By Lynn L. Bergeson and Carla N. Hutton
On March 5, 2021, the U.S. Environmental Protection Agency (EPA) announced that “in support of the Biden-Harris Administration’s commitment to making evidence-based decisions to protect human health, U.S. Environmental Protection Agency (EPA) is taking an important step by proposing the cancellation of the registration of pentachlorophenol.” Pentachlorophenol, a well-recognized wood preservative in use for decades, is registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA, it is used primarily on utility poles.
EPA states that after completing a risk assessment, it determined that pentachlorophenol poses significant human health risks to workers. To address this issue, EPA proposes to cancel all uses of pentachlorophenol through the FIFRA registration review process. EPA will accept public comments on the proposed interim decision (PID) for 60 days in docket EPA-HQ-OPP-2014-0653. Comments are due May 4, 2021. 86 Fed. Reg. 12940. At this time, the PID has not yet been posted in the docket. After considering any comments concerning the PID, EPA will issue an interim decision, which would make final the cancellation of pentachlorophenol.
EPA notes that this proposed action would align the United States with the United Nation’s (UN) Stockholm Convention on Persistent Organic Pollutants, which has banned the use of pentachlorophenol. According to EPA, it worked with industry stakeholders “to identify a number of viable, safer alternatives such as copper naphthenate and DCOIT, along with well-established wood preservatives such as chromated arsenicals and creosote.” EPA’s March 5, 2021, Federal Register notice also announces the availability of PIDs for creosote and chromated arsenicals and dichromic acid, disodium salt, dehydrate.
That EPA is seeking to eliminate pentachlorophenol is by no means surprising and its demise has been in the works for a while. Its commercial use is already banned in many countries. The Biden Administration was expected to propose cancellation, and wasted little time in doing so. The real debate will be in the terms that EPA eventually settles upon with regard to phase-out and continued use of stockpiled material. The elimination of this product paves the way for a more robust commercial future for the existing pentachlorophenol replacements, and likely soon to be emerging replacements that are efficacious and more sustainable.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On December 7, 2020, the U.S. Environmental Protection Agency (EPA) issued for comment the Proposed Interim Decision (PID) for chlorpyrifos. 85 Fed. Reg. 78849. EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments. The PID proposes the following measures:
- Label amendments limiting application to address potential drinking water risks of concern.
- Additional personal protection equipment and application restrictions to address potential occupational handler risks of concern.
- Spray drift mitigation, in combination with the use limitations and application restrictions identified to address drinking water and occupational risks, to reduce exposure to non-target organisms.
EPA states that the PID presents proposed mitigation with the 10-fold (10x) Food Quality Protection Act (FQPA) safety factor, reflecting the uncertainties around doses that may cause pre- and post-natal neurodevelopmental effects. Under FQPA, EPA evaluates new and existing pesticides to ensure they can be used with a reasonable certainty of no harm to infants, children, and adults. EPA is required to consider the special susceptibility of children to pesticides by using an additional 10x safety factor unless adequate data are available to support a different factor. EPA additionally included a FQPA factor of 1x to reflect the range of potential risk estimates of chlorpyrifos, as illustrated in the September 2020 draft risk assessments.
Comments on both the September 2020 draft risk assessments and the PID are due on or before February 5, 2021. EPA states that by holding the comment period for both actions at the same time, the public has access to more information and can provide more informed, robust comments. Comments can be submitted at EPA-HQ-OPP-2008-0850.
EPA announced that it will also consider the input and recommendations from the September 2020 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting once it releases its report in December 2020. Depending on the SAP’s conclusions, EPA may further revise the human health risk assessment.
The inclusion of both 1x and 10x calculations for the appropriate FQPA safety factor is unusual. EPA states the final decision on the appropriate FQPA safety factor is partly dependent on any recommendations expected from the SAP meeting, which reviewed the “use of new approach methodologies (NAMs) to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment.” This is part of a larger and longer evaluation of whether test methods that avoid using test animals can reliably substitute for current test guideline requirements, that is, whether it is appropriate to rely on in vitro test protocols to substitute for current in vivo testing protocols.
EPA’s articulation at this point in time of mitigation needed if the FQPA 10x safety factor is retained may indicate a prediction about the SAP’s likely recommendations. It will be important to monitor developments on this issue closely.
By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson
On October 28, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2018 (2018 Report). 85 Fed. Reg. 68327. Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area. The 2018 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration. The 2018 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA. The report is available at EPA-HQ-OPP-2014-0125. Comments can be submitted on or before December 28, 2020.
EPA’s completed product reregistration actions totaled 177, short of EPA’s goal of 400 actions. The table below details the actions completed in FY 2018.
Table 1. Product Reregistration Actions Completed in FY 2018 (as of September 30, 2018)
|Product reregistration actions
|Product amendment actions
|Product cancellation actions
|Product suspension actions
EPA also states that 4,193 products had product reregistration decisions pending at the end of FY 2018, compared to 4,370 products with product reregistration decisions pending at the end of FY 2017, and 4,621 products with product reregistration decisions pending at the end of FY 2016. Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”
The number of applications for registration requiring expedited processing (i.e., “fast-track” applications) that EPA considered and approved has been more consistent in recent years, with 2,422, 2,574, and 2,303 in 2016, 2017, and 2018, respectively.
By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson
On August 5, 2020, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use or Removal Order (SSURO) against EcoShield LLC (EcoShield) for selling a clip-on badge product called the Eco AirDoctor Portable that claims to sanitize the air of pathogens. EPA states that the product was being sold and distributed in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) because it is an unregistered pesticide making false disinfectant claims. The SSURO against EcoShield is another in a series of enforcement actions EPA has taken against products that EPA believes are making claims in violation of FIFRA during the COVID-19 public health emergency. Some of these actions include the Amazon and eBay SSURO and the prevention of importation of the unregistered “Virus Shut Out” pesticide product. (See our blogs here and here for more information on these two actions.)
Under FIFRA, products that claim to kill or repel bacteria or germs, including disinfectants, are considered pesticides and must be registered with EPA. EPA will not register a disinfectant until it has been determined that it will not pose an unreasonable risk when used according to the label directions. In this case, Eco AirDoctor Portable was marketed as a “personal air sanitizer” that users hang from shirts or backpacks. The product claims to release chlorine dioxide gas to sanitize the air of pathogens. EcoShield also claimed on its website and social media that the product is a “safe and effective germ-killing agent” and, EPA claims, implies protection against SARS-CoV-2. EPA also expressed concerns regarding prolonged exposure to and inhalation of chlorine dioxide gas, which EPA states can adversely affect the health of users.
To find EPA-registered disinfectant products that are qualified for use against SARS-CoV-2, please search EPA’s List N, which currently contains 473 products, including products that went through the expedited review process for emerging viral pathogens.
Additional information on EPA enforcement actions on unregistered products is available here.
This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below.
This week I sat down with James Aidala, B&C’s Senior Government Affairs Consultant, to catch up on what the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) is up to and to get a sense of what we might expect to develop over the remainder of the year. As a former Assistant Administrator of what is now the Office of Chemical Safety and Pollution Prevention, Jim’s thoughts and analyses are always spot on.
We discuss leadership within OPP, which is transitioning. Not surprisingly, who holds the position of Office Director is always of great interest to the agricultural and biocidal chemical communities.
We also touch upon a number of high-profile pesticide science policy debates about substances, some of which have been raging literally for years. These substances include dicamba, glyphosate, and chlorpyrifos. The legal and scientific administrative and judicial reviews under way in the United States and internationally are fascinating, precedent setting, and closely watched.
Our conversation also includes a bit about the commercial agricultural chemical community. Industry consolidation and international trade issues continue to challenge the commercial landscape, and they make keeping up with these issues all the more important.
ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.
By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson
On April 6, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year 2017 (2017 Report). Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area. The 2017 Report discusses the completion of tolerance reassessment and describe the status of various regulatory activities associated with reregistration. The 2017 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA. The report is available at EPA-HQ-OPP-2014-0125. Comments can be submitted on or before June 5, 2020.
EPA’s completed product registration actions totaled 255, short of EPA’s goal of 600 actions. The table below details the actions completed in FY 2017.
Table 1.—Product Reregistration Actions Completed in FY 2017 (as of September 30, 2017)
|Product reregistration actions
|Product amendment actions
|Product cancellation actions
|Product suspension actions
EPA also states that there were 4,370 products had product reregistration decisions pending at the end of FY 2017, compared to 4,621 products with product reregistration decisions pending at the end of FY 2016, and 5,133 products with product reregistration decisions pending at the end of FY 2015. Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”
The number of applications for registration requiring expedited processing (i.e., “fast track” applications) that EPA considered and approved has been more consistent in recent years, with 2,223, 2,422, and 2,574 in 2015, 2016, and 2017 respectively.
By Kelly N. Garson and Carla N. Hutton
On January 27, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a notification for Project Number OA&E-FY20-0095, announcing that it will begin fieldwork to audit EPA’s adherence to pesticide registration risk assessment regulations, policies, and procedures. In a memorandum addressed to EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), OIG stated that its objective is to evaluate EPA’s ability to address human health and environmental risks prior to pesticide product registration. OIG will conduct the audit from EPA headquarters. According to the memorandum, the anticipated benefits of this audit include determining whether EPA has adequate controls to address human health and environmental risks prior to pesticide product registration.
OIG is an independent office created by the Inspector General Act of 1978, as amended. Though located within EPA, Congress funds OIG separately to ensure independence as it conducts activities such as audits and investigations to determine the efficiency and effectiveness of EPA’s operations and programs. Following the audit, OIG will prepare a report that may include recommendations for corrective actions OCSPP should take based upon OIG’s findings. More information on OIG’s previous reports and audit system is available on OIG’s website. Recent OIG reports regarding the implementation of FIFRA include:
By Timothy D. Backstrom
On February 3, 2020, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of an interim registration review decision for glyphosate. EPA previously issued a proposed interim registration review decision (PID) for glyphosate for comment in April 2019. At the time EPA issued the glyphosate PID for comment, EPA also issued a draft human health risk assessment and a preliminary ecological risk assessment for glyphosate. After reviewing the comments received concerning these assessments, EPA has not made any revisions to either assessment. EPA has determined that there are no dietary, residential, bystander, or occupational human health risks of concern associated with glyphosate use. EPA has also determined that there are some potential risks to plants, birds, mammals, and invertebrates from glyphosate use, but that these can be appropriately mitigated by label changes requiring enforceable spray drift management measures and adding a warning concerning the potential hazards to non-target organisms. EPA also has proposed some new measures to manage the development and spread of herbicide-resistant weeds. EPA has generally retained the proposed labeling changes identified in the PID, except for some modest adjustments to the proposed language concerning droplet size restrictions and swath displacement restrictions for aerial applications, and removal of spray drift advisory language for airblast application.
Despite considerable publicity recently concerning purported carcinogenic risks for glyphosate, including allegations that human exposure to glyphosate can be linked to non-Hodgkin's lymphoma, EPA has determined that glyphosate is not likely to be a human carcinogen and has steadfastly adhered to this basic conclusion. EPA made this determination for glyphosate after convening a meeting of the FIFRA Scientific Advisory Panel (SAP) to evaluate the carcinogenic potential of glyphosate in 2016.
The general purposes of the PID process are to allow EPA to move forward with aspects of the registration review process that are essentially complete, and to adopt interim risk mitigation measures, even though some of the actions required prior to a final registration review decision are not yet complete. As in the case of most recent PIDs, EPA states that it has not yet made a complete determination concerning potential effects or any required consultation for glyphosate under the Endangered Species Act (ESA), nor has it made a determination for glyphosate under the Endocrine Disruptor Screening Program (EDSP). In addition, EPA is considering a pending petition to prohibit preharvest use of glyphosate on oats, and to reduce the tolerance for glyphosate in oats, that was filed in 2018 by the Environmental Working Group and others. This petition is predicated on the potential carcinogenicity of glyphosate. Finally, EPA is still evaluating the question of whether additional data will be needed to evaluate properly the potential effects of glyphosate use on pollinators.
More information on glyphosate and EPA’s interim registration review decision is available here.
EPA's interim registration review decision for glyphosate is predicated on EPA's prior determination that the best available scientific data do not substantiate the claims that glyphosate may be a human carcinogen. As discussed above, the potential carcinogenicity of glyphosate was thoroughly evaluated by the FIFRA SAP in 2016. EPA's determination after that review that glyphosate is not a carcinogen has also been supported by other pesticide regulatory authorities. Nonetheless, EPA's view conflicts with a cancer classification decision for glyphosate by the World Health Organization (WHO), and with some recent tort case decisions that were based on the premise that there is a credible linkage between glyphosate exposure and human cancer. EPA recently announced that it would not permit or approve any cancer warning statements for inclusion in glyphosate labeling (including any statements that may be required pursuant to California's Prop 65) because EPA believes that such statements are false or misleading and would therefore cause the pesticides to be "misbranded."
It appears probable there will be continued litigation based on the purported carcinogenicity of glyphosate, along with various proposals to ban or restrict glyphosate use. The pending petition to restrict use of glyphosate on oats that was filed by EWG, et al., is expressly predicated on the potential carcinogenicity of glyphosate, so it appears probable that this petition will ultimately be denied by EPA. Nonetheless, unless WHO decides to reverse or modify its classification determination, or the courts determine that the recent tort awards for glyphosate users cannot be scientifically substantiated, the battles over the claimed carcinogenicity of glyphosate may persist for years.
More information on glyphosate issues is available on our blog under keyword glyphosate.
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.