NCC Comments Regarding Tribufos Registration

In response to EPA's Sept. 25, 2015 Federal Register notice opening a public comment period on EPA’s draft human health and ecological risk assessments for the registration review of a group of 35 different pesticides known as sulfonylureas and other identified chemicals, the NCC provided comments that urged EPA to retain the current labeled uses of tribufos as a defoliant for cotton. opportunity to provide the following comments related to the importance of the pesticide dimethoate as an insect management product The NCC urges EPA to retain all labeled uses of dimethoate for control of cotton pests. opportunity to provide the following comments related to the importance of the pesticide dicrotophos as an insect management product.

Published: February 24, 2016
Updated: February 24, 2016

February 23, 2016

OPP Docket
Environmental Protection Agency Docket Center (EPA/DC), (28221T)
1200 Pennsylvania Ave. NW
Washington, DC 20460-0001

Ms. Marianne Mannix, Re-Evaluation Division (7508P)
Office of Pesticide Programs
Environmental Protection Agency
1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001

Re: Docket ID No. EPA–HQ–OPP–2008-0883.

Dear Ms. Mannix:

In response to the Environmental Protection Agency's (EPA) September 25, 2015 Federal Register notice opening a public comment period on EPA's draft human health and ecological risk assessments for the registration review of a group of 35 different pesticides known as sulfonylureas and other identified chemicals, the National Cotton Council (NCC) appreciates the opportunity to provide the following comments related to the importance of the pesticide tribufos as a critical harvest management product.

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 10 and 14 million acres of cotton. Annual cotton production, averaging approximately 16 to 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.

Tribufos is an extremely critical crop defoliation tool for cotton. Cotton defoliation is often referred to as an art because of the many factors that impact successful defoliation. The goal is to cause cotton plants to drop all leaves, eliminate all green plant matter, and encourage all cotton bolls to open for the harvesting of cotton lint and seed. Because cotton is a perennial plant, regrowth may occur. In some cases, leaves may die without dropping from the plant. Regrowth and stuck leaves result in staining of lint and excess trash in lint that reduces the grade and value of the cotton lint. In addition, if the plant is totally killed and becomes brittle, then the plant may shatter resulting in excess bark and stalk debris also reducing grade and quality. In order to minimize trash in cotton and minimize stain and damage to lint, producers utilize various combinations of defoliation and boll opening materials to achieve the needs of a particular field. The decision is influenced by anticipated days before the harvest equipment will be available to begin harvesting the particular field, temperature fluctuations anticipated during the treatment time, rain and other anticipated weather influences, the estimate of mature bolls not yet open, and past experience with products. Tribufos has historically produced effective leaf drop with consistency across environments (including temperature), and in combination with other products to enhance opening of cotton bolls or other harvest needs. Tribufos remains an economical defoliation product with consistent, effective results across environments and is a critical component of many harvest management strategies. Without the product, tremendous variability will be introduced into the harvest of cotton, which can result in excess trash, increased ginning to remove more trash, and decreased grades and strength of cotton lint due to trash and increased ginning requirements. All of these would result in increased costs and reduced income for cotton producers.

The NCC is aware of the September 15, 2015 memo claiming justification to include a 10X Food Quality Protection Act (FQPA) safety factor for risk assessment of all organophosphates. The determination to include the safety factor represents a major policy change but EPA did not engage stakeholders in a public notice procedure thereby eliminating transparency and the opportunity for impacted stakeholders to comment on the policy change. Simultaneously, EPA released "Pesticide Registration Review; Draft Human Health and Ecological Risk Assessments for Sulfonylureas and Certain other Pesticides; Notice of Availability and Request for Comments" on September 25, 2015 (EPA-HQ-OPP-2015-0386).The notice announced draft human health risk assessments for some 35 various chemicals, with several, but not all, organophosphate chemicals listed among numerous Sulfonylureas and other pesticides including some insect growth regulators. The Agency identifies some ecological risk assessments that were conducted as group assessments and separate human health risk assessments. Although the Notice stated that comments could be submitted to the docket identified by EPA-HQ-OPP-2015-0386, the NCC was later instructed that comments were to be submitted individually to single dockets. The NCC has submitted comments to several dockets, but expresses to the Agency that the announcement created confusion about what was grouped, what was not grouped, and whether comments could be submitted to the one notice of the 35 chemicals or were commenters to locate the individual dockets in order to comment separately. The Notice format with the 35 chemicals, not all of a similar chemical group, some ecological risk assessments for similar chemicals grouped, health assessments not grouped, and no single holding site for the materials contained in the notice of the 35 chemicals created confusion and difficulty in locating and understanding what the Agency was doing.

The EPA's argument for including the 10X safety factor relies predominantly on an epidemiology study conducted at Columbia University. The Agency notes other studies that suggest associations and speak of correlations of various studies, but the Agency knows well that correlations do not demonstrate cause and can easily be flawed by the inclusion of inappropriate variables or omission of relevant variables. Many examples have been developed to demonstrate how correlations can result in absurd conclusions and do not identify the real causal effect. For that reason, it would seem mandatory for EPA to have complete access to study data before giving the study sufficient credibility as a basis to adopt a major policy change.

The study in question did not originate in an agricultural setting, but rather in an urban housing setting where a particular organophosphate once held a legal use for control of household pests. It should be noted that most of the organophosphates were never registered for household use. It is clearly understood that conditions in a home limit the degrading process of pesticides as compared to agricultural environment conditions. Sunlight, soil organisms, moisture, and many other factors of degradation are greatly reduced in home settings. Similarly, movement in home settings greatly increases the likelihood of contacting treated areas. The epidemiology study conducted by scientists at Columbia University reportedly focused on chlorpyrifos exposure in home settings and utilized a prenatal sample to document the exposure level. The study reportedly followed the development of the children for the subsequent 7 years and conducted an IQ test. The study reported a correlation in decreased IQ and exposure to chlorpyrifos as measured from the prenatal sample 7 years prior. While this is admittedly a crude synopsis of a complex study, it does demonstrate why the study should be questioned openly before the Agency uses it to claim justification of policy change and certainly before it is used to justify application to other chemicals –including tribufos –which has never had home uses and is currently only registered for use on cotton. In the Agency's own assessment of the study, numerous flaws and limitations were highlighted that are critical to its interpretation to justify a 10X safety factor for any individual chemical, let alone all, organophosphates. For example, no data was obtained after the prenatal sample to ensure additional exposure did not occur. Were there other potential exposure concerns such as heavy metals (i.e. lead based paint) in the study homes? Were there subsequent uses of stored pesticides that resulted in exposure levels above those measured? Were demographic variables sufficiently controlled? How do the study conclusions relate to vast numbers of mandated EPA studies specifically designed to scientifically evaluate causal effects? What evidence in the study scientifically shows the cause is a general mechanism of all organophosphates? Additionally, the NCC does not find where the Agency compared the study to the vast number of required studies in order to weigh the contrast among conclusions. Such an approach would seem necessary given that the Agency has stated they can find no causal relationship between chlorpyrifos and these effects.

While the NCC is not refuting the Columbia University study, or other cited studies with suggested associations, the NCC believes the action of the Agency to implement a 10X safety factor on all organophosphates - most of which are used only in agricultural settings – represents a major policy change that warrants a separate public notice and comment with a high level of transparency and scrutiny before being utilized to conduct multiple risk assessments. However, the Agency has taken a different course by conducting multiple risk assessments with the 10X safety factor and announcing all simultaneously without separate consideration for the adoption of the 10X safety factor. Of equal importance, these studies should be held to the same standards of transparency and scientific rigor required of registrants.

The NCC urges EPA to explain what causal effect the Columbia Study identifies, and what data support that causal effect for all organophosphates. The NCC urges the Agency to withdraw all organophosphate risk assessments conducted with the 10X safety factor until such time that the Agency has completed notice, review with public comments, and final determination whether the 10X safety factor is supported by scientific evidence of a causal effect.

The NCC urges EPA to retain the current labeled uses of tribufos as a defoliant for cotton. The NCC supports the protection of human health and notes that tribufos has been used safely in cotton for many years. Unfortunately, the NCC has concerns that EPA is inferring harm beyond the scope of scientific data. The NCC urges EPA to return to the historic path of reliance on credible scientific data and require all studies to be evaluated based on scientific quality and merit.

Respectfully submitted,

Reece Langley
VP – Washington Operations
National Cotton Council