June 29, 2009
Regulatory Analysis and Development, PPD
APHIS, Station 3A-03.8
4700 River Road
Riverdale, MD 20737-1238
Re: Proposed Rule and Programmatic Environmental Impact Statement for the Introduction of Genetically Engineered Organisms, APHIS Docket 2008-0023
Cc: USDA Secretary Vilsack
USDA Deputy Merrigan
The Organic Trade Association (OTA) thanks APHIS for the opportunity to comment on the proposed regulations for genetically engineered (GE) crops, and for extending its public comment period to enable a fuller examination of the implications of these proposed rules by those affected. While we have several concerns with this proposal, our comments focus on the impact of this proposal on organic producers and on the public perception of organic products as providing a “safe harbor” for those wishing to avoid GE materials.
Please refer to previous comments submitted by OTA on September 11, 2007 in response to Docket No. APHIS-2006-0112] RIN 0579-AC31, a notice of availability of draft environmental impact statement, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering.”
This rulemaking process is an important opportunity for the Department of Agriculture to develop and implement an effective strategy to prevent further GE contamination of the organic seed and food supply. OTA is concerned that failure to do so will decrease public confidence in the USDA certified organic label, lead to erosion of markets for organic food in the U.S. and abroad, and harm American organic farmers as organic production is increasingly "offshored" to countries better able to provide GE-free supplies, such as Argentina and China.
This threat to public confidence in the organic label is a result of pervasive contamination of the organic/non-GE food, feed and seed supply with GE materials. The proposed rules do not address the need to protect organic crops and products from such contamination, which has already caused considerable harm to this vibrant industry. The continued growth and success of the organic industry requires that consumers be assured that such contamination is being prevented.
Organic producers are called upon to protect their crops from contamination and often must conduct expensive testing to confirm the purity even of reputedly GE-free seeds. Others use buffer zones and practice "temporal isolation," or plant earlier or later than GE crop-growing neighbors to mitigate contamination risk, though often to no avail. OTA suggests that the burden of preventing contamination should be born by those who benefit from the proliferation of GE organisms.
Evidence of current damage to organic producers and handlers
Contamination of organic and conventional seeds and crops is widespread and has been documented around the world. A recent report documented 39 cases in 2007 and more than 200 in the last decade. The harms incurred by organic farmers and food companies from transgenic contamination are myriad, and include: lost markets, lost sales, lower prices, negative publicity, withdrawal of organic certification, expensive testing and prevention measures, and product recalls.
In at least one case, pervasive transgenic contamination has eliminated an entire organic sector. According to an article in the journal Nature Biotechnology:
"[T] he introduction of transgenic herbicide-tolerant canola in Western Canada destroyed the growing, albeit limited, market for organic canola."
There are literally hundreds of instances of U.S. organic and non-GE farmers being adversely affected by contamination from genetically engineered crops. A few of many examples are cited below:
* According to a conservative estimate by the Union of Concerned Scientists in 2001, U.S. organic corn growers lose over $90 million annually due to transgenic contamination.
* Organic grain elevators in Minnesota (Earthwise) and North Dakota (SK Foods International) have reported rejection of 2% to 5% of incoming loads due to GE contaminants.
* In the year 2000, North Dakota farmer Tom Wiley lost $10,000 on a contract to supply non-GE, food grade soybeans to a Japanese buyer when his agent tested his load and detected 1.37% transgenic contamination.
* Organic dairy farmer Albert Straus started testing corn fed to his 300-head dairy herd in 2007, and found that about one-third had GE contaminants. He now tests every lot of grain he buys. According to Strauss: "I started to test our products to see if there was an issue or not. It turned out there was an issue. There is so much contamination." Strauss is now adding a label to his dairy products to alert his customers to the GE contaminants, though doing so puts him at risk of losing markets.
* Organic grain supplier Clarkson Grain Company of Cerro Gordo, Illinois, obtains organic seed corn from Argentina, where it is possible to isolate the seed field with a three-mile buffer zone. According to President of Clarkson Grain and OTA Board Member Lynn Clarkson, "I would be happy to do it in Illinois, Indiana, or Iowa, but I can't find that degree of segregation with any reliability."
Contamination can occur at many stages of the farming, grain-handling and seed production process. Without appropriate regulatory safeguards one of the most promising sectors of our agricultural economy will be jeopardized.
Suggested Revisions to the Proposed Rules
OTA suggests that the proposed rules be substantially rewritten in order to provide adequate oversight of GE crops. Following are general recommendations that should be considered in making these revisions:
1. APHIS Must Rely on “Sound Science”
APHIS must rely first and foremost on “sound science,” as required under the PPA and President Obama’s Memorandum concerning “Scientific Integrity.” The Memorandum stipulates that “[s]cience and the scientific process must inform and guide decisions of my Administration,” with the “highest level of integrity in all aspects of the executive branch’s involvement with scientific and technological issues.” APHIS has frequently violated the tenets of sound science in its decision-making documents on GE crops in numerous ways: excessive reliance on applicants’ analysis and data; frequent citation of dubious, industry-sponsored white papers with little or no scientific merit; egregious factual errors biasing decisions in favor of the applicant; among other unscientific practices.
In contrast, sound science requires the agency to undertake its own independent and holistic analysis of the impacts of GE crops; base its decision-making on peer reviewed scientific literature whenever possible; critically examine applicant claims and analysis rather than uncritically accept them; and call in independent experts from outside the agency for external peer review. In addition, unduly narrow assessments – for example, not assessing impacts from pesticides used in conjunction with herbicide-tolerant GE crops – cannot be considered sound science. Finally, sound assessments must also apply the social sciences, for instance, to analyze the economic impacts of transgenic contamination of non-GE crops.
2. Retain Oversight for all GE Crops
The proposed rules give biotech firms undue discretion in determining whether APHIS
regulations even apply to a new GE crop. It is critical that the scope of regulation cover all genetically engineered crops, “as there is no scientific basis on which to forecast which ones might pose a risk.” Straightforward use of the process of genetic engineering as the trigger for regulatory oversight, as recommended by a National Academy of Sciences committee, is both necessary to protect against potential harms from the introduction of genetically engineered organisms, and provides clarity and consistency to the regulatory process.
3. Eliminate "Non-Regulated Status" and Adopt Commercial Permitting
APHIS should end its practice of unconditionally removing GE crops and their progeny from its oversight through a "determination of non-regulated status." This deregulation decision is normally sought by companies prior to commercial introduction of a GE crop. Instead, APHIS should retain authority to monitor and regulate GE crops under commercial permits whenever and wherever their commercialization presents the risk of contaminating sexually-compatible non-GE/organic crops. This step is in line with a recommendation made by the Government Accountability Office (GAO) in a recent report. Commercial permits should be issued only with conditions requiring the GE crop developer and/or grower to employ scientifically sound isolation measures to prevent contamination of surrounding (organic) crops; to pay for third-party, independent testing for transgenic contamination upon the request of neighboring (organic) growers; and to enact other needed measures, such as geographic restrictions on GE crop cultivation, to prevent contamination.
4. Apply the Noxious Weed Authority Fully
APHIS should properly interpret and apply its robust noxious weed authority under the Plant Protection Act (PPA). This includes assessing potential harm from GE crops to “the interests of agriculture,” the environment, and public health, in fulfillment of its statutory mandates under the PPA. Both direct and indirect harms can independently trigger APHIS’s authority and both must be assessed. Application of the PPA’s noxious weed authority is particularly important in the following three areas:
Economic harms from GE crop contamination: Contamination from GE crops, whether via crosspollination or admixture of seeds, is a physical harm that poses risks to organic and conventional farmers’ livelihoods. These risks are properly assessed under this authority and cannot be dismissed as mere marketing or perception issues.
Herbicide-tolerant crops, resistant weeds and pesticide use: The most widely planted class of GE plants – herbicide-tolerant (HT) crops – are specifically designed to withstand application of one or more herbicides (one form of pesticide). HT crop systems – defined as the HT crop and use of the associated herbicide(s) – require regulation as noxious weed risks for their propensity to: 1) Foster the rapid evolution and spread of herbicide-resistant weeds, which can: (a) lead to increased use of and pollution of
the environment with toxic herbicides, with attendant harms such as adverse impacts on farm workers and wildlife; (b) spur increased soil erosion through greater use of tillage to control resistant weeds; and c) increase weed control costs for growers of all crops; 2) Lower agricultural productivity through the adverse impacts of excessive pesticide use on soil life; and 3) Reduce the availability of weed control options by undermining the efficacy of the HT crop-associated herbicide(s), among other harms.
Public Health: APHIS must implement its authority to regulate and assess the safety of GE crops for human and animal consumption for several reasons: 1) Absence of mandatory assessment of GE crops by the FDA; 2) The use of food crops as biofactories for potentially hazardous pharmaceutical and industrial compounds; and 3) Policies permitting the contamination of commercial food, feed and seed with untested GE crop material.
5. Prohibit Outdoor Cultivation of GE Biopharmaceutical Crops and Any Such Cultivation of Biopharmaceutical Food Crops (Indoors or Outdoors)
Biopharm crops produce experimental pharmaceuticals that in some cases may pose risks to human health or the environment, yet no risk assessment is required before they are grown out of doors. Public interest groups, the food industry, many scientists and even some in the biotech industry advocate an end to outdoor cultivation of biopharm crops to avoid the inevitable contamination of food. In its programmatic EIS, APHIS proposed (and rejected) alternatives that would either bar outdoor cultivation of ALL biopharm crops, or of all biopharm food crops. APHIS’s “current thinking” – that concerns about biopharm crops are nothing more than “marketing” or “public perception” issues – is wrong. Biopharm crops can pose real risks to human health and the environment. Thus, APHIS should prohibit the outdoor cultivation of plants for drug production and the cultivation of ANY such food crops (indoors or outdoors).
6. Eliminate the Low Level Presence Policy:
In its revised regulations implementing the Plant Protection Act, USDA has proposed to codify its existing "Low Level Presence" policy (LLP). The LLP policy allows APHIS to take no recall or similar action when unapproved, experimental GE crops grown in field trials are found contaminating commercial (including organic) food, feed or seed. Exposure to experimental GE crops contaminating food may pose health risks, yet the LLP policy contains no protocols for assessing such potential harms. Despite its appellation, the LLP policy proposes no quantitative, maximum threshold for contamination, so "low level" means whatever level of contamination in fact occurs.
Most importantly, by making such contamination "non-actionable," the LLP policy will greatly reduce the incentive of biotech companies to strive for 100% containment. Under LLP, biotech companies testing new GE crops (sometimes on thousands of acres) will have little incentive to assume the expense of adequately isolating their experimental plots to prevent transgenic contamination in the first place. USDA should eliminate this unscientific policy, and instead make "zero tolerance" of contamination its management goal by mandating recalls whenever experimental GM crops are found contaminating the organic food, feed or seed supply. While "zero tolerance" may not always be achievable in practice, setting the bar lower, as the LLP policy does, will undoubtedly lead to more frequent contamination episodes.
7. Implement the Congressional Mandates in the 2008 Farm Bill
With the adoption of the 2008 Farm Bill, Congress mandated that APHIS "improve the management and oversight" of GE crop field trials (§ 10204), implement measures outlined in the agency's "Lessons Learned" document prepared in the wake of the 2006 'Liberty Link' rice contamination debacle, and adopt a series of other new measures to mitigate transgenic contamination. The proposed rules, however, fail to comply with many of the Farm Bill mandates, such as requiring representative samples of GE crops to be retained by GE crop field trial permit holders, submission of contingency and corrective action plans to address contamination episodes, and use of cutting edge science and technology to ensure effective isolation of GE crops grown in field trials from commercial supplies, among several others. APHIS must revise its proposed rules to comply with these Congressional mandates.
The organic industry provides many benefits to society: healthy foods for consumers, economic opportunities for family farmers, and a farming system that improves the quality of the environment. However, the continued vitality of this sector is imperiled by minimal measures to protect organic production systems from contamination and subsequent environmental, consumer, and economic losses. The USDA's revision of its agricultural biotechnology regulations under the Plant Protection Act offers an important opportunity to develop measures to ensure a fair, transparent and workable regime.
We respectfully request that you give our recommendations to this end serious consideration as you move forward with this important process. We would be happy to discuss these matters further with you at your convenience.
Consultant to the Organic Trade Association
Policy and Regulatory Affairs Manager
Organic Trade Association
 Warwick, supra note 9, at 30 (story of Iowa farmers Roger and Amy Lansink).
 Jerry Perkins, Genetically modified mystery, Des Moines Reg., Aug. 10, 2003, available at http://www.cropchoice.com/leadstry8dc3.html?recid=1968.
 See, e.g., New Study Finds GM Genes in Wild Mexican Maize, New Scientist, Feb. 21, 2009; Rex Dalton (2008) Modified genes spread to local maize: findings reignite debate over genetically modified crops, Nature, 456 (7219), 2000, at 149; The Institute for Nutrition and Food Technology (INTA), Chile enters the list of countries contaminated with GMOs: A report from INTA has detected transgenic contamination of maize in the fields of central Chile, Oct. 22, 2008;Graeme Smith, Illegal GM Crops Found In Scotland, Herald, Sept. 13, 2008; Elizabeth Rosenthal, Questions on Biotech Crops with No Clear Answers, N.Y. Times, June 6, 2006; Gene Flow underscores growing concern over biotech crops, Associated Press, Sept. 22, 2004; Andrew Pollack, Can Biotech Crops be Good Neighbors?, N.Y. Times, Sept. 26, 2004; Lyle F. Friesen et al., Evidence of contamination of pedigreed canola (Brassica napus) seedlots in Western Canada with genetically engineered herbicide resistance traits, 95 Agron. J., 1342-1347 (2003); Simon Jeffery, Rogue genes: An unauthorised strain of GM crops has been found across England and Scotland., Guardian, Aug. 16, 2002; Alex Roslin, Modified Pollen hits organic farms: Genetically altered strains spread by wind, Toronto Star, Sept. 30, 2002; Fred Pearce, The Great Mexican Maize Scandal, New Scientist 2347, June 15, 2002.
 Greenpeace International. GM Contamination Register Report 2007, February 28, 2008, at http://www.greenpeace.org/international/press/reports/gm-contamination-register-2007.
See, e.g., K.L. Hewett, The Economic Impacts of GM Contamination Incidents on the Organic Sector, 16th IFOAM Organic World Congress, Modena, Italy, June 16-20, 2008.
 Smyth et al .(2002). Liabilities and Economics of Transgenic Crops, 20 Nature Biotechnology, June 2002, at 537-541.
See, e.g., Bennett Hall, Battle over Beets, Corvallis-Gazette-Times, May 30, 2009; UM Researcher Cites GE Contamination; Genetic Herbicide Resistance Found in Seeds, Bangor Daily News, Jan. 13, 2006; Scott Miller & Scott Kilman, Biotech-Crop Battle Heats Up as Strains Mix With Others, Wall St. J., Nov. 5, 2005; Paul Elias, New 'Gene Flow' Problems Concern Crop Producers, Associated Press, Sept. 23, 2004; Erica Walz, Fourth National Organic Farmers' Survey: Sustaining Organic Farms in a Changing Organic Marketplace, Organic Farming Research Foundation, 2004; David Barboza, As Biotech Crops Multiply, Consumers Get Little Choice, N.Y. Times, June 10, 2001; Anthony Shadid, Blown profits --Genetic drift affects more than biology - US farmers stand to lose millions, Boston Globe, Apr. 8, 2001.
 Jane Rissler & Margaret Mellon, Comments to the Environmental Protection Agency on the Renewal of Bt-Crop Registrations, Union of Concerned Scientists, Sept. 10, 2001, at 14. http://web.peacelink.it/tematiche/ecologia/bt_renewal_ucs.pdf.
 Hugh Warwick & Gundula Meziani, Seeds of Doubt: North American farmers' experiences of GM crops, 27, Soil Association 2002, at http://www.soilassociation.org/Web/SA/saweb.nsf/9f788a2d1160a9e580256a71002a3d2b/9ce8a24d75d3f65980256c370031a2d0/$FILE/SeedsOfDoubt.pdf (follow "GM" hyperlink under Why Organic? at bottom of page; then follow "Reports" hyperlink under GM on the left side of the screen; then follow hyperlink to the report).
 Id. at 28.
 Carey Gillam., U.S. organic food industry fears GMO contamination, Reuters, Mar. 12, 2008, available at http://www.reuters.com/article/domesticNews/idUSN1216250820080312.
 Testing Methodologies in Tracing, Segregating and Labeling Foods Derived from Modern Biotechnology: Proceedings, Center for Food and Nutrition Policy, Feb. 25, 2003 at 54, available at http://cfnap.umd.edu/Outreach/Conference%20Proceedings/pdfs/Biotech_Proceedings.pdf.
 Margaret Mellon & Jane Rissler, Gone to Seed: Transgenic Contaminants in the Traditional Food Supply, Union of Concerned Scientists, 2004, available at http://www.ucsusa.org/assets/documents/food_and_agriculture/seedreport_fullreport.pdf.
 Barack Obama, Memo for the Heads of Departments and Agencies, March 9, 2009, at
 USDA (2007). Introduction of Genetically EngineeredOrganisms: Draft Programmatic Environmental Impact Statement, USDA Animal and Plant Health Inspection Service, July 2007, p. 20.
 NAS (2002). Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation, Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants, National Research Council, National Academy of Sciences, 2002, pp. 79, 83.
 Genetically engineered crops: Agencies are proposing changes to improve oversight, but could take additional steps to enhance coordination and monitoring, Report to the Committee on Agriculture, Nutrition, and Forestry, U.S. Senate, U.S. Government Accountability Office, GAO 09-060, Nov. 2008, at 30-32.
 USDA (2007), op. cit., Alternatives 3 and 4, pp. 32-33.