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Conditional Pesticide Registration
FIFRA section 3(c)(7) authorizes EPA to conditionally register pesticides under certain well-defined circumstances. As with all pesticide registrations, the first step in the Agency’s evaluation is to determine whether a pesticide’s proposed use meets the registration standard to ensure the protection of human health and the environment.
If EPA finds that the pesticide meets the standard for registration, but there are outstanding data requirements, the Agency may, under certain circumstances, grant a “conditional” registration pursuant to FIFRA section 3(c)(7). However, before granting a conditional registration, EPA must determine that, although an application lacks some of the required data, use of the pesticide would not significantly increase the risk of unreasonable adverse effects on people or the environment during the time needed to generate the necessary data.
- When can EPA grant a conditional registration?
- Conditional registration history
- GAO’s assessment and report on conditional pesticide registrations
- EPA’s efforts to improve information about conditional registration
- Information about conditional registrations from 2000 to 2014
If EPA determines the pesticide meets the standard for registration in section 3(c)(7), the Agency may grant the application for registration with conditions that require the registrant to provide additional information within a specified time. If the registrant does not comply with the conditions, EPA may cancel the registration pursuant to FIFRA section 6(e). The amount of time given to a registrant to provide required data is usually based upon the amount of time EPA determines is necessary to conduct a study or otherwise satisfy the condition.
The following are the limited circumstances where EPA may grant a conditional registration:
FIFRA Section 3(c)(7)(A) - Identical/Substantially Similar Products (generally called “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:
- the pesticide and proposed use are identical or substantially similar to any currently registered pesticide and use thereof, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; and
- approving the registration or amendment in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment.
Under all conditional registrations, each registrant must ultimately submit or cite the same data that would be required for the unconditional registration of a similar product under FIFRA section 3(c)(5).
The data to support the conditional registration must be submitted or cited to no later than the time the data are required to be submitted for the previously registered similar pesticide product(s). If a notice requiring these data has been issued under FIFRA section 3(c)(2)(B) before the new product’s application has been approved, the applicant must submit or cite those data at the time specified in the notice.
Since EPA is periodically requiring registrants of existing products to perform new studies to show their products continue to meet the statutory safety standards of FIFRA, and since pesticide companies frequently apply to bring new products to market, conditional registrations granted under this authority are relatively common.
FIFRA Section 3(c)(7)(B) - New Uses of an Existing Registered Product
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 an unconditional registration, if the Agency determines that:
- the applicant has submitted satisfactory data pertaining to the proposed additional use; and
- amending the registration in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment.
Each registrant must at a later date submit or cite the same data that would be required for the unconditional registration of a similar product under FIFRA section 3(c)(5).
FIFRA 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:
- insufficient time has elapsed since the imposition of the data requirement for those data to be generated and submitted;
- EPA receives the required data by the end of the time allowed for submission of the data, and such data do not show that the use will meet or exceed risk criteria stated in the regulations issued under FIFRA and other conditions issued by the Agency;
- the use of the pesticide during such period will not cause any unreasonable risk to the environment; and
- the use of the pesticide is in the public interest.
The first pesticide control law was enacted in 1910. The modern law known as FIFRA was enacted in 1947. Since that time, FIFRA has undergone many important revisions. In 1970 Congress transferred the responsibility for regulating pesticides to EPA, and in 1972 Congress essentially rewrote FIFRA. Among other things, the 1972 amendments established a new standard for the registration of pesticides that shifted the emphasis to protection of human health and the environment. In doing so, Congress gave EPA the authority to register a pesticide only if the Agency had sufficient data to show the pesticide would not cause unreasonable adverse effects on human health and the environment when used according to the use directions and restrictions provided on the pesticide product label.
After this standard was added, EPA could not register a new pesticide unless its registration application was supported by all the information required under then-current scientific standards. Because scientific standards evolve over time, applicants seeking registration for new pesticide products were typically required to provide significantly more data than had been required in the past for virtually the same product. This led to an unfair situation:
- When considering the registration of a new product (product B) that was identical or substantially similar to a currently registered product (product A), FIFRA required EPA to deny registration if the data requirements had evolved to require additional information that was not required when product A was registered.
- The grounds for the denial of registration for product B was that EPA lacked the data necessary to conclude that the new product met the “no unreasonable adverse effects” on human health and the environment standard, even though an identical product, product A, was still allowed to be sold and used.
To remedy this situation, in 1978, Congress amended FIFRA by adding section 3(c)(7), which gave EPA the authority to register a pesticide product “conditionally” if it was identical or substantially similar to a currently registered product, even if there were gaps in the data, as long as EPA could make the necessary statutory findings. Congress also gave EPA the authority to register products conditionally in certain other limited circumstances, i.e., to conditionally amend a registration to permit additional uses of an existing product and to conditionally register new active ingredients allowing time for the generation and submission of data necessary for registration.
The provisions of section 3(c)(7) are discussed in more detail below.
In 2013, the Government Accountability Office (GAO) conducted a review of EPA’s registration program as it relates to conditional registrations and reported that the total number of conditional product registrations granted was unclear, in part due to the limitations of EPA’s databases and the Agency’s incorrect classification of some registrations as conditional.
GAO recommended that EPA:
- Complete plans to automate data related to conditional registrations to more readily track the status of these registrations and related registrant and Agency actions and identify potential problems requiring management attention.
- Pending development of an automated data system for tracking the status of conditional registrations, develop guidance to ensure that product managers use a uniform methodology to track and document this information, including when data are submitted by registrants and reviewed by EPA, in the files maintained by each pesticide product manager.
- Review and correct, as appropriate, EPA’s website on conditional registrations to ensure that the information presented is clear, concise, and accurate, including defining terms.
The Pesticide Registration Improvement Extension Act (PRIA) of 2012 amended FIFRA to provide, among other things, funding to improve information systems capabilities for EPA. The amendments provide this funding to support enhancing the EPA information system capacity to track pesticide registration decisions, including the status of conditional registration decisions.
EPA is taking steps to improve the accuracy of information about and internal tracking of conditional registration decisions. These efforts are intended to promote consistency, enhance transparency and better understanding of decision-making under FIFRA section 3(c)(7).
This work includes development and implementation of new “response codes” for EPA’s integrated database OPPIN (Office of Pesticide Programs Information Network), which will permit better tracking of conditional registrations and modification of OPPIN to make it easier to check the Data Call-In status for any active ingredient and formulated product. (FIFRA § 3(c)(2)(B), authorizes EPA to issue “Data Call-Ins,” or require pesticide registrants to generate and submit data to the Agency, when such data are needed to maintain an existing registration of a pesticide.)
EPA conditionally registered 149 chemicals under section 3(c)(7) between 2000 and 2014. As shown in the pie chart below, 725 studies were associated with those conditional registrations and, as of April 2015, 82% (591) of them have been satisfied. Another 12% (90) are in review, and 6% (44) are not yet due. There are no overdue studies.
EPA has received and reviewed all the required data for 59% (88) of the 149 conditionally registered chemicals. The remaining required data for another 19% (29) of them are in review; 6% (9) of them were not conditioned on the submission of additional data; 11% (16) have been canceled, and the remaining 5% (9) chemicals have studies that are not yet due.