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.

EPA has responded to public comment on its proposed interpretation and clarification of the definition of a pesticide label “panel” and the placement of first aid statements on such labels. The Agency states that first aid language for Toxicity Category II and III products are not required to be placed on a visible front, back or side panel.  However, EPA strongly recommends that registrants take the following steps:

• Include duplicative first aid language on the very back of the booklet, accordion, or saddle stitch label that is immediately attached to the container in case the label is accidentally removed, regardless of whether a pesticide is classified as a Toxicity Category I, II or III product; and,

• Consider the design and reconfiguration of new labels that are not easily removed from the container in meeting the requirement under 40 CFR part 156.10(a)(4) which calls for labels to be “securely attached” to the immediate container.

EPA affirms that except in rare cases where an exception or variance has been approved, first aid statements for Toxicity Category I products must continue to appear on the front panel as required under 40 CFR 156.68(d) and PR Notice 2001-1.

EPA’s response follows the release of a December 2016 memorandum for public comment 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.  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.  EPA asserted that this interpretation of the term “panel” is consistent with the guidance contained in PR Notice 2001-1.  While EPA acknowledged that it would consider requests for alternative placement of first aid language on Toxicity Category I products on a case-by-case basis, the Agency underscored “it is unlikely we would allow Toxicity Category I first aid statements to be placed only within a fold-out label format.” 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.

Common themes articulated in the comments received by the Agency focused on the lack of a definition of the term “panel” in the CFR, the absence of any regulatory mandate stipulating that first aid language for Toxicity Category II and III products be immediately visible on the container, and EPA’s apparent attempt to depart from long-standing label approval practices without sufficient justification or input from the states demonstrating a need for such a change. Commenters pointed out that there is no evidence that first aid statements placed within a multi-page label has resulted in users not easily locating first aid treatment when needed.  Commenters also elaborated on the logistical and financial challenges that would be associated with a regulatory mandate calling for the revision of product labels so that first aid statements are clearly visible on “any panel.” Among these are the space limitations precluding the inclusion of first aid, environmental hazard, and use directions on a visible panel, especially for smaller product containers. Several commenters also expressed concern that the costs incurred in reconfiguring and redesigning product labels, especially for those companies that may sell or distribute 1,000 or more products, could be prohibitive.

In announcing its decision in the recently issued response document, EPA acknowledged many of the concerns conveyed by industry:  “…Based on the comments received and the apparently wide reliance by the regulated community on an interpretation that ‘any panel’ included inside panels, the Agency will not require the first aid statements for Toxicity Categories II and III products to bear the first aid statements on a visible front, back or side panel (as the Agency memorandum posted to the docket on December 7, 2016, had proposed)…”  The Agency’s memorandum and full response to public comment may be reviewed in docket number EPA-HQ-OPP-2016-0545 which may be accessed by clicking here.

On September 7, 2017, the Pest Management Regulatory Agency (PMRA) published in the Canada Gazette a set of amendments to the Pest Control Products Regulations (PCPR) for implementation of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA).  A key objective of CETA is to eliminate trade barriers between Canada and the European Union (EU) on most goods.  The recently published amendments have an effective date of September 21, 2017 and seek to align the PCPR with Article 20.30 of CETA which requires Canada to promulgate regulations aimed at avoiding duplicative animal testing.  Under the amendments, an applicant or registrant of a pest control product will be allowed to rely on a previous study involving animals rather than completing a new, duplicative study in support of an application, re-evaluation or special review of a chemical.  PMRA states, “Health Canada is engaged in ongoing efforts to develop and implement testing methods that avoid the use of live animals and adhere to the ‘Three Rs’ (reduce, refine, replace), which are the guiding principles for more ethical use of animals in testing.”  PMRA provides as an example Health Canada’s implementation of guidance and criteria that allow for data waivers and bridging or extrapolation of data from one pesticide product to another.

Prior to the promulgation of the amendments to the PCPR, Health Canada consulted with affected stakeholders, including generic pesticide product manufacturers, in early May 2017.  As part of this outreach effort, Health Canada invited interested parties to engage in a May 4, 2017 conference call and webinar that had 40 participants.  During this event, several stakeholders representing the generic pesticide manufacturing industry urged Health Canada to create an online accessible database of existing test data which would identify the protection status of such data.  Generic registrants also called upon Health Canada to specify in the database which data have already received compensation in the EU.  Health Canada noted that it is working on the establishment of an online database that would be available to applicants and registrants for purposes of viewing the status of protected data.  However, with regard to tagging that data for which compensation has already been made in the EU, Health Canada maintained that this information would be disclosed during the normal course of data compensation negotiation and/or arbitration proceedings.

The amendments to the PCPR as published in the Canada Gazette may be accessed by clicking here.

On September 8, 2017, the CPDA Agrotechnology Committee held its first inaugural meeting via conference call.  As reported previously, the CPDA Board of Directors approved the merger of the CPDA Regulatory and Adjuvants & Inerts Committees to establish a new CPDA Agrotechnology Committee effective September 1, 2017.  This move was designed to provide a more efficient structure for managing the regulatory and non-regulatory priority issues for CPDA members, while minimizing the duplication of issue management activities.  The CPDA Agrotechnology Committee is co-chaired by Dave Ferguson (Huntsman Corporation) and Gary Halvorson (independent consultant).

During its September 8^th call, the Committee took several important actions including its decision to reconstitute the CPDA DRT Work Group.  Historically over the years, this Work Group has collaborated with EPA in providing input on the development of the Agency’s voluntary Drift Reduction Technology (DRT) program. Committee members agreed that the Work Group should be reformed for purposes of educating EPA staff on how possible changes to the protocol now used by the Agency in its program could result in more realistic DRT ratings taking into account the latest scientific findings and research pertaining to drift.

In other actions, the Committee agreed to reform the Inerts and Organic Production Work Group which will monitor the activities of USDA’s National Organic Standards Board (NOSB).  Chairing the Work Group will be Steve Ralls (Evonik).  As reported previously, CPDA has engaged with the NOSB on issues relating to the retention of the former List 4 of inerts on the National List of Allowed and Prohibited Substances in organic production.  CPDA has also provided recommendations to NOSB on a proposal to revise regulatory language to allow the use of substances on EPA’s Safer Chemical Ingredient List (SCIL) as inert ingredients in pesticides used in organic production.  These and other issues will likely be revisited by the newly resurrected CPDA Work Group.

Finally, the CPDA Agrotechnology Committee agreed to meet on a standing basis every 2^nd Friday of the month from 2 p.m. to 3 p.m. EST. An additional meeting will take place on Monday October 9^th from 3 p.m. to 5 p.m. EST, during the ASTM International Committee E-35  gathering in New Orleans. This meeting, which will be held in Grand Ballroom E of the Sheraton Hotel in New Orleans, is open to all CPDA members as well as attendees of the ASTM conference.

As reported previously, on March 20, 2017, H.R. 1029, the “Pesticide Registration Enhancement Act of 2017” (PRIA 4), was passed by the U.S. House of Representatives and sent to the Senate for consideration.  On May 11, 2017, the Senate Committee on Agriculture, Nutrition and Forestry held a hearing seeking comments from EPA, industry and other stakeholders on the proposed legislation.  On June 30, 2017, the committee approved the legislation for floor consideration without objection.  Due to various issues in the Senate, however, the bill has not yet been scheduled for a vote or debate.

Given the few legislative days remaining in September and the number of priority issues demanding more immediate Congressional attention, it appears unlikely that lawmakers will pass a reauthorization measure before current PRIA expires at the end of this month.  Moreover, the measure adopted by the Senate committee contains several modifications to the House passed bill.  Among these, the Senate committee bill establishes a three-year extension of PRIA from the current sunset date of September 30, 2017 to September 30, 2020.  In contrast, the House measure provides for a six-year authorization of the statute ending on September 30, 2023.  In other changes, the registration action fees for certain product categories adopted in the Senate committee bill differ in some cases from those approved by the full House.  As such, if the full Senate were to pass the committee bill as currently drafted, these differences would have to be reconciled in a House-Senate conference committee where it is possible that further changes to the measure could be made.  The conferenced bill would then need to be passed by each chamber before the President could sign it into law.  This process could take several weeks or more to complete.

It is important to note that even if a reauthorization measure is not enacted into law by September 30^th, EPA’s authority to collect registration service fees will not end abruptly on that date.  The recent bi-partisan budget agreement to keep the federal government operating for three months beyond September 30^th (the end of the federal fiscal year) provides EPA the authority to collect fees at current levels through the end of 2017.  Moreover, if Congress and the Administration fail to enact PRIA by the end of the year, the current statute provides a gradual phase down of EPA’s authority to collect fees with a 40% reduction in fees during FY 2018 and a 70% reduction during FY 2019.  Once a reauthorization measure is enacted into law, PRIA fee collections will resume as if the legislation had been passed in a timely manner.  In summary, while PRIA may technically end on September 30^th, there should be no impact on the funding of OPP pesticide review activities until January 2018 at which time it is expected that the statute will have been reauthorized.

CPDA is now focusing its efforts on securing the enactment of adequate appropriations in support of pesticide review activities conducted by the Office of Pesticide Programs (OPP) under PRIA.  Competition for limited appropriated funds proposed under the President’s budget Agency-wide will be fierce – especially given the monumental task faced by the Agency in conducting the review of some 10,000 chemicals as mandated under the set of reforms enacted to update the Toxic Substances Control Act (TSCA).  Moreover, on September 14, 2017 the House passed a $1.2 trillion spending package for FY 2018 that begins October 1^st.  The omnibus spending bill reduces EPA’s budget by $534 million compared to last year’s enacted level. In the face of these challenges surrounding EPA appropriations for the coming federal fiscal year, CPDA is calling upon its member companies to assist our efforts as we advocate for full funding of OPP.  Specifically, CPDA is encouraging its member company representatives to write to House appropriators urging them to fully fund OPP/PRIA in the FY 2018 budget.  Concurrently, CPDA is meeting with Members of Congress seeking their support of full funding of OPP pesticide review activities.  CPDA is committed to working in support of full funding of EPA’s pesticide program and the reauthorization of PRIA legislation and will keep its members informed of further developments as they occur.  Should you have any questions, please contact CPDA Director of Legislative Affairs Don Davis at ddavis@cpda.com.

On September 19, 2017, CPDA President Sue Ferenc and CPDA Director of Regulatory Affairs Sylvia Palmer met with Bill Perry and Maureen Ruskin, Director and Deputy Director, respectively, of OSHA’s Directorate of Standards and Guidance, to discuss the upcoming December 1, 2017 deadline under the 2012 Hazard Communication Standard (HCS 2012) for the relabeling of non-pesticide agricultural products, under the control of a distributor, that are packaged in sealed containers and stored in warehouses.  The deadline is set forth under OSHA Directive Number CPL 02-02-079, issued on July 9, 2015.  During the meeting, CPDA staff conveyed their concerns regarding the December 1, 2017 deadline explaining that while it granted temporary relief from the original deadline of December 1, 2015, it was nonetheless limited in scope and duration and did not fully take into consideration the unique way in which non-pesticide agricultural products are sold and resold in the agricultural chemicals marketplace.  CPDA representatives raised the possibility of OSHA granting an extension of the deadline in the form of an amendment to its Directive that would be narrowly crafted and limited specifically to products of extremely long shelf life including tank-mix adjuvants, plant nutritional products, soil amendments and fertilizer products.

As reported previously, CPDA has engaged extensively with OSHA on advocating for changes to HCS 2012 that would stipulate that sealed containers in warehouses would not have to be relabeled based on new hazard information if an updated label is transmitted electronically to downstream entities as is allowed for updated safety data sheets.  Throughout these discussions, OSHA officials have expressed a willingness to work with the Council in the development of possible modifications to the regulation as part of a future rulemaking to better align it with the sixth revision of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  CPDA is in the process of drafting formal comments for submission to an OSHA open docket that will urge the Agency to follow an approach patterned after EPA’s “Released for Shipment” precedent to prevent the need to relabel compliantly labeled pesticide products once manufactured and released for warehousing and distribution.  CPDA will also encourage allied associations representing affected members of the chemical manufacturing and distribution industry to submit similar comments to the docket.

In the interim, CPDA will continue to work with OSHA in securing a limited carve-out from the December 1^st deadline for compliance with the Directive that currently applies to distributors of non-pesticide agricultural products such as tank-mix adjuvants, plant nutritional products, and fertilizers pending a final resolution of this issue as part of the anticipated effort to update HCS 2012.

On July 25, 2017, legislation (S. 1624) titled the “Protect Children, Farmers, and Farmworkers from Nerve Agent Pesticides Act of 2017” was introduced by Senators Tom Udall (D-NM), Richard Blumenthal (D-CT), Cory Booker D-NJ), Ben Cardin (D-MD) and others.  The measure would prohibit the use of chlorpyrifos on food and it would amend Section 402 of the Federal Food, Drug and Cosmetic Act (FFDCA) to stipulate that adulterated food includes any food that “bears or contains chlorpyrifos, including any residue of chlorpyrifos, or any other added substance that is present on or in the food primarily as a result of the metabolism or other degradation of chlorpyrifos.”  In addition, the bill would require the EPA Administrator to enter into a contract with the National Research Council to conduct a cumulative and aggregate risk assessment that addresses all populations, and the most vulnerable subpopulations including infants, children, and agricultural workers, to organophosphate pesticides.

Introduction of the bill follows EPA Administrator Scott Pruitt’s March 29, 2017, decision to deny a 2007 petition filed by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) seeking the revocation of all tolerances for chlorpyrifos and the cancellation of all product registrations for the chemical.  Among the claims asserted by the petitioners was that EPA failed to adequately assess the potential for chlorpyrifos to cause neurodevelopmental effects in children at exposure levels below the Agency’s existing regulatory standard (10% cholinesterase inhibition).  In an effort to resolve the scientific issues surrounding the potential risks associated with chlorypyrifos, EPA committed to completing the expedited registration review of the chemical several years in advance of the October 1, 2022 statutory deadline.  Although EPA had expedited its registration review, the petitioners were not satisfied with the Agency’s progress in responding to the petition and filed a lawsuit in the 9^th Circuit Court of Appeals to compel EPA to either issue an order denying the petition or to grant the petition by initiating the tolerance revocation process.

In August 2015, the Court issued a ruling in favor of the petitioners.  Following the judicial ruling, in November 2015 EPA issued for public comment a proposal to revoke all chlorpyrifos tolerances citing the uncertainties pertaining to the chemical’s potential to cause neurodevelopmental effects.  Subsequently, the 9^th Circuit announced that it would retain jurisdiction over the chlorpyrifos matter and on August 12, 2016 directed EPA to issue a final decision on the petition no later than March 31, 2017.  In so doing, the Court made it clear that no further extensions in responding to the petition would be granted.  Pursuant to the Court order, in November 2016 EPA published for public comment notice of availability of its revised risk assessment for chlorpyrifos.

In its March 29, 2017 decision to deny the petition seeking a ban on the use of chloryprifos, the Agency stated:

“Following a review of comments on both the November 2015 proposal and the November 2016 notice of data availability, EPA has concluded that, despite several years of study, the science addressing neurodevelopmental effects remains unresolved and that further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos. EPA has therefore concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution on those issues. As noted, Congress has provided that EPA must complete registration review by October 1, 2022. Because the 9th Circuit’s August 12, 2016 order has made clear, however, that further extensions to the March 31, 201 7 deadline for responding to the Petition would not be granted, EPA is today also denying all remaining petition claims.”