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Diane Schute

EPA Delists 72 Inert Ingredients From Use in Pesticides

On December 20, 2016 EPA announced the removal of 72 inert ingredients from its list of chemicals approved for use in pesticide products.  The use of these substances in the future will require that they go through the Agency’s formal inert ingredient re-approval mechanism, a burdensome process that will require the submission of an extensive amount of data developed through very costly and time consuming testing required to demonstrate the safety of the chemical in question.  The type of data needed to evaluate a new inert ingredient includes studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative.

 

Some of the 72 inert ingredients are a subset of a larger list of 371 inert ingredients that were the subject of two petitions submitted to EPA in 2006 identifying these substances as hazardous and requesting that the Agency issue a rule requiring that the identities of these inert ingredients appear on the labels of pesticide products containing any of these chemicals in their formulations.

 

In its initial response to the petitions, EPA proposed an Advanced Notice of Proposed Rulemaking (ANPRM) published in the December 23, 2009 Federal Register.  The ANPRM solicited comment on a range of issues including the question of whether a rulemaking should be limited to mandatory disclosure of potentially hazardous ingredients or broadened in scope to require disclosure of most or all inert ingredient identities, regardless of hazard.  The ANPRM also sought feedback on other questions such as how disclosure would impact CBI protections for inert ingredients under Section 10 of FIFRA.  Subsequently, in a May 22, 2014 letter to the petitioners, EPA announced its decision to abandon pursuit of a rulemaking aimed at mandatory disclosure of inert ingredients.  The Agency cited the many complexities surrounding the issue of inert ingredient disclosure as well as the significant staff time and resources involved in the rulemaking process.  Instead, EPA set forth a series of alternative actions under consideration that it believed would reduce the presence of hazardous inert ingredients in specific pesticide products.  Among these was a proposal to remove from the approved list of inert ingredients those that are no longer being used in pesticide products.

 

The 72 inert ingredients recently delisted by EPA were originally the subject of a Notice published in the October 22, 2014 Federal Register in which the Agency proposed to revoke their approved status.  In the Notice, EPA explained that the list of 72 inert ingredients was generated by an Agency evaluation of pesticide product compositional information to determine which of those 371 chemical substances referenced in the 2006 petitions and listed as inert ingredients on the EPA-approved list are in use or not in use in currently registered pesticide formulations.  The Agency noted that its proposed action would fulfill one of its commitments as described in the May 22, 2014 amended response to the petitioners.

 

On January 20, 2015, CPDA submitted comments to EPA on the delisting proposal, emphasizing that such action is not in accordance with EPA’s clear obligation under FIFRA to make risk-based decisions about registered pesticides (including their inert ingredients) and not hazard-based decisions based on their appearance on non-FIFRA related lists of hazardous substances.  Moreover, CPDA emphasized that removal of these inerts would subsequently require an expensive and time-consuming data generation and reapplication process in order to use them again.  CPDA also pointed out that it was not clear from the proposal whether EPA was focusing only on non-food use inerts, and that this delisting could inadvertently adversely affect tank-mix adjuvants that are used on food crops.  The ingredients in tank-mix adjuvants that are applied to food crops with pesticides must have a tolerance or exemption from a tolerance.  EPA’s review of pesticide formulations to determine whether an inert is currently being used would not have identified those approved inerts that are used in adjuvants applied with pesticides.  CPDA therefore asked EPA to confirm that food-use inerts are not part of this delisting, since they may be currently used in tank-mix adjuvants.  In addition, CPDA noted that one or more of these 72 inerts may be present in approved inerts as low concentrations of residual impurities such as unreacted monomers.  These impurities do not contribute to the function of the inert ingredient, but due to various regulatory list triggers, they may appear in product safety data sheets.  CPDA therefore requested that EPA confirm that these residual impurities are not covered by the proposed action.

 

In the aftermath of EPA’s recent decision to remove the 72 chemical substances from the list of approved inerts, CPDA is seeking a better understanding of what factors prompted the Agency to finalize its proposal at this particular time.  CPDA will also engage with the Agency on appropriate next steps our member companies should take in response to this development.  In so doing, CPDA welcomes input from its member companies on devising a strategy in response to the Agency’s recent and unexpected decision to delist these products.

 

The list of the 72 inert ingredients may be accessed by clicking here.

PMRA Publishes Proposed Changes to Ministerial Agreement

On December 30, 2016, Health Canada’s Pest Management Regulatory Agency (PMRA) published its long-awaited proposed revisions to the Agreement for Data Protection under Section 66 of the Pest Control Products Act (PCPA), currently known as the “Ministerial Agreement” (MA).  The MA governs the process by which an applicant for a generic pesticide registration in Canada obtains the right to use or rely on data provided by the basic registrant under the PCPA.  The MA sets forth the mechanism for entering into negotiations and arbitration over data compensation and specifies the requirements for enforcement of the arbitral award.  PMRA is accepting public comment on the proposed revisions to the MA through February 13, 2017.

 

Concurrent with its release of the draft revisions to the Ministerial Agreement, PMRA has published for public comment a consultation document on the eligibility criteria for compensable protection status for foreign test data.  This draft consultation document describes the situations under which foreign test data will be eligible for 12 years of compensable protection from the initiation date of the Canadian re-evaluation or special review for the active ingredient.  Public comment on this document will be accepted for 45 days from the December 30th publication date of the proposed consultation.

 

The CPDA-Canada Committee is in the process of reviewing both proposed consultations in preparation for the submission of comments to PMRA.  Both documents, along with instructions for submitting comment, may be accessed on PMRA’s web site by clicking here.

 

CPDA-Canada Committee Members Meet with PMRA Staff on December 15, 2016

The publication of the two draft consultation documents comes shortly after a December 15, 2016 meeting during which CPDA-Canada President Sue Ferenc and several members of the CPDA-Canada Committee traveled to Ottawa for an update from PMRA staff on possible changes to the Canadian data compensation and arbitration process.  The December 15th session was a follow up to a July 28th meeting with PMRA representatives during which CPDA-Canada members elaborated on the need for changes to the Ministerial Agreement that would facilitate the establishment of a fair and equitable data compensation scheme and remove some existing barriers to generic registration in Canada.

The December meeting also included a discussion pertaining to a CPDA-Canada Committee “white paper” that was presented to PMRA earlier in 2016.  The white paper included a summary of a literature search that was conducted to determine the number of generic products with newer chemistries that have been registered in Canada as a result of the 2010 changes to the data protection system under the “Protection of Proprietary Interests in Pesticide Data in Canada (PPIP)” regulations.  CPDA-Canada concluded that there were no generic products with newer chemistries registered since PPIP became effective in 2010.  The CPDA-Canada white paper addressed the arbitration regime set forth under the existing MA objecting that it is unworkable.  Specifically, under the arbitration terms of the existing MA, an arbitral tribunal is required to choose either the generic applicant’s “willing-to-pay” final offer or the registrant’s “willing-to-accept” final offer, a scheme referred to as Final Offer Settlement (FOS).  CPDA-Canada emphasized that the FOS approach is inappropriate for arbitration and subjects the generic registrant to inordinate financial risk.  The white paper proposed a series of minimal changes that PMRA could adopt in developing a functional data compensation scheme that levels the playing field for generic pesticides seeking market entry in Canada.

 

Other discussion at the December 15th meeting focused on PMRA’s progress in developing a searchable database for studies in support of pesticide registration submissions and changes to the Agency’s efficacy data requirements in support of the registration of tank-mix adjuvants in Canada.

 

During the meeting, PMRA representatives provided the CPDA-Canada Committee delegation several documents including:  PMRA Guidance on Adjuvants ( Published in April 2016); an Update on the Data Protection Program; and PMRA Registration Requirements for Adjuvant Products.

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