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, Karin F. Baron, and Margaret R. Graham

On December 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity studies for pesticide formulations.”

For this pilot program, EPA is requesting submission of acute oral and acute inhalation toxicity study data paired with mathematical calculations (GHS Mixtures Equation data) to support the evaluation of pesticide product formulations; instruction for doing so are available on the GHS Equation Pilot Program webpage, and Guidance on the GHS Mixtures Equation is available in the Guidance on the Application of the CLP (Classification, Labeling and Packaging) Criteria.

The program is an interesting approach considering the conceptual differences of risk assessment and hazard determination that exist at the core of  EPA risk approaches and GHS fundamentals.  Also, the definition of the EPA Categories compared to GHS has been problematic for hazard communication applications. 

Mixture calculation tools rely on the availability of data for all components and would only be applicable if the data for each were generated using the same species under similar exposure conditions.  

This pilot program is being developed under EPA’s initiative to develop non-animal alternatives for acute toxicity testing, as well as EPA’s Office of Pesticide Programs’ Strategic Vision for Adopting 21st Century Science Methodologies.  More information on these initiatives can be found on our Pesticide Law and Policy blog under key phrase “toxicity testing.”


 

By Margaret R. Graham

On November 29, 2016, the U.S. Environmental Protection Agency (EPA) announced the issuance of its new guidance for testing pesticides designed to reduce animal testing for acute dermal toxicity for pesticides, Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis, in final.  This guidance was issued as part of the Office of Pesticide Programs’ (OPP) Strategic Vision for implementing the 2007 National Research Council’s report on Toxicity Testing in the 21st Century.

OPP states that it “receives about 200-300 dermal formulation toxicity tests annually, each of which generally use 10 animals per test,” and “[w]e expect this waiver guidance to save 2,500 or more laboratory animals every year.”  Further, as described in OPP Director Jack Housenger’s March 17, 2016, letter to stakeholders, “[t]his new policy represents significant progress toward EPA’s goal of significantly reducing the use of animals in acute effects testing.”

More information on OPP’s Strategic Direction for Adopting 21st Century Science Methodologies is available on EPA’s website and in our blog item EPA’s OPP Releases Guidance Documents Related to Strategic Vision for Adopting 21st Century Science Methodologies.


 

By Lisa M. Campbell and Margaret R. Graham

On March 17, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP), announced in an open letter to stakeholders, that it has developed new tools to “enhance the quality of its risk assessments and risk management decisions and better ensure protection of human health and the environment from pesticide use.”  These tools have been developed as part of EPA’s efforts to implement OPP’s Strategic Vision for Adopting 21st Century Science Methodologies (Strategic Vision) initiative.  As part of this initiative, OPP released two guidance documents:

  1. Final Guidance:  Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies.  OPP states that this guidance will “expand the use of alternative methods for acute toxicity testing” and “describes a transparent, stepwise process for evaluating and implementing alternative testing methods (not using live animals) for acute oral, dermal and inhalation toxicity, along with skin and eye irritation and skin sensitization.”  
  2. Draft Guidance:  Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations. OPP states that this draft guidance “to waive all acute lethality dermal studies for formulated pesticide products” was developed through an analysis “across numerous classes representing conventional pesticides, antimicrobials, and biopesticides [that] examined the utility of the acute dermal toxicity study for formulations in pesticide labelling for end-use products.”  

Comments on the draft guidance for waiving acute dermal toxicity tests are due May 16, 2016.  The National Research Council’s 2007 report, Toxicity Testing in the 21st Century:  A Vision and a Strategy, instigated OPP’s Strategic Vision initiative.  EPA states that these guidance documents are significant steps in the report’s implementation and intended to reduced animal testing. 


 

By Lynn L. Bergeson and Lara A. Hall, M.S., RQAP-GLP

On January 9, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it released a new draft guidance document in its effort to help expand the acceptance of alternative methods for acute toxicity testing. EPA states that the rapid advances in science and continual development of new technologies, it recognizes there is an increasing potential for the use of alternative methods in regulatory risk assessments.

EPA’s goals for alternative testing approaches include:

*  Assessing a broader range and potentially more human-relevant adverse effects;

*  Generating and reviewing data more quickly and less expensively; and

*  Reducing use of laboratory animals in regulatory testing.

The draft guidance, Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies, describes the process for evaluating and implementing alternative methods of testing for acute oral, dermal, and inhalation toxicity, along with skin and eye irritation and skin sensitization. Additionally, there is a discussion of the three major phases of the process, and the implications for reporting information under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2). Successfully putting this process into place will require an open dialogue with stakeholders, other regulatory organizations, and the scientific community.

This draft guidance is one step in the application of OPP’s strategic vision for implementing the 2007 National Research Council report on Toxicity Testing in the 21st Century.

EPA is accepting comments on the draft guidance for 60 days, until March 10, 2015, and should be submitted to Christopher Schlosser at .(JavaScript must be enabled to view this email address) or regular mail at Christopher Schlosser, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., MC: 7509P, Washington, DC 20460.