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 Timothy D. Backstrom

On February 10, 2016, the U.S. Environmental Protection Agency (EPA) announced it was initiating an external peer review of the updated draft protocol for testing the antimicrobial efficacy of copper-containing surface products.  The products in question are hard surface copper-containing surface products such as door handles, light switch panels, and bed rails, which are utilized for their antimicrobial characteristics.  EPA states that “the testing described in this draft protocol is designed to support registration of copper-containing surface products (such as door knobs or other items that are not intended for food contact) that bear sanitizer claims.”  Numerous changes have been made to the draft, including changes to the test microbes, culture preparation, quality control process, and product characterization.  Following completion of the review, EPA states that it will evaluate the findings and revise the draft as appropriate prior to posting the final protocol.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA evaluates the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health.  EPA indicates that antimicrobial efficacy testing of copper-containing surface products poses challenges because of the prolonged product life span, the likelihood that cleaning and disinfecting agents would be used on the surfaces, and the wide variation in potential product forms and use patterns.  EPA states the following regarding the protocols and how they will affect the test results:

  • This protocol is designed to address these issues by including a product characterization component that challenges the product’s physical durability and chemical stability when used as proposed;
  • The efficacy assessment component of the protocol involves evaluation of the performance of two product manufacturing lots against two pathogenic microorganisms -- Staphylococcus aureus and Pseudomonas aeruginosa; and
  • The efficacy test results, in combination with the product durability/stability component, will be used to determine the sanitizing activity of the copper-containing surface.

More information is available on EPA’s Antimicrobial Pesticide Registration website.  Information regarding other antimicrobial pesticide issues is available in our blog items EPA Posts Revised Antimicrobial Pesticides Use Site Index and EPA Releases Guidance Document:  Antimicrobial Pesticides Use Site Index.

Commentary

Products that are intended to have pesticidal efficacy over a protracted period require testing that differs materially from those pesticides that are only effective for a transient period and, thus, must be used repeatedly.  Some believe copper-containing surfaces have great promise as antimicrobial sanitizers, particularly in health care environments where limiting patient exposure to potential pathogens has become a critical institutional concern.  EPA’s enhanced test protocols are intended to address questions EPA and others have raised concerning the continued efficacy of a copper-containing surface over a prolonged life span, and the potential impact of cleaning and disinfecting agents.


 

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.
 


 

By Susan Hunter Youngren, Ph.D.

On October 15, 2014, the Office of Pesticide Programs (OPP) announced a voluntary program to document the effectiveness of agricultural pesticide spray application technologies on reducing pesticide spray drift. Under the Drift Reduction Technology (DRT) Program, agricultural equipment manufacturers would conduct (or make arrangements for a testing facility to conduct) studies to determine the percent drift reduction according to a verification protocol. Once completed, the manufacturer would submit the study to the U.S. Environmental Protection Agency (EPA) for review and evaluation. As verified, these reductions could then be quantitatively credited in the environmental risk assessments used to develop the drift reduction measures appearing on the label of the pesticide product. EPA will then review the manufacturers’ studies and, based on these data, it will assign spraying devices a rating on a four-star scale:

* Four stars: Device can reduce spray drift by 90 percent or more.

* Three stars: Device can reduce spray drift by between 75 percent to 89 percent.

* Two stars: Device can reduce spray drift by between 50 percent to 74 percent.

* One star: Device can reduce spray drift by between 25 percent to 49 percent.

* No stars: Device can reduce spray drift by less than 25 percent.

EPA allows pesticide manufacturers to include labeling on their products that contain dual-use instructions, one for farmers using devices that have received stars through the DRT program and another for those using devices that do not have a DRT rating.
 


 
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