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 firstname.lastname@example.org 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.
CPDA Adjuvants & Inerts Conference to Feature Key Experts on Major Topics in Agrotechnology
The CPDA Annual Adjuvants & Inerts Conference – Agrotechnology Challenges in Today’s Ever-Changing Market – will provide attendees unique opportunities to hear from experts from around the nation about trends and developments shaping the current state of the agrotechnology industry. The program features presentations and panel discussions on a range of key topics, including how changes to the California’s Proposition 65 labeling requirements, which go into effect August 30, 2018, could affect many pesticide and adjuvant labels. Inert products used in adjuvant or pesticide formulations could be also be subject to the label changes.
In March, as part of the Council’s Regulatory Conference, CPDA members met with officials at the EPA Office of Pesticide Programs to discuss, among other issues, how the Agency was preparing to handle potential changes that could affect pesticide labels and seek guidance for the regulated community on how to comply with dual requirements of federal and state regulators. At the 2018 conference, Dr. Renee Pinel, President of the Western Plant Health Association, will continue to highlight this important issue and provide conference attendees an understanding of what needs to be done to meet the new requirements for a proper Proposition 65 label warning.
Other key topics to be featured at this year’s conference include:
- “Biostimulant” Regulations in the United States and Canada
- Drift Reduction Technology
- Auxin Herbicides and Weed Resistance Management
- Rhizosphere Engineering – Innovative Approach to Influence Soil Health
- The Organic Materials Review Institute Program
- Advancements in Tank Cleaning Technology
This year’s keynote speaker will be Dr. Matthew Phillips, a well-known authority on the agricultural chemicals industry, whose address will discuss how companies are navigating and re-positioning themselves to remain competitive amid the many multi-national corporate mergers and consolidations taking place today. The full conference program can be viewed here.
CPDA will host two conference receptions on the evenings of May 1st and 2nd, as well as a CPDA-PAC sponsored golf tournament on May 1st at Canyon Springs Golf Club, located just 20 minutes from the San Antonio River Walk. For more information about the golf, please contact CPDA Director of Legislative Affairs, Don Davis at email@example.com or (202) 386-7407. CPDA will not have a Sporting Clay Shooting networking option for May 1st, due to the unavailability of multiple locations.
The 2018 A&I Conference is made possible through the generous sponsorships of companies including:
Huntsman Performance Products, Helena Agri-Enterprises, Stepan Company, Chemorse, Oxiteno USA, LLC, Oleon, Precision Laboratories, LLC, AkzoNobel Surface Chemistry, KALO Inc, Croda Inc, Evonik Corporation, Dow Crop Defense, Clariant Corporation, Exacto Inc, Albaugh Inc., and Brandt Incorporated.
For information and further details about the conference program and sponsorship opportunities, please contact CPDA Director of Regulatory Affairs Sylvia Palmer at firstname.lastname@example.org or (202) 386-7407. You may also visit the conference registration page here.
We look forward to seeing you in San Antonio!
EPA Seeks Public Comment on Final Biological Opinion Addressing ESA Effects of Chlorpyrifos, Malathion and Diazinon
In the March 23, 2018 Federal Register, EPA announced that it is seeking public comment on the final Biological Opinion issued pursuant to the Endangered Species Act (ESA) by the National Marine Fisheries Service (NMFS) on the potential effects of chlorpyrifos, malathion and diazinon on listed species and their critical habitats. Comments are due by May 22, 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 (BiOp) 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.
On December 29, 2017, in response to a deadline issued 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 National Marine Fisheries Service transmitted its final BiOp to EPA which addresses the potential effects of chlorpyrifos, malathion and diazinon on 77 listed species and 50 designated critical habitats as part of registration review.
In its Opinion, NMFS concluded that EPA’s proposed registration of pesticides containing chlorpyrifos is likely to jeopardize the continued existence of 38 of the 77 listed species, and adversely modify 37 of the 50 designated critical habitats. Likewise, for diazinon, NMFS found jeopardy for 25 of the 77 listed species and adverse modification of 18 of the 50 designated critical habitats. NMFS also determined that registration of pesticides containing malathion is likely to jeopardize 38 of the 77 listed species and adversely modify 37 of the 50 designated critical habitats. NMFS set forth a series of Recommended Prudent Alternatives (RPAs) which, according to the Service, were drafted using “the best available information on current agricultural practices and pesticide reduction strategies to reduce pesticide exposure to aquatic species and their habitats.” The RPAs include a list of chemical alternatives as well as specific measures to reduce loading of pesticide chemicals into aquatic habitats.
However, EPA contends that the court’s failure to extend the deadline for issuance of the Opinion did not allow for appropriate public input and is “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 emphasizes 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 making a decision on whether to reinitiate consultation with NMFS or move forward with implementing the measures contained in the Opinion. The Biological Opinion appears in the public docket established by EPA which may be accessed by clicking here. Should you have any questions, please contact CPDA’s offices.
EPA Publishes Final PR Notice 2018-1 on Determination of Minor Use Under FIFRA
On March 22, 2018. EPA published on its web site PR Notice 2018-1, titled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(II),” which provides guidance to registrants as to how the Agency determines a “minor use” as applicable to the registration of a pesticide. Specifically, PR Notice 2018-1 describes the Agency’s revised approach in evaluating “sufficient economic incentive” under FIFRA when determining the eligibility of a pesticide use for classification as a minor use. Under FIFRA Section 2(II), a minor use is defined as either: 1) the use of a pesticide on a crop for which the total acreage in the United States is less than 300,000 acres; or, 2) the use does not provide sufficient economic incentive to support the initial or continued registration of a pesticide. These provisions in FIFRA are intended to encourage the continuation of minor use registration of pesticides that might otherwise be discontinued for economic reasons alone. Under FIFRA, registrants of minor uses may receive a new or extended exclusive use period for data submitted in support of a minor use registration thereby providing the company an economic incentive to pursue new or existing minor use registrations and ensuring the availability of products used on low-acreage crops and other small-volume uses.
To date, EPA has relied on the guidance contained in PR Notice 97-2 in its interpretation of what constitutes an economic minor use – namely, the standard adopted in PR Notice 97-2 holds that a use is minor under FIFRA section 2(II) if gross revenues at full market potential do not cover the costs of registration including data generation, registration fees, and the cost of paperwork burden associated with the registration process. EPA, however, believes that the standard in PR Notice 97-2 does not consider all relevant factors for determining whether there is insufficient economic incentive to pursue a new minor use registration or continue to support an existing minor use registration.
EPA bases its revised methodology as set forth in PR Notice 2018-1 on the concept of the registration of a pesticide as being an investment. In so doing, EPA will consider:
- The difference in time between incurring costs of generating data for registration and obtaining revenue from product sales,
- The multiple years over which revenue is generated, and
- The costs of producing and distributing the product.
The Agency states that evaluating registration costs as an investment results in several measures by which EPA can assess whether there are sufficient incentives for the registration of a pesticide use and that each of these measures “provides insight into the magnitude of the incentive to register or maintain the registration of a pesticide.”
In its other provisions, PR Notice 2018-1 clarifies that minor use under FIFRA is based on acreage reported in the USDA Census of Agriculture.
A draft of PR Notice 2018-1 was published for public comment on June 6, 2016. Public comments received by the Agency and EPA’s response document may be accessed at www.regulations.gov (Docket identification number EPA-HQ-OPP-2015-0813).