=93SYSTEM FAILURE: ABORT AND RETRY.=94
O.F.R.F. CALLS FOR OVERHAUL OF THE U.S. REGULATORY SYSTEM FOR BIOENGINEER=
ED
FOODS
Testimony of Mark Lipson, Policy Program Director
Organic Farming Research Foundation
PO Box 440, Santa Cruz CA 95061
831-426-6606; mark@ofrf.org, www.ofrf.org
Food and Drug Administration, Public Hearing on =93Biotechnology in the Y=
ear 2000
and Beyond=94
Oakland CA, =20
December 13, 1999
[Federal Register Docket# 99N-4282]
The Organic Farming Research Foundation is a producer-directed organizati=
on
dedicated to the improvement and adoption of organic farming methods. As
analysts of U.S. policy for food and agricultural issues, we appreciate t=
he
opportunity to comment on FDA=92s policies and performance regarding
=93bioengineered foods.=94
We are not categorically opposed to every use of =93bioengineering=94 in
agriculture, but OFRF believes that the federal government has fundamenta=
lly
failed to provide an adequate regulatory regime for transgenic technologi=
es and
products. In particular, the division of responsibilities among FDA, EPA=
and
USDA ensures that there is no comprehensive, public interest oversight
governing the release of transgenic organisms into the environment and th=
e food
supply. The environmental, agricultural, food safety and food security i=
ssues
cannot be considered in isolation from each other, and sound public polic=
y
cannot be formulated or implemented in such a fragmented system. =20
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. Th=
e
Administration should immediately begin the process of forging a new,
comprehensive regulatory process, with extensive participation from consu=
mers,
farmers and the public interest community. Unless and until a new regula=
tory
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 no=
tice
for this meeting, we have the following comments.=20
=93Scientific/Safety Issues:=94
1. [Has FDA's consultation process achieved its intended purpose? Based o=
n
experience to date, should this regulatory approach ``sunset,'' continue =
in its
current state, be made mandatory, or otherwise be revised?] FDA=92s so-ca=
lled
=93consultation process=94 has failed to assure public safety and it has =
helped to
undermine confidence in the products of U.S. agriculture. The process sh=
ould
be scrapped immediately and reformulated in the context of a new, unified
regulatory system.
2. [What newly emerging scientific information related to the safety of f=
oods
derived from bioengineered plants is there, if any? Are there specific te=
sts
which, if conducted on such foods, would provide increased assurance of s=
afety
for man or animals consuming these foods?]
There is substantial new information related to the safety of =93bioengin=
eered=94
foods, as well as old information that the agency has apparently ignored.=
New
information includes emerging knowledge of the massive and ubiquitous eff=
ects
from transgenic plants in the agricultural environment and livestock
physiology. These effects may indeed have important implications for foo=
d
safety and they have not been recognized by any U.S. regulatory agency.=20
Mandatory pre-market safety testing must be based on the actual transgeni=
c
product, as used in the real world and as consumed by real people and ani=
mals.=20
In addition to the requirement for real-world pre-market testing, there m=
ust be
much more rigorous controls on the transparency and objectivity of the te=
sting
that is done.
3. [What types of food products derived from bioengineered plants are pla=
nned
for the future? Will these foods raise food safety issues that would requ=
ire
different approaches to safety testing and agency oversight? If so, what =
are
those approaches?]=20
The powerful and uncertain qualities of current and planned transgenic fo=
od
=93events=94 demand a complete overhaul of the governmental approach to s=
afety
testing and agency oversight, as we have stated. =20
=93Public Information Issues:=94
1. [Should FDA's policy requiring labeling for significant changes, inclu=
ding
changes in nutrients or the introduction of allergens, be maintained or
modified? Should FDA maintain or revise its policy that the name of the n=
ew
food be changed when the common or usual name for the traditional counter=
part
no longer applies? Have these policies regarding the labeling of these fo=
ods
served the public?]=20
FDA=92s labeling policy has failed to serve the public interest. The fai=
lure 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 food=
s. We
are bearing the demand of consumers to know what is in their food. The p=
ublic
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 cos=
ts and
liabilities on the patent-holders and their licensees.
2. [Should additional information be made available to the public about =
foods
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 =
fate
in the environment of transgenic food products and ingredients must be pr=
ovided
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 sector.
3. [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=
other
means?]=20
FDA should use every means at its disposal to distribute information to t=
he
public, and it must also make a much stronger effort to include the publi=
c in
its decision-making. Above all it must heed what it is hearing from cons=
umers
and contribute to overhauling the entire regulatory system for =93bioengi=
neered=94
foods.
=20
# # #
Organic Farming Research Foundation
Mark Lipson, Policy Program Director
ph: 831-426-4006 or -6606; fax: 831-426-6670
PO Box 440, Santa Cruz, CA 95061
<http://www.ofrf.org/policy/index.html>
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O.F.R.F. CALLS FOR OVERHAUL OF THE U.S. REGULATORY SYSTEM FOR
BIOENGINEERED FOODS
Testimony of Mark Lipson, Policy Program Director
Organic Farming Research Foundation
PO Box 440, Santa Cruz CA 95061
831-426-6606; mark@ofrf.org,
www.ofrf.org
Food and Drug Administration, Public Hearing on =93Biotechnolo=
gy
in the Year 2000 and Beyond=94
Oakland CA,
December 13, 1999
[Federal Register Docket# 99N-4282]
We are not categorically opposed to every use of =93bioengineering=94 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, EPA 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 forging a new, comprehensive regulatory
process, with extensive participation from consumers, farmers and the
public interest community. Unless and until a new 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 notice for this meeting, we have the following comments.
=93Scientific/Safety Issues:=94
1. [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=92s so-called =93consultation process=94 has fai=
led 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.
2. [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?]
There is substantial new information related to the safety of
=93bioengineered=94 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 objectivity of the
testing that is done.
3. [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 those approaches?]
The powerful and uncertain qualities of current and planned
transgenic food =93events=94 demand a complete overhaul of the government=
al
approach to safety testing and agency oversight, as we have stated.
=93Public Information Issues:=94
1. [Should FDA's policy requiring labeling for significant
changes, including 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 counterpart no longer applies? Have these policies regarding
the labeling of these foods served the public?]
FDA=92s 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 their licensees.
2. [Should additional information be made available to the
public about foods 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 fate 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 sector.
3. [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 other means?]
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 public in its decision-making. Above all it must heed what it
is hearing from consumers and contribute to overhauling the entire
regulatory system for =93bioengineered=94 foods.
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