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California DPR Issues Cancellation Notices for Chlorpyrifos, and Establishes a Work Group to Recommend and to Develop Alternatives to Chlorpyrifos
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.
EPA Issues Guidance Regarding Prop 65 Labeling Requirements for Glyphosate Products and OEHHA Responds
On August 7, 2019, EPA took long awaited action concerning the inclusion of Prop 65 warning statements for glyphosate on EPA registered pesticide labels, which will likely impact the broader ongoing debate over EPA approval of Prop 65 warnings on pesticide labels. EPA’s August 7, 2019, letter to glyphosate registrants states that EPA “will no longer approve labeling that includes the Proposition 65 warning statement for glyphosate-containing products.” EPA stated further that “[t]he warning statement must also be removed from all product labels where the only basis for the warning is glyphosate and from any materials considered labeling under FIFRA for those products.” Moreover, EPA unequivocally states that “pesticide products bearing the Proposition 65 warning statement due to the presence of glyphosate are misbranded” under FIFRA Section 2(q)(1)(A). Registrants with glyphosate products currently bearing Prop 65 warning language, where the exclusive basis for such warning is based on the presence of glyphosate, must submit draft amended labeling that removes this language by November 5, 2019.
By way of background, California’s Office of Environmental Health Hazard Assessment (OEHHA) listed glyphosate as a chemical known to the state of California to cause cancer on July 7, 2017. OEHHA’s listing of glyphosate as a substance under Prop 65 is based on the International Agency on the Research for Cancer (IARC) classifying it as “probably carcinogenic to humans.” EPA scientists subsequently completed an independent review of the available scientific data on the potential carcinogenicity of glyphosate and do not agree with the IARC classification. Additional information regarding glyphosate is available at B&C’s blog.
Also of note is a February 26, 2018, preliminary injunction issued by the U.S. District Court for the Eastern District Court of California, in response to a motion filed by a coalition including Monsanto, CropLife America, and several growers associations alleging that the IARC classification decision for glyphosate is contrary to the international scientific consensus, that the required Prop 65 warning would be misleading to the ordinary consumer, that compelling the manufacturers of glyphosate to provide such a warning would violate the First Amendment because the warning is not factual and uncontroversial, and that the applicable criteria for injunctive relief were met. The February 26, injunction precluded OEHHA from enforcing its Prop 65 warning requirements against glyphosate registrants that otherwise would have taken effect on July 7, 2018. The Court did not rule that glyphosate should be removed from the Prop 65 list as a chemical known to the State of California to cause cancer, but did state that products containing glyphosate would not be required to comply with the warning requirements. In issuing the preliminary injunction, the Court stated that the required warnings are “false and misleading” and that plaintiffs “have shown that they are likely to succeed on the merits of their First Amendment claim, are likely to suffer irreparable harm absent an injunction, and that the balance of equities and public interest favor an injunction, the court will grant plaintiffs’ request to enjoin [Prop 65]’s warning requirement for glyphosate.” More information on that case is available at B&C’s blog. That injunction has not been appealed and remains in place.
Although the glyphosate warning that EPA has refused to allow is based on OEHHA’s recent listing under Prop 65, Prop 65 warnings on pesticide labels generally have been a significant issue since 2016 when OEHHA issued revised regulations regarding the content and transmission of Prop 65 warnings. As a result of these revisions, many registrants sought to add Prop 65 warning requirements to pesticide labels to meet Prop 65 requirements, but many registrants have not been able to obtain EPA approval for such warnings, resulting in much controversy and discussion. More information regarding the changes to Prop 65 warning requirements also are available at B&C’s blog.
In its press release announcing its guidance to glyphosate registrants, EPA Administrator Andrew Wheeler states: “It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a cancer risk. We will not allow California’s flawed program to dictate federal policy.” EPA states that its “independent evaluation of available scientific data included a more extensive and relevant dataset than IARC considered during its evaluation of glyphosate, from which the agency concluded that glyphosate is ‘not likely to be carcinogenic to humans.’” Wheeler is further quoted as stating: “It is critical that federal regulatory agencies like EPA relay to consumers accurate, scientific based information about risks that pesticides may pose to them. EPA’s notification to glyphosate registrants is an important step to ensuring the information shared with the public on a federal pesticide label is correct and not misleading.”
OEHHA immediately released its own press release on August 13, 2019, in which it “objects to US EPA’s characterization of any warning concerning glyphosate’s carcinogenicity as a false claim.’” After reiterating OEHHA’s listing glyphosate based on the IARC determination, OEHHA states that EPA’s position “conflicts with the determination made by IARC” and that “it is disrespectful of the scientific process for US EPA to categorically dismiss any warnings based on IARC’s determinations as false.”
The Court’s February 26, 2018, preliminary injunction was considered a significant development both for glyphosate specifically and perhaps for Prop 65 warning requirements generally, especially considering the recent influx to EPA of label amendments seeking EPA approval of revised Prop 65 warning language to address OEHHA’s revised regulatory changes. EPA’s guidance is equally significant, as EPA has now rejected the inclusion of a Prop 65 warning that EPA believes is misleading on a federal pesticide product label.
FIFRA Section 24(b) expressly prohibits any State from requiring any label language for a registered pesticide product beyond the labeling approved by EPA, and EPA has now declined to approve pesticide labeling that includes the Prop 65 warning for glyphosate. In some instances, EPA has been willing as a courtesy to approve labeling changes requested by a State, but the glyphosate determination demonstrates that EPA will not accept any label revisions that conflict materially with its own determinations. Although glyphosate is a fairly complex and controversial case, it will be important for registrants to monitor the evolution of EPA’s standard for when it will or will not approve a Prop 65 warning on a federal label, since this issue has been the subject of considerable controversy over the past several years.
Parties Who Requested that EPA Revoke All Tolerances and Cancel All Registrations for Chlorpyrifos, and Eight States, File New Petitions Challenging EPA’s 2019 Order Denying that Request, Seek Consolidation with the Existing Chlorpyrifos Case, and Oppose a Motion by EPA to Dismiss the Existing Case as Moot
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.
On August 2, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced that it has decided to reduce the Food Quality Protection Act (FQPA) safety factor for infants and children for pyrethroids from its current value of 3X to a new value of 1X. This decision is based on a July 1, 2019, OPP report entitled “USEPA Office of Pesticide Programs’ Re-evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA Program Data Review.” Risk assessments incorporating the new lower FQPA safety factor for pyrethroids will be utilized in developing proposed registration review decisions for these compounds, and EPA has stated it will be taking public comment on the OPP report reducing the FQPA safety factor for pyrethroids after EPA publishes a notice of availability for the proposed registration review decisions.
Pyrethroids are a group of insecticides that includes natural pyrethrins (found in chrysanthemums) and more than 30 synthetic compounds with similar structure and activity. EPA has determined that it is appropriate to establish one FQPA safety factor for all pyrethroid active ingredients because these compounds all have the same mode of action and similar patterns of toxicity. Pyrethroid insecticides are widely used in and around residential structures, on pets, in treated clothing, for mosquito control, and in various agricultural applications. EPA indicates that although pyrethroids have relatively low mammalian toxicity, EPA believes that the principal concern for human risk assessment is a potential to cause acute neurotoxic effects.
The FQPA safety factor is intended to account for “potential pre- and post-natal toxicity and completeness of data with respect to exposure and toxicity to infants and children.” The FQPA safety factor is set by statute at a default value of 10X, but EPA may select a lower value for this safety factor if EPA determines based on “reliable data” that such a lower value will be safe for infants and children. This determination necessarily depends on EPA’s assessment of the quality of the data that address the susceptibility to adverse effects of the pesticide of infants and children. Based on current EPA guidance, OPP evaluates the need for the default FQPA safety factor of 10X in two components: a safety factor of about 3X assigned to pharmacodynamic (PD) differences and a safety factor of about 3X assigned to pharmacokinetic (PK) differences. PD differences refer to the sequence of events at the molecular or cellular level leading to a toxic response to a substance, while PK differences refer to absorption, distribution, metabolism, and excretion of the substance.
EPA previously evaluated the adequacy of the database concerning risks to infants and children posed by pyrethroid active ingredients in 2011. At that time, EPA decided that there were sufficient data concerning the mechanism for potential neurotoxic effects of pyrethroids to allow EPA to reduce the factor for PD differences to 1X, but EPA retained the 3X factor for PK differences because EPA believed that the available pharmacokinetic data for pyrethroids was not sufficient for EPA to conclude that infants and children would not confront a greater risk of neurotoxic outcomes. After EPA made the 2011 determinations, the Council for the Advancement of Pyrethroid Human Risk Assessment (CAPHRA) conducted a variety of additional research to address whether children are more sensitive to the neurotoxic effects of pyrethroid exposure, and this research assessed both PD and PK differences. CAPHRA submitted a peer-reviewed physiologically based pharmacokinetic (PbPk) model for pyrethroids to EPA in 2018. After reviewing the new CAPHRA data and the current public literature for pyrethroids, EPA has now concluded that the factor for PD differences should be maintained at 1X, but the factor for PK differences should be reduced from 3X to 1X. Collectively, these determinations mean that EPA has concluded that there are reliable data to support a determination that infants and children are not more susceptible to the neurotoxic effects of pyrethroids than adults, so there is no need to retain either the default FQPA safety factor of 10X or the previous FQPA safety factor used for pyrethroids of 3X.
The adoption by EPA of a new FQPA safety factor of 1X for all pyrethroid active ingredients will likely facilitate retention of existing use patterns and use directions for a large number of pyrethroid insecticides that are commonly used in and around human residences and workplaces.
From a larger perspective, the process by which EPA evaluated and selected a proposed FQPA safety factor for pyrethroids may be seen as typical for most pesticides or classes of pesticides. The selection of a FQPA safety factor for a particular pesticide usually is based on review of available animal data, including PD and PK data, to determine whether there is any basis for concluding that infants and children may be more susceptible to adverse effects of that pesticide than adults. Where EPA decides that the animal data addressing this question are insufficient, affected registrants and other proponents of registration can consult with EPA concerning studies that will address the uncertainties. Depending on the outcome of such studies, EPA may be able to conclude that there is a scientific basis for a partial or complete reduction of the default FQPA safety factor.
Compared to this typical evaluation process, the recent decision by EPA to retain the default FQPA safety factor for all organophosphate (OP) active ingredients, which was based on EPA’s interpretation of neurodevelopmental effects reported at low exposure levels (below the threshold for acetylcholinesterase inhibition) in epidemiology studies for chlorpyrifos, may be seen as an aberration. EPA’s decision to rely on epidemiology studies that may be susceptible to methodological biases, and the decision to utilize epidemiology studies for chlorpyrifos to set the FQPA safety factors for all OP pesticides, have both been controversial.
EPA’s recent decision to retain the current tolerances and registrations for chlorpyrifos was based in significant part on EPA’s interpretation of a PbPk model for chlorpyrifos previously submitted by DowAgro (now Corteva), which mitigated to some degree EPA’s retention of the default FQPA safety factor for chlorpyrifos. Corteva may submit further data addressing PD and PK differences for chlorpyrifos, and EPA has also stated that it intends to review some new animal studies for chlopyrifos, which purport to show neurodevelopmental effects at low exposure levels. Perhaps these data will allow EPA to establish a point of departure (POD) for chlorpyrifos risk assessment without any need for a further excursion into the unfamiliar risk assessment territory represented by EPA’s use of epidemiology data for chlorpyrifos.
On July 12, 2019, the U.S. Environmental Protection Agency (EPA) announced in a Decision Memorandum that it has registered new uses and restored previously registered uses for sulfoxaflor. EPA has approved the use of sulfoxaflor on alfalfa, corn, cacao, grains (millet, oats), pineapple, sorghum, teff, teosinte, tree plantations, and restored the uses on citrus cotton, cucurbits (squash, cucumbers, watermelons, some gourds), soybeans, and strawberries. EPA states that substantial data show that when sulfoxaflor is used according to the label, it poses no significant risk to human health and poses a lower risk to non-target wildlife, including pollinators, than other registered alternative products. EPA’s registration decision is available at www.regulations.gov in Docket Number EPA-HQ-OPP-2010-0889-0570.
EPA’s decision follows an opinion issued on September 10, 2015, by the U.S. Court of Appeals for the Ninth Circuit vacating EPA’s 2013 unconditional registration for the pesticide sulfoxaflor, and remanding the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies. That decision is discussed in our blog item available here. In response to that decision, EPA also issued a cancellation order that included provisions for the disposition of existing stocks of sulfoxaflor products.
After the decision of the Ninth Circuit Court of Appeals, EPA reevaluated the data and on October 14, 2016, approved sulfoxaflor end-use registrations for limited uses that did not include crops that attract bees. EPA also has been granting emergency exemptions for sulfoxaflor since 2012, with the most recent emergency exemptions granted on June 17, 2019, for the use of sulfoxaflor to control tarnished plant bugs on cotton in 12 states, and to control sugarcane aphids on sorghum in 14 states.
In the July 12, 2019, decision adding new uses, restoring previous uses, and removing certain application restrictions, EPA states an unconditional registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(5) for new uses of sulfoxaflor is backed by substantial data, including numerous pollinator studies submitted by the registrant, Dow AgroSciences (DAS). With specific regard to sulfoxaflor’s impact on bees, EPA states the following:
EPA’s decision also removes previously imposed application restrictions:
EPA’s decision includes the following crop specific restrictions:
EPA found that the FIFRA standard for registration is met for the registration of sulfoxaflor on the uses approved, and that the benefits of these uses outweigh the risks, but also set specific label requirements including restrictions to minimize potential exposure to bees:
This new decision by EPA may finally be the culmination of a long and convoluted process to register sulfoxaflor. The litigation that resulted in vacatur of the initial registrations began in 2013. At the time the Ninth Circuit issued its decision in 2015, vacatur was viewed by many observers as a novel and radical response to an EPA decision to register a new pesticide. Since that time, registrants and users of newly approved active ingredients have encountered more aggressive litigation in which vacatur is often cited as a possible remedy. This has created more uncertainty and concern about product availability, even after EPA approves an eagerly anticipated new product to meet a pressing pest control need. In the case of sulfoxaflor, EPA has clearly determined that the data submitted by DAS demonstrate that any risks to pollinators presented by sulfoxaflor will be less than the risks presented by currently registered insecticides sulfoxaflor is likely to replace. This determination concerning relative risk based on review of additional data should address the deficiencies in the EPA rationale found by the Court when it vacated the 2013 sulfoxaflor registrations.
Interestingly, the current EPA decision may raise a similar issue concerning the sufficiency of EPA’s rationale concerning the effects of sulfoxaflor on endangered species. EPA states the following in its Decision Memorandum:
While it is clearly sensible for EPA and the Services to prioritize the limited resources available to make and to consult concerning effects determinations for endangered species by addressing existing pesticide classes that are likely to present the greatest risk before products with new chemistries that are intended to be more selective, it remains to be seen whether reviewing courts will be inclined to accept this type of rationale. In particular, it will be interesting to see whether the sufficiency of this approach to endangered species determinations becomes an issue in any future litigation regarding sulfoxaflor or other newly registered active ingredients.
EPA Issues Final Order Denying Objections to EPA’s March 2017 Order Denying PANNA’s and NRDC’s 2007 Petition to Revoke All Tolerances and Cancel All Registrations for Chlorpyrifos
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’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:
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.
EPA Extends Deadline to Submit Comments on Proposed Interim Registration Review Decision for Glyphosate
On June 26, 2019, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment deadline on its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms. 84 Fed. Reg. 30112. EPA states that it is extending the comment deadline “after receiving public comments requesting additional time to review the Glyphosate Proposed Interim Registration Review Decision and supporting materials.”
The deadline to submit comments was extended from July 5, 2019, to September 3, 2019. The public can submit comments on EPA’s proposed decision at www.regulations.gov in Docket Number EPA-HQ-OPP-2009-0361.
More information on glyphosate issues is available on our blog.
On June 14, 2019, Canada’s Pest Management Regulatory Agency (PMRA) began a public consultation on Discussion Document DIS2019-01, “Consultation on Inspecting Confidential Test Data for Post-market Reviews in the Reading Room.” Before a pesticide can be registered for use in Canada, PMRA states that it reviews the available scientific test data to determine whether there are concerns for human health or safety, or the environment, when the product is used according to the label. Some of the data reviewed by the PMRA scientists include confidential test data on:
According to PMRA, the purpose of the consultation document is to seek input on a proposal to expand access to confidential test data by inviting interested members of the public to inspect these data at the proposed decision stage for post-market reviews such as re-evaluations and special reviews. Currently, PMRA prepares confidential test data for public inspection only after it makes a final decision. PMRA proposes to allow interested parties seeking to understand the scientific basis for a proposed re-evaluation or special review decision to inspect the data used by PMRA earlier in the process. PMRA states that by viewing these data earlier, comments submitted through the existing consultation process may be more well-informed.
PMRA notes that the proposed change would still require the inspection of confidential test data to take place at its National Head Office in Ottawa, Ontario. PMRA states that it is aware that this could be burdensome and is investigating alternative approaches for the future that may allow the inspection of data through other means, such as satellite reading rooms or secure portals. Publication of the consultation document began a 60-day comment period.
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.
On May 30, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order in National Family Farm Coalition v. EPA, No. 17-70810 (filed Mar. 21, 2017) regarding the scope of its review of a petition challenging a 2017 U.S. Environmental Protection Agency (EPA) Notice of Pesticide Registration. This 2017 order addresses Dow AgroSciences LLC’s Enlist Duo product. The Petitioners include the National Family Farm Coalition and the Natural Resources Defense Council.
The May 30, 2019, order addresses whether the court could review two prior EPA orders, one issued in 2014 and one in 2015, regarding the registration of Enlist Duo. Those 2014 and 2015 EPA orders had also been challenged in court, and subsequently remanded to EPA to consider additional information. Following EPA’s consideration of this additional information, EPA increased the allowed use sites for the Enlist Duo registration to include cotton and increased the number of states authorized to use Enlist Duo from 15 to 34 states.
The Ninth Circuit’s May 30, 2019, order finds that the 2017 order “reissues the original Enlist Duo registration and amendment addressed in the 2014 and 2015 orders, thus making the full registration of Enlist Duo for GE corn, soybean and cotton for use in 34 states subject to [its] review.” The court based its decision on the language of EPA’s 2017 order and EPA’s Final Registration Decision. The court found persuasive, for example, that EPA’s 2017 order states that it “supercedes” EPA’s 2014 order, which the court stated is “consistent with our determination that the 2014 order previously remanded to EPA has now been finalized.” Since EPA identified its 2017 order as final and had characterized its 2014 and 2015 orders as having an incomplete record, the court stated that it will “review the 2017 order on the combined records of the 2014, 2015 and 2017 orders, all of which is incorporated into the 2017 order’s record.”
The court further noted that EPA’s “2017 order also purports to extend the 2014 registration’s (and that of the 2015 amendment) initial 2020 expiration date by two years.” Since the court found that nothing “suggests that this term is specific to the new uses on GE cotton in 34 states or GE corn and soybean in the additional 19 states,” the court stated that the 2017 EPA order could not have been limited to adding only these post-2015 uses as EPA had asserted.
Following this determination, the Ninth Circuit stated that “submission of this case is deferred” pending additional briefing to address “all challenges to the initial registration (2014 order) and the original amendment (2015 order), as that registration and amendment has been reissued in the 2017 order -- including challenges to all supporting documentation” and “what relief [it] should provide if Petitioners’ claims are successful, ‘in whole or in part.’” The timing for such briefing is as follows:
California DPR Announces Changes to California-like Conditions for Terrestrial Field Dissipation Studies
On May 29, 2019, the California Department of Pesticide Regulation (DPR) released California Notice 2019-05: Changes to California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2019-05), which updates the guidance in California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2018-06).
Notice 2018-06, issued in January of 2018, provided to applicants for California registration of new agricultural use pesticides guidance specifically related to the requirement to submit at least one terrestrial field dissipation (TFD) study conducted under “California or similar environmental use conditions.” DPR states it is revising this guidance based on comments from the Western Plant Health Association. The updated guidance is summarized below.
Notice 2019-05 also extends the effective date to July 1, 2020; for applications submitted July 1, 2020, or later, DPR states it will consider a TFD study to have been conducted under “California or similar environmental use conditions” if the study was conducted within or outside of California in accordance with U.S. Environmental Protection Agency (EPA) study guidelines and under certain criteria, as provided below.
1. Timing: April 1 shall be the earliest study start date and September 30 shall be the latest start date. This timing ensures a potential leaching environment with respect to the amount of percolating water produced relative to evapotranspiration (ET).
3. Water Inputs:
DPR states that if a TFD study submitted to DPR to meet the statutory requirement of having been conducted under “California or similar environmental use conditions” does not meet one or more of the above criteria, the applicant may include in its submission a justification for any different criteria to avoid a determination that the study is unacceptable.
Table 1. USDA textural classes1 of soils acceptable for TFD studies
1Based on USDA particle-size classification.
On May 28, 2019, the California Department of Pesticide Regulation (DPR) posted a new presentation identifying the top ten agricultural pesticide use violations of 2018. Its announcement states that “DPR suggests reviewing these common violations of pesticide laws and regulations to help ensure … compliance.” The presentation, “Top 10 Agricultural Pesticide Use Violations of 2018,” is available here. The violations are listed from the least common (number 10) to the most common (number 1):
10. Handler Training, regulated under Title 3 of the California Code of Regulations (C.C.R.) § 6724. Examples of handler training violations listed in the presentation are: not updating employee training before a new pesticide is handled; and not providing employees handler training before they work on or repair equipment previously used to apply pesticides.
9. Application-Specific Information (ASI) for Fieldworkers, regulated under 3 C.C.R. § 6761.1. Examples of violations listed in the presentation are: not including a specific description of the location of the ASI on the Pesticide Safety Information Series (PSIS) A-9 leaflet so that workers have unimpeded access; and not displaying the ASI before fieldworkers work in a treated field.
8. Hazard Communication for Fieldworkers, regulated under 3 C.C.R. § 6761. Examples of these types of violations listed in the presentation are: not retaining Safety Data Sheets (SDS) for the pesticides listed in the pesticide use records within the past two years; and not informing employees or the Farm Labor Contractor (FLC) of the location of the pesticide use records before the employees enter a treated field.
7. Handler Decontamination Facilities, regulated under 3 C.C.R. § 6734. Examples of these types of violations listed in the presentation are: not having an emergency eye flush station able to rinse the eye gently for 15 minutes at the mix and load site, when protective eyewear is required by the pesticide labeling; and handlers using hand sanitizer for decontamination instead of soap and water.
6. Availability of Labeling, regulated under 3 C.C.R. § 6602. Examples of labeling availability violations listed in the presentation are: not having relevant Special Local Needs (SLN) labeling at the site when mixing, loading, or applying; and not having the labeling booklets on-site when mixing, loading, or applying.
5. Service Container Labeling, regulated under 3 C.C.R. § 6678. Examples of service container labeling violations listed in the presentation are: not including the signal word on a service container label; and not including the address of the company or person responsible for the container on the label.
4. Annual Registration with County Agricultural Commissioner by Anyone Who Intends to Advertise, Solicit, or Operate as a Pest Control Business in California, regulated under California Food and Agriculture Code (FAC) § 11732. An example of a violation is performing pest control activities in a county before registering with the County Agricultural Commissioner (CAC).
3. Emergency Medical Care Requirements, regulated under 3 C.C.R. § 6726. Examples of violations listed in the presentation are: not taking employees suspected of a pesticide illness to the doctor immediately; and failure to post the handler emergency medical care information.
2. Personal Protective Equipment (PPE) Requirements, regulated under 3 C.C.R. § 6738. Examples of violations listed in the presentation are: storing PPE in the same place pesticides are stored; and an employer not providing the proper PPE required by the labeling.
1. Labeling and Permit Conditions Compliance, regulated under FAC § 12973. Examples of violations listed in the presentation are: not following the pesticide storage requirements listed on the labeling; and applying a pesticide to a site or crop not listed on the labeling.
Additionally, DPR has created an informative presentation about the 2019 license renewal process to help spread awareness to those renewing this year (last names and business names starting with M-Z). DPR states that it encourages continuing education (CE) sponsors, CAC staff, and others to use the presentation to inform license and certificate holders renewing this year about DPR’s renewal process, CE requirements, important dates, and the benefits of renewing early. The 2019 Renewal Process presentation is available here.
Please check out Bergeson & Campbell, P.C.'s (B&C®) new podcast "Inside OCSPP with EPA Assistant Administrator Alexandra Dapolito Dunn" on its All Things Chemical™ webpage. In this podcast, Lynn L. Bergeson, Managing Partner of B&C, presents a very special guest, the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP): Alexandra Dapolito Dunn.
As Assistant Administrator Dunn has spent just over five months in office, she and Lynn sit down and talked about what it’s been like to take over OCSPP at this crucial time when the amended Toxic Substances Control Act (TSCA), post-Lautenberg, is just coming into its maturity. They discuss the challenges OCSPP is currently facing, and how Alex and her team have kept morale up while managing to meet all of the many deadlines imposed on OCSPP thus far.
This is a fantastic opportunity to gain insight into what has been going on inside the OCSPP over the last few months, and what to expect from it in the next few months.
On May 21, 2019, the U.S. Environmental Protection Agency (EPA) announced that “to increase transparency and ensure information is easily accessible,” it has created a new web-based table of the most recent pesticide registration review actions that contains a list of the registration review actions EPA has taken over the current fiscal year, including the chemical name, docket number, and public comment period when applicable. EPA will update the table each time a registration review action is published. Stakeholders and the public can now quickly locate and sort through the following information for each active ingredient with a recent registration review action:
The new table also provides direct links to dockets, making it easy to access supporting information and documents related to a pesticide’s registration review. EPA states that it plans to update continuously this table as new registration review actions occur.
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:
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’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.