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 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.

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.

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.

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.

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.