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By Lisa R. Burchi

 

On June 19, 2015, the United States District Court for the District of Columbia granted a motion for default judgment by the Non-Dietary Exposure Task Force (Task Force) and confirmed an arbitration award against an Indian pesticide manufacturer, Tagros Chemicals India, Ltd. (Tagros) (Non-Dietary Exposure Task Force v. Tagros Chems. India Ltd., 2015 BL 195490, D.D.C., 1:15-cv-00132, 6/19/15).  The Task Force sued Tagros after Tagros refused to sign a $500,000 settlement agreement negotiated by the parties in the midst of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) arbitration proceeding, and continued its refusal to pay after the Task Force successfully moved the arbitrator to issue an award enforcing the settlement agreement.  The Court determined it has jurisdiction because FIFRA “confers jurisdiction on the judiciary to enforce [such] arbitration awards” in federal court and Tagros’ participation in the arbitration allowed the court to exercise jurisdiction over Tagros.  The Court found that the arbitration award must be confirmed in full absent evidence of fraud, misrepresentation, or other misconduct by one of the parties, and no such allegations were put forth.  The Court also granted the Task Force’s motion seeking permission to register this judgment in other district courts based on information that Tagros’ assets were not in the District of Columbia and evidence of assets in other jurisdictions. 

 

This decision adds to a growing number of recent cases where companies have sought judicial enforcement of a FIFRA arbitration award.  Judicial judgments enforcing arbitration awards, in addition to judicial authority to register such judgments in districts where assets are available, are tools data owners are increasingly using to obtain the compensation owed. 


 

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.