News

CPDA Adjuvants & Inerts Conference to Feature Key Experts on Major Topics in Agrotechnology

The CPDA Annual Adjuvants & Inerts Conference – Agrotechnology Challenges in Today’s Ever-Changing Market – will provide attendees unique opportunities to hear from experts from around the nation about trends and developments shaping the current state of the agrotechnology industry. The program features presentations and panel discussions on a range of key topics, including how changes to the California’s Proposition 65 labeling requirements, which go into effect August 30, 2018, could affect many pesticide and adjuvant labels. Inert products used in adjuvant or pesticide formulations could be also be subject to the label changes.

In March, as part of the Council’s Regulatory Conference, CPDA members met with officials at the EPA Office of Pesticide Programs to discuss, among other issues, how the Agency was preparing to handle potential changes that could affect pesticide labels and seek guidance for the regulated community on how to comply with dual requirements of federal and state regulators. At the 2018 conference, Dr. Renee Pinel, President of the Western Plant Health Association, will continue to highlight this important issue and provide conference attendees an understanding of what needs to be done to meet the new requirements for a proper Proposition 65 label warning.

Other key topics to be featured at this year’s conference include:

  • “Biostimulant” Regulations in the United States and Canada
  • Drift Reduction Technology
  • Auxin Herbicides and Weed Resistance Management
  • Rhizosphere Engineering – Innovative Approach to Influence Soil Health
  • The Organic Materials Review Institute Program
  • Advancements in Tank Cleaning Technology

This year’s keynote speaker will be Dr. Matthew Phillips, a well-known authority on the agricultural chemicals industry, whose address will discuss how companies are navigating and re-positioning themselves to remain competitive amid the many multi-national corporate mergers and consolidations taking place today. The full conference program can be viewed here.

CPDA will host two conference receptions on the evenings of May 1st and 2nd, as well as a CPDA-PAC sponsored golf tournament on May 1st at Canyon Springs Golf Club, located just 20 minutes from the San Antonio River Walk. For more information about the golf, please contact CPDA Director of Legislative Affairs, Don Davis at  ddavis@cpda.com  or (202) 386-7407. CPDA will not have a Sporting Clay Shooting networking option for May 1st, due to the unavailability of multiple locations.

The 2018 A&I Conference is made possible through the generous sponsorships of companies including:

Huntsman Performance Products, Helena Agri-Enterprises, Stepan Company, Chemorse, Oxiteno USA, LLC, Oleon, Precision Laboratories, LLC, AkzoNobel Surface Chemistry, KALO Inc, Croda Inc, Evonik Corporation, Dow Crop Defense, Clariant Corporation, Exacto Inc, Albaugh Inc., and Brandt Incorporated.

For information and further details about the conference program and sponsorship opportunities, please contact CPDA Director of Regulatory Affairs Sylvia Palmer at spalmer@cpda.com or (202) 386-7407.  You may also visit the conference registration page here.

We look forward to seeing you in San Antonio!

House Version of Farm Bill Includes PRIA and NPDES Provisions

On April 12, 2018, Representative Mike Conaway (R-TX), Chairman of the House Committee on Agriculture, introduced H.R. 2, the “Agriculture and Nutrition Act of 2018,” also known as the Farm Bill.  As written, H.R. 2 contains two provisions strongly supported by CPDA – namely, it would enact into law H.R. 1029, the “Pesticide Registration Enhancement Act” which provides a long-term reauthorization of PRIA along with an increase in maintenance fees, an adjustment in registration service fees as well as product category/review times, and eliminates the existing constraint on spending maintenance fees without matching appropriation dollars as contained in current PRIA.  H.R. 2 also includes language that would amend FIFRA and the Federal Water Pollution Control Act (the Clean Water Act) to prohibit EPA or a state from requiring an additional permit under the Clean Water Act for a discharge of a pesticide from a point source into navigable waters of the United States.  This provision in the Farm Bill to eliminate the National Pollutant Discharge Elimination System (NPDES) permit for FIFRA registered pesticides is similar to language in H.R. 953, the “Reducing Regulatory Burdens Act.”

CPDA has been a strong proponent of both H.R. 1029 and H.R. 953 and has engaged in extensive lobbying efforts in building a broad base of support for each of these legislative initiatives in the 115th Congress.  CPDA will continue its efforts in seeking enactment of these provisions as part of the next Farm Bill and will keep its members informed of further developments as they occur.  Should you have any questions, please contact CPDA Director of Legislative Affairs Don Davis at ddavis@cpda.com or call CPDA’s office at (202) 386-7407.

The following is a brief recap of activity surrounding H.R. 1029 and H.R. 953.

PRIA Reauthorization (H.R. 1029)

As reported previously, H.R. 1029 (“PRIA 4”) was passed by the House on March 20, 2017 under a suspension of the rules and would extend EPA’s ability to collect maintenance fees through 2023 at $31 million/year (current maintenance fees are set at $27.8 million/year).  The bill would also allow EPA to average across years to correct for over or under collection of maintenance fees.  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, PRIA 4 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 measure 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 would remove the existing prohibition in PRIA which bars EPA from spending maintenance fees without a matching appropriation thus allowing the Agency better access to carryover maintenance fee funds that have built up partially due to this restriction.  The removal of this limitation would free up additional resources to be spent on such activities as the Agency’s obligation under registration review to complete decisions on 725 chemical cases by October 1, 2022.

Elimination of NPDES Permitting Requirements (H.R. 953)

H.R. 953, the “Reducing Regulatory Burdens Act,” would amend FIFRA and the Clean Water Act to eliminate the requirement to obtain a National Pollutant Discharge Elimination System (NPDES) permit for the application of FIFRA registered pesticides in, over, or near waters of the United States.  The measure, which passed the House on May 24, 2017 by a vote of 256-165 under a suspension of the rules, would overturn a 2009 U.S. Sixth Circuit Court of Appeals decision in National Cotton Council v. EPA which required the Agency to establish a federal permitting system for the application of pesticides on, over or near navigable waters subject to Clean Water Act jurisdiction.  The bill also clarifies Congressional intent that NPDES permits are not required for lawful pesticide applications and shields pesticide users from litigation arising from the use of registered but unpermitted pesticides.  The legislation adopted by the House was referred to the Senate Committee on Environment and Public Works where it awaits further action as S. 340.  CPDA has been a strong advocate of this measure and has written numerous letters to members of Congress and participated in a series of lobbying visits in seeking to advance this measure through the legislative process.

PRIA 3 Extension Included in Omnibus Spending Bill Signed Into Law

On March 23, 2018, the President signed into law the omnibus spending bill that provides funding for government operations through the remainder of the 2018 federal fiscal year ending September 30th.  CPDA is pleased to report that included in the omnibus spending measure is an extension of current PRIA (PRIA 3) through September 30th of this year.  The legislation funds EPA’s pesticide program at current levels and includes an additional $6.96 million increase for product review activities associated with PRIA.

 

As reported previously, PRIA has been extended in a series of stop-gap funding measures or Continuing Resolutions (CR) since September 30th of last year. While the measure enacted as part of the omnibus spending bill extends PRIA 3 through September 30, 2018, reauthorizing legislation still needs to be enacted to ensure the continuation of the statute beyond that date.  Importantly, PRIA 4 as a legislative proposal could still be considered by Congress and passed into law. The main issues CPDA is concerned with regarding the current status of PRIA are as follows:

 

Funding:  The industry would like to see the modification of funding mechanisms that allow fees to be “sequestered” when they do not equal federal appropriations.  CPDA’s position, in line with other stakeholders and EPA leadership, is that this system should be changed so that when fees are collected they can be used to process applications. This should help in addressing any delays or backlogs. This change is included in PRIA 4.

 

Reauthorization period: While the House version of PRIA 4 extends the program for 7 years, the Senate changed the reauthorization to 3 years. CPDA’s position, in line with other stakeholders and EPA leadership, is that it would be better to have the extended reauthorization period but not at the cost of the legislation failing to pass. CPDA will continue to work with stakeholders and the Agency in developing an acceptable resolution of this issue.

 

During the weeks leading up to passage and enactment of the omnibus spending measure, CPDA made a series of House and Senate office visits in seeking Congressional support for inclusion of PRIA as part of the funding package.  CPDA also asked its member companies to supplement these lobbying activities by writing to their Senators and Representatives urging support for PRIA as part of the next budget bill.  To all those CPDA member companies who participated in this grass roots effort, we would like to convey our thanks.  The calls and letters of our member companies to their senators and representatives helped CPDA’s advocacy efforts on PRIA.

 

Nevertheless, much work remains to be done.  In the months ahead, CPDA will dedicate its efforts in securing the enactment of legislation to reauthorize PRIA beyond September 30th.  To this end, CPDA continues to work closely with other members of the PRIA Coalition in building consensus and Congressional support for this critical legislation.

 

CPDA will keep its members informed of further developments as they occur.  In the interim, should you have any questions, please contact CPDA Director of Legislative Affairs Don Davis.

CPDA 2018 Regulatory Conference Speaker Presentations Now Available

Speaker presentations from the very productive 2018 CPDA Regulatory Conference, held on Tuesday, March 13th in Arlington, Virginia, are now accessible on CPDA’s web site.  The program featured an array of speakers who addressed key topics such as market forces and economic factors shaping trends in corporate mergers within the agricultural chemicals industry, an update on priority activities underway within EPA’s Office of Pesticide Programs (OPP) including the Agency’s inert ingredient assessment branch, an overview of FIFRA related developments with a special focus on the status of the reauthorization of PRIA, efforts to synchronize the consultation process under the Endangered Species Act, and related topics impacting the agrotechnology industry, the status of OSHA’s plans to revise its Hazard Communication Standard (HCS) to better align it with the latest iteration of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and the implications of new product labeling requirements that will take effect at the end of August 2018 under California’s Proposition 65 ballot initiative.  The CPDA Regulatory Conference concluded with a meeting at the headquarters of the Office of Pesticide Programs where attendees had the opportunity to engage with EPA personnel on important regulatory issues of importance to Council members and the industry.

 

The CPDA Regulatory Conference speaker presentations may be accessed by clicking the links below.

 

“Impact of Mergers in Agricultural Chemical Markets,” James MacDonald, U.S. Department of Agriculture

 

“2018 FIFRA Regulatory Outlook,” Sheryl Lindros Dolan, Bergeson & Campbell, P.C.

 

“Overview of OPP Priorities and Issues,” Michael Goodis, U.S. Environmental Protection Agency

 

“Pesticide Inert Ingredient Activities,” P.V. Shah, U.S. Environmental Protection Agency

 

“Impact of Upcoming Changes to California Proposition 65,” Dave Lawson, Western Plant Health Association

 

“Hazard Communication Standard and GHS Update,” Maureen Ruskin, U.S. Occupational Safety and Health Administration

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.

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