Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Susan M. Kirsch

On September 30, 2019, the U.S. Environmental Protection Agency (EPA) released an updated Aquatic Life Benchmarks Table for registered pesticides.  The update includes four newly registered pesticides and their degradants as well as new values for more than 30 previously registered pesticides. The benchmarks inform state and local regulators in their interpretation of water quality monitoring data. Waterbodies where benchmarks are exceeded may be prioritized for further investigation.  EPA derived the latest updates from toxicity values from the most recent ecological risk assessments for the registered pesticides as part of the regular registration review. EPA aims to update the table on an annual basis.  The full table and links to source documents for each of the benchmarks are accessible on EPA’s website here.


 

By Kelly N. Garson and Carla N. Hutton

On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food.  EFSA is seeking comments from interested parties on the assessments.  The first assessment considers the chronic effects of multiple pesticides on the thyroid system.  The second looks at acute effects on the nervous system.

EFSA produced the assessments in collaboration with the National Institute for Public Health and the Environment for the Netherlands (RIVM) using monitoring data from 2014, 2015, and 2016.  In approving pesticides for use in the European Union (EU), EFSA establishes a maximum level of pesticide residue (MRL) allowed in food or animal feed.  The MRL considers the cumulative effects of pesticides.  Pesticides may only be placed on the EU market if they have no harmful effects on humans, including cumulative effects.  In the two pilot assessments, EFSA classified pesticides into “cumulative assessment groups” (CAG) based upon whether they produce similar toxic effects in a specific organ or system.  EFSA states that “[t]he overall draft conclusion for both assessments is that consumer risk from dietary cumulative exposure is below the threshold that triggers regulatory action for all the population groups covered.”

In 2020, EFSA will prepare the assessments in final, which will serve to “inform risk managers in the European Commission and Member States who regulate the safe use of pesticides in the EU.”

EFSA will present the assessments at a special stakeholder event in Brussels, Belgium, on October 22, 2019.  The meeting is intended to allow stakeholders with expertise and interest in the area to discuss the technical issues relating to the draft assessments.  Registration for the meeting closes on October 11, 2019.

All comments must be submitted by November 15, 2019.  Comments on the “Cumulative dietary risk characterisation of pesticides that have chronic effects on the thyroid” may be submitted at https://ec.europa.eu/eusurvey/runner/PC_CRA_Thyroid_Sept-2019.  Comments on the “Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system” may be submitted at https://ec.europa.eu/eusurvey/runner/PC_CRA_Nerv_Syst_Sept-2019.

The two draft assessments are available on EFSA’s website.


 

By Heather F. Collins, M.S. and Barbara A. Christianson

On October 2, 2019, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and soliciting public comment on, the draft document entitled “Antimicrobial Performance Evaluation Program (APEP) A (Draft) Risk Based Strategy to Ensure the Effectiveness of Hospital-Level Disinfectants” (draft Strategy).  EPA states that “The draft Strategy provides a framework to ensure that registered hospital-level disinfectants and tuberculocide products continue to meet Agency efficacy standards once they are in the marketplace.”

The draft Strategy was developed in response to EPA’s Office of Inspector General’s (OIG) report “EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants,” which recommends EPA’s Office of Pesticide Programs (OPP) to develop a risk-based strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace.  EPA developed the draft Strategy based on OIG’s recommendations.

EPA states that the draft Strategy uses a risk-based approach “to inform the Agency on the prioritization and selection of hospital-level disinfectants and associated label claims for testing,” and states that its order of priority is as follows:

  1. Product label claims for specific microbes and disease prevalence data;
  2. Evaluation of uncommon label claims and unique product application processes; and
  3. Evaluation of products tested using new and/or recently revised methods.

Additional refinement factors may also be considered such as:

  1. Issues identified during post-registration, product reregistration, and registration review;
  2. Trends observed under the previous testing program (Antimicrobial Testing Program (ATP)); and
  3. Products with high production volumes.

EPA states that it will be considering two options individually or in combination for obtaining samples for testing:  (1) EPA purchase of products in the marketplace; and (2) product samples provided by the registrant.  Several options for allocating efficacy and chemistry testing resources may be utilized individually or in combination; these options include: (1) Office of Pesticide Programs Microbiology Laboratory and the Analytical Chemistry Laboratory; (2) interagency agreements and contracts; (3) third-party verification testing; and (4) registrant testing; and/or Data Call-Ins.

In the Federal Register notice, EPA lists six focus questions on which it is specifically requesting public comment:

  1. Please comment on the proposed risk factors and refinements, their proposed prioritization, their strengths and limitations, and recommendations for other risk factors not considered.
  2. Are the options provided for sample collection suitable for the purpose of the testing program, and if not, what approaches would you suggest to optimize sample collection.  Please provide advantages and disadvantages to your recommendations as appropriate.
  3. Should the Agency and/or stakeholders conduct the laboratory evaluation (formulation chemistry and product efficacy) of disinfectant products? Provide examples to support your opinions and itemize situations where one approach would be more favorable versus the other.
  4. Please comment on the flexibility and feasibility of the example workplan approach (See Appendix A, draft Strategy).
  5. Please comment on the proposed communication strategy to convey test results to registrants and the general public including the preferred frequency of updates.
  6. Please provide suggested routes for resolution of efficacy failures.  Previously, these were addressed by “regulatory fixes” to include retesting, label amendments, etc.

EPA states that the draft Strategy may be of interest to health care/hospital professionals and all entities who have EPA registered antimicrobial products that are available in the marketplace, particularly those with products that make hospital disinfectant claims (e.g., claims against Staphylococcus aureus and Pseudomonas aeruginosa) and other claims for notable public health pests (e.g., Clostridium difficile, methicillin resistant Staphylococcus aureus, Mycobacterium spp.).

All comments on the draft Strategy document must be received by EPA on or before December 2, 2019.  EPA expects to publish the APEP final strategy in 2020 and schedule implementation to begin in 2022. 

Documents referenced in the draft Strategy are available at www.regulations.gov in Docket Number EPA-HQ-OPP-2018-0265.  More information on the APEP is available on our blog.


 

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 Barbara A. Christianson and Heather F. Collins, M.S.

On September 24, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the premises treatment final test guideline, under Series 810, Product Performance Test Guidelines.  The guideline, 810.3500 Premise Treatment, provides recommendations on how to conduct efficacy testing against invertebrate pests in premises, such as cockroaches, ticks, mosquitoes, flies and wasps in connection with registration of pesticide products for use against public health pests.  This guideline does not, however, apply to efficacy testing for treatment of livestock or pets, wide-area mosquito control, structural protection from termites, or bed bug products.

EPA states that “The final guideline clarifies the original guideline published in 1998 based on public comments and recommendations from the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP).”

Revisions to 810.3500 include

  • Clarifying bait product testing;
  • Offering more flexibility in testing design;
  • Updating the replication recommendations based on statistical modeling and ease of obtaining pests; and
  • Refining the statistical analyses recommendations.

Documents pertaining to the revision of the product performance guidelines, including public comment submissions, and the agency’s response to comments are available at www.regulations.gov in Docket Number EPA-HQ-OPP-2017-0693.  More information on test guidelines is available on our blog.


 

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.

Commentary

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 Jason E. Johnston

On September 4, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ Environmental Fate and Effects Division (EFED) announced that the next Environmental Modeling Public Meeting (EMPM) will be held on October 16, 2019.  The EMPM is a semi-annual public forum for EPA, pesticide registrants, and other stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for risk assessments in a regulatory context.

In a press release to the public, EPA indicates that the topics covered at the October meeting will include sources of usage data (relating to the actual application of pesticides, in terms of the quantity applied or units treated); spatial applications of usage data; model parameterization; extrapolation of usage data to fill in gaps; temporal variability of usage; and updates on ongoing topics.  Presentations concerning the incorporation of pesticide usage data into environmental exposure and ecological risk assessments will also be included.

Registration is required. Requests to participate in the meeting must be received on or before September 23, 2019, as noted in the Federal Register notice.


 

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

On August 28, 2019, the U.S. Environmental Protection Agency (EPA) released the Frequently Asked Questions (FAQ) web resource for the Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines.  As of August 28, 2019, efficacy testing should be in compliance with the following Product Performance Test Guidelines published by EPA in February 2018:

  • 810.2000: General Considerations for Testing Public Health Antimicrobial Pesticides, Guide for Efficacy Testing;
  • 810.2100: Sterilants, Sporicides, and Decontaminants, Guide for Efficacy Testing; and
  • 810.2200: Disinfectants for Use on Environmental Surfaces, Guide for Efficacy Testing.

The guidelines provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides against public health microbial pests.  83 Fed. Reg. 8666.  EPA states that these FAQs “provide prompt and transparent guidance to all applicants regarding commonly asked questions concerning the 810 guidelines updated in February 2018.”

With the exception of confirmatory testing (as described under OCSPP guideline 810.2000, Section (B)(7)), all studies initiated on or after August 28, 2019, should be in compliance with the 2018 revised guidelines for testing.  The study initiation date is defined under 40 CFR Part 160.3 as the date the protocol is signed by the study director.  Studies that were initiated prior to the implementation date but submitted to EPA for review after the implementation date may use either the previous 2012 version of the guidelines or the 2018 revised guidelines, as appropriate. EPA states that it “intends to address confirmatory testing through a separate guidance, which will be made available for public comment prior to finalization.”

The FAQs include general testing questions and questions related to each specific guideline.  The appendices to the FAQs include examples of label use-directions for dilutable products, repeat testing guidance with example scenarios, and sample virucidal calculations.

There has been some concern in the regulated community regarding the need for clarification on the guidelines before they became effective.  EPA’s new FAQs are intended to provide these clarifications, but the timing of their issuance may be of concern to some.  Also of interest is whether additional FAQs will be issued in the future.


 

By Lynn L. Bergeson and Carla N. Hutton

On August 26, 2019, the National Institute of Environmental Health Sciences (NIEHS) announced that the results of an NIEHS-funded study show that graphene could provide alternatives to chemicals in insect repellant and protective clothing.  The study, “Mosquito Bite Prevention through Graphene Barrier Layers,” was published in the Proceedings of the National Academy of Sciences.  According to the abstract, the researchers hypothesized that graphene films may provide mosquito bite protection for light, fiber-based fabrics.  The researchers investigated the fundamental interactions between graphene-based films and the mosquito species Aedes aegypti through a combination of live mosquito experiments, needle penetration force measurements, and mathematical modeling of mechanical puncture phenomena.  The abstract states that “the results show that graphene or graphene oxide nanosheet films in the dry state are highly effective at suppressing mosquito biting behavior on live human skin.  Surprisingly, behavioral assays indicate that the primary mechanism is not mechanical puncture resistance, but rather interference with host chemosensing.”  The researchers propose that the interference is “a molecular barrier effect that prevents Aedes from detecting skin-associated molecular attractants trapped beneath the graphene films and thus prevents the initiation of biting behavior.”  According to the abstract, placing water or human sweat on the external film surface circumvents the molecular barrier effect.  In this scenario, the abstract states, “pristine graphene films continue to protect through puncture resistance -- a mechanical barrier effect -- while graphene oxide films absorb the water and convert to mechanically soft hydrogels that become nonprotective.”


 

By Jason E. Johnston

On August 27, 2019, the U.S. Environmental Protection Agency (EPA) published a proposed rule in the Federal Register that makes several changes to the current “Crop Group 19:  Herbs and Spices Group.”  This latest proposal, which is the fifth in a series of crop group amendments, was created in response to a petition developed by the International Crop Group Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4 (IR-4).  The goals of the crop group amendment program include reducing regulatory burden, coordination with international definitions, and removing barriers to trade.  The major components of this proposal are revision of the commodity definition for marjoram; addition of three new commodity definitions for basil, edible flowers, and mint; and replacement of the existing “Crop Group 19:  Herbs and Spices Group” with two new crop groups, “Crop Group 25:  Herb Group” and “Crop Group 26:  Spice Group.”  Recognizing that the existing combined Crop Group 19 Herb and Spice Group has limited the establishment of crop group tolerances, EPA has proposed creating the two new separate crop groups to benefit herb and spice growers.  The new crop groups are quite large, containing 317 herb commodities in Crop Group 25 and 166 spice commodities in Crop Group 26.  The proposal specifies all commodities in the new crop groups (and the subgroups therein, i.e., 25A and 25B for fresh herbs and dried herbs) and provides updated representative commodities for each crop group and subgroup.

The Federal Register notice requests that comments on the proposal be submitted on or before October 28, 2019.  The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2006-0766.


 
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