UCS Comments to USDA on Kansas Pharma Rice
UNION OF CONCERNED SCIENTISTS
1707 H St., N.W. Suite 600
Washington, DC 20006
March 29, 2007
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-2007-0006
To whom it may concern:
The Union of Concerned Scientists (UCS) is grateful for the opportunity to comment on the U.S. Department of Agriculture's (USDA's) environmental assessment of Ventria Bioscience's (Ventria's) proposal to plant genetically engineered (GE) pharmaceutical-producing (pharma[1]) rice in Kansas in 2007.
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 UCS CONCLUSIONS AND RECOMMENDATION
UCS's analysis of USDA's environmental assessment (EA) of Ventria's permit applications leads us to conclude that the EA provides insufficient evidence to determine whether an environmental impact statement (EIS) is required under the National Environmental Policy Act (NEPA). Key conclusions in the EA rely on information withheld from the public. Without that information, the USDA cannot support its NEPA analysis. The evidence it presents does not support the finding that the impacts of planting pharmaceutical-producing rice will be insignificant. Given the USDA's poor record in implementing its current regulatory system, UCS concludes that the department is unable to protect the food supply from contamination by pharma food crops. As a result, the only prudent policy is for USDA to ban the outdoor production of all pharma food crops. UCS urges USDA to deny Ventria's requests and immediately implement a ban.
BACKGROUND
In the February 28, 2007, Federal Register (FR),[2] the USDA published an EA[3] on the department's proposed approval of permits for commercial scale production by Ventria of GE pharma rice in Kansas and announced a public comment period.
Ventria's application
According to the FR notice, Ventria submitted applications in October 2006 for three permits (06-278-01r, 06-278-02r, 06-285-02r) to grow GE pharma rice in Geary County, Kansas. While the EA did not give the planned acreage, other USDA data indicate that Ventria proposed to plant 3200 acres in pharma rice.[4]
If granted, these three permits would bring to 23 the total issued to the company over the past decade. Since 1997, the USDA has issued permits to Ventria to grow rice engineered to produce a variety of pharmaceutical compounds in California, Hawai'i, and North Carolina.[5] In recent years, the company has concentrated on pharma rice engineered with human genes to synthesize lactoferrin, lysozyme, and serum albumin proteins.
The 2007 field plantings are intended to be used to produce rice seed for subsequent plantings and for extraction of the three proteins for commercial and research products.[6] According to the EA, the company plans to market lactoferrin and lysozyme as medical foods (such as oral rehydration solutions) and nutritional supplements (for example, in food bars and performance beverages) and serum albumin for use in cell culture.[7]
InVitria is currently selling the three proteins produced in GE rice under the trade names Lacromin™ (lactoferrin), Lysobac™ (lysozyme), and Cellastim™ (serum albumin) for research, diagnostic, and bioprocessing purposes.[8]
Environmental assessment: USDA's findings
The analysis in the EA is intended to support both 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 that the USDA 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,[9] which provides the data and analysis determining whether the effect on the environment is significant enough to require an EIS.[10] If an EA produces a finding of no significant impact, no EIS is required.
The EA concludes, based on USDA's "review and analyses of the data packages presented by the applicant" that the proposed production "should not have a significant impact, either individually or cumulatively, on the quality of the human environment."[11]
USDA regulations
Under the Plant Protection Act of 2002 and regulations governing GE organisms,[12] companies must secure permits from the USDA to plant pharma crops. Typically, the department's EA on an engineered crop includes 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, the department's review and analyses of Ventria's submissions "indicate that the proposed field plantings do not present a risk of introduction and dissemination of a plant pest …."[13] The department proposes to issue permits with supplemental conditions for Ventria's production of pharma rice in Kansas.
UCS CONCLUSIONS AND RECOMMENDATION
1. THE EA IS INADEQUATE ON TWO COUNTS.
The Ventria EA fails to provide sufficient evidence to the public to determine whether to prepare an EIS or a finding of no significant impact. The evidence it does offer does not support the conclusion that the impacts of planting pharma rice will be insignificant.
- The EA provides insufficient evidence to the public to determine 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."[14]
The EA fails to provide critical risk-related information to the public in two important respects. First, the EA withholds the acreage of the proposed plantings. As noted above, USDA data indicate that Ventria proposes to plant 3200 acres of pharma rice in 2007. However, the EA does not mention this or any other specific acreage. Rather, the document notes that "Ventria has proposed to plant acreages comparable in size and scope to those grown in North Carolina in 2006 (http://www.aphis.usda.gov/brs/ph_permits.html. See permit numbers 05-293-01r, 05-332-01r, and 05-332-02r)."[15] At that website, the only data on acreage are:
- 05-293-01r 10-49 acres/trait/crop/institution/year[16]
- 05-332-01r >100 acres/trait/crop/institution/year[17]
- 05-332-02r >100 acres/trait/crop/institution/year.[18]
This information does not disclose the actual size of the field plantings USDA is poised to approve. Rather, it appears that the department will allow Ventria to grow anywhere from a 100 acres to hundreds or even thousands of acres under each of the two permits—05-332-01r and 05-332-01r.
Without knowledge of the acres to be planted, the public cannot begin to evaluate the risks of the pharma rice plantings or confinement measures.
Second, USDA's finding of no significant impact rests on the department's certainty that the company can "ensure that none of the engineered rice plants persist in the environment beyond the termination of the plantings."[19] That certainty in turn depends on the company's strict adherence to procedures and safeguards described in the company's permit applications, the company's standard operating procedures (SOPs), and USDA's supplemental permit conditions.[20] However, the permit applications and SOPs are unavailable to the public despite a Freedom of Information Act (FOIA) request submitted by UCS. Since these documents are central to the EA's conclusion of no significant impact, the evidence contained therein must be made public.
An EA that withholds the key risk-related information identified above is unacceptable legally and provides the public little confidence in the USDA.
- The EA improperly concludes that the environmental impacts of planting pharma rice would be insignificant.
USDA acknowledges that routes exist for pharma rice to be disseminated from the production sites but concludes that the routes appear either unlikely or are blocked by containment measures required by the department. As shown below, however, the EA fails to analyze two major routes of potential contamination and virtually ignores the potential for weather events to disperse pharma rice seeds.
i. The EA ignores two major routes of contamination.
Seed production and transport to Kansas planting sites
The EA fails to consider the potential for contamination during seed production and transport, ignoring, for example, where the pharma rice seed was produced, the conditions under which it was produced, how and where the seed was stored before shipment, the distance and means of transport to the proposed production sites, and storage at the production sites. As three recent instances of contaminated GE rice seed have illustrated, the seed production stage offers multiple important opportunities for contamination.[21]
Post-harvest transport within Kansas
The EA ignores two important opportunities for contamination during post-harvest shipping within Kansas. First, the USDA does not evaluate the transport of pharma rice seeds from the field production sites to the processing facility. The EA merely notes that seeds "will be machine-harvested using a dedicated combine and dried and cleaned in a designated/dedicated staging area in the same county using a dedicated dryer and cleaner (emphasis added).[22]
Second, the USDA fails to consider the potential for seed dissemination during intrastate shipment of seeds from storage to planting sites in Kansas.[23] USDA writes that "[s]ome viable seed may be stored in APHIS-inspected locations and/or shipped to other locations for analysis or planting in subsequent seasons. All interstate shipments will be done under APHIS permits (emphasis added)."[24] The EA does not address the potential for dispersal of pharma rice seeds during intrastate transport from the Kansas storage/processing facility to planting sites elsewhere in the state.
ii. The EA virtually ignores the potential for weather events to disseminate pharma rice seeds.
USDA's assessment gives little attention to the possibility that weather events could disseminate pharma rice seeds away from the planting sites. A reference to flooding is the EA's only acknowledgement of the possible role of weather in dispersal, noting, without substantiation, that the proposed planting sites "are not prone to flooding" and "do not have a history of flooding."[25] The fields are within three to four miles of the Kansas River and one mile of the Smoky Hill River[26] (a tributary of the Kansas River).
The USDA does not provide the sources of information on the flood history of the sites. As a result, we cannot evaluate its conclusions about the potential for flooding in the future. We do not know, for example, whether the planting sites were inundated during the flood of 1993, which affected much of the Midwest. According to the National Oceanic and Atmospheric Administration, "[m]oderate to major flooding occurred in a large part of the Kansas River Basin during July 1993. The Kansas, Big Blue, Black Vermillion, Smoky Hill, Solomon, Saline, and Republican Rivers, along with their tributaries, produced flooding of agricultural fields, numerous secondary roads, and many county, State, and Federal highways."[27]
Major rainfall events and subsequent flooding in the future could be important for two reasons. First, if Ventria's fields were flooded soon after planting or near harvest, pharma rice seeds could easily be carried away from the production sites. Second, heavy rainfall and flooding might create water-soaked habitats outside the production sites and perhaps in fields planted to food crops where the disseminated seeds might germinate and grow.
The EA also ignores the possibility that tornadoes could disseminate pharma rice seeds over long distances. Kansas ranks third among states in the frequency of tornadoes, averaging 47 per year.[28]
The USDA and Ventria's indifference to the potential role of weather in pharma crop contamination of the food supply is not new. In September 2005, Hurricane Ophelia blew through the area in North Carolina where the company's pharma rice fields were located. Those fields were less than a mile away from a breeding nursery for food rice varieties. Records obtained from the USDA under FOIA show no evidence of communication between USDA and Ventria concerning the hurricane, even though hurricane-force winds, heavy rains, and flooding might have carried pharma rice seeds away from the company sites. Even with the rice nursery less than a mile away, it appears that Ventria did not contact USDA and the department took no action to determine the effects of the hurricane and waited until mid-December to inspect the site.[29]
In summary, the EA fails to demonstrate that the production of pharma rice would have no significant impact on the human environment and that no EIS is required.
2. UCS RECOMMENDS THAT THE USDA DENY VENTRIA'S REQUESTS AND IMMEDIATELY INSTITUTE A BAN ON THE OUTDOOR PRODUCTION OF ALL PHARMA FOOD CROPS.
Over the 15 years that the USDA has regulated GE pharma crops, it has become apparent that confining pharma genes and seeds in outdoor settings is an immense challenge. Although the department has progressively strengthened its oversight, the current system is not up to the task of protecting the food supply from contamination. Too often, as illustrated by this EA, the USDA errs on the side of lax regulation.
Even if the department were to substantially strengthen its pharma crop oversight to a level that theoretically would completely protect the food supply, we believe that such a system would be enormously costly and complex—and well beyond the department's capacity to establish and oversee.[30]
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.[31]
Second, UCS's analysis of USDA documents reveals serious deficiencies in the department's inspection and compliance system. In response to the FOIA request, noted above, for information on Ventria's 2005 pharma rice production in North Carolina, 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 Ventria to ignore reporting requirements as the released documents contained only one of nine reports required.
Third, in the past year, three court judgments have criticized the department for its poor oversight of GE crops.[32]
Finally, in the last six months, three different GE rice varieties, none of which have been marketed in the United States, have been found contaminating non-GE varieties in the U.S. rice supply.[33]
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 the department to ban the outdoor production of pharma food crops. UCS urges USDA to adopt and implement such a policy.
A ban would accelerate the development of safer drug-producing alternatives. Some closed systems that do not threaten the food supply already exist, and, unlike pharma crops, have been used to produce FDA-approved pharmaceuticals.[34] In particular, a recombinant human lactoferrin produced in a closed system is already in clinical trials for treatment of lung cancer and diabetic foot ulcers.[35]
Thank you for your consideration of these comments.
Sincerely,
Jane Rissler, Ph.D.
Senior Scientist and Deputy Director
Food and Environment Program
Margaret Mellon, Ph.D., J.D.
Director
Food and Environment Program
[1] UCS uses the term "pharma" to encompass crops engineered for both pharmaceutical and industrial purposes.
[2] USDA Animal and Plant Health Inspection Service (APHIS). 2007. Ventria Bioscience; availability of an environmental assessment for field tests of rice genetically engineered to express lactoferrin, lysozyme, or serum albumin. Federal Register 72:8959-60, February 28.
[3] USDA APHIS. 2007. Draft environmental assessment in response to permit applications 06-278-01r, 06-278-02r, 06-285-02r received from Ventria Bioscience to conduct field plantings of rice (Oryza sativa) genetically engineered to express human lysozyme, lactoferrin and serum albumin. Online at www.aphis.usda.gov/brs/aphisdocs/06_27801r_ea.pdf, www.aphis.usda.gov/brs/aphisdocs/06_27802r_ea.pdf, www.aphis.usda.gov/brs/aphisdocs/06_28502r_ea.pdf. (hereinafter Draft EA)
[4] Information Systems for Biotechnology (ISB). 2007. Field test releases in the U.S. Virginia Polytechnic and State University. Online at www.isb.vt.edu/cfdocs/fieldtests1.cfm.
[5] ISB, Field test releases; some permits were issued under the company's earlier name, Applied Phytologics, Inc.
[6] USDA APHIS, February 28 Federal Register notice.
[7] USDA APHIS, Draft EA, p. 4.
[8] InVitria web site: www.invitria.com.
[9] Except for certain categorically excluded actions that do not require an EA, e.g., routine measures (7 CFR part 372.5)
[10] 40 CFR parts 1500-1508, 7 CFR part 372
[11] USDA APHIS, Draft EA, p. 4.
[12] 7 CFR part 340
[13] USDA APHIS, Draft EA, p. 4.
[15] USDA APHIS, Draft EA, p. 8.
[16] USDA APHIS Biotechnology Regulatory Services (BRS), Environmental Risk Analysis Division. 2006. NEPA decision worksheet, 05-293-01r, January 23. Online at www.aphis.usda.gov/brs/aphisdocs/05_29301r_ndd.pdf.
[17] USDA APHIS BRS, Environmental Risk Analysis Division. 2006. NEPA decision worksheet, 05-332-01r, January 19. Online at www.aphis.usda.gov/brs/aphisdocs/05_33201r_ndd.pdf.
[18] USDA APHIS BRS, Environmental Risk Analysis Division. 2006. NEPA decision worksheet, 05-332-02r, January 19. Online at www.aphis.usda.gov/brs/aphisdocs/05_33202r_ndd.pdf.
[19] USDA APHIS, Draft EA, p. 4.
[20] USDA APHIS, Draft EA, pp. 4, 8, 9.
[21] R. Weiss. 2007. USDA backs production of rice with human genes. Washington Post, March 2, p. A2; USDA APHIS. 2007. USDA provides update for farmers on genetically engineered rice. Biotechnology Regulatory Services Program Announcement, February; USDA APHIS. 2007. USDA identifies safe protein in Clearfield 131 rice seed, March 22. Online at www.aphis.usda.gov/newsroom/content/2007/03/protein_clearfield131rice.shtml.
[22] USDA APHIS, Draft EA, p. 9.
[23] The EA notes that Ventria intends to grow pharma rice in Kansas over the next several years (USDA APHIS, Draft EA, p. 5.)
[24] USDA APHIS, Draft EA, p. 9.
[25] USDA APHIS, Draft EA, p. 10.
[26] USDA APHIS, Draft EA, p. 10.
[27] Cited in U.S. Geological Survey. 2003. The 1903 and 1993 floods in Kansas—the effects of changing time and technology. USGS Fact Sheet 019-03, March, p. 2. Online at www-ks.cr.usgs.gov/Kansas/pubs/fact-sheets/fs.019-03.pdf.
[28] Kansas tornadoes. 2007. Online at www.disastercenter.com/kansas/tornado.html.
[29] Union of Concerned Scientists (UCS). 2006. UCS uncovers lax USDA oversight of pharma crops. Online at www.ucsusa.org/food_and_environment/genetic_engineering/usda-ventria-oversight.html. UCS recently received a document from USDA written nearly a year after Hurricane Ophelia commenting on the hurricane and the Ventria site (A. Sengupta NC/APHIS/USDA to T. Sim MD/APHIS/USDA@USDA. Subject: Ventria-summary, July 17, 2006).
[30] For more detail on UCS's analysis, see A Growing Concern: Protecting the Food Supply in an Era of Pharmaceutical and Industrial Crops, 2004. Available at www.ucsusa.org/food_and_environment/genetic_engineering/pharmaceutical-and-industrial-crops-a-growing-concern.html.
[31] 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.
[32] 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).
[33] R. Weiss. 2007. USDA backs production of rice with human genes. Washington Post, March 2, p. A2; USDA APHIS. 2007. USDA provides update for farmers on genetically engineered rice. Biotechnology Regulatory Services Program Announcement, February; USDA APHIS. 2007. USDA identifies safe protein in Clearfield 131 rice seed, March 22. Available at www.aphis.usda.gov/newsroom/content/2007/03/protein_clearfield131rice.shtml.
[34] See Freese, B. 2002. Alternatives to open-air biopharming, Appendix 5. In Manufacturing Drugs and Chemicals in Crops: Biopharming Poses New Threats to Consumers, Farmers, Food Companies and the Environment. Friends of the Earth and Genetically Engineered Food Alert. Online at www.foe.org/camps/comm/safefood/biopharm/biopharm_report.pdf.
[35]Agennix. N.D. Agennix, a biopharmaceutical company focused on developing protein-based drugs for cancer and diabetic ulcers. Online at www.agennix.com/contentpages/introduction.htm.
