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By Lisa M. Campbell and Timothy D. Backstrom

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) submitted a status report in the Ninth Circuit Court of Appeals case concerning a petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke the tolerances and cancel the registrations for chlorpyrifos.  The Court of Appeals issued an order on December 10, 2015, requiring EPA to take final action concerning the PANNA and NRDC petition no later than December 30, 2016.  To comply with an earlier order, EPA issued a proposed rule to revoke the tolerances for chlorpyrifos before it could complete a refined drinking water assessment or propose a new “point of departure” for chlorpyrifos based on biomonitoring data from an epidemiological study. 

EPA’s status report states that it has made “significant progress” towards meeting the December 30, 2016, deadline, but “extraordinary circumstances exist that make it impracticable for the Agency to meet the Court’s deadline.”  Based on these extraordinary circumstances, EPA has requested a six-month extension for final action on the petition. 

EPA notes that a proposed new point of departure was presented to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP), but was not favorably received.  At the same time, EPA states that the SAP “raised concerns about the approach EPA adopted in the Proposed Rule, namely that the continued use of acetylcholinesterase inhibition as the point of departure may not be sufficiently health protective.”  EPA infers that the SAP may be disposed to recommend a “hybrid approach,” but the written SAP report will not be issued until the end of July, 2016.

EPA states that it had planned to seek public comment on its refined drinking water assessment and new point of departure for chlorpyrifos immediately after the SAP meeting.  EPA now believes that it would be best to obtain the final SAP report before deciding how to establish a point of departure.  Accordingly, EPA proposes to seek comment on its refined drinking water analysis and analysis of the epidemiological data by early Fall 2016, and to take final action on the PANNA and NRDC petition by June 30, 2017.

Commentary

EPA expects that the refined drinking water assessment for chlorpyrifos will allow “tailored risk mitigation” that could eliminate one basis for the proposed revocation of chlorpyrifos tolerances.  In contrast, EPA’s concerns about the potential neurodevelopmental effects of chlorpyrifos may not be as readily addressed by risk mitigation.  If EPA decides either to retain the Food Quality Protection Act (FQPA) 10X safety factor for chlorpyrifos based on purported neurodevelopmental effects observed in epidemiological studies, or to adopt some “hybrid” risk assessment methodology for neurodevelopmental effects in response to the SAP recommendations, debate on the merits of doing so will likely be strong.  The status report does not appear to suggest that EPA is currently considering revisiting its general views on the chlorpyrifos epidemiological data; if EPA is not doing so, considerable continued debate on this issue is also likely.


 

By Lisa M. Campbell and Sheryl L. Dolan                                

On September 8, 2015, the Environmental Protection Agency (EPA) announced that it will host a Disinfection Hierarchy Stakeholder Workshop and corresponding webinar on October 7, 2015, from 8:30 a.m. - 5:00 p.m. (EDT).  The “disinfection hierarchy” describes the descending order of susceptibility of classes of microorganisms to antimicrobial chemicals.  Demonstrated efficacy against a representative organism would support a manufacturer’s claims against more susceptible (easier to kill) organisms, potentially eliminating the need to test against, or alternatively, to submit data for each individual organism.  EPA has relied on the disinfection hierarchy concept historically.  For example, EPA relied on the disinfection hierarchy concept to take timely action to address the H1N1 virus in 2009, by allowing reliance on Influenza A data.  More recently, EPA states that it agreed that use of a registered hospital disinfectant with a label claim for use against a non-enveloped virus was appropriate for disinfection of surfaces contaminated with the ebola virus.

EPA is considering expanding its use of disinfection hierarchy concepts for the registration of public health antimicrobial pesticides.  EPA states that its goals for expanding the use of these concepts are:

  1. To provide guidance to health care officials and the public on the most effective type of registered antimicrobial products on the market to combat an emerging pathogen; and
  2. To increase the efficiency of, and lower the costs associated with, registering antimicrobial pesticides, while maintaining a high level of public health protection.

According to the announcement, the workshop will focus on the scientific merits of the hierarchy, and will provide a forum for stakeholders to discuss:

  • The current science on which disinfection hierarchy concepts are based;
  • Scientific issues that may present challenges for use of the disinfection hierarchy in registering antimicrobial pesticide products; and
  • Ideas on how to address these issues.

A panel of approximately 15 stakeholders from the public sector, academia, and industry will address a series of charge questions, followed by the opportunity for audience questions or comments.  The current list of panel members is available here.

EPA’s Office of Pesticide Programs has developed a draft white paper on disinfection hierarchy concepts that will serve as the basis for discussion during the workshop.  The draft white paper includes questions on which EPA states it is seeking input.  The agenda for the workshop is available here

More information on disinfection hierarchy is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum Summary of Ninth Antimicrobial Workshop.


 
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