News

2017 Annual Adjuvants & Inerts Conference Speaker Presentations

CPDA’s 2017 Annual Adjuvants & Inerts Conference held May 3rd in Indianapolis, Indiana featured an informative and comprehensive speakers program that covered an array of topics such as drift reduction technologies, effective management of weed resistance, the short and long-term outlook for the agricultural economy, and challenges associated with reducing off-site drift of  auxin herbicides.  At the request of a number of our members who attended the Conference, we are providing access to the speaker presentations for whom we have received permission to post.

Dr. Greg Kruger, University of Nebraska-Lincoln

Brian Finstrom, Capstan AgSystems

Steve Smith, Red Gold Inc.

Dr. Doug Doohan, Ohio State University

Dr. Michael Boehlje, Purdue University

 

 

 

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.

House Adopts “PRIA 4” By Voice Vote

On Monday, March 20, 2017, the U.S. House of Representatives adopted by voice vote H.R. 1029, the “Pesticide Registration Enhancement Act” under a suspension of the rules.  Introduced in the 115th Congress by Representative Rodney Davis (R-IL), the measure was reported favorably out of the House Committee on Agriculture on February 16, 2017.  Among its provisions, the bill would authorize the collection of $31 million in maintenance fees for each of fiscal years 2017 through 2023 (current maintenance fees are set at $27.8 million/year).  In addition, the measure provides for an increase in the maintenance fee cap for large and small businesses and it continues the current prohibition on the imposition of tolerance fees as well as any other registration fee not specifically authorized by PRIA through fiscal year 2023.

 

In its other provisions, the measure provides for a set-aside of between 1/9 and 1/8 of maintenance fees collected for the review of inert ingredient submissions and me-too pesticide applications.  The bill also adjusts registration service fees and decision review times for product submissions subject to PRIA and provides for two 5% increases in registration service fees during the effective period of the statute.  Finally, H.R. 1029 reauthorizes existing provisions of PRIA for seven years, as opposed to the five-year extensions in previous iterations of the statute.

 

 

CPDA Conducts Legislative Policy Conference in Washington, D.C.

CPDA held its 2017 Legislative Policy Conference at the Club Quarters Hotel in Washington, D.C. on March 8th.  The conference featured a presentation and Q&A with Cameron Bishop, Legislative Director in the office of Representative Austin Scott (R-GA), Chairman of the House Agriculture Committee’s Subcommittee on Commodity Exchanges, Energy, and Credit.  Bishop provided attendees an overview of current activities in the House including an update on prospects for reauthorization of the Farm Bill this year.

 

Rep. Rodney Davis

The 2017 Legislative Policy Conference marked several important changes in format from previous years.  First, following the morning session and Legislative Committee meeting, attendees traveled to Capitol Hill for a small Congressional roundtable luncheon held in the House Agriculture Committee hearing room where several Hill staffers came by for informal conversation over a quick bite to eat.  In another important change, in lieu of the traditional Congressional reception held in years past, the 2017 Legislative Policy Conference concluded with a small dinner hosted by the CPDA-PAC at the Capitol Hill Club.  The honored guest was Representative Rodney Davis (R-IL) who chairs the Subcommittee on Biotechnology, Horticulture, and Research of the House Agriculture Committee.  As reported previously, Representative Davis is the lead sponsor of H.R. 1029, legislation to reauthorize PRIA, which was recently reported out favorably by the House Committee on Agriculture.  This small, intimate dinner provided those in attendance the chance to discuss in much greater detail a range of matters critical to the success of their business operations.  CPDA believes that the new format of this year’s Legislative Policy Conference facilitated greater interaction between Council members and their elected Representatives and provided Members of Congress and their Congressional staff a better understanding of the unique challenges agrotechnology companies face in the day-to-day management of their businesses.

Council members had the opportunity to meet Representative Rodney Davis (center) during a small dinner hosted by the CPDA-PAC at the Capitol Hill Club.

 

Cameron Bishop Addresses CPDA Members

Of course, the primary focus of the Legislative Policy Conference that brought CPDA representatives to Washington was the “Rally on the Hill” during which Council members fanned out for a series of Congressional office visits to discuss several priority initiatives and issues of importance to the agrotechnology industry.  Among these was industry’s support for the reauthorization of PRIA, the call for enactment of legislation to eliminate duplicative NPDES permitting requirements for EPA approved pesticides, the need for meaningful regulatory reform that does not subject companies to unnecessary burden and costs, and raising awareness regarding the problematic relabeling requirements of OSHA’s 2012 revisions to the Hazard Communication Standard.

CPDA Seeks Exemption for Final PRIA Actions from Administration’s Regulatory Freeze

On February 14, 2017, CPDA wrote to then-EPA Acting Administrator Catherine R. McCabe requesting that pesticide registration actions under PRIA be exempt from the regulatory freeze established under a January 20, 2017 White House memorandum mandating a temporary hold on all new or pending regulations so as to allow the Administration sufficient time to review these rule for questions of “fact, law and policy.”  The memorandum, issued by Reince Priebus who serves as President Trump’s Assistant and Chief of Staff, sets forth a Presidential directive prohibiting all federal agencies from sending any regulation to the Office of the Federal Register (OFR) for publication until a department or agency head appointed by the President reviews and approves the rule.  Rules that have been sent to the OFR but have not yet been published in the Federal Register must be immediately withdrawn pending review by the Administration.  Until such time as the restrictions detailed in the so-called “Freeze Memorandum” are lifted, EPA submission of final rulemakings to the OFR for publication of products approved under PRIA are on hold.  The memorandum does include the opportunity for an affected entity to request an exemption to the prohibition on sending a rule to the OFR and/or the necessary rescinding of a submitted but unpublished rule with specific reasoning.

 

The mandate of the Priebus memorandum has resulted in a round of negotiated due dates under PRIA for those applications currently in the pipeline as well as those awaiting the last step of publication in the Federal Register.  CPDA has learned that many member and non-member companies have received requests from the Agency for renegotiated due dates of current PRIA actions.  It is unclear whether submissions made now or since January 20th will be time-stamped for submission or whether an applicant will be notified of receipt of submission. Exacerbating this situation are reports that the Trump Administration has also ordered a freeze on all new federal contracts (the bulk of PRIA application review is performed under contract).

 

In its February 14th letter to EPA, CPDA cited a provision in the Priebus memorandum which specifically excludes from its mandate those regulatory actions subject to statutory deadlines.  CPDA explained that the primary benefit of the statutorily established review timelines under PRIA is to provide certainty and regulatory predictability while allowing for independent review of applications for product registrations.  CPDA emphasized that the delay in publication of registration approval in the Federal Register nullifies this benefit and creates a critical situation for the agricultural and pesticide manufacturing and distribution sectors whose businesses depend on the date-certain approval of products so that they are made available for use by farmers during the limited window of the spring growing season.  Any delay in making these products available to users, CPDA added, could have serious financial consequences not only for the pesticide industry but for farmers who depend on ready access to these crucial products in making their spring planting decisions.  CPDA will continue to keep a close eye on this situation and report on further developments as they occur.

CPDA-Canada Addresses PMRA Draft Consultations on Data Compensation

On February 24, 2017, CPDA-Canada submitted comments to Health Canada’s Pest Management Regulatory Agency (PMRA) in response to the Agency’s December 30, 2016 consultation document containing proposed revisions to the Agreement for Data Protection under Section 66 of the Pest Control Products Act (PCPA) formerly known as the Ministerial Agreement.  In its comments, CPDA-Canada expressed its disappointment with the changes proposed by PMRA emphasizing that the Agency “still refuses to implement an equitable data compensation and regulatory mechanism that balances the interests of companies that develop new pesticides (‘innovator’ companies) fairly with companies that produce generic pesticides (‘generic companies’).”

 

CPDA-Canada focused on the inequities inherent in the “Final Offer Settlement” (FOS) approach to arbitration maintained from the Ministerial Agreement by PMRA and recommended by the Intersol Group in its report to the Agency.  The mechanism set forth under PMRA’s consultation document on the new Agreement is essentially identical to the arbitration terms of the existing Ministerial Agreement.  Namely, an Arbitral Tribunal is required to choose either the generic company’s “willing-to-pay” final offer or the innovator company’s “willing-to-accept” final offer.  CPDA-Canada emphasized that the FOS approach is inappropriate for this type of arbitration and subjects the generic registrant to inordinate financial risk.  CPDA-Canada pointed out that there is no evidence that a single registered generic pesticide product was based on an arbitral award utilizing FOS arbitration under the existing Ministerial Agreement since 2010.  “Instead of addressing the fundamental cause of this limitation (a severely biased arbitration approach that eliminates the availability of important lower-priced agricultural products to Canadian growers), the Agency seems insistent on perpetuating the problem by maintaining this inequitable and unworkable form of arbitration,” CPDA-Canada stated.

 

In its comments, CPDA-Canada addressed the lack of provisions in the proposed Agreement that would confer upon the generic company the right to discovery during negotiations and arbitration.  CPDA-Canada emphasized that without the right to discovery, the generic company is effectively denied access to the type of information that is necessary in accurately assessing the likely profitability of commercializing the product, especially if the product in question is the first or second generic chemical to enter the marketplace.  As such, the generic company is put at a decided disadvantage in making a “willing-to-pay” final offer under the FOS arbitration approach.  Moreover, CPDA-Canada pointed out that the proposed Agreement could unfairly subject the generic company to stiff financial penalties in the form of reimbursement to the innovator company for legal costs and disbursements incurred during the arbitration proceedings.  This penalty would be applicable in situations where the generic company either withdraws from the arbitration proceedings and/or decides that it would not be economically feasible to move forward with the registration after an award is made.

 

CPDA-Canada called upon PMRA to remedy these impediments to the generic registration process by replacing the FOS approach with an unbounded binding arbitration mechanism (under the Canadian Arbitration Act or CAA) that would include the right to discovery and information sharing during negotiations.  CPDA-Canada further urged PMRA to allow the generic company to withdraw from the arbitration proceedings at any time before the award is made without fear of financial penalty and to require that arbitration costs be split between the parties with each party responsible for its own expenses.  In addition, CPDA-Canada recommended that the Agreement include timelines of 30 days for negotiations and 120 days for arbitration.  CPDA-Canada explained that particularly in situations where the product in question would be the first generic product to enter the marketplace, the innovator company is likely to delay negotiations in an effort to keep competing companies out of the market for as long as possible.  CPDA-Canada stated that there is no incentive for an innovator company to negotiate in a timely manner in such situations.  However, CPDA-Canada noted that in cases where the negotiations are progressing at a reasonable pace, the parties can mutually agree to extend the time.  The result could be a negotiated agreement and a letter of access (LOA) or a request to go to binding arbitration.  Lastly, CPDA-Canada recommended that the final offers by the party be shared with the other party when submitted to the Arbitral Tribunal.  To read the full version of the comments, please click here.

 

CPDA-Canada also submitted comments to PMRA in response to the Agency’s draft consultation document on the eligibility criteria for compensable protection status for foreign test data as proposed on December 30, 2016.  CPDA-Canada expressed its support for PMRA’s clarification of the compensation status of the foreign data the Agency considers during re-evaluations, special reviews, and the registration of generic products calling it “appropriate and needed.”  However, CPDA-Canada reiterated the need for PMRA to revise the negotiation and arbitration component of the current data compensation process so as to make it equitable.  “Unless the Agency does so,” CPDA-Canada emphasized, “the helpful clarifications of this current proposed action will remain irrelevant to achieving a ‘fair’ and ‘equitable’ data compensation process for timely registration of generic products based on newer chemistries.”  To read CPDA-Canada’s comments, please click here.

 

(To learn more about the draft consultations proposed by PMRA please visit our archived news item by clicking here).

 

 

PMRA Issues 2015-2016 Annual Report

Health Canada’s Pest Management Regulatory Agency (PMRA) has issued its annual report for its 2015-2016 fiscal year which provides a summary of the Agency’s accomplishments and activities during this period.  According to the report, 18 new active ingredients were registered for use in Canada during 2015-2016, resulting in the registration of 38 new end-use products.  In addition, during 2015-2016, PMRA registered 44 generic products including 27 technical or manufacturing products and 17 end-use products.  In its other highlights, the report summarizes PMRA’s progress in meeting its 2015-2016 proposed targets for the initiation and completion of re-evaluations and special reviews.  The PMRA annual report 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.