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 and Margaret R. Graham

On June 14, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances.  82 Fed. Reg. 27254.  EPA states that this test guideline provides “guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA,” and “recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products intended to repel, attract, and/or kill the  common bed bug (Cimex lectularius) in connection with registration of pesticide products under the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].”  EPA states that this guidance applies to products “in any formulation such as a liquid, aerosol, fog, or impregnated fabric, if intended to be applied to have a pesticidal purpose such as to attract, repel, or kill bed bugs.”  This guideline provides appropriate laboratory study designs and methods for evaluating the product performance of pesticides against bed bugs and includes statistical analysis and reporting.

EPA issued the draft guideline on February 14, 2012.  This original document was the subject of FIFRA Scientific Advisory Panel (SAP) review conducted on March 6-7, 2012.  EPA indicates that the final version of the guideline reflects revisions to the original draft based on comments from the SAP and the public.  EPA states that the revisions include the following:

  • Decreasing the number of individuals and replicates tested;
  • Rescinding the recommendation to test each field strain for its resistance ratio; and including a resistance management statement;
  • Clarifying the agency's Good Laboratory Practices (GLP) requirements;
  • Reducing the recommended length of time individuals are exposed to insecticides;
  • Recommending individuals to be observed up to 96 hours after treatment; and
  • Revising the statistical analyses recommendations.

EPA has also placed two other relevant documents in the docket:


 

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

On October 27, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs Policies and Procedures to Manage Public Pesticide Petitions in a Transparent and Efficient Manner” (OIG Report).  OIG evaluated how EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) tracks the receipt, disposition and resolution of public petitions, focusing on OCSPP’s Office of Pesticide Programs (OPP) and its policies and procedures used to ensure consistency and transparency when responding to pesticide-related public petitions.  Although pesticide petitions can be submitted to EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), the Administrative Procedure Act (APA), or any combination of these authorities, OIG’s “At a Glance,” a document summarizing the OIG Report, states that OPP “does not have policies or procedures to ensure transparency when managing public pesticide petitions.” 

OIG’s Report outlines three main areas for improvement in communication, stating that OPP has not effectively communicated with petitioners in the following manner:  (1) acknowledging petition receipt; (2) providing updates about the agency’s work to resolve petitions; and (3) providing petition decisions.  For example, OIG noted that since FIFRA does not set forth requirements for EPA to respond to a petition within a specific timeframe, petitioners in many circumstances filed lawsuits claiming EPA had not responded within a reasonable amount of time as required under the APA.

In addition, OIG states that OPP lacks policies and procedures to manage petitions in a generally efficient or effective manner, specifically noting:  (1) petition documentation is not readily accessible, which was inconsistent with each of the EPA’s Records Management Policies in place during the timeframe of OIG’s review; (2) some petition data are inaccurate, which results in the duplication of work to confirm data; (3) according to OPP, petitions may take weeks to arrive at the correct office for action, because there is no guidance on how to submit petitions directly to OPP; and (4) OPP does not provide guidance to the public on how to submit complete petitions, which results in some petitioners providing supplemental information, therefore increasing the time and resources to reach petition decisions.

The report makes four recommendations of actions that should be taken by the Assistant Administrator for OCSPP that OIG believes will address the issues.  In a memorandum attached to the OIG report, OCSPP agreed with these recommendations, provided corrective actions, and estimated completion dates.  OIG’s recommendations and OCSPP’s Corrective Actions in response to them are as follows:

Recommendation 1:  Develop policies and standard operating procedures to manage public petitions received by OPP in a transparent and efficient manner, which includes direct communication with petitioners by:

  • Providing a letter to the petitioner acknowledging receipt of the petition;
  • Communicating petition decisions to the petitioner in writing; and
  • Providing updates to petitioners about the status and progress of pending petitions.

Corrective Action 1:  OCSPP’s OPP will develop appropriate policies and standard operating procedures (SOP) to manage public petitions received by OPP in a transparent and efficient manner.  The procedures will include the direct communication protocols listed in the OIG’s recommendation.  Estimated date of completion:  October 2016.

Recommendation 2:  Train staff managing public pesticide petitions to adhere to the EPA’s Records Management Policy.

Corrective Action 2:  The SOPs described in Corrective Action 1 will address maintaining appropriate records for covered petitions.  When the SOP is final, OPP will issue a memorandum informing appropriate staff and management of their responsibilities for maintaining these records, and directing the use of the SOPs to meet their responsibilities under the Agency’s Records Management Policy.  Estimated date of completion:  November 2016.

Recommendation 3:  Develop and implement an effective petition tracking system for public pesticide petitions.

Corrective Action 3:  The SOPs described in Corrective Action 1 will include procedures for tracking petitions not covered by certain regulations, including petitions seeking FIFRA and APA rulemaking or cancellation of registrations.  Estimated date of completion:  October 2016.

Recommendation 4: Provide criteria and guidelines for submission of public pesticide petitions that provide sufficient information for EPA review.

Corrective Action 4:  OCSPP commits to develop and post to the Agency Pesticides website criteria and guidelines for public submission of pesticide petitions not covered by 40 CFR § 180.7.  Estimated date of completion:  October 2017.

Commentary

Petitions under FIFRA have been a relatively obscure tool in the past because of some of the issues this report seeks to address.  With no deadline for a response, some petition responses have languished for many years (reportedly up to seven years in some cases).  This partly becomes a “chicken and egg problem;” since it was not clear if and when a response would be forthcoming, it was a relatively unused tool.  Indeed, as OIG’s report points out, only 40 pesticide petitions were submitted between FY2005 and 2014, with almost half (17) still pending.

In recent years, the Obama Administration has made it a point to respond more timely to FIFRA petitions, and as a result, petition filings may have become more attractive to various stakeholders.  One practice that has been a vulnerability for OPP in the past is that not responding whatsoever would more likely lead to a successful “unreasonable delay” suit.  OSCPP’s agreement with the OIG Report recommendations to more clearly state rules of engagement and how to frame expectations about a petition response process appears to be a continuation of the emphasis of EPA leadership on responding to petitions in a timely and more predictable manner.