NCC Submits Comments on GE Organisms

The NCC submitted comments to the Animal and Plant Health Inspection Service in response to their stakeholder message on Feb. 27 when they announced the withdrawal of the ’08 proposed rule that would have amended the regulations for certain genetically engineered organisms.

Published: June 26, 2015
Updated: June 26, 2015

June 22, 2015


Regulatory Analysis and Development
PPD, USDA-APHIS, Station 3A-03.8
4700 River Road, Unit 118
Riverdale, MD 20737-1238

RE: Docket No. APHIS-2015-0036

New Stakeholder Engagement on APHIS Biotechnology Regulations

In response to the Animal and Plant Health Inspection Service (APHIS) March 4, 2015 Federal Register notice withdrawing the 2008 proposed rule (7 CFR Part 340) and asking for more stakeholder engagement, the National Cotton Council (NCC) provides USDA/APHIS the following comments to consider.

The NCC is the central organization of the United States cotton industry. Its members include producers, ginners, cottonseed processors and merchandizers, merchants, cooperatives, warehouses and textile manufacturers. A majority of the industry is concentrated in 17 cotton-producing states stretching from Virginia to California. NCC represents producers who cultivate between 10 and 14 million acres of cotton. Annual cotton production, averaging approximately 20 million 480-lb bales, is valued at more than $5 billion at the farm gate. 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 230,000 workers and produce direct business revenue of more than $27 billion. Accounting for the ripple effect of cotton through the broader economy, direct and indirect employment surpasses 420,000 workers with economic activity well in excess of $120 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 the U.S. in 1996 and U.S. cotton farmers adopted the new technology rapidly. Currently, approximately 90% of U.S. cotton is planted with insect resistant or herbicide tolerant genetically enhanced cotton varieties.The latest estimates of the benefits of these insect resistant 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 farmers.1The benefits of herbicide tolerant biotech cotton in the U.S. include a 6.2 million

1Plant 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.

lbs/year decrease in herbicide active ingredients applied and $133 million/year savings in weed control costs.2

U.S. cotton farmers 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. NCC appreciates the efforts of APHIS to upgrade their biotechnology regulations and looks forward to providing input on the four questions posed.

NCC believes APHIS should continue its regulations on biotechnology products based on the plant pest risk posed by the product, and not the technology used to produce it. In addition, APHIS regulations are based upon the Plant Protection Act (PPA), which grants APHIS the authority to prevent the introduction and establishment of plant pests. In turn, APHIS should only regulate those products which pose such risk and should exclude or exempt from regulation those organisms for which there is no scientifically-plausible reason to believe they are likely to present such risk.

In terms of noxious weeds, APHIS already has existing regulations by which it may regulate noxious weeds, based upon the authority granted under the PPA. Despite more than one hundred risk assessments, APHIS has never affirmatively identified a product of agricultural biotechnology to be a noxious weed. However, if APHIS believes that a product of agricultural biotechnology may be a noxious weed, it already has adequate regulations to impose appropriate oversight if needed. Additionally, APHIS should refrain from creating contradictory double standards regarding what it considers to be a noxious weed. Meaning, should APHIS identify such a plant, genetically engineered or not, they have the authority to regulate it. Although, APHIS would risk contorting its statutory authority beyond logic if it were to hold non-GE weeds and plants to one standard, while using a different standard when applied to organisms derived from agricultural biotechnology.

APHIS' mission as derived from the PPA is to protect U.S. agriculture by preventing the introduction and dissemination of plant pests and noxious weeds into the United States and has sufficient authority within PPA to protect U.S. agriculture from these potential risks. Additionally, under the Coordinated Framework, agency review is shared among USDA, FDA and EPA, depending on the product use, ensuring thorough regulatory oversight. Currently, APHIS has not identified a specific need to seek additional legal authorities. Therefore, in the absence of such an identified need, APHIS appears to seek to regulate for the sake of regulation per se, rather than to address a specific protection goal.

NCC looks forward to working with APHIS to identify non-regulatory solutions and/or policy opportunities to assist the agency in meeting its regulatory goals. 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 2011 regulatory timelines for

2 The 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.

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) oversight of field trails should be proportionate to the actual risk posed by the organism.

NCC appreciates this opportunity to provide comments concerning a technology so important to the U.S. cotton industry. Please do not hesitate to contact us with any questions or concerns.

Respectfully submitted,

Reece Langley
VP – Washington Operations