June 10, 2016
Ms. Dana Friedman
Pesticide Re-Evaluation Division (7508P)
Office of Pesticide Programs
Environmental Protection Agency
1200 Pennsylvania Ave. NW
Washington, DC 20460-0001
Regarding Docket No. EPA-HQ-OPP-2008-0850 – Draft Biological Evaluations: Chlorpyrifos, Diazinon, and Malathion Registration Review
Dear Ms. Friedman:
In response to the Environmental Protection Agency’s (EPA) notice “Draft Biological Evaluations: Chlorpyrifos, Diazinon, and Malathion Registration Review”, the National Cotton Council (NCC) appreciates the opportunity to provide comments related to the importance of the pesticide chlorpyrifos as a crop protectant product and express our concerns with the process used in the Interim Approach draft biological evaluations (BEs) for organophosphates (OPs).
The NCC is the central organization of the United States cotton industry. Its members include producers, ginners, cottonseed processors and merchandizers, merchants, cooperatives, warehousers and textile manufacturers. A majority of the industry is concentrated in 17 cotton-producing states stretching from Virginia to California. The NCC represents producers who cultivate between 9 and 12 million acres of cotton. Annual cotton production, averaging approximately 12 to 18 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 125,000 workers and produce direct business revenue of more than $21 billion. Accounting for the ripple effect of cotton through the broader economy, direct and indirect employment surpasses 375,000 workers with economic activity well in excess of $75 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.
Chlorpyrifos is used on cotton (predominantly in western US production areas) to control aphids, lygus and whiteflies. It is one of the few remaining crop protection products that provides a broad spectrum of control for multiple insect pests. Without control of these pests, producers can sustain yield loss and quality loss. The quality loss results from the sugary excrement of honey dew by the insect pests followed by sooty mold, a black mold that infests the honey dew deposits. The contaminated cotton fiber has a black appearance with a sticky secretion that interferes with textile processing and is referred to as “sticky cotton.” Sticky cotton is known to deposit the sticky residue in fiber processing equipment and clog equipment until the residue is removed. Sticky cotton is a major threat to potential sales of U. S. cotton fiber world-wide. Chlorpyrifos is an important component of Integrated Pest Management (IPM) systems that rotate chemistry modes of action as necessary for control of the cotton insect pests responsible for creating this contamination and to manage development of pest resistance.
The NCC believes EPA’s ecological risk assessment process has been overtaken by an unnecessarily conservative approach to the Endangered Species Act (ESA) consultation process with the Services. This approach results in a slowed registration process, which has become more focused on theoretical hazards, without considering realistic risk, product benefits or practicality. The delayed process, increased costs and unpredictable decisions have thwarted innovation and will likely lead to fewer crop protection products and technologies, and reduce food and fiber production across the U.S. Not only does EPA’s process use many of the same models already existing in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) screening level risk assessment, it is also designed to simulate exposures that are unlikely to be seen in real world environments and may use pathways or exposure scenarios that are either speculative or physically impossible, or both. Lastly, the assessment ignores factual information on the cause of species declines as well as successful recovery of species. As a result, meaningful consultations cannot be carried out with the methods that have been developed in the draft BEs.
These draft BEs demonstrate that the “interim approaches” being used by the EPA with these OPs, cannot possibly work and must be replaced with a more streamlined methodology. The goals envisioned by Congress of providing food security and public safety through the availability of pesticides can only be achieved if EPA’s expertise in ecological risk assessment is recognized and the Service’s roles are limited to only the difficult, unusual issues. The current assessments employ a “precautionary principle”-type approach, which is not supported by law and is unsustainable from a practical point of view. While EPA attempts to position the current efforts as learning and methodology development exercises to improve the process for future cases, the BEs as currently written are not scientifically or legally valid assessments for regulatory decision-making for these active ingredients.
EPA has erred on the side of conservatism for all species and all scenarios to the degree that the exposure and risk scenarios are unrealistic. Selection of very low effects endpoints and very high estimates of exposure create the high numbers of “likely to adversely affect” (LAA) determinations. The extreme and unrealistic level of conservatism is demonstrated by the fact that, in addition to almost all of the endangered species that may be found in agricultural regions, species that are intuitively unlikely to be associated with agricultural operations, such as killer whales, sea turtles and the desert pronghorn antelope, received LAA determinations. It is also clear that different parts of the federal government are not coordinating actions under ESA. For example, a recently released report from the President’s Council on Environmental Quality touts the recovered status of the Louisiana Black Bear, while the EPA’s BE classified this species as at high risk from the use of chlorpyrifos.
The science behind the assessments is lacking. The assessment relied upon “provisional” models and approaches that have not been independently reviewed or validated. The spatial distribution estimates of species ranges are also clearly flawed. For example, several whale species were identified as occupying habitat in Indiana. Significant improvement and review is necessary before these assessments are can be considered even adequate for further regulatory decisions and actions.
The complexity of the documentation also proves there is no way this approach could be followed for every active ingredient undergoing registration review every fifteen years and for every new product. Congress has made it clear, by legislative amendments in 1988 and 2015 and in numerous oversight hearings, that the interests of agriculture should be given considerable weight in designing and implementing FIFRA/ESA integration, but the interim approaches documented here are inconsistent with those directives.
With the draft BEs lacking any appropriate data quality standards or screens for the chemical/species hazard/endpoint determinations, the NCC believes the following technical alterations to the approach taken in the BEs could provide meaningful improvements to the FIFRA/ESA review process:
• Recognize that just because a pesticide is used in an area of species habitat doesn’t mean there is automatically a reason for EPA to consult with the Services. EPA has authority to make a “no effect” determination.
• Determine an acceptable risk definition for chemical/species interactions that utilizes EPA’s considerable scientific and ecological risk management experience based “solely on the best scientific and commercial data available.”
• Use USDA crop data and cropping areas appropriately to make reasoned determinations of the risks associated with foreseeable chemical/species interactions.
o Consider pesticide use and usage data, consistent with the March 19, 2013 “Stakeholder” document to refine usage estimates.
• Improve the species location information.
• Improve the species exposure models.
o Where available, make use of real-life, site specific monitoring data.
o Develop appropriate models for public health applications.
If this proposed process is used as ESA consultation moves forward, the restrictions on crop protection products would have significant and unjustified impacts on U.S. agriculture. The NCC supports the protection of human health, animal health, and the environment, but has concerns that EPA is inferring harm beyond the scope of scientific data. The NCC urges EPA to continue the historic path of reliance on credible scientific data and require all studies submitted to meet the same requirements as those required of registrants.
VP – Washington Operations