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CPDA Engages with WSDA in Calling for an Expedient Process that would Allow Alternatives to BIT in Adjuvant Formulations

In related activities surrounding the shortage of BIT, CPDA has been engaged with the Washington State Department of Agriculture (WSDA) in calling for guidance that would set forth a streamlined process allowing registrants of spray adjuvants to substitute alternative preservatives in their products. In a request sent to WSDA’s Registration and Licensing Services Program on September 18th, CPDA Interim President Gary Halvorson emphasized that the BIT shortage is not likely to abate any time soon and he requested that the Department move quickly in providing instructions for the modification of adjuvant registrations of existing formulations.

WSDA in response has specified three steps that registrants are required to take if they choose to revise their adjuvant formulations:

  1. Determine the appropriate revisions to the adjuvant CSF, based on the preservative use limits in 40 CFR 180.910 or .920 (assuming the adjuvant is intended for use on food or feed crops).
  2. Submit a revised adjuvant CSF to WSDA using the secure pesticide registration portal (https://agr.wa.gov/PestFert/Pesticides/ProductRegistration.aspx#Secure), and mention in the “Notes” box that the only change is the preservative. Do not submit a CSF by email, since this method is not secure.
  3. Contact the assigned Registration Specialist (https://agr.wa.gov/PestFert/Pesticides/ProductRegistration.aspx#RegContacts) and let them know that the registrant is submitting a revised adjuvant CSF.

WSDA has instructed that in lieu of these actions, a revised CSF can be submitted by ground mail or fax. The registrant should include a cover letter explaining that the only change is the preservative in such cases.

EPA’s Office of Inspector General Issues Report on Needed Improvements to FIFRA Section 18 Emergency Exemption Process

On September 25, 2018, EPA’s Office of Inspector General (OIG) issued a report summarizing the conclusions of its audit of the Agency’s FIFRA Section 18 pesticide emergency exemption process. Section 18 of FIFRA allows the Agency to grant federal and state agencies the authority to approve the limited application of an unregistered pesticide not currently registered for that use in the event of a serious pest problem that jeopardizes production of agricultural goods, the environment, or public health and for which there are inadequate tools to address the situation. The regulations governing implementation of FIFRA Section 18 establish four types of emergency exemptions (specific, quarantine, public health and crisis) with different time periods allowed for each.

In its report, the OIG concluded that while EPA’s Office of Pesticide Programs (OPP) collects human health and environmental data through its emergency exemption process, it does not use this data to capture outcome measures that would demonstrate how well the emergency exemption process maintains human health and environmental safeguards. In addition, the OIG found that OPP does not have comprehensive internal controls to manage the emergency exemption data it collects and cited specific deficiencies in the Agency’s online public database, internal guidance documents, and its annual progress reports to the Office of Management and Budget (OMB) and Congress. Finally, OIG determined that the OPP does not consistently communicate emergency exemption information with its stakeholders.

The OIG recommended that EPA’s Assistant Administrator for Chemical Safety and Pollution Prevention develop outcome-based performance measures; develop or update procedures on data collection, database management and the re-use of data submitted by state lead agencies; and communicate changes to the emergency exemption process in a timely manner. The full OIG report, including EPA’s response to the recommendations contained in the report, may be accessed by clicking here.

CPDA Seeks Solution to Problems Posed by BIT Shortages

CPDA continues to work with EPA and allied industry trade associations urgently seeking a resolution to the shortage of the active ingredient 1,2-benzisothiaxolin-3-one (BIT). Preservative products containing BIT are used in the formulation of hundreds of agricultural pesticide products by many registrants. The precursor chemical o-nitrochlorobenzene, essential to the manufacture of BIT products, is sourced almost exclusively from China. BIT can serve as both an active ingredient or an inert ingredient depending on whether or not it has a pesticidal effect when used in a registered end use product.

Over this past summer, the Chinese government, as part of its anti-pollution Blue Sky initiative, shut down key BIT and BIT precursor manufacturing operations pending the results of ongoing environmental site inspection of these facilities. These closures have led to inventory shortages of BIT and BIT precursor products which has adversely impacted a number of pesticide formulation operations. Some registrants have been notified by their suppliers that they will be unable to fulfill their long-standing supply contracts. CPDA received reports from companies that the BIT shortage is seriously impeding their ability to find alternate sources of these products, thus creating the potential for major manufacturing disruptions as registrants prepare for the 2019 growing season.

In response, CPDA and allied trade associations have engaged with EPA personnel in an effort to address this situation, requesting that the Agency approve a streamlined self-certification process, in lieu of submitting an amended Confidential Statement of Formula (CSF), for impacted end use products for which an alternate supply of BIT is used.  The trade association coalition gathered feedback from their respective member companies in order to develop a list of possible alternatives to BIT for use in pesticide formulations. This has been presented to EPA for review and approval.

On August 23, 2018, EPA sent a letter to the industry coalition agreeing to a time-limited self-certification process, not to exceed 24 months, whereby registrants could notify the Agency of a change in the source of BIT without having to submit an amended CSF. For each end use product in which BIT is used as an active ingredient, registrants are directed to submit a Formulator’s Exemption form (EPA Form 8570-27) as described in PR Notice 98-10. For products where BIT is used as an inert ingredient, EPA will allow notification of the source change to be submitted in the form of a single letter which covers all impacted products. EPA states that at the end of the 24-month period, barring any evidence of continued market instability due to extended BIT shortages, the Agency will require the submission of new or amended CSFs for which the source of BIT has changed from what is listed in the current CSF. Submissions would be required within 90 days of August 23, 2020 or upon the identification of “stable source(s),” whichever is earlier.

While the streamlined process of notification set forth by EPA is limited to seven specific alternate registered sources of BIT as listed in the August 23rd letter, CPDA has learned that this list will likely be expanded and that an update will be released by the Agency shortly. In the meantime, CPDA and other members of the industry coalition continue to collaborate with EPA on this issue in an effort to avert the looming crisis that could unfold during the 2019 growing season in the face of continued shortages of BIT.

Lawsuit Filed Against EPA Over Agricultural Worker Protection Standard (WPS)

On May 30, 2018, the Attorneys General from the states of California, Maryland and New York filed a lawsuit against EPA over the Agency’s delay in publishing a notice of availability of revised training materials that focus on the expanded pesticide safety and application requirements under the Agency’s changes to its 2015 Worker Protection Standard (WPS).  The suit, filed in the U.S. District Court for the Southern District of New York, asserts that EPA’s delay in the publication of a notice of availability of these materials effectively denies farmworkers and pesticide handlers training that can enhance health and safety protections in the application of pesticides.

In November 2015, EPA promulgated a final rule making changes to the WPS among which was a requirement that employers provide training to farmworkers and pesticide handlers covering a list of health and safety topics that were expanded under the revised regulation.  The 2015 rule required employers to comply with the new pesticide safety training provisions within 180 days after EPA published in the Federal Register a notice of availability of the updated training materials.

Subsequently, on December 21, 2017, EPA published a notice in the Federal Register announcing that it was initiating a proposed rulemaking to revise certain provisions of the 2015 rule pertaining to minimum age for pesticide handlers, the requirement that employers provide pesticide safety and application information to designated farmworker representatives, and application exclusion zone restrictions.  EPA stated that the compliance dates set forth in the 2015 regulation would remain in effect except for the requirement that training of farmworkers and pesticide handlers include the expanded content mandated under the rule.  EPA acknowledged that while training materials pursuant to the requirements of the 2015 rule had been developed and were readily available, the Agency stated it would not publish a notice of their availability until it had completed its proposed rulemaking on the WPS focusing on the minimum age, designated representative, and application exclusion zone requirements.  The Agency explained the delay was necessary “to prevent extra work and costs to developers of the training materials and EPA reviewers.”

In their lawsuit, the Attorneys General maintain that by not committing to a deadline for completing the rulemaking process, the Agency has essentially delayed indefinitely the compliance dates of the enhanced pesticide training requirements promulgated in 2015.  They called the delay “arbitrary and capricious” and argued that it denied farmworkers and pesticide handlers the improved training that would protect their health and safety.  The Attorneys General requested that EPA immediately be made to publish a Federal Register notice announcing the availability of the training materials already developed.  A copy of the complaint filed by the Attorneys General may be accessed by clicking here.

EPA Announces Public Hearing and Extension of Public Comment Period on its Proposed “Transparency in Regulatory Science” Rule

EPA has announced an extension of the comment period and a public hearing on its proposed rule titled “Strengthening Transparency in Regulatory Science,” published in the Federal Register on April 30, 2018.  The public comment period, originally scheduled to close on May 30, 2018, will now end on August 16, 2018.  Comments may be submitted at www.regulations.gov identified by docket number EPA-HQ-OA-2018-0259.  The public hearing will be held on July 17, 2018 at EPA’s William Jefferson Clinton East Building, Main Floor Room 1153, 1201 Constitution Avenue, N.W., Washington, D.C., from 8:00 a.m. to 8:00 p.m. (EST).  Individuals wishing to present oral testimony must register by July 15th via email at staff_osa@epa.gov or online by clicking here.

EPA states that its proposed rule is intended to establish a clear policy for the transparency of the scientific information used for significant regulations (those having an economic impact of $100 million or more) and to ensure that the data supporting its regulatory actions can be independently verified.  More specifically, the Agency states that its proposal is designed to “increase access to dose response data and models underlying ‘pivotal regulatory science’ in a manner consistent with statutory requirements for the protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests.”  The draft rule sets forth a definition of ‘pivotal regulatory science’ as “the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated.”

The draft rule would require EPA to conduct independent peer review on all ‘pivotal regulatory science’ used to justify regulatory decisions.  In addition, the proposal would allow the EPA Administrator to grant exemptions to its data transparency requirements on a case-by-case basis.  EPA cites a number of environmental statutes as providing the underlying authority for its proposed rulemaking including the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

The Agency is seeking comment on a number of far-reaching issues such as the potential effects of the proposed rule on individual EPA programs, how to balance appropriate protection of confidential business information with the proposed requirements for increased transparency of pivotal regulatory science, and whether the transparency requirements should apply to other types of regulatory actions such as guidance.  EPA provides an expansive list of other issues for which it is inviting public comment on the draft rule.

Since its publication, the draft rule has generated a significant level of controversy from critics who voice concerns that its proposed requirements would limit the available scientific information and studies upon which EPA bases its regulatory decisions.  They also charge that EPA truncated the required Office of Management and Budget (OMB) review process in a rush to get the proposed rule published in the Federal Register.

It is not clear to what extent the proposed rule, as written, would have on EPA pesticide registration and tolerance review activities.  While EPA states that “nothing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections,” there is concern within the pesticide registrant community that CBI protections could be weakened or compromised under this initiative.  A copy of the draft rule may be accessed by clicking here.

Registration for the CPDA Summer Conference & Annual Meeting in Chicago is Now Open!

Register today for the upcoming CPDA Summer Conference and Annual Meeting to be held at the Omni Chicago Hotel July 16-18 in Chicago.  This year’s meeting will showcase a new strategic direction for CPDA that charts a new way of conducting operations and a new philosophy to enhance the value of CPDA membership. Members and non-members will have the opportunity to learn more about how this new approach will enable CPDA to better meet their needs.

Click here to learn more and to register!

CPDA Interim President Gary Halvorson to Address the WPHA 2018 Regulatory Conference

CPDA Interim President Gary Halvorson will present at the Western Plant Health Association (WPHA) 2018 Regulatory Conference, scheduled for July 25-26 in Sacramento, California.  He will provide an overview of CPDA’s voluntary Adjuvant Certification Program and how registrants and users of adjuvants bearing the CPDA certification logo can be assured that the product conforms to specific product claims and EPA requirements.

Over the last several months, CPDA has engaged with WPHA on mandatory revisions to product label warning requirements under California’s Prop 65.  Most recently, WPHA President Renee Pinel spoke at CPDA’s 2018 Adjuvants & Inerts Conference in San Antonio where she summarized the pending changes and likely impact on product labels.  CPDA looks forward to its continued collaboration with WPHA on the new Prop 65 label warning requirements as well as issues surrounding the registration of adjuvants by the California Department of Pesticide Regulation (CDPR) – both of which are crucial issues for Council members that sell and/or distribute their products for use in California.

EPA Announces Extension of Deadline for Public Comment on Final Biological Opinion for Chlorpyrifos, Diazinon and Malathion

EPA has announced a 60-day extension of the deadline for the submission of public comments on the final Biological Opinion (BiOp), issued by the National Marine Fisheries Service (NMFS) under the Endangered Species Act, on the potential effects of chlorpyrifos, diazinon, and malathion on listed species and critical habitats. The Biological Opinion found jeopardy to 38 species and adverse modifications to 37 critical habitat units. It also includes a series of Recommended Prudent Alternatives (RPAs) based on the “best available information on current agricultural practices and pesticide reduction strategies to reduce pesticide exposure to aquatic species and their habitats.” Comments are due by July 23, 2018 and may be submitted via www.regulations.gov identified by docket number EPA-HQ-OPP-2018-0141.

Under Section 7(a)(2) of the ESA, if EPA determines that a pesticide is likely to adversely affect a listed species or its designated critical habitat, the Agency must consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (collectively known as the “Services”).  Following consultation, the Service(s) prepares a Biological Opinion on whether the registration action will jeopardize or adversely affect a listed species or habitat and, if so, may include reasonable and prudent alternatives and/or reasonable and prudent measures to avoid or minimize such impacts.

The final BiOp was issued on December 29, 2017 pursuant to a court-ordered deadline set by the U.S. District Court for the Western District of Washington in the case of Northwest Coalition for Alternatives to Pesticides, et. al. v. NMFS.  The deadline was established after the court denied a request from NMFS seeking additional time to engage in more extensive collaboration with EPA and stakeholders in developing the final BiOp.

In announcing its request for public comment on the BiOp, EPA maintained that the court’s failure to extend the deadline for issuance of the Opinion was “at odds” with an interim approach developed by the Agency in 2013, with the support of the Services and USDA, for assessing the potential ESA effects of pesticides.  According to EPA, this interim approach is intended to establish an “open and transparent process” for ESA consultations.  The Agency emphasized that “stakeholder input is critical to the development and evaluation of any measures EPA may implement to address risks to listed species and designated critical habitat.”  As such, EPA is seeking public comment and stakeholder input before deciding to reinitiate consultation with NMFS or move forward with implementing the measures contained in the Opinion.

Meanwhile, EPA continues to work with the Services to refine an interim scientific approach and create a sustainable process for completing consultations that meet requirements of both the ESA and FIFRA.  As part of this process, EPA is collaborating with the Services to determine an appropriate method for incorporating available usage data in the evaluation of pesticides for ESA effects.  EPA personnel state that the Agency’s objective is to streamline the process so that it is protective of species, ensures timely FIFRA registration review decisions, transparent to the public, and takes into consideration the limited resources available to the Agency.

Farm Bill (H.R. 2), the “Agriculture and Nutrition Act of 2018,” Fails to Advance on the House Floor

House passage of the Farm Bill (H.R. 2), titled the “Agriculture and Nutrition Act of 2018,” fell short by a vote of 198-213 during floor debate on the measure held May 18, 2018.  The bill failed to advance largely due to the leadership’s refusal to agree to the demands of a bloc of House Republicans seeking a separate vote on an unrelated package of immigration measures.  Discussions in the House are now underway as the leadership tries to end the impasse and find a way to bring the Farm Bill to the floor for a second vote.

As reported previously, Title IX of the Farm Bill contains two provisions strongly supported by CPDA.  First is language that would enact into law H.R. 1029, the “Pesticide Registration Enhancement Act,” which provides a long-term reauthorization of PRIA along with an increase in maintenance fees, an adjustment in registration service fees as well as product category/review times, and eliminates the existing constraint on spending maintenance fees without matching appropriation dollars as contained in current PRIA.  H.R. 2 also includes language that would amend FIFRA and the Federal Water Pollution Control Act (the Clean Water Act) to prohibit EPA or a state from requiring an additional permit under the Clean Water Act for a discharge of a pesticide from a point source into navigable waters of the United States.  CPDA has engaged in extensive lobbying efforts in building a broad base of support for each of these legislative initiatives in the 115th Congress.

Most recently, CPDA joined with a broad cross-section of agricultural, non-agricultural, and public health interests in signing onto a May 8, 2018 letter to Representative Mike Conaway (R-TX), Chairman of the House Committee on Agriculture, thanking him for his leadership in authoring several key provisions in the Farm Bill that relate to the registration and use of pesticides.  The signatories to the May 8th letter also thanked Chairman Conaway for his inclusion of other language in Title IX of the Farm Bill that would establish much-needed regulatory reforms by clarifying the role of state lead agencies in promulgating pesticide regulations and streamlining the pesticide review/approval process when considering implications to endangered species.

CPDA and the other signatories to the letter emphasized that the pesticide provisions contained in Title IX would “increase the global competitiveness of American agriculture, encourage much needed innovation, and reduce costs to American farmers and ranchers and other users of pesticides at a time when they can least afford it.”

As of this writing, it was not clear whether an agreement over immigration would be reached that would clear a path for reconsideration of the Farm Bill on the House floor.  Meanwhile, work in the Senate is ongoing as the leadership in that chamber drafts its own version of the Farm Bill.  CPDA will keep its membership apprised of further developments as they occur.