By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On August 18, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will stop the use of the pesticide chlorpyrifos on all food. In the pre-publication of the Federal Register notice released on August 19, 2021, EPA revoked all “tolerances” for chlorpyrifos, which establish an amount of a pesticide that is allowed on food. In addition, EPA states that it will issue a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to cancel registered food uses of chlorpyrifos associated with the revoked tolerances. EPA has stated the cancellation order will follow in approximately six months after the tolerance revocations.
EPA’s announcement responds to the Ninth Circuit’s order, issued on April 29, 2021, that vacated EPA orders issued in 2017 and 2019 denying a 2007 petition filed by Pesticide Action Network North America and Natural Resources Defense Council. That petition requested that EPA revoke all chlorpyrifos tolerances, or the maximum allowed residue levels in food, because those tolerances were not safe, in part due to the potential for neurodevelopmental effects in children. The 2017 and 2019 orders denying the 2007 petition were challenged in the Ninth Circuit by a coalition of farmworker, health, environmental, and other groups.
In its order, the Ninth Circuit found that “...EPA had abdicated its statutory duty under the Federal Food, Drug and Cosmetic Act (FFDCA) ...” to “conclude, to the statutorily required standard of reasonable certainty, that the present tolerances caused no harm.” After vacating the 2017 and 2019 orders, the court remanded the matter to EPA with instructions to: “(1) grant the 2007 Petition; (2) issue a final regulation within 60 days following issuance of the mandate that either (a) revokes all chlorpyrifos tolerances or (b) modifies chlorpyrifos tolerances and simultaneously certifies that, with the tolerances so modified, the EPA ‘has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information,’ including for ‘infants and children’; and (3) modify or cancel related FIFRA registrations for food use in a timely fashion consistent with the requirements of 21 U.S.C. § 346a(a)(1).”
In its announcement, EPA states that it has determined that the current aggregate exposures from the use of chlorpyrifos do not meet the legally required safety standard that there is a reasonable certainty that no harm will result from such exposures. Chlorpyrifos is an organophosphate insecticide used for a large variety of agricultural uses and has been continually reviewed with regard to potential adverse effects, including possible neurological effects in children, which has been the subject of considerable controversy for many years. EPA’s announcement notes that a number of other countries, including the European Union and Canada, and some states, including California, Hawaii, New York, Maryland, and Oregon, have taken similar action to restrict the use of this pesticide on food.
EPA states its action also will be incorporated into the ongoing registration review for chlorpyrifos. EPA is continuing to review the comments submitted on the chlorpyrifos proposed interim decision, draft revised human health risk assessment, and draft ecological risk assessment. These documents are available in the chlorpyrifos registration review docket EPA-HQ-OPP-2008-0850 at www.regulations.gov and a discussion of these issues is available on our blog here.
After considering public comments, EPA will proceed with its registration review of the remaining non-food uses of chlorpyrifos by issuing the interim decision, which may consider additional measures to reduce human health and ecological risks.
Separate from any issues of science, evidence, or interpretation, the FFDCA’s channels of trade provision is designed to address what happens if EPA cancels a pesticide product for not meeting Food Quality Protection Act (FQPA) standards and then revokes the tolerance. EPA’s initial description of its decision was unclear on this important point regarding the status of food already in the channels of trade that may contain chlorpyrifos residues.
EPA statements at an August 18, 2021, phone briefing with agricultural stakeholders appeared to present a position that the tolerance revocations would be in effect immediately upon publication in the Federal Register. This implied that there may be an immediate revocation of the tolerances before any parallel action to cancel the associated pesticide registrations. The pre-publication version of the notice clarified that the revocation of chlorpyrifos tolerances would not become effective until six months after the publication of the notice in the Federal Register. As of August 24, 2021, the notice has not been published in the Federal Register.
This revocation delay of six months aligns with the statement also made by EPA to cancel the registration of chlorpyrifos food use products six months after the revocation notice. EPA may face questions from some of the groups that have been advocating for this type of EPA action concerning why, if these tolerances need to be revoked, the use of the pesticide will continue in effect for the remainder of this growing season. Ed Messina, Office Director of the Office of Pesticide Programs, made a glancing reference to this at the phone conference when he stated EPA and the U.S. Food and Drug Administration (FDA) are “having discussions.”
According to EPA, use of chlorpyrifos has been in decline due to restrictions at the state level and reduced production. EPA also notes that some alternatives have been registered in recent years for most crops, other chemistries and insect growth regulators are available for certain target pests, and that EPA is committed to reviewing replacements for and alternatives to chlorpyrifos. Some growers, however, are using registered chlorpyrifos products on food crops and hoped to be able to continue certain uses.
EPA states in the pre-publication notice that some uses in certain areas appear to be able to meet the FQPA standard as evaluated in its 2016 and 2020 risk assessment documents, even if including the full 10x FQPA “extra” safety factor (these assessments are the reference documents EPA cites in its revocation notice). EPA further states that the Ninth Circuit’s order did not provide EPA with time to consider further changes to the use patterns or label restrictions to align with such changes hinted at in the revocation notice, and so EPA is issuing the revocation decision now. This begs the question of whether EPA might consider some continued uses in the future, although even considering any “new” tolerance would be very controversial.
In addition, none of the current actions affect (for now) the tolerances for stored grains using the sister chemical (chlorpyrifos-methyl) with a similar toxicological profile. There also are non-food use applications of chlorpyrifos, for example, mosquito control application of chlorpyrifos sprayed over a large area, that are not affected by the tolerance revocation.
This mix of messages may not be easy to explain to users and the consuming public.
Issues regarding the timing of the revocations and continued uses are also likely to present challenges for FDA. For example, there are various blended commodities (e.g., animal feed grain, possibly co-mingling harvests from different times) where FDA may be unable to determine what part of any enforcement sample came from a particular date of use.
The orderly transition for treated commodities was designed to avoid public and grower confusion that characterized the episodes of StarLink corn chaos in 2000 or the Cheerios contamination incident in 1994 involving a reported over 100 million boxes of cereal that were eventually destroyed. EPA cites international trade obligations as another reason for the coordinated actions effective in six months to notify foreign trading partners with a “reasonable interval” for adjusting to a changed regulatory situation.
Additional information on chlorpyrifos is available on our blog.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On December 7, 2020, the U.S. Environmental Protection Agency (EPA) issued for comment the Proposed Interim Decision (PID) for chlorpyrifos. 85 Fed. Reg. 78849. EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments. The PID proposes the following measures:
- Label amendments limiting application to address potential drinking water risks of concern.
- Additional personal protection equipment and application restrictions to address potential occupational handler risks of concern.
- Spray drift mitigation, in combination with the use limitations and application restrictions identified to address drinking water and occupational risks, to reduce exposure to non-target organisms.
EPA states that the PID presents proposed mitigation with the 10-fold (10x) Food Quality Protection Act (FQPA) safety factor, reflecting the uncertainties around doses that may cause pre- and post-natal neurodevelopmental effects. Under FQPA, EPA evaluates new and existing pesticides to ensure they can be used with a reasonable certainty of no harm to infants, children, and adults. EPA is required to consider the special susceptibility of children to pesticides by using an additional 10x safety factor unless adequate data are available to support a different factor. EPA additionally included a FQPA factor of 1x to reflect the range of potential risk estimates of chlorpyrifos, as illustrated in the September 2020 draft risk assessments.
Comments on both the September 2020 draft risk assessments and the PID are due on or before February 5, 2021. EPA states that by holding the comment period for both actions at the same time, the public has access to more information and can provide more informed, robust comments. Comments can be submitted at EPA-HQ-OPP-2008-0850.
EPA announced that it will also consider the input and recommendations from the September 2020 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting once it releases its report in December 2020. Depending on the SAP’s conclusions, EPA may further revise the human health risk assessment.
The inclusion of both 1x and 10x calculations for the appropriate FQPA safety factor is unusual. EPA states the final decision on the appropriate FQPA safety factor is partly dependent on any recommendations expected from the SAP meeting, which reviewed the “use of new approach methodologies (NAMs) to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment.” This is part of a larger and longer evaluation of whether test methods that avoid using test animals can reliably substitute for current test guideline requirements, that is, whether it is appropriate to rely on in vitro test protocols to substitute for current in vivo testing protocols.
EPA’s articulation at this point in time of mitigation needed if the FQPA 10x safety factor is retained may indicate a prediction about the SAP’s likely recommendations. It will be important to monitor developments on this issue closely.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On February 6, 2020, Corteva Agriscience (Corteva), announced it will discontinue all production of the organophosphate (OP) insecticide chlorpyrifos by the end of the year. Corteva and its corporate predecessor, Dow AgroSciences, have been the principal global manufacturers of chlorpyrifos. Corteva announced that its decision to stop selling chlorpyrifos was based entirely on financial considerations. This announcement came on the same day that Corteva had previously agreed it would end further sales of chlorpyrifos in California, and less than a week after the date the European Union (EU) ended all sales of chlorpyrifos in member states. These actions followed a number of prior actions taken by other national and state governments to ban or severely restrict chlorpyrifos. Corteva emphasized in its public statements that the science demonstrates that chlorpyrifos can be safely used, but that the company made a business decision based on the declining markets for the product. In an interview reported by the Washington Post, Susanne Wasson, Corteva's President for Crop Protection said, “It’s a tough decision for us to make, but we don’t feel like it’s viable going forward.” In other statements, Corteva noted that in the last ten years their share of the global chlorpyrifos market had declined from 75% to less than 20%.
Chlorpyrifos has been registered for use in the U.S. for over 50 years, but has become increasingly controversial in the dozen years since the Pesticide Action Network of North America and the Natural Resources Defense Council filed a petition in 2007 to cancel all registrations and revoke all tolerances for chlorpyrifos. Following a protracted court battle and a decision by the Ninth Circuit Court of Appeals to force the U.S. Environmental Protection Agency (EPA) to take final administrative action concerning the 2007 petition, EPA proposed near the end of the Obama Administration to revoke all existing tolerances for chlorpyrifos. A significant basis for this proposal was a controversial decision by a panel of EPA scientists that the default tenfold safety factor established by the Food Quality Protection Act (FQPA) for infants and children, which EPA had previously waived based on studies establishing a threshold for acetylcholinesterase (AChE) inhibition, should be reinstated.
The new EPA safety factor determination was based in large measure on epidemiology studies that reported an association between exposure to chlorpyrifos at levels below the presumed threshold for AChE inhibition and adverse neurodevelopmental effects in children. Many industry scientists disputed the scientific basis for this EPA determination because confounding exposures and methodological biases in the epidemiology studies may have influenced the reported association with neurodevelopmental effects and because the EPA determination made unprecedented use of epidemiology data. Beyond the effect on chlorpyrifos, the EPA decision will likely continue to be controversial because EPA included a similar safety factor determination for all OP pesticides, even though the mechanism responsible for the reported neurodevelopmental effects attributed to chlorpyrifos has not been identified and the other OP products were not studied in the epidemiology studies.
In the first year of the Trump Administration, EPA Administrator Scott Pruitt decided not to adopt EPA’s previously proposed tolerance revocation and instead to deny formally the 2007 petition, citing unresolved scientific issues. This reversal of course, however, was not accompanied by any new scientific assessment or by any explicit revision of the prior FQPA safety factor determination. Later, the California Department of Pesticide Regulation (DPR) decided to designate chlorpyrifos as a Toxic Air Contaminant, a decision that was noteworthy because it was based primarily on new toxicology studies that DPR stated reported neurodevelopmental effects well below the threshold for AChE inhibition. DPR deemphasized the epidemiology data relied on in the EPA safety factor determination in its decision. Although EPA later stated that it would address these new toxicology studies as part of an accelerated registration review process, there were intervening decisions by the EU and by California to ban new sales, which may have contributed to Corteva’s February 6, 2020, decision to cease chlorpyrifos production.
The decision by Corteva to cease manufacturing chlorpyrifos reminds us that the decision to continue marketing any chemical substance cannot be based solely on the scientific data, but must also consider the regulatory climate and the economic viability of the product. For those of us with a long memory, the decision by Corteva is reminiscent of the decision nearly 40 years ago by the Dow Chemical Company to pull the plug on 2,4,5-T and silvex, after Dow had expended millions of dollars and many years of effort to contest an emergency suspension and subsequent cancellation of these herbicides. Dow made this decision even though it believed that the available data demonstrated the safety of those products.
By Timothy D. Backstrom and Kelly N. Garson
On December 6, 2019, the European Union (EU) announced that it will no longer permit sales of chlorpyrifos after January 31, 2020. The Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) voted in favor of two draft Implementing Regulations that denied the renewal of approvals for chlorpyrifos and chlorpyrifos-methyl. The European Commission is expected to formally adopt the regulations in January 2020. At that time, Member States will need to withdraw authorizations for products containing chlorpyrifos and chlorpyrifos-methyl as active substances and may implement a grace period, at a maximum of three months, for final storage, disposal, and use of the substances.
The ban in the EU follows increased concerns over the human health effects of the substances. On August 2, 2019, the European Food Safety Authority (EFSA) published a report concluding that no safe exposure level could be determined for chlorpyrifos and that based upon available data, the approval criteria under Article 4 of Regulation (EC) No 1107/2009 for human health were not met. EFSA also published an updated statement reiterating the same conclusion for chlorpyrifos-methyl on November 26, 2019. EFSA’s primary health concerns were potential developmental neurotoxicity based on the available animal data and epidemiological evidence, and unresolved concerns regarding potential genotoxicity. EFSA also concluded that toxicological reference values could not be established for either of these effects, thereby precluding a valid risk assessment for consumers, workers, or bystanders.
Prior to the PAFF Committee meeting, eight EU states had already banned or never approved the use of chlorpyrifos. Canada proposed a ban of chlorpyrifos on May 31, 2019. (More information on this proposal is available in our blog post).
Within the United States, state governments have taken steps to regulate chlorpyrifos. On June 13, 2018, Hawaii passed an act that banned the use of pesticides containing chlorpyrifos as an active ingredient beginning January 1, 2019.
Several recent actions in California culminated in a ban on chlorpyrifos. First, the California Department of Pesticide Regulation (DPR) decided that chlorpyrifos should be designated as a Toxic Air Contaminant. This action was based primarily on a point of departure derived from new animal studies that report neurodevelopmental effects well below the level that inhibits cholinesterase. On August 14, 2019, DPR issued cancellation notices for chlorpyrifos products based primarily on the same new animal data. DPR subsequently announced on October 9, 2019, an agreement with pesticide manufacturers to end the sale of chlorpyrifos by February 6, 2020. Growers will not be able to possess or use chlorpyrifos products in the state after December 31, 2020.
In New York State (NYS), recent efforts to ban the substance through legislation were unsuccessful. On December 10, 2019, NYS Governor Andrew Cuomo vetoed a bill passed by the NYS Legislature (A.2477/S.5343) to phase out chlorpyrifos from use by December 1, 2021. Governor Cuomo stated that the NYS Department of Environmental Conservation is responsible for taking regulatory action on the issue, but recommended that the agency implement its own phased-in ban of chlorpyrifos.
On the federal level, chlorpyrifos products remain registered and have been since 1965. The U.S. Environmental Protection Agency (EPA) has taken measures to restrict the use of chlorpyrifos within households and on particular crops, but some non-governmental organizations (NGO) have long advocated that chlorpyrifos should be banned in its entirety. On September 12, 2007, the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) filed a petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos. EPA’s failure to respond fully to this petition was the subject of several decisions in the 9th Circuit Court of Appeals, and the Court ultimately issued a writ of mandamus requiring that EPA take final action concerning the petition.
At one point, EPA proposed to revoke all tolerances for chlorpyrifos. This action was based in part on a controversial determination that EPA should reinstate the default safety factor for tolerance assessments under the Food Quality Protection Act (FQPA) for all organophosphate (OP) pesticides. This determination was based on developmental neurotoxicity associated with chlorpyrifos exposure in certain epidemiology studies. After further deliberation and a change of administrations, EPA issued an order denying the 2007 petition in its entirety on March 29, 2017, based in part on a conclusion stating that further evaluation was needed to properly assess potential neurodevelopmental effects of chlorpyrifos. EPA later issued a final order that denied all objections to the March 2017 petition denial order. A number of NGOs (including the original petitioners) and several states have challenged this decision, filing petitions on August 8 and August 9, 2019, respectively for judicial review of EPA’s final order retaining tolerances and registrations for chlorpyrifos. EPA has stated that it intends to complete its evaluation of the epidemiology studies for chlorpyrifos, as well as the new animal data relied on by California, in the context of the pending registration review of chlorpyrifos under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(g). A final registration review decision concerning chlorpyrifos is due by October 1, 2022, although EPA has stated that it intends to accelerate that process. More information on the petitions and chlorpyrifos is available on our blog.
At this juncture, the long-term impact of the gradual accumulation of adverse decisions on chlorpyrifos from EFSA and various other governmental agencies is uncertain. Most user groups in the United States continue to describe chlorpyrifos as an essential agricultural tool. Some commodities treated with chlorpyrifos are destined for export markets where chlorpyrifos has been banned, however, and the impacts of this change will need to be monitored closely.
EPA’s interpretation of the epidemiology studies for chlorpyrifos remains controversial in the scientific community. Indeed, although the EFSA conclusion is predicated in part on these epidemiology studies that are the basis of the controversial EPA interpretation, the wording of the EFSA report indicates that there were some dissenters. Moreover, the extension of EPA’s FQPA determination for chlorpyrifos to other organophosphate (OP) pesticides has never been satisfactorily explained.
The NGOs and states that have challenged EPA’s final order refusing to revoke the tolerances and cancel the registrations for chlorpyrifos will argue that the final order cannot be reconciled with EPA’s prior scientific determinations. Even if EPA can successfully rebut those arguments, there is also a possibility that EPA’s own review of the new animal chlorpyrifos studies may obviate that controversy. On balance, the remaining manufacturers and registrations for chlorpyrifos are likely to confront a variety of challenges in the coming months.
By Lisa M. Campbell and Timothy D. Backstrom
On August 14, 2019, the California Department of Pesticide Regulation (DPR) issued cancellation notices to thirteen California registrants of pesticide products containing chlorpyrifos, including Dow Agrosciences LLC (now Corteva). Each of these notices is referred to as an "Accusation," and each affected registrant has 15 days to request a hearing concerning the proposed cancellation. DPR's issuance of these notices followed a final decision by the U.S. Environmental Protection Agency (EPA) to deny an administrative petition to revoke the tolerances and cancel the U.S. registrations for chlorpyrifos. DPR states: "Despite the Trump administration's reversal of a decision to ban the pesticide at the federal level, California continues to move forward to protect public health, workers, and the environment." Although it is unusual for a State to act unilaterally to cancel a State registration for a pesticide that is still registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), FIFRA Section 24(a) provides that States may separately regulate Federally registered pesticides so long as they do not purport to authorize any sale or use that is otherwise prohibited under FIFRA.
The risk assessment that supports DPR's proposal to cancel chlorpyrifos products is based on five animal studies published in 2016, 2017, and 2018, that report neurotoxicity from chlorpyrifos at exposure levels that are considerably lower than the levels that cause acetylcholinesterase inhibition. Based on its evaluation these studies, DPR has concluded that developmental neurotoxicity is the critical endpoint for chlorpyrifos and has derived a point of departure for chlorpyrifos risk assessment. Based on this assessment, DPR previously concluded that chlorpyrifos should be designated as a Toxic Air Contaminant (TAC). DPR presented its TAC findings to California's Scientific Review Panel at a meeting on July 30, 2018, and the Panel subsequently concluded that the DPR assessment of the developmental neurotoxicity of chlorpyrifos was "based on sound scientific knowledge, and represents a balanced assessment of our current scientific understanding."
On the same day DPR issued its cancellation notices for chlorpyrifos, DPR also announced it has established an Alternatives to Chlorpyrifos Work Group with experts from "agriculture, California universities, environmental justice groups, farmworker health and safety organizations, and pesticide manufacturers…" DPR has asked this Work Group to develop short-term practical alternatives to chlorpyrifos, along with a five-year action plan. The Work Group is supposed to conclude its work by the spring of 2020. The budget for 2019-2020 approved by the California Legislature also includes $5 million in grant funding to develop sustainable alternatives to chlorpyrifos.
The DPR decision to cancel chlorpyrifos relies primarily on new animal studies that report that chlorpyrifos causes neurodevelopmental effects at levels that are well below those that inhibit cholinesterase. DPR refers in passing to the epidemiology studies for chlorpyrifos that EPA used to make its Food Quality Protection Act (FQPA) determination for all organophosphate (OP) pesticides, but these data were not used by DPR to derive its point of departure for chlorpyrifos risk assessment.
EPA scientists have not yet prepared a formal evaluation of the new animal studies for chlorpyrifos, but EPA's decision to deny the petition to revoke tolerances and cancel registrations for chlorpyrifos states that EPA intends to evaluate the new animal studies as part of its registration review deliberations for chlorpyrifos. The FIFRA registrations for chlorpyrifos may also be affected by pending judicial actions challenging EPA's decision to deny the petition to revoke the tolerances and cancel the registrations for chlorpyrifos. In this complicated environment, it will be important to monitor the registrants’ and industry’s response to DPR's cancellation actions, as well as their efforts on the pending Federal court litigation and EPA's registration review process for chlorpyrifos.
By Lisa M. Campbell and Timothy D. Backstrom
On August 7, 2019, the League of United Latin American Citizens, Pesticide Action Network North America, Natural Resources Defense Council, and other petitioners (Petitioners) filed a new petition in the Ninth Circuit Court of Appeals seeking judicial review of United States Environmental Protection Agency (EPA) orders denying their request that EPA revoke all tolerances and cancel all registrations for chlorpyrifos. On August 8, 2019, New York, California, Hawaii, Maryland, Vermont, Washington, Massachusetts, and the District of Columbia (States) also filed a new petition for judicial review concerning the refusal of EPA to ban chlorpyrifos. The Petitioners and the States seek judicial review of the July 18, 2019, final order by EPA dismissing all objections to the initial decision by EPA to retain tolerances and registrations for chlorpyrifos, and of EPA’s March 29, 2017, order that initially denied a 2007 petition to revoke all tolerances and cancel all registrations for chlorpyrifos.
The Petitioners and the States also seek consolidation of their newly filed petitions for judicial review with currently pending chlorpyrifos litigation in LULAC, et al. v. Wheeler, et al. As part of rehearing in the LULAC case, the Ninth Circuit vacated a prior decision that ordered EPA to cancel chlorpyrifos registrations, and instead issued a writ of mandamus requiring EPA to respond to objections to the 2017 denial order within 90 days. EPA then issued the July 18, 2019, order denying all objections, along with a motion on July 19, 2019, to dismiss the LULAC case as moot. EPA seeks dismissal of LULAC because it contends that the 2017 initial order was never itself reviewable, and EPA has now done everything that the writ of mandamus required. The Petitioners oppose the motion to dismiss because it would require the Court to take a position on a jurisdictional issue which they contend was not decided during rehearing. The Petitioners and the States also argue that dismissal would be unnecessary and inefficient, requiring the challenging parties to reconstitute the record for review compiled in LULAC.
Petitioners also note that the Ninth Circuit retained jurisdiction when it issued mandamus in LULAC, and they request that their combined challenge to the EPA decision to retain the existing tolerances and registrations for chlorpyrifos be heard by the Court en banc as well.
The latest petitions for judicial review of EPA’s 2019 decision to retain all tolerances and registrations for chlorpyrifos pending registration review were anticipated by all parties, and all parties agree that the procedural requisites for a judicial determination concerning the legality of EPA’s final decision to deny the 2007 administrative petition have now been satisfied. The Petitioners and the States will likely argue that prior scientific determinations by EPA, including EPA analysis of epidemiology studies that purport to establish a link between exposure to chlorpyrifos and adverse neurodevelopmental effects in children, require that EPA proceed to revoke all tolerances and cancel all registrations for chlorpyrifos, while EPA will likely argue that difficult scientific issues concerning chlorpyrifos remain unresolved and should be addressed by EPA as part of the pending registration review for chlorpyrifos.
In addition to the dispute about combining the new petitions for review with the LULAC case, an interesting element of the latest filing by the Petitioners is that they attempt to bootstrap en banc review of the 2019 order in which EPA finally denied the administrative petition to revoke tolerances and cancel registrations for chlorpyrifos. En banc review for an initial hearing (as opposed to en banc rehearing in a previously decided case) is allowed by the applicable appellate rules, but such review is disfavored and would be highly unusual. Petitioners argue that it is warranted here because the en banc panel in the rehearing in the LULAC case reserved jurisdiction. Given the motion by EPA to dismiss the LULAC case as moot, it can be presumed that EPA is likely to oppose this vicarious argument for en banc judicial review. EPA can argue that the only reason the en banc panel retained jurisdiction was to assure that EPA would timely comply with the writ of mandamus that required EPA to rule on the objections within 90 days.
For further information on the long history of litigation concerning the petition to ban chlorpyrifos, please review our prior blog entries.
By Lisa M. Campbell, Timothy D. Backstrom, James V. Aidala, and Lisa R. Burchi
On July 18, 2019, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a Federal Register notice announcing a final order denying the Pesticide Action Network North America’s (PANNA) and the Natural Resources Defense Council’s (NRDC) 2007 Petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos (Order). This Order constitutes final Agency action denying all of the Petitioners’ objections to EPA’s previous refusal to revoke the tolerances for chlorpyrifos. This Order also constitutes final administrative action concerning all parts of the 2007 Petition that were not previously addressed by EPA. Given the previous extensive chlorpyrifos litigation, this latest action by EPA will likely lead to further litigation challenging EPA’s decision to allow continued use of chlorpyrifos under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).
The FIFRA registrations and related tolerances for chlorpyrifos have a complicated regulatory and legal history, as discussed in previous blogs available here.
EPA’s new Order denies objections made by PANNA and NRDC under the FFDCA to EPA’s March 29, 2017, order denying the request by PANNA and NRDC that EPA revoke all tolerances for chlorpyrifos and cancel all chlorpyrifos product registrations. In the Order, EPA begins by summarizing its prior responses to the 2007 Petition, in which EPA denied each of ten claims raised in support of the Petitioners’ request that EPA revoke all chlorpyrifos tolerances and cancel all chlorpyrifos registrations. The ten claims are:
- EPA has ignored genetic evidence of vulnerable populations.
- EPA has delayed a decision regarding endocrine disrupting effects.
- EPA has ignored data regarding cancer risks.
- EPA’s 2006 cumulative risk assessment (CRA) for the organophosphates misrepresented risks and failed to apply the Food Quality Protection Act (FQPA) 10X safety factor.
- EPA over-relied on registrant data.
- EPA has failed to address properly the exporting hazard in foreign countries from chlorpyrifos.
- EPA has failed to incorporate quantitatively data demonstrating long-lasting effects from early life exposure to chlorpyrifos in children.
- EPA has disregarded data demonstrating that there is no evidence of a safe level of exposure during pre-birth and early life stages.
- EPA has failed to cite or incorporate quantitatively studies and clinical reports suggesting potential adverse effects below 10 percent cholinesterase inhibition.
- EPA has failed to incorporate inhalation routes of exposure.
EPA’s Order next focuses on the June 2017 objections to the March 29, 2017, Denial Order that were filed by several public interest groups and states. The three main objections, and EPA’s response, are as follows:
- Claims Regarding the Legal Standard for Reviewing Petitions to Revoke: Objectors assert that EPA’s Denial Order applied the wrong legal standard. Objectors assert that neither “scientific uncertainty” nor the October 2022 deadline for registration review under FIFRA Section 3(g), nor the widespread agricultural use of chlorpyrifos, provide a basis for denying petitions to revoke. Objectors claim that EPA has unlawfully left chlorpyrifos tolerances in place without making the safety finding required by the FFDCA.
- EPA Response: In its Order, EPA denies the objections related to Petitioners’ claims regarding neurodevelopmental toxicity, stating that the objections and the underlying Petition are not supported by valid, complete, and reliable evidence sufficient to meet the Petitioners’ burden under the FFDCA, as set forth in EPA’s implementing regulations. Specifically, EPA states that Objectors have not met their regulatory burden to provide “reasonable grounds” for revocation, including an assertion of facts to justify the modification or revocation of the tolerance (40 C.F.R. § 180.32(b)) or the initial evidentiary burden for persons seeking revocation to come forward with sufficient evidence to show that pesticide tolerances to be modified or revoked are not safe. After summarizing its review of available epidemiologic data, including feedback from the 2012 and 2016 FIFRA Scientific Advisory Panel (SAP) meetings, EPA states that “the epidemiologic studies are central to the Petitioner’s claims regarding neurodevelopmental effects, yet the Petitioners and Objectors rely only on summaries in publications to present their case. Petitioners have not presented the raw data from the epidemiology studies for consideration of their claims.” EPA “concludes that the information yet presented by Petitioners is not sufficiently valid, complete, and reliable to support abandoning the use of AChE inhibition as the critical effect for regulatory purposes under the FFDCA section 408” and also that Petitioners have “failed to meet their initial burden of providing sufficiently valid, complete, and reliable evidence that neurodevelopmental effects may be occurring at levels below EPA’s current regulatory standard and no information submitted with the objections addresses this shortcoming of the Petition.”
- Objections Asserting that EPA Has Found Chlorpyrifos to Be Unsafe: Objectors assert that EPA has previously found that chlorpyrifos tolerances are unsafe and has not disavowed those findings. Specifically, they claim that EPA has found that chlorpyrifos results in unsafe drinking water exposures and results in adverse neurodevelopmental effects to children and that EPA must therefore revoke the tolerances.
- EPA Response: EPA denies making any regulatory findings that chlorpyrifos tolerances are not safe, stating that its statements in its 2015 proposed tolerance revocation was not a final action. EPA states: “Proposed rules are just that -- proposals; they do not bind federal agencies. Indeed, EPA made clear it was issuing the proposal because of the court order, without having resolved many of the issues critical to EPA’s FFDCA determination and without having fully considered comments previously submitted to the Agency.” Regarding those objections related to drinking water, EPA states that since the Petition did not identify drinking water exposure as a basis for seeking tolerance revocation, the Objectors cannot now raise that concern as a basis for challenging EPA’s denial of the Petition. EPA also states: “The mere fact that EPA is considering the potential impact of chlorpyrifos exposures in drinking water in the Agency’s FIFRA section 3(g) registration review does not somehow provide Petitioners and Objectors with a vehicle for introducing that topic in the objections process on the Petition denial.” EPA instead will continue its FIFRA Section 3(g) registration review and complete its evaluation of drinking water exposures to chlorpyrifos, and address these issues in its upcoming registration review decision.
- Objections Asserting that the Denial Order Failed to Respond to Significant Concerns Raised in Comments: Objectors argue that EPA’s Denial Order committed a procedural error by failing to address significant concerns raised in the comments on EPA’s 2014 risk assessment and 2015 proposed revocation that EPA’s assessment fails to protect children. In particular, the Objectors focus on concerns raised in comments asserting that (1) EPA’s use of 10 percemt cholinesterase as a regulatory standard is not protective for effects to children’s developing brains; (2) EPA has not properly accounted for effects from inhalation of chlorpyrifos from spray drift and volatilization; and (3) EPA inappropriately used the Corteva physiologically based pharmacokinetic (PBPK) model to reduce inter- and intra-species safety factors because the model is ethically and scientifically deficient.
- EPA Response: EPA denies the objections claiming procedural error, stating it “has no obligation to respond to rulemaking comments in denying the Petition or responding to objections, both of which are adjudicatory actions that are not part of the rulemaking process. EPA also restated its prior response to the Petition that the “objections fail to meet burden of presenting evidence sufficiently valid, complete and reliable to demonstrate that chlorpyrifos results in neurodevelopmental effects that render its tolerances not safe.” EPA further “believes it is lawful and appropriate for it to consider federally enforceable chlorpyrifos product labeling restrictions in assessing the extent of bystander risk from spray drift under both the FFDCA and FIFRA.”
This latest EPA assessment appears to be more finely crafted than the earlier March 2017 response to the tolerance revocation Petition. EPA explains that it does not consider the epidemiology studies cited by the Petitioners to be persuasive sufficiently to change EPA’s fundamental approach to assessing chlorpyrifos risks. EPA notes that its current risk assessment utilizes the default 10X safety factor for infants and children specified by the FQPA, so any argument that it has not utilized this safety factor is moot. At the same time, EPA maintains that the epidemiology studies do not justify changing EPA’s point of departure for risk assessment, which remains the threshold for 10 percent acetylcholinesterase (AChE) inhibition. EPA states that there are significant problems with using the epidemiology studies for risk assessment, including lack of access to the underlying data, the absence of any known mechanism for neurodevelopmental effects below the threshold for AChE inhibition, and a lack of scientific consensus on a method for choosing an alternate point of departure based on the epidemiology studies. This interpretation of the epidemiology studies for chlorpyrifos will remain controversial and these studies will continue to be cited by those who seek to eliminate chlorpyrifos use.
EPA has also taken a position that the burden is on the Petitioners to support a petition to revoke tolerances with reliable data. What is less clear is “how much” evidence EPA considers sufficient to meet the threshold for tolerance revocation. Meanwhile, EPA will defer its assessment of possible neurodevelopmental effects of chlorpyrifos below the threshold for AChE inhibition pending completion of the registration review for chlorpyrifos. The deadline for EPA to complete registration review is October 1, 2022, although EPA states that it intends to expedite this process and to issue a proposed registration review decision by October 2020.
EPA also has included in its decision an intriguing discussion of some new animal studies for chlorpyrifos that purport to show low-level neurodevelopmental effects from chlorpyrifos. The California Department of Pesticide Regulation relied substantially on these new studies when it designated chlorpyrifos as a Toxic Air Contaminant. If these new chlorpyrifos studies are deemed credible, they could supplant efforts to use the chlorpyrifos epidemiology data in risk assessments and allow EPA to establish a new point of departure for chlorpyrifos that is not based on AChE inhibition. Rather than disregarding these new data, which were not submitted in support of the tolerance revocation Petition, EPA says affirmatively that it intends to review them in the pending registration review.
By Lisa M. Campbell and Lisa R. Burchi
On May 31, 2019, Health Canada’s Pest Management Regulatory Agency (PMRA) issued its Proposed Re-evaluation Decision PRVD2019-05, Chlorpyrifos and Its Associated End-use Products: Updated Environmental Risk Assessment (Updated Environmental Risk Assessment). PMRA states that this re-evaluation “considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies” and that “Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.”
PMRA is proposing the cancellation of most uses of chlorpyrifos, including almost all agricultural uses, due to PMRA’s belief that they pose unacceptable risks to the environment. The proposal would allow a small number of uses to continue if certain label changes are made. More specifically, PMRA states that its evaluation of available scientific information “has not found acceptable risks to beneficial arthropods, birds, mammals and all aquatic biota in the environment for most current chlorpyrifos uses” but “[g]reenhouse ornamental, outdoor ornamentals (container stock only) for control of Japanese beetle larvae, indoor and outdoor structural, adult and larval mosquito uses of chlorpyrifos have been shown to be acceptable from the environmental perspective.” The label changes that PMRA states would be required for these uses to continue include the following: (1) standard environmental hazard statements to inform users of the potential toxic effects to non-target species; and (2) standard environmental advisory statements for prevention of contamination of aquatic systems and to reduce volatilization.
There is a 90-day public consultation period on the proposal, which began on May 31, 2019, during which the public may submit written comments and additional information to PMRA. PMRA states that the public may submit additional information that could be used to refine risk assessments and that the final re-evaluation decision will take into consideration the comments and information received during the comment period, which could result in revised risk mitigation measures. The re-evaluation decision document will include the final re-evaluation decision, the reasons for it, and a summary of comments received on the proposed re-evaluation decision with Health Canada’s responses.
More information on chlorpyrifos issues, including California’s recent announcement that it would be initiating cancellation proceedings of chlorpyrifos, can be found on our blog.
By Lisa M. Campbell and Lisa R. Burchi
On May 8, 2019, the California Environmental Protection Agency (CalEPA) announced that the California Department of Pesticide Regulation (DPR) will be initiating cancellation proceedings of chlorpyrifos. In its press release, CalEPA states that the decision to commence cancellation proceedings “follows mounting evidence, including recent findings by the state’s independent Scientific Review Panel on Toxic Air Contaminants, that the pesticide causes serious health effects in children and other sensitive populations at lower levels of exposure than previously understood.”
DPR’s decision, following years of review in California of chlorpyrifos, is sure to garner significant controversy, comments, and, potentially, litigation.
Chlorpyrifos first entered the comprehensive risk assessment process after being designated by DPR with a “high” priority status in 2011, and some of the DPR documents supporting the current action were issued in 2011.
In December 2015, DPR released a draft risk assessment for public comment. Since the risk assessment identified potential human exposure to spray drift (via inhalation or deposition) as a concern, DPR entered chlorpyrifos in its formal evaluation process to determine the scientific evidence for listing it as a pesticide Toxic Air Contaminant (TAC) (CA Food & Agric. Code §§ 14021-14027).
DPR’s assessments were intended to evaluate chlorpyrifos as a pesticide TAC as defined in California regulations (Title 3, Section 6864). The determination of a pesticide TAC is based on whether the air concentrations, either measured or modeled, exceed the reference concentration (RfC) divided by ten. Under the applicable California statutory provisions, designation of an active ingredient as a TAC is based on an evaluation that assesses the following:
- The availability and quality of data on health effects;
- The potency, mode of action, and other relevant biological factors;
- An estimate of the levels of exposure that may cause or contribute to adverse health effects; and
- The range of risks to humans resulting from current or anticipated exposure (CA Food & Agric. Code § 14023(a)).
DPR published its draft revised report entitled "Evaluation of Chlorpyrifos as a Toxic Air Contaminant" in December 2017 and an addendum to that report in June 2018. DPR issued its final TAC evaluation in July 2018. The July 2018 evaluation concludes that “chlorpyrifos meets the criteria of TAC designation by using either the developmental neurotoxicity endpoint or the [acetylcholinesterase (AChE)] inhibition endpoint, even without the additional 10x uncertainty factor necessary to account for the fact that the developmental neurotoxicity effects occur at a lower level than AChE inhibition.”
DPR’s findings, public comments, and responses to those comments were reviewed by the Scientific Review Panel (SRP) on TACs. SRP’s findings on chlorpyrifos issued in August 2018 “unanimously concluded that the report, with the revisions requested by the Panel, is based on sound scientific knowledge, and represents a balanced assessment of our current scientific understanding.”
In April 2019, chlorpyrifos was listed in California as a TAC, which triggered a DPR requirement to “develop control measures to protect the health of farm workers and others living and working near where the pesticide is used.” In its press release announcing the cancellation proceedings, CalEPA states that “DPR has determined, in consultation with CDFA, the Office of Environmental Health Hazard Assessment (OEHHA), and the California Air Resources Board (CARB), that sufficient additional control measures are not feasible.”
DPR’s announcement is the beginning of what DPR estimates could be a two-year cancellation proceeding, although in reality the process may take even longer. Other actions proposed in conjunction with the cancellation proceeding include:
- DPR to consult with county agricultural commissioners and local air pollution control districts before filing for cancellation.
- DPR to support “aggressive” enforcement of existing restrictions on the use of chlorpyrifos, including a ban on aerial spraying, quarter-mile buffer zones, and limiting use to crop-pest combinations that lack alternatives.
- DPR and CDFA to convene a cross-sector working group to identify, evaluate, and recommend safer and more practical and sustainable alternative pest management solutions to chlorpyrifos.
- California Governor Gavin Newsom to propose $5.7 million in new budget funding “to support the transition to safer, more sustainable alternatives.
DPR’s action must also be viewed in conjunction with various federal and state reviews and resulting litigation regarding chlorpyrifos’ continued registration and use. The U.S. Environmental Protection Agency (EPA) for example, is conducting its own registration review of chlorpyrifos, and was ordered by the U.S. Court of Appeals for the Ninth Circuit to issue, within 90 days of the April 19, 2019, order, its final decision regarding the continued registration of chlorpyrifos.
Other states are also taking action to ban chlorpyrifos, notably Hawaii, which enacted legislation in 2018 to ban the use of chlorpyrifos in Hawaii by 2022; and New York, whose legislature approved bills in April 2019 to ban chlorpyrifos use in New York by 2021.
Stakeholders should review all these issues closely, as these unprecedented decisions are likely to provide multiple opportunities to comment or otherwise participate to ensure that regulatory requirements are indeed being met for cancellation.
More information concerning chlorpyrifos is available on our blog.
By Timothy D. Backstrom
On April 19, 2019, the U.S. Circuit Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order following an en banc rehearing in League of United Latin Am. Citizens (LULAC) v. Wheeler, No. 17-71636. The February 6, 2019, Ninth Circuit decision to grant a U.S. Environmental Protection Agency (EPA) request for rehearing effectively vacated an August 9, 2018, decision in LULAC that had ordered EPA to revoke all tolerances and cancel all registrations for chlorpyrifos. After rehearing, the en banc panel issued a writ of mandamus directing EPA “to issue, no later than 90 days after the filing of this order, a full and fair decision on LULAC’s objections" to an initial EPA order denying a 2007 petition to revoke all tolerances for chlorpyrifos. The en banc order states that the court has discretion to construe the Petitioners' opening brief as a request for mandamus relief, even though the Petitioners sought judicial review of EPA's initial denial decision without waiting for EPA to rule on their objections and even though they did not file a petition for mandamus under the applicable procedural rule. The court then states that “[c]onsidering the history and chronology of this matter and the nature of the claims, we conclude mandamus is appropriate, and we hereby GRANT the Petition for a Writ of Mandamus.”
The court states that “EPA represented that it could issue a final decision with respect to petitioners’ objections within 90 days of an order issued by this court” during oral argument on March 26, 2019. The en banc ruling, however, does not discuss the jurisdictional issues presented when the Petitioners sought judicial review of EPA's initial denial decision without waiting for EPA to rule on their objections. Moreover, the ruling does not discuss the substantive dispute concerning EPA's authority to decline to revoke the tolerances and cancel the registrations for chlorpyrifos based on the current administrative record.
The procedural questions presented in the LULAC litigation are unusual and reflect a long and contentious history. EPA’s April 5, 2017, decision to deny a 2007 petition to revoke the tolerances and cancel the registrations for chlorpyrifos came after issuance of a prior writ of mandamus that required EPA to take action on the pending petition, an EPA proposal to revoke the tolerances for chlorpyrifos issued in response to the prior writ, and a subsequent decision by EPA during the early days of the Trump administration to reverse course on the proposal and keep the tolerances in place while EPA completed the registration review process. The Petitioners in LULAC duly filed objections to the initial denial of their tolerance petition, which was a necessary statutory prerequisite to pursuing further judicial review. In addition, however, they elected to file for judicial review of EPA's initial denial of their tolerance petition on the same day as they filed their objections. The Petitioners could not yet reasonably seek mandamus at that time because EPA had not been afforded any time yet to respond to their objections. Instead, the Petitioners argued that requiring them to follow the normal administrative process would be futile.
Although the Ninth Circuit's decision after en banc rehearing may appear to a procedural victory for EPA, it can also be seen as a solution to the quandary created by the Petitioners' actions and the first court decision. The Ninth Circuit as a whole was apparently not comfortable with the decision by the first panel that the Petitioners should be allowed to obtain review of a non-final order because waiting for final and reviewable EPA action would be a futility. Nevertheless, by issuing a new writ of mandamus, the court seems to be sending a clear signal that it will not countenance further delays in EPA’s taking final action on the petition to revoke the chlorpyrifos tolerances. In the relatively brief time remaining before the court deadline for final action, EPA confronts a significant challenge of ensuring all relevant data have been adequately and appropriately considered, particularly given the many controversies concerning the data that EPA used to support its initial decision to revoke the tolerances.
More information on the protracted litigation concerning chlorpyrifos is available on our blog under key words chlorpyrifos and ninth circuit.