By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
A noteworthy development in the U.S. Environmental Protection Agency’s (EPA) ongoing and controversial consideration of the potential use of epidemiological data in its pesticide risk assessments occurred on May 25, 2017, when EPA placed in the public dockets for certain organophosphate (OP) pesticides an “update” of the September 15, 2015, Literature Review and Food Quality Protection Act (FQPA) determination, along with a response to comments on the original document. These documents were signed by EPA scientists on December 29, 2016, prior to the new Administration, but were placed in the docket only last month, under the new Administration. The documents attempt to rebut the various criticisms of EPA’s assessment of the epidemiology studies for chlorpyrifos and the original FQPA safety factor determination for OP pesticides, and they reaffirm the policy embodied in the original Literature Review. Because these new documents were signed in the last days of the Obama Administration, they may be viewed by some industry stakeholders as an effort by some at EPA to “lock in” the prior policy concerning OP pesticides.
The public release of the “updated” Literature Review and response to comments must be considered in the context of the ongoing chlorpyrifos battles that have received significant public attention. During the five months between the date that these “update” documents were signed and the date that EPA placed them in the public docket, EPA Administrator Pruitt issued a decision on March 29, 2017, to deny the petition filed by the Pesticide Action Network North America (PANNA) and the National Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos products. See EPA Denies Petition to Ban Chlorpyrifos. In his denial decision, Administrator Pruitt concluded it would be appropriate for EPA to defer determining whether chlorpyrifos is likely to cause neurodevelopmental effects at exposure levels below the levels that cause acetylcholinesterase (AChE) inhibition until the completion of the registration review process for chlorpyrifos. Administrator Pruitt based his decision on the premise that “the science addressing neurodevelopmental effects remains unresolved” and that “significant uncertainty … exists regarding the potential for chlorpyrifos to cause adverse neurodevelopmental effects.”
Some industry stakeholders may argue that the decision by the EPA scientists who prepared the “updated” Literature Review which concluded that EPA should retain the 10X FQPA uncertainty factor for OP pesticides can be reconciled with Administrator Pruitt’s subsequent denial decision, because the “updated” FQPA safety factor determination does not preclude further scientific discussion concerning the potential for neurodevelopmental effects from OP pesticide exposures. On the other hand, other industry stakeholders may be concerned about the immediate adverse impact of this “updated” FQPA determination on the risk assessments prepared by EPA for OP pesticides and the measures that will be demanded by EPA to mitigate purported risks.
On April 5, 2017, PANNA and NRDC responded to Administrator Pruitt’s March 29, 2017, decision to deny their petition to revoke the tolerances and cancel the registrations for chlorpyrifos by submitting to the Ninth Circuit Court of Appeals a Motion for Further Mandamus Relief. That motion was substantially based on the premise that EPA does not “suggest that it has reconsidered its finding that chlorpyrifos is unsafe.” The briefing on the new mandamus motion was completed on May 5, 2017, several weeks before EPA disclosed the documents concerning the “updated” FQPA determination. Nevertheless, petitioners could try to argue that these documents constitute further evidence supporting their key premise that EPA has not actually revisited its prior determination that chlorpyrifos exposures are unsafe.
The legal and policy issues posed by EPA’s evaluation of the epidemiological data for chlorpyrifos and by EPA’s determination that these data create sufficient uncertainty to warrant retention of the FQPA 10X safety factor for all OP pesticides will be a continued source of controversy, and will be watched with interest by all stakeholders.
More information and updates on chlorpyrifos, the epidemiological data, and their surrounding legal issues is available on our blog item under keyword chlorpyrifos.
By Lynn L. Bergeson, Karin F. Baron, and Margaret R. Graham
On December 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity studies for pesticide formulations.”
For this pilot program, EPA is requesting submission of acute oral and acute inhalation toxicity study data paired with mathematical calculations (GHS Mixtures Equation data) to support the evaluation of pesticide product formulations; instruction for doing so are available on the GHS Equation Pilot Program webpage, and Guidance on the GHS Mixtures Equation is available in the Guidance on the Application of the CLP (Classification, Labeling and Packaging) Criteria.
The program is an interesting approach considering the conceptual differences of risk assessment and hazard determination that exist at the core of EPA risk approaches and GHS fundamentals. Also, the definition of the EPA Categories compared to GHS has been problematic for hazard communication applications.
Mixture calculation tools rely on the availability of data for all components and would only be applicable if the data for each were generated using the same species under similar exposure conditions.
This pilot program is being developed under EPA’s initiative to develop non-animal alternatives for acute toxicity testing, as well as EPA’s Office of Pesticide Programs’ Strategic Vision for Adopting 21st Century Science Methodologies. More information on these initiatives can be found on our Pesticide Law and Policy blog under key phrase “toxicity testing.”
By Lisa M. Campbell and Timothy D. Backstrom
On July 5, 2016, a three judge panel of the U.S. Court of Appeals for the Ninth Circuit issued a brief opinion denying a petition for review of a U.S. Environmental Protection Agency (EPA) order in which EPA declined to “immediately adopt interim prohibitions on the use of toxic drift-prone pesticides … near homes, schools, parks, and daycare centers or wherever children congregate.” Petitioners Pesticide Action Network North America (PANNA), United Farm Workers, and Pineros y Campesinos Unidos del Noroeste (PANNA, et al.) filed an administrative petition in 2009 asking EPA to conduct pesticide-specific drift assessments and to impose interim buffer zones to protect children from pesticide drift.
The Circuit Court agreed with EPA’s contention that the petitioners do not have jurisdiction to review the reregistration and tolerance determinations previously made by EPA pursuant to the Food Quality Protection Act (FQPA), because such challenges are now time barred. EPA agreed with the petitioners that it should consider potential risks from spray drift as part of the registration review under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The petitioners argued that EPA had thereby acknowledged legal error when it previously reregistered food-use pesticides, but EPA has vigorously contested that premise. In 2014, EPA issued a proposal describing the methodology for assessing risk from pesticide drift that EPA will use prospectively in making registration review decisions.
The petitioners requested that EPA adopt interim relief by imposing uniform buffer zones for all pesticides that are registered for application by ground sprayers, broadcast, or aerial application, and that may cause certain human health effects. EPA rejected this request for across-the-board buffer zones as unscientific and inefficient and likely to result in a misallocation of EPA resources. The Circuit Court concluded that “substantial evidence” supports EPA’s decision to deny this interim relief, stating that “[t]he record suggests that the risk of exposure to pesticide draft depends on a number of factors, including pesticide toxicity, the method of application, the size of pesticide droplets, and weather conditions,” and “adequately supports EPA’s conclusion that the imposition of uniform buffer zones is not the most ‘scientifically appropriate’ method for mitigating the risk of exposure to pesticide drift.”
The Circuit Court has clearly recognized that uniform buffer zones like those sought by the petitioners would not be “scientifically appropriate.” While this decision is both welcome by industry and constructive, the evaluation of potential exposure and risk from pesticide drift during the registration review process for individual pesticides will likely remain controversial.
More information on EPA’s spray drift policy is available in our memorandum Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions.
By Lisa M. Campbell, Lisa R. Burchi and James V. Aidala
On September 28, 2015, the U.S. Environmental Protection Agency (EPA) announced revisions to its worker protection standard. EPA states that these revisions are intended to “enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective equipment, and the providing of supplies for routine washing and emergency decontamination.”
Among the changes to the WPS are the following:
- Training: The final rule retains proposed content expansions that have been the subject of considerable discussion and concern (e.g., provisions that EPA intends to reduce take-home exposure) and the requirement for employers to ensure that workers and handlers receive pesticide safety training every year (increased from existing rules that require training every five years). EPA has eliminated the proposed training “grace period,” that would have allowed employers to delay providing full pesticide safety training to workers under certain circumstances.
- Notification: The final rule retains the proposed requirements for employers to: (1) post warning signs around treated areas in outdoor production when the product used has a restricted-entry interval (REI) greater than 48 hours; and (2) provide to workers performing early-entry tasks (i.e., entering a treated area when an REI is in effect), information about the pesticide used in the area where they will work, the specific task(s) to be performed, the personal protective equipment (PPE) required by the labeling, and the amount of time the worker may remain in the treated area. EPA has not promulgated the proposed requirement for employers to keep a record of the information provided to workers performing early-entry tasks.
- Hazard Communication: The final rule requires employers to post pesticide application information and a safety data sheet (SDS) for each pesticide used on the establishment at a central location on the establishment (the “central display”). This is a departure from the proposal to eliminate the existing requirement for a central display of pesticide application-specific information. The final rule also requires the employer to maintain and make available to workers and handlers, their designated representatives, and treating medical personnel upon request, the pesticide application-specific information and the SDSs for pesticides used on the establishment for two years. EPA has eliminated the proposed requirement for the employer to maintain copies of the labeling for each product used on the establishment for two years.
- Requirements During Pesticide Applications: The final rule requires an “application exclusion zone,” that is, the area immediately surrounding the application equipment, from which workers and other persons must be excluded. An application exclusion zone of 100 feet horizontally from the application equipment in all directions applies when the pesticide is applied by any of the following methods: (1) aerially; (2) air blast application; (3) as a spray using a spray quality (droplet spectrum) of smaller than medium (volume median diameter of less than 294 microns); or (4) as a fumigant, smoke, mist, or fog. An application exclusion zone of 25 feet horizontally from the application equipment in all directions applies when the pesticide is sprayed from a height of greater than 12 inches from the planting medium using a spray quality (droplet spectrum) of medium or larger (volume median diameter of 294 microns or greater). This “application exclusion zone” differs from the proposed “entry-restricted areas,” that would have extended a specified distance around the entire treated area during application based on the application equipment used. The final rule requires handlers to suspend application, rather than cease application, if they are aware of any person in the application exclusion zone other than a properly trained and equipped handler involved in the application.
- Minimum Age: The final rule increases the minimum age for handlers and workers performing early-entry tasks from a proposed 16 years old to at least 18 years old. EPA states it increased the minimum age from 16 to 18 based on “comments received and an evaluation of existing literature related to adolescents’ development of maturity and judgment.” EPA provides an exemption from minimum age requirements for adolescents working on an establishment owned by an immediate family member. The final rule does not require the employer to record workers’ or handlers’ birthdates as part of the training record, but does require the employer to verify they meet the minimum age requirements.
- PPE: The final rule cross-references certain Occupational Safety and Health Administration (OSHA) requirements for respirator use for which employers will be required to comply. In response to comments, the final rule expands the respirators subject to fit testing beyond the proposal to include filtering facepiece respirators. The final rule maintains the existing exception from the handler PPE requirements when using a closed system to transfer or load pesticides, and adopts a general performance standard for closed systems, which differs from the specific design standards based on California’s existing standard for closed systems discussed in the proposal.
EPA received a significant number of comments on the proposed rule, which has generated significant controversy. While it appears that EPA has modified the final WPS in certain respects in response to concerns raised, there remain many provisions that are controversial and will require significant work, with significant costs, by agricultural and handler employees to meet.
Controversy regarding these new requirements is longstanding. At its most simple form, critics of increasing the stringency of the current regulations ask why significant changes were needed after twenty years of greater protection offered by the existing regulatory requirements. In addition, over the intervening years, for a variety of reasons, many (not all) of the most hazardous pesticides have been removed from the market or otherwise are used less. More complex concerns address potential jurisdictional overreaches and the paltry record supporting what some view as expansive and expensive regulatory requirements. Others, not surprisingly, cite the number of reported (and unreported) incidents as proof for the need nonetheless to improve the extent and effectiveness of the current regulations. What EPA has issued here as the final revisions to the regulations attempts to balance these views.
Some believe that, in similar situations, where industry and activist groups criticize an action, albeit for very different reasons, the EPA action at issue must have struck the correct balance of disparate views. This breezy measure of success in an important health protection program such as this rule addresses by definition is not likely to satisfy either perspective, and complaints about the new requirements can be expected to continue, especially about the economic impact of the new requirements for some, and for others, how the occupational risks of pesticides remain too high and deserve even greater restrictions.
Outside the boundaries of the worker protection regulations, some of the underlying logic and regulation of the updated requirements indicate that EPA, at least under the current Administration, will continue its emphasis on the broader goals of environmental justice and protecting “children” from the hazards of pesticide exposure. (For example, among the most controversial elements of the changes is the prohibition on certain activities for those under the age of 18, while beforehand the cutoff age was 16; this seems partly a result of EPA’s attempt to make its policy of prohibiting testing of pesticides on children consistent with its policy of who might be exposed in occupational settings.)
The final rule will become effective 60 days after it is published in the Federal Register, but agricultural employers and handler employers will not be required to comply with most of the new requirements in the final rule until 14 months after the effective date.
For more information, please see Bergeson & Campbell, P.C.’s (B&C®) memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2015 and James V. Aidala Comments on EPA’s Worker Protection Standards. More information is also available on EPA’s Worker Protection Standard webpage.
By Lynn L. Bergeson and Carla N. Hutton
On May 19, 2015, the U.S. Environmental Protection Agency (EPA) announced that it issued a conditional registration for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.” This is the second nanosilver registration issued by EPA and reflects the Agency’s growing expertise in addressing, processing, and approving nanopesticide registration applications. According to EPA, the product will be used as a non-food-contact preservative to protect plastics and textiles from odor- and stain-causing bacteria, fungi, mold, and mildew. Items to be treated include household items, electronics, sports gear, hospital equipment, bathroom fixtures, and accessories. EPA based its decision “on its evaluation of the hazard of nanosilver after reviewing exposure data and other information on nanosilver from the applicant, as well as data from the scientific literature.” EPA states that these data show that treated plastics and textiles release “exceedingly small amounts of silver.” Based on this evaluation, EPA “determined that NSPW-L30SS will not cause unreasonable adverse effects on people, including children, or the environment and that it would be beneficial because it will introduce less silver into the environment than competing products.” EPA notes that it is requiring the company “to generate additional data to refine the Agency’s exposure estimates.” According to EPA, it will post a response to comments received on its 2013 proposed registration decision document, as well as the current decision document, in the rulemaking docket.
By Lisa M. Campbell and James V. Aidala
On May 8, 2015, in El Comite Para El Bienestar De Earlimart v. EPA, a Panel of the U.S. Court of Appeals for the Ninth Circuit denied a petition for review filed by several groups that the court describes as “community organizations” who challenged the U.S. Environmental Protection Agency’s (EPA) 2012 approval of California State Implementation Plan (SIP) elements under the Clean Air Act (CAA), including its related approval of certain fumigant regulations. This challenge was previously discussed in our blog post "Ninth Circuit to Consider Civil Rights Issue in Review of California SIP".
Of particular interest in the case is the contention before the court that “EPA failed to secure necessary assurances from California that its proposed rules would not violate Title VI of the Civil Rights Act by exposing Latino schoolchildren to a disparate impact from pesticide use.” The court rejected this and other contentions by the community groups.
The court’s findings with regard to the alleged Civil Rights violation state a standard that appears to defer greatly to EPA and its review of the record. More specifically, the court found with regard to the claimed Civil Rights Act violation that “EPA explained that this evidence failed to draw any connection between the proposed rules and a potential disparate impact,” and that EPA “fulfilled its duty to provide a reasoned judgment because its determination was cogently explained and supported by the record.”
By way of background with regard to the Civil Rights Act claim, the petitioners argued that EPA’s determination that California provided assurances that no federal or state law prohibits the SIP approval was arbitrary and capricious because EPA failed to consider evidence claimed to support a violation of Title VI of the Civil Rights Act. This claim rested on an EPA finding of a Title VI violation in connection with an earlier administrative complaint, referred to as the Angelita C. complaint, which was filed with the EPA Office of Civil Rights in 1999. There, Latino parents and schoolchildren alleged that schools with high percentages of Latino children were disparately affected by the California Department of Pesticide Regulation’s (DPR) renewal of the registration for methyl bromide, a fumigant pesticide. EPA concluded in that action that there was support for “a preliminary finding of a prima facie Title VI violation,” and EPA and DPR entered a settlement agreement in 2011.
Petitioner argued that EPA’s findings in Angelita C., and evidence that it claimed to demonstrate that pesticide use had not gone down since EPA completed its original review, supported the claimed Title VI violations that are the subject of the Ninth Circuit petition, and further that EPA did not do enough to determine that California had satisfied its burden to provide assurances of compliance with federal law. The Ninth Circuit decision states in this regard that the petitioner “effectively contends the EPA should have evaluated California’s assurances the same way the EPA would have to deal with a pending Title VI complaint setting forth allegations of a current violation.”
The court states: “El Comite’s argument fails because it misconstrues the EPA’s burden regarding the ‘necessary assurances’ requirement. The EPA has a duty to provide a reasoned judgment as to whether the state has provided ‘necessary assurances,’ but what assurances are ‘necessary’ is left to the EPA’s discretion.” The court further found: “El Comite provided no proof of a current or ongoing violation. It merely provided evidence of the earlier violation, and pointed to continued pesticide use since that time. The EPA explained that this evidence failed to draw any connection between the proposed rules and a potential disparate impact. The EPA fulfilled its duty to provide a reasoned judgment because its determination was cogently explained and supported by the record.”
The decision in this case is of significant interest to many who have been observing the emerging trends regarding environmental justice issues arising in connection with pesticide applications. This concern may grow larger as EPA continues and expands its evaluations of the potential bystander risks from pesticide use, potentially leading to additional restrictions for certain pesticides in the future.
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.