To USDA: Deregulation of LLRICE601
Comments from the Union of Concerned Scientists
October 10, 2006
Regulatory Analysis and Development
USDA APHIS PPD
Station 3A-03.8
4700 River Road Unit 118
Riverdale, MD 20737-1238
Submitted via Federal eRulemaking Portal: Docket No. APHIS-2006-0140
To whom it may concern:
The Union of Concerned Scientists (UCS) is grateful for the opportunity to comment on the USDA's environmental assessment of and preliminary decision to deregulate Bayer CropScience's genetically engineered (GE) rice variety, LibertyLink® (LL) 601.
UCS, the leading science-based nonprofit working for a healthy environment and a safer world, combines independent scientific research and citizen action to develop innovative, practical solutions and secure responsible changes in government policy, corporate practices, and consumer choices. A major goal of UCS's Food and Environment Program is to strengthen the regulatory system that applies to products of agricultural biotechnology.
SUMMARY OF RECOMMENDATIONS
Based on our review of USDA, Bayer, and other relevant documents, UCS recommends that the USDA:
1. Take no action on Bayer's petition to deregulate LL601 until:
- The department fully investigates LL601's contamination of U.S. commercial rice and seed supplies and determines whether Bayer failed to comply with field-testing performance standards or the performance standards were inadequate to prevent the contamination
- The department reevaluates the plant pest characteristics of LL601, prepares a new environmental assessment of LL601 that fully evaluates its environmental risks, and allows the public to comment on the new assessment and the department's new preliminary decision on deregulation
- The FDA issues a food safety consultation letter on LL601.
2. Require companies to provide the department with the molecular probes needed to detect genes and/or gene products from GE food/feed crops field tested in the United States.
BACKGROUND
UCS is submitting these comments in response to a September 8, 2006, Federal Register notice announcing the availability of an environmental assessment (EA) and preliminary USDA decision to extend the nonregulated status of two Bayer CropScience GE rice events, LL06 and 62, to another of the company's GE rice events, LL601. After receiving comments on the EA and preliminary decision, the department will decide whether to deregulate LL601. As described below, LL601 currently unlawfully contaminates the U.S. rice supply. If the USDA were to deregulate LL601, it would be considered an "approved" variety and its presence in the U.S. rice supply would no longer violate U.S. laws.
LL601 has contaminated U.S. commercial rice, with serious consequences
On August 18, 2006, USDA Secretary Mike Johanns announced that U.S. supplies of long grain rice have been contaminated with Bayer CropScience's LL601, a bioengineered rice variety not approved for commercial production in the United States. According to Riceland Foods, an Arkansas-based farmer-owned rice cooperative, the GE contaminant was discovered in January 2006 by one of its customers.[1] After confirming the presence of the contaminant in rice samples from several storage sites, Riceland alerted Bayer CropScience. Bayer then conducted its own tests and reported to the USDA on July 31 that commercial supplies of U.S. long grain rice were contaminated with unapproved LL601 rice. Nearly three weeks later, the USDA publicly acknowledged the contamination.
Like previous GE food contamination incidents, in particular, the StarLink corn incident in 2000, the revelation of widespread contamination of rice with this unapproved variety has had a serious impact on the commercial rice industry. Since the USDA's announcement, U.S. rice prices have fallen 10%, and analysts have predicted that market losses may ultimately reach $150 million.[2] According to the USDA, before the LibertyLink contaminant was discovered, the 2006 long grain rice export market was valued at roughly $700 million.[3]
LibertyLink rice varieties were engineered in the 1990's to resist Liberty herbicides
In the 1990's, AgrEvo, a German biotechnology company, engineered several LibertyLink rice varieties, including LL601, 06, and 62, to resist the herbicide glufosinate-ammonium, sold as Liberty®.[4] Bayer subsequently acquired the LibertyLink varieties in 2002 when it merged Aventis CropScience (the successor to AgrEvo) with its own crop pesticide business to form Bayer CropScience. As described below, the company gained USDA approval to market LL06 and 62 but never sold the varieties. Bayer abandoned plans to commercialize LL601 several years ago.
The USDA shares responsibility for LibertyLink rice regulation with the FDA and the EPA
In addition to the USDA, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA) share responsibility for regulating engineered herbicide-resistant crops like LibertyLink rice. Working with the three agencies, AgrEvo/Aventis cleared the regulatory hurdles for LL06 and 62.
USDA. The USDA oversees both field testing and commercialization of herbicide-resistant GE crops under the federal Plant Pest Act (PPA). Under USDA field-testing authority,[5] AgrEvo/ Aventis conducted 27 field tests of LL601 in Arkansas, Louisiana, Mississippi, Puerto Rico, and Texas from 1998 to 2001,[6] 12 field tests of LL06 (10 in California and two in Puerto Rico) in 1997 and 1998, and four of LL62 (two each in Louisiana and Puerto Rico) also in 1997 and 1998.[7]
USDA approval of commercialization takes the form of deregulating a variety so that it is no longer subject to PPA requirements. Nonregulated status means that a variety can be grown anywhere and at any scale in the United States without USDA authorization. The department granted nonregulated status to LL06 and 62 in 1999.[8]
FDA. Biotechnology companies typically volunteer to consult with the FDA on food safety issues under the agency's 1992 policy on GE foods.[9] In 2000, Aventis and the FDA completed a voluntary food safety consultation on LL06 and 62 varieties.[10]
EPA. Before Liberty herbicide could be sold for application to LibertyLink rice, the herbicide manufacturer was required to petition the EPA to establish food and feed tolerances for residues of glufosinate on rice under the Federal Food, Drug, and Cosmetic Act. The EPA established tolerances for glufosinate on rice in 2003,[11] after which glufosinate herbicides could be used on any LL rice variety.
Bayer and the USDA have not explained how LL601 contamination occurred
Neither Bayer nor the USDA has explained how LL601 ended up in the U.S. commercial rice supply—five years after it was last field tested in the United States. It is not clear whether Bayer failed to comply with the department's field-testing performance standards[12] or the performance standards themselves were at fault.
Information from Louisiana State University (LSU) indicates that contamination of foundation seed, which is used to produce seed sold to farmers, may have led to contamination of commercial rice supplies. Soon after the August 18 rice contamination announcement, LSU reported that LL601 had been found in the 2003 foundation seed supply of one of the university's long grain rice varieties. According to an LSU rice breeder, the 2003 foundation seed would have been planted throughout the southern United States. From 1999 through 2001, Bayer and LSU conducted field trials of Liberty Link rice at the university's Rice Research Station.[13]
The USDA and the FDA announced that LL601 is safe for consumers and the environment
In mid-August, after revealing that LL601 had contaminated U.S. rice, the USDA and the FDA immediately issued statements regarding LL601's safety. USDA Secretary Johanns announced that the department had conducted a risk assessment and found LL601 to be "safe in the environment."[14] The FDA asserted that LL601 posed no food or feed safety concerns, based on the agency's consultations on LL06 and 62 rice varieties and other glufosinate-resistant crops, which, according to the agency, produce the same novel protein as LL601.[15] The FDA considers the case closed on LL601.
Bayer sought expedited deregulation of LL601 after contamination was revealed
After field testing LL601 from 1998 to 2001, Bayer abandoned plans to commercialize the variety and until August 2006 did not petition the USDA for nonregulated status or engage in voluntary food safety consultations with the FDA.
On August 17, Bayer petitioned the USDA to deregulate LL601 under its expedited review process, arguing that LL601 is sufficiently similar to LL06 and 62, the two previously deregulated varieties, to qualify for accelerated review under USDA's extension process.[16] The USDA established this process years ago to expedite decisions granting nonregulated status to GE crop varieties similar to varieties previously deregulated.[17] Under the extension process, Bayer was required only to submit a petition comparing LL601 to LL06 and 62.[18]
On September 8, the USDA responded to Bayer's petition in a Federal Register notice inviting public comment on its preliminary decision to deregulate LL601 by extension from LL06 and 62 and its assessment of LL601's environmental risks.[19] The USDA agrees with Bayer that LL601 is sufficiently similar to the other two varieties to warrant deregulation by extension. The USDA's risk assessment concludes that LL601 is not a plant pest and presents no significant impact on the environment.[20]
UCS RECOMMENDATIONS
1. The USDA should take no action on Bayer's petition to deregulate LL601 until the following steps are completed:
a. The USDA fully investigates LL601's contamination of U.S. commercial rice and seed supplies and determines whether Bayer failed to comply with field-testing performance standards or the performance standards were inadequate to prevent the contamination.
The USDA should defer a final decision on the LL601 deregulatory petition until it fully investigates the contamination incident and determines whether Bayer's non-compliance with USDA performance standards or inadequate performance standards were responsible. Otherwise, a quick decision to deregulate in the absence of such a determination would send the wrong message to the biotech industry—that companies will not be held accountable if they ignore U.S. regulations—and to the public—that the USDA places a company's welfare above that of consumers.
The department allows field tests of regulated varieties like LL601 provided the applicant meets field-testing performance standards detailed at 7 CFR 340.3(c). According to the USDA, "[T]he performance standards are a set of six conditions that must be met in order to ensure containment of the introduced regulated article. The goal of the performance standards is to manage the introduced regulated article such that it or its offspring will not persist in the environment."[21]
The discovery of widespread LL601 contamination of commercial rice indicates that the goal of the performance standards was not met. The USDA should investigate this failure and determine: i) the route and extent of LL601 contamination of the rice food and seed supplies; ii) whether the USDA's performance standards failed, and if so, where, when, and how; and iii) whether Bayer failed to comply with USDA performance standards, and if so, where, when, and how.
If the investigation reveals that Bayer failed to comply with USDA regulations, the department should assess penalties on the company, not relieve it of responsibility for illegally contaminating the food supply. In addition, the USDA should evaluate and strengthen its compliance and enforcement program in order to prevent companies in the future from contaminating the food supply as a result of their failure to comply with performance standards.
If, on the other hand, the USDA determines that LL601 contamination occurred despite Bayer's full compliance with the performance standards, the department should evaluate the adequacy of the standards and recommend changes to protect the food supply from unapproved varieties.
b. The USDA reevaluates the plant pest characteristics of LL601, prepares a new environmental assessment of LL601 that fully evaluates its environmental risks, and allows the public to comment on the new assessment and the department's new preliminary decision on deregulation.
Before LL601 can be granted nonregulated status, the USDA must satisfy both PPA and National Environmental Policy Act (NEPA) requirements. Under the PPA deregulatory process,[22] the department must determine whether a GE variety is a plant pest. NEPA requires the USDA to prepare an environmental assessment (EA), which evaluates a variety's potential environmental impacts if it were to be deregulated.
The USDA may grant nonregulated status if it: i) determines that the GE variety is not a plant pest and therefore should no longer be a regulated article and ii) finds, based on the EA, that the variety will have no significant impact on the environment as a result of deregulation.[23]
Based on our analysis, the USDA has met neither PPA requirements nor NEPA standards.
PPA requirements. The USDA has failed to meet PPA requirements because it incorrectly concluded that LL601 poses no plant pest risk. To the contrary, LL601 poses substantial risk as a plant pest because it may increase the weediness of red rice, already a serious pest of southern U.S. rice fields,[24] and may accelerate the evolution of other difficult-to-control rice weeds.[25]
Red rice, which is sexually compatible with cultivated rice, could become even more difficult to control if it were to acquire glufosinate-resistance genes from LL601. Even though hybridization rates would be low, where LL601 and red rice co-exist and their flowering times overlap, growers could almost certainly expect herbicide-resistant red rice to develop—and develop quickly if Liberty herbicides were used repeatedly under continuous rice cultivation.[26]
Frequent use of LibertyLink rice and Liberty herbicides may also accelerate the emergence of other difficult-to-control weeds by increasing the selection pressure for the weeds to develop herbicide resistance—just as the rapid emergence of glyphosate-resistant weeds was fueled by engineered glyphosate-resistant crops.[27]
NEPA standards. The USDA has not met NEPA standards because its EA fails to satisfactorily address potential environmental impacts of LL601. The deficiencies in the EA include the following:
- Lack of experimental data to support conclusions on the impacts of LL601 introgression into red rice
- Lack of experimental data to support the conclusion that the haphazard insertion of an extra copy of the CaMV 35S promoter creates no unintended consequences
- Failure to investigate potential pleiotropic or unintended effects, such as LL601's short stature compared with the parent line and LL601's moderate level of seed shattering compared to very low levels in other LL rice lines
- Failure to request data and investigate potential changes in LL601's susceptibility to insect pests
- Failure to require analysis of LL601 rice seeds for three known antinutrients found in rice: phytic acid, lectin, and trypsin inhibitor.
The USDA should prepare a new EA that thoroughly evaluates the potential environmental impacts of LL601.
As we noted above, the USDA has not determined either the means by which LL601 entered the commercial rice supply or the extent to which it contaminates food rice or the rice seed supply. A proper analysis of potential impacts, as NEPA calls for in the preparation of an EA, would include an evaluation of how broadly spread LL601 is in the environment, including the food and seed supplies.
The USDA should delay completion of a new EA pending completion of the investigation into the LL601 contamination and incorporation of the findings into the EA.
Upon completion of a new EA and reconsideration of LL601's plant pest status, the USDA should make the EA and its preliminary deregulatory decision available for public comment for at least 60 days.
c. The FDA issues a food safety consultation letter on LL601.
The USDA should take no action on Bayer's deregulatory petition until the company and the FDA complete a food safety consultation on LL601. Even though the FDA's voluntary consultation process is inadequate to protect the food supply, LL601 has not yet undergone even this modest review.
The FDA assumes that LL601 is safe because it has consulted on other glufosinate-resistant crops producing the PAT protein. UCS does not agree with this assumption, as the impacts of adding a novel gene vary from crop to crop and from variety to variety within a particular crop. For example, protein glycosylation patterns may differ each time the same gene is spliced into different varieties of the same crop.
This assumption is also contrary to the FDA's position as stated in its 2001 proposed rule concerning premarket notices for bioengineered foods:[28]
Because some rDNA-induced unintended changes are specific to a transformational event …, FDA believes that it needs to be provided with information about foods from all separate transformational events, even when the agency has been provided with information about foods from rDNA-modified plants with the same intended new trait and has had no questions about such foods.[29]
The FDA defines a transformation event as "the introduction into an organism of genetic material that has been manipulated in vitro."[30]According to that definition, LL601 is a separate transformation event from LL06 and 62 rice, LL canola, and LL corn—all glufosinate-resistant crops that produce the same PAT protein and have been previously considered by the FDA. Under the rationale behind the FDA's 2001 proposed rule, the agency would not rely on consultations on other PAT-protein crops to assert LL601's safety. Rather, Bayer would be expected to open a new consultation with the FDA based on food safety data obtained on LL601.
The FDA's LL601 consultation should take into account the possibility that genetic engineering may create a new allergen. That potential was highlighted last year by research indicating that genetic engineering between two non-allergenic food crops created a new allergenic protein. Australian scientists reported that field peas engineered to produce a protein from common beans were unexpectedly immunogenic.[31]
2. The USDA should require companies to provide the department with the molecular probes needed to detect genes and/or gene products from GE food/feed crops field tested in the United States.
Because the USDA does not regularly test for the presence of unapproved GE varieties in U.S. seed and grain supplies, contamination incidents like LL601 can easily go undetected for months or years. Moreover, because it does not have molecular probes for unapproved GE varieties, the department is handicapped in dealing expeditiously with putative contamination events. In the LL601 case, the USDA had to wait for Bayer to turn over the probes after the contamination was reported, wasting valuable response time.
The USDA, as the lead federal agency overseeing agricultural biotechnology products, should have access to the tools needed to detect food or environmental contamination by unapproved GE crops. This would make rapid testing possible whenever necessary, facilitating protection of the food supply, consumers, farmers, and others in the international grain trade and facilitating enforcement of USDA regulations.
UCS recommends that from now on the USDA require companies, as a condition of approval of field testing, to provide the molecular tools needed to test for introduced genetic material in all GE crops.
CONCLUSION
Confidence in the USDA's ability to protect the food supply from unapproved GE varieties will not be enhanced if the department moves precipitously to approve Bayer's request to legalize LL601's presence in commercial rice. Companies will have little incentive to comply with USDA regulations if the department ignores potential compliance infractions in a rush to alleviate the negative impacts of contamination for the industry.
To engender public confidence, the USDA should abandon its accelerated review process in favor of a careful, thorough assessment of LL601's plant pest risks and potential environmental impacts. Only after considering public comment on the new assessment should the department decide LL601's regulatory status.
Finally, UCS is also concerned that contamination events may involve pharmaceutical and industrial chemicals. Will the USDA's handling of the LL rice contamination incident embolden pharma crop companies to think they can ignore USDA requirements with impunity? This possibility strengthens our conviction that a ban on the outdoor production of pharma/industrial food crops is the only way to completely protect the U.S. food supply from contamination by pharmaceutical and industrial compounds.
Thank you for your consideration of our comments.
Sincerely,
Margaret Mellon, Ph.D., J.D., Director
Food and Environment Program
Jane Rissler, Ph.D., Senior ScientistFood and Environment Program
Karen Perry Stillerman, M.P.A., Senior Analyst
Food and Environment Program
Notes:
[1] Reed, B. 2006. Statement Regarding Genetically Engineered Material in Rice. Riceland Foods, Inc., Stuttgart, AK, August 18.
[2] Weiss, R. 2006. Gene-Altered Profit Killer: a Slight Taint of Biotech Rice Puts Farmers' Overseas Sales in Peril. Washington Post, September 21.
[3] USDA. 2006. Fact Sheet: Genetically Engineered Rice. Office of Communication Release No. 0306.06, August.
[4] All three varieties were engineered to contain the bar gene from a soil bacterium (Streptomyces hygroscopicus) and the 35S promoter from the cauliflower mosaic virus (CaMV). The bar gene codes for the enzyme phosphinothricin-N-acetyltransferase (PAT), which converts the active ingredient of Liberty herbicide into an inactive form. The 35S CaMV promoter directs rice plant cells to constitutively produce high levels of PAT. LL601 also contains a second copy of the 35S promoter inserted at unknown sites in the genome. The terminator genetic element in LL601 is the nos (nopaline synthase) terminator from a soil bacterium (Agrobacterium tumefaciens) and in LL06 and 62 is the 35S CaMV terminator. Both terminators control the expression of the bar gene. [Bayer CropScience. 2006. Application for an Extension of the Determination of Nonregulated Status for Glufosinate-Tolerant Rice (98-329-01p): Transformation Event LLRICE601. Research Triangle Park, NC, August 17.]
[5] 7 CFR 340.3 and 4
[6] Bayer CropScience. 2006. Application for an Extension of the Determination of Nonregulated Status for Glufosinate-Tolerant Rice (98-329-01p): Transformation Event LLRICE601. Research Triangle Park, NC, August 17.
[7] AgrEvo. 1998. Petition for Determination of Nonregulated Status: Liberty Link Rice Transformation Events LLRICE06 and LLRICE62. Wilmington, DE, November 20.
[8] USDA Animal and Plant Health Inspection Service (APHIS). 1999. AgrEvo USA Co.; Availability of Determination of Nonregulated Status for Rice Genetically Engineered for Glufosinate Herbicide Tolerance. Federal Register 64:22595-6, April 27.
[9] FDA. 1992. Statement of Policy: Foods Derived from New Plant Varieties; Notice. Federal Register 57:22984-23005. Even though FDA is charged with assuring the safety of the U.S. food supply, the agency has no authority to approve or deny marketing or to require submission of food safety data for most GE foods.
[10] FDA. 2000. Biotechnology Consultation: Note to the File and Agency Response Letter, BNF No. 000063. Center for Food Safety and Applied Nutrition., August 31.
[11] EPA. 2003. Final Rule. Glufosinate Ammonium; Pesticide Tolerance. Federal Register 68:55833-49, September 29.
[12] 7 CFR 340.3(c)
[13] Reuters. 2006. U.S. Rice Variety Tests Positive for GMO, September 4. Online at www.truthabouttrade.org/article.asp?id=6264.
[14] USDA. 2006. Transcript of Remarks by Agriculture Secretary Mike Johanns and Dr. Robert Brackett, Director of the Food and Drug Administration's Center for Food Safety and Applied Nutrition. Office of Communications Release No. 0308.06, August 18, paragraph 10.
[15] FDA. 2006. Statement on Report of Bioengineered Rice in the Food Supply. Center for Food Safety and Applied Nutrition, August 18. Online at www.cfsan.fda.gov/~lrd/biorice.html. FDA. 2006. Statement.
[16] Bayer CropScience. 2006. Application.
[17] 7 CFR 340.6(e)
[18] USDA APHIS. 2006. Draft Environmental Assessment in Response to Bayer CropScience Petition 06-234-01P Seeking Extension of Determination of Non-regulated Status for Glufosinate Resistant Rice, Oryza sativa, Event LLRICE601. Biotechnology Regulatory Services.
[19] USDA Animal and Plant Health Inspection Service (APHIS). 2006. Bayer CropScience; Availability of an Environmental Assessment and a Preliminary Decision for an Extension of a Determination of Nonregulated Status for Rice Genetically Engineered for Glufosinate Herbicide Tolerance. Federal Register 71:53076-7, September 8.
[20] USDA APHIS. 2006. Draft Environmental Assessment.
[21] USDA APHIS. No date. User's Guide for Introducing Genetically Engineered Plants and Microorganisms, Part IV.A.3. What are the performance standards? Online at www.aphis.usda.gov/brs/notgen.html.
[22] 7 CFR 340.6
[23] USDA APHIS. 2006. Bayer CropScience.
[24] Red rice infestations of cultivated fields are harmful because they compete with food rice for water, nutrients, and growing space and therefore lower yield and because the presence of red rice seeds in food rice lowers the crop's market value.
[25] According to the USDA definition of plant pest at 7 CFR 340.1, an organism is considered a plant pest if it can "directly or indirectly injure or cause disease or damage in or to any plants … or any processed, manufactured, or other products of plants."
[26] Lu, B. and A. Snow. 2005. Gene Flow from Genetically Modified Rice and Its Environmental Consequences. BioScience 55:669-78, August.
[27] Benbrook, C. 2004. Genetically Engineered Crops and Pesticide Use in the United States: the First Nine Years. Online at www.ucsusa.org/food_and_environment/genetic_engineering/genetically-engineered-crops-pesticide-use.html.
[28] FDA. 2001. Premarket Notice Concerning Bioengineered Foods; Proposed Rule. Federal Register 66:4706-38. The FDA has taken no action on this proposed rule—either to withdraw it or move it forward—in the five years since it was published.
[29] FDA. 2001. Premarket Notice, p. 4711.
[30] FDA. 2001. Premarket Notice, p. 4734.
[31] V.E. Prescott, et al. 2005. Transgenic Expression of Bean α-Amylase Inhibitor in Peas Results in Altered Structure and Immunogenicity. Journal of Agricultural and Food Chemistry 53:9023-30.
