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 Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a new web portal that is available to the public to search for EPA guidance documents.  The EPA Guidance Portal (Portal) was created under Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents,” where agencies are to develop a central web portal for the public to review active guidance documents and the ability to request for modification or withdrawal of the guidance documents. 

Information available about each guidance document listed on the Portal includes:

  • A concise name for the guidance document;
  • The date on which the guidance document was issued;
  • The date on which the guidance document was posted to the web portal
  • An agency unique identifier;
  • A hyperlink to the guidance document;
  • The general topic addressed by the guidance document; and
  • A summary of the guidance documents’ content.

EPA states that the “guidance documents lack the force and effect of law, unless expressly authorized by statute or incorporated into a contract” and EPA “may not cite, use, or rely on any guidance that is not posted on this web area, except to establish historical facts.”

The portal is broken down by office, including regional offices:

  • Office of Air and Radiation (OAR)
  • Office of Chemical Safety and Pollution Prevention (OCSPP)
  • Office of Enforcement and Compliance Assurance (OECA)
  • Office of General Counsel (OGC)
  • Office of International and Tribal Affairs (OITA)
  • Office of Land and Emergency Management (OLEM)
  • Office of Mission Support (OMS)
  • Office of Research and Development (ORD)
  • Office of Water (OW)
  • All EPA Regional offices

Currently, there are a total of 1,735 guidance documents listed under OCSPP.  Within the 1,735 documents, 117 appear to be specific to FIFRA. Examples of guidance documents included in the portal are:

  • Inert Ingredients Overview and Guidance;
  • Exporting Unregistered Pesticides: Foreign Purchaser Acknowledgement Statements;
  • EPA's Regulation of Biotechnology for Use in Pest Management;
  • CPARD USER GUIDE: For State Lead Agency (SLA) and Tribal Representatives with Certification Plans (CPs);
  • Frequent Questions for the 2018 Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines;
  • Pesticide Registration Manual;
  • Guidance on FIFRA 24(c) Registrations;
  • Design for the Environment Logo for Antimicrobial Pesticide Products;
  • Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants;
  • Structured Product Labeling (SPL) Draft Implementation Guide with Validation Procedures and User Guide;
  • Reregistration and Other Review Programs Predating Pesticide Registration Review;
  • FIFRA Pesticides Export Policy: Questions & Answers Issue: Research and Development Pesticides; Active Ingredient Concentrations;
  • State FIFRA Issues, Research, and Evaluation Group Final Guidance for State Lead Agencies for the Development and Implementation of Managed Pollinator Protection Plans; and
  • E-FAST, Down the Drain Assessment Model.

Under OECA, there are six documents specific to FIFRA.  The guidance documents included in this portal are:

  • Compliance Advisory: High Number of Complaints Related to Alleged Misuse of Dicamba Raises Concerns;
  • Good Laboratory Practices - Questions and Answers;
  • EPA and Association of American Pesticide Control Officials (AAPCO) Advisory Notice on Pesticide-related E-Commerce;
  • Fact Sheet on Pesticides Sales in E-Commerce;
  • Documents with Questions and Answers on FIFRA Pesticides Export Policy; and
  • FIFRA Pesticide Export Policy: Interpretive Guidance: Multilingual Labeling.

Of note, the portal sets forth an option for petitioning EPA to modify or withdraw a guidance document from the Portal by completing an online form.  The required information to submit using the online form is name, email address, unique identifier of the guidance document, the office and/or region, and comments related to the withdrawal or modification of the guidance document.


 

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.