Posts By :

Diane Schute

CPDA and Other Members of the PPC Address ESA Consultation Process for Pesticides

This month, CPDA and other members of the Pesticide Policy Coalition (PPC) sent a letter to members of the House and Senate Agriculture Committees as part of an outreach effort aimed at developing a more efficient and coordinated process by which pesticides are assessed for their potential impacts to listed species and habitats under the Endangered Species Act (ESA).  Under Section 7(a)(2) of the ESA, federal agencies are required to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (collectively known as the “Services”) to ensure a federal action does not jeopardize the continued existence of a listed species or adversely modify its 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 to listed species or the environment.  Unfortunately, EPA and the Services historically have differed in their approach to assessing pesticides for ESA impacts.  This conflict has given rise to lengthy delays in the consultation process as well as endless litigation brought against EPA by environmental and public interest groups citing the lack of a procedural framework for FIFRA-ESA consultation.  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.  Ultimately, farmers and growers are denied access to the beneficial pesticides they need because of the undue delay in bringing these products to market.

 

CPDA and other members of the PPC are working with Congress with the goal of establishing a more streamlined ESA consultation process for pesticides that eliminates the wasteful duplication of complicated study reviews and avoids the inordinate delays that impede the mechanism currently in place.  In its letter to the House and Senate Agriculture Committees, the PPC stated:

 

“As the agency charged by Congress with regulating the human health and environmental safety of pesticides, EPA has decades of issue area expertise with these products and their impacts on the environment, including their potential toxicity and exposure to wildlife. That experience should be supplemented with the species expertise of the Services, but its work should be neither ignored nor duplicated. Potential threats to protected species and their habitat can be better assessed and more effectively regulated to encourage a more efficient, timely process, providing enhanced species review, along with greater regulatory certainty for growers, other users and manufacturers.”

 

CPDA will keep its members informed of this ongoing effort to improve and better coordinate the ESA consultation process between EPA and the Services.

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.

EPA and the Department of the Army Issue Final Rule Delaying Effective Implementation Date of the WOTUS Rule

On January 31, 2018, EPA and the U.S. Department of the Army finalized a rule delaying the effective implementation date of a controversial rule, promulgated by the Obama Administration in 2015, titled “Clean Water Rule:  Definition of ‘Waters of the United States’” (WOTUS).  The final rule was published in the Federal Register on February 6, 2018 and establishes an applicability date of February 6, 2020.

The 2015 WOTUS rule, which originally had an effective date of August 28, 2015, significantly expanded the scope of water bodies in the United States that would be subject to regulation and NPDES permitting requirements under the Clean Water Act.  The rule was widely deemed to be “regulatory overreach” by a diverse range of industry and agricultural interests.  Shortly after its promulgation, the WOTUS rule became the subject of numerous judicial challenges filed in several federal district and appellate courts over concerns that the expanded and far-reaching definition of “waters of the United States” as adopted by EPA exceeded the Agency’s authority vested under the Clean Water Act.

On October 9, 2015 the U.S. Court of Appeals for the Sixth Circuit issued a nationwide stay of the WOTUS rule.  However, on January 22, 2018 the U.S. Supreme Court determined that original jurisdiction over the rule resided with the district court, rather than the appellate court, and as such, the Sixth Circuit lacked the authority to issue a stay.  Consequently, the stay issued by the Sixth Circuit appellate court was lifted except in 13 states (Alaska, Arizona, Arkansas, Colorado, Idaho, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, South Dakota, and Wyoming) that were parties to a suit filed in the U.S. District Court for the District of North Dakota.  On August 27, 2015 the North Dakota district court granted a preliminary injunction against implementation of the WOTUS rule pending a decision by the Supreme Court.

EPA states that the delay in implementation of the WOTUS rule is necessary given the confusion surrounding the Supreme Court’s decision on the existing nationwide stay issued by the Sixth Circuit and its finding that original jurisdiction over legal challenges of the WOTUS rule rests at the federal district court level.  The Agency emphasizes that its final rule will eliminate the uncertainty that has been caused by litigation over the WOTUS rule in multiple federal district courts.  EPA explains that its recent rule will simply maintain the legal status quo by retaining the definition of “waters of the United States” that existed prior to promulgation of the WOTUS rule, thus providing continuity for the regulated community.

Meanwhile, EPA continues to move forward with a substantive rulemaking effort to rescind the 2015 rule and revise the definition of “waters of the United States.”  EPA’s rulemaking efforts were initiated in response to Executive Order (EO) 13778 issued by President Donald Trump on February 28, 2017 titled “Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the ‘Waters of the United States’ Rule.”  EO 13778 directs the EPA Administrator and the Assistant Secretary of the Army for Civil Works to publish for notice and comment a proposed rule rescinding or revising the WOTUS rule in keeping with the Administration’s stated goal of promoting economic growth and minimizing regulatory uncertainty.

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.