October 13, 2015

Regulatory Analysis and Development Animal Plant Health Inspection Service United States Department of Agriculture
4700 River Road Unit 118
Riverdale, MD 20737-1236 Docket No. APHIS-2015-0048

Submitted electronically via www.regulations.gov

RE: OFRF Comments on the Petition for Determination of Non- regulated Status: Monsanto Company; Maize Genetically Engineered for Resistance to Dicamba and Glufosinate

On behalf of the Organic Farming Research Foundation (OFRF), we submit the following comments to the Animal Plant Health Inspection Service, U.S. Department of Agricultureʼs (USDA) on the U.S. Department of Agriculture Animal and Plant Health Inspection Serviceʼs (APHIS) request for comment on a petition by Monsanto that APHIS grant non-regulated status to a variety of maize (MON 87419), which has been genetically engineered for resistance to the herbicides dicamba and glufosinate. APHIS has made the petition available for public review, and is specifically requesting comments to help the agency “identify potential issues and impacts that APHIS should be considering” in evaluating the petition.

The Organic Farming Research Foundation (OFRF) is a national, public-interest organization founded in 1990 to foster the improvement and widespread adoption of organic farming systems.The organization was founded as a response to rising demand for organic agriculture research, extension and education to meet the information needs of a growing community of organic farmers and to educate the public and policy decision-makers about organic farming issues.

Because of our work with organic farming systems, OFRF works closely with organic farmers with several serving on our Board of Directors. USDA organic certification standards prohibit organic and transitioning farmers from growing genetically engineered (GE) crops. If organic products are contaminated with unintended GE material at levels exceeding market or organic certifier specifications, these producers sustain substantial economic losses. A survey OFRF conducted with US organic farmers found that 2.2 percent of surveyed farmers has a shipment of product rejected because of GE contamination. The survey also found that GE contamination is a major concern among organic growers. One survey respondent stated that in 2013 90% of their corn was contaminated with GEʼs. One farmer stated, “ I always have fear that traveling GE pollen may impact our farm. I believe that the lawsuits that have prevailed to the demise of small farms are a shame to our history.”

The drift that occurs with GE traits and the lack of process in place to assign liability has led to a practice whereby the non-GE producer must bear the costs associated with GE contamination. This relieves the industry of any incentive to improve the technology or its management to avoid this contamination. This is an unfair and unsustainable system which penalizes the farmer, and should be taken into considered when evaluating the deregulation of new GE varieties.

Because of the critical role biotechnology regulatory decisions have on the economic viability of organic farmers and the integrity of the organic brand, OFRF is submitting comments on this issue.

The Director of Research for OFRF attended the USDA Stakeholder Workshop “Key USDA Activities Already Underway in Response to Recommendations From the USDA Advisory Committee on Biotechnology and 21st Century Agriculture (AC21)” and “New Proposed USDA Activities in Response to Recommendations From the USDA Advisory Committee on Biotechnology and 21st Century Agriculture (AC21)” held in Raleigh, NC on March 12 and 13th, 2015. At that time, we were concerned by the lack of balance and scientific integrity during several of the presentations. Clearly much work remains before USDA understands the documented scientific benefits of organic agriculture and our concerns with the impact of GE on the integrity of the organic brand. In addition, OFRF submitted comments  to USDA on the issue of agricultural co-existence following the meeting in Raleigh, NC. Because no one agency at USDA has the full responsibility to regulate the impact of transgenic crops, organic farmers face two challenges. increased rate of pesticide drift due to gaps in regulation, and uncontrolled gene drift that can lead to transgenic sequences in organic and identity-preserved seed and crops.

OFRF believes that USDA needs a strong regulatory framework to oversee the biotechnology approval process. Obviously, USDA is reviewing this approach based on the recent stakeholder coexistence workshop in April 2015 and the comment period that followed the meeting. Until this framework is established, it would seem judicious for APHIS to wait until this broader regulatory framework is in place before deregulating any new GE crop varieties.

A strong regulatory framework for biotechnology must:

•   Develop a regulatory process that is transparent and informed by independent science;

•   Include farmers and other stakeholders throughout the regulatory and review process;

•   Build into the process the authority to consider and evaluate the long term ecological and human health impacts take into consideration that each new biotechnology product and process pose;

•   Implement a rigorous post-commercialization monitoring system of biotechnology products that informs future regulatory decisions;

•   Develop regulations that improve oversight and tracking on experimental field trials of biotechnology products;

•   Require implementation of contamination prevention practices for GE crop producers and users to safeguard organic producers;

•   Create robust compensation mechanisms for farmers affected by GE contamination resulting in harm, including but not limited to economic losses; and

•   Support non-regulatory actions that bolster research and education for non-GE seed and crop production.

Increased Commitment to Organic Research

The comments and recommendations of OFRF are based on our extensive experience and research on organic farming systems.

National research to determine the causes of incidental transgene presence.

OFRF supports a national research effort to identify the causes of incidental transgene presence, to determine at what stages of production and distribution these occur and to identify solutions for the users of GE technology to address the ongoing problem of incidental transgene presence in organic crops.

OFRF would like USDA to continue to fund crop stewardship and gene flow risk mitigation. Specifically, does gene flow occur in the field via pollen transfer or does it come from the seed itself or occurring during shipment in containers that contain trace levels of transgenic crops? This research could focus on landscape-scale gene flow in alfalfa or on the control of corn pollen germination. OFRF also believes it is important to develop an approach for examining trueness-to-type of holdings in the USDA/ARS National Plant Germplasm System. Without greater clarity on were gene flow occurs, it will be impossible to create prevention strategies.

OFRF supports the reestablishment of the National Genetic Resources Advisory Council. Their future report evaluating available non-GE organic seed varieties and identifying market needs for producers serving GE-sensitive markets will be helpful for organic farmers. Once this report is complete, OFRF supports USDA targeting additional resources to ensure increased organic and public cultivar development. An additional step would be to utilize the Biotechnology Risk Assessment Research Grants Program (BRAG) to conduct independent risk assessment of current and proposed biotech crops for economic and environmental harms. These steps would ensure that USDA helps reverse the trend of fewer public plant breeders along with the loss of biodiversity and genetic resources. Given the challenges related to food security and a changing climate, our country needs to focus on maintaining and increasing a diverse stock of plant and animal genetics.

Update procedures and best management practices for GE traits in plant germplasm and breeding stocks.

OFRF supports a revision of procedures and best management practices for GE traits to reflect the changing research environment and concerns of organic farmers. To maintain genetic diversity, USDA must protect our nationʼs seed supplies from transgenic sequences and keeping them true to type.

OFRF is committed to working as a partner with APHIS and USDA to represent the needs of the organic research community and organic farmers. The issues we raise in our comments reflect our communication and work with the broader organic community.

We appreciate that APHIS is requesting input from stakeholders on specific issues while the agency reviews the petition for deregulating MON 87419. There is also a need to consider broader implications of water quality and human health as the agency considers the increased use of dicamba and glufosinate. A comparative analysis would also be in the public interest evaluating the safety of these substances compare to other herbicides.

There needs to be a balanced and clearly defined process that reflects the shared responsibility between the producers of GE crops and those who suffer loss of market value due to the unintended transfer of transgenic sequences. US agriculture is at a critical juncture as we try to balance food security and a changing climate with an increased need for genetic diversity. Given these high stakes, it is important to move forward deliberately and within a well-thought framework which considers the needs of all stakeholders, particularly producers.

OFRF is committed to working with APHIS and USDA as a partner to represent the needs of the organic research community and organic farmers. The issues we raise in our comments reflect our views on the broader, foundational elements of the biotechnology regulatory framework, as well as some specific areas where research would be beneficial. We appreciate your consideration of our views.


Brise Tencer
OFRF Executive Director

Jane E. Shey
Policy Associate