AGRICULTURAL RESOURCES CENTER
PESTicide EDucation Project
115 West Main Street, Carrboro, North Carolina 27510
Phone /FAX 919/967-1886
October 18, 1995
Docket No. 95-040-01
Regulatory Analysis and Development PPD
Suite 3C034700 River Road, Unit 118
Riverdale, MD 20737-1238
By U.S. Mail and E-mail
Please accept these comments on proposed changes by the U.S.
Department of Agriculture, Animal and Plant Health Inspection Service
(USDA/APHIS) biotechnology program. The proposed new rule was announced
on August 22, 1995 (Federal Register 60:43567-73). We understand that
comments are due by October 23.
The Agricultural Resources Center is a private, non-profit
educational organization based in Carrboro, North Carolina. Since 1986,
ARC's Pesticide Education Project (PESTed) has been interested in the
potential impact of biotechnology on agriculture, the environment, and
public health and has commented on numerous applications for
environmental releases of genetically engineered organisms to the USDA
and the State of North Carolina.
ARC/PESTed is concerned about the substance and the timing of the
proposed rule. It would essentially deregulate field testing and
commercialization of genetically engineered crops and virtually eliminate
risk assessment of field trials of transgenic crops. The proposed rule
would exempt almost all transgenic plants from the current permitting
process, exempt most viral genes from risk assessment, end the
requirement for companies to submit reports to USDA on field trials, and
expedite commercialization of crop varieties "closely related" to
varieties already approved for commercialization. Notification proposed
is no substitute for the current process, which despite significant
shortcomings, is valuable and offers the possibility of controlling high
risk releases. The new proposal also leaves undefined important terms
such as what would constitute a "closely related" variety. The lack of
scientific justification for the proposed changes is also a major concern.
ARC/PESTed believes that the proposal should be substantially
revised to protect the environment from potential risks of genetically
engineered crops. Specifically, we recommend the following:
A. TRANSFER TO WEEDY RELATIVES: USDA should require risk assessments
and permits for all plants which have wild relatives with which they can
interbreed. Flow of new genes from transgenic crops to wild relatives
may present serious ecological risks that should be evaluated before
testing is allowed. Under the proposed changes, sunflowers, a native
plant with many wild relatives in the United States and engineered to
produce insecticidal toxins, could be tested on thousands of acres
without undergoing a risk assessment.
B. VIRAL GENES: USDA should require risk assessments and permits for
all viral genes. Little is known about the ecological implications of
viral genes engineered into plants.
C. REPORTING: USDA should continue to require companies to submit
reports on field tests they have conducted. This information is critical
to the public's ability to assess the safety of field testing in this
country. Failure to learn from experience only increases the chances of
ill effects from future releases.
D. NARROWLY DEFINE "CLOSELY RELATED" SPECIES: USDA should not expedite
the commercial approval of plant varieties "closely related" to varieties
previously commercialized. This provision potentially opens a huge
loophole for companies to avoid risk assessments of new crop varieties
once they have obtained approval of one variety.
E. PROVIDE JUSTIFICATION FOR CHANGES: USDA should provide a basis,
including data and scientific publications, to justify the sweeping
deregulatory proposals published August 22.
ARC/PESTed is also very concerned about the timing of the
proposed new rule and its effect on the states. North Carolina decided
earlier this year to allow its state program of review of proposed
environmental releases of genetically engineered organisms to "sunset" on
September 30, 1995. It did so in large part because of assurances that
the Federal review by USDA/APHIS of such releases was adequate. The
proposed new rule, which virtually deregulates most releases, underscores
the necessity for state and local oversight in the absence of effective
Federal review. While we recognize that few states have thus far chosen
to establish state oversight of environmental releases of genetically
engineered organism's, the vast reduction in the scope of Federal
oversight proposed appears to make such programs prudent and necessary.
The timing for North Carolina couldn't have been worse.
Based on what we know about genetically engineered crops, any
move for such sweeping deregulation of environmental releases is
premature and unwise. We urge that it be reconsidered.
Thank you very much for your consideration of these comments.
Please keep me informed of future developments regarding this proposal.