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EPA Seeks Public Comment on its Interpretation of the Definition of a Label “Panel” in Relation to Placement of First Aid Statements

EPA is inviting public comment on its interpretation and clarification of the definition of a label “panel” and the placement of first aid statements on such labels based on the product’s Toxicity Category.  The Agency’s interpretation and clarification were set forth in a December 2016 memorandum in which the Agency explains that while the Code of Federal Regulations (CFR) does not specifically define the term “panel,” the CFR does nonetheless stipulate that first aid statements must appear on the front panel for Toxicity Category I products and any panel for Toxicity Category II and III products.  EPA plans to update its Label Review Manual to reflect this clarification of the term “panel” in relation to the placement of first aid statements on the label for Toxicity Category I products and, in preparation, has established a public comment period ending on March 7, 2017.  Comments may be submitted to EPA docket number EPA-HQ-OPP-2016-0545 which may be accessed by clicking here.

 

In its memorandum, EPA references PR Notice 2001-1 which states, “First aid statements for other than Toxicity Category I products may appear on the front, side or back panel of the label.  Any time first aid statements appear on the side or back panel of the label, EPA expects that a referral statement such as ‘see side/back panel for additional precautionary statements’ will appear on the front panel of the label near the signal word.  First aid statements appearing on the side or back panel of the label would then be grouped near the other precautionary labeling, yet be set apart or distinguishable from the other label text.”

 

The Agency reiterates its long-standing interpretation of the term “panel” as being that portion of a label that is immediately visible on a pesticide product at the time the pesticide is sold or distributed.  As such, first aid language must be readily seen on a visible panel (front, side or back depending on Toxicity Category) and may not be placed inside multi-page labeling (i.e., “extended text,” “accordion,” “saddle stitched,” “pull-out,” “booklet,” or other type of formatted labels) that would be accessible only by manually opening a booklet or unfolding accordion style pages.  EPA states that this interpretation of the term “panel” is consistent with the guidance contained in PR Notice 2001-1.  While EPA acknowledges that it will consider requests for alternative placement of first aid language on a case-by-case basis, the Agency underscores “it is unlikely we would allow Toxicity Category I first aid statements to be placed only within a fold-out label format.”

 

CPDA welcomes feedback from its member companies on the possible ramifications of the Agency’s interpretation of the term “panel.”  Please click here to read EPA’s memorandum.

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.

CPDA-Canada

CPDA-Canada is an incorporated subsidiary in Canada of the Council of Producers & Distributors of Agrotechnology based in Washington, DC, USA. CPDA-Canada was created in 2013 in response to growing interest from CPDA members looking to establish a firm foothold in the Canadian agrotechnology market that would provide growers greater access to effective and competitively priced generic pesticide products and tank-mix adjuvants.

CPDA-Canada is the only legally incorporated trade association in Canada representing the interests of manufacturers, formulators, and distributors of post patent pesticides and tank-mix adjuvant products, working to minimize current barriers to market entry.

CPDA-Canada strives to replicate CPDA’s U.S. successes in Canada; to bring fairness and equity to the Canadian pesticide industry. CPDA-Canada works diligently to better increase  the availability of high quality, low priced post patent pesticides and adjuvant products to Canadian growers and producers.

CPDA-Canada membership is open to any U.S or Canadian company that manufactures, formulates or distributes agrotechnology products in the United States and/or Canada. CPDA-Canada members have access to the resources of an experienced organization dedicated to advocating for the Canadian agrotechnology industry before regulatory officials. For more information, contact us at 202-386-7407

CPDA Submits Comments on EPA’s Proposed Registration Review Decision for 22 Sulfonylurea Herbicides

On Monday, November 14, 2016, CPDA submitted comments to EPA in response to the Agency’s “Proposed Interim Registration Review Decision for 22 Sulfonylurea (SU) Herbicides.”  The availability of the proposed interim decision document was originally announced for public comment in the July 14, 2016 Federal Register and subsequently reopened for public comment in the September 28, 2016 Federal Register.

 

In its comments, CPDA objected to EPA’s proposed adoption of an “ultra-conservative” approach which would mandate the use of very coarse nozzles for all 22 SUs including those chemicals in the group with the smallest risk footprint.  CPDA called upon the Agency to instead determine for each SU whether a medium, coarse or very coarse droplet nozzle is appropriate, balancing the marginal benefit of the mitigation measure with the costs to farmers and the potential for inadvertent promotion of weed resistance.  CPDA emphasized that a blanket requirement calling for the use of coarse nozzles for all of the SU herbicides ignores the benefits that can be derived from employing Drift Reduction Technology (DRT) in the application of these chemicals, including the use of certain adjuvant-nozzle combinations that have been shown to reduce drift.  CPDA stated, “Each SU herbicide may have a different toxicity index and thus exhibit a unique set of characteristics when used with various adjuvant-nozzle combinations.  These are DRT practices that offer better herbicide performance, resistance management and drift reduction.”  CPDA pointed out that EPA’s “one size fits all” approach would actually result in an effect contrary to the Agency’s stated objective of minimizing herbicide resistance.  The less efficacious application method of using coarse nozzles, CPDA explained, would likely result in farmers resorting to increased application rates and increased numbers of applications in trying to achieve the same desired outcomes in weed control.  Such activity could actually promote, rather than reduce, herbicide resistance.  CPDA concluded its comments by offering to meet with EPA to provide more information on the effect of droplet size on the efficacy of SUs and pesticides.  To read CPDA’s comments, please click here.

OSHA Petition

HCS 2012

CPDA Calls Upon OSHA to Amend HCS 2012 Relabeling Requirements to Protect Warehouse Employees from Unnecessary Chemical Exposures and Ergonomic Risks

 

On May 24, 2016, the Council of Producers & Distributors of Agrotechnology, the Agricultural Retailers Association, the International Sanitary Supply Association, and the Society of Chemical Manufacturers and Affiliates submitted a petition to the U.S. Occupational Safety and Health Administration (OSHA) requesting that the Agency issue a Direct Final Rule to amend its 2012 Hazard Communication Standard (HCS 2012).  The revision sought by the petitioners would clarify that when firms handling products in sealed containers in warehouses become aware of significant new chemical hazard information they may comply with HCS 2012 by the electronic transmission of an updated label to downstream entities in a manner similar to how updated safety data sheets are transmitted.

CPDA is now working with Members of Congress in an effort to build support for the remedy to the HCS 2012 dilemma as set forth in the joint industry petition.

The cover letter accompanying the petition may be accessed by clicking here.  Following the submission of the petition, CPDA issued a news alert which may be accessed here.