June 19, 2017
Regulatory Analysis and Development
PPD, APHIS, Station 3A-03.8,
4700 River Road Unit 118,
Riverdale, MD 20737-1238.
Mr. Sidney W. Abel
Assistant Deputy Administrator
Biotechnology Regulatory Services
4700 River Road Unit 147
Riverdale, MD 20737-1236
RE: Docket ID No. APHIS-2015-0057-0001. Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms.
Dear Dr. Abel,
The National Cotton Council (NCC) appreciates the opportunity to provide input in response to the USDA Animal and Plant Health Inspection Service’s (APHIS) request for public comment on the proposed revisions to its biotechnology regulations in 7 CFR part 340.
The NCC is the central organization of the United States cotton industry. Its members include producers, ginners, cottonseed processors and merchandisers, merchants, cooperatives, warehousers and textile manufacturers. A majority of the industry is concentrated in 17 cotton-producing states stretching from California to Virginia. U.S. cotton producers cultivate between 9 and 12 million acres of cotton with production averaging 12 to 18 million 480-lb bales annually. The downstream manufacturers of cotton apparel and home furnishings are located in virtually every state. Farms and businesses directly involved in the production, distribution and processing of cotton employ more than 125,000 workers and produce direct business revenue of more than $21 billion. Annual cotton production is valued at more than $5.5 billion at the farm gate, the point at which the producer markets the crop. Accounting for the ripple effect of cotton through the broader economy, direct and indirect employment surpasses 280,000 workers with economic activity of almost $100 billion. In addition to the cotton fiber, cottonseed products are used for livestock feed, and cottonseed oil is used as an ingredient in food products as well as being a premium cooking oil.
Biotech cotton was first introduced in 1996 and U.S. cotton producers adopted the new technology rapidly. Currently, approximately 90% of U.S. cotton is planted with insect resistant and/or herbicide tolerant genetically enhanced cotton varieties. The latest estimates of the benefits of these insect resistant biotech varieties are 185 million lbs/year increase in production; 1.9 million lbs/year decrease in insecticide use; and $103 million/year increase in net revenue for U.S. cotton producers. The benefits of herbicide tolerant biotech cotton in the U.S. include a 6.2 million lbs/year decrease in herbicide active ingredients applied and $133 million/year savings in weed control costs.2
While the current Federal regulatory system for biotechnology products effectively protects human health and the environment, advances in science and technology have altered the product landscape in recent years. In addition, the complexity of the current regulatory system can make it difficult for the public to understand how the safety of biotechnology products is evaluated and creates challenges for small and mid-sized businesses to navigate the regulatory process for these products. To address these challenges, on July 2, 2015, the Executive Office of the President issued a memorandum (July 2015 EOP Memorandum) directing the primary agencies that regulate the products of biotechnology (USDA, FDA & EPA) to accomplish three tasks, but to primarily update the Coordinated Framework for the Regulation of Biotechnology (51 FR 23302; June 26, 1986).
Today, biological breakthroughs are enabling producers to confront the overall challenge for agriculture: doing more with less. Society still faces the challenge of clothing and feeding an ever-expanding population, which will reach nine billion by 2050 and require at least a 70 percent increase in food, fiber, feed and fuel production. Advancing the adoption of innovations and technology for agricultural production and long-term, sustainable rural development is a key goal in the White House’s recently published directive promoting US agriculture and rural prosperity. A regulatory climate that fosters innovation in agricultural biotechnology will be an important component in meeting that goal, by continuing to provide a set of precise yet flexible tools for meeting the challenges facing US producers today.
The NCC would like to commend APHIS for its attempt to develop a better regulatory system for agriculture biotechnology as well as for recognizing the long history of scientific evidence that supports the safety of products developed using these methods. However, the proposed revisions to the APHIS regulations raise concerns significant enough to prevent the NCC from supporting the current proposal. After our close examination of the proposal, we decided there are too many significant problems that need to be addressed before APHIS can achieve its innovation-related goals. Those problems include the following:
- Lack of transparency and clarity, and potential arbitrariness, in the regulation;
- Increased regulatory burden imposed on the research and development phases of product innovation;
- Inability of the agency to implement the proposed regulatory system on a scale compatible with current research and development, potentially leading many products to be trapped in regulatory limbo;
- Potential inconsistency with other APHIS programs implementing the same regulatory authority; and,
- Significant unintended consequences for other regulatory agencies, and domestic and international markets
The issues listed above will have a significant negative impact on agricultural innovation, particularly for small companies and universities focused on developing products for a specific regional need or environmental use. Therefore, in order to address these problems, the NCC believes APHIS will need to re-propose the rule using a different regulatory pathway, which will give them the opportunity to meet their goals with fewer risks and disruptions.
We believe that APHIS will be best able to successfully improve its regulatory system by making more focused, precise changes, strategically focused on addressing specific issues, rather than by undertaking a radical departure from the current system. Our key recommendations include:
- APHIS should abandon its “up front” regulatory status evaluation concept and instead define clear, risk-based criteria defining the scope of regulation;
- APHIS should refine the plant pest risk scope of 7 CFR 340 by incorporating the agency’s proposed plant pest-related triggers;
- APHIS should add a new mechanism to its regulations to allow the agency to assess and potentially remove from regulation broader categories of familiar species-trait combinations; and,
- If necessary, APHIS should propose revisions to its noxious weed regulations (7 CFR 360) to identify specific categories of GE plants (if any) that need further evaluation as possible noxious weeds.
The current regulatory system has operated quite successfully for decades and has resulted in no adverse plant health impacts to U.S. agriculture. In the end, we believe that making targeted strategic improvements to the current regulatory system will engender broader support, prove easier to implement, and have a much more immediate impact with fewer unintended consequences.
Finally, we appreciate the strong position APHIS is providing regarding pre-market review of products of newer techniques like genome editing, and the similarity of many products derived from these techniques to conventional plant breeding. However, policies that are globally consistent for products of plant breeding innovation are essential to avoid trade disruptions. Therefore, U.S. government agencies should be encouraged to actively engage with our trading partners as soon as possible to work toward consistent, science-based policies across countries.
U.S. cotton producers have a vested interest in the continued availability of new biotechnology products under a regulatory system that is efficient and streamlined while protecting the health and safety of the American public and environment. In addition, we encourage APHIS to explore policy options that make implementation of its existing regulations more consistent with the risks posed by the activities it oversees, such as: 1) meet its regulatory timelines for making final determinations on petitions, in order to improve the timeliness and predictability of its reviews; 2) expand the use of the extension process for products similar to those already reviewed; 3) exclude or exempt from regulation categories of organisms that are unlikely to be plant pests; and 4) field trails should have appropriate oversight proportionate to the actual risk posed by the organism.
The NCC appreciates this opportunity to provide comments on proposed revisions to APHIS biotechnology regulations. Please do not hesitate to contact us with any questions or concerns.
Senior Scientist, Regulatory and Environmental Issues
 Plant Biotechnology: Current and Potential Impact For Improving Pest Management In U.S. Agriculture: An Analysis of 40 Case Studies by Leonard P. Gianessi, Cressida S. Silvers, Sujatha Sankula and Janet Carpenter, National Center for Food and Agricultural Policy, June 2002.
2The Potential for Biotechnology to Improve Crop Pest Management in the U. S.:40 Case Studies by Leonard P. Gianessi, Cressida S. Silvers, Sujatha Sankula and Janet Carpenter National Center for Food and Agricultural Policy, June 2002.