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Diane Schute

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.

 

Background

 

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).

Register for the CPDA Adjuvants & Inerts Conference!

Registration for the CPDA Adjuvants & Inerts Conference, to be held May 1-3, 2018 in San Antonio, Texas, is now open!  The conference provides a forum for education and information exchange on the latest developments shaping the agrotechnology industry.  This event also provides important networking opportunities for catching up with established business contacts and making new ones. The Adjuvants & Inerts Conference continues to be CPDA’s flagship event of the year drawing a diverse audience of manufacturers, formulators, distributors, importers, suppliers and users of adjuvant and inert ingredient products as well as registered end use products.  Over the years, the CPDA Adjuvants & Inerts Conference has built its reputation as a conference developed by industry for industry.

 

The theme of this year’s conference is “Agrotechnology Challenges in Today’s Ever-Changing Market” and will feature keynote speaker Dr. Matthew Phillips.  His address will focus on the ways 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 conference program will also include panel discussions and presentations on an array of key topics of pivotal importance to your company and others in the agrotechnology industry.  We hope to see you in San Antonio this May!  For more information and to register, please click here.

CPDA 2018 Regulatory Conference Speaker Presentations Now Available

Speaker presentations from the very productive 2018 CPDA Regulatory Conference, held on Tuesday, March 13th in Arlington, Virginia, are now accessible on CPDA’s web site.  The program featured an array of speakers who addressed key topics such as market forces and economic factors shaping trends in corporate mergers within the agricultural chemicals industry, an update on priority activities underway within EPA’s Office of Pesticide Programs (OPP) including the Agency’s inert ingredient assessment branch, an overview of FIFRA related developments with a special focus on the status of the reauthorization of PRIA, efforts to synchronize the consultation process under the Endangered Species Act, and related topics impacting the agrotechnology industry, the status of OSHA’s plans to revise its Hazard Communication Standard (HCS) to better align it with the latest iteration of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and the implications of new product labeling requirements that will take effect at the end of August 2018 under California’s Proposition 65 ballot initiative.  The CPDA Regulatory Conference concluded with a meeting at the headquarters of the Office of Pesticide Programs where attendees had the opportunity to engage with EPA personnel on important regulatory issues of importance to Council members and the industry.

 

The CPDA Regulatory Conference speaker presentations may be accessed by clicking the links below.

 

“Impact of Mergers in Agricultural Chemical Markets,” James MacDonald, U.S. Department of Agriculture

 

“2018 FIFRA Regulatory Outlook,” Sheryl Lindros Dolan, Bergeson & Campbell, P.C.

 

“Overview of OPP Priorities and Issues,” Michael Goodis, U.S. Environmental Protection Agency

 

“Pesticide Inert Ingredient Activities,” P.V. Shah, U.S. Environmental Protection Agency

 

“Impact of Upcoming Changes to California Proposition 65,” Dave Lawson, Western Plant Health Association

 

“Hazard Communication Standard and GHS Update,” Maureen Ruskin, U.S. Occupational Safety and Health Administration

Representative Rodney Davis Writes to EPA Administrator Scott Pruitt Expressing Concerns About a Possible Lapse in PRIA

Representative Rodney Davis (R-IL), Chairman of the Subcommittee on Biotechnology, Horticulture and Research of the House Committee on Agriculture, released a letter he sent to EPA Administrator Scott Pruitt on February 22, 2018 expressing his concerns about the potential of a lapse in PRIA.  In his letter, Chairman Davis wrote, “PRIA ensures that companies regulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) can confidently invest in the research and development of new products because they know that there is a prescribed timeline in which the EPA must review registrations.  To support PRIA’s prescribed timeline, companies pay fees to provide a predictable level of funding which augments the EPA’s annual appropriations.”
Chairman Davis’ letter was prompted by the looming March 23rd deadline by which Congress must either pass legislation to fund the federal government for the remainder of the FY 2018 fiscal year ending September 30th or adopt yet another stop-gap spending measure to avert a government shutdown.  As reported previously, since October 1, 2017 the federal government has been operating under a series of short-term Continuing Resolutions which have temporarily extended EPA’s authority to collect the full level of registration service fees under PRIA which expired at the end of last September.  If Congress fails to extend EPA’s fee collection authority as part of the next funding measure, fees would continue at a reduced rate over a two-year phase-out period established under PRIA before terminating altogether in FY 2020.  However, while fees would be collected during this phase-out period, PRIA timelines for product review would no longer be in effect.
In his letter to Administrator Pruitt, Chairman Davis asked for an analysis of the impact of both a possible lapse in PRIA and the continuation of current law focusing on such activities as staffing levels of EPA’s pesticide program, the collection of product registration service fees and maintenance fees, the Agency’s ability to adhere to timelines for registration and registration review, and other areas directly affected by PRIA.
As a member of the Pesticide Policy Coalition (PPC), CPDA is working closely with Chairman Davis and other members of the House and Senate Agriculture Committees in an effort to secure a permanent, long-term reauthorization of PRIA.  CPDA applauds Chairman Davis for recognizing the importance of PRIA and for his leadership as he works to secure the continuation of the statute.  CPDA will keep its members apprized of further developments on PRIA and the federal budget process as they occur.  To read a copy of Chairman Davis’ letter, please click here.

EPA Responds to Chairman Davis’ Letter with a Detailed Analysis of the Impact of a Lapse in PRIA

On March 7, 2018, EPA responded to Chairman Davis (see previous story) with a detailed analysis of what the impact would be on the Agency under three scenarios including a lapse in PRIA, a continuation of authority under the existing PRIA 3, and the passage and enactment of PRIA 4.

 

Approximately 33% of the funding of the Agency’s pesticide program activities comes from PRIA in the form of registration service fees for new product submissions and annual maintenance fees for products currently in the marketplace.  The bulk of maintenance fees collected is used to support EPA’s implementation of registration review which has a statutory deadline for completion of October 1, 2022.

 

EPA’s analysis indicates that a lapse in PRIA would ultimately result in the loss of some 166 FTEs at the end of the statute’s two-year phase out period during which the Agency would be allowed to collect registration service fees but at a reduced rate (i.e., fees would be reduced 40% in FY 2018 and 70% in FY 2019).  In addition, EPA would no longer have the authority to collect maintenance fees which, according to the Agency, would severely impact its ability to conduct registration review and other maintenance-fee supported activities such as the processing of fast-track amendments and notifications.

 

In contrast, PRIA 4 is projected to generate an additional $1 million in registration service fees due to the establishment of new fee categories and changes to existing fees.  Maintenance fees collected under PRIA 4 would increase $3.2 million annually above the $27.8 million/year authorized under law for a projected total of $31 million/year.  Moreover, PRIA 4 would remove the existing matching appropriations constraint under current law thus freeing up EPA’s ability to spend collected maintenance fees that now remain frozen on pesticide review activities.  EPA states, “The provision in section 4(k)(2) [of PRIA] prohibiting EPA from spending maintenance fee dollars without matching with appropriation dollars would be removed with enactment of PRIA 4, allowing EPA to better access carryover maintenance fee funds that have built up partially as a result of this provision.  This would provide additional resources to the activities for which these funds can be spent, foremost of which is meeting the statutory obligation under registration review to complete decisions on 725 chemical cases by October 1, 2022.”  The Agency signals that the additional registration service fees and maintenance fees anticipated under PRIA 4 would allow EPA to retain current staffing levels and possibly hire additional FTEs in support of pesticide registration, registration review, inert ingredient review, and expedited processing of substantially similar product submissions and amendments.

 

As a member of the Pesticide Policy Coalition (PPC), CPDA is working closely with Chairman Davis and other members of the House and Senate Agriculture Committees in an effort to secure a permanent, long-term reauthorization of PRIA.  CPDA applauds Chairman Davis for recognizing the importance of PRIA and for his leadership as he works to secure the continuation of the statute.  CPDA will keep its members informed of further developments on PRIA and the federal budget process as they occur.

 

EPA Issues Final Guidance Clarifying Placement of First Aid Statements on Pesticide Label Panels

EPA has released final guidance which clarifies where first aid statements should appear on the label of pesticide products.  In December 2016, EPA released a memorandum titled  Guidance for Pesticide Registrants 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.  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.

 

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.

 

In both the response document released at the end of the public comment period and the recently issued final guidance document, EPA affirms that it will continue to require that Toxicity Category I products have first aid statements visible on the front panel except in cases where a variation has been approved.  Toxicity Categories II and III products must have statements on a front, back, side or inside panel (any panel).  These statements are optional for Toxicity Category IV products.  In addition, EPA provides the following recommendations:

 

  • For Toxicity Category I products, the Agency strongly recommends that registrants consider placing duplicative first aid language on the very back page of the booklet/accordion/saddle stitch label that is immediately stuck to the container in case the booklet/accordion/saddle stitch label is accidentally removed.

 

  • Regardless of whether a registrant chooses to place the first aid statements for Toxicity Categories II and III products on a visible front, back, side or inside panel, it is recommended that duplicative first aid language appear on the very back page of the booklet/accordion/saddle stitch label that is immediately attached to the container in case the booklet/accordion/saddle stitch label is accidentally removed. EPA states that this recommendation is not intended to suggest other information that registrants typically include on the very back page should be moved elsewhere.

 

  • The Agency recommends that the registrant community consider designing new booklets/accordion/saddle stitch labels that are not easily removed from the containers. Per 40 CFR part 156.10(a)(4) the labels are to be “securely attached” to the immediate container of the pesticide product. However, the Agency believes that in many instances these labels are easily removed which is why many registrants have already chosen to put the duplicative first aid statements on the very last page (as recommended above) of the label that is attached to the container.

The final guidance document may be accessed by clicking here.

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.