Monthly Archives :

February 2018

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.