Regulatory Analysis and Development, PPD
APHIS, Station 3A-03.8
4700 River Road Unit 118
Riverdale, MD 20737-1238
Docket No. APHIS – 2010-0047
MONSANTO COMPANY AND KWS SAAT AG AVAILABILITY OF AN ENVIRONMENTAL ASSESSMENT FOR SUPPLEMENTAL REQUEST FOR PARTIAL DEREGULATION OF SUGAR BEED GENETICALLY ENGINEERED TO BE TOLERANT TO THE HERBICIDE GLYPHOSATE
Dear Mr. Coker:
The Organic Trade Association (OTA) thanks you for this opportunity to comment. OTA is the membership-based business association for organic agriculture and products in North America. Its members include growers, shippers, processors, certifiers, farmers' associations, distributors, importers, exporters, retailers and others. OTA’s Board of Directors is democratically elected by its members, and our mission is to promote and protect the growth of organic trade to benefit the environment, farmers, the public and the economy (http://www.ota.com/).
As the leading voice for the organic trade in the United States, OTA has a unique stakeholder interest in the potential deregulation of genetically engineered (GE) crops. The National Organic Standards prohibit the use of genetically engineered crops or materials; while the organic standards are process-based, consumers expect organic products to be GMO free. Future consumer confidence and the economic viability of organic agriculture rest on keeping organic crops and products free of GE contamination.
Inadvertent contamination has real economic consequence to organic farmers and product manufacturers. GE contaminated organic crops and products lose their market value, and the costs to prevent contamination and testing costs to verify the crops and products are free of such contamination are all borne by the organic industry solely. In fact, the U.S. Department of Agriculture’s own Economic Research service (ERS) states,
“ In the United States, an alternative approach [to the EU] has been used, implicitly allocating risks and costs to non-GE producers. Organic and other non-GE products are labeled, and the non-GE producers assume the full cost and liability of accidental contamination form GE crops. The open-ended economic risk to non-GE producers from accidental contamination by GE crops may dampen prospects for growth in the domestic organic farm sector”.
It is a prerequisite that any and all policy decisions regarding GE regulation shift the cost(s) associated with enabling meaningful co-existence from the organic and non-GE sectors to the patent holders of the GE crops. Steps must be taken to protect the organic industry from market losses that currently occur under USDA’s de facto approach to co-existence.
Summary of comments to proposed alternatives presented in the draft EA:
Alternative 3 – Partial Deregulation of Event H7-1 Sugar Beets (Seed/Root)
Not only did the petitioner, as USDA recognizes, not explain or identify any mechanism(s) that would be imposed to prevent potential plant pest risks, or how compliance with conditions would be assured, but given the recent court decisions it is inconceivable for USDA-APHIS to consider proceeding with alternative 3. We thank the department for not identifying this alternative as the “Preferred Alternative”.
Alternative 2 –Event H7-1 Sugar Beets (Seed/Root) Under APHIS 7 CFR Part 340
Firstly, OTA applauds APHIS for taking seriously the necessity of mandatory conditions to prevent any potential plant pest risks from cultivation of RR sugar beets (RRSB) with the intent of minimizing the potential for contamination of non-GE crops by the release of GE sugar beets. We believe this approach, if developed fully with stakeholder input, could in the future address many of the impediments to meaningful co-existence. However, as drafted these ‘mandatory conditions’ do not offer adequate assurances, nor does Alternative 2 address the fundamental issue of compensation for losses due to contamination in the event that the mandatory conditions prove inadequate. OTA outlines, further in this comment, the full spectrum of pre-requisites to meeting this adequacy threshold for meaningful co-existence.
Secondly, OTA does not believe that commercialization of RRSB should be permitted until the court ordered EIS is completed.
Lastly, USDA has far greater powers at its disposal than it currently utilizes in the regulation of biotech crops. USDA derives its primary authority for the regulation of biotech crops from the Plant Protection Act (PPA). This was enacted in 2000 based on recognition that the existing regulatory construct was inadequate to meet the challenges of biotechnological advances in agriculture. USDA must broaden the factors considered in assessing the potential environmental impacts of RRSB and other GE crop deregulation.
Alternative 1 –APHIS Denies Petition Request for Partial Deregulation/ No Further Actions to Authorize Cultivation of Event H7-1 Sugar Beets
OTA asks that USDA adopt alternative 1 and deny the petition request for partial deregulation of H7-1 Sugar Beets at this time.
Should cultivation of RRSB be permitted, under any conditions, in advance of a completed Environmental Impact Statement (EIS)?
While the Environmental Assessment (EA) in this proceeding goes to great lengths to assess the impacts associated with the introduction of H7-1 sugar beets, genetically engineered to be tolerant to the herbicide glyphosate, and a determination of the “carefully tailored interim measures” that would allow for commercial production of H7-1 sugar beets until such time as a Court ordered Environmental Impact Statement (EIS) can be finalized, there are a number of more fundamental issues that need to be addressed.
The process being advanced raises many questions and concerns in the minds of organic producers and processors. First and foremost is whether any commercial production of H7-1 sugar beets, being developed and marketed by Monsanto and KWS as Roundup Ready Sugar Beets (RRSB), should be permitted until the Court-ordered Environmental Impact Statement (EIS) is completed.
The Courts have found that APHIS had failed to comply with National Environmental Policy Act (NEPA) mandates, ordered the agency to complete an EIS and vacated USDA’s decision to deregulate RRSB. In reaching its decision, the Court detailed areas of concern that the agency needed to address in the EIS process. The USDA has embarked on the EIS process and contemplates that it will be completed in March 2012. Until the time the EIS is completed, RRSB is once again in regulated status.
We have grave concerns about the propriety of the requested action. APHIS characterizes the Petition as a supplemental request for “partial deregulation” or for similar administrative action to authorize the cultivation of event H7-1 sugar beets subject to carefully tailored interim measures. We agree with APHIS’ conclusion that partial deregulation cannot be considered until such time as the court-ordered EIS is completed. Not only did the petitioner, as USDA recognizes, not explain or identify any mechanism(s) that would be imposed to prevent potential plant pest risks, or how compliance with conditions would be assured, it is inconceivable for USDA-APHIS to consider proceeding with alternative 3 and thus, we thank the department for not recommending this alternative.
Historically, compliance with the procedures and processes required for deregulated status under 7 CFR 340.6 provided the regulatory pathway to commercial production for all GE crops. In the case of RRSB, the Court determined that an informed decision on deregulated status required an EIS given the number of potential environmental and inter-related socio-economic impacts. In this proceeding the USDA is considering the unprecedented action of using its permit and notification authority under 7 CFR 340.3 and 7 CFR 340.4, respectively, to allow commercial production of RRSB. Permits and notifications have traditionally been used to conduct field trials and other aspects of research and development, and not as an alternative regulatory mechanism to allow commercial production. Whether commercial production of RRSB is conducted as a result of deregulation, permit or notification, the completion of an EIS should be a precondition for the commercial production of RRSB. This is especially true because, as the EA indicates that it is likely that 1 million acres of RRSB will be planted in 10 or more states.
We believe that permits and/or notifications are improper for commercial-scale production of regulated articles. While there is no limit to acreage and/or field size in the relevant statutes or regulations, permits and notifications are typically used on small field trials. Their purpose is to provide a regulatory mechanism for USDA to conduct effective oversight and management of biotech crops in the field trial research and development phase. Although permits and notifications provide USDA with authority to mandate compliance with permit conditions designed to minimize contamination, a 2005 USDA Office of Inspector General audit was highly critical of USDA’s failures to meet its obligations for oversight, management and administration of field trials. APHIS lacks the resources, capacity and personnel to meet the responsibilities required under Alternative #2 to effectively monitor and administer permit conditions on over 1 million acres of RRSB. Turning those responsibilities over to Monsanto/KWS through Stewardship Agreements is not an option. Ultimately, utilizing permits and/or notifications contravenes the intent of the court to ensure that all impacts of RRSB are appropriately assessed prior to the time commercial planting is undertaken.
While USDA has gone to great lengths to provide assurances in the EA that RRSB will be contained through the conditions mandated in the permitting and notification processes, these regulatory mechanisms are not intended to be used in situations involving commercial production. Regardless of the validity of the findings and conclusions regarding the significance of the impacts involved in the commercial production of RRSB, the EA should not be allowed to worsen an already faulty process.
We are perplexed by the USDA’s continued reliance on assessment and deregulation processes that the courts have repeatedly determined to be inadequate. The existing system of agricultural biotechnology regulation has resulted in “regulation by litigation” that provides no certainty to conventional, organic or biotech growers and producers. In this instance, APHIS has attempted three alternative regulatory pathways to commercial production. The Court has vacated the original RRSB deregulation decision and ordered an EIS. The subsequent attempt by USDA to utilize permit authority to allow commercial planting was found lacking due to the agency’s failure to conduct an EIS addressing the areas of concern identified in its initial Order. On December 2, 2010, the Court, ordered that RRSB planted pursuant to the permit process to be destroyed.
Here, USDA seeks to justify its actions by conducting an environmental assessment that meets the “areas of concern” identified by the Court to allow commercial planting of RRSB as an “interim action of limited scope and duration pending the completion of the court ordered EIS”, which according to its own calculation, will be completed in March 2012. At best this would allow RRSB to be planted for 1-2 growing seasons. There is little likelihood that this “alternative process” will result in more certainty to the biotech, conventional or organic producer.
Does USDA have regulatory authority beyond the current policy which is limited to the sole determination of whether the regulated article poses a plant pest risk?
The Plant Protection Act (PPA) provides the basis for the regulation of biotech crops, providing the Secretary of the USDA with the authority to adopt regulations preventing the introduction and dissemination of plant pests. 7 U.S.C § 7711(a). Consistent with that authority, the Animal & Plant Health Inspection Service (APHIS), a division of USDA, regulates the introduction of organisms and products altered or produced through genetically engineering that are plant pests or believed to be plant pests, or regulated articles. The regulations covering biotech crops are contained in 7 C.F.R. § 340.
The problem is that the USDA relies on an antiquated biotechnology crop regulatory system based the Federal Plant Pest Act (FPPA) and other “quarantine” authorities that were repealed as part of the enactment of the PPA in defining “plant pests.” The FPPA and those quarantine statutes were intended to protect agriculture against “plant pests” and have always been a legal stretch because crops only rarely act as pests on other plants. However, the USDA continues to utilize these authorities as the basis for the existing comprehensive regulatory system for biotech crops, despite their failure to address the broader environmental and economic impacts of GE crops.
Under the existing regulatory framework, the USDA inquiry is limited to whether the inserted genetic material poses a “plant pest risk,” defined as: “any living stage of any of the following that can directly or indirectly injure, cause damage to …any plant of plant product.” 7 U.S.C. § 7702(14). APHIS regulations similarly define “plant pests” as “any living state of … bacteria … or any organisms similar to allied with the foregoing … which can directly or indirectly injure, cause disease or damage in or to any plants or plant parts thereof, or any processed, manufactured or other product of plants.” 7 C.F.R. § 340.1. Those same regulations reference plant pest analysis as including “indirect plant pest effects on other agriculture products.” 7 C.F.R. § 340.6(c)(4).
USDA has indicated that the findings, conclusions and assessments contained in this EA will not be used as precedent or provide the basis for the court-ordered EIS. APHIS is utilizing its limited resources to find a legally sufficient mechanism to allow one producer group to commercially produce a GE variety for 1-2 growing seasons. These resources would be much better utilized in finalizing and promulgating final regulations for agriculture biotech regulation, a process that was initiated in 2004 with a Proposed Rule (APHIS-2008-0023) published in 2008.
The Proposed Rule and the Supplemental Comments represent a comprehensive rulemaking that address many of the issues being litigated, clarify issues of regulatory and statutory authority, and incorporate Plant Protection Act provisions into the regulatory processes. Dedicating USDA resources to finalizing and promulgating these regulations, particularly if those rules adopt the precedent established in GE Alfalfa and RRSB litigation, would not only be a better use of agency resources but also would bring clarity to all producer groups as to how biotech crops would be regulated.
Does the draft EA provide adequate safeguards that GE sugar beets and non-GE sugar beets and organic crops can meaningfully co-exist?
We have serious concerns about the representations expressed in the EA regarding the effectiveness of “co-existence” and the ability of coexistence to provide sufficient protection for all sectors of U.S. agriculture.
First and foremost, there has never been a transparent or public discussion of what “co-existence” policy is, what it means, how it will be implemented and/or enforced. The USDA cites the definition created by the USDA Advisory Committee on Biotechnology and the 21st Century. It should be noted that this is small group of individuals who largely represent the interests of the biotechnology industry and production agriculture, and did not include direct involvement from the organic industry. There has been no policy framework for co-existence that has been developed, there have been no hearings on the definition of coexistence, much less how it can be utilized as an effective tool in ensuring that biotech contamination of organic or conventional crops and seeds will not result in economic harm to non-biotech crop or commodity producers, and how non-GE producers will be compensated for losses in the event of contamination.
USDA on numerous occasions has described coexistence as the “cornerstone” of U.S. biotech policy. If that is to be the case, a participatory and transparent policy development process needs to be established. OTA stands ready to engage in the important policy discussion directly, in an open and transparent manner that reflects the input of the diverse set of stakeholders impacted by USDA policies in this regard.
In terms of co-existence as applied to biotech contamination of organic crops/products, USDA utilizes a simplistic and narrow definition of “organic” based on the legal definition in the National Organic Program. USDA concludes that “because organic is based on process and not product, the mere presence of plant materials produced through excluded methods (i.e. genetic engineering) will not jeopardize products labeled as organic as long as the grower follows required production protocols. (EA at p. 119, 120). According to USDA, since inadvertent use of genetically engineered crops/products will not result in loss of organic certification, biotech contamination is a “no harm, no foul” situation.
The EA validates the no-harm, no-foul approach by indicating that “coexistence-enabling factors identified are existing legal and regulatory frameworks that enabled different markets to develop without foreclosing the ability of participants in the food and feed supply to establish standards and procedures (e.g., not setting specific mandatory adventitious presence thresholds and having process-based rather than product-based organic standards).” The implication that biotech contamination will not adversely affect organic producers, processors and markets belies the reality of the modern organic industry. (EA at p.121).
The USDA has arbitrarily concluded that “co-existence” works in other situations where biotech contamination has been demonstrated. Most notably in the GE Alfalfa EIS, where it was claimed that co-existence has been achieved merely by the fact that 200,000 acres of GE Alfalfa had been planted during the two years of deregulated crop production. No studies or research were cited to support the conclusion that co-existence had been achieved. Subsequent reports from Cal/West Seeds found GE alfalfa content in more than 12% of fields in 2008 and more than 30% of fields in preliminary 2009 data. These levels of biotech contamination were corroborated by Dairyland Seeds, another major farmer cooperative producing alfalfa seed. These levels of contamination occurred despite the fact that 200,000 acres represents less that 1% of total U.S. alfalfa acreage.
We believe that “co-existence” is not an apt description for the policy goals that we believe are fundamental to discussions on deregulating new biotech crops. The goal of any co-existence policy must be to ensure that biotech contamination does not result in economic harm to organic or conventional producers or industries. Consistent with that goal, there must be policies to ensure that remedies are available to provide compensation to producers suffering economic harm as a result of biotech contamination. We suggest that the terminology be changed from “co-existence” to “meaningful co-existence through contamination prevention and compensation” to more appropriately describe the policy goals and objectives for the program.
Essential components of this type of meaningful co-existence include but are not limited to:
- Assignment of liability to the patent holder, including a system of compensation for losses due to inadvertent contamination that does not pit farmer against farmer,
- Compensation for perpetual costs of co-existence including testing and commingling prevention throughout the supply chain,
- Preservation of seed stock supply and genetic diversity—critical to food security,
- Comprehensive environmental, public health and socio-economic assessments prior to deregulation,
- Retention of regulatory authority by USDA after deregulation through creation of “commercialization permit,”
- Labeling of GM crops and product ingredients.
These safeguards should be viewed as perquisites to any commercialization of GE crops.
cc: Tom Vilsack, Secretary of Agriculture
 Greene, Cathy and Smith, Katherine, Economic Research Service, 2nd Qtr 2010, Choices Magazine, a publication of Agriculture and Applied Economics Association