TRAC Regulatory Mechanisms Table 2/18/99

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

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.

The issue of how to deal with existing stocks is not addresses in this paper.
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.

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.

DRAFT 8/12/98 (Revised 9/3/98) REGULATORY MECHANISMS FOR ACHIEVING PESTICIDE RISK MANAGEMENT

DRAFT 8/12/98
(Revised 9/3/98)
REGULATORY MECHANISMS FOR ACHIEVING PESTICIDE RISK MANAGEMENT