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 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 Lisa M. Campbell and James V. Aidala

Recently, the results of a three-year University of Maryland study assessing the potential chronic sublethal effects on whole honey bee colonies of a diet containing imidacloprid, an insecticide that belongs to the neonicotinoid class of chemicals, at 5, 20, and 100 μg/kg over multiple brood cycles have been released. The study, Assessment of Chronic Sublethal Effects of Imidacloprid on Honey Bee Colony Health, funded primarily by a Cooperative Agreement with the U.S. Department of Agriculture (USDA) Agricultural Research Service (ARS) Bee Research Laboratory, concludes that: “chronic exposure to imidacloprid at the higher range of field doses…could cause negative impacts on honey bee colony health and reduced overwintering success, but the most likely encountered high range of field doses relevant for seed-treated crops (5 μg/kg) had negligible effects on colony health and are unlikely a sole cause of colony declines.”

This study examines a number of recent controversial issues behind the bee health discussion, including: whether pesticides have an impact when one examines exposure levels approximating actual field condition exposure levels and whether the pesticide use has a substantial impact on hive and hive survival (and not just an impact on individual bees). The study results will likely be used by others to help evaluate the meaning of many of the studies various researchers have conducted over the past three to five years that are often cited in the media. Critics of these other studies have noted the “excessive” amounts of the pesticides used in the research protocol. They have also noted that, as insecticides, the neonicotinoid products are designed to kill insects, and since bees are insects, some bee mortality can be expected if exposed to the material. The University of Maryland study sought to emulate more realistic field conditions in the study protocol. Its conclusion, that there were “negligible effects on colony health” over a three-year period, is significant.

Also fairly recently, the Congressional Research Service (CRS) issued a report on bee health and pesticides, Bee Health: the Role of Pesticides. The report states that although the report focuses on bee exposure to pesticides, this does not imply that pesticides have a higher influence on the health and wellness of bees than other identified factors. The report states: “Although pesticides have been shown to damage bee health, it is unclear whether the level of harm is sufficient to attribute pesticides as the single or as the major cause of honey bee population declines.” The report further states that there is “the possibility that bees are being negatively affected by cumulative, multiple exposures and/or the interactive effects of several of these factors.” The CRS report refers to conclusions outlined in the USDA and the U.S. Environmental Protection Agency’s (EPA) joint Report on the National Stakeholders Conference on Honey Bee Health, including that “no research conclusively points to one single cause for the large number of honey bee deaths.”

The report details several actions the federal government is taking to promote the health of honey bees and other pollinators:

* The establishment of a Pollinator Health Task Force co-chaired by USDA and EPA that will “focus federal efforts on understanding, preventing, and recovering from pollinator losses.”

* EPA’s pesticide registration review of all neonicotinoid insecticides, and EPA’s development of new pesticide labels that prohibit use of some neonicotinoid pesticide products where bees are present, including products containing imidacloprid, dinotefuran, clothianidin, thiamethoxam, tolfenpyrad, and cyantraniliprole.

* The U.S. Fish and Wildlife Service (FWS) will be phasing out the use of neonicotinoid pesticides in all of its wildlife refuges as well as the feeding of genetically engineered crops to wildlife by January 2016.
 


 

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.


 

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.
 


 
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