News

House Agriculture Committee Approves PRIA Reauthorization Bill

The 115th Congress of the United States has convened and one of the most important issues that CPDA and its members are working on is the reauthorization of the Pesticide Registration Improvement Act (PRIA).  PRIA was first enacted as part of the Consolidated Appropriations Act of 2004 to establish firm deadlines by which EPA must make decisions on pesticide registration actions submitted to the Agency.  As originally enacted, the Act required Congress to reauthorize the program through legislation every 5 years with the current program set to expire on September 30, 2017.

 

A measure, titled the “Pesticide Registration Enhancement Act of 2017” (H.R. 1029), was introduced in the House on February 14, 2017 by Representative Rodney Davis (R-IL) and was favorably reported out of the House Agriculture Committee by voice vote on February 16th.  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.  A copy of the bill may be accessed by clicking here and a section-by-section summary is available here.

 

While CPDA is generally supportive of the provisions in H.R. 1029, the Council does have some concerns with regard to how the bill, as presently written, would impact appropriations.  Specifically, current PRIA requires that in order to release collected funds, Congress must appropriate corresponding funds to support the program. Funds are then released on a dollar-for-dollar accounting basis.  Fees that do not have a matching appropriation cannot be spent and are held by the Agency.  As a result of dwindling appropriations, EPA has amassed a significant amount of funds totaling approximately $20 million that cannot be expended on the registration activities for which they were intended.  Some have suggested that “de-linking” appropriations and fees in the Act will solve this problem.  CPDA believes that de-linkage is an inappropriate way to release these frozen funds because:

  • The link between fee collection and appropriations is the mechanism that guarantees that Congress will continue to fund PRIA;
  • De-linkage does not solve the ongoing problem of the mismatch between appropriations and fee collections; and
  • The problem of the mismatch between appropriations and fee collections can be easily solved by passing a one-time waiver to release currently frozen funds.

 

CPDA is working with lawmakers to support a waiver process that would allow these funds to be released while maintaining the Congressional incentive to appropriate the necessary funding to support PRIA.  The original intent of PRIA was to create an EPA funding mechanism that would completely support the pesticide registration process through funds collected from industry (maintenance and registration fees) as a supplement to the appropriations enacted by Congress.  However, due to the failure of Congress to enact the base level of appropriations specified in current PRIA, EPA’s registration program has not seen full funding for the past several years.  Over the coming weeks and months, CPDA staff will be visiting with members of Congress to address this issue.

 

With regard to the timing of how PRIA might move through Congress, it is expected that the measure will be the subject of at least one hearing, if not several, all of which will likely wrap up by late spring before the bill is sent to the House floor for a vote.  Once approved by the House, the measure will be sent to the Senate for consideration and passage.  A joint House-Senate committee must then reconcile any differences in the legislation as passed by both chambers.  The bill will then be sent back to the House and Senate floors for a vote before going to the President to be signed into law.  The process of moving a bill through Congress can be slow or fast depending on the issues involved.  PRIA is expected to move in a “normal manner” with a target for completion either right before or soon after the August recess.

 

The reauthorization of PRIA will be one of the key advocacy issues to be discussed during the Congressional office visits we are planning as part of the CPDA Legislative Policy Conference scheduled for March 8, 2017.  We encourage all member company representatives to attend.  Additional information on how to register for the Conference is available 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.

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.

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.

We’re Working on It!!

Welcome to the new and revamped CPDA web site!  As you can see, we’re still going through some growing pains and pulling our hair out as we continue to build a site that will better serve your needs.  Please be patient with us as we go through this process.  Once done, we promise you will be pleased with the results!

PMRA Publishes Proposed Amendments to the Pest Control Products Regulations

On December 10, 2016, a set of proposed amendments to the Pest Control Products Regulations (PCPRs) was published in the Canada Gazette by Health Canada’s Pest Management Regulatory Agency (PMRA).  Among these is a revision to the data protection (arbitrator liability) provisions of Subsection 17.91(4) of the PCPR that would allow the arbitrator to extend the 120-day time period during which an arbitral award must be made upon notifying the parties to an arbitration.  PMRA states that this proposed amendment is similar to the ability of the parties to agree to an extension as already provided for under existing regulations.  The proposed amendment addresses concerns that an arbitrator/arbitral tribunal may not be able to comply with the mandatory 120-day timeline for issuing an arbitral award in a situation where, for example, one or both parties in the arbitration “fail to cooperate sufficiently so that a decision can be made within the required time period.”  A copy of the proposal as it appears in the Canada Gazette may be accessed by clicking 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.