By Lisa M. Campbell and Timothy D. Backstrom
In July 2018, the California Environmental Protection Agency’s Department of Pesticide Regulation (DPR), Human Health Assessment (HHA) Branch, issued its final toxic air contaminant (TAC) evaluation of chlorpyrifos. This final TAC evaluation updates the December 2017 draft evaluation of chlorpyrifos as a TAC for the Scientific Review Panel (SRP) which updated the August 2017 draft and was reviewed by the SRP on TACs, and incorporates certain changes based on SRP recommendations. As part of their review of the December 2017 draft, the SRP recommended “additional and detailed review of developmental neurotoxicity studies, in particular recent in vivo animal studies as well as a more in depth analysis of human effects of chlorpyrifos” and “that DPR reevaluate the critical endpoints, the associated [(uncertainty factors (UF)], and the resulting [reference concentrations (RfC)] and [reference doses (RfD)] for each endpoint.”
DPR determines that a pesticide is a TAC for a non-cancer adverse effect if the projected air concentrations associated with use of the pesticide are more than one tenth of the inhalation RfC established based on animal toxicity and epidemiology data. In the draft TAC evaluation for chlorpyrifos, DPR utilized the threshold for red blood cell acetylcholinesterase (AChE) inhibition in humans and a target margin of exposure (MOE) of 100, including a factor of 10 intended to account for potential neurodevelopmental effects below the threshold for RBC AChE inhibition. In the final TAC evaluation for chlorpyrifos, DPR increased the MOE for AChE inhibition to 300, based on deficiencies in the human inhalation parameters used to model the threshold for AChE inhibition.
In addition, the final TAC evaluation establishes a new No Observed Effect Level (NOEL) for neurodevelopmental effects in animal studies with chlorpyrifos reported at exposure levels well below the threshold for AChE inhibition. Based on this NOEL, DPR has derived a new inhalation RfC for neurodevelopmental effects, using a standard MOE of 100 consisting of 10X for interspecies sensitivity and 10X for intraspecies variability. This new inhalation RfC based on neurodevelopmental effects in animal studies is about one-half the revised inhalation RfC based on the threshold for AChE inhibition. Because the modeled spray drift air concentrations for chlorpyrifos are more than one tenth of this new inhalation RfC, DPR concludes “that chlorpyrifos meets the criteria to be listed as a TAC pursuant to the law of California.”
In the final TAC evaluation for chlorpyrifos, DPR concluded that there is sufficient evidence from animal studies to establish a new NOEL for neurodevelopmental effects, which is well below the level that has been shown to cause AChE inhibition in the same animals. Although the U.S. Environmental Protection Agency (EPA) has previously issued a determination that the default 10X safety factor for infants and children established by the Food Quality Protection Act (FQPA) should be retained for chlorpyrifos, this determination was based on epidemiology studies that purported to show adverse neurodevelopmental outcomes in humans at exposure levels below the threshold for AChE inhibition. The methodology used in these epidemiology studies has been harshly criticized by the pesticide industry. DPR views these epidemiology studies as providing corroboration, but the new DPR risk assessment is predicated instead on DPR’s view that animal studies with chlorpyrifos report neurodevelopmental effects below the threshold for AChE inhibition. The DPR risk assessment based on these animal studies uses a standard MOE of 100. How EPA may or may not view DPR’s conclusion is not known. In light of the August 9, 2018, decision by the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) directing EPA to proceed with revocation of all tolerances and cancellation of all registrations for chlorpyrifos, the effect of the DPR conclusion on EPA actions is not clear. Nevertheless, it is worth noting that, because the mechanism by which chlorpyrifos would cause such neurodevelopmental effects is unknown and is below the level that causes AChE inhibition, any presumption by EPA that other organophosphate (OP) pesticides may cause the same type of effects will likely be vigorously disputed by industry on scientific grounds.
Please see our blog item Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos for more information on the Ninth Circuit’s August 9, 2018, decision.
By Timothy D. Backstrom
On July 9, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) held oral argument in League of United Latin American Citizens (LULAC) v. Pruitt, a case brought to challenge the decision by the U.S. Environmental Protection Agency (EPA) to deny a 2007 petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC). The 2007 petition requested that EPA revoke all chlorpyrifos tolerances granted under the Federal Food, Drug, and Cosmetic Act (FFDCA) and all chlorpyrifos registrations granted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). After a series of delays and court decisions concerning EPA action on the 2007 petition, the Ninth Circuit issued a writ of mandamus in In re PANNA v. EPA requiring that EPA take action to grant or to deny the petition no later than March 31, 2017. Although EPA proposed in November 2015 to partially grant the 2007 petition and to revoke all chlorpyrifos tolerances based on concerns about neurodevelopmental effects in children, EPA ultimately decided to deny the entire PANNA and NRDC tolerance revocation petition in a decision dated March 29, 2017. More information on EPA’s March 29, 2017, decision is available in our blog item “EPA Denies Petition to Ban Chlorpyrifos.”
After the March 29, 2017 denial decision, the Ninth Circuit denied a motion for further mandamus relief in the PANNA case. The court stated that, once EPA denies a tolerance revocation petition under FFDCA, “[f]iling objections and awaiting their resolution by the EPA Administrator is a prerequisite to obtaining judicial review of EPA’s final response to the petition.” The petitioners in the current LULAC case filed administrative objections to EPA’s denial decision on June 5, 2017, but, on the same date, they also brought a new action seeking immediate judicial review. Five States and the District of Columbia subsequently intervened in the new case. EPA filed a motion to dismiss the LULAC case for lack of jurisdiction on August 21, 2017, but the court denied that motion, without prejudice to EPA renewing its jurisdictional arguments during briefing on the merits.
Background to Tolerance Petition Decision
EPA’s risk assessments concerning the potential neurodevelopmental effects of chlorpyrifos have been the subject of scientific controversy for a number of years. In decisions that were the subject of significant criticism and controversy, EPA scientists construed the associations reported in certain epidemiological studies of exposure to chlorpyrifos as evidence that chlorpyrifos may cause neurodevelopmental effects in children at exposure levels that are less than the threshold for induction of acetylcholinesterase inhibition. In November, 2016, EPA issued an updated risk assessment for chlorpyrifos and all organophosphate (OP) pesticides based on the same epidemiology studies, which included a determination that EPA would retain the default 10X safety factor established by the Food Quality Protection Act (FQPA) for chlorpyrifos and for all OP pesticides. Pesticide industry representatives have raised concerns about the design and conduct of the chlorpyrifos epidemiology studies, the scientific plausibility of the proposed association of neurodevelopmental effects with low level chlorpyrifos exposure, and the rationale for extending the FQPA determination to OP pesticides other than chlorpyrifos.
Prior to the change in administration in 2017, it appeared that EPA would proceed with its 2015 proposal to revoke chlorpyrifos tolerances based on the 2016 updated risk assessment. Instead, on March 29, 2017, EPA decided to deny the 2007 petition and to defer its ultimate scientific decision concerning the neurodevelopmental effects of chlorpyrifos until after EPA completes the currently pending registration review process for chlorpyrifos.
Briefs in the LULAC Case
In their briefs, the petitioners and the intervenors in the LULAC case have objected to further delay in EPA’s scientific decision concerning the neurodevelopmental risks presented by chlorpyrifos, as well as to the procedures specified by FFDCA that would require that they await resolution of their objections before seeking judicial review. From their perspective, EPA has already determined repeatedly that continued chlorpyrifos exposure is unsafe for infants and children, and EPA is therefore required to proceed with immediate revocation of all chlorpyrifos tolerances.
In their briefs, the petitioners and the intervenors argued that the procedures required by FFDCA are not jurisdictional, and that the court therefore has discretion to waive exhaustion of these procedures. They also argued that exhaustion should be waived in this instance because allowing EPA time to rule on their objections would ultimately be futile, and because further delay would perpetuate EPA’s purported disregard of the FFDCA safety standard. Further, they argued that, if immediate review is not available under FFDCA, it should be available under FIFRA because EPA also denied a request to cancel the FIFRA registrations for chlorpyrifos. Finally, the petitioners requested during briefing that the court issue “a writ of mandamus directing EPA to decide LULAC’s objections within 60 days.”
In its brief, EPA argued that the petitioners lack any jurisdiction to bring the current case because the detailed procedures specified in the FFDCA are jurisdictional in nature, and exhaustion of these procedures therefore cannot be waived by a reviewing court. EPA also argued that, even if the court could waive the exhaustion requirement, the petitioners have raised the same issues in their objections as they raised in their briefs, and there is no basis for the court to presume that allowing EPA to address these issues would be futile. Moreover, EPA argued that FFDCA Section 346a(h)(5) expressly precludes separate judicial review under FIFRA of EPA’s decision concerning the 2007 petition. Finally, EPA contended in its brief that the petitioners’ request for a writ of mandamus must be denied because the petitioners did not follow the procedure for making such a request in Federal Rule of Appellate Procedure 21(a).
During the oral arguments on July 9, 2018, two of the three judges on the Ninth Circuit panel reportedly expressed frustration concerning the prospect for years of further delay before EPA makes its ultimate decision concerning chlorpyrifos. Although it is not clear how the court would overcome the formidable jurisdictional barriers to immediate judicial review, it appears that some sort of judicial decision or order compelling EPA to take more immediate action on chlorpyrifos is a possibility. More information regarding these proceedings is available on our blog under key word chlorpyrifos.
by James V. Aidala
Time is running out on the Pesticide Registration Improvement Act (PRIA), and it could die a natural death on January 19, 2018, absent Congressional action. Congress enacted PRIA in 2003 and in so doing established a fee schedule for pesticide registration and amendment applications and critically important specified decision time periods within which the U.S. Environmental Protection Agency (EPA) must make a regulatory decision. PRIA has been reauthorized twice, and was scheduled to expire at the end of the 2017 federal fiscal year, on September 30, 2017. A short term funding measure saved the day, but it expires on January 19.
As was the case for PRIA and its prior reauthorizations, a coalition of registrants, labor, and environmental advocates were working with Congress relatively smoothly to pass what will be “PRIA 4” before the expiration date. In May 2017, however, EPA announced that as part of its regulatory review efforts, there would be delays in implementing recent regulations making changes to worker protection standard (WPS) regulations and requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) certification and training (C&T) programs run by the states -- all Obama initiatives. Some farm advocacy groups, the American Farm Bureau in particular, raised concerns about a few elements of the WPS regulations, and the National Association of State Departments of Agriculture (NASDA) also raised concerns about some elements of the WPS and C&T programs. More information regarding the status of the WPS and C&T rulemakings is available in our blog item “EPA Signals New Rulemakings On Worker Protection Standard and Certification of Pesticide Applicators.”
When EPA announced plans to review and possibly change these regulations, farmworker advocacy groups withdrew their support for the draft PRIA legislation. Along with concerns about possible regulatory changes and delays, environmental groups also expressed concerns with the Administration’s decisions allowing the continued use of chlorpyrifos as part of a petition response announced in March 2017. The tumult fractured the PRIA coalition and a group of Democratic Senators supporting the environmental and labor advocates’ position blocked the PRIA legislation preventing changes to the current WPS regulations, and separately introduced legislation that would effectively end the use of chlorpyrifos (S. 1624).
The PRIA reauthorization has already been approved by the House of Representatives, but now there is a sufficient number of Senate Democrats to block movement of the legislation. As a result, there is currently an impasse, with discussions reportedly ongoing but with no clear path towards resolution.
As the deadline nears, it is expected that a temporary PRIA renewal will be part of any additional short extension, with a less certain outlook about the chances of being included in any comprehensive, year-long legislation to fund government operations. The expectation is that some kind of resolution will be found, but the specific parameters of any solution have not yet been identified.
PRIA has also included the authorization for the “maintenance fee” provisions first included in the 1988 amendments to FIFRA, designed as general support for the EPA pesticide program budget. Taken together, PRIA reauthorization has become a major contributor to the program budget.
Should PRIA not be reauthorized, then the current law allows for a phase-down of the current submissions which include PRIA fees and are subject to decision deadlines. The larger issue would be the potential for the elimination of approximately 200 positions from the pesticide program workforce, which is about one-third of the current staff (and is in line with the share of program costs supported by fees).
Stay tuned -- we will monitor this important topic. More information on PRIA issues is available on our blog under key word PRIA.
By Lisa M. Campbell and Timothy D. Backstrom
On December 20, 2017, the U.S. Court of Appeals for the Ninth Circuit issued an order in LULAC v. Pruitt, Case No. 17-71636, a case challenging an order denying administrative petitions to revoke the tolerances and cancel the registrations for chlorpyrifos. The court’s order includes actions concerning two pending motions. The court has denied a motion by the U.S. Environmental Protection Agency (EPA) and Administrator Pruitt (Respondents) to dismiss the case for lack of jurisdiction while granting a motion by League of United Latin American Citizens (LULAC), et al. (Petitioners) to expedite briefing and hearing in the case. More information on these two motions is available in our blog item “NGOs and Farmworkers File Motion for Expedited Briefing and Hearing in Chlorpyrifos Litigation.”
In support of their August 21, 2017, motion to dismiss the case for lack of jurisdiction, Respondents argued that the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the Petitioners to exhaust their administrative remedies by submitting formal objections to the order denying their request to revoke the tolerances for chlorpyrifos and then waiting for EPA to issue a final order before they may seek judicial review. The Petitioners argued in response that requiring exhaustion in this instance would be “futile,” and that the court should also consider reviewing the EPA order under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), because EPA has declined to cancel the registrations for chlorpyrifos. In response, Respondents argued that Petitioners have not shown that requiring exhaustion of administrative remedies would be futile, and that 21 U.S.C. § 346a(h)(5) explicitly prohibits judicial review of any order concerning pesticide tolerances under any other statute, including FIFRA.
After the motion to dismiss was fully briefed, the court summarily denied it, but also characterized that denial as “without prejudice to renewing the arguments in the answering brief.” The court also denied a motion by the Petitioners for oral argument concerning the pending motion to dismiss. These two actions indicate that the court has decided to defer argument and resolution of the jurisdictional issues presented by the motion to dismiss until briefing and argument on the merits.
The court also granted an October 13, 2017, motion by the Petitioners to expedite briefing and hearing in the case. Petitioners submitted this motion to expedite because they contend that the refusal of EPA to revoke the tolerances and cancel the registrations for chlorpyrifos is causing ongoing harm even though EPA “did not and cannot determine that chlorpyrifos is safe under the Food Quality Protection Act.” The court set the following expedited briefing schedule: Petitioners’ opening brief is due January 23, 2018; Intervenors’ brief(s) are due February 6, 2018; Respondents’ answering brief is due March 8, 2018; Petitioners’ optional reply brief is due 28 days after service of Respondents’ brief; and Intervenors’ optional reply brief(s) are due 42 days after service of Respondents’ brief. The court also directed the Clerk to “calendar this case [for argument] as soon as possible upon completion of briefing.”
The current actions of the court should be viewed in the context of the prior decision by this same court to issue a writ of mandamus that required EPA to take action on pending petitions to cancel the registrations and revoke the tolerances for chlorpyrifos after what Petitioners claimed was a quite protracted administrative delay, and the subsequent decision by EPA under Administrator Pruitt to defer final action on chlorpyrifos, after the prior Administration had proposed to take the actions sought by the Petitioners. By granting the motion to expedite, and also by deferring the ultimate disposition of the jurisdictional issues raised by EPA, the court appears to have given the Petitioners a prompt and full opportunity to explain why judicial intervention at this stage of the administrative process is warranted. Nevertheless, because the jurisdictional arguments made by EPA are supported by substantial precedent, it could prove difficult for the Petitioners ultimately to overcome these arguments.
More information on the chlorpyrifos litigation and related matters is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell and Timothy D. Backstrom
On October 13, 2017, Petitioners League of United Latin American Citizens (LULAC), et al. filed a motion to expedite briefing and hearing in League of United Latin American Citizens v. Pruitt, Case No. 17-71636 (9th Cir. June 5, 2017). In their motion, Petitioners request that the court “expedite proceedings because of the harm being caused by [U.S. Environmental Protection Agency (EPA)] Administrator Pruitt leaving chlorpyrifos tolerances in effect when he did not and cannot determine that chlorpyrifos is safe under the Food Quality Protection Act.”
Petitioners state there is good cause for expedition “because children continue to be exposed to chlorpyrifos in their food, drinking water, and the air around their homes, schools, and playfields, putting them at risk of such brain impairments as lower IQ, attention deficit disorders, and developmental delays,” and “Ninth Circuit Rule 27-12 provides that ‘motions to expedite briefing and hearing may be filed and will be granted upon a showing of good cause,’” including ‘“situations in which … in the absence of expedited treatment, irreparable harm may occur.’” Pursuant to Ninth Circuit Rule 27-12, Petitioners determined the position of EPA counsel on the motion, who stated that, “EPA opposes the motion to expedite as premature under Circuit Rule 27-11(b).”
The Petitioners’ motion to expedite briefing was submitted despite the pendency of an unresolved motion to dismiss submitted by Respondents Administrator Pruitt and EPA on August 21, 2017. In that motion, EPA argued that the court lacks jurisdiction to review the March 29, 2017, order denying the petition by Pesticide Action Network North America (PANNA) and Natural Resources Defense Council (NRDC) to revoke all Federal Food, Drug, and Cosmetic Act (FFDCA) tolerances for chlorpyrifos, until after the Petitioners have exhausted their administrative remedies by filing objections to the denial, and EPA has issued a final order ruling on such objections. In its motion to dismiss, EPA noted that the Ninth Circuit denied a motion by PANNA and NRDC for further mandamus relief in In re PANNA on July 18, 2017, stating that “one valid agency response to a petition challenging a pesticide’s tolerances is to ‘issue an order denying the petition,’” and ‘“now that EPA has issued its denial, substantive objections must first be made through the administrative process mandated by’ the FFDCA.”
On September 27, 2017, Petitioners filed their opposition to the motion to dismiss. Petitioners argued that exhaustion of administrative remedies by filing objections under the FFDCA is not an absolute jurisdictional prerequisite to judicial review, and that the court can proceed with review under the “futility doctrine” because EPA’s refusal to revoke the tolerances for chlorpyrifos constitutes a “flagrant violation of a statutory prohibition.” Petitioners also argued that even if FFDCA exhaustion is required, EPA has also denied the petition by PANNA and NRDC to cancel the registrations of chlorpyrifos, and that additional denial constitutes a final order that is subject to immediate review under FIFRA Section 16(b) because the notice and comment process concerning the petition was a “public hearing” under the applicable precedent.
The new motion by Petitioners LULAC, et al. to expedite briefing on the challenge to EPA’s denial of the PANNA and NRDC petition reflects the view of the Petitioners that this matter is urgent because continued use of chlorpyrifos jeopardizes the health of children, but this motion is unlikely to be resolved before the court rules on EPA’s pending motion to dismiss. EPA has stated that it will oppose the Petitioners’ motion to expedite briefing as premature. Moreover, EPA has not yet replied to the arguments made by the Petitioners in their opposition to the pending dismissal motion.
To prevail on their argument that exhausting the administrative process prescribed by the FFDCA will be “futile,” the Petitioners likely will have to persuade the Court that these FFDCA procedures are not jurisdictional prerequisites to judicial review, and that there is little likelihood that EPA will change its mind in response to their objections. With respect to the argument that EPA’s denial of the petition to cancel the registrations for chlorpyrifos is final agency action subject to immediate review under FIFRA Section 16(b), EPA will likely contend that this argument is contravened by 21 U.S.C. § 346a(h)(5), which states: “any issue as to which review is or was obtainable under this subsection shall not be the subject of judicial review under any other provision of law.” It could be difficult for Petitioners to defeat this jurisdictional prohibition in the FFDCA; they would presumably need to show the court that their substantive contentions concerning the hazards posed by chlorpyrifos would not be directly implicated in EPA’s final determination of whether or not to revoke the tolerances for chlorpyrifos.
This case will be carefully watched by pesticide industry observers.
More information on regulatory issues related to chlorpyrifos is available on our blog.
By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham
On July 18, 2017, four Senators (Tom Udall (D-NM); Benjamin Cardin (D-MD); Richard Blumenthal (D-CT); and Cory Booker (D-NJ)) submitted a letter to Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI), the Chairman and the Ranking Member of the Senate Committee on Agriculture, Nutrition, and Forestry, regarding reauthorizing the Pesticide Registration Improvement Act (PRIA), worker protections, and the U.S. Environmental Protection Agency’s (EPA) “legal duty to protect the public from unreasonable harm from pesticides.” H.R. 1029, the Pesticide Registration Improvement Extension Act of 2017, which reauthorizes PRIA, was passed by the Agriculture Committee on February 16, 2017. The letter states that it should include a “limited number of improvements” before being approved by the full Senate, including “adequately reflect[ing] important worker safety priorities” via “ensuring that the worker protection rules are implemented in a timely manner” and “finalizing the EPA staff recommended ban on chlorpyrifos.” The letter states the EPA’s decision to deny the petition to ban chlropyrifos should be “reversed immediately.”
More information on H.R. 1029 is available in our blog item House Agriculture Committee Passes Pesticide Registration Enhancement Act of 2017.
On July 25, 2017, Udall, Blumenthal, Booker, Cardin, and several other Senators introduced S. 1624, the Protect Children, Farmers, and Farmworkers from Nerve Agent Pesticides Act of 2017, which prohibits the use of chlorpyrifos on food and directs EPA to enter into a contract with the National Research Council to “conduct a cumulative and aggregate risk assessment that addresses all populations, and the most vulnerable subpopulations, including infants, children, and fetuses, of exposure to organophosphate pesticides.” S. 1624 proposes to amend Section 402 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to add to the list of adulterated food any food that “bears or contains chlorpyrifos, including any residue of chlorpyrifos, or any other added substance that is present on or in the food primarily as a result of the metabolism or other degradation of chlorpyrifos.”
The Senate letter regarding issues with H.R. 1029 can possibly forestall the reauthorization of PRIA, which would cause many problems for EPA’s Office of Pesticide Programs (OPP), as the PRIA funds are necessary for OPP to operate the pesticide regulatory program.
Politically, the hiccup on PRIA reauthorization indicates a further acceleration of the partisan sniping already sapping the ability of the Senate to reach agreement on any subject. PRIA contributes to EPA’s budget, with specific funds directed to support farmworker protection. As such, it has not proven to be controversial in past reauthorization efforts. PRIA represents an industry contribution to support EPA’s regulatory reviews and farmworker protection programs, and without it, EPA’s budget will face further cuts. Normally, democratic members of Congress would be expected to be against further cuts to EPA and applaud the more robust regulatory regime supported by the regulated community’s own fees.
The chlorpyrifos legislation also portends a new, more hostile operating environment for the current leadership of EPA. It has been years since action on specific pesticide products has seen a serious legislative proposal; generally Congress is reluctant to engage on a specific regulatory conclusion which has complex scientific disputes at its core.
Opposition to current EPA leadership and Administration agendas appears to be so intense that partisan bickering will surround almost any EPA-related initiative brought to the Senate floor.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On July 18, 2017, a panel of three judges at the U.S. Court of Appeals for the Ninth Circuit issued an order denying petitioners’ Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) Motion for Further Mandamus in the chlorpyrifos proceedings. In that motion, Petitioners asked the court to grant further mandamus relief, asserting that the U.S. Environmental Protection Agency’s (EPA) denial of Petitioners’ petition to revoke all food tolerances and cancel all chlorpyrifos registrations was inadequate because it contained “no new safety findings” and no “final determination as to whether chlorpyifos food tolerances must be revoked.” More information on the motion is available in our blog item Petitioners File Motion for Further Mandamus Relief in Response to EPA’s Order Denying Petition to Ban Chlorpyrifos.
In its order, the panel held that since the prior mandamus proceedings “addressed the timing, not the substance, of EPA’s response,” EPA had “complied with the panel’s previous orders by issuing a ‘final response to the petition.’” The mandamus motion thus was “premature, and its substantive objections to the EPA’s denial must first be made through the administrative process mandated by statute.”
The demand imposed by the court earlier was to make a decision, and EPA met that deadline with its denial. This is a significant win for industry, but is far from the end of this debate, which will continue in a number of different forums. More information on the proceedings is available on our blog under key word chlorpyrifos.
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 Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On June 22, 2017, a complaint was filed against the U.S. Environmental Protection Agency (EPA) by American Oversight, a nonprofit organization (Plaintiff), in the United States District Court for the District of Columbia. The complaint asks the court to compel EPA to provide information in response to a Freedom of Information Act (FOIA) request submitted by the Plaintiff on April 11, 2017, “seeking communications between certain individuals at each agency and certain outside entities related to chlorpyrifos or other pesticides.” The records requested included: (1) a copy of any decision memoranda and attachments associated with the decision to deny the petition to ban chlorpyrifos; and (2) all communications between certain individuals involved with EPA’s Administration as well as certain transition team members, and the following listed entities:
- Any agricultural or other trade group with an interest in pesticides, including but not limited to CropLife, the American Farm Bureau, the National Corn Growers, or the Oklahoma Farm Bureau;
- Any pesticide manufacturer or anyone acting on behalf of a pesticide manufacturer, including but not limited to Dow Chemical or Dow AgroSciences;
- Any member of Congress or anyone acting on behalf of a member of Congress (including both personal and committee staff) regarding agricultural issues or pesticides; and
- Any think tanks, including but not limited to the Heritage Foundation, regarding agricultural issues or pesticides.
The complaint asserts that although EPA responded to the FOIA request by stating that it was “proceeding with the search,” EPA “has not taken any additional actions,” and as of June 14, 2017, had not provided any of the requested records. Plaintiff claims that EPA has failed to comply with the applicable time-limit provisions of FOIA and the complaint contains two Counts: Count I: Failure to Conduct Adequate Search for Responsive Records; and Count II: Wrongful Witholding of Non-Exempt Records. Based on these alleged violations, Plaintiff asks the court to order EPA to conduct a search reasonably calculated to uncover all records responsive to the FOIA request; order EPA to produce any and all non-exempt records responsive to the FOIA request and indexes justifying the withholding of any responsive records withheld under claim of exemption; and enjoin EPA from continuing to withhold any and all non-exempt records responsive to the FOIA request.
This Plaintiff appears to be seeking the responsive records to demonstrate that some kind of untoward or inappropriate communication occurred between the incoming Administration and outside groups leading to the chlorpyrifos petition response that allowed continued use of chlorpyrifos products, pending the completion of the registration review process. Given the record that the Obama Administration constructed to propose the revocation of the chlorpyrifos tolerances, environmental advocates were disappointed that the new EPA leadership decided to postpone a decision. EPA in its petition response articulated its rationale for its decision, but the Plaintiff may believe that these documents would likely show the “politics” behind the decision. This is somewhat ironic since many stakeholders in the agricultural user community are convinced that the initial proposal to revoke chlorpyrifos tolerances issued during the prior Administration was itself an example of “politics over science.”
In this instance, it does not appear that EPA has made any determination yet whether any of the requested records are exempt from disclosure. Moreover, the Plaintiff appears to be seeking decision memoranda and communications between EPA employees and other parties outside of EPA; this fact could affect EPA’s consideration of the applicability of the “deliberative process” privilege set forth in FOIA Exemption 5 to try to withhold any of the requested records, an issue that could be controversial.
The Plaintiffs contend that EPA has not met the mandatory time limits applicable to a FOIA request. This is a common problem, particularly when multiple individuals must participate in the search for responsive records, the records requested are voluminous, or exempt material like confidential commercial information must be redacted from otherwise responsive records. Unless EPA ultimately determines that some records can and should be withheld, and Plaintiff disagrees, this suit may become moot in the event that EPA produces the requested documents before the case can be adjudicated. Regardless of the outcome, Plaintiff has succeeded in keeping EPA’s controversial chlorpyrifos decision in the spotlight.
By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham
On April 27, 2017, Senator Elizabeth Warren (D-MA) and Representative Frank Pallone (D-NJ) sent a letter to Inspector General Arthur Elkins, Jr. at the Office of Inspector General (OIG) at the U.S. Environmental Protection Agency (EPA) requesting the OIG to conduct an investigation into EPA’s March 29, 2017, order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos. The letter refers to the March 29, 2017, order as “Administrator Scott Pruitt’s order,” and asks OIG to address questions specifically targeting the rationale, communications, and consideration that Administrator Pruitt took prior to reaching the decision.
The letter states that Administrator Pruitt's “hasty reversal of this decision … appears not to be based on EPA’s existing recent scientific findings about the risk, or any new information that contradicts the findings about the health and safety risks of chlorpyrifos.” Further, the letter asserts that “it does not appear to be consistent with the law, which requires that pesticide products cannot be used unless ‘there is reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical residue.’”
- How did Mr. Pruitt reach the decision he announced on March 29, 2017? What was the timeline leading up to this decision? With whom did he communicate within EPA, the White House, or elsewhere in the Administration? With which outside entities did he communicate? Specifically, did Mr. Pruitt have any communication with staff or representatives of Dow Chemical or any pesticide industry trade groups including CropLife America?
- What was the rationale for Mr. Pruitt's decision, and why did he reverse an agency decision that had been years in the making? How was this rationale developed? Was it based on any new information or evidence?
- Was Mr. Pruitt's decision consistent with the requirements of the Administrative Procedures Act? Did he provide appropriate notice and comment and appropriately consider all relevant comments and information?
- Was Mr. Pruitt's decision consistent with the requirements of the FFDCA, which establishes a standard that, to maintain a pesticide tolerance, there must be "reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical petitition to revoke tolerances.pdf residue"? Has the EPA met the "reasonable certainty [of] no harm" standard in the law? Why did Mr. Pruitt note that chlorpyrifos was "widely used" when he announced his decision? Was this "wid[e] use" a factor in Mr. Pruitt's decision, and, if so, was this appropriate under the law? What other factors were taken into consideration by Mr. Pruitt?
- Is the EPA accurately and transparently presenting information to the public with regard to previous EPA actions concerning chlorpyrifos? For example, the EPA website for chlorpyrifos on January 2, 2017 contained information indicating that EPA "proposed to revoke all chlorpyrifos tolerances," and contained a link with detailed information about the health risks and the reasons for the EPA action. This reference to the proposed ban, and the link to the detailed EPA analysis are no longer available on the chlorpyrifos web page, and the link to the analysis (as of April 3, 201 7) now gives a "Page Not Found" error.
This letter not surprisingly continues the debate over the appropriate regulatory status of chlorpyrifos. Those disappointed by the recent EPA decision, apparently including Senator Warren and Representative Pallone, want to press EPA to explain in more detail not only the reasons for the decision not to revoke chlorpyrifos tolerances at this time, but also the rationale EPA used to rebut what they believe to be the decision-making record that EPA had accumulated over the last two to three years.
The explanation that the arrival of new leadership at EPA with the Administration led to a change in position is perhaps only part of the answer. The change in Administration did not change the underlying statutory requirements governing EPA’s registration, reregistration, and tolerance decisions, and EPA relied on these requirements as the basis for its decision not to make a decision at this time, as discussed in EPA Denies Petition to Ban Chlorpyrifos.
EPA’s response to any investigation initiated by this letter, as well as the OIG response, will be watched closely by all stakeholders.