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Diane Schute

EPA Announces Public Comment Period on Proposed Renewal of an Information Collection Request for Reporting Adverse Effects Incidents Under FIFRA Section 6(a)(2)

In the February 8, 2018 Federal Register, EPA published a notice announcing a public comment period, ending April 9, 2018, on a proposed renewal of an Information Collection Request (ICR) titled “Submission of Unreasonable Adverse Effects Information under FIFRA Section 6(a)(2).”

The Agency anticipates an estimated increase of 71,778 burden hours under the proposed ICR renewal which translates into a 16% increase in the number of responses from 93,000 under the current ICR to 108,000 under the proposed ICR renewal.  EPA attributes this expected increase to additional information the Agency has requested on the use of spot-on pesticide products for pets, alleged tree and plant damage associated with application of a certain herbicide, and concerns about neonicotinoid pesticides and the loss of bee colonies.

Section 6(a)(2) of FIFRA requires the registrant to submit any information that it acquires regarding adverse effects associated with the use of a pesticide product.  The Agency then determines whether that information constitutes an unreasonable adverse effect.  EPA explains that the adverse effects information submitted under Section 6(a)(2) of FIFRA provides an important means of focusing the Agency’s attention on key problem areas regarding the use of a pesticide.  This information is considered by EPA in conjunction with other information to determine whether pesticide products containing a specific active ingredient should be reregistered, or whether the terms and conditions of registration should be changed.  According to EPA, this type of information may also be pertinent to granting FIFRA Section 18 emergency exemptions.

Once EPA considers the public comments it receives in response to its announcement of this proposed ICR renewal, the Agency will amend the ICR package as appropriate and submit it to the Office of Management and Budget (OMB) for review and approval.  At that time EPA will issue another Federal Register notice to announce the opportunity to submit additional public comment to OMB.  Public comment on EPA’s proposed ICR renewal may be submitted electronically at www.regulations.gov identified by docket number EPA-HQ-OPP-2017-0687.

EPA and the “Services” Establish Interagency Working Group to Address a Process for Streamlining ESA Pesticide Consultations

On January 31, 2018, EPA announced the establishment of an Interagency Working Group pursuant to a Memorandum of Agreement between EPA, the U.S. Fish and Wildlife Service, and the National Marine Fisheries Service (i.e., the “Services”), aimed at facilitating and improving the coordination of agency consultations required under Section 7(a)(2) of the Endangered Species Act (ESA) in assessing the impacts of pesticide registration actions on threatened species and habitats.

In seeking to devise a streamlined mechanism that would eliminate many of the impediments that have encumbered the pesticide consultation process, the Working Group will:

  • Review the statutory requirements under ESA and FIFRA, existing regulations for the pesticide consultation process, and case law that has developed around the intersection of ESA and FIFRA;
  • Examine current and previous pesticide consultations to identify areas for management as well as best practices that should be used in pesticide consultations;
  • Develop recommendations on scientific and policy approaches to ESA pesticide consultations that would more clearly differentiate and identify which actions require no consultation, informal consultation, or formal consultation; and
  • Provide clarity on what constitutes “best scientific and commercial data available” with regard to pesticide use and ecological risk assessment.

Background

Section 7 of the ESA directs all federal agencies to use their existing authorities to conserve threatened and endangered species and, in consultation with the Services, to ensure that their actions do not jeopardize listed species or destroy or adversely modify critical habitat.  This ESA directive applies to all EPA pesticide licensing activities.  When EPA registers a pesticide, the Agency is required under FIFRA to ensure that the proposed action does not cause any unreasonable adverse effect on the environment.

If EPA determines that a proposed pesticide registration action will have no effect on any listed species or designated critical habitat, consultation is not required. A determination that a proposed pesticide registration action is not likely to adversely affect any listed species or designated critical habitat is subject to “informal consultation” with the Services, the result of which is typically a letter in which the Services concur or non-concur with EPA’s determination.  If the Services do not concur with EPA’s determination that a pesticide is not likely to adversely affect a listed species or habitat or if EPA determines that a pesticide registration action is likely to adversely affect a listed species or critical habitat, EPA is required to engage with the Services in a process called “formal consultation.”  At the completion of formal consultation, the Services may propose reasonable and prudent alternatives, to the extent available, to avoid jeopardy to a listed species or habitat.

Historically, the EPA and the Services have differed in their approach to meeting their ESA obligations in assessing the environmental risks of pesticides to listed species and habitats.  This has resulted in a consultation process that is complex and vulnerable to lengthy delays.  In addition, ambiguity in the definition of “best available scientific data” upon which ESA decisions are made has further contributed to the challenges of developing a streamlined process for consultation on the ESA effects of pesticides.  These challenges have given rise to costly litigation brought against the Agency by environmental and public interest groups citing the lack of a procedural framework for FIFRA-ESA consultation.  This litigation, in turn, has resulted in the imposition of court mandated use restrictions such as buffer zones and other product application restrictions set forth in settlement agreements between the EPA and the litigants.  The difficulties inherent in the pesticide consultation process is further exacerbated by the fact that EPA is required to complete registration review of more than 700 chemical dockets by a statutory deadline of 2023 including an assessment of these pesticides for their potential effects on threatened species and habitats.

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.

 

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.

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.

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 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.