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September 2017

PMRA Publishes Amendments to Pest Control Products Regulations to Implement CETA

On September 7, 2017, the Pest Management Regulatory Agency (PMRA) published in the Canada Gazette a set of amendments to the Pest Control Products Regulations (PCPR) for implementation of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA).  A key objective of CETA is to eliminate trade barriers between Canada and the European Union (EU) on most goods.  The recently published amendments have an effective date of September 21, 2017 and seek to align the PCPR with Article 20.30 of CETA which requires Canada to promulgate regulations aimed at avoiding duplicative animal testing.  Under the amendments, an applicant or registrant of a pest control product will be allowed to rely on a previous study involving animals rather than completing a new, duplicative study in support of an application, re-evaluation or special review of a chemical.  PMRA states, “Health Canada is engaged in ongoing efforts to develop and implement testing methods that avoid the use of live animals and adhere to the ‘Three Rs’ (reduce, refine, replace), which are the guiding principles for more ethical use of animals in testing.”  PMRA provides as an example Health Canada’s implementation of guidance and criteria that allow for data waivers and bridging or extrapolation of data from one pesticide product to another.

Prior to the promulgation of the amendments to the PCPR, Health Canada consulted with affected stakeholders, including generic pesticide product manufacturers, in early May 2017.  As part of this outreach effort, Health Canada invited interested parties to engage in a May 4, 2017 conference call and webinar that had 40 participants.  During this event, several stakeholders representing the generic pesticide manufacturing industry urged Health Canada to create an online accessible database of existing test data which would identify the protection status of such data.  Generic registrants also called upon Health Canada to specify in the database which data have already received compensation in the EU.  Health Canada noted that it is working on the establishment of an online database that would be available to applicants and registrants for purposes of viewing the status of protected data.  However, with regard to tagging that data for which compensation has already been made in the EU, Health Canada maintained that this information would be disclosed during the normal course of data compensation negotiation and/or arbitration proceedings.

The amendments to the PCPR as published in the Canada Gazette may be accessed by clicking here.

CPDA Agrotechnology Committee Holds Inaugural Meeting as Newly Restructured Entity

On September 8, 2017, the CPDA Agrotechnology Committee held its first inaugural meeting via conference call.  As reported previously, the CPDA Board of Directors approved the merger of the CPDA Regulatory and Adjuvants & Inerts Committees to establish a new CPDA Agrotechnology Committee effective September 1, 2017.  This move was designed to provide a more efficient structure for managing the regulatory and non-regulatory priority issues for CPDA members, while minimizing the duplication of issue management activities.  The CPDA Agrotechnology Committee is co-chaired by Dave Ferguson (Huntsman Corporation) and Gary Halvorson (independent consultant).

 

During its September 8th call, the Committee took several important actions including its decision to reconstitute the CPDA DRT Work Group.  Historically over the years, this Work Group has collaborated with EPA in providing input on the development of the Agency’s voluntary Drift Reduction Technology (DRT) program. Committee members agreed that the Work Group should be reformed for purposes of educating EPA staff on how possible changes to the protocol now used by the Agency in its program could result in more realistic DRT ratings taking into account the latest scientific findings and research pertaining to drift.

 

In other actions, the Committee agreed to reform the Inerts and Organic Production Work Group which will monitor the activities of USDA’s National Organic Standards Board (NOSB).  Chairing the Work Group will be Steve Ralls (Evonik).  As reported previously, CPDA has engaged with the NOSB on issues relating to the retention of the former List 4 of inerts on the National List of Allowed and Prohibited Substances in organic production.  CPDA has also provided recommendations to NOSB on a proposal to revise regulatory language to allow the use of substances on EPA’s Safer Chemical Ingredient List (SCIL) as inert ingredients in pesticides used in organic production.  These and other issues will likely be revisited by the newly resurrected CPDA Work Group.

 

Finally, the CPDA Agrotechnology Committee agreed to meet on a standing basis every 2nd Friday of the month from 2 p.m. to 3 p.m. EST. An additional meeting will take place on Monday October 9th from 3 p.m. to 5 p.m. EST, during the ASTM International Committee E-35  gathering in New Orleans. This meeting, which will be held in Grand Ballroom E of the Sheraton Hotel in New Orleans, is open to all CPDA members as well as attendees of the ASTM conference.

Update on Congressional Consideration of the Pesticide Registration Improvement Act (PRIA)

As reported previously, on March 20, 2017, H.R. 1029, the “Pesticide Registration Enhancement Act of 2017” (PRIA 4), was passed by the U.S. House of Representatives and sent to the Senate for consideration.  On May 11, 2017, the Senate Committee on Agriculture, Nutrition and Forestry held a hearing seeking comments from EPA, industry and other stakeholders on the proposed legislation.  On June 30, 2017, the committee approved the legislation for floor consideration without objection.  Due to various issues in the Senate, however, the bill has not yet been scheduled for a vote or debate.

Given the few legislative days remaining in September and the number of priority issues demanding more immediate Congressional attention, it appears unlikely that lawmakers will pass a reauthorization measure before current PRIA expires at the end of this month.  Moreover, the measure adopted by the Senate committee contains several modifications to the House passed bill.  Among these, the Senate committee bill establishes a three-year extension of PRIA from the current sunset date of September 30, 2017 to September 30, 2020.  In contrast, the House measure provides for a six-year authorization of the statute ending on September 30, 2023.  In other changes, the registration action fees for certain product categories adopted in the Senate committee bill differ in some cases from those approved by the full House.  As such, if the full Senate were to pass the committee bill as currently drafted, these differences would have to be reconciled in a House-Senate conference committee where it is possible that further changes to the measure could be made.  The conferenced bill would then need to be passed by each chamber before the President could sign it into law.  This process could take several weeks or more to complete.

 

It is important to note that even if a reauthorization measure is not enacted into law by September 30th, EPA’s authority to collect registration service fees will not end abruptly on that date.  The recent bi-partisan budget agreement to keep the federal government operating for three months beyond September 30th (the end of the federal fiscal year) provides EPA the authority to collect fees at current levels through the end of 2017.  Moreover, if Congress and the Administration fail to enact PRIA by the end of the year, the current statute provides a gradual phase down of EPA’s authority to collect fees with a 40% reduction in fees during FY 2018 and a 70% reduction during FY 2019.  Once a reauthorization measure is enacted into law, PRIA fee collections will resume as if the legislation had been passed in a timely manner.  In summary, while PRIA may technically end on September 30th, there should be no impact on the funding of OPP pesticide review activities until January 2018 at which time it is expected that the statute will have been reauthorized.

CPDA is now focusing its efforts on securing the enactment of adequate appropriations in support of pesticide review activities conducted by the Office of Pesticide Programs (OPP) under PRIA.  Competition for limited appropriated funds proposed under the President’s budget Agency-wide will be fierce – especially given the monumental task faced by the Agency in conducting the review of some 10,000 chemicals as mandated under the set of reforms enacted to update the Toxic Substances Control Act (TSCA).  Moreover, on September 14, 2017 the House passed a $1.2 trillion spending package for FY 2018 that begins October 1st.  The omnibus spending bill reduces EPA’s budget by $534 million compared to last year’s enacted level. In the face of these challenges surrounding EPA appropriations for the coming federal fiscal year, CPDA is calling upon its member companies to assist our efforts as we advocate for full funding of OPP.  Specifically, CPDA is encouraging its member company representatives to write to House appropriators urging them to fully fund OPP/PRIA in the FY 2018 budget.  Concurrently, CPDA is meeting with Members of Congress seeking their support of full funding of OPP pesticide review activities.  CPDA is committed to working in support of full funding of EPA’s pesticide program and the reauthorization of PRIA legislation 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.

CPDA Representatives Meet With OSHA Officials to Discuss Relabeling Requirements of HCS 2012

On September 19, 2017, CPDA President Sue Ferenc and CPDA Director of Regulatory Affairs Sylvia Palmer met with Bill Perry and Maureen Ruskin, Director and Deputy Director, respectively, of OSHA’s Directorate of Standards and Guidance, to discuss the upcoming 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.  During the meeting, CPDA staff conveyed their concerns regarding the December 1, 2017 deadline explaining that while it granted temporary relief from the original deadline of December 1, 2015, it was nonetheless 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 raised the possibility of OSHA granting an extension of the deadline in the form of an amendment to its Directive that would be narrowly crafted and limited specifically to products of extremely long shelf life including tank-mix adjuvants, plant nutritional products, soil amendments and fertilizer products.

 

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 expressed a willingness to work with the Council in the development of possible modifications to the regulation as part of a future rulemaking to better align it with the sixth revision of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  CPDA is in the process of drafting formal comments for submission to an OSHA open docket that will urge the Agency to follow an approach patterned after 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 interim, CPDA will continue to work with OSHA in securing a limited carve-out from the December 1st deadline for compliance with the Directive that currently applies to distributors of non-pesticide agricultural products such as tank-mix adjuvants, plant nutritional products, and fertilizers pending a final resolution of this issue as part of the anticipated effort to update HCS 2012.