Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell, Heather F. Collins, M.S., and Margaret R. Graham

On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017.  Comments now must be received by EPA on or before December 5, 2017.  The notice states that it will “allow stakeholders additional time to submit comments on the proposed guidance.”  Eleven comments were filed in the docket, most of which expressed significant concern with changes EPA is proposing, in addition to requesting an extension to the previous deadline which was set to end on October 6, 2017.

EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.”  A full summary of the changes in the draft guidance is available in our blog item "EPA Releases Draft Guidance for Pesticide Registrants on Notifications, Non-notifications, and Minor Formulation Amendments."

Some of the more substantive comments noted the following issues:

  • Several commenters stated objections to the provisions in the draft PR Notice that would eliminate the ability of registrants of formulated products to use notification to add or change sources of either registered technical active ingredients or inert ingredients.  Concerns expressed with this proposed change included the effect it would have on the ability of registrants to respond quickly to market changes and conditions, including the availability and price of technical and inert ingredients needed for formulations.
  • One commenter had concerns with regard to the proposed changes to the inert ingredient disclosure statement, as EPA is “considering whether the notification method or the non-notification method is an appropriate avenue for industry requested inert disclosure based upon third-party vendor requirements.”  The commenter stated that it “believes there is an approach that satisfies third-party vendors while minimizing the burden on the Agency’s resources,” and “a significant delay to this issue could have third-party vendor impacts.” 
  • Commenters also expressed disappointment with EPA’s notification delivery, stating that EPA “provided very little notice to Stakeholders of this major change in its policies regarding notification” and “as a result, many potentially affected registrants may overlook this change and fail to file comments on it.”

More information on this draft notice and other pesticide registration notice issues is available on our blog under key phrase Pesticide Registration Notice.


 

By Lisa M. Campbell, Sheryl L. Dolan, and Barbara A. Christianson

On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of and seeking public comment on draft guidance, Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments.  EPA states it is issuing this notice to “align the notification program with the requirements of the Food Quality Protection Act (FQPA) and [the Pesticide Registration Improvement Act (PRIA)] and to clarify the processes for accepting minor, low risk registration amendments to be accomplished through notification, non-notification or as accelerated amendments.”  EPA is requesting comments, and specifically information on projected cost implications of this draft updated guidance.

PR Notices are issued by the Office of Pesticide Programs (OPP).  EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.”  The PR Notice lists the changes from PRN 98-10 in a table.  Those changes include:

In addition to the changes listed on the table, modifications to PR Notice 98-10 consist of the following:

Notifications

  • F. Product Composition:  (1) Pesticide Category -- Under PR Notice 98-10, the pesticide categories "disinfectant" and "sanitizer" were two pesticide categories that were allowed to be added to a label by notification.  Under the proposed PR Notice, "disinfectant" and "sanitizer" were removed.
     
  • F. Product Composition: (2) Odor -- Under PR Notice 98-10, the terms "fragrance free" and "unscented" were allowed to be added to a label by a notification provided that the product is odorless or nearly odorless and contains odor-masking ingredient such as a perfume.  Under the proposed PR Notice, these terms were removed. 

Minor Formulation Amendments

  • A. Minor Formulation Amendments:  (1) Addition, deletion or substitution of one or more colorants in a formulation -- Under PR Notice 98-10, if a product was intended for a use as a seed treatment or rodenticide, it would not be eligible for an accelerated review; that restriction was deleted from the proposed PR Notice.
     
  • A. Minor Formulation Amendments:  (2) Addition, deletion or substitution of one or more inert ingredients (other than colorants and fragrances) in a formulation -- Under the proposed PR Notice, if a product is a dog/cat pet spot-on product or if an inert is a bittering agent or a safener, the product would not be eligible for an accelerated review. 
     
  • A. Minor Formulation Amendments:  (3) Addition, deletion or substitution of one or more fragrances in a formulation -- Under the proposed PR Notice, fragrances will be eligible for an accelerated review if all fragrance component ingredients are included on the Fragrance Ingredient List; individual fragrance component ingredients that exceed 0.1 percent (by weight) of the total pesticide product composition have existing approval for non-food use as an inert ingredient; and new/modified fragrances for antimicrobial products making public health claims are within the certified limits established for fragrances already approved for the product. 
     
  • Under the proposed PR Notice, products that are not eligible for accelerated review under minor formulation amendments are:
    • Pet spot-on products;
    • Rodenticides;
    • Change to an active ingredient source; 
    • Change to nominal concentration of the active ingredient; or
    • Addition of new or additional Confidential Statements of Formula (CSF).

 

EPA Procedures to Review Notifications

Under the proposed PR Notice, EPA outlines changes to the policy for processing notifications by the Registration Division (RD) and the Biopesticides and Pollution Prevention Division (BPPD), but procedures to process notifications by the Antimicrobials Division remain the same. 

One item to note under the proposed notification process for RD and BPPD is that a registrant may distribute or sell a product modified by notification once EPA receives the notification but, if EPA determines that a product has been modified through notification inappropriately, EPA may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application to amend the registration.

Registrants Submitting Minor Formulation Amendments

Under the proposed PR Notice, EPA requires that registrants submit with their application for registration a cover letter listing names and dates of all EPA accepted CSFs.  EPA will consider any CSFs not listed in the cover letter as superseded/no longer valid.

Comments on this PR notice are due October 6, 2017, and can be submitted online under Docket ID EPA-HQ-OPP-2016-0671.

Commentary

Registrants should review the draft PR Notice carefully, as it includes important changes.  For example, the consequence for submitting a minor formulation amendment and neglecting to include a list of all current CSFs is severe.  As another example, EPA signals in its proposal that proceeding to market with a product revised through the notification process may be risky if the submitter has erred in its judgment regarding what is eligible for a notification.  Should the PR Notice be issued without change to this provision, submitters may wish to give close consideration to waiting until it has EPA’s written confirmation that a notification has been accepted before introducing the revised product to market.  Comments on issues of concern should be considered.