Beveridge & Diamond
 
Related Practices
Related Practices
Related Industries
Related Industries

EPA Issues Long-Awaited Regulations on Pesticide Data Submitters’ Rights

Beveridge & Diamond, P.C., February 5, 2014

EPA has issued a long-awaited final rule updating its pesticide data compensation regulations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).  Most significantly, the final rule amends 40 C.F.R. § 152.84 to confirm that applicants who choose to cite data in support of their applications must provide offers to pay to data submitters at the time of their applications.  It also confirms that such applicants must submit data certification forms to EPA at the time of application confirming they have made the required offers.  

In support of the final rule, EPA stated that “[t]here is no dispute that FIFRA section 3(c)(1)(F) requires applicants for registration or amended registration to offer to pay compensation to original data submitters when the application seeks to rely on previously submitted data that are subject to FIFRA compensation requirements.”  EPA noted that the recent passage of the Pesticide Registration Improvement Renewal Act (commonly called PRIA 3), “has only made it more clear that a completed data certification form must be submitted at the time of application.”   EPA stated that ensuring that data submitters receive offers to pay at the beginning of the application process rather than the end serves “to assist EPA in ensuring that the Agency meets its FIFRA section 3(c)(1)(F) obligations,” to allow data submitters to protect their rights in the data, and to “encourage early resolution of data compensation disputes,” and that it is more efficient than allowing “piecemeal” submission of application materials.  EPA noted that the original regulatory language allowing submission of application materials “at any later time prior to EPA’s approval of the application” was not intended to allow follow-ons to withhold their offers to pay and data certification forms, but to avoid delays caused by the data gap certification process, which has been eliminated in the revised regulations. 

In adopting the final rule, EPA rejected the argument that the data certification form served only an “administrative function,” stating that it “lies at the core of EPA’s duty to ensure compliance with the data protection provisions of FIFRA Section 3(c)(1)(F).”  EPA also rejected the suggestion that follow-ons should be permitted to provide notices of intent instead of offers to pay at the start of the application, concluding that EPA could not lawfully consider applications to be complete without the data certification form confirming that offers to pay had been submitted. 

The final rule also takes the following actions:

1.      Definition of “exclusive use period.”

EPA updated the definition of the term “exclusive use period” to incorporate additional exclusive use criteria established under the 1996 Food Quality Protection Act.

2.      Sources of data requirements.

The final rule removes from 40 C.F.R. § 152.90(a) the requirement for an applicant to use a Registration Standard (the EPA reregistration decision documents issued prior to 1988) as the source of his/her list of data requirements for the selective method as registration standards are out of date.  Instead, the regulations refer applicants to the data requirements in 40 C.F.R. Part 158.  In the preamble to the final rule, EPA explains that this change is not intended to limit follow-ons’ compensation obligations to only those data that are identified in Part 158.  EPA states that its regulations “make it explicitly clear that the regulations are intended to be flexible and that EPA reserves the right to require additional data, or, in some instances, to waive studies that EPA concludes are not relevant to its registration decision under FIFRA.”  EPA expressly confirms that “where EPA has imposed additional requirements beyond those listed in the 40 C.F.R. part 158 data tables, applicants will be required to satisfy those requirements . . . .” 

3.      Data gaps.

Regarding data gaps, EPA continues to allow a claim of a data gap to satisfy an initial screen of an application, but has eliminated the data gap certification procedures.  EPA believes that without this requirement, there are still numerous means to ensure protection of a data submitter’s interest in compensable data should an applicant incorrectly assert a data gap exists.  EPA notes that data submitters may petition to deny applications for which they believe offers to pay should have been submitted for more studies than the follow-on included in the letter. 

4.      Exclusions from subpart E and data call-ins.

EPA has revised 40 C.F.R. Part 152, subpart E to replace the limited listing of actions to which subpart E does not apply with a single reference to actions that may be accomplished by notification or non-notification.  EPA also clarifies in the final rule that recipients of data call-ins (DCIs) must follow the procedures established in the DCI rather than the procedures in subpart E. 

5.      Means of contact.

The regulations require data citers to include an email address in the contact information provided with an offer to pay.

*          *          *

A copy of the Federal Register notice announcing the final rule is available here.  For more information on EPA’s final rule, or issues related to data submitters’ rights generally, please contact Kathy Szmuszkovicz at kes@bdlaw.com, David Barker at dab@bdlaw.com, or Mackenzie Schoonmaker at mss@bdlaw.com