News

PMRA Releases its 2016-2017 Annual Report

On February 5, 2018, Health Canada’s Pest Management Regulatory Agency (PMRA) published its 2016-2017 annual report which provides a summary of the Agency’s pesticide registration and re-evaluation/special review activities for the year.  According to PMRA, in 2016-2017 a total of 54 generic pesticide products were registered in Canada including 33 technical or manufacturing grade products and 21 end-use products.  In its report, PMRA highlights the importance of the availability of generic pesticides emphasizing that these products “enhance market competition to the benefit of users, including growers.”  The Agency states that it continues to seek ways to improve the data protection program for innovator companies and generic registrants.  However, PMRA makes no reference to the status of its December 30, 2016 consultation document containing proposed revisions to the Agreement for Data Protection under Section 66 of the Pest Control Products Act (currently called the Ministerial Agreement for Data Protection under the Pest Control Products Act).

The Agreement sets forth the mechanism for data compensation and arbitration that must be followed when a generic registrant wishes to rely on the data generated by the innovator in support of the registration of a generic product.  As reported previously, on February 17, 2017, CPDA-Canada submitted comments to PMRA on the proposed revisions expressing disappointment that the changes did not remedy the inequities and obstacles inherent in the Canadian data compensation and arbitration/negotiation process.  CPDA-Canada representatives will be meeting with PMRA officials on April 18th to continue the ongoing discussions with the Agency on how the Canadian data compensation and arbitration mechanism can be made more equitable and balanced so as to meet the Agency’s objective of enhancing market competition.

In other areas, PMRA reports that in 2016–2017, the Agency published final decisions for 15 re-evaluations and eight special reviews.  Of these, nine re-evaluations and four special reviews, involving 374 end-use products, were scheduled for future publication in accordance with PMRA’s 2015–2020 work plan.  However, PMRA acknowledges that it did not meet its overall 80% performance target for re-evaluations and special reviews as called for in the 5-year work plan.  The Agency cites contributing factors such as significant resources being diverted to the re-evaluation of neonicotinoids and other priority areas.

To access a copy of the PMRA 2016-2017 annual report, please click here.

CPDA Provides Recommendations to EPA on the Agency’s Voluntary Drift Reduction Technology Program

On January 8, 2018, CPDA sent a letter to Jeff Herndon, Acting Director of EPA’s Office of Pesticide Programs, with recommendations for how the Agency’s Drift Reduction Technology (DRT) program testing protocol could be made more workable to increase industry participation in the program.  The letter is a follow-up to a meeting of members of the Council’s DRT work group with EPA staff on November 16, 2017.

 

CPDA emphasized that modifying the current DRT test protocol to allow use of an appropriate surrogate for adjuvant testing would remove a significant barrier that has obstructed growth of the program.  CPDA explained that instead of testing an adjuvant with each pesticide formulation and each nozzle, a protocol that would allow for the use of a surrogate in place of a pesticide formulation would provide one verified product to test.  In so doing, companies seeking a star rating under the DRT program would no longer need to test every active ingredient with every nozzle for each adjuvant – a very costly and burdensome endeavor that has deterred participation in the program.

 

CPDA also pointed out the need for guidance to address the type of star rating language that should be added to a label.  CPDA emphasized that unless such ratings appear widely on pesticide labels, the program provides no benefit to customers looking to select verified DRT rated products.

 

CPDA will continue to work with the Agency and provide specific input aimed at making the DRT program more widely accepted throughout the agrotechnology industry.  To read the CPDA January 8th letter to EPA please click here.

Gary Halvorson is Named Interim President of CPDA

The CPDA Board of Directors is pleased to announce that Gary Halvorson, formerly with WinField United and most recently co-chair of the CPDA Agrotechnology Committee, has been appointed to serve as Interim President of the Council.  Gary assumed his new role effective December 18, 2017 following the departure of Susan A. Ferenc on December 15, 2017.  Gary is a familiar face to many CPDA members, having served as a long-time member of the CPDA Board of Directors, and Chairman from 2012-2013. He has also served as an officer on the CPDA Executive Committee.  Throughout his involvement with CPDA, Gary has shared his expertise and guidance with staff to help advance an array of regulatory priorities of critical importance to the Council membership.  He has provided leadership on various CPDA work groups addressing key regulatory issues.  During the 2014 Summer Conference & Annual Meeting held in Santa Fe, New Mexico, Gary was honored with the CPDA “Service to the Council Award” in recognition of his efforts in working with staff on a range of critical issues of importance to manufacturers, formulators and distributors of agrotechnology products both in the U.S. and in Canada.  Gary may be reached at CPDA’s offices at (202) 386-7407 or by email at ghalvorson@cpda.com.  Please join us in welcoming Gary as he assumes the duties of Interim President of CPDA.

CPDA Requests Two-Year Extension of December 1, 2017 Relabeling Deadline Under HCS 2012

On October 4, 2017, CPDA President Sue Ferenc sent a letter to Thomas Galassi, Acting Deputy Assistant Secretary of Labor of the Occupational Safety and Health Administration (OSHA), requesting a 2-year extension of an impending December 1, 2017 deadline under the 2012 Hazard Communication Standard (HCS 2012) for the relabeling of non-pesticide agricultural products, under the control of a distributor, that are packaged in sealed containers and stored in warehouses.  The deadline is set forth under OSHA Directive Number CPL 02-02-079, issued on July 9, 2015.  The October 4 letter follows a September 19, 2017 meeting with William Perry and Maureen Ruskin, Director and Deputy Director, respectively, of OSHA’s Directorate of Standards and Guidance, during which CPDA staff conveyed the Council’s concerns regarding the December 1 deadline.  CPDA representatives explained that while OSHA had indeed granted temporary relief from the original deadline of December 1, 2015, such relief was limited in scope and duration and did not fully take into consideration the unique way in which non-pesticide agricultural products are sold and resold in the agricultural chemicals marketplace.  CPDA representatives asked OSHA to consider granting an extension of the deadline in the form of an amendment to its Directive that would apply specifically to products of extremely long shelf life including tank-mix adjuvants, plant nutritional products (i.e., biostimulants and biorationals), soil amendments and fertilizers in end-use containers (bags and jugs).

As reported previously, CPDA has engaged extensively with OSHA on advocating for changes to HCS 2012 that would stipulate that sealed containers in warehouses would not have to be relabeled based on new hazard information if an updated label is transmitted electronically to downstream entities as is allowed for updated safety data sheets.  Throughout these discussions, OSHA officials have been open to considering the Council’s suggestions for possible modifications to the regulation and hinted the possibility of incorporating this in future rulemaking aimed to better align HCS 2012 with the sixth revision of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  CPDA is drafting comments for submission to an OSHA open docket that will urge the Agency to follow EPA’s “Released for Shipment” precedent to prevent the need to relabel compliantly labeled pesticide products once manufactured and released for warehousing and distribution.  CPDA will also encourage allied associations representing affected members of the chemical manufacturing and distribution industry to submit similar comments to the docket.

In the meantime, CPDA will continue to work with OSHA in securing that extension to the December 1st deadline for compliance with the Directive.  To read a copy of the October 4th CPDA letter, please click here.

CPDA Provides OSHA an Evaluation of Cost Impact of HCS 2012 Relabeling Requirements

On April 21, 2017 CPDA President, Sue Ferenc wrote a letter to Maureen Ruskin, Deputy Director of OSHA’s Directorate of Standards and Guidance, that details the significant financial costs that would be imposed upon distributors of non-pesticide agricultural products under the relabeling requirements of  paragraph (f)(11) of the  Hazard Communication Standard (HCS 2012).  CPDA’s letter was submitted in response to a request made by OSHA, during a November 16, 2016 stakeholder meeting, that the Council evaluate the regulatory ramifications of substituting the word “manufactured” for the word “shipped” in paragraph (f)(11).  During the November stakeholder meeting, OSHA also requested that CPDA provide supplemental information on costs associated with relabeling products in warehouses due to the current use of the word “shipped” in the regulation, instead of the word “manufactured” as CPDA has proposed.

 

OSHA’s request came as the Agency announced that it would be initiating efforts to modify HCS 2012 to better align the rule with the sixth revision of the GHS.  Agency officials have signaled that potential revisions to HCS 2012 could encompass a range of implementation issues including those emanating from section (f)(11) of the regulation that requires non-pesticide agricultural product labels to be updated within six months of receiving new hazard information before they can be shipped from the warehouse.

 

CPDA has engaged extensively with OSHA on this issue voicing concerns that warehouses are not equipped to safely relabel sealed product containers and that this requirement would subject warehouse workers to unnecessary health and safety risks.  Moreover, CPDA has argued that OSHA’s switch from “hazard determination” to “hazard reclassification” as the trigger for relabeling product under HCS 2012 is likely to result in a “dynamic” or recurring and costly compliance requirement that will significantly expand the scope of the (f)(11) provision of the regulation.  In addition, CPDA has objected that this provision of HCS 2012 conflicts with another requirement in the rule that prohibits defacing or removing labels from hazardous chemicals in sealed containers in warehouses.

 

In its April 21st letter, CPDA reiterated its recommendation that OSHA follow the “Released for Shipment” precedent that was developed when EPA amended its pesticide container and containment final rule to identify the point in time that a product first enters commerce and becomes subject to label compliance enforcement.  This is when the product leaves the production line for storage, sale or distribution, and is packaged and labeled in a manner in which it will be distributed, sold or stored.  Thus, CPDA explained, a production unit is “Released for Shipment” only once and retains that status, including its label compliance status, until it dissipates in commerce.

 

In its letter, CPDA summarized the results of an informal survey of its member companies regarding the costs and options associated with the potential need to relabel product that was compliantly labeled when manufactured.  CPDA pointed out that for the agrotechnology product industry alone, if revision of HCS 2012 does not exempt HCS 2012-compliantly labeled warehoused products from the requirement to be relabeled given reclassification or rulemaking, all individual “end-use” product containers could need to be relabeled.  “A very conservative estimate of the number of agrotechnology product containers that would have to be relabeled by distributors,” CPDA stated, “would be approximately 1,250,000 containers on 13,500 pallets.”  CPDA noted that the costs of relabeling or reworking product in the warehouse or reworking the product by shipping and repackaging elsewhere, will vary greatly depending on such factors as product type (liquid versus dry), container type (small jugs, large bulk tanks/totes, plastic bags), and the volume as well as value of the product.  CPDA emphasized, “There are no economies of scale in relabeling product so the cost to relabel high volumes of product containers can be crippling.”

 

As OSHA proceeds with its consideration of possible revisions to HCS 2012, CPDA will continue to advocate for the requested change from “shipped” to “manufactured” in any modification of the regulation.  A copy of CPDA’s April 21st letter may be accessed by clicking here.

OSHA Acknowledges CPDA Concerns in Response to Joint Industry Petition on Relabeling Requirements of HCS 2012

 

The U.S. Occupational Safety and Health Administration (OSHA) has issued a December 9, 2016 response to the joint industry petition filed on May 24, 2016 by CPDA, the Agricultural Retailers Association, the International Sanitary Supply Association, and the Society of Chemical Manufacturers and Affiliates requesting that the Agency issue a Direct Final Rule to amend its 2012 Hazard Communication Standard (HCS 2012).  Under the existing regulations, all products bearing 1994 or 2012 compliant labels when initially received in a warehouse are subject to relabeling within six months of obtaining new hazard information before they can be shipped from the warehouse.  CPDA and the other petitioners sought to have OSHA 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.  Unfortunately, OSHA denied the request for a Direct Final Rule maintaining that the remedy sought by the petitioners constituted a “multifaceted” change to the HCS 2012 that would impact not only manufacturers and distributors, but workers as well and hence would require a full rulemaking with notice and comment.  However, the Agency did express its willingness to consider CPDA’s concerns as OSHA begins the process of initiating a rulemaking to align the HCS 2012 with the sixth revision of the GHS.  Specifically, OSHA acknowledged CPDA’s concerns with regard to the significant chemical exposure and ergonomic risks that workers would be subjected to if required to re-label products previously packaged for shipment and stored in warehouses.  Furthermore, OSHA recognized the concerns articulated by CPDA that most warehouses lack the automated equipment necessary to re-label these products in an ergonomically safe and effective manner.

 

These issues were raised by CPDA President Sue Ferenc during a November 16, 2016 “listening session” conducted by OSHA for purposes of receiving stakeholder input as the Agency prepares to begin its rulemaking to revise the HCS 2012.  As a follow-up to the November meeting, CPDA is preparing comments for submission to OSHA in early January on the relabeling impacts of HCS 2012 as it is currently written, including its associated ergonomic and worker safety risks, estimated compliance costs, and the regulatory impacts of allowing revised labels to appear on products manufactured (rather than shipped) six months after learning of significant new hazard information.  To read OSHA’s December 9, 2016 response to the joint industry petition, click here.

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.

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