December 30, 2015
Ms. Dana Friedman
Pesticide Re-Evaluation Division (7508P)
Office of Pesticide Programs
Environmental Protection Agency
1200 Pennsylvania Ave. NW.
Washington, DC 20460-0001
RE: Docket o. EPA–HQ–OPP–2015–0653:Tolerance Revocations: Chlorpyrifos
Dear Ms. Friedman:
The National Cotton Council (NCC) appreciates the opportunity to comment on the Environmental Protection Agency’s (EPA’s) proposal to revoke all tolerances for chlorpyrifos. The NCC urges EPA to retain all tolerances for chlopyrifos, and especially those for cotton.
The NCC is the central organization of the U.S. cotton industry representing producers, ginners, warehouses, merchants, cooperatives, textile manufacturers, and cottonseed processors and merchandisers in 17 states stretching from California to the Carolinas. The NCC represents producers who historically 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. While a majority of the industry is concentrated in the 17 cotton-producing states, the down-stream manufacturers of cotton apparel and home-furnishings are located in virtually every state. The industry and its suppliers, together with the cotton product manufacturers, account for more than 230,000 jobs in the U.S. In addition to the cotton fiber, cottonseed products are used for livestock feed and cotton-seed oil is used for food products ranging from margarine to salad dressing. Taken collectively, the annual economic activity generated by cotton and its products in the U.S. economy is estimated to be in excess of $120 billion.
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 lint 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 lint processing equipment and clog equipment until the residue is removed. Sticky cotton is a major threat to potential sales of U. S. cotton lint world-wide. Chlorpyrifos is an important component of IPM systems that rotate chemistries as necessary for control of cotton insect pests.
EPA has stated that in its attempt to comply with the Ninth Circuit Court of Appeals order to respond to an administrative Petition to revoke all tolerances for the insecticide by October 31, 2015, by either denying the Petition or issuing a proposed or final tolerance revocation, the Agency is unable to conclude that the risk from the use of chlorpyrifos meets the safety standards. More specifically, the Agency states it has “determined” that safe levels of chlorpyrifos in the diet may be exceeded for people whose drinking water is derived from certain vulnerable watersheds throughout the United States. The Agency notes that Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” The Agency further noted that refinement in the water assessment suggests geographic differences as well as water shed scale differences and the use in these areas. However, EPA states “At this time this more refined drinking water assessment that will allow EPA to better identify where at-risk watersheds are located throughout the country is not completed. Thus, we are not currently able to determine with any great specificity which uses in which areas of the country do or do not present a risk concern.” In essence, EPA is stating the Agency does not have reliable data identifying a concern for drinking water (especially no monitoring data), but does not have time to complete its job due to time constraints imposed by the Ninth Circuit Court of Appeals. The Agency indicates that if it were provided time to complete the revised water assessment, it may be able to identify where risk concerns exist and potentially identify mitigation measures. The Agency further notes changes in the historical risk assessment procedures because of “Newer lines of research on chlorpyrifos, notably epidemiological studies…”. The changes in the historical risk assessment are contentious points of concern because the Agency altered procedure without engaging stakeholders, and the Agency seems to have granted enormous credibility and weight to one study, referred to as the “Columbia study,” in making this decision.
EPA acknowledges numerous deficiencies in the “Columbia study,” including a lack of understanding of the exposure dose or if subsequent exposures took place. It is our understanding that EPA requires registrants to provide toxicological studies under specific guidelines and GLP (Good Laboratory Practices). However, we fail to see where EPA compared and contrasted the findings of the required toxicological studies of registrants with the three epidemiology studies reported-- especially those in the “Columbia study.” The contrast of the controlled studies required of registrants with the reported studies, and more weight being placed on the reported studies is directly inconsistent with past EPA protocol. EPA admits to not having been granted access to the raw data despite multiple requests. This raises issues of transparency of the data and studies used by the EPA. It is also unclear how the Agency fully accounted for confounding factors that may have contributed to the results. EPA also acknowledges that it can find no causal relationship between chlorpyrifos and these effects. Considering the questions about the linkages between exposure and effects, it is even more important for agriculture to have assurance that EPA held these studies to the same level of transparency and scientific rigor they require of registrants before using the studies to take such significant regulatory action and increasing the FQPA safety factor from 1 to 10.
The NCC understands that, as in other cases, water monitoring data has been provided to EPA that does not reflect the water concerns implied by EPA’s computer simulation model. It is understandable that in the absence of real data, the water model is the best available alternative, but the NCC has concerns that the model does not seem to be validated with real world data. The NCC understands the model has been reviewed by a Scientific Advisory Panel, but that does not validate the model results compared with real world data. It remains plausible that assumptions in the model are incorrect or at least extreme if they cannot be validated and matched closely to real world data. Please address what monitoring data indicates related to drinking water and how that data compares to EPA’s water model. Also, we understand the EPA failed to consider a study submitted that provided guidance on how to use monitoring data with modeling and the outcome was very different with all crop uses passing the assessment. Finally, we understand the EPA also failed to consider a toxicology study provided to the Agency that showed no toxicological effect, (so no risk) at the maximum levels of the chemical you could potentially find in water. We request the Agency to consider all submitted studies and reverse its final decisions.
The NCC supports the protection of human health, 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.
The NCC appreciates the opportunity to provide these comments on EPA’s proposal to revoke all tolerances for chlorpyrifos and urges EPA to not finalize this proposal. The NCC urges EPA to retain all tolerances for chlorpyrifos, and especially those for uses on cotton.
If you have any questions or need any further information regarding this comments, please contact us.
VP – Washington Operations