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 Lynn L. Bergeson, Oscar Hernandez, Ph.D., Lara A. Hall, MS, RQAP-GLP, and Margaret R. Graham

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA).  The notice states that these test guidelines “serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions,” and they “provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA.”  The test guidelines will be accessible through EPA Docket ID Numbers EPA-HQ-OPPT-2009-0150 through EPAHQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576 on www.regulations.gov.

The changes to test guidelines are varied.  Some of the changes include:

  • Simple cosmetic changes, e.g., presentation of test conditions, test validity criteria, and equations for calculating response measurements;
  • Housekeeping changes, e.g., the addition of final versions of draft guidelines that had not been prepared in final yet;
  • The addition of a limit test option to several acute invertebrate toxicity tests;
  • Changes from “cut off” dosages in existing guidelines to limit concentrations and a change in the limit concentration for industrial chemicals from “1,000 milligrams/liter (mg/L)” to “100 mg/L” for acute toxicity tests and “10 mg/L” for chronic tests; and
  • Changes to terminology, e.g., to clarify 10-day versus acute exposures for sediment-dwelling invertebrate toxicity tests and saltwater versus marine conditions.

The addition of a limit test option aligns well with the new TSCA mandate to reduce vertebrate testing as a matter of federal policy.  EPA notes that certain guidelines were not issued in final, but remain available for reference as draft guidelines.  In that certain ecological effects guidelines relate to guidelines already developed for the Endocrine Disruptor Screening Program (EDSP), EPA notes that it will consider test design elements from the relevant EDSP guidelines in the development of OSCPP 850 series guidelines.


 

By Lynn L. Bergeson, Lisa M. Campbell, and Lisa R. Burchi

On June 29, 2016, the U.S. District Court for the Northern District of California (Court) issued an opinion dismissing the complaint and denying the motion for summary judgment of the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (CEH, et al.), and granting the U.S. Environmental Protection Agency’s (EPA) motion for summary judgment. 

Background

This case stems from a petition filed in 2006 requesting EPA to initiate a rulemaking to require the labeling of 371 inert ingredients in pesticides.  EPA issued an Advance Notice of Proposed Rulemaking (ANPR) in 2009, but did not proceed further with a rulemaking.  CEH, et al. filed a second lawsuit in March 2014, alleging that EPA’s failure to complete the rulemaking process started by the ANPR violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Administrative Procedure Act (APA).  In May 2014, EPA responded by amending its response to the 2006 petition to explain that it had decided to pursue an approach different from requiring mandatory disclosure on the pesticide label of a hazardous inert ingredient.  EPA announced that it would instead pursue a “‘combination of regulatory and focused non-regulatory actions that do not rely on rulemaking’ including potentially:  (1) removing over ninety chemicals from the list of inert ingredients approved for pesticide use; (2) evaluating the effect of the 371 inert ingredients on food crops; (3) directing pesticide registrants to modify their registrations by replacing hazardous inert ingredients with less hazardous ones; and (4) seeking to expand the existing voluntary disclosure program.”  The Court granted EPA’s motion for judgment on the pleadings in the March 2014 lawsuit, “finding that there was no further relief that [the Court] could offer to plaintiffs and that the action was moot.”

CEH, et al.’s complaint in the case at issue challenges EPA’s May 2014 denial of its rulemaking petition, alleging that under FIFRA and APA, EPA’s decision to deny the rulemaking petition was “arbitrary, capricious, and contrary to [FIFRA].”  CEH, et al. requested the court to “set aside the denial and to remand the decision to the EPA to consider ‘the evidence weighing in favor of disclosure of inert pesticide ingredients.’”  Background on the complaint is available in our blog item NGOs File Suit Regarding Inert Ingredients’ Disclosure.

In support of its ruling to grant EPA’s motion for summary judgment, the court stated:  “EPA is not mandated to require disclosure of the inert ingredients at issue,” since “[p]laintiffs have provided no persuasive evidence that EPA’s decision to forego rulemaking is inconsistent with the ANPR.”  The Court noted, for example, that EPA’s regulation governing disclosure of inert ingredients, 40 C.F.R. § 156.10(g)(7), states that “[t]he Administrator may require the name of any inert ingredient(s) to be listed in the ingredient statement if he determines that such ingredient(s) may pose a hazard to man or the environment”; this allows EPA to require applicants to list hazardous inert ingredients, but “does not mandate it.”  In addition, the Court found that EPA’s decision “that a series of non-rule actions would achieve a greater reduction in the risks from the use of pesticides and could be implemented in a timelier manner,” was not arbitrary or capricious, even if it “conceivably offers a less effective remedy than what plaintiffs sought.”

Discussion

The decision supports EPA’s discretionary authority to determine how to best manage and address any inert ingredients that may cause unreasonable adverse effects on the environment.  EPA has set forth several actions that it is taking or intends to take in lieu of mandatory label disclosure of inert ingredients.  For example, on October 22, 2014, EPA proposed to remove 72 chemical substances from the current listing of inert ingredients approved for use in pesticide products because the inert ingredients are no longer used in any registered pesticide product.  Registrants of any pesticides containing a potentially hazardous inert ingredient should monitor how EPA’s regulatory and focused non-regulatory actions affect such substances.  


 

By Lisa M. Campbell and Lisa R. Burchi

On May 10, 2016, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued guidelines on highly hazardous pesticides (HHP) (Guidelines) as part of the International Code of Conduct on Pesticide Management (Code of Conduct).  HHPs are defined in the Guidelines as “pesticides that are acknowledged to present particularly high levels of acute or chronic hazards to health or environment according to internationally accepted classification systems such as WHO or GHS or their listing in relevant binding international agreements or conventions.  In addition, pesticides that appear to cause severe or irreversible harm to health or the environment under conditions of use in a country may be considered to be and treated as highly hazardous.”  The Guidelines state that they are “intended to help national or regional pesticide regulators with limited resources to design a process to address HHPs that follows the three steps of identification, assessment and mitigation,” and they aim “to underscore the importance of adequate pesticide legislation, and risk and needs assessment as part of the registration process.”

Background

In 2006, the FAO Council endorsed FAO participation in the Strategic Approach to International Chemicals Management (SAICM) and noted that the International Code of Conduct on the Distribution and Use of Pesticides was to be considered an important element of the SAICM process.  The Council “suggested that the activities of FAO could include pesticide risk reduction, including the progressive banning of Highly Hazardous Pesticides (HHPs).”  The Joint FAO/WHO Meeting on Pesticide Management (JMPM) developed the criteria that defines HHPs when the Code of Conduct was revised in 2013.

In 2015, SAICM’s International Conference on Chemicals Management adopted a resolution recognizing “HHPs as an issue of concern and called for concerted action to address HHPs, with emphasis on promoting agro-ecologically based alternatives and strengthening national regulatory capacity to conduct risk assessment and risk management.”

2016 HHP Guidelines

The Guidelines include information on:

Identification of HHPs:  The Guidelines set forth the following eight criteria for identifying HHPs (i.e., HHPs should be defined as having one or more of the following characteristics):

  • Criterion 1: Pesticide formulations that meet the criteria of classes Ia or Ib of the WHO Recommended Classification of Pesticides by Hazard;
  • Criterion 2: Pesticide active ingredients and their formulations that meet the criteria of carcinogenicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS);
  • Criterion 3: Pesticide active ingredients and their formulations that meet the criteria of mutagenicity Categories 1A and 1B of the GHS;  
  • Criterion 4: Pesticide active ingredients and their formulations that meet the criteria of reproductive toxicity Categories 1A and 1B of the GHS; 
  • Criterion 5: Pesticide active ingredients listed by the Stockholm Convention in its Annexes A and B, and those meeting all the criteria in paragraph 1 of Annex D of the Convention;
  • Criterion 6: Pesticide active ingredients and formulations listed by the Rotterdam Convention in its Annex III;
  • Criterion 7: Pesticides listed under the Montreal Protocol; or
  • Criterion 8: Pesticide active ingredients and formulations that have shown a high incidence of severe or irreversible adverse effects on human health or the environment.

Assessment: The Guidelines set forth guidance to assess the risks to human health and the environment under the conditions of use, as well as the needs for the products.  FAO developed a Pesticide Registration Toolkit (Toolkit) to assists registrars in the evaluation for authorization of pesticides and review of registered pesticides. The Guidelines state:

  • The Toolkit can best be considered as a web-based registration handbook intended for day-to-day use by pesticide registrars.  It supports and facilitates informed decision-making by registrars, but is not an automated system that suggests decisions for registrars.
  • Registrars can use the Toolkit to support several of their regular tasks. With respect to highly hazardous pesticides (HHPs), the Toolkit can be used as an aid to implement the three steps described in these guidelines:  Identification, Assessment and Mitigation.

Mitigation:  The Guidelines provide options for mitigating risks of HHPs currently in use, and for possible new HHPs.  Specifically, the Guidelines state the “main lines for risk mitigation are ending, restricting or changing formulations or uses.  Selection of the most appropriate option will vary from case to case and depend on risk levels and needs, but also on policies and adequacy of institutional infrastructure for pesticide management.”

Planning:  The Guidelines set forth steps for designing an action plan to address HHPs.  FAO and WHO note the importance of effective communication and involvement with stakeholders in the pesticide supply chain (e.g., growers, food retailers, consumers) in developing an action plan.

Prevention:  The Guidelines discuss elements to prevent future problems with HHPs, particularly possible revision of the registration system, strengthened enforcement, extensive training, and the installation of surveillance systems.

Discussion

Concerns have been raised previously regarding any potential for efforts by WHO and FAO to eliminate HHPs to be based purely on hazard without consideration of risk.  The Guidelines include discussions related to the steps to “assess the risks that [HHP] products are posing to human health and the environment under the conditions of use in that country and to review the needs for these products, taking into consideration available alternatives.”  Whether this provision sufficiently addresses past concerns should be examined.

Companies will need to review the Guidelines, and the Toolkit, to determine how their products would be identified, assessed, prioritized, and managed under the Guidelines and Toolkit.  While some elements of the Guidelines are relatively straight-forward, others may be more subjective and thus much more controversial, such as, for example, the HHP criteria that a pesticide active ingredient or formulation has “shown a high incidence of severe or irreversible adverse effects on human health or the environment.”  In addition, the Toolkit is under development, meaning that several modules are not completed and that webpages may not yet be completed.  It, thus, will be important to continue to monitor how the Guidelines and Toolkit are developed and applied. 

 


 

By Lisa M. Campbell and Lisa R. Burchi

On November 6, 2015, the U.S. Environmental Protection Agency (EPA) announced that it has a new webpage that compiles information about secondary containers and service containers for pesticides.  Secondary and service containers are containers that are used by the pesticide industry as part of the process of applying pesticides, not for further sale or distribution.  EPA states that the website combines and replaces information previously found on the Labeling Questions and Answers page and in the Label Review Manual, and addresses frequently asked questions.  The announcement states “this is not new guidance, but the EPA hopes this new resource will make information on secondary and service containers easier to find and will lead to improved handling of these containers.”  According to EPA, the webpage is designed to help pesticide registrants and applicators:

  • Understand EPA’s definition of secondary and service containers;
  • Learn about EPA’s recommendations for good management practices when labeling secondary and service containers; and
  • Learn how to properly identify the contents of a secondary or service container, including when the pesticide is diluted.

Although registrants are not required to submit labels to secondary containers to EPA for review, EPA provides the following Q&A for when EPA will approve such labels if submitted to EPA for review:

      Q:  If a registrant wishes to submit and have EPA review the secondary container label, what does EPA require?

      A:  As it isn't required that a secondary container label be submitted, there are no requirements per se.  EPA will review them on a case-by-case basis and would be likely to accept them if:

  • The EPA-approved master label includes directions for diluting the product.
  • The secondary container label is submitted as part of the master label.
  • The master label bears a statement that the secondary container must be labeled as presented on the master label (e.g., “When this product is diluted in accordance with the directions on this label, the dilution container must bear the following statements:”)
  • The secondary container contains a statement prohibiting further sale or distribution.
  • The secondary container may have reduced precautionary language (if supported by dilution-specific acute toxicity data), but not a reduced signal word.

Requirements governing secondary containers are often a source of questions within the regulated community; many may find EPA’s new website a useful source of information on this topic.


 

By Lara A. Hall, MS, RQAP-GLP, Jane S. Vergnes, Ph.D., DABT®, and Lisa M. Campbell
 
On Tuesday, August 25, 2015, in a Federal Register notice, the U.S. Environmental Protection Agency (EPA) announced the addition of three Office of Chemical Safety and Pollution Prevention (OCSPP) final test guidelines to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines,” as follows:

These test guidelines are part of a series of test guidelines established by OCSPP for use in developing data on potentially adverse effects of pesticides and chemical substances on the endocrine system for submission to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C. 346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.).  These final guidelines have been revised based on public comments received following the release of draft test guidelines in January 2015, existing EPA test guidelines, and concurrent Organisation for Economic Co-operation and Development (OECD) test guidelines
 
EPA worked with OECD to harmonize test guidelines for MEOGRT and LAGDA.  The specific OECD Guidelines for the Testing of Chemicals, Section 2, that apply to MEOGRT and LAGDA, are available here.  Substantive changes reflected in the final OCSPP MEOGRT and LAGDA test guidelines include:
 
1.         The test will end following hatching of the second generation (F2) offspring.  The option for extending the MEOGRT through reproduction by the F2 generation has been removed from the final test guideline pending additional data. This is consistent with the decision made in the draft OECD test guideline for MEOGRT. This test guideline may be updated as new information and data are considered. For example, guidance on extending the F2 generation through reproduction may be potentially useful under certain circumstances (e.g., chemicals with high bioconcentration potential or indications of trans-generational effects in other taxa).
 
2.         The mean water temperature over the duration of the MEOGRT has been changed to 25 ± 2 °C to be consistent with the analogous OECD test guideline.
 
3.         The LAGDA developmental stage terminology has been clarified to avoid confusion with what is meant by complete metamorphosis.
 
4.         An effort was made to clarify and provide more explicit guidance as to what specific histopathology is appropriate based on the results of the study, e.g., the conduct of liver and kidney histopathology in the MEOGRT and LAGDA test guidelines with respect to overt toxicity.
 
5.         The rationale for use of solvent control only, dilution water control only, or pooled controls in the statistical analyses for the MEOGRT and LAGDA was clarified.
 
6.         The guidelines have been modified to address commenters' concerns that they be more flexible and less prescriptive. Examples have been provided as appropriate to add clarity. 
 
The JQTT draft test guideline (OCSPP 890.2100) was revised to address comments provided by the public, the draft OECD test guideline for the avian two-generation toxicity test in the Japanese quail, as well as the existing EPA test guidelines and OECD test guidelines for avian one-generation toxicity tests.
 
EPA revised the terminology, procedures, endpoints measured, figures, tables, and appendices in the JQTT test guideline to clarify specific points raised by public commenters, and to address commenters' concerns that they be more flexible and less prescriptive, as follows:

1.         The revised test guideline includes fewer endpoints.  For example, the revisions eliminated behavioral endpoints to reduce the overall numbers of birds required for the study; eliminated endpoints that are difficult to obtain (i.e., hormone levels measured in embryo blood samples); and eliminated redundant endpoints and statistical analyses.
 
2.         For clarity, the test terminates with measurement of the 14-day survival of the F2 generation chicks.  This is the minimum length of the study necessary to evaluate and measure a chemical's effect on the first generation’s (F1) reproductive performance.  If delayed reproduction is observed in F1 birds, a decision to extend the F2 generation may be made.  If extended, the test should be terminated when F2 birds are approximately 6 weeks old, when 90 percent of control animals have reached sexual maturity.  The decision to limit the length of the JQTT is consistent with EPA's efforts to move to extended one-generation reproduction test protocols for Tier 2 testing rather than require multigenerational studies.  Extended one-generation reproduction tests are scientifically justified in many cases, reduce the use of animals in testing, and reduce costs.

Electronic access to OCSPP test methods and guidelines is available here.
 
The release of these final testing guidelines marks another significant step in the overall Endocrine Disruptor Screening Program (EDSP), making way for the anticipated Tier 2 testing phase with the List 1 chemicals.  EPA recently released Tier 1 weight-of-evidence assessments for List 1 substances in the EDSP and registrants are now receiving the associated data evaluation records (DER) for the Tier 1 screening studies.  The purpose of the Tier 1 screening was to identify potential interactions with three hormonal pathways (estrogen, androgen and thyroid) in the endocrine system.  As a result of the  potential interactions with one or more of these pathways observed, EPA has recommended Tier 2, multigenerational studies across various species for 18 of the 52 List 1 chemicals, including the MEOGRTS (13 chemicals) and LAGDA (5 chemicals).  Test Orders for Tier 2 studies will be issued following completion of the Information Collection Request (ICR) process within the Office of Management and Budget (OMB).  The public review and comment period for this ICR concludes on September 2, 2015, with a response from OMB to follow in early October 2015.  In the interim, registrants are closely reviewing their respective assessments and DERs, and industry groups are assessing the approach employed by EPA in these Tier 1 assessments, including but not limited to, the statistical reanalysis of study data and conclusions drawn by EPA.


 

By Sheryl L. Dolan and Henry M. Jacoby, M.S.

 

On June 17, 2015, the Environmental Protection Agency (EPA) published a notice announcing the availability for comment of three draft revised 810 series test guidelines developed by the Office of Chemical Safety and Pollution Prevention (OCSPP).  These test guidelines will provide updated guidance on antimicrobial efficacy testing to the regulated community.

 

EPA states that when these guidelines were published in final in 2012, they drew criticism as confusing and inaccurate.  EPA states that the guidelines have been reformatted, corrected and updated to reflect policy and technical changes during the intervening three years.  The draft revised guidelines include expanded upfront summaries and appear more accessible with bolded titles for sections and subsections.  Recent policy and technical changes that are incorporated into the draft revised test guideline include the following:  a requirement that certain product efficacy testing must be conducted at the active ingredient’s (AI) lower certified limit (LCL) concentration; and the updated test methodology for Clostridium difficile (C. diff).  In 2013, EPA specified in separate guidance that specific efficacy testing must be conducted on products with the AI at the LCL concentration.  In 2014, EPA announced the revised C. diff test methodology.  The substance of these two guidance documents is now incorporated into the draft revised test guideline. 

 

EPA is inviting public comment on the three draft revised 810 Series test guidelines, available at the below links:

 

 

Comments must be received on or before August 17, 2015.

 


 

By Lynn L. Bergeson

The Environmental Law Institute will host a complimentary webinar, “Neonicotinoids and Colony Collapse Disorder: Regulating and Product Stewardship in the Face of Uncertainty,” on Tuesday, February 24, 2015, from 12:00 p.m. - 1:30 p.m. (EST). The webinar is open to the public but registration is required.

Fraught with both scientific uncertainty and the potential for significant agricultural and ecological consequences, the debate over neonicotinoid regulation is at the forefront of environmental policy discussions, raising important issues about regulation and product stewardship in the face of scientific uncertainty paired with significant risk. This webinar will address the current questions regarding neonicotinoid pesticides and their regulation, including:

          ■ What is the state of the science around the role neonicotinoids may play in pollinator decline?

          ■ What other factors may be significant causes?

          ■ What should be the approach of regulators and company product stewards given the scientific uncertainty?

Bergeson & Campbell, P.C.’s (B&C®) Senior Government Consultant James V. Aidala will moderate the webinar. Mr. Aidala, former Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now the Office of Chemical Safety and Pollution Prevention) is a leading expert on the policy and regulatory issues associated with the confluence of pollinators and pesticides. He writes and speaks frequently on the subject; recent works include “Presidents and Pesticides: What’s Up with the Presidential Memo on Pollinators?,” “Neonicotinoids: EPA’s New Get-Tough Measures,” and the keynote address at the 2014 Spring Board Meeting of the Association of American Pesticide Control Officials. Mr. Aidala is also a regular contributor to B&C’s Pesticide Law and Policy Blog.
 


 

By Lynn L. Bergeson

On January 30, 2015, the U.S. Environmental Protection Agency (EPA) released drafts of new guidelines for animal testing of the endocrine disrupting effects of pesticides and other chemicals. The proposed guidelines outline how scientists can use Japanese quail, medaka fish, or amphibian larvae to conduct various endocrine tests. EPA reportedly also considered including mysid crustaceans on its list of non-mammals acceptable to use in endocrine testing, but did not because the data were not deemed "fully reliable" across all endpoints. Comments are due March 31, 2015.


 
 < 1 2 3