September 11, 2007
Docket No. APHIS-2006-0112
Regulatory Analysis and Development
4700 River Road Unit 118
Riverdale, MD 20737-1238.
RE: [Docket No. APHIS-2006-0112] RIN 0579-AC31
To Whom It May Concern:
The Organic Trade Association (OTA) thanks APHIS for the opportunity to comment on this notice of availability of draft environmental impact statement, "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering."
As APHIS is probably aware the National Organic Standards promulgated and enforced by the National Organic Program (NOP) staff of the Agriculture Marketing Service (AMS) of USDA do not permit organic growers to use genetically engineered seed to grow certified organic products. However, organic growers do report occasional pollen drift onto organic crops. This incidence of genetically engineered pollen and contamination can lead to major problems for organic farmers and processors as they try to prevent any incidence of genetically modified material in organic products.
While OTA appreciates that APHIS requires that all plants genetically engineered to produce pharmaceutical or industrial compounds be grown under extremely strict management protocols, with these plants required to be grown in a way that maintains confinement of the plant to the release area, with additional precautions taken to prevent the escape of pollen, seeds, or plant parts from the field test site, OTA nonetheless believes that APHIS should revise its regulations regarding the importation, interstate movement, and environmental release of genetically engineered organisms (GEOs).
The OTA Board adopted the following statement June 13, 2003 as part of its policy on GEOs:
OTA calls for a moratorium on GMOs in agriculture. This technology has the potential to cause unintended effects on the environment and on human health. More independent research and regulation are necessary before any more GMOs are allowed in the food system. As long as GMOs continue to be allowed, organic producers are at risk from background levels of GMOs. (See http://www.ota.com/pp/otaposition/geos.html.)
In the APHIS preamble to this notice APHIS indicated its rejection of a moratorium on GEO agriculture, and therefore, while OTA's Board of Directors would prefer that there be a moratorium on GEOs in agriculture, OTA has chosen to respond to the options APHIS has presented rather than remain entirely silent on the draft environmental impact statement. Therefore OTA is offering these comments in the context within which APHIS has written its notice.
As the recent experience with genetically modified rice (LibertyLink) demonstrated, vectors for the contamination of wild or domesticated crops are not as well understood as we would like. We are thus skeptical about how effectively the current regulation is being enforced, and request that APHIS consider that such previously deregulated genetically engineered organisms pose plant pest risks and should, therefore, be brought back under Agency oversight.
DEIS Issue 1 and 5-Scope of the Program
OTA commends APHIS for undertaking the review of GEO regulation. We agree that
given the rapid advances in biotechnology, the present scope of the regulations may not be of sufficient breadth to cover the full range of genetically engineered organisms and the full range of potential agricultural and environmental risks posed by these organisms, including risks to public health.
OTA also agrees that APHIS has very broad jurisdiction over GE plants, along with FDA and EPA. We support APHIS's regulation of genetically engineered plants that are noxious weeds, and further support APHIS' authority to require that questions of food safety be addressed through the regulatory process.
OTA believes that GEOs may become at least plant pests, especially in relation to organic production, which prohibits the use of GEOs as the primary means of minimizing GEO content in organically produced products. We do not believe that simply because organic farmers are not directly penalized in the U.S. for incidental contamination by GEOs, that this lack of penalty is a sufficient reason for discounting the damage done to the organic system, both agronomic and economic, as many foreign countries have stricter controls over GEOs. Organic companies, who have no reason to think they do not meet those other control targets, are then forced to undertake testing to determine whether their products have been contaminated-an indication that GEOs may indeed become noxious weeds.
Regarding event-based "versus" trait-based regulation, OTA is nor convinced that these two approaches are mutually exclusive, and suggests that APHIS use both methods in regulating GEOs. This is especially important while the science is still being refined, as the different approaches may produce different risk factors. That the science is still being refined may be demonstrated by APHIS' assertion that "[e]ach event can be genetically unique, even if the event results from a single transformation experiment in which many individual cells were treated under identical conditions." If the individual cells being treated are genetically the same, and the conditions are identical, each event should be the same as well. If the cells being treated are not the same, the experiment has unknown degrees of freedom and is therefore relatively rudimentary. Coupled with the understanding that one gene may not be linked simply to one trait, this quote shows some of the limits of scientific understanding of the processes involved, and argues for a combination of event-based and trait-based regulation.
Regarding the proposed exclusion from regulation of certain organisms based on risk, OTA notes that due to the unfolding understanding of genetic science, it would be unwise to automatically exclude any organism from regulation, though there might be varying degrees of regulation for various known classes of risk. As understanding develops, GEOs might move from class to class, but they should never be free from some regulatory oversight.
OTA further notes that consumers of organically produced products have consistently voiced their preference for food that does not contain products made from GEOs (see comments on the National Organic Program Proposed Rule of 1997). Therefore, we strongly support APHIS broadening the scope of its regulations to reflect its authority over noxious weeds and biological control organisms.
For Issue 1, OTA supports Alternative 3, "expand the scope of what is regulated by adding considerations of noxious weed risk and regulating GE biological control organisms in addition to plant risk. Use novelty of the trait in the species as the trigger for regulation," with the caveat that events and traits should be complementary, not competing, bases for regulation, hence the novelty of the trait in the species should not be the sole trigger for regulation. For Issue 5, OTA supports Alternative 3, "Regulate all nonviable GE plant material."
DEIS Issue 2-Transparent, Risk Based Permit System
OTA supports broadening and increasing the transparency of the regulations relating to risk as a means to clarify the issues. However, creating tiers, which are artificial aggregations, work against this end.
OTA especially supports broadening risk categories to include risks to the ecological system, both agro-ecological systems and the ecological system as a whole. This would include consideration of genetic drift into wild plants, cross-species genetic drift, and other ecological factors.
In the case of plant pesticides, particular attention should be given to the risk of pest resistance, which increases over time as pests are exposed to pesticides. The development of resistance may not be well enough understood scientifically to make definitive statements, but this is precisely why risk assessments should include this parameter. In a 2001 whitepaper, Susan C. MacIntosh, Product Safety Manager for Aventis, stated in a paper titled Unique Attributes of Cry9C (StarLink) Bt Help Assure Long-Term Viability of Bt in Crop Protection, "A possible threat to Bt arises from the potential development of insect resistance to Bt." This statement was used to justify the development of a new generation of Bt plants. If the biotech industry is not only concerned about the issue but planning for it, APHIS should also take the threat seriously and not use the lack of scientific understanding as a reason to dismiss concerns.
For Issue 2, OTA supports Alternative 2, "Abolish categories and treat all future proposals for the introduction of GE organisms on a case-by-case basis."
DEIS Issue 3-Nonregulated Status
While OTA welcomes APHIS's recognition that future development and commercialization of plants with less familiar traits may pose new challenges for the Agency because even a thorough and comprehensive assessment may not resolve all unknowns regarding an article proposed for deregulation, OTA does not believe any GEO should be completely deregulated. At the least, periodic scientific reports on all GEOs should be required to inform APHIS of any change in the literature regarding either the theory or the results of biotechnology knowledge and research. These reports would fulfill the requirements of due diligence for companies regarding products that have already been marketed, but about which new information may have been generated.
OTA also urges APHIS to either clearly detail the differences between major and minor risks through a public process, or compare the degrees of risks on a spectrum without categorizing any particular risk as major or minor.
In addition, OTA notes that despite APHIS' claim that (p. 29) "[i]n spite of widespread cultivation of GE crops, there have been no reports of deregulated GE plants causing harm to agriculture or the human environment," there is widespread acceptance of the threat of eventual insect resistance to Bacillus thuringiensis, especially due to the low-to-moderate doses over the growing season from GEO gene expression. In addition, there are numerous reports of problems with "super-weeds" deriving from genetic drift, as well as from intentionally planted pesticide-resistant GEO plants that subsequently volunteer and become pests of the then current crop. All of these events qualify as causing harm to agriculture since they impose unwanted genetic materials on agricultural operations committed to avoiding GEO contamination or presence.
For Issue 3, OTA would support Alternative 2, "Continue to allow for the option of granting full nonregulated status and develop appropriate criteria and procedures through which crops can be removed from permitting but some degree of Agency oversight as necessary to mitigate any risks retained," over Alternative 1, "No Action-continue with a system granting full nonregulated status to crops that removes them from all regulatory obligations under 7 CFR part 340," but believes that all GEOs should have some level of regulation, including a reporting requirement.
DEIS Issue 4-Oversight of Pharmaceuticals and Industrial Substances
OTA strongly opposes the use of any food plants in producing pharmaceutical and industrial substances. If such an allowance is made, OTA would strongly oppose any open air introductions. OTA therefore requests that APHIS withdraw its preliminary determination that food crops can safely be used for production of these substances.
If APHIS allows open air introductions, OTA suggests that a minimum of semi-annual unannounced inspections, with the possibility of additional unannounced inspections, be the minimum requirement for any regulated GEO producing pharmaceutical or industrial substances.
For Issue 4, OTA supports Alternative 3, "Do not allow crops producing substances not intended for food uses to be field tested, that is, these crops could only be grown in contained facilities."
DEIS Issue 6-Commercialization Under Multi-Year Permits
OTA suggests that a minimum of annual unannounced inspections of sites and facilities, with the possibility of additional inspections, along with scientific reporting requirements, be the minimum requirement for any regulated GEO.
For Issue 6, OTA supports Alternative 2, "Allow for special multi-year permits, with ongoing oversight. The new system would maintain these crops under regulation, but APHIS oversight would be exercised in a different manner than under the current system of permits." OTA believes the multi-year defined should be quite limited and not equate to a long permit period.
DEIS Issue 7-Low Levels of Biotechnology-Derived Genes and Gene Products Occurring in Commerce That Have Not Gone Through All Applicable Regulatory Reviews
As in the determination of risk above, what constitutes the definition of a "low level" of Biotechnology-Derived Genes and Gene Products may not be well enough understood scientifically to make definitive statements. OTA urges APHIS to provide information along the spectrum of incidence, with scientific justification for a meaning of "low level" that is not arbitrary.
OTA calls on APHIS to recognize that organic consumers prefer zero occurrence of such genes or gene products in their food. This would presumably especially include any such gene or gene product that has not completed all applicable reviews. Therefore OTA strongly opposes the creation of any criteria under which the occurrence of regulated articles would be allowable, that is, considered not actionable by APHIS. The risk involved is the risk of the occurrence of contamination, not some poorly understood risk to health. Additionally, in this regard, the absence of evidence regarding health effects should not be taken as evidence of absence regarding such effects. OTA would note that organic agriculture has been cited by USDA itself as among the fastest growing areas of agriculture, and as such it should be protected from contamination that may reach unwilling consumers, or that could impede organic agriculture's ability to export certified organic products to other countries with GEO standards stricter than those of the United States.
For Issue 7, OTA supports Alternative 4, "Impose a very strict confinement regime on all field tests, as is currently done for pharmaceutical and industrial crops, that would further reduce the likelihood of regulated articles occurring in commercial commodities or seeds."
DEIS Issue 8-Importation of Genetically Engineered Commodities Not Intended for Propagation
Nonpropagative "use" must not be confused with nonpropogative "ability." Any imports should be sterile.
For Issue 8, OTA supports Alternative 1, "No Action-continue to evaluate commodity importation requests on a case-by-case basis," with the understanding that all imports should be sterile.
DEIS Issue 9-Interstate Movement of Well-Studied, Low Risk Organisms
Given the well-documented incidents of genetic drift between genetically engineered rapeseed (canola) and wild mustard, OTA is surprised that APHIS would use Arabidopsis spp. as an example for this purpose. Simply because a plant is well understood and used in research is no reason that it may avoid becoming a noxious weed, as genetically engineered rapeseed arguably has become. This is a poor example and an equally poor proposal.
For Issue 9, OTA supports Alternative 1, "No Action-Require interstate movement authorizations for all organisms on the list in 7 CFR § 320.2(b)."
DEIS Issue 10-Environmental Considerations for Container Requirements
The determination of which containers meet APHIS' regulatory goals should be performed by APHIS.
For Issue 10, OTA supports Alternative 1, "No Action-retain current list of approved containers and issue variances when necessary."
Thank you very much for your consideration.
Regulatory and Policy Manager
Organic Trade Association