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By Lisa M. Campbell and Lisa R. Burchi

On Thursday, April 30, 2015, the U.S. Environmental Protection Agency (EPA) issued interim guidance that it intends to clarify its toxicology data requirements for antimicrobial pesticides used on food contact surfaces.  In addition, EPA issued a letter to antimicrobial registrants that EPA states is intended “to summarize how the Agency has been implementing 158W with respect to existing registered antimicrobial pesticides, as well as new and pending antimicrobial pesticide applications.” 

The interim guidance is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC), which followed ACC’s July 2013 initiation of a legal challenge to the antimicrobial data requirements (subpart 158W of Title 40 of the Code of Federal Regulations) in the U.S. Court of Appeals in the District of Columbia.  The settlement agreement is discussed here. 

In the settlement, EPA agreed to issue, within 60 days of the Agreement becoming final, an interim guidance document explaining EPA’s interpretation of the 200 parts per billion (ppb) residue level above which additional toxicology testing would be required for indirect food uses. 

The interim guidance states with regard to the 200 ppb standard: 

No later than September 2, 2017, the Agency will propose a correction to 40 CFR Part 158W to make the rule’s language as it pertains to the 200 ppb level established in 40 C.F.R. § 158.2230(d) consistent with the U.S. Food and Drug Administration’s use of that same level. The proposal will be to clarify that the 200 ppb level established in the rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity. The Agency is providing this interim guidance to registrants that the referenced 200 ppb level is based on total estimated daily dietary intake rather than on the amount of residue present on only a single commodity.

EPA states that this interpretation is consistent with the U.S. Food and Drug Administration’s (FDA) policy.  In general, if pesticide residues in food resulting from use on food contact surfaces are 200 ppb or less, EPA requires certain toxicology data.  If residues are greater than 200 ppb, additional data may be required, depending on other conditions such as test results.

Also in the settlement, EPA agreed to propose, within four months of the Agreement becoming final, a guidance document entitled Antimicrobial Pesticide Use Site Index (USI), and provide a 30-day comment period.  The USI guidance will provide descriptions of direct food uses, indirect foods uses, and nonfood uses.  The letter states the following regarding its development of the USI guidance:

The Agency is developing a guidance document called the Antimicrobial Pesticide Use Site Index (USI) that will serve as a compilation of existing use sites and will identify how each use site fits within the twelve use patterns established in 158W.  The guidance document will serve to assist prospective registrants with the application requirements by making it easier for them to identify which data are necessary to register their product(s). 

EPA’s letter also discusses the following regarding existing and pending antimicrobial pesticide applications:

  • EPA may find it necessary, “in the context of, but not limited to, the requirements in 158W,” to call in data as each active ingredient is evaluated under the Registration Review program.  EPA does not intend to conduct this generic evaluation for new products or applications to amend existing products that are covered in Pesticide Registration Improvement Extension Act (PRIA3) fee category Table 9 -- Antimicrobial Division -- New Products and Amendments.
  • During early implementation of the 158W requirements, EPA recognizes that not all new applications will have all the newly-required data.  EPA may thus find it appropriate to issue Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) conditional registrations and set a deadline for the submission of the required data.
  • Any application submitted after July 8, 2013 (the effective date of the 158W requirements) must contain the required data or an adequate justification for any data requirements not submitted.  On the issue of timing, applicants should explain why any data are not yet submitted and when the data can be submitted.  Failure to submit required data or provide an adequate justification will result in EPA rejecting the application as incomplete under the 45/90 day preliminary technical screen under the Pesticide Registration Improvement Act (PRIA).

The settlement agreement and additional documents are available at http://www2.epa.gov/pesticide-registration/epa-data-requirements-registration-antimicrobial-pesticides-part-158w#interim and www.regulations.gov in docket EPA-HQ-OPP-2008-0110.  More information on antimicrobial policies and guidance is available here.


 

By Lynn L. Bergeson, James V. Aidala, and Lisa R. Burchi

On March 20, 2015, the United Nations World Health Organization’s International Agency for Research on Cancer (IARC) announced it had completed evaluations assessing the carcinogenicity of five organophosphate pesticides. Specifically, IARC classified the herbicide glyphosate and the insecticides malathion and diazinon as probably carcinogenic to humans (Group 2A), and classified the insecticides tetrachlorvinphos and parathion as possibly carcinogenic to humans (Group 2B). IARC also found there is “limited evidence” that glyphosate can cause non-Hodgkin’s lymphoma and lung cancer in humans.

A summary of the final evaluations, together with a brief rationale, is published online in The Lancet Oncology; the detailed assessments will be published as Volume 112 of the IARC Monographs. IARC’s press release announcing its evaluation is available at http://www.iarc.fr/en/media-centre/iarcnews/pdf/MonographVolume112.pdf.

Monsanto, on behalf of glyphosate task forces in the U.S. and the European Union (EU), immediately voiced its vigorous disagreement with IARC’s conclusions, noting various scientific issues with IARC’s evaluation that resulted in a conclusion that has not been reached following review by the U.S. Environmental Protection Agency (EPA) and in the EU. Monsanto’s statement is available at http://news.monsanto.com/news/monsanto-disagrees-iarc-classification-glyphosate.

The IARC announcement with regard to glyphosate will further energize both sides of the debate about genetically modified organism (GMO) crops, since there are several crops that have been genetically engineered to be resistant to glyphosate. If some occupational risks are identified as needing possible further mitigation, the distinction between food safety issues and occupational risks may be lost in the rhetoric. Opponents of GMO crops and those who support GMO food product labels can be expected to cite the IARC designation regardless of any further clarification or nuance that the scientific debate over the data might provide. Defenders of the technology will insist that not only is the IARC designation wrong and misleading, but it is clearly at odds with numerous other conclusions reached by multiple competent governmental authorities concerning the safety of using glyphosate and especially consuming GMO crops.

Regardless of Monsanto’s rapid and detailed response, “dueling science” views are not helpful towards enhancing public confidence in the safety of the food supply, which is ultimately where this headline will be most influential. That will only add pressure on the review process and conclusions contained in the expected EPA registration review of glyphosate data scheduled for completion in 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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