June 10, 2016
Mr. Steven Snyderman
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-2009-0317 – Draft Biological Evaluations: Chlorpyrifos, Diazinon, and Malathion Registration Review
Dear Mr. Snyderman:
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 Malathion to the cotton industry’s Boll Weevil Eradication Program (BWEP) 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.
The ongoing BWEP, in which an ultra-low volume (ULV) formulation of Malathion is the only insecticide used, has proved to be one of the most effective advancements for the U.S. cotton industry. In 1958, the National Cotton Council officially recognized the economic havoc the boll weevil was wreaking on U.S. cotton production. With Congressional leadership and support, a USDA Boll Weevil Research Lab was created opening the door for basic discoveries about the biology, life cycle, feeding, mating and overwintering habits of the boll weevil. In the late 1970’s, the BWEP was launched by USDA-APHIS in cooperation with state regulatory agencies and cotton growers along the Virginia-North Carolina border. Following the successful demonstration that eradication was feasible, the program expanded into other Southeastern states during the 80’s and during the 90’s programs were conducted in the Mid-South states, Texas, Oklahoma, and New Mexico. In 2005, the last two eradication zones in the U.S. (both in Texas) initiated program activities. Additionally, all of the cotton producing areas in Mexico along the US and Mexico border have programs underway. Without the continued availability of Malathion, the BWEP will not be able to carry out the eradication activities to bring the program to a successful conclusion in the coming years. Eliminating the availability of Malathion will put in jeopardy the tremendous investment of industry and government resources and the success of the BWEP. This will likely lead to the re-infestation of the entire cotton belt, wreaking havoc again on cotton producers, and forcing additional use of pesticides to control the boll weevil, while driving up production costs.
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, resulting 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.
EPA’s regulatory actions must meet statutory obligations, including statutorily mandated timelines, under both FIFRA and ESA. FIFRA requires EPA to avoid “unreasonable adverse effects on the environment” taking into account the “economic, social and environmental costs and benefits” of pesticide and other uses; a generalized mandate for prompt action on registration applications with deadlines for those actions set in FIFRA; and, a specific mandate to EPA to complete regular and routine updates of all FIFRA registration determinations on a statutory schedule. The ESA Section 7 and its implementing regulations impose both substantive and procedural requirements on EPA to protect listed species, including reliance on existing “best available scientific and commercial data” not a rudderless search for any data regardless of its quality or relevance. The successful integration of ESA consultation requirements into FIFRA registration and registration review decisions should be accomplished in a timely, predictable manner consistent with these statutory timelines.
The joint preparation of draft BEs for the first three OPs, (coordinating efforts of EPA, the Services and USDA) has failed to deliver any lawful or reliable measures, processes or knowledge. Because the BEs were constructed around sets of unreliable and unintelligible “zero risk” ground rules, the effort is needlessly complex and unnecessarily requires that virtually all chemical/species interactions must undergo another round of scrutiny to determine whether any species will be jeopardized.
EPA’s draft BE evaluated risk to Malathion exposure for all ESA listed species, proposed species, and candidate species in the United States. For Malathion, EPA reached the May Affect/Likely to Adversely Affect (MA/LAA) determination for 1725 out of 1782 assessed species (i.e., 97%) and 787 of the 795 assessed critical habitats (99%), suggesting that biological opinions are required for almost all species/ critical habitats evaluated. Aside from being biologically implausible in light of the fact that these pesticides have been used for over thirty years without the predicted devastating effects on wildlife, completing formal consultations on this scale is a near impossible undertaking for the Services. While it is recognized that considerable effort went into the development of the draft BE, it is clear that using the Interim Approach to make informed decisions using the best available science and data has resulted in a cumbersome, inefficient, and scientifically indefensible process to screen for pesticides that may pose significant risks to endangered species for in-depth evaluation by the Services through the formal consultation process.
Specific to the Malathion draft BE, some of the major issues and concerns are:
• As drafted, the BE lacks any appropriate and/or penetrating data quality standards or screens for the chemical/species hazard/endpoint determinations. In fact, the BE is filled with serious flaws in data directly concerning substantive and procedural requirements on EPA to protect listed species. These errors, omissions and technical miscues describing foreseeable chemical/species interactions are not addressed or acknowledged at all in any detail.
• Transcription and calculation errors;
• Use of threshold values that were not quality assured;
• Use of toxicological measures of effects or attributes that were not linked to apical ecological risk assessment endpoints (mortality, growth and reproduction);
• The use of the newly developed aquatic bin conceptual models resulted in physically impossible Malathion EECs for numerous scenarios. These erroneous EECs occurred due to flaws in the scenario assumptions given the constraints of the EPA standard aquatic exposure modeling tools.
• Lack of transparency necessary for reproduction of results; and
• Use of a risk quotient single line of evidence approach that is guided by very conservative decision trees and environmentally unrealistic exposure hypothesis.
Because the draft BEs lack 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.
EPA should adopt a more streamlined integration of ESA consultation requirements into FIFRA registration and registration review decisions, recognizing mitigated findings that would allow EPA to implement effective and efficient hazard/endpoint data screens of chemical/species risks, protect listed species and meet statutory timelines.
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