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Diane Schute

CPDA 2018 Regulatory Policy Conference

The CPDA 2018 Regulatory Policy Conference will be held on March 13 at the Hyatt Regency Hotel in Crystal City, VA.  This conference provides CPDA members and non-members alike the opportunity to gather to discuss key developments and regulatory challenges, unique to the agrotechnology industry, that must be addressed for companies to stay competitive and operate successfully in the global marketplace.

Participants will receive insights from agency officials on addressing the regulatory requirements specific to manufacturers, formulators, distributors, and suppliers of adjuvants and inert ingredients. The day-long event will also include a visit with staff at the Environmental Protection Agency (EPA), Office of Pesticide Programs, to share information and ask questions about an array of important pesticide related regulatory issues.

For more information please click here.

 

EPA States that First Aid Language for Toxicity Category II and III Products Need Not Appear on a Visible Label Panel on the Container

EPA has responded to public comment on its proposed interpretation and clarification of the definition of a pesticide label “panel” and the placement of first aid statements on such labels. The Agency states that first aid language for Toxicity Category II and III products are not required to be placed on a visible front, back or side panel.  However, EPA strongly recommends that registrants take the following steps:

  • Include duplicative first aid language on the very back of the booklet, accordion, or saddle stitch label that is immediately attached to the container in case the label is accidentally removed, regardless of whether a pesticide is classified as a Toxicity Category I, II or III product; and,

 

  • Consider the design and reconfiguration of new labels that are not easily removed from the container in meeting the requirement under 40 CFR part 156.10(a)(4) which calls for labels to be “securely attached” to the immediate container.

 

EPA affirms that except in rare cases where an exception or variance has been approved, first aid statements for Toxicity Category I products must continue to appear on the front panel as required under 40 CFR 156.68(d) and PR Notice 2001-1.

 

EPA’s response follows the release of a December 2016 memorandum for public comment in which the Agency set forth its proposed interpretation and clarification of the definition of a label “panel” and the placement of first aid statements on such labels based on the product’s Toxicity Category.  In its memorandum, the Agency articulated its interpretation of the term “panel” as being that portion of a label that is immediately visible on a pesticide product at the time the pesticide is sold or distributed.  EPA maintained that first aid language must be readily seen on a visible panel (front, side or back depending on Toxicity Category) and may not be placed inside multi-page labeling (i.e., “extended text,” “accordion,” “saddle stitched,” “pull-out,” “booklet,” or other type of formatted labels) that would be accessible only by manually opening a booklet or unfolding accordion style pages.  EPA asserted that this interpretation of the term “panel” is consistent with the guidance contained in PR Notice 2001-1.  While EPA acknowledged that it would consider requests for alternative placement of first aid language on Toxicity Category I products on a case-by-case basis, the Agency underscored “it is unlikely we would allow Toxicity Category I first aid statements to be placed only within a fold-out label format.” The Agency initially established a 30-day public comment period on its proposal and then subsequently granted a 60-day extension for comment that ended March 7, 2017.

 

Common themes articulated in the comments received by the Agency focused on the lack of a definition of the term “panel” in the CFR, the absence of any regulatory mandate stipulating that first aid language for Toxicity Category II and III products be immediately visible on the container, and EPA’s apparent attempt to depart from long-standing label approval practices without sufficient justification or input from the states demonstrating a need for such a change. Commenters pointed out that there is no evidence that first aid statements placed within a multi-page label has resulted in users not easily locating first aid treatment when needed.  Commenters also elaborated on the logistical and financial challenges that would be associated with a regulatory mandate calling for the revision of product labels so that first aid statements are clearly visible on “any panel.” Among these are the space limitations precluding the inclusion of first aid, environmental hazard, and use directions on a visible panel, especially for smaller product containers. Several commenters also expressed concern that the costs incurred in reconfiguring and redesigning product labels, especially for those companies that may sell or distribute 1,000 or more products, could be prohibitive.

 

In announcing its decision in the recently issued response document, EPA acknowledged many of the concerns conveyed by industry:  “…Based on the comments received and the apparently wide reliance by the regulated community on an interpretation that ‘any panel’ included inside panels, the Agency will not require the first aid statements for Toxicity Categories II and III products to bear the first aid statements on a visible front, back or side panel (as the Agency memorandum posted to the docket on December 7, 2016, had proposed)…”  The Agency’s memorandum and full response to public comment may be reviewed in docket number EPA-HQ-OPP-2016-0545 which may be accessed by clicking here.

CPDA Annual Adjuvants & Inerts Conference

The CPDA 2018 Annual Adjuvants & Inerts Conference will be held on May 1-3 at the Hyatt Regency Riverwalk Hotel in San Antonio, Texas.  This year’s conference will examine the many challenges and opportunities within the agrotechnology industry that center around the development of products and tools designed to maximize crop yields and instill greater efficiency in crop production methods.  Current plant production strategies are complex and include measures that address the need to effectively manage the proliferation of herbicide resistance, and minimize the potential for pesticide spray drift and related liability risks.  In other trends, today’s growers more and more are opting to use innovative crop input products and methods shown to improve the delivery of water and nutrients to the plant.  Producers are also embracing organic agricultural growing methods in seeking to satisfy increased consumer demand.  Manufacturers of adjuvants, inerts and other agrotechnology products are responding to these changes in the marketplace with a continued focus on the development of innovative products and technologies that reach well beyond the traditional chemical mindset.

 

The Adjuvants & Inerts Conference will look at how these changes are shaping the way in which manufacturers, formulators, distributors, and suppliers, of adjuvants and inert ingredients are responding to growers’ needs.  As past attendees of this conference will attest, this meeting has come to be known as a leading forum for education, outreach, and the exchange of information with a speakers’ program developed by industry for industry.

 

 

Speakers’ Program:

 

The speakers’ program will kick off on the morning of May 2nd with a keynote address focusing on how companies are navigating and repositioning themselves to remain competitive amid the many multi-national corporate mergers and consolidations taking place across the agrotechnology industry.  The program will include presentations and panel discussions on key issues impacting the agrotechnology industry such as:

 

  • The Status of “Biostimulant” Regulation in the United States and Canada
  • Auxin Herbicides and Weed Resistance Management
  • Adjuvants, Inert Ingredients and Soil Health
  • Drift Reduction Technologies and the EPA’s Voluntary Drift Reduction Program
  • The OMRI Certification Program and Organic Production

 

 

Conference Receptions:

 

Conference registration will include attendance at two receptions to be held the evening of May 1st and May 2nd.  These events will provide attendees the opportunity to network with industry counterparts and to establish new business contacts.  The opening and closing receptions offer the chance to catch up on industry happenings in a relaxed social setting.  Further details and sponsorship opportunities for these events will be announced shortly.

 

Conference Venue:

 

The 2018 Annual Adjuvants & Inerts Conference will take place at the Hyatt Regency Riverwalk Hotel in San Antonio, Texas.  The hotel is situated directly on the Riverwalk and is a quick three-minute walk from the Alamo.  A room block will be open for reservations at a discounted conference rate which will be available on a first-come, first-served basis.  A dedicated link for making hotel reservations will be made available in the coming weeks.

 

CPDA-PAC Golf Tournament:

 

The CPDA-PAC will sponsor a golf tournament on the afternoon of May 1st.  As in years past, tournament prizes will be offered.  The CPDA-PAC Golf Tournament is the perfect opportunity to catch up with business associates during a relaxing afternoon on the greens while also enhancing CPDA’s abilities to represent your legislative interests in Washington.  Further details on the CPDA-PAC Golf Tournament will be posted here so check back often.

 

Registration:

 

Opening soon!

 

Sponsorship Opportunities:

 

The CPDA Adjuvants & Inerts Conference offers a variety of sponsorship opportunities at four different levels (Diamond, Platinum, Gold and Silver) as well as specific event sponsorships from which to choose.  Details on sponsorship opportunities will be announced shortly.  Your sponsorship will go a long way in enhancing the quality and value of the Adjuvants & Inerts Conference while simultaneously boosting the visibility of your company among attendees.

 

 

We look forward to seeing you at the Adjuvants & Inerts Conference next May! Should you have any questions please contact the office of CPDA at (202) 386-7407.

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.

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.

Legislation to Ban Chlorpyrifos Introduced in Senate

On July 25, 2017, legislation (S. 1624) titled the “Protect Children, Farmers, and Farmworkers from Nerve Agent Pesticides Act of 2017” was introduced by Senators Tom Udall (D-NM), Richard Blumenthal (D-CT), Cory Booker D-NJ), Ben Cardin (D-MD) and others.  The measure would prohibit the use of chlorpyrifos on food and it would amend Section 402 of the Federal Food, Drug and Cosmetic Act (FFDCA) to stipulate that adulterated food includes any food that “bears or contains chlorpyrifos, including any residue of chlorpyrifos, or any other added substance that is present on or in the food primarily as a result of the metabolism or other degradation of chlorpyrifos.”  In addition, the bill would require the EPA Administrator to enter into a contract with the National Research Council to conduct a cumulative and aggregate risk assessment that addresses all populations, and the most vulnerable subpopulations including infants, children, and agricultural workers, to organophosphate pesticides.

Introduction of the bill follows EPA Administrator Scott Pruitt’s March 29, 2017, decision to deny a 2007 petition filed by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) seeking the revocation of all tolerances for chlorpyrifos and the cancellation of all product registrations for the chemical.  Among the claims asserted by the petitioners was that EPA failed to adequately assess the potential for chlorpyrifos to cause neurodevelopmental effects in children at exposure levels below the Agency’s existing regulatory standard (10% cholinesterase inhibition).  In an effort to resolve the scientific issues surrounding the potential risks associated with chlorypyrifos, EPA committed to completing the expedited registration review of the chemical several years in advance of the October 1, 2022 statutory deadline.  Although EPA had expedited its registration review, the petitioners were not satisfied with the Agency’s progress in responding to the petition and filed a lawsuit in the 9th Circuit Court of Appeals to compel EPA to either issue an order denying the petition or to grant the petition by initiating the tolerance revocation process.

In August 2015, the Court issued a ruling in favor of the petitioners.  Following the judicial ruling, in November 2015 EPA issued for public comment a proposal to revoke all chlorpyrifos tolerances citing the uncertainties pertaining to the chemical’s potential to cause neurodevelopmental effects.  Subsequently, the 9th Circuit announced that it would retain jurisdiction over the chlorpyrifos matter and on August 12, 2016 directed EPA to issue a final decision on the petition no later than March 31, 2017.  In so doing, the Court made it clear that no further extensions in responding to the petition would be granted.  Pursuant to the Court order, in November 2016 EPA published for public comment notice of availability of its revised risk assessment for chlorpyrifos.

In its March 29, 2017 decision to deny the petition seeking a ban on the use of chloryprifos, the Agency stated:

Following a review of comments on both the November 2015 proposal and the November 2016 notice of data availability, EPA has concluded that, despite several years of study, the science addressing neurodevelopmental effects remains unresolved and that further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos. EPA has therefore concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution on those issues. As noted, Congress has provided that EPA must complete registration review by October 1, 2022. Because the 9th Circuit’s August 12, 2016 order has made clear, however, that further extensions to the March 31, 201 7 deadline for responding to the Petition would not be granted, EPA is today also denying all remaining petition claims.”

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