By Lisa M. Campbell and James V. Aidala
On April 2, 2015, the U.S. Environmental Protection Agency (EPA) sent a letter to all registrants of nitroguanidine neonicotinoid pesticide products stating that “until the data on pollinator health have been received and appropriate risk assessments completed,” EPA is “unlikely to be in a position to determine that such uses would avoid ‘unreasonable adverse effects on the environment’ as required under FFIRA to support further regulatory expansion of these pesticides in outdoor settings.” EPA asks that the affected registrants withdraw or modify pending new outdoor use/expansion and/or pending nitroguanidine neonicotinoid registrations with a new outdoor use by April 30, 2015.
The letter states that the letter recipients are companies that have submitted an application for a new outdoor use and/or hold registrations for products containing imidacloprid, dinotefuran, clothianidin or thiamethoxam that have directions for outdoor application.
Affected neonicotinoid actions include:
* New Uses (including crop group expansion requests);
* Addition of New Use Patterns, such as aerial application;
* Experimental Use Permits; and
* New Special Local Needs Registrations.
The letter does not, however, preclude the approval of “me-too” products -- “products that are identical or substantially similar to existing uses.” In addition, EPA states that if a significant new pest issue should arise that may be uniquely addressed by one of these chemicals, EPA may consider whether an emergency use under FIFRA Section 18 might be appropriate. In the event that an emergency use is requested, EPA plans to assess such requests by relying on available information and risk mitigation strategies.
This new missive from EPA provides yet another example of a recent trend that many registrants believe is of concern, whereby EPA makes a broadly applicable set of regulatory decisions without an associated administrative process. With this approach, EPA summarily issues a letter to a class of registrants with immediate direct affect on their registrations with little or no room for consideration of individual facts, and with little explanation of important risk issues. In this letter, for example, EPA precludes the expansion of new uses, but yet allows the continued processing of “me-too” applications with no explanation from a risk profile of the risk difference that allows one type of product to be processed, but not the other. There are many possible scenarios where a new or expanded use of a product would not present any more risk to pollinators than the me-too product that EPA indicates will be considered.
This one-size-fits-all approach also appears to exclude consideration of any risk reduction potential of the pending applications (for example, when a pending neonic application represents a reduction in worker risk or endangered species when compared to an existing use pattern). Some applications may replace current exposure levels to organophosphate insecticides that EPA has generally sought to reduce. The potential processing of Section 18 exemptions may provide an avenue for such considerations, but the presumption that the pollinator issue a priori makes all other risk elements secondary is a tacit admission of where EPA currently evaluates the potential risk to honeybees in comparison to other possible impacts from pesticide use, including human health risks.
More information on EPA’s efforts to protect pollinators: http://www2.epa.gov/pollinator-protection.
By Lisa R. Burchi
An ad hoc committee of the National Research Council (NRC) released a report, Review of California's Risk-Assessment Process for Pesticides, following its scientific and technical evaluation of the California Environmental Protection Agency’s (EPA) risk assessment process for pesticides.
The NRC committee review, which commenced in October 2013, examined documents provided by the California EPA’s Department of Pesticide Regulation (DPR) regarding the processes it uses for hazard identification, exposure assessment, dose-response analysis, and risk characterization. The Report discusses the following issues:
■ Setting Priorities Among Pesticides: The NRC committee generally supported DPR’s process under which pesticides are reviewed as candidates for risk assessment, but made recommendations for DPR to: (1) update and provide more details regarding its documentation of the priority setting process; (2) provide more explicit documentation and support for how pesticides are categorized into groups of high, medium, and low priority; and (3) develop a more objective and structured approach for ranking high-priority pesticides.
■ Risk Assessment Methods and Practices: The NRC committee reviewed DPR’s risk assessment guidance documents as well as three recently completed risk assessments for chloropicrin, carbaryl, and methyl iodide. The NRC committee found DPR’s documents to be comprehensive but questioned “whether the extensive effort needed to conduct a comprehensive risk assessment independently of EPA is justified in light of DPR’s resources.” The Committee recommended that DPR: (1) determine whether an independent and comprehensive evaluation of pesticides is required in every case where a risk assessment is performed; (2) incorporate problem formulation and other relevant elements recommended in the 2009 NRC report Science and Decisions: Advancing Risk Assessment into its risk assessment process; and (3) update its guidance documents “regularly and perhaps develop additional reference materials to reflect the most current risk-assessment practices.”
■ California Data to Inform Priority-Setting and Risk Assessment: The NRC committee found DPR’s practice of supplementing its exposure assessments with California-specific information to be “among the most valuable contribution to DPR’s risk-assessment process.” The committee suggests expanding DPR’s current Pesticide Use Reporting (PUR) program to include all licensed pesticide applicators and, if resources allow, “PUR data should be reviewed in relation to air-monitoring data and pesticide-illness surveillance data to determine whether any patterns are evident and to judge the accuracy of exposure assumptions or models.” The committee also had recommendations to improve the reporting of pesticide-related illnesses, including, for example, improving the training of physicians and searching electronic health records.
By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.
On January 5, 2015, the Natural Resources Defense Council (NRDC) filed a petition for review in the U.S. Court of Appeals for the Ninth Circuit challenging the November 6, 2014, decision of the U.S. Environmental Protection Agency (EPA) to allow the continued use of tetrachlovinphos (TCVP) in flea control products used on pets. NRDC’s 2009 petition sought to cancel all pet uses of TCVP based on alleged potential health risks to children.
In February 2014, NRDC filed a petition for a writ of mandamus in the United States Court of Appeals for the District of Columbia Circuit seeking the court to compel EPA to respond to NRDC’s petitions to cancel all manufacturer registrations and uses of propoxur and TCVP, which are used in pet flea treatment products. Sergeant’s Pet Care Products, Inc., Wellmark International, and Hartz were among flea collar brands at issue.
In March 2014, EPA announced an agreement with Sergeant’s Pet Care Products, Inc. and Wellmark International, whereby the companies voluntarily cancelled the use of propoxur in flea collars. Related uses of other chemicals, including TCVP in pet collars, were not addressed in that agreement, and EPA denied, in November 2014, NRDC’s 2009 petition seeking to cancel all pet uses of TCVP.
NRDC first petitioned EPA to cancel propoxur uses in pet collars in 2007. NRDC filed a petition in April 2009 to cancel all pet uses of TCVP based on its Poison on Pets II report, which asserted that unsafe levels of pesticide residues are present on dogs and cats after a flea collar is used.
EPA conducted a risk assessment of multiple pet use products (e.g., shampoos, dips, powders, and flea collars) containing TCVP in 2006 during the reregistration process. The majority of the uses were assessed using registrant-submitted chemical-specific data. Potential post-application assessments for the majority of the uses included assessing dermal contact with the treated animal (e.g., a child hugging a dog) and hand-to-mouth contact by a toddler following contact with treated animals (e.g., touching the dog and then putting their hand in their mouth). These were considered to be worst-case assessments based on the amount of dermal and hand-to-mouth contact used by EPA. Potential post-application exposure to adults and children were not assessed for flea collars. In the case of flea collars, EPA concluded: “Post application exposure to residues from pet collars is considered to be insignificant when compared with exposure to other products. Because other, higher exposure uses were not of concern, an assessment for collars was not conducted.”
This last sentence is especially important, as EPA is likely to reiterate this conclusion, whether curtly or in detail, as its direct response to the petition. As this is a fairly predictable Agency response, NRDC appears to want this petition to signal its continuing concerns about organophosphate use generally, and be able to raise concerns about “children’s risks” in particular.
By Lynn L. Bergeson and Lara A. Hall, M.S., RQAP-GLP
On January 9, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it released a new draft guidance document in its effort to help expand the acceptance of alternative methods for acute toxicity testing. EPA states that the rapid advances in science and continual development of new technologies, it recognizes there is an increasing potential for the use of alternative methods in regulatory risk assessments.
EPA’s goals for alternative testing approaches include:
* Assessing a broader range and potentially more human-relevant adverse effects;
* Generating and reviewing data more quickly and less expensively; and
* Reducing use of laboratory animals in regulatory testing.
The draft guidance, Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies, describes the process for evaluating and implementing alternative methods of testing for acute oral, dermal, and inhalation toxicity, along with skin and eye irritation and skin sensitization. Additionally, there is a discussion of the three major phases of the process, and the implications for reporting information under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2). Successfully putting this process into place will require an open dialogue with stakeholders, other regulatory organizations, and the scientific community.
This draft guidance is one step in the application of OPP’s strategic vision for implementing the 2007 National Research Council report on Toxicity Testing in the 21st Century.
By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.
The U.S. Environmental Protection Agency’s (EPA) January 5, 2015, release for public comment of the revised human health risk assessment of chlorpyrifos (http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2008-0850-0195) reflects another step taken to implement its new spray drift and volatilization policies. These policies were long in the making and the subject of significant discussion and controversy over the years. EPA, with this assessment, has also taken a very public step to implement its controversial policy, announced in December 2009, to apply, effectively, Food Quality Protection Act (FQPA) risk assessment techniques to pesticide uses not subject to FQPA, as part of its commitment to environmental justice.
The spray drift and volatilization policies were discussed in an October 2014 webinar and discussed in our September 17, 2014, memorandum. EPA’s Revised Risk Assessment Methods for Workers, Children of Workers in Agricultural Fields, and Pesticides with No Food Uses, issued in 2009, is discussed in our December 8, 2009, memorandum.
Spray Drift and Volatilization
EPA had been assessing spray drift and volatilization for chlorpyrifos for a number of years, and many of the EPA-derived spray drift and volatilization tools are based on chlorpyrifos data. The January 5 assessment updates the assessment conducted in 2011. This document assesses both potential risks to workers (mixing/loading/applying and re-entry) as well as potential risks to residents (bystanders and food/water consumption). The bystander assessment uses the new tools that EPA released in Spring 2014 to assess potential risks from volatilization and spray drift (as discussed in the B&C webinar). The buffer zones EPA had previously estimated to mitigate spray drift are reduced in the new assessment. The risks noted in the assessment were for workers and specific water areas.
FQPA Risk Assessment Methods Use for Non-FQPA Assessment
In addition to implementing its spray drift and volatilization policies, EPA also assessed exposure in a manner that appears intended to implement the 2009 policy that was the subject of much concern when released for public comment. In that policy, EPA stated its intent to apply risk assessment techniques developed in implementing FQPA’s “extra safety factor” to any pesticide product’s risk assessment, regardless of whether it falls under FQPA, “so long as application of the risk assessment technique is consistent with good scientific practice and is not otherwise prohibited by law.” EPA stated then that this would include “using an additional safety/uncertainty factor to protect children,” as well a number of other factors. EPA announced this policy originally as part of its commitment to considerations of environmental justice.
The chlorpyrifos assessment is based on a physiologically-based, pharmacokinetic-pharmacodynamic (PBPK-PD) model to estimate the toxicologic Points of Departure (POD), thus deriving different toxicological values of concern based on the age, sex, and duration of exposure. The PBPK-PD model is also used to estimate intra-species uncertainty factors (UF), as there is no need for inter-species factors because the model estimates human red blood cell (RBC) acetylcholinesterase/cholinesterase (AChE/ChE) inhibition. Based on the PBPK-PD model, a 10X intra-species factor was used for females of childbearing years whereas it was 4X for all other groups assessed.
The worker of concern in the assessment is defined to be a female of childbearing years due to concern of not only RBC AChE/ChE inhibition, but also the potential for neurodevelopmental effects as seen in epidemiological studies. The epidemiological studies are controversial because there have been many questions about actual exposure to chlorpyrifos, particularly as two studies measured a biomarker that can be seen from exposure to other organophosphates (OP). The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Science Advisory Panel (SAP) reviewed EPA’s assessments of these studies in 2008 and 2012. The SAP concluded that “chlorpyrifos likely played a role” in the observed neurodevelopmental outcomes. EPA determined that based on the weight of evidence (WOE) from animal studies and epidemiological studies, reduction of the 10x “FQPA Safety Factor (SF)” was not appropriate. The residential dietary assessments were compared to a Margin of Exposure (MOE) of 100 (10X FQPA SF x 10X intra-species factor) for women and an MOE of 40 (10X FQPA SF x 4X intra-species factor) for all other ages. The occupational assessments were compared to an MOE of 100 for women and 40 for all other age groups (with no explanation of the reasoning behind those values).
This is noteworthy and should be examined closely because EPA has effectively used an additional “FQPA factor” as a safety factor for occupational assessments. EPA stated in its press release announcing the assessment that potential restrictions may be necessary to protect workers and water.
There is a 60-day comment period for this document, which are due on or before March 16, 2015. Among the issues commenters are likely to address include:
Use of the PBPK-PD model to estimate PODs;
Use of the PBPK-PD model to estimate intra-species uncertainty factors;
Use of the epidemiological data; and
Use of a 10X SF for occupational exposure.
The full impact of this assessment is not yet clear, but it raises many issues of interest to registrants.
By Lynn L. Bergeson
On October 22, 2014, the U.S. Environmental Protection Agency (EPA) requested public comment on a proposal to remove 72 chemicals from its list of substances approved for use as inert ingredients in pesticide products. EPA reportedly is responding to petitions submitted by the Center for Environmental Health, Beyond Pesticides, Physicians for Social Responsibility, and others that have asked EPA to issue a rule requiring disclosure of 371 inert ingredients found in pesticide products. EPA developed an alternative strategy designed to reduce the risks posed by hazardous inert ingredients in pesticide products more effectively than by disclosure rulemaking. EPA outlined its strategy in a May 22, 2014, letter to the petitioners, which is available online. Many of the 72 inert ingredients targeted for removal are on the list of 371 inert ingredients identified by the petitioners as hazardous. The 72 chemicals are not currently being used as inert ingredients in any pesticide product. The list of chemicals is available online.
Ingredients that are directly responsible for controlling pests such as insects or weeds are called active ingredients. An inert ingredient is any substance that is intentionally included in a pesticide that is not an active ingredient. Comments are due November 21, 2014. General information on inert ingredients can be found online.