of its way to document and explain all information
about the regulatory actions of the agency, including conflict-of-interest
recusals by the numerous FDA personnel who have worked in the biotechnology
- [How should additional information be made available to the public: e.g.,
on the Internet, through food information phone lines, on food labels, or by
FDA should use every means at its disposal to distribute information to the
public, and it must also make a much stronger effort to include the
its decision-making. Above all it must heed what it is hearing from
consumers and contribute to overhauling the entire regulatory system for
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