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UPDATE BRIEFING PAPER #9(1)

REGULATORY MECHANISMS FOR

ACHIEVING PESTICIDE RISK MITIGATION

Background:

The attached paper was developed to provide information for TRAC and other stakeholders about the regulatory mechanisms that would be available to the EPA in its tolerance reassessment process, in the event that EPA makes a finding that the risks posed by a pesticide (or group of pesticides sharing a common mechanism of toxicity) exceed the "reasonable certainty of no harm" safety standard under FQPA.

TRAC Discussion:

Discussion by the TRAC centered primarily around the timing of the different regulatory mechanisms, whether the Agency had a preferred regulatory option and under which circumstances one regulatory approach might be used over another. The Agency acknowledged that the timeframes noted in the staff paper were the statutory minimums only and did not reflect any additional steps to increase stakeholder opportunity for participation in the process.

The TRAC also noted that the minimum process requirements effectively eliminated meaningful participation from all but the pesticide registrants. The TRAC then discussed what steps might be added to the process to ensure adequate participation by other interested stakeholder groups.

Next Steps:

This document will provide the basis for stakeholder awareness for the regulatory tools which the Agency will consider for the OP reregistration and tolerance reassessment.



Staff Paper for TRAC Workgroup#2 8/12/98

REGULATORY MECHANISMS FOR

ACHIEVING PESTICIDE RISK MITIGATION

If EPA determines that the risks posed by a pesticide (or any group of pesticides sharing a common mechanism of toxicity) exceed the "reasonable certainty of no harm" safety standard in section 408 of the FFDCA, there are a number of possible ways to achieve risk reduction. Risk reduction action could be taken under either the FFDCA or FIFRA, or both. This paper discusses five possible mechanisms for reducing risk. Since FIFRA is essentially a licensing statute, each potential regulatory mechanism is examined under two possible scenarios: one where the licensee (pesticide registrant) consents to the risk mitigation, and the other where no such consensus can be reached. The table on the following page summarizes these scenarios. This table is followed by a paper which examines these scenarios in greater depth.

This paper also sets forth the minimum required time lines and process for finalizing the regulatory actions discussed. In many cases, additional procedures and opportunities for public comment could be provided if desired. If additional procedures and opportunities for public participation are included in the process, these must be factored into the time lines. In addition, if data must be generated to support certain changes (such as change in preharvest interval), that must also be factored into the time line. This paper should not be read as an Agency endorsement of the minimum process requirements as sufficient.

It should also be kept in mind that each outcome will raise issues concerning the treatment of existing stocks of pesticides. The Agency generally defines existing stocks as stocks manufactured and released for shipment by a registrant before the effective date of a regulatory action that results in the amendment of a label, deletion of uses, or cancellation of a registration. The issue of how to deal with existing stocks is not addressed in this paper.

DRAFT 8/12/98

(Revised 9/3/98)

REGULATORY MECHANISMS FOR ACHIEVING PESTICIDE RISK MANAGEMENT


Outcomes Consensual Approach* Agency Action if Consensus Cannot Be Reached
1. Changes in Use Reflected in Label Changes. e.g.,
  • Increase Preharvest Interval.
  • Lower application rate.
  • Reduce number of permissible applications.
  • Soil type restrictions.
 
  • Registrant submits application for amendment to registration.
  • Registrant submits request for modification of tolerance.
 
  • "NOIC Unless" - The Agency issues Notice of Intent to Cancel unless label changes are made.
  • Modification of tolerances.
2. Change to Conditions of Registration. e.g.,
  • Production cap.
  • Requirement to perform studies (e.g., confirmatory data).
  • Taking product off the market until conditions are met (suspended animation).
SAME AS #1ABOVE. There could be tolerance revocation during suspended animation.  
  • SAME AS #1 ABOVE.
  • If there is a tolerance revocation during suspended animation.
3. Elimination of Use(s). e.g.,
  • Deletion of one or more agricultural uses.
  • Deletion of one or more non-ag uses (e.g., residential uses or non-food uses that result in residues in water).
 
  • Registrant submits request for voluntary cancellation under FIFRA section 6(f).
  • Registrant submits request for tolerance revocation if food use.
 
  • NOIC Use(s): The Agency issues Notice of Intent to Cancel use(s).
  • Tolerance revocation of food use.
4. Elimination of Active Ingredient. SAME AS #3

(All registrants must do this)

 
  • Agency issues NOIC.
  • Revocation of tolerances.
5. Phase-Out: Delayed Elimination of Use(s) or Active Ingredient.
  • Cancel active ingredient or use(s) and/or revoke tolerance effective some time in the future to allow transition.
SAME AS #3 and #4, except registrant submits a "conditional FIFRA section 6(f)". Registrant will agree to voluntarily cancel provided they get a phase-out. SAME AS #3 or #4.


* A consensual approach requires that every affected registrant agrees.

  1. The issue of how to deal with existing stocks is not addresses in this paper.
  2. If a tolerance is revoked for a registered pesticide, EPA will seek voluntary cancellations or follow up with an action to prevent adulteration of food, such as cancellation.

OUTCOME 1: LABEL CHANGES AND RELATED TOLERANCE ACTIONS

Some risk mitigation can be accomplished through changes in the way pesticides are used. These changes are generally reflected in changes to the label of a pesticide. Some label changes, such as extending pre-harvest intervals and reducing the number of applications or application rates, could reduce the level of pesticide residues in food. Other changes, such as limiting use to situations where pest populations exceed a certain level or to certain geographic locations, could reduce risk by reducing the volume of the pesticide used. Other label changes, such as limiting use of a pesticide to certain soil types or creating buffer zones around bodies of water, could mitigate water-related exposure to the pesticide. If label changes result in a reduction in the maximum amount of pesticide residue that could be found in food (assuming the label is followed), affected tolerances could be lowered accordingly.

REGULATORY TOOLS FOR ACCOMPLISHING OUTCOME 1

If a registrant consents to label changes, the registrant can request that its registration be amended to reflect the new label language. The Agency could grant the request and amend the registration accordingly. The registrant (or some other person) could petition the Agency to modify any existing tolerance where appropriate.

If a registrant does not consent to label changes, the Agency could issue a notice of intent to cancel the affected registrations unless the changes are made. The outcome of such a cancellation action could be the cancellation of the affected registrations (if the registrant continued to decline to accept a registration with the required changes) or the amendment of the registration to reflect the necessary changes (if the registrant eventually consents to the changes). If tolerance revisions were appropriate and no person submitted a petition to revise the affected tolerances, the Agency could issue a proposal on its own initiative to modify the tolerance. Alternatively, the Agency could proceed under the FFDCA and propose to revoke tolerances if the amendments are not made (and the existing risks without the amendments exceed the safety standard). If a tolerance is revoked, the Agency must also obtain a voluntary cancellation or follow-up with an NOIC.

MANDATORY TIMELINES FOR ACCOMPLISHING OUTCOME 1

If a registrant requests that a registration be amended, the amendment can be immediately granted without any required process or notice. There are no statutory requirements concerning the process to be followed when someone requests that a tolerance be modified under FFDCA § 408(d), although in similar circumstances the Agency has generally allowed for 60 days of public comment before acting on other requests submitted under section 408(d).

If consensus is not reached and cancellation is pursued, the Agency must submit a draft notice of intent to cancel to both USDA and the SAP at least 60 days before publishing a notice of intent to cancel. Interested persons are given 30 days to request a hearing after publication of the notice of intent. If EPA proposes on its own initiative to revoke or modify a tolerance, § 408(e) requires that a 60 day public comment opportunity be provided before a proposed tolerance can be finalized.

OUTCOME 2 - CHANGES TO CONDITIONS OF REGISTRATION

Some risk reduction can be accomplished through changes to the conditions of one or more registrations. Such changes could include limits on the amount of a pesticide that could be produced, or requirements to perform certain studies. It would even be possible to place conditions on registrations that limit some or all use of a pesticide unless certain specified triggers occur (such as the generation of additional data that allows for greater risk refinement or the development of resistance to other pesticides). Such conditions could be accompanied, where appropriate, by tolerance reductions or revocations as well.

REGULATORY TOOLS FOR ACCOMPLISHING OUTCOME 2

Similar to the tools for accomplishing outcome 1.

MANDATORY TIMELINES FOR ACCOMPLISHING OUTCOME 2

Same as for outcome 1.

OUTCOME 3 - DELETIONS OF USES/REVOCATIONS OF AFFECTED TOLERANCES

Another means of reducing risk is to delete certain uses from the registration of a pesticide. These uses could either be agricultural uses or non-agricultural uses (such as residential uses or non-food uses that result in residues in water) that contribute to the inability to make the safety finding. If the deleted uses are food uses, associated tolerances could be proposed to be revoked as well.

REGULATORY TOOLS FOR ACCOMPLISHING OUTCOME 3

If a registrant agrees to the deletion of particular uses, the registrant can submit under section 6(f) of FIFRA a request to delete the uses from the registration. If EPA grants the request, the registration is amended accordingly. A registrant or other person could request that associated tolerances be revoked accordingly.

If a registrant does not agree to the deletion of particular uses, the Agency could issue a notice of intent to cancel the registration unless the uses are removed from the registration. At the conclusion of a cancellation proceeding, the registrant could be left with the option of accepting the deletion of the uses or having the entire registration cancelled. If any food uses are canceled under cancellation procedures because of dietary risk concerns, EPA is required to revoke the associated tolerance (FFDCA § 408(l)(2)).

Alternatively, if a registrant did not agree to delete uses, EPA could propose to revoke the tolerances for the affected uses under the FFDCA. This could initially be done before or without issuance of a Notice of Intent to Cancel. However, if a tolerance is revoked, the Agency must also obtain a voluntary cancellation or follow-up with an NOIC.

MANDATORY TIMELINES FOR ACCOMPLISHING OUTCOME 3

If a request for voluntary deletion of uses is received under section 6(f) of FIFRA, the statute provides for a minimum 30 day comment period before the request can be granted. If EPA determines that the requested revocation would affect the availability of the pesticide for use on a minor agricultural use, a 180 day comment period must be provided unless the registrant requests a shorter comment period or EPA determines the continued use of the pesticide on the use would cause unreasonable adverse effects on the environment. There are no statutory requirements concerning the process to be followed when someone requests that a tolerance be revoked under FFDCA § 408(d), although in similar circumstances the Agency has generally allowed for 60 days of public comment before acting on other requests submitted under section 408(d).

Cancellation timelines are addressed in outcome.

Alternatively, the Agency could issue a proposal to revoke the tolerances. Such a proposal must be accompanied by a comment period of at least 60 days.

OUTCOME 4 - CANCELLATION OF ACTIVE INGREDIENT

Risk reduction can be achieved through cancellation of all products containing an active ingredient. This would likely be accompanied by revocations of associated tolerances.

REGULATORY TOOLS FOR ACCOMPLISHING OUTCOME 4

If registrants agree to the cancellation of all registrations of a particular active ingredient, the registrants can submit under section 6(f) of FIFRA a request to cancel their registrations. If EPA grants the requests, all the registrations are cancelled. A registrant or other person could request that associated tolerances be revoked accordingly.

If a registrant does not agree to the cancellation of its registration, the Agency could issue a notice of intent to cancel all registrations containing the active ingredient. At the conclusion of a cancellation proceeding, all registrations could be cancelled. If the cancellation is in part attributed to dietary risk concerns, EPA is required to revoke the associated tolerances (FFDCA § 408(l)(2)).

Alternatively, EPA could propose under the FFDCA to revoke all tolerances associated with the active ingredient. This could initially be done before or without issuance of a Notice of Intent to Cancel. However, if a tolerance is revoked, the Agency must also obtain a voluntary cancellation or follow-up with an NOIC.

MANDATORY TIMELINES FOR ACCOMPLISHING OUTCOME 4

Timelines would be the same as under outcome 3.

OUTCOME 5 - DELAYED CANCELLATION OF ACTIVE INGREDIENT OR USES

There are circumstances where certain uses or all registrations of an active ingredient could be cancelled at some designated time in the future. Under such a scenario, an agreement or ruling could be made that results in the cancellation of some uses or all of an active ingredient to be effective at a later date. Generally, such "phase outs" are the result of negotiated settlements between registrants and the Agency, although they could conceivably result from formal regulatory proceedings.

REGULATORY TOOLS FOR ACCOMPLISHING OUTCOME 5

Registrants can conditionally request a voluntary cancellation under section 6(f) of FIFRA, with the condition being that the cancellation not take effect for a specified period of time. If the Agency agrees to the condition, the request can be granted and the cancellation will become effective at the specified time. The registrant or other person could request that associated tolerances be revoked accordingly at some time after the cancellation becomes effective.

There may also be circumstances where it is appropriate for the Agency to itself suggest a delayed effectiveness date in a notice of intent to cancel. The Agency could also propose on its own initiative to initiate tolerance revocations effective at some specified date in the future. If the cancellation is in part attributed to dietary risk concerns, EPA is required to revoke the associated tolerances (FFDCA § 408(l)(2)).

MANDATORY TIMELINES FOR ACCOMPLISHING OUTCOME 5

1. Timelines are the same as with outcome 3.

This paper was published as Staff Paper 32 for the September 15, 1998 TRAC meeting.


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updated February 24, 1999