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November 8, 2010

EPA Proposes Revisions to FIFRA Procedures to Ensure Protection of Data Submitters’ Rights

Bergeson & Campbell, P.C.

On November 5, 2010, the U.S. Environmental Protection Agency (EPA) proposed revisions to the regulations at 40 C.F.R. Part 152, governing the procedures for the satisfaction of data requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 75 Fed. Reg. 68297 (online). EPA states that these regulations have not been revised since they were first issued in 1984, so many of the proposed revisions accommodate statutory and procedural changes that have occurred since then (i.e., Food Quality Protection Act (FQPA), Pesticide Registration Improvement Renewal Act (PRIA II)) or reflect changes to EPA’s needs and practices since that time. Key proposed revisions are as follows:

  • Clarifying the Circumstances When the Procedures to Ensure the Protection of Data Submitters’ Rights Apply: EPA’s current regulations at 40 C.F.R. § 152.81(b) set forth those circumstances when the procedures to ensure protection of data submitters’ rights do not apply. EPA states that the circumstances listed are based on the principle that “if EPA does not need to review scientific data in order to make its regulatory determinations, it need not require that applicants address the satisfaction of data requirements at all.” EPA states that the list of circumstances set forth at § 152.81(b)(4) were not intended to be “all-inclusive” and that EPA “reserved the right to make determinations on the need for scientific data on a case-by-case basis.”EPA further notes that it has more recently modified its procedures (40 C.F.R. § 152.46 and Pesticide Registration (PR) Notice 98-10) for when registration changes can be accomplished through notification or non-notification. According to EPA, an action that will “have no potential to cause unreasonable adverse effects” as used in 40 C.F.R. § 152.46, “as equivalent to a determination that no scientific data are needed to make the change within the meaning of 40 CFR 152.81(b)(4)(xvi).” By comparing the list of actions set forth at 40 C.F.R. § 152.81(b)(4) for when the procedures to ensure protection of data submitters’ rights do not apply with the list of actions at 40 C.F.R. § 152.46 and PR Notice 98-10 for when application changes can take place by notification or non-notification, EPA determined that the actions were not the same, but perhaps should be.Accordingly, EPA is proposing to eliminate the list of actions set forth at 40 C.F.R. § 152.81(b)(4) in favor of a new provision at 40 C.F.R. § 152.81(b)(5) to exclude from data submitters’ rights procedures “a modification to registration of a currently registered product that may be accomplished under the notification or non-notification procedures of 40 CFR 152.46 and any procedures thereunder.” EPA appears to believe that by aligning the circumstances between 40 C.F.R. §§ 152.81(b) and 152.46, the proposed provisions will likely assist applicants in determining when the procedures to ensure protection of data submitters’ rights apply. While less clear, these proposed revisions would appear to expand the circumstances when applicants/registrants do not need to address data compensation issues.
  • Updating the Definition of “Exclusive Use Study”: EPA’s regulations at 40 C.F.R. § 152.83 provide definitions for several terms, including “exclusive use study.” In the proposed rule, EPA plans to “update and restructure” the current definition to incorporate additional exclusive use criteria added by FQPA. Specifically, the proposed definition of “exclusive use study” will: (1) allow for the extension of an original 10-year exclusive use provision for a period of up to an additional three years when the registrant adds minor uses meeting certain criteria to the original registration for which the exclusive use data were submitted; and (2) create exclusive use rights in data an applicant or registrant submits to support an amendment adding a new use to an existing registration that does not retain any period of exclusive use, provided such data relate solely to a minor use of a pesticide. This revision, long overdue, is intended to update the regulations to reflect FQPA changes.
  • Specifying that Necessary Forms and Information Pertaining to the Satisfaction of Data Requirements Must be Submitted at the Time of Application: Currently, EPA’s regulations at 40 C.F.R. § 152.84 state:All information required by this subpart should be submitted with the application, but may be submitted at any later time prior to EPA’s approval of the application. The Agency will not approve any application until it determines either that the application is not subject to these requirements or that all required materials have been submitted and are acceptable.PRIA II revised FIFRA by adding Section 33, which requires, under Section 33(f)(4)(B), that EPA determine during the initial screen (i.e., 21 days after receiving an application and the required registration service fee) that “the application contains all the necessary forms, data, and draft labeling, formatted in accordance with guidance published by the Administrator.” This conflicts with EPA’s current regulations that allow some circumstances when information can be submitted after the application and prior to EPA’s approval. EPA notes that, as discussed in more detail below, it is proposing to eliminate the primary rationale for allowing applicants to make submissions following the application submittal, namely, the 60-day waiting period for data gap certification letters. Thus, EPA is proposing to revise 40 C.F.R. § 152.84 to specify that all necessary forms and information pertaining to satisfaction of data requirements must be submitted at the time the application is submitted. Specifically, the proposed regulation would state: “Information and materials required by this subpart must be submitted at the time of application, unless the application is determined not to be subject to the requirements of this subpart.”
  • Adding the Use of Electronic Methods as a Means of Communications Between Applicants: Under the current regulations at 40 C.F.R. §§ 152.86(b)(2)(iv) and 152.95(b)(2)(v), when an applicant is required to provide offers to pay, it must provide its name, address, and telephone number. To “update communication methods between applicants,” EPA is proposing to revise these regulations to require applicants also provide e-mail addresses. This requirement is not expected to have much impact on current procedures, as companies already communicate electronically.
  • Removing the Requirement that the Registration Standard or any Specific EPA List of Data Requirements be Used as the Basis for Determining Data Requirements Under the Selective Citation Method: EPA’s regulations at 40 C.F.R. § 152.90 set forth the procedures for applicants relying on the selective method of data citation. Under the “selective method” regulations, the applicant may list “the specific data requirements that apply to his product, its active ingredients, and use patterns, and demonstrating his compliance for each data requirement by submitting or citing individual studies, or by demonstrating that no study has previously been submitted to the Agency.” The regulations currently require applicants to make determinations regarding data requirements based on the availability of, and information contained in, Registration Standard documents. EPA has not issued Registration Standards since 1988, and even Reregistration Eligibility Decisions (REDs), the documents that superseded Registration Standards, are now likely to be superseded or updated under EPA’s new Registration Review program required by FIFRA Section 3(g). Based on these developments, EPA states:Given the growth and evolution of the program’s systematic review of existing pesticides, EPA believes that it should no longer identify by regulation a specific type of decision document as the source of data requirement listings. These documents are a snapshot of the data requirements at a particular review period, and are likely to become outdated over time as EPA’s risk assessments evolve and new types of data are needed.In the proposed rule, EPA proposes to remove references to Registration Standards and instead cite the data requirements regulations at 40 C.F.R. Parts 158 and 161 “as the primary source of the data listings needed for the selective method.” EPA notes, however:Notwithstanding, consideration of existing decision documents such as REDs will continue to provide useful guidance to applicants and registrants in determining how EPA has applied the data requirements to individual products and uses. However, such documents do not represent a binding Agency determination regarding the data requirements that must be fulfilled to satisfy the requirements of any individual registration.Given how outdated Registration Standard documents are, EPA’s proposed regulation will assist applicants in avoiding the confusion of addressing data citation issues with outdated Registration Standard documents. EPA’s statement in its proposed rule that REDs or similar documents “do not represent a binding Agency determination regarding the data requirements that must be fulfilled” is remarkably ambiguous and expected to have a significant impact on data owners and follow-on registrants in current and forthcoming data compensation negotiations and/or arbitrations. This is because follow-on registrants frequently make the argument that data available for review by EPA when the RED is developed, but not cited by EPA when the RED is issued, are presumptively not compensable data. EPA’s statement that REDs or similar documents “do not represent a binding Agency determination regarding the data requirements” could be cited by data owners to support the view that EPA’s citation, or reference to data in the RED or similar document, is not dispositive of the scope of compensable data. Commenters should urge EPA to clarify this statement.
  • Specifying that Reregistration Eligibility and Registration Review Decisions May be Referred to by Applicants Evaluating Data Waivers and that Data Waiver Denials are Final Agency Action: EPA’s regulations at 40 C.F.R. § 152.91 set forth the procedures for demonstrating compliance for a data requirement under the selective citation method by documenting the existence of a waiver. The current regulations states:An applicant may claim that a waiver previously granted by the Agency also applies to a data requirement for his product. To document this claim, the applicant must provide a reference to the Agency record that describes the previously granted waiver, such as an Agency list of waivers or an applicable Registration Standard, and must explain why that waiver should apply to his product.EPA has not issued a Registration Standard since 1988. EPA thus proposes to add to this regulation references to REDs and Registration Review decision documents. EPA states: “This revision does not change the substance of the provision, as the current listing of applicable documents is merely illustrative.”EPA also proposes to specify that a denial of a waiver decision is a final agency action. EPA states: “Similar language is already included in the Agency’s regulations on waivers found in 40 CFR 158.45, and this proposal would simply modify 40 CFR 152.91 to reflect the Agency’s existing position.”
  • Eliminating the Requirement that Applicants Provide Data Submitters with Requests to Confirm Data Gaps: EPA’s regulations at 40 C.F.R. § 152.96 set forth the procedures for an applicant to satisfy a data requirement for which data have not yet been submitted, referred to as the “data gap” procedures. Under these regulations, an applicant can satisfy a data requirement by documenting that no data were submitted to fulfill the data requirement. As part of this process, the applicant is required to write to data submitters and seek confirmation that they have not submitted data to satisfy a particular data requirement. The data submitter is not required to respond, but its right to later challenge a applicant’s claim is limited if the data submitter does not respond in writing, delivered to the applicant within 60 days of receipt of the applicant’s data gap letter.EPA notes that these procedures have rarely been utilized, and the increase in data submittals over the years has reduced greatly the opportunity to claim that a data gap exists. In addition, EPA documents like REDs and future Registration Review documents explicitly state when a data element is not available. Since “most data gaps have been eliminated,” and “EPA is in a much better position today to evaluate the legitimacy of data gaps claims because of its reregistration program,” EPA proposes to eliminate the procedure where applicants must seek from data submitters, verification that they have not submitted data for a particular data requirement.EPA notes that the proposed elimination of the data gap certification procedures does not eliminate the ability of an applicant to claim a data gap, although EPA will “scrutinize such claims carefully, as it believes that few claims can be supported given the significant amounts of data now available for most pesticides.” EPA further notes that data submitters can still be informed of data gap claims, as its current procedures under 40 C.F.R. § 152.119 require EPA to make available, 30 days after registration, the means by which an applicant satisfied the data requirements, including whether under the selective method, the applicant claimed a data gap. The only additional changes that EPA is proposing as a result of the elimination of the data gap certification procedures are: (1) allowing data submitters to petition for cancellation under 40 C.F.R. § 152.99(a)(2)(iv) because an applicant “has falsely or improperly claimed that a data gap existed at the time of his/her application,” instead of the current regulations that allow data submitters to petition for cancellation because an applicant “failed to comply with the procedure for showing that a data gap exists;” and (2) eliminating the requirement at 40 C.F.R. § 152.97(b) that data submitters respond to data gap letters.

The proposal contains much information and a careful review is warranted. Comments are due January 2, 2011. As noted above, the proposal raises interesting and controversial issues, and FIFRA stakeholders are urged to provide comment.