By Timothy D. Backstrom and James V. Aidala
On December 18, 2019, the Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) issued for comment a Proposed Interim Decision (PID) in the ongoing registration review process for each of the three registered triazine herbicides: atrazine, propazine, and simazine. EPA will allow 60 days for comment on each of these triazine PIDs, but the specific comment deadline will only be established after EPA has published notice concerning the proposed interim decisions in the Federal Register. EPA can utilize an “interim registration review decision” under 40 C.F.R. Section 155.56 whenever it is not yet ready to complete the registration review process, but EPA has nonetheless completed sufficient review to determine that new or interim risk mitigation measures are needed or that additional data or information should be submitted to complete the review. For each of the three triazine herbicides, EPA is proposing to impose specific risk mitigation measures for particular registered uses to mitigate potential health and environmental risks. For each triazine herbicide, EPA is not yet ready to make a final registration review decision because EPA has not made findings in the Endocrine Disruptor Screening Program (EDSP) or an effects determination under the Endangered Species Act (ESA). Several key factors that will affect the final registration review decision for each of the triazine herbicides are discussed below.
Common Factors for Triazine Risk Assessment
There are several common factors to consider with regard to the triazines risk assessment. These include:
- Atrazine, propazine, and simazine are all included in the chlorotriazine chemical class. EPA has determined that these three herbicides, along with three specific chlorinated metabolites, share a common mechanism of toxicity, so human health risks from all of these substances are being assessed by EPA together through one cumulative triazine risk assessment. The contribution of each product to aggregate human risk differs because of somewhat dissimilar use patterns. The combining of risks resulting from use of each triazine means, however, that it may be necessary for EPA to coordinate the ultimate registration review decisions for the three active ingredients.
- As part of the ecological risk assessment for each triazine herbicide, EPA plans to make an effects determination for potentially vulnerable species under the ESA, which in turn will determine whether it is necessary for EPA to consult with the Fish and Wildlife Service or the National Marine Fisheries Service (the Services) concerning potential impacts of each active ingredient and relevant metabolites on endangered or threatened species. Atrazine, propazine, and simazine are all included in a stipulated settlement between the parties in Center for Biological Diversity et al. v. EPA et al. No. 3:11 cv 0293 (N.D. Cal.), and EPA agreed in that stipulated settlement to set August 14, 2021, as the deadline for EPA to make a nationwide effects determination for each active ingredient, and to request any required consultation with the Services, under ESA Section 7(a)(2).
- EPA states that the predominant human health effect of concern for all three of the triazine herbicides and their chlorinated metabolites is potential suppression of the luteinizing hormone (LH) surge, which is considered to be both a neuroendocrine and a developmental effect. Atrazine and simazine were both included on List 1 for screening testing under the EDSP required by the Food Quality Protection Act (FQPA) amendments. All of the required Tier 1 screening assays for each of these substances are complete and have been evaluated by EPA, but EPA has not yet made human health or environmental findings under the EDSP. The EDSP screening testing has not been completed yet for propazine.
Risk Mitigation Measures
Each PID proposes specific risk mitigation measures intended to address potential human and environmental risks identified by the EPA risk assessments.
For atrazine, the PID includes the following measures to mitigate aggregate human risk:
- Reduce the permissible application rates for use of granular and liquid formulations on residential turf.
- Require additional personal protective equipment (PPE) and engineering controls for certain uses.
- Restrict aerial applications to liquid formulations only.
- Limit backpack sprayer applications to landscape turf to spot treatment only.
- Prohibit pressurized handgun application to certain commodities.
To mitigate ecological risks, the atrazine PID proposes to require various spray drift reduction measures, to add a non-target advisory statement to labeling, and to adopt a nationwide stewardship program.
For propazine, the PID proposes to cancel the greenhouse use to mitigate aggregate human risk. Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.
For simazine, the PID includes the following measures to mitigate aggregate human risk:
- Cancel simazine use on residential turf.
- Require additional PPE and engineering controls for certain uses.
- Limit pressurized handgun applications to certain commodities to spot treatment only.
Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.
In each of the PIDs for the triazine herbicides, EPA has focused its efforts on adopting mitigation measures which should be efficacious in reducing human and ecological risks without materially impairing the availability of the products in question for key agricultural uses. In some instances, the PID documents explicitly state that the product registrants have agreed to proposed changes. An EPA Pesticide Program Update dated December 19, 2019, that discusses the interim decision for atrazine includes statements of support from several grower groups.
By Timothy D. Backstrom
On December 5, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced the availability of a revised interim registration review decision for use of sodium cyanide in the M-44 predator control device. The M-44 device is a restricted use pesticide (RUP) and may be used only by certified applicators in compliance with specific mandatory restrictions set forth on the label. Although the registration review process for sodium cyanide remains pending, EPA has decided to issue an interim decision for the M-44 device now to adopt new label restrictions intended to mitigate potential risks. The revised interim decision adopts two new restrictions and also modifies certain existing restrictions, which EPA states "will reduce the potential for unintended impacts on humans, pets, and other non-target animals.”
The M-44 predator control device uses a spring-loaded ejector to fire a capsule containing a single lethal capsule of sodium cyanide. The M-44 is used by livestock producers to control predators (primarily coyotes) that kill sheep, goats, and cattle. Registrations for the M-44 device are currently held by the U.S. Department of Agriculture, and by five individual States (South Dakota, Texas, Montana, Wyoming, and New Mexico) where livestock predation has been a particular problem.
New or revised restrictions that will be incorporated in the approved labeling for the M-44 device include:
- Requiring a 600-foot buffer zone around residences where an M-44 cannot be used (except for a cooperating landowner who has given written permission).
- Requiring that the applicator notify occupants of all residences within a 0.5 mile radius (by face-to-face communication, person-to-person telephone communication, door hanger, or certified mail) prior to an M-44 placement.
- Increasing from 50 feet to 300 feet the distance from designated public paths and roads where M-44 use is prohibited.
- Requiring two elevated warning signs placed 15 feet from the M-44 device and facing the most likely directions of approach, instead of one elevated sign placed 25 feet from the device.
Livestock producers and State departments of agriculture contend that the M-44 device is essential to limit economic losses resulting from predation, which reportedly amount to hundreds of millions of dollars annually. In contrast, wildlife advocates have strongly opposed any continued use of the M-44 device. In 2017, WildEarth Guardians and the Center for Biological Diversity petitioned EPA to suspend and cancel all registrations for M-44 capsules, but EPA concluded that the petition did not contain substantial new information and denied the petition in 2018. Although the new and modified label restrictions adopted by EPA in the interim decision for the M-44 device are not likely to satisfy opponents, these changes should nonetheless reduce the likelihood that humans, pets, or other non-target species will be exposed to the M-44 capsules or the toxin they contain.
By Heather F. Collins, M.S. and Barbara A. Christianson
On October 1, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the that fees under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) were increased by five percent for pesticide applications received on or after October 1, 2019. The five percent increase is on fee amounts established by Public Law 116-8, which became effective on March 8, 2019. The revised fees will remain in effect until September 30, 2021.
The fee schedule provided in PRIA 4 identifies the registration service fees and decision times organized according to the organizational units of the Office of Pesticide Programs (OPP) within EPA. EPA presents the schedules as 19 tables, organized by OPP Division and by type of application or pesticide subject to the fee, and lists the registration service fee for actions received in fiscal years 2020 and 2021. Applicants must submit fee payments at the time of application. EPA will reject any application that does not contain evidence that the PRIA 4 fee has been paid.
The revised fee schedule for PRIA 4 fiscal years 2020 and 2021 is available on EPA’s website. More information on the PRIA 4 legislation is available on our blog under key word PRIA.
By Lisa M. Campbell and Timothy D. Backstrom
On September 9, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) published a notice in the Federal Register announcing the availability of, and an opportunity for comment on, a document describing an “interim process” that OPP’s Environmental Fate and Ecological Effects Division is currently using to evaluate potential synergistic effects of mixtures of pesticide active ingredients on non-target organisms. As part of a lawsuit challenging the 2012 decision by EPA to register Enlist Duo Herbicide (a combination of 2,4-D and glyphosate), OPP scientists learned that patent applications for some registered pesticide products included claims that particular combinations of active ingredients provide “synergistic” control of target species. Although EPA was not at that time considering potential synergies in assessing the risk for ecological effects on non-target organisms, based on the patent application claims regarding synergy for Enlist Duo, EPA decided to request that the reviewing court vacate its registration decision and remand the application for Enlist Duo for further study of these effects and any measures that might be needed to mitigate the risk to non-target organisms. This decision sparked much controversy, and many in industry were concerned that patent application claims were not being correctly interpreted by EPA for the category of pesticide products at issue.
The new document released by EPA for review and comments is entitled: “Process for Receiving and Evaluating Data Supporting Assertions of Greater Than Additive (GTA) Effects in Mixtures of Pesticide Active Ingredients and Associated Guidance for Registrants.” EPA states that it “has generally been applying this interim process since 2016.” The process described in the document has five steps: (1) registration applicants must search for any granted patents that include synergy (GTA) claims for combinations of pesticides; (2) applicants must review the patent claims and supporting data for relevance to ecological risk assessment; (3) applicants must report to EPA all effects testing data from the relevant patents; (4) applicants must do a statistical analysis (using a method prescribed by EPA) to determine whether any observations of GTA effects are statistically significant; and (5) EPA will review all submitted information to decide whether it should be utilized in ecological risk assessment.
In the Federal Register notice, OPP lists five specific areas pertaining to the interim risk assessment process described in the document on which it is requesting comment:
- Are there technical aspects of the interim process that warrant change? If so, what changes are recommended?
- What aspects of the process could be applied to the evaluation of open literature sources of GTA effects pesticide interactions?
- Should EPA consider standardizing a more detailed search and reporting approach, and how should EPA do that?
- Should EPA continue the evaluation process as described in this document? If so, what performance metrics (e.g., number of evaluations) should EPA consider before deciding the utility of this approach?
- What applicant burden is associated with the activities described in this memorandum, including compiling, analyzing, and submitting the information? Specifically, does an estimate of 80-240 hours of burden per applicant cover the respondent burden associated with the interim process?
When the National Research Council (NRC) evaluated the importance of toxicological interactions between pesticide active ingredients in 2013, the NRC concluded that such interactions are rare, but that EPA should nonetheless consider such interactions when the best available scientific evidence supports such an evaluation. In the current Federal Register notice, EPA makes it clear that it is uncertain concerning the utility for risk assessment of the information used by manufacturers to support synergistic effects claims in pesticide patents. According to EPA, 24 applicants for new registrations have submitted patent data to date, but only three of these submissions contained information that indicated a need for further testing and no submission ultimately led to any adjustment of the ecological risk assessment. At this juncture, EPA will continue collecting patent data that may be pertinent to GTA effects, but when it has sufficient experience upon to base a general policy it may either continue or improve this process or discontinue it after explaining why.
When EPA requested that the reviewing court vacate and remand the registration EPA had granted for Enlist Duo, the parties seeking judicial review located data in the patent applications that EPA had not previously seen or reviewed and that EPA believed could possibly be pertinent to potential adverse effects on non-target plants. EPA concluded that it should revisit the decision based on the additional data. Although EPA decided to request vacatur and remand, the applicant Dow AgroSciences had arguably followed all of the procedures then in place, because FIFRA Section 3(c)(5) allows EPA to waive data requirements pertaining to efficacy, and EPA typically registers pesticide product that are not intended to protect public health without any independent evaluation of efficacy data. Nevertheless, in general EPA may choose to evaluate pesticidal efficacy data; such circumstances in the past often involved cases where EPA was required to consider whether pesticide benefits are sufficient to outweigh identified risks. In the Enlist case, EPA determined that it should do so where potential synergy in pesticidal efficacy is pertinent to evaluating ecological effects on non-target species.
What EPA must decide now is how often efficacy data that has been deemed adequate by the Patent and Trademark Office to support a patent for a new pesticide mixture will have any material significance in the context of ecological risk assessment. Before EPA makes a determination whether or not patent data has sufficient pertinence to continue requiring routine collection and evaluation of such data, EPA has decided it is prudent to afford all stakeholders an opportunity to comment on whether EPA has been asking the right questions.
All comments on the draft document must be submitted no later than October 24, 2019.
By Lisa M. Campbell and Timothy D. Backstrom
On August 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the receipt of 10 applications to amend currently registered pesticide products to add hemp as a new use site. The 10 application amendments are the result of the 2018 Farm Bill, signed in to law on December 20, 2018, that removed hemp from the Controlled Substances Act and legalized commercial use and production of hemp that contains less than 0.3% tetrahydrocannabinol (THC).
EPA states in the notice that Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(4) does not require EPA to provide notice and opportunity to comment concerning these 10 applications because hemp falls within the terrestrial outdoor and residential outdoor use pattern previously approved for the pesticidal active ingredients in question, and approval of the applications would therefore not involve "a changed use pattern." Instead, EPA states that it has decided to provide an opportunity to comment in this instance "because of the potential significant interest from the public" and to be "completely transparent about these applications." EPA also states that it does not intend to provide notice or opportunity to comment for similar applications to add hemp that are likely to be submitted in the future.
EPA also states that the products with requested label amendments contain active ingredients for which EPA "has previously determined the residues will be safe under any reasonably foreseeable circumstances." Each active ingredient has an established tolerance exemption for residues on all raw agricultural or food commodities.
The 10 products for which EPA has received an application to add hemp are:
- Debug Turbo, EPA Registration No. 70310-5, active ingredients: azadirachtin and neem oil;
- Debug Optimo, EPA Registration No. 70310-7, active ingredients: azadirachtin and neem oil;
- Debug Trés, EPA Registration No. 70310-8, active ingredients: azadirachtin and neem oil;
- Debug-ON, EPA Registration No. 70310-11, active ingredient: neem oil;
- REGALIA Bioprotectant Concentrate, EPA Registration No. 84059-3, active ingredient: extract of Reynoutria sachalinensis;
- MBI-110 EP, EPA Registration No. 84059-28, active ingredient: Bacillus amyloliquefaciens strain F727;
- GH CMT, EPA Registration No. 91865-1, active ingredients: soybean oil, garlic, oil, and capsicum oleoresin extract;
- GH MPMT, EPA Registration No. 91865-2, active ingredient: potassium salts of fatty acids;
- GH DNMT, EPA Registration No. 91865-3, active ingredient: Bacillus amyloliquefaciens strain D747; and
- GH NAMT, EPA Registration No. 91865-4, active ingredient: azadirachtin.
Once public comments are received, EPA anticipates making its decision on adding hemp as a new use site on the specific products before the end of 2019, so that these products may be available for the 2020 growing season.
Although the Federal government has legalized commercial production and use of hemp (as opposed to marijuana that contains higher levels of THC), not every State has changed its laws to conform to the new classification. EPA took the unusual step of announcing receipt of the new amendment applications at Hemp Production Field Day at the University of Kentucky. Senator Rand Paul of Kentucky has long been a proponent of commercial hemp production, and about 1,000 growers in Kentucky now have licenses to grow hemp for commercial use.
As hemp production increases, there will also be increased demand for pesticides to combat weeds, insects, and plant diseases that pose a potential threat to this crop. Although hemp fiber and oil have many potential industrial uses, hemp also has potential medicinal uses because extracts containing cannabidiol (CBD) are now being widely marketed for their purported health benefits. This use of hemp means that EPA will have to consider whether new tolerances may be required for some active ingredients before they can applied to hemp. As EPA has noted, the active ingredients in the 10 products for which EPA announced that applications are pending to add labeling for hemp already have tolerance exemptions, and therefore do not present this issue.
Comments are due on or before September 23, 2019. The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2019-0369.
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, and James V. Aidala
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.
By Lisa M. Campbell, Timothy D. Backstrom, Lisa R. Burchi, and James V. Aidala
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:
Since the vacatur in 2015, DAS has submitted numerous additional pollinator studies. The pollinator data requirements listed in 40 CFR 158.630 have all been submitted or waived. EPA’s risk assessment process for pollinators has evolved since those data requirements were promulgated and now EPA generally assesses risks to bees using a three-tier process based on a more robust data set as described in two guidance documents: “Guidance for Assessing the Risks of Pesticides to Bees” (USEPA 2014) and “Guidance on Exposure and Effects Testing for Assessing Risks to Bees” (USEPA 2016). For sulfoxaflor, all Tier I data have been submitted. Three additional Tier II semi-field (tunnel) studies and two colony feeding studies have been submitted. Pollen and nectar residue data have been submitted for multiple crops. The submitted data covers all of the requested use patterns. For those crops that did not have data specific to pollen and nectar residues, data was extrapolated as appropriate from other crops. All regulatory data requirements for assessing pollinators have now been addressed and the EPA has adequate data to demonstrate that there will be no unreasonable adverse effects to honey bees resulting from the expanded registration of sulfoxaflor.
EPA’s decision also removes previously imposed application restrictions:
- Removed the prohibition of use on crops grown for seed because EPA believes pollinator protection restrictions, including low use rates, will be in place regardless of whether the crop is grown for seed or for commodity harvest;
- Removed the restriction to post-bloom application for bee-attractive crops only when there is low risk or limited potential for exposure to bees;
- Removed the 12-foot buffer requirement because EPA believes the spray drift mitigation requirements on labels are adequate to limit drift; and
- Removed the 2016 restriction against tank mixing because EPA states data show that there is no additional risk when sulfoxaflor is tank mixed with other compounds.
EPA’s decision includes the following crop specific restrictions:
- Citrus: Only one application is allowed per year between 3 days before bloom and until after petal fall.
- Ornamentals: Only one application is allowed during bloom, and that bloom must not exceed a rate of 0.071 lb ai/acre.
- Pome Fruit, Stone Fruit, Tree Nuts and Pistachio: No application is allowed any time between 3 days prior to bloom and until after petal fall.
- Small Fruit Vine Climbing and Low Growing Berry, Tree Plantations: No application is allowed any time between 3 days prior to bloom and until after petal fall.
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:
- Worker Protection: “Applicators and other handlers must wear: Long-sleeved shirt and long pants, shoes plus socks, protective eyewear” and “Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of” 24 hours (for Transform WG label) and 12 hours (for Closer SC label).
- Environmental Hazards Statement: “This product is highly toxic to bees and other pollinating insects exposed to direct treatment or to residues in/on blooming crops or weeds. Protect pollinating insects by following label directions intended to minimize drift and reduce pesticide risk to these organisms.”
- The RT25 (how long foliar residues of sulfoxaflor exhibit toxicity to honey bees): “The RT25 for this product is less than or equal to 3 hours.”
- Directions for Use: “Notifying known beekeepers within 1 mile of the treatment area 48 hours before the product is applied will allow them to take additional steps to protect their bees. Also, limiting application to times when managed bees and native pollinators are least active, e.g. 2 hours prior to sunset or when the temperature is below 50°F at the site of application will minimize risk 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:
EPA has not made an effects determination for sulfoxaflor. EPA is currently focusing most of its resources for assessing impacts to listed species on its registration review program for currently registered pesticides. EPA believes that, as a general matter, older pesticides present a greater degree of risk to listed species than most new chemistries, including sulfoxaflor, and that it is therefore environmentally preferable in most circumstances for EPA to assess the impacts of existing pesticides sooner in the process than newer pesticides that are designed to compete with more risky alternatives. EPA believes that is especially true for sulfoxaflor, where the alternatives include organophosphates, neonicotinoids and pyrethroids. As a result, EPA does not believe the environment or the public would be best served by delaying the registration of new uses for sulfoxaflor to complete consultation. Focusing the limited resources of EPA, the Fish and Wildlife Service and the National Marine Fisheries Service on completing a consultation on the effects of sulfoxaflor would by necessity come at the expense of putting more resources into evaluating – and consequently regulating, where appropriate – what EPA believes to be more toxic compounds, that, among other things, pose greater risk, to endangered species than does sulfoxaflor.
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.
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 Barbara Christianson
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.