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.

By Lisa M. Campbell and Carla N. Hutton

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:

• Toxicology related to human health;
• Bystander and occupational exposure;
• Food residue trials;
• Environmental toxicology and fate;
• Product efficacy, crop tolerance, and benefits of the product; and
• Other scientific data or studies submitted to, or considered by the PMRA.

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.

By Lisa M. Campbell and Lisa R. Burchi

On May 31, 2019, Health Canada’s Pest Management Regulatory Agency (PMRA) issued its Proposed Re-evaluation Decision PRVD2019-05, Chlorpyrifos and Its Associated End-use Products: Updated Environmental Risk Assessment (Updated Environmental Risk Assessment).  PMRA states that this re-evaluation “considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies” and that “Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.”

PMRA is proposing the cancellation of most uses of chlorpyrifos, including almost all agricultural uses, due to PMRA’s belief that they pose unacceptable risks to the environment.  The proposal would allow a small number of uses to continue if certain label changes are made.  More specifically, PMRA states that its evaluation of available scientific information “has not found acceptable risks to beneficial arthropods, birds, mammals and all aquatic biota in the environment for most current chlorpyrifos uses” but “[g]reenhouse ornamental, outdoor ornamentals (container stock only) for control of Japanese beetle larvae, indoor and outdoor structural, adult and larval mosquito uses of chlorpyrifos have been shown to be acceptable from the environmental perspective.”  The label changes that PMRA states would be required for these uses to continue include the following:  (1) standard environmental hazard statements to inform users of the potential toxic effects to non-target species; and (2) standard environmental advisory statements for prevention of contamination of aquatic systems and to reduce volatilization.

There is a 90-day public consultation period on the proposal, which began on May 31, 2019, during which the public may submit written comments and additional information to PMRA.  PMRA states that the public may submit additional information that could be used to refine risk assessments and that the final re-evaluation decision will take into consideration the comments and information received during the comment period, which could result in revised risk mitigation measures.  The re-evaluation decision document will include the final re-evaluation decision, the reasons for it, and a summary of comments received on the proposed re-evaluation decision with Health Canada’s responses.

More information on chlorpyrifos issues, including California’s recent announcement that it would be initiating cancellation proceedings of chlorpyrifos, can be found on our blog.

By Lisa M. Campbell and Lisa R. Burchi

On May 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:

• Counsel for each Petitioner is directed to file a supplemental brief of 7,000 words or less within 60 days of the date of the order (by July 30, 2019);
• Counsel for Respondent and Intervenor are directed to file a responsive brief of 7,000 words or less within 60 days from the date of filing of Petitioners’ briefs; and
• Petitioners may each file reply briefs not to exceed 3,500 words within 30 days from the date of the filing of Respondent’s brief. 

By Lisa M. Campbell and Lisa R. Burchi

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).

2. Soil:

• The study is conducted in a coarse-texture soil in accordance with the U.S. Department of Agriculture (USDA) soil textural classification (see Table 1).  The minimum depth-weighted average sand content for representative samples taken across the test site should be no less than 68 percent as measured within the top 30 cm of soil.  The allowable minimum soil sand content that is included in the average is 61 percent.
• The soils used for the study do not have a restrictive layer to the movement of water as indicated within the soil profile, such as a hardpan, compacted layer, or an abrupt change in texture.
• The maximum depth-weighted average organic matter content for representative samples taken across the test site should be no greater than 1.4 percent as measured within the top 30 cm of soil.  The allowable maximum organic matter content that is included in the average is 1.6 percent.
• Studies shall be conducted on bare soil plots.  Exceptions are possible for studies conducted in the presence of a crop or turf with sufficient justification.

3. Water Inputs:

• Water applications to the study site are sufficient to create levels of percolating water that reflect the potential amount lost from crop irrigations (i.e., 160 percent of ET).  Approximately 60 percent of applied water is available for movement below the coring depth, which would equate to water applications of approximately 160 percent of ET.  Therefore, a scheduled water input would approximate the cumulative daily ET since the previous water input multiplied by an excess demand factor of 1.6.  For bare soil plots, ET can represent reference ET or, if preferred, soil evaporation when calculated using a scientifically defensible methodology. These water inputs supersede those in EPA’s guidance document for TFD studies.
• The initial water application to the study site occurs within one week of chemical application.  Subsequent water applications shall be at seven-day intervals or less for the duration of the study.
• Water inputs from rain are subtracted from scheduled water input amounts.

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.

By Lisa M. Campbell and Lisa R. Burchi

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.  

By Lisa M. Campbell and Lisa R. Burchi

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 docket number (with a direct link to the docket);
• Comment period deadline (if applicable);
• Case number;
• Designated division;
• Registration review action type; and
• Contact information for the chemical review manager.

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.

By Lisa M. Campbell and Lisa R. Burchi

On May 8, 2019, the California Environmental Protection Agency (CalEPA) announced that the California Department of Pesticide Regulation (DPR) will be initiating cancellation proceedings of chlorpyrifos.  In its press release, CalEPA states that the decision to commence cancellation proceedings “follows mounting evidence, including recent findings by the state’s independent Scientific Review Panel on Toxic Air Contaminants, that the pesticide causes serious health effects in children and other sensitive populations at lower levels of exposure than previously understood.”

DPR’s decision, following years of review in California of chlorpyrifos, is sure to garner significant controversy, comments, and, potentially, litigation.

Background

Chlorpyrifos first entered the comprehensive risk assessment process after being designated by DPR with a “high” priority status in 2011, and some of the DPR documents supporting the current action were issued in 2011.

In December 2015, DPR released a draft risk assessment for public comment.  Since the risk assessment identified potential human exposure to spray drift (via inhalation or deposition) as a concern, DPR entered chlorpyrifos in its formal evaluation process to determine the scientific evidence for listing it as a pesticide Toxic Air Contaminant (TAC) (CA Food & Agric. Code §§ 14021-14027).

DPR’s assessments were intended to evaluate chlorpyrifos as a pesticide TAC as defined in California regulations (Title 3, Section 6864).  The determination of a pesticide TAC is based on whether the air concentrations, either measured or modeled, exceed the reference concentration (RfC) divided by ten.  Under the applicable California statutory provisions, designation of an active ingredient as a TAC is based on an evaluation that assesses the following:

• The availability and quality of data on health effects;
• The potency, mode of action, and other relevant biological factors;
• An estimate of the levels of exposure that may cause or contribute to adverse health effects; and
• The range of risks to humans resulting from current or anticipated exposure (CA Food & Agric. Code § 14023(a)).

DPR published its draft revised report entitled "Evaluation of Chlorpyrifos as a Toxic Air Contaminant" in December 2017 and an addendum to that report in June 2018.  DPR issued its final TAC evaluation in July 2018.  The July 2018 evaluation concludes that “chlorpyrifos meets the criteria of TAC designation by using either the developmental neurotoxicity endpoint or the [acetylcholinesterase (AChE)] inhibition endpoint, even without the additional 10x uncertainty factor necessary to account for the fact that the developmental neurotoxicity effects occur at a lower level than AChE inhibition.”

DPR’s findings, public comments, and responses to those comments were reviewed by the Scientific Review Panel (SRP) on TACs.  SRP’s findings on chlorpyrifos issued in August 2018 “unanimously concluded that the report, with the revisions requested by the Panel, is based on sound scientific knowledge, and represents a balanced assessment of our current scientific understanding.”

In April 2019, chlorpyrifos was listed in California as a TAC, which triggered a DPR requirement to “develop control measures to protect the health of farm workers and others living and working near where the pesticide is used.”  In its press release announcing the cancellation proceedings, CalEPA states that “DPR has determined, in consultation with CDFA, the Office of Environmental Health Hazard Assessment (OEHHA), and the California Air Resources Board (CARB), that sufficient additional control measures are not feasible.”

Commentary

DPR’s announcement is the beginning of what DPR estimates could be a two-year cancellation proceeding, although in reality the process may take even longer.  Other actions proposed in conjunction with the cancellation proceeding include:

• DPR to consult with county agricultural commissioners and local air pollution control districts before filing for cancellation.
• DPR to support “aggressive” enforcement of existing restrictions on the use of chlorpyrifos, including a ban on aerial spraying, quarter-mile buffer zones, and limiting use to crop-pest combinations that lack alternatives.
• DPR and CDFA to convene a cross-sector working group to identify, evaluate, and recommend safer and more practical and sustainable alternative pest management solutions to chlorpyrifos.
• California Governor Gavin Newsom to propose $5.7 million in new budget funding “to support the transition to safer, more sustainable alternatives.

DPR’s action must also be viewed in conjunction with various federal and state reviews and resulting litigation regarding chlorpyrifos’ continued registration and use.  The U.S. Environmental Protection Agency (EPA) for example, is conducting its own registration review of chlorpyrifos, and was ordered by the U.S. Court of Appeals for the Ninth Circuit to issue, within 90 days of the April 19, 2019, order, its final decision regarding the continued registration of chlorpyrifos.

Other states are also taking action to ban chlorpyrifos, notably Hawaii, which enacted legislation in 2018 to ban the use of chlorpyrifos in Hawaii by 2022; and New York, whose legislature approved bills in April 2019 to ban chlorpyrifos use in New York by 2021.

Stakeholders should review all these issues closely, as these unprecedented decisions are likely to provide multiple opportunities to comment or otherwise participate to ensure that regulatory requirements are indeed being met for cancellation. 

More information concerning chlorpyrifos is available on our blog.

By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was seeking comment on its Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides (Draft Revised Method).  84 Fed. Reg. 22120.  It also announced that it would host a public meeting on June 10, 2019, in which it will present the Draft Revised Method and provide an additional opportunity for the public to provide feedback. 

The Draft Revised Method states it is intended to be “used in the evaluation of potential risks from pesticides to listed species” and that it will be “used by EPA for making effects determinations under registration review, which will also be used to inform biological opinions from the Fish and Wildlife Service and the National Marine Fisheries Service [(the Services)].”

EPA states that the Draft Revised Method document “describes proposed revisions to the interim methods used to conduct effects determinations as documented in EPA’s [biological evaluations (BE)] for federally threatened and endangered species for pesticides.”  EPA states the revisions are based on: (1) “refinements” following the method used in the first three national-level BEs for chlorpyrifos, diazinon, and malathion; (2) consideration of public comments provided through stakeholder meetings and submitted to the docket for the pilot draft BEs; (3) consideration of National Research Council (NRC) recommendations; and (4) “lessons learned during the development of the first three BEs.”

EPA states that the following are major aspects of its proposed revisions on which it is seeking comments:

• To more accurately represent where and to what extent a pesticide is likely to be applied, EPA is proposing an approach for incorporating pesticide-specific usage data into Steps 1 and 2 of the BEs.  While the pilot BEs relied on use assumptions from pesticide product labels to represent where the pilot chemicals were likely to be applied (e.g., applied to all labeled crops at maximum application rates simultaneously), the Draft Revised Method proposes to incorporate usage data (e.g., survey data, including actual application rates) in the determination.
• Based on the accuracy of the spatial data utilized and the conservative assumptions related to the action area and potential drift, EPA’s notice states that it is proposing to interpret “a <1% overlap of listed species’ ranges with potential use sites as unreliable and not representative of real exposure potential.”
• EPA is proposing an approach for introducing components of probabilistic analysis into the BE, as the “goal of the probabilistic analysis is to more fully capture and characterize the variability in the range of potential exposures and toxicological effects to listed species to better inform the biological opinion.”
• EPA is proposing a weight-of-evidence framework “to distinguish those listed species that are likely to be adversely affected (LAA) from those that are not likely to be adversely affected (NLAA), based on criteria (e.g., dietary preferences, migration patterns, extent of range potentially exposed) associated with the likelihood that an individual will be exposed and affected.”

The June 10 public meeting, which EPA states “is part of the federal government’s coordinated effort to improve the Endangered Species Act (ESA) process that is used when pesticides are federally registered,” will be held from 9:00 a.m. to 12:00 p.m. (EDT) in the lobby-level conference center of EPA’s offices at Potomac Yard South in Arlington, Virginia.  Those wishing to attend either in person or via teleconference/webinar must register by May 30, 2019.  Registration is available online.  Comments on the Draft Revised Method are due by July 1, 2019, in Docket No. EPA-HQ-OPP-2019-0185 on www.regulations.gov.

Commentary

This is the latest chapter in the long saga of coordination between ESA review by the Services and EPA registration activities.  The steps outlined in the Draft Revised Method are designed to improve the coordination of work between the agencies and represent an important step in designing a framework that might make the current situation more reliable, predictable, and efficient.  The current process has been subject to criticism on a number of fronts, with the current BE process seen as unsustainable given the amount of resources and time consumed by the first BEs. 

The goal is eventually to have the Services and EPA “play nice together” and implement a leaner and more efficient process, which is considered absolutely necessary if EPA hopes ever to complete appropriate ESA assessments on hundreds of active ingredients formulated into thousands of end use pesticide products.  Such efforts could also represent a cornerstone of the agencies’ meeting provisions in the 2018 Farm Bill (Section 10115), which includes requirements for the agencies to “… increase the accuracy and timeliness” of the ESA consultation process, as well as implement these same policies stated in the Memorandum of Agreement between EPA, the Department of the Interior, and the Department of Commerce on Establishment of an Interagency Working Group to Coordinate Endangered Species Act Consultations for Pesticide Registrations and Registration Review.

By Lisa M. Campbell and Lisa R. Burchi

On May 15, 2019, the U.S. Environmental Protection Agency (EPA) announced that it is extending the comment period for the Draft Guidance for Plant Regulator Label Claim, Including Plant Biostimulants that was made available on March 27, 2019.  94 Fed. Reg. 21773.  The original comment date was May 28, 2019; comments are now due by July 28, 2019, in Docket No. EPA-HQ-OPP-2018-0258.  Several trade groups and a number of individual companies had requested an extension due to the complexity and breadth of the guidance.  EPA’s grant of additional time is likely very welcome to many stakeholders, given the significant issues that this guidance addresses and given the work that many stakeholders have done on the issues it addresses. 

EPA states that the draft guidance is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and thereby distinguish claims that would not subject plant biostimulants to regulation under FIFRA as plant regulators. 

More information on the guidance is available in our April 2, 2019, memorandum “EPA Releases Draft Guidance for Pesticide Registrants on Plant Regulator Label Claims, Including Plant Biostimulants.”

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On May 6, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms.  84 Fed. Reg. 19782.  In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential risk to terrestrial and aquatic plants from off-site spray drift, consistent with glyphosate’s use as a herbicide.”  Even with these potential risks, the PID states that “EPA concludes that the benefits outweigh the potential ecological risks when glyphosate is used according to label directions” and proposes certain risk mitigation strategies, including:

• “To reduce off-site spray drift to non-target organisms, the EPA is proposing certain spray drift management measures” with specific spray drift mitigation language to be included on all glyphosate product labels for products applied by liquid spray application;
• “To preserve glyphosate as a viable tool for growers and combat weed resistance, the EPA is … proposing that herbicide resistance management language be added to all glyphosate labels” and to require measures “for the pesticide registrants to provide growers and users with detailed information and recommendations to slow the development and spread of herbicide resistant weeds”;
• Inclusion on labels of a non-target organism advisory statement to alert users of potential impact to non-target organisms; and
• “EPA is also proposing certain labeling clean-up/consistency efforts to bring all glyphosate labels up to modern standards.”

EPA states that these measures were discussed with glyphosate registrants, who do not oppose the proposed risk mitigation measures outlined in the PID.

The public can submit comments on EPA’s proposed decision at www.regulations.gov in Docket Number EPA-HQ-OPP-2009-0361.  Public comments are due by July 5, 2019.  In addition to the PID, EPA is also posting to the glyphosate docket EPA’s response to comments on glyphosate’s usage and benefits (dated April 18, 2019), EPA’s response to comments on the human health risk assessment (dated April 23, 2018), and EPA’s response to comments on the preliminary ecological risk assessment (dated November 21, 2018). 

This PID was issued shortly after the Agency for Toxic Substances and Disease Registry’s announcement on April 8, 2019, of the opening of a docket on the draft toxicological profile for glyphosate.  84 Fed. Reg. 13922.  ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile.  Comments are due by July 8, 2019.

Commentary

EPA’s PID and related documents, along with ATSDR’s draft profile and the peer review which will follow, can be expected to become part of the larger debate about the potential risks of glyphosate.  In 2017, EPA evaluated the carcinogenic risk of glyphosate, and released its draft human health and ecological risk assessments.  See our December 19, 2017, blog item "EPA Releases Draft Human Health and Ecological Risk Assessments for Glyphosate for Public Comment" for more information. 

EPA’s PID is interesting not only for the conclusions EPA reached following its review of data submitted by registrants in response to a data call-in (DCI) and following the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel’s (SAP) meeting to consider and review scientific issues related to EPA’s evaluation of the carcinogenic potential of glyphosate, but for the issues that remain to be addressed.  Notably, EPA states that it has not considered the petition filed on September 27, 2018, to reduce glyphosate’s tolerance because the petition was filed after the comment period for the human health and ecological risk assessments closed.  Instead, EPA plans to post the petition in the glyphosate docket and address the petition concurrently with the development of the Interim Registration Review Decision.

In addition, EPA has not in the PID or related documents addressed issues regarding its Endangered Species Act (ESA) assessment or its Endocrine Disruptor Screening Program (EDSP) activities.  EPA states it intends to complete an assessment of risk to ESA-listed species prior to completing its final registration review decision for glyphosate, and that it also will make an EDSP determination under Federal Food, Drug, and Cosmetic Act (FFDCA) Section 408(p) before completing its registration review.  EPA also notes that it continues to evaluate risks to pollinators, and that if it determines “that additional pollinator exposure and effects data are necessary to help make a final registration review decision for glyphosate, then the EPA will issue a DCI to obtain these data.”  Although there are significant areas that remain to be resolved, EPA issued the PID “so that it can (1) move forward with aspects of the registration review case that are complete and (2) implement interim risk mitigation.”

More information on glyphosate issues is available on our blog.

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was seeking comments on the experts who are candidates to serve as ad hoc panelists for the review of EPA’s Draft Product Performance Test Guidelines OCSPP 810.3300:  Treatments Topically Applied to Pets to Control Certain Invertebrate Ectoparasitic Pests.  The candidate list is available on EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) website.  Comments on the candidates are due by May 18, 2019, to the Designated Federal Official (DFO) Dr. Suhair Shallal (.(JavaScript must be enabled to view this email address)).  EPA is requesting these comments prior to the FIFRA SAP public in-person meeting scheduled for June 11-14, 2019, from 9:00 a.m. to 5:00 p.m. (EDT), which will review EPA’s proposed guidelines referenced above and the supplemental document Sample Size for Pet Product Studies.  84 Fed. Reg. 15214.  The charge questions to the panel are available here (Charge Questions). 

EPA’s Federal Register notice announcing the meeting states that the meeting will be augmented with additional experts to provide independent scientific advice on the proposed guidelines.  Preceding the in-person meeting, there will be a public half-day preparatory virtual meeting to consider the scope and clarity of the draft charge questions for this peer review.  The in-person meeting on June 11-14, 2019, will be held at the EPA Conference Center, Lobby Level, One Potomac Yard (South Building), 2777 South Crystal Drive in Arlington, Virginia.  The meeting will also be available via webcast.

EPA’s original Product Performance Test Guidelines, OPPTS 810.3300, Treatments to Control Pests of Humans and Pets were published in March 1998.  EPA’s Charge Questions state that “[t]o increase clarity and consistency in efficacy testing and to include current scientific standards, the agency is revising this product performance guideline.”  Further, the proposed guidelines apply to products “in any topically applied formulation, such as a spray, spot-on, collar, shampoo, or dust, if intended to be directly applied to pets for a pesticidal purpose such as to kill, repel, or control ticks, fleas, mosquitoes, and biting flies”; do not apply “to those products exempt from FIFRA Registration under 40 CFR 152.25, products applied to humans or livestock, or product performance testing described in other agency guidelines”; and, in addition to guidance for testing efficacy against fleas, ticks, mosquitoes, and biting flies, the proposed guideline “also includes testing methods for evaluating efficacy under simulated environmental conditions.”

EPA believes the current Draft Guidelines represent the state of the science with regard to efficacy testing for these products; but is still seeking advice and recommendations from the FIFRA SAP on scientific issues related to the Draft Guidelines.  EPA states that it is committed to reducing the use of animals in testing but, at this time, no reliable non-animal alternatives are available to avoid the use of animals for efficacy testing of fleas, ticks, mosquitoes, and biting flies.  EPA is soliciting comment from the FIFRA SAP on approaches that may, in the future, support the replacement or reduction of animal use in efficacy testing of ectoparasitic pests on pets.

Information on attending the meeting in person and via webcast can be found on the FIFRA SAP website.  EPA is requesting that written comments on the documents undergoing peer review be submitted to Docket No. EPA-HQ-OPP-2019-0161 by May 17, 2019, to provide the FIFRA SAP the time necessary to consider and review the written comments.

By Lisa M. Campbell and Heather F. Collins, M.S.

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W.  84 Fed. Reg. 18993.  The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food,” as EPA states was incorrectly implied by the previous regulatory text.  EPA initially proposed this change on August 18, 2017 (82 Fed. Reg. 39399) because it agreed to do so in a settlement agreement with the American Chemistry Council (ACC) after ACC filed a petition for review of the 2013 final rule titled “Data Requirements for Antimicrobial Pesticides” (78 Fed. Reg. 26936 (May 8, 2013)) in the U.S. Court of Appeals for the District of Columbia Circuit.  Specifically, EPA agreed to make this correction to “make the language consistent” with the U.S. Food and Drug Administration’s (FDA) policy set forth in FDA’s “Guidance for Industry, Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Final Guidance. April 2002.”  EPA states that the change is intended to “enhance understanding of the data required to support an antimicrobial pesticide registration and does not alter the burden or costs associated with these previously promulgated requirements” and that it is not establishing “any new data requirements or any other revisions (substantive or otherwise) to existing requirements.”  The final rule will become effective on July 2, 2019.

By Timothy D. Backstrom

On April 19, 2019, the U.S. Circuit Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order following an en banc rehearing in League of United Latin Am. Citizens (LULAC) v. Wheeler, No. 17-71636.  The February 6, 2019, Ninth Circuit decision to grant a U.S. Environmental Protection Agency (EPA) request for rehearing effectively vacated an August 9, 2018, decision in LULAC that had ordered EPA to revoke all tolerances and cancel all registrations for chlorpyrifos.  After rehearing, the en banc panel issued a writ of mandamus directing EPA “to issue, no later than 90 days after the filing of this order, a full and fair decision on LULAC’s objections" to an initial EPA order denying a 2007 petition to revoke all tolerances for chlorpyrifos.  The en banc order states that the court has discretion to construe the Petitioners' opening brief as a request for mandamus relief, even though the Petitioners sought judicial review of EPA's initial denial decision without waiting for EPA to rule on their objections and even though they did not file a petition for mandamus under the applicable procedural rule.  The court then states that “[c]onsidering the history and chronology of this matter and the nature of the claims, we conclude mandamus is appropriate, and we hereby GRANT the Petition for a Writ of Mandamus.”

The court states that “EPA represented that it could issue a final decision with respect to petitioners’ objections within 90 days of an order issued by this court” during oral argument on March 26, 2019.  The en banc ruling, however, does not discuss the jurisdictional issues presented when the Petitioners sought judicial review of EPA's initial denial decision without waiting for EPA to rule on their objections.  Moreover, the ruling does not discuss the substantive dispute concerning EPA's authority to decline to revoke the tolerances and cancel the registrations for chlorpyrifos based on the current administrative record.

Commentary

The procedural questions presented in the LULAC litigation are unusual and reflect a long and contentious history.  EPA’s April 5, 2017, decision to deny a 2007 petition to revoke the tolerances and cancel the registrations for chlorpyrifos came after issuance of a prior writ of mandamus that required EPA to take action on the pending petition, an EPA proposal to revoke the tolerances for chlorpyrifos issued in response to the prior writ, and a subsequent decision by EPA during the early days of the Trump administration to reverse course on the proposal and keep the tolerances in place while EPA completed the registration review process.  The Petitioners in LULAC duly filed objections to the initial denial of their tolerance petition, which was a necessary statutory prerequisite to pursuing further judicial review.  In addition, however, they elected to file for judicial review of EPA's initial denial of their tolerance petition on the same day as they filed their objections.  The Petitioners could not yet reasonably seek mandamus at that time because EPA had not been afforded any time yet to respond to their objections.  Instead, the Petitioners argued that requiring them to follow the normal administrative process would be futile.

Although the Ninth Circuit's decision after en banc rehearing may appear to a procedural victory for EPA, it can also be seen as a solution to the quandary created by the Petitioners' actions and the first court decision.  The Ninth Circuit as a whole was apparently not comfortable with the decision by the first panel that the Petitioners should be allowed to obtain review of a non-final order because waiting for final and reviewable EPA action would be a futility.  Nevertheless, by issuing a new writ of mandamus, the court seems to be sending a clear signal that it will not countenance further delays in EPA’s taking final action on the petition to revoke the chlorpyrifos tolerances.  In the relatively brief time remaining before the court deadline for final action, EPA confronts a significant challenge of ensuring all relevant data have been adequately and appropriately considered, particularly given the many controversies concerning the data that EPA used to support its initial decision to revoke the tolerances. 

More information on the protracted litigation concerning chlorpyrifos is available on our blog under key words chlorpyrifos and ninth circuit.