Glyphosate-Tolerant Alfalfa Events J101 and J163: - Organic Trade Association
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Glyphosate-Tolerant Alfalfa Events J101 and J163: 01-20-11


The Honorable Tom Vilsack
U.S. Department of Agriculture
1400 Independence Ave., SW
Washington, DC 20585

Glyphosate-Tolerant Alfalfa Events J101 and J163:

Request for Non-regulated Status


Dear Secretary Vilsack:

The Organic Trade Association (OTA) extends the organic industry’s strong support for the U.S. Department of Agriculture’s recent proposal to consider the broad economic consequences of unrestricted deregulation of Round-up Ready (RR) Alfalfa, including the impact on organic agriculture and products in the United States.

OTA truly appreciates your admonition to seek meaningful co-existence for all agricultural production, and your facilitation of dialog between the parties has proven beneficial. Your leadership in calling for this dialog is historic. Thank you.
The organic industry firmly believes that USDA has taken an important first step in acknowledging organic and identity preserved (IP) agriculture’s right to exist within a policy framework of co-existence. Accordingly, a meaningful co-existence policy framework must take into consideration the interests of all parties. The organic industry, in turn, has applied itself with seriousness to answering the question, “Under what conditions can organic and IP alfalfa production co-exist with Glyphosate Tolerant (GT) Alfalfa?”

OTA’s membership proposes a set of specific recommendations for improvement to “Alternative 3” that, if adopted by USDA, would provide a fair, viable framework for co-existence of organic and identity preserved alfalfa with RR alfalfa. In summary, “Alternative 3” must include four provisions: 1) final adopted stewardship measures in advance of any planting, 2) goals for protecting the seed supply, 3) a mechanism for ongoing oversight by USDA, and 4) a shifting of the cost-burden away from IP producers and markets.

OTA asserts that these conditions must be adopted and that the USDA only move forward under the frame work of “Alternative 3” as it considers deregulation of Round-up Ready (RR) Alfalfa by a Record of Decision.

Background & Statement of significant interest

The Organic Trade Association (OTA) thanks you for this opportunity to comment on the alternatives under consideration by USDA as it contemplates a Record of Decision regarding the application to deregulate Glyphosate Tolerant (GT) or Round-up Ready (RR) alfalfa. 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 its 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/). OTA’s membership, including the full organic supply chain from single operator growers to Fortune 250 companies, represents over 4,500 certified organic operations in the United States.

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.

While OTA members have a significant interest in this issue, it is not one of pro-business and anti-business forces at odds but rather a crossroads between two industries vital to a vibrant U.S. economic recovery. The two industries do not fall into camps along the lines of organic versus conventional but rather traditional production agriculture versus biotech-agriculture. Organic is a significant, and one of many important parts, of the traditional or identity preserved (IP) agricultural base that serves sensitive markets and consumers concerned about the adventitious presence (AP) of genetically engineered crops and products. U.S. agriculture cannot be successful on the backs of biotech-agriculture alone, IP agriculture must have its place in the future of agriculture in order for rural livelihoods to thrive into the 21st Century and beyond. Both markets must be protected in order for farmers to maintain the right to choose the best farming practices as well as markets for their crops.

The organic sector is an important part of a diverse U.S. agricultural economy—a 26.6- billion-dollar-a-year industry that employs tens of thousands around the country, and helps keep at least 14,540 family farms operating in our rural countryside. Except for 2009, the organic industry has experienced double digit growth annually—often over 20% every year—for over a decade. Organic operations are entrepreneurial, and play a contributing role in revitalizing America’s rural economy, an issue that we know is a high priority for you. As our country has been dramatically affected by the worst economic downturn in 80 years, the organic industry has remained in positive growth territory and has come out of the recession hiring employees, adding farmers and increasing revenue.

The U.S. organic dairy sector is at the heart of the organic industry’s interest in the Record of Decision in the request to deregulate GT alfalfa. Organic alfalfa forage serves as an important feed source to the organic dairies. Organic dairy comprises 15% of the total organic market. Organic dairy is an important entry category for new organic consumers and most importantly, in the context of this decision, has the most directly connected and developed U.S. supply base. This supply base is critical to the growing organic industry and offers a viable economic model for small- and medium-sized dairy farms in a historically challenging environment for dairy farms as a whole. There are 250,000 organic dairy cows in the United States today compared to 13,000 just over a decade ago. The success in organic dairy is not to be underestimated for its positive impact on many rural communities.

The continued health and growth of the organic industry/market requires that our supply chain not be compromised. Contamination by the increased unrestricted planting of GMO crops presents a grave threat to our ability to meet growing consumer demand. GE-contaminated organic crops and products lose their market value, and the costs to prevent contamination and testing to verify that crops and products are free of such contamination are all currently borne solely by the organic industry. Contamination has real economic consequences to organic farms and product manufacturers. Not only are export markets, critical to the future growth of our industry, put at real risk but U.S. organic processors will be forced to source agricultural ingredients overseas when U.S. supplies become contaminated. Our consumers simply will not accept GE-contaminated products. That is, in fact, one of the major reasons that they buy USDA certified organic products.


No issue is more important than the ongoing role of government oversight, with the USDA establishing meaningful co-existence in the case of alfalfa specifically, and GE and IP crops generally. The organic industry’s clear and strong-felt position is that retention of regulatory oversight is essential to meeting the goals of co-existence through deregulation with conditions for RR alfalfa. We cannot state this more emphatically. Critical components to an ongoing authority for USDA in this regard are:

  • establishment of a goal(s) – long-term secure supply of ‘pure’ seed,
  • built-in mechanisms for evaluation (performance audit) and improvement,
  • penalties and consequences for not meeting performance goals, and
  • formal balanced stakeholder input.


A discussion of the legal basis for ongoing authority is beyond the scope of these comments on the FEIS on RR alfalfa. An overview of OTA’s position in this regard can be seen in Appendix 2 in the broader policy on co-existence outside of the alfalfa question at hand. But suffice it to say, co-existence between organic and IP alfalfa and RR alfalfa without ongoing oversight by USDA is not meaningful and represents the status quo, in other words meaningless co-existence, in name only.

A specific recommendation in this area is for USDA to immediately reestablish the National Genetic Resources Advisory Council (NGRAC), with updated appointments representing the broad stakeholders across agriculture, with a mandate to advise the Secretary on meaningful co-existence framework development, performance monitoring, and recommendations for continuous improvement.

The President announced an Executive Order on Jan. 18, 2011, to “require that federal agencies ensure that regulations protect our safety, health and environment while promoting economic growth. And it orders a government-wide review of the rules already on the books to remove outdated regulations that stifle job creation and make our economy less competitive. It’s a review that will help bring order to regulations that have become a patchwork of overlapping rules, the result of tinkering by administrations and legislators of both parties and the influence of special interests in Washington over decades.” OTA believes meaningful co-existence, as defined in our comments, meets the test of this order and can stimulate jobs in rural America, protect a diversity of markets and protect against one-sided outcomes advocated by a few powerful special interests through targeted ongoing oversight by USDA.



A reliable, viable and ongoing supply of IP seed, uncontaminated by GE alfalfa, is at the heart of meaningful co-existence in the context of restricted/conditional deregulation of GE alfalfa. To that end, USDA should invest in public alfalfa cultivar development and expand the scope and funding for the National Germplasm System. The industry-led informal working group comprised of IP, organic and biotech industry representatives reached substantial agreement with the following statement:

There needs to be a high level of confidence that public and private alfalfa breeders can maintain a sustainable supply of conventional alfalfa germplasm, breeding stock and foundation seed with the goal of non-detectable adventitious presence (AP) with an initial maximum level of < 0.1% with 95% confidence level.

The organic industry as whole supports this statement as a critical goal or performance measure from which to evaluate the effectiveness of deregulation with conditions. Without a concrete goal or established performance measure, the plan for RR alfalfa includes only a quality assurance program without a quality control plan. The goal of non-detectable presence of genetically engineered traits becomes essential in the context of seed bank inventories. It must be noted that any threshold goal cannot be separate from the need for liability and compensation.


Stewardship plan

Prior to the planting of any RR Alfalfa, a specific stewardship plan must be finalized and adopted, and that stewardship plan must be linked to regulatory oversight, compliance, enforcement and penalties.

Geographic zones and isolation distances must be implemented in advance of any planting of GT alfalfa seed in order for a stewardship plan to be viable. These zones must isolate the production of RR alfalfa in a significant and rigorous way, and the implementation of these zones for seed production must coincide with the release of any RR alfalfa seed for forage planting. Zones must be established for the production of RR alfalfa seed as well as zones set aside for the production of IP alfalfa seed.

The three zones proposed by USDA in “Alternative 3” may not be optimal to reach the objectives of maintaining an ongoing pure seed supply. We have concerns regarding the ability of the proposed isolation distances, geographic limitations and the tiered system approach contained in the GT Alfalfa FEIS Alternative 3 to provide an effective regulatory framework that minimizes GT Alfalfa contamination, and to meet the purpose and need of USDA to promote programs that support co-existence. Despite those concerns, we continue to support Alternative 3 conditioned on USDA maintaining regulatory authority over GT Alfalfa as proposed in the FEIS.

Our concern with the proposed framework for the establishment of isolation distances, geographic limitations and creation of the tiered system approach is based on USDA’s over-reliance on the seed certification programs as a basis for the regulatory framework.

Generally, the purpose of the seed certification programs is to promote “varietal purity” in order to limit the commingling of hybrids between seed fields growing different varieties of the same crop. The purpose is to ensure that the seed in the bag that the farmer purchases is largely the variety he wants and does not contain a substantial amount of “off type” seeds (i.e., different hybrid/same crop). The 165' setback requirement in the GT Alfalfa FEIS is a “certification standard” designed to ensure that no substantial commingling of hybrids occurs. The isolation distances established pursuant to the certification standard are not designed to ensure that contamination does not occur between genetically engineered seed and non-propriety seeds of the same crop.

The need for a different standard for establishing isolation distances between GT and non-GT Alfalfa is recognized by the Association of Official Seed Certifying Agencies (AOSCA). The AOSCA Alfalfa Seed Stewardship Program (ASSP) 2010 standard requires isolation distances of five miles between GT and non-GT seed fields and two miles between GT hay and non-GT seed fields. This ASSP standard conforms to USDA’s acknowledgement in the GT Alfalfa FEIS that alfalfa is a bee-pollinated crop and that leafcutter bees will forage up to one mile, with honey bees foraging up to 1.86 miles and alkali bees from 4-5 miles. We believe that isolation distances need to be established which ensure that GT Alfalfa contamination of GE-sensitive conventional and organic alfalfa hay and seed fields does not occur, and the purpose and need to promote co-existence are achieved. The AOSCA ASSP standard is more appropriate to that purpose. Additionally, USDA must retain authority to monitor compliance and effectiveness of the isolation distances imposed, and have the ability to modify setback standards if goals/objectives regarding contamination distances are not being achieved.

Similarly, we have concerns regarding the methodology used by USDA in establishing the geographical limitations imposed pursuant to the proposed tiered system. USDA indicates that it bases the categorization on U.S. Agriculture Census figures for “commercial seed production.” We are not clear on the definition, but the conclusions are clearly contrary to discussions with alfalfa seed and hay producers in the Midwest, for example. Those producers assume that USDA defines commercial seed production as by those alfalfa seed producers who are certified. Those producers indicate that participation in the seed certification program is voluntary, and many producers opt out of the program since they see little economic benefit from participating in the certification program. If those assumptions are accurate and there is a significant amount of alfalfa seed grown in the Midwest, particularly South Dakota, then the entire tiered system is skewed, and seed producers in the Tier 1 and 2 states are not receiving adequate protection against the threats of GT Alfalfa contamination. Ultimately, this could result in substantial contamination of alfalfa seed and hay forage. This issue is of particular significance to organic alfalfa growers, dairy and beef producers in Tier 1 and 2 states.

OTA is not convinced that the rationale to establish the tiered system is adequate to prevent contamination. We would propose that prior to any finalization of theses geographical restrictions, USDA address the regional variations and the fact that seed certifications are voluntary, with many producers opting out.


Handling, storage, and the prevention of commingling are critical to the effectiveness of a stewardship program, and again must be finalized and adopted prior to the release of RR seed for planting. The organic standards serve as an effective model for cleaning procedures, record keeping, audit and verification of practices to prevent commingling. Labeling and identity markers should be included as well. Additional specific suggestions that must be included in a final stewardship plan but not yet detailed in Alternative 3 are:

  • A provision for dealing with unused GT alfalfa seed (seed that is left over after the grower finishes planting a field) must be included in a final stewardship plan. Left-over seed should be returned to the seed supplier or destroyed (documentation required).
  • Feasibility for ensuring compliance to the provision requiring forage be harvested at less than 10% bloom in fields planted within 165 feet in ‘Tier II’ states is a concern.
  • More prescriptive language to accomplish the objective of preventing comingling is required in a final stewardship plan.



Alternative 3 takes significant steps to protect alfalfa seed stock purity, but does not afford the same protection to forage. We strongly urge USDA to include forage in the regulatory framework to provide the same protections afforded alfalfa seed producers. We believe that we have demonstrated that there is sufficient GE sensitivity in the organic dairy and beef industry marketplace to warrant inclusion.




At present, there is no structure for compensating for economic harm suffered as a result of GE crop contamination. The FEIS indicates that failures to comply with Alternative 3 mandates could result in penalties. 7 U.S.C. 7734 provides for criminal and civil penalties when PPA violations occur. The Civil Penalty provisions contained in 7 U.S.C. 7734(b) provide for fines of up to $500,000 for violations that are not willful or “twice the gross gain/loss that results in a person deriving pecuniary gain or causing pecuniary loss to another.”

The compliance component of Alternative 3 contemplates penalties for failure to adhere to the management practices, isolation distances and geographic restrictions mandated, and biotech adopters (i.e., marketers) will be held responsible for compliance failures. The final Record of Decision must include a framework for penalties.

OTA refers to the compensation appendix presented in the Final Report to the Secretary from the Alfalfa Stakeholders Working Group.



In summary, “Alternative 3” must include: final adopted stewardship measures in advance of any planting, goals for protecting the seed supply, a mechanism for ongoing oversight by USDA, and a shifting of the cost burden away from IP producers and markets. OTA requests these improvements be adopted and USDA move forward under “Alternative 3” to deregulate Round-up Ready (RR) Alfalfa with concrete conditions in its Record of Decision.

OTA’s comments have focused exclusively on the alfalfa question at hand, but resolution of meaningful co-existence between organic and IP agriculture with Biotech agriculture is an issue that will not go away until resolved. OTA’s full membership recognizes the strategic importance to the industry and will stay fully engaged going forward. To that end, attached in Appendix 2 is an overview of OTA’s broad co-existence policy.
The Organic Trade Association (OTA) again thanks the Secretary for the U.S. Department of Agriculture’s recent proposal to consider the broad economic consequences of unrestricted deregulation of Round-up Ready (RR) Alfalfa, including the impact to organic agriculture and products in the United States.

OTA truly appreciates your admonition to seek meaningful co-existence for all agricultural production. Your facilitation of dialog between the parties has proved beneficial. Your leadership in calling for this dialog is historic. We remain committed to seeking meaningful co-existence policies, frameworks and regulations.

Respectfully submitted on behalf of the U.S. organic industry,

Christine Bushway
CEO, Organic Trade Association


Kathleen Merrigan, Deputy Secretary
Edward Avalos, Under Secretary, Marketing and Regulatory Programs
Ann Wright, Deputy Under Secretary, Marketing and Regulatory Programs
Cindy Smith, Administrator, APHIS
Max Holtzman, Senior Advisor to the Secretary, Office of the Secretary
Michael Gregoire, Deputy Administrator, Biotechnology Regulatory Services
Mark Lipson, Organic and Sustainable Agriculture Policy Advisor.



US Organic Agricultural Production, 1997 - 2008
Selected Products and Major States



Top States in 2008




Hay, All Dry (tons)





US total


























North Dakota














Milk cows (number)





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New York

























OTA Co-existence Policy

Contamination of organic crops by GE crops is the critical strategic issue for the organic industry.

Prevention of GE contamination of organic crops is essential to the continued health and growth of the industry. Consumer choice in the marketplace, consumer confidence in the USDA organic label, and value-added market opportunities for US farmers will be undermined without this protection. Regardless of the organic regulation’s tolerating non-intentional contamination, organic consumers do not want GE contaminated products.

  • The marketplace is responding to this consumer demand and has begun encouraging additional third-party verification of the “non-GMO” status of organic products.
  • Future consumer confidence and the economic viability of organic agriculture rest on keeping organic crops and products free of GE contamination.

As the organic industry grows world wide, Damage to the global organic market from contamination of organic crops by genetically engineered crops is significant. For US organic farmers that supply the consumer’s increasing demand for organic products, inadvertent contamination has real negative economic consequence on the supply chain. Our consumers simply will not accept GE contaminated products. That is in fact one of the major reasons that they buy USDA certified organic products. Such contamination forces manufacturers to look overseas for commodities, to countries that either have not de-regulated the GE crops or maintain necessary safeguards to prevent contamination. The best picture for a vibrant organic economy is a vibrant U.S. production base.

This unique partnership between organic farmers, producers and suppliers and USDA, that through its seal, has placed the perceived government stamp of approval on all the production practices that organic delivers to the consumer, must have the continued support and protection of the Department in order to exist and grow. The whole world is indeed watching and as organics growth contributes to the President’s goal of doubling exports in the next five years, it is expected that the Department WILL NOT impede that progress.

GE contaminated organic crops and products lose their market value. Currently, the costs to prevent contamination and verification testing are borne solely by the organic industry. In fact, USDA economists have stated,

“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 from 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”.


A policy for contamination prevention and compensation through meaningful co-existence is imperative

It is a prerequisite that any and all policy decisions regarding GE regulation shift the cost(s) and burden(s) associated with meaningful co-existence (complete prevention of contamination form GE crops) from the organic sector 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.

First and foremost, there must be a transparent process or public discussion that includes ALL stakeholders, of what a meaningful “co-existence” policy is, what it means, how it will be implemented and/or enforced.

We believe that “co-existence” is not an apt description for the policy goals that are fundamental to discussions on deregulating new biotech crops. We suggest that the terminology be changed from “co-existence” to “contamination prevention and compensation through meaningful co-existence” to more appropriately describe the policy goals and objectives for the program.

Essential components must include but are not limited to:

  • Assignment of liability to the GE patent holder, including a system of compensation for losses due to inadvertent contamination,
  • 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 of GE through creation of “commercialization permit” that places the burden of contamination prevention on the planters of GE crops versus the current model where the burden is borne solely by Non-GE and organic farmers and handlers
  • Labeling of GE crops and product ingredients.


These safeguards should be viewed as perquisites to any commercialization of GE crops.


  • USDA resources must be utilized to finalize and promulgate final regulations for agriculture biotech regulation, a process that was initiated in 2004 with a Proposed Rule (APHIS-2008-0023) published in 2008.


  • Create a transparent public process engaging ALL stakeholders in formal revision of USDA’s co-existence policy.


USDA resources must be utilized to finalize and promulgate final regulations for agriculture biotech regulation, a process that was initiated in 2004 with a Proposed Rule (APHIS-2008-0023) published in 2008.

USDA has far greater powers at its disposal than it currently utilizes in the regulation of GE 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.

The PPA provides the basis for the regulation of biotech crops, providing 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) regulates the introduction of organisms and products altered or produced through genetic engineering that are plant pests or believed to be plant pests, or regulated articles. The regulations covering GE crops are contained in 7 C.F.R. § 340.

Currently, USDA relies on an antiquated biotechnology crop regulatory system based on 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.

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).

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 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.


The major organic grain in California 1997 was rice, at 8,877 acres

The major organic grain grown in Minnesota in both 1997 and 2008 was corn, at 10,002 acres (1997) and 27,565 acres (2008)

In 1997, Minnesota had 2,425 organic milk cows; Pennsylvania, 1,226; and Maine, 1,020

No 1997 livestock data from State

No 1997 livestock data from State

No 1997 livestock data from State

Greene, Cathy and Smith, Katherine, Economic Research Service, 2nd Qtr 2010, Choices Magazine, a publication of Agriculture and Applied Economics Association

2014 Annual Fund

Research and Promotion 2012