You have requested the opinion of the Office of General Counsel as to the requirements of FIFRA regarding the cancellation of a 3(c)(7) (C) conditional registration where data submitted to fulfill one of the imposed conditions indicates that the pesticide meets or exceeds an RPAR risk criterion. This memorandum focuses on the requirements of FIFRA for the cancellation of a conditional registration in the situation where data indicating that an RPAR criterion has been met or exceeded is submitted prior to or at the end of a conditional term, as well as on the procedures required for granting a 3(c) (5) registration, when appropriate in light of risk/benefit considerations, for a pesticide whose conditional registration has been cancelled..

Section 3(c)(7) (C) of FIFRA provides that:

"The Administrator may conditionally register a pesticide
containing an active ingredient not contained in any
currently registered pesticide for a period reasonably
sufficient for the generation and submission of required
data
On the condition that by the end of such period
the Administrator receives such data and the data ac not
meet or exceed risk criteria enumerated in regulations
issued under this 'Act and on such other conditions as
the Administrator may prescribe. .

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Section 6(e) provides that:

"The Administrator shall issue a notice of intent to
cancel a registration issued under section 3(c) (7)
of this Act if . . at the end of the period provided
for satisfaction of any condition imposed, that condi-
tion has not been met.

Questions Presented

1. Does FIFRA require the Agency to cancel a 3(c) (7) (C) conditional registration where a study which is submitted at the end of the conditional term in fulfillment of one of the imposed conditions demonstrates that the pesticide meets or exceeds an RPAR risk criterion?

2. If the answer to Question 1 is "yes", where such a study is submitted before the end of the conditional term, does FIFRA require cancellation at the time the study is submitted or not until the end of the conditional term?

3. Where a conditional registration is cancelled because a study submitted in fulfillment of a condition meets or exceeds one of the RPAR criteria, do FIFRA and the implementing regulations provide a mechanism for the registration under 3(c) (5) of some cr all of the uses of this pesticide once all the studies required by the terms of the conditional registration have been submitted to the Agency and evaluated?

Answer

1. FIFRA requires the cancellation of the conditional registration of a pesticide which has been shown, at the end of the conditional time period, in a study submitted in satisfaction of an imposed condition, to meet or exceed one or more of the RPAR risk criteria.

2. In the situation in which a study demonstrating that the pesticide meets or exceeds one of the RPAR criteria is submitted prior to the end of the conditional time period, the Agency must initiate a section 6(e) cancellation action within a reasonable time after receiving the data which demonstrate that a risk criterion has been met or exceeded.

3. A conditionally registered pesticide chemical which is cancelled because it meets or exceeds one of the RPAR criteria could be granted a registration for some or all uses at the completion of an RPAR review (or modified RPAR review) which subjects the uses of the pesticide to a risk/benefit evaluation.

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Discussion

Standard for Cancellation Where Triggering Data
Submitted at End of Conditional Time Period

The language of FIFRA is very clear in providing that a conditionally registered pesticide chemical must be cancelled if data submitted in fulfillment of a condition at the end of the conditional term indicates that the pesticide meets or exceeds any of the RPAR risk criteria. In specifically setting forth the RPAR criteria as the standard for determining the viability of a conditional registration, the statute clearly does not contemplate that a less restrictive standard, such as a finding that the benefits exceed the risks, would be adequate to maintain the conditional registration in effect. This interpretation is not contradicted by any discussion of the conditional registration provisions in the legislative history, and is consistent with the general framework for conditional registration set forth in the

According to the statute, a conditional registration can be granted where a finding is made that the use of the pesticide will no cause unreasonable adverse effects on the environment for the term of the conditional registration. Since the concitionally registered pesticide is registered for use with less than the full complement of test data, there is some uncertainty with regard to the unreasonable adverse effects findings. Holding a conditionally registered pesticide to the strict standard of not meeting or exceeding the RPAR criteria assures that the use of the products will not cause unreasonable adverse effects beyond the term specified for satisfaction of the conditions.

Time Frame for Cancellation Where Triggering Data Is
Submitted Prior to the End of the Conditional Time
Period

Section 6(e) specifies that "The Administrator shall issue a notice of intent to cancel a registration issued under section 3(c) (7) . . . if at the end of the period provided for satisfaction of any condition imposed, that condition has not been met". Although this provision would appear by itself to require the Agency to initiate a cancellation action where the risk criteria are met or exceeded only at the end of the conditional time period even if such data are submitted earlier, a reading of the language of 6(e) in conjunction with 3(c)(7) (C) indicates that the Agency is obliged to cancel once it has determined that a risk criterion has been met or exceeded. This conclusion is based on the provisions of 3(c)(7)(C) which give

the Administrator discretion to conditionally register a pesticide with a new active ingredient "on the condition that by the end of such period the Administrator receives such data and the data do not meet or exceed risk criteria. . . . In setting up the two conditions that the data must be submitted in a timely manner and that the risk criteria must not be met or exceeded, this section of FIFRA looks to the point in time at which the Agency receives data indicating that an RPAR criterion has been met or exceeded as the logical termination point for the conditional registration. This conclusion is consistent with the general focus of the conditional registration provisions which allow conditional registration only where the Agency can make a determination that the issuance of the conditional registration will not cause unreasonable adverse effects on the environment for the term of the registration. Clearly, once the Agency receives evidence that its unreasonable adverse effects determination may have been in error, it is obliged to take action to terminate the conditional registration within a reasonable time to insure that the statutory standard is upheld.

Application for 3(c)(5) Registration Following
Cancellation of Conditional Registration

A registrant whose conditionally registered pesticide is cancelled on the grounds that his chemical meets or exceeds one of the RPAR criteria is not barred from seeking a 3(c)(5) registration once he has completed all the studies required by the Agency. Pursuant to the provisions of 40 CFR 162.7. which requires an RPAR review for applications for new and amendeċ registrations where the RPAR criteria are met or exceeded, the chemical should be subjected to an RPAR review to determine if the risks exceed the benefits for each use under consideration.

The regulations at 40 CFR 162.11 contemplate a stepwise RPAR review in which the Agency (1) issues a position document setting forth its determination as to the RPAR criteria which have been met or exceeded (PD 1), (2) allows a comment period for submission of rebuttal information, (3) evaluates the rebuttal comments and issues a position document (PD 2/3) setting forth the Agency's proposed regulatory decision, (4) presents the proposed decision to the SAP for review and to the public for comments, and (5) issues a final position document (PD 4) setting forth the Agency's regulatory determinations. However, in a number of instances the RPAR review process has been "collapsed" and the Agency has issued PD 1/2/3 documents which bypass the initial issuance of a position document and the receipt of comments in response to this document. This procedure is appropriate in situations where the Agency has determined that the benefits of use exceed the risks without modification to the terms and conditions of

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registration (or with modifications which have a de minimus cost impact). A similar mechanism could be employed for the risk/benefit analysis of a cancelled conditionally registered pesticide to avoid the time delay and the resource intensity of a complete RPAR review. Although there is some risk of a legal action against the Agency in using a process which abbreviates the scheme set forth in the regulations, the risk would be largely overcome by the publication of a Federal Register notice setting forth the rationale for the Agency's determination regarding the granting of a 3(c) (5) registration to the pesticide in question. This Notice would have to present an adequate risk/benefit analysis of the uses of the pesticide, in light of the alternatives, to substantiate the Agency's conclusion that the registration of the pesticide would not result in unreasonable adverse effects on the environment.

A problem which arises out of the requirement for the cancellation of the conditional registration of a pesticide which meets or exceeds one or more of the RPAR criteria is the time lag between the cancellation action and the granting of a 3(c)(5) registration after a risk/benefit analysis. Since the Agency is obliged to cancel the conditional registration within a reasonable time after it determines that an RPAR criterion has been met or exceeded, there could be a substantial interim period during which the pesticide would not be registerable, particularly in the situation where long-term studies are still outstanding. Ever in the situation where all the requisite studies have been submitted, the Agency review process to determine if the benefits exceed the risks could require an extensive time for completion. To minimize or eliminate the potential registration gap during the pendency of this risk/benefit review, the Agency should conduct an expeditious risk/benefit analysis in conjunction with a' review of conditional data which indicates that a pesticide meets or exceeds one or more of the RPAR criteria. Where a determination can be made that granting a 3(c)(5) registration is appropriate, the transition from a conditional registration to a 3(c) (5) registration could then be achieved with a minimal time gap, or contemporaneously, in most instances.