EPA Releases New Website on FIFRA Conditional Registrations
On April 25, 2011, the U.S. Environmental Protection Agency (EPA) released a website regarding conditional registrations granted under Section 3(c)(7) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The website, entitled “Conditional Registration,” is available online. A related press release is available online. As discussed more below, the new website appears to raise as many questions as it seeks to answer.
EPA states: “The Office of Pesticide Programs (OPP) initiated and recently completed an internal review of the use of conditional registrations. The review looked at the variability in the use of the term “conditional registration” in the program, how the internal computer coding associated with conditional registrations has been applied, the status of actions that have been characterized as conditional registrations, and the potential for improvements and clarifications.”
EPA begins by summarizing the three different ways that a product can be conditionally registered:
- Section 3(c)(7)(A) – Identical/Substantially Similar (Formerly Me-Too) Products: EPA may conditionally approve an application for registration or amended registration of a pesticide product under FIFRA Section 3(c)(7)(A) if the Agency determines that: (1) it possesses all data necessary to make the determinations required by FIFRA Section 3(c)(7)(A) with respect to the pesticide product that is the subject of the application (including, at a minimum, data needed to characterize any incremental risk that would result from approval of the application); (2) the pesticide and proposed uses are identical or substantially similar to any currently registered pesticide and its uses, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; and (3) approving the registration or amendment in the manner proposed would not significantly increase the risk of any unreasonable adverse effect on the environment.
- Section 3(c)(7)(B) – New Uses: EPA may conditionally amend the registration of a pesticide to permit additional uses, even if the data concerning the pesticide may be insufficient to support the unconditional registration, if the Agency determines that: (1) the applicant has submitted satisfactory data pertaining to the proposed additional use; (2) amending the registration would not significantly increase the risk of any unreasonable adverse effect on the environment; and (3) each registrant must submit or cite the same data that would be required for unconditional registration of a similar product under FIFRA Section 3(c)(5).
- Section 3(c)(7)(C) – New Active Ingredients: EPA may conditionally register a pesticide containing an active ingredient not in any currently registered product for a period reasonably sufficient for the generation and submission of data necessary for registration under FIFRA Section 3(c)(7)(C), if the Agency determines that: (1) insufficient time has elapsed since the imposition of the data requirement for those data to be developed, on the condition that when the Agency receives such data that they do not meet or exceed risk criteria stated in the regulations issued under FIFRA and other conditions issued by the Agency; (2) the use of the pesticide during such period will not cause any unreasonable risk to the environment; and (3) the use of the pesticide is in the public interest.
EPA states that identification of conditional registration actions in its Office of Pesticide Programs Information Network (OPPIN) is “out of date and inaccurate.” Regarding its current issues tracking conditional registration in its OPPIN system, EPA states:
The pesticide program does not have an information technology system designed for tracking or managing conditional registration actions. In the absence of such a system, the program has used the Office of Pesticide Programs Information Network (OPPIN) to provide some minimal reporting capacity. OPPIN has some limited codes allowing identification of regulatory actions as conditional registrations.
However, once an action is identified as a conditional registration in OPPIN, the designation cannot be updated or changed for that specific action. There is no data system mechanism to identify or inform the Agency of milestones or deadlines for conditional registration actions. In addition, there is no easy means for OPPIN to identify if the required data or label changes have been submitted, or whether the Agency reviewed or acted on those submissions. The system does not lend itself to analysis of whether conditions have been satisfied that would change the status of a product from conditional to unconditional. Therefore, OPPIN does not provide accurate data on the current status of conditional registrations.
Specifically, based on its review, EPA states it has determined that it has been “imprecise in describing the appropriate regulatory basis” for its actions by using the term “conditional registration” to cover actions beyond the scope intended under FIFRA Section 3(c)(7). As an example of decisions “imprecise[ly]” classified as conditional, EPA states that label changes could have been identified under FIFRA Section 3(c)(7) when they should have been identified as actions taken pursuant to the authority of 40 C.F.R. Parts 158 and 161. EPA states the specific results of OPP’s review as follows:
OPPIN records historic information on the approximately 90,000 distinct registration decisions for currently registered Section 3 products. Over time, there can be multiple decisions for a single Section 3 registration. These records provide data to distinguish among different actions that have been labeled as conditional registrations in the system. The review determined that among these actions,
- There are 65,000 registration decisions classified as unconditional.
- There are 25,421 registration decisions classified as conditional for the 11,205 Section (c)(7)(B) and (C) conditionally registered products:
- 1,408 are related to new active ingredients and new uses, and
- 24,013 are related to other actions (product formulation data, label amendments, “me-too” registrations, etc.).
Therefore, only about two percent of the registration decisions identified in OPPIN as conditional registrations are actions within the statutory scope of FIFRA Section 3(c)(7)(B) and (C). The overwhelming majority of actions identified in the data systems as conditional registrations are non-Section 3(c)(7) program actions. This indicates that, as statutorily intended, the authority for conditional registrations for registering new uses or new ingredients has been used in narrow circumstances.
To address this issue, EPA states it will begin training staff on the scope of Section 3(c)(7) conditional registrations “to provide internal and external clarification on the basis for Agency actions and eliminate potential confusion.” EPA also states: “Based upon the small number of conditional registrations that have necessitated modifications in risk assessments and label requirements, the Agency will explore reducing the use of Section 3(c)(7) conditional registrations.” EPA further notes that it is in the process of replacing OPPIN and will include designing the new system to improve identification and tracking of conditional registrations. In the meantime, EPA is taking the following steps “to ensure the information in OPPIN is not misleading:”
- Removing the conditional status classifications from the system for those registrations identified as not being new active ingredient or new use registrations;
- Having the current system allow conditional registration classification only for new active ingredients/new use products;
- Classifying “other” registration actions that include additional actions on the part of the registrant to “registered with comments”;
- Ensuring future system developments include the ability to accurately track conditional registrations; and
- Conducting quarterly OPP meetings to review the status of conditional registration actions.
The notice does not discuss the reasons EPA decided to undertake this review. EPA states that identification of conditional registration actions in its OPPIN is “out of date and inaccurate,” and sets forth its plan to update its database to better track these actions. While this may be a non-substantive change, it is noteworthy because EPA states that only about two percent of the registration decisions identified in OPPIN as conditional registrations are actually actions within the statutory scope of FIFRA Section 3(c)(7)(B) and (C). This effectively means it would be reclassifying 98 percent of the actions currently classified as conditional registrations.
EPA appears correct that many registrations have been improperly classified as “conditional” when they did not fit within any of the three categories in FIFRA Section 3(c)(7). The now routinely adopted “terms and conditions” for particular registrations are often not the specific type of requirements that would make them subject to FIFRA Section 3(c)(7) and thus properly termed conditional registrations. FIFRA Section 3(c)(7) applies only to registrations granted when necessary data have not yet been generated.
Interestingly, EPA does not seem to include those conditional registrations that are granted under FIFRA Section 3(c)(7)(A) when discussing the actions that should be identified in OPPIN as conditional registrations. Instead, EPA groups “me-too” registrations, which can be a permissible type of conditional registration under FIFRA Section 3(c)(7)(A), with product formulation data and label amendments. EPA identifies this grouping as an example of how conditional registration decisions have been imprecisely classified. Some level of confusion, or at least opaqueness, may continue even as EPA “clarifies” the situation. Further, there may be circumstances when “me-too” registrations for active ingredients or use patterns originally registered under FIFRA Section 3(c)(7)(B) or (C) could also be conditional registrations under FIFRA Section 3(c)(7)(A), depending on whether the data requirements originally imposed at the time of conditional registration remain outstanding. Yet, EPA does not seem to distinguish between the number of conditional “me-too” registrations granted under FIFRA Section 3(c)(7)(A) for currently registered active ingredients and use patterns that have outstanding data requirements, but that were not originally registered under FIFRA Section 3(C)(7)(B) or (C), and the number of “me-too” registrations under FIFRA Section 3(c)(7)(A) for active ingredients or uses originally registered under FIFRA Sections 3(c)(7)(B) or (C).
There are questions regarding what effects, if any, EPA intends the new process to have on the relationship between original registrants of new active ingredients and other follow-on registrants that obtain registrations for that same active. The new process might continue to appear to be confusing if original registrations can be conditional but some follow-on registrations cannot. It also raises questions as to whether EPA will treat differently those registrations that were previously classified as “conditional” but will now be classified as “registered with comments” in terms of data requirements, label changes, and like matters. Further clarification from EPA likely will be necessary on these and other issues.