Pesticide registrants should review EPA’s draft Pesticide Registration Notice (PRN), which provides guidance on whether they should provide the Agency with a notice regarding minor modifications they wish to make to a registration. The draft would supersede PRNs issued in 1995 and 1998. Those PRNs addressed actions by registrants that do not require extensive EPA review and do not have the potential to cause unreasonable adverse effects to the environment. According to the draft PRN, notification guidance in the two previous PRNs requires revision following passage of the 2004 Pesticide Registration Improvement Act (PRIA) and subsequent PRIA reauthorizations. “Certain actions previously accepted under PRN 98-10 are now actions scheduled by the PRIA action tables,” notes the EPA.
The specific intent of the draft is to clarify the processes for accepting minor, low-risk registration amendments to be accomplished through notification, non-notification, or as accelerated amendments, as previously established in the 1998 notice (PRN 98-10). Changes that may not be accomplished by notification, non-notification, or as accelerated amendments must be effected by application to amend the product registration.
The following items included in the categories of notification, non-notification, and minor formulation amendments are subject to the conditions described in the draft PRN.
Actions requiring notifications include:
- Changes to brand names;
- Adding to the label a claim that a pest does not pose a threat to public health;
- Changes to the shape or color of packaging and changes to labeling statements that are directly related to changes in the package size, shape, and color;
- Changes to pictures, symbols, logos, and graphics provided they do not substitute for or conflict with label text and are not false or misleading;
- Removal of redundant labeling statements;
- Addition of certain statements about product composition, for example, regarding plant-derived ingredients or inert ingredients; and
- Other topics under notifications include risk reduction, changes to use directions, and warranty statements.
Action that may be taken without notifying the Agency, which must be incorporated on subsequent amendments (i.e., the registrant does not need to inform the Agency before the change), include:
- Typographical and printing errors.
- Revision, addition, or deletion of label elements not regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
- Changes in the name or address of the registrant on the label.
- Redesign of label format.
- A non-pesticidal claim provided it is not false or misleading, does not conflict with the pesticide labeling, and is consistent with other applicable statutes or regulations that may apply to such claims. Examples of such claims include “cleans,” “whitens and brightens laundry,” “removes soap scum,” and “eliminates pet dander.”
- Where product is made.
Minor formulation amendments
In the 1998 PRN, the Agency described an accelerated review for certain applications to amend registration with minor formulation changes. The draft PRN would continue to allow specific changes to registrations as minor formulation amendments, including:
- Addition, deletion, or substitution of one or more colorants in a formulation;
- Addition, deletion, or substitution of one or more inert ingredients (other than colorants and fragrances) in a formulation; and
- Addition, deletion or substitution of one or more fragrances in a formulation.
The draft PRN also describes how the Agency will review notifications and the response times registrants can expect.
PRNs are guidance documents only, meaning they are not binding on either the EPA or any outside parties. “The EPA may depart from the guidance where circumstances warrant and without prior notice,” the Agency states. “Likewise, pesticide registrants may assert that the guidance is not appropriate for a specific pesticide or situation.”
The draft PRN is available here, docket ID: EPA-HQ-OPP-2016-0671.