On June 10, 2024, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a draft Pesticide Registration Notice entitled Revised Procedures for Citing Data to Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35) (Draft PR Notice). 89 Fed. Reg. 48893. EPA states that this Draft PR Notice will supersede PR Notice 98-5, entitled New Forms for the Certification with Respect to Citation of Data,which was issued on June 12, 1998. EPA states the purpose of this Draft PR Notice is to provide updated guidance to registrants and applicants concerning the submission and public availability of EPA Form No. 8570-35 (Data Matrix) and EPA Form No. 8570-34 (Certification with Respect to Citation of Data). Comments are due on or before July 10, 2024, and can be submitted under docket ID EPA-HQ-OPP-2023-0398.
There are two major changes being proposed in the Draft PR Notice. First, EPA proposes to eliminate the instruction in PR Notice 98-5 that registrants submit two versions of the Data Matrix — the “Internal Agency Use Copy” and the other “Public File Copy.” EPA states that since 1998, its procedures have changed and it has not used or treated these versions differently; thus, having one version will reduce redundancies. In addition, EPA states that having one version will “decrease confusion by addressing and preventing the assumption that EPA Form 8570-35 (‘Data Matrix’) contains [confidential business information (CBI)] or other information protected from public release.” On this point, EPA notes that it “already releases both versions of the form in response to a [Freedom of Information Act (FOIA)] request” based on its determination that there is no information provided on the Data Matrix that can be considered CBI. EPA finds support for its position in its regulations at 40 C.F.R. Section 152.119(b), which states:
Materials that will be publicly available include an applicant’s list of data requirements, the method used by the applicant to demonstrate compliance for each data requirement, and the applicant’s citations of specific studies in the Agency’s possession if applicable.
EPA asserts that CBI claims for information submitted under EPA’s data requirements set forth at 40 C.F.R. Part 158 are “strictly limited in 40 CF.R 158.33 to manufacturing or quality control processes, the details of any methods for testing, detecting, or measuring the quantity of any deliberately added inert ingredient of a pesticide, and the identity or percentage quantity of any deliberately added inert ingredient of a pesticide, pursuant to [Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)] section 10(d)(1) (A) through (C).” EPA states that since none of the types of information that can be claimed as CBI is included in the Data Matrix, there is no information in the Data Matrix that can be protected from public release.
The second proposed change is to eliminate the instruction to allow paper submissions as described in PR Notice 98-5 but instead require that these forms be completed and submitted electronically. The Draft PR Notice provides updated instructions for completing and submitting these forms electronically through the Pesticide Submission Portal (PSP) that the Office of Pesticide Programs (OPP) established to allow registrants to create and submit packages electronically in lieu of submitting multiple paper copies. The PSP is accessed through EPA’s Central Data Exchange (CDX) Network, which is a web-based system used for various electronic environmental data submissions to EPA.
Commentary
As with all PR Notices, EPA states the Draft PR Notice is intended to provide guidance to EPA personnel and decision-makers and to pesticide registrants, is not binding on either EPA or pesticide registrants, and that EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation.
Regardless of such disclaimers, procedures and policies set forth in PR Notices are routinely followed by registrants and EPA, and there can be delays and other consequences for registrants that do not follow such procedures. As referenced in the Draft PR Notice, EPA has for some time been releasing Data Matrix forms online or in response to a FOIA request. Indeed, when uploading the Data Matrix to EPA via its CDX, there has been a pop-up notice alerting registrants that they cannot claim CBI in the Data Matrix. The current instructions for the Data Matrix also state that the Data Matrix and Certification with Respect to Citation of Data will be publicly available in part after the registration/reregistration of the product has been granted and can be available fully through a FOIA request. Electronic filings likely also already comprise the vast majority of submissions. The Draft PR Notice thus in many respects is only updating EPA’s written procedures to align with its current practices.
It also should be noted that there have been legitimate questions raised regarding EPA’s determination that no information in the Data Matrix or Certification with Respect to Citation of Data is entitled to confidential treatment. Although some may say “that ship has sailed” based on EPA practices for the past few years, stakeholders may still wish to review this Draft PR Notice and voice their concerns regarding EPA’s decisions to deny categorically a company’s ability and right to claim certain information regarding the data supporting its registrations as confidential.
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