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.

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 115^th 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 8^th 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.

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.

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).

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.