Comments to USDA on Pharma Safflower
UNION OF CONCERNED SCIENTISTS
1707 H St., N.W., Suite 600
Washington, DC 20006
CONSUMERS UNION
101 Truman Ave.
Yonkers, NY 10703
March 7, 2007
Regulatory Analysis and Development
USDA APHIS PPD
Station 3A-03.8
4700 River Road, Unit 118Riverdale, MD 20737-1238
Submitted via Federal eRulemaking Portal: Docket No. APHIS-2006-0190
To whom it may concern:
The Union of Concerned Scientists (UCS) and Consumers Union (CU) are grateful for the opportunity to comment on the USDA's environmental assessment and preliminary decision to allow SemBioSys Genetics, Inc., to plant up to 1000 acres of genetically engineered drug-producing safflower in Washington.
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.
CU, publisher of Consumer Reports, is a nonprofit membership organization chartered to provide consumers with information, education and counsel about goods, services, health, and personal finances; and to initiate and cooperate with individual and group efforts to maintain and enhance the quality of life for consumers.
SUMMARY OF UCS AND CU CONCLUSIONS AND RECOMMENDATION
UCS and CU's analysis of USDA's environmental assessment (EA) of SemBioSys' permit application leads us to conclude that the EA fails to provide sufficient public evidence and analysis for determining whether to prepare an environmental impact statement (EIS) or a finding of no significant impact under the National Environmental Policy Act (NEPA). The public evidence it does contain does not support the finding that the impacts of planting hormone-containing safflower will be insignificant. Given the USDA's poor record in implementing its current regulatory system, UCS and CU conclude that the department is unable to protect the food supply from contamination by pharma[1] food crops. As a result, the only prudent policy is for USDA to ban the outdoor production of all pharma food crops. UCS and CU urge USDA to adopt and implement such a policy.
BACKGROUND
In the February 5, 2007, Federal Register, USDA announced a public comment period on an EA and preliminary decision to allow SemBioSys to grow genetically engineered (GE) drug-producing safflower (pharma safflower) in Washington State this year.[2]
Safflower is a food crop valued primarily for its oily seeds, which are used to produce edible oil for human consumption, birdseed, and as supplements for fish and animal feed.
SemBioSys' application
On September 5, 2006, SemBioSys submitted a permit application (06-250-02r) to USDA requesting approval to plant 1000 acres of hormone-producing safflower on up to 10 different sites in Washington. The purpose of the 2007 planting is to obtain "a seed increase of material for future use as a supplement in aquaculture meal."[3]
This request is a 50-fold increase over last year's 20-acre field trial in Washington, which was conducted under USDA permit 05-320-01r. If this year's request is approved, the company could move into commercial production whenever it wishes.
SemBioSys engineered the safflower to produce a carp growth hormone in its seeds with the aim of selling the pharmaceutical seed meal to the aquaculture industry. The company plans to market the hormone-containing meal to treat diseases in farmed shrimp and promote growth of farmed fish.[4] SemBioSys expects to begin selling the product in late 2007 or 2008 under the trade name ImmunoSphere™.[5]
Environmental assessment: USDA's findings
The analysis in USDA's EA of SemBioSys' proposed pharma safflower production is intended to support the department's determination of whether a full EIS is required under NEPA and whether a permit should be issued under USDA's Plant Protection Act regulations.
NEPA
NEPA requires USDA to prepare an EIS for major federal actions that significantly affect the quality of the human environment. When an EIS is not categorically required or excluded, the department must prepare an EA, which lays out the data and analysis determining whether the effect on the environment is significant enough to require an EIS.[6] If an EA produces a finding of no significant impact, no EIS is required.
USDA's EA concludes that SemBioSys' proposed production poses no significant environmental impact and that "there are no applicable, extraordinary, or other reasonably foreseeable circumstances under which significant environmental effects could occur given the protective and ameliorative measures specified [in the EA]."[7]
USDA regulations
Under the Plant Protection Act of 2002 and regulations governing GE organisms,[8] companies must secure permits to plant pharmaceutical-producing crops. Typically, the department's EAs on engineered crops include an analysis of the crop's plant pest and other environmental risks that underlie the determination of whether to grant or deny a permit.
In this case, USDA decided to issue a permit with supplemental conditions for the SemBioSys production "based on [the department's] scientific analysis of the permit application."[9] USDA makes no determination on the likelihood that the escaped safflower genes or seed posed unacceptable or plant pest risks, but instead determines that imposition of the measures outlined in the supplemental permit conditions[10] would "prevent spread of the organism outside the field production area,"[11] and "ensure no significant harm to the environment."[12]
UCS AND CU CONCLUSIONS AND RECOMMENDATION
1. THE EA IS INADEQUATE ON TWO COUNTS.
The SemBioSys EA fails to provide sufficient public evidence and analysis for determining whether to prepare an EIS or a finding of no significant impact. The public evidence it does provide does not support the conclusion that the impacts of planting hormone-containing safflower will be insignificant.
- The EA fails to provide sufficient public evidence and analysis for determining whether to prepare an EIS or a finding of no significant impact.
Under NEPA, an EA is a "public document … that … provide[s] sufficient evidence and analysis for determining whether to prepare an environmental impact statement or a finding of no significant impact."[13]
In this EA, however, USDA has withheld information from the public that appears to be critical to the conclusion that pharma safflower can be contained. That information is being kept from the public on the grounds that it is confidential business information (CBI).
USDA's finding of no significant impact rests on the department's certainty that the company can confine the pharma safflower to planting and other production sites. That certainty in turn depends on the company's strict adherence to procedures and safeguards described in three documents:[14] the company's permit application, the company's standard operating procedures (SOPs),[15] and USDA's supplemental permit conditions.
However, the department has withheld two of those documents—the permit application and the SOPs—from the public as CBI.[16] Since these two documents are central to the EA's conclusion of no significant impact, the evidence contained therein must be made public. An EA that withholds key scientific information is unacceptable legally and provides the public little confidence in the department.
- The EA improperly concludes that the impacts of planting hormone-containing safflower would be insignificant.
The essence of the scientific argument made by the USDA in the EA is that routes exist for pharma safflower to escape from the production sites (and potentially contaminate the food supply) and, upon close examination, the routes appear either unlikely or are blocked by containment measures imposed by USDA. As shown below, the EA fails to analyze two stages of the safflower production process within which contamination could occur, underestimates the likelihood of routes it did analyze, and overestimates the effectiveness of control measures.
i. The EA ignores two major routes of contamination.
Seed production and transport to the production site
The EA fails to even mention the issues surrounding seed production, e.g., where the pharma safflower seed was produced,[17] the conditions under which it was produced, how and where the seed was stored before shipment, the distance and means of transport to the multiple production sites, and storage at the production sites. This stage offers multiple important opportunities for contamination as demonstrated by three recent instances of contaminated GE rice seed.[18]
Post-harvest transport
The EA fails to delineate and analyze the opportunities for contamination during post-harvest transport. The EA merely notes that after harvest SemBioSys will ship bagged pharma safflower seeds to its Washington storage and processing facility, following SOPs submitted to USDA.[19] Since the SOPs are CBI, it is impossible to know if bagging, transport, and storage procedures will prevent escape of drug-containing seeds into or near food-crop fields.
An EA that essentially ignores two major routes of contamination is inadequate on its face.
- The EA underestimates routes of contamination and overestimates effectiveness of control measures.
USDA acknowledges that pharma genes and seeds could move off the field during crop production and establishes control measures to respond but they are inadequate. For example, the EA notes that dedicated equipment will be used for planting and harvesting but does not indicate if each of the up-to-ten production sites will have its own dedicated equipment.[20] If not, then the EA has not adequately addressed the possibility of pharma seed dispersal to food-crop fields from the movement of potentially incompletely cleaned equipment from site to site.
According to the EA, to rule out pharma pollen outcrossing to feed or food safflower, no safflower will be grown and no apiaries will exist within ten miles of the production sites.[21] However, the department does not explain how these ten-mile safflower-free and apiary-free zones will be monitored and enforced. Has SymBioSys entered into contracts or obtained commitments from all growers to refrain from growing safflower within a 10-mile radius of each production site? Will the company conduct farmer surveys during the planting season and inspect fields after crops have emerged to be certain the zone is free of safflower? SemBioSys asserts that no registered apiaries are found within the 10-mile radius of each site. How will the company be sure that no apiaries are established in the 2007 growing season?
The EA also notes that wild bees and other pollinating insects are not expected to cross pollinate pharma and food safflower because the insects will be killed as farmers apply insecticides on adjacent wheat and barley fields to control insect pests. We hope that Washington State wheat and barley farmers are doing everything they can to preserve, not kill, wild bees and other pollinators. But in any case, there would be delicate timing issues to assure that pesticide applications on nearby fields would block cross pollination in safflower. How can USDA be sure that all fields will be sprayed and that all bees and other pollinators will be killed? Will SemBioSys survey farmers during the growing season to ensure that insecticides are applied at appropriate times to all fields? Will the company monitor for these insects during the growing season?
The EA has also not adequately addressed the potential for pharma safflower seeds to be dispersed to food-crop fields where they may grow as volunteers in the next growing season and then be harvested as a contaminant in a food crop such as wheat or barley.[22] Extreme weather events could deposit seeds a considerable distance from production sites into wheat or barley fields. USDA ignores this possibility.
Animals may carry seeds from production sites into adjacent food-crop fields. USDA addresses this possibility but ends up dismissing it with vague and unsubstantiated statements, which do not stand up to scrutiny. For example, the EA asserts without documentation that animals would find barley and wheat seeds more palatable than safflower seeds and would therefore be less likely to browse in the pharma safflower fields than in nearby cereal fields.[23] USDA acknowledges that birds could scavenge loose seeds after harvest but asserts that birds prefer other safflower varieties and "would most likely be more attracted to the nearby cereal grain fields."[24] None of these statements is substantiated and even if they were they do not rule out the possibilities for drug-containing safflower seeds to be dispersed by animals to food-crop fields where they may grow and contaminate next year's food crops.
Finally, USDA points to safflower's general lack of seed dormancy[25] to support its argument that pharma safflower will not germinate and grow as a volunteer in subsequent growing seasons.[26] However, a "general lack of seed dormancy" does not mean zero seed dormancy, leaving open the possibility that some pharma safflower seeds may germinate the following growing season in food-crop fields.
In summary, the EA fails to demonstrate that the production of pharma safflower would have no significant impact on the human environment and that no EIS is required.
2. GIVEN USDA'S APPARENT INABILITY TO ESTABLISH AN OVERSIGHT SYSTEM THAT PROTECTS THE FOOD SUPPLY FROM CONTAMINATION BY PHARMA SAFFLOWER AND OTHER PHARMA FOOD CROPS, UCS AND CU RECOMMEND THAT THE DEPARTMENT DENY THE SEMBIOSYS REQUEST AND IMMEDIATELY INSTITUTE A BAN ON THE OUTDOOR PRODUCTION OF ALL PHARMA FOOD CROPS.
USDA's 15-year history regulating pharma crops has demonstrated the immensity of the biological challenge inherent in forcing genes and seeds used in the open air to stay put. Although USDA's regulations have gotten progressively stronger, the department errs too often on the side of lax oversight, even now as demonstrated in this EA.
But even if USDA were to strengthen its pharma crop oversight to a level that would theoretically completely protect the food supply, the new system would be enormously costly and complex to establish and implement. After considerable analysis, UCS and CU have concluded that regulations sufficiently strong to protect the food supply would be well beyond the department's capacity to institute and oversee.[27]
Our judgment is backed by evidence, noted below, of USDA's poor record in implementing its current regulatory system, which is much simpler than one that would be necessary to fully control the movement of pharma genes and seeds.
First, a December 2005 report from the USDA's Office of Inspector General (OIG) detailed significant deficiencies in the department's oversight of GE crop field tests, including trials of pharma crops. For example, the OIG found that the department failed to inspect pharma crop fields as often as promised and to ensure proper and timely disposal of the crops after harvest.[28]
Second, UCS's analysis of USDA documents reveals serious deficiencies in the department's oversight system. In response to a Freedom of Information Act request for information on Ventria Bioscience's 2005 pharma rice production in North Carolina,[29] USDA released documents showing that it completed only three of five required inspections and failed to inspect the fields as promised during critical planting and harvesting events. The department also apparently allowed the company to ignore reporting requirements as the released documents contained only one of nine reports required from the company. Finally, the records showed no contact between USDA and Ventria after Hurricane Ophelia, which passed close to the site in September 2005, despite the fact that the severe weather might have spread pharma rice seeds into a nearby government-run rice-breeding plot.
Third, in the past year, three court judgments have criticized the department for its poor oversight of GE crops.[30]
Finally, in the last six months, three different GE traits or elements have been found in non-GE varieties in the U.S. rice supply.[31]
In light of the potential economic, environmental, and public health consequences of contamination with pharma and industrial genes and the USDA's inability to prevent such contamination, the most prudent policy is for USDA to ban the outdoor production of pharma food crops. UCS and CU urge USDA to adopt and implement such a policy.
Thank you for your consideration of these comments.
Sincerely,
Jane Rissler, Ph.D.
Senior Scientist and Deputy Director
Food and Environment Program
Union of Concerned Scientists
Margaret Mellon, Ph.D., J.D.
Director
Food and Environment Program
Union of Concerned Scientists
Michael Hansen, Ph.D.
Senior Scientist
Consumers Union
[1] UCS uses the term "pharma" to encompass crops engineered for both pharmaceutical and industrial purposes.
[2] USDA Animal and Plant Health Inspection Service. 2007. Availability of an environmental assessment for a proposed field release of genetically engineered safflower. Federal Register 72:5263-64, February 5.
[3] USDA Animal and Plant Health Inspection Service (APHIS). 2007. Draft environmental assessment in response to permit application (06-250-02r) received from SemBioSys, Inc. for a field-test to produce carp growth hormone in genetically engineered safflower (Carthamus tinctorius) seeds, p. 4. Available at http://aphis.usda.gov/brs/aphisdocs/06_25001r_ea.pdf. (hereinafter Draft EA)
[4] USDA APHIS, Draft EA, p. 3.
[5] SemBioSys. ImmunoSphere™ feed additive. Available at www.sembiosys.com/Main.aspx?id=18.
[6] 40 CFR parts 1500-1508, 7 CFR part 372
[7] USDA APHIS, Draft EA, p. 29.
[8] 7 CFR part 340
[9] USDA APHIS, Draft EA, p. 7.
[10] USDA APHIS, Draft EA, appendix VII.
[11] USDA APHIS, Draft EA, p. 5.
[12] USDA APHIS, Draft EA, p. 6.
[13] 40 CFR part 1508.9
[14] USDA APHIS, Draft EA, p. 32, point 3.
[15] SOPs detail the company's procedures for planting, harvesting, transporting, and storing pharma safflower to prevent accidental dispersal from the production sites.
[16] UCS has submitted a Freedom of Information Act (FOIA) request to the department for the SemBioSys permit application and SOPs. However, USDA's history of long delays in FOIA responses means that we have not received the information in time to consider it in these comments.
[17] The February 5, 2007, Federal Register notice (72 FR 5263) indicates that the seed was produced in Chile.
[18] R. Weiss. 2007. USDA backs production of rice with human genes. Washington Post, March 2, p. A2; USDA APHIS. 2007. Statement by Dr. Ron DeHaven regarding APHIS hold on Clearfield CL131 long-grain rice seed, March 5. Available at www.aphis.usda.gov/newsroom/content/2007/03/ge_riceseed_statement.shtml.
[19] USDA APHIS, Draft EA, pp. 9, 23.
[20] USDA APHIS, Draft EA, p. 26.
[21] USDA APHIS, Draft EA, pp. 4-5. Apiaries are important because bees cross pollinate safflower.
[22] A precedent for this concern is the 2002 ProdiGene incident in which volunteer pharma corn was harvested along with food/feed soybeans, ultimately leading to the destruction of 500,000 bushels of contaminated soybeans.
[23] USDA APHIS, Draft EA, p. 8.
[24] USDA APHIS, Draft EA, p. 8.
[25] Meaning the seed typically would germinate before, not during, the next growing season
[26] USDA APHIS, Draft EA, p. 11.
[27] For more detail on the analysis, see UCS's 2004 report, A Growing Concern: Protecting the Food Supply in an Era of Pharmaceutical and Industrial Crops. Available at www.ucsusa.org/food_and_environment/genetic_engineering/pharmaceutical-and-industrial-crops-a-growing-concern.html.
[28] USDA, Office of Inspector General, Southwest Region. 2005. Audit report: Animal and Plant Health Inspection Service controls over issuance of genetically engineered organism release permits. Audit 50601-8-Te, December. Available at www.usda.gov/oig/webdocs/50601-08-TE.pdf.
[29] For more information, including documents released by USDA, see the following UCS web page: UCS uncovers lax USDA oversight of pharma crops. Available at www.ucsusa.org/food_and_environment/genetic_engineering/usda-ventria-oversight.html.
[30] Center for Food Safety, et al. v. Johanns, et al. Docket No. 03-0020 (D. Hawaii, August 31, 2006); International Center for Technology Assessment, et al. v. Johanns, et al. Docket No. 03-00020 (D.D.C., February 5, 2007); Geertson Seed Farms, et al. v. Johanns. Docket No. 06-1075 (N.D. Cal., February 14, 2007).
[31] R. Weiss. 2007. USDA backs production of rice with human genes. Washington Post, March 2, p. A2; USDA APHIS. 2007. Statement by Dr. Ron DeHaven regarding APHIS hold on Clearfield CL131 long-grain rice seed, March 5. Available at www.aphis.usda.gov/newsroom/content/2007/03/ge_riceseed_statement.shtml.
