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.”

CPDA’s 2017 Annual Adjuvants & Inerts Conference held May 3rd in Indianapolis, Indiana featured an informative and comprehensive speakers program that covered an array of topics such as drift reduction technologies, effective management of weed resistance, the short and long-term outlook for the agricultural economy, and challenges associated with reducing off-site drift of  auxin herbicides.  At the request of a number of our members who attended the Conference, we are providing access to the speaker presentations for whom we have received permission to post.

Dr. Greg Kruger, University of Nebraska-Lincoln

Brian Finstrom, Capstan AgSystems

Steve Smith, Red Gold Inc.

Dr. Doug Doohan, Ohio State University

Dr. Michael Boehlje, Purdue University

In an April 10 decision, the U.S. District Court for the Middle District of North Carolina ruled that FIFRA precludes claims of copyright infringement for the required parts of the labels of “me-too” registered products.  The decision was issued in Syngenta Crop Protection, LLC v. Willowood, LLC., a lawsuit in which Syngenta alleged that Willowood had willfully and knowingly violated copyright protections of one of its product labels when Willowood used substantial portions of the label for a generic me-too version of the product in question.  The North Carolina District court decision rejected the conclusions of the U.S. District Court for the Eastern District of Pennsylvania issued in a previous case, FMC Corp. v. Control Solutions, Inc., involving similar claims of copyright infringement of the pesticide label.

In a very lengthy 2005 decision, the Pennsylvania District court found that Control Solutions, Inc. had willfully infringed on the copyright of the label of one of FMC’s proprietary pesticide products (TalstarOne).  The court stated, “…To quickly enter the same market, defendant CSI took an impermissible short-cut.  Instead of investing the resources necessary to develop an independent product label, CSI simply appropriated FMC’s existing copyrighted labels. Wholesale copying, as CSI did with FMC’s label, is not consistent with the statutes, regulations or process mandated by the EPA for having a me-too pesticide registered to permit the sale of a generic pesticide product.”  The Pennsylvania District court issued a temporary injunction against CSI “to prevent further sales or facilitation of sales of any product utilizing a product label that has been approved by the EPA…based upon a me-too submission by CSI that consists of a product label based on the virtually verbatim copying of the TalstarOne label.”

However, in its recent ruling, the North Carolina District court found the decision issued in 2005 to be “unconvincing,” concluding instead that federal pesticide law “contemplates that a [generic] applicant will copy from the original pesticide label in ways that would otherwise infringe a copyright…Congress intended a narrow exception to copyright protection for the required elements of pesticide labels as against me-too registrants.”

The issue of copyright infringement as it pertains to a generic registrant’s use of a basic manufacturer’s product label for a me-too pesticide has been a contentious legal topic over the years.  Shortly after the decision in FMC Corp. v. Control Solutions, Inc., CPDA wrote a July 11, 2005 letter to Susie Hazen who was then OPPTS Deputy Assistant Administrator at EPA.  In its letter, CPDA voiced concerns that the court decision could trigger a deluge of me-too label changes submitted to the Agency by companies seeking to avert the possibility of copyright infringement legal action brought by the original manufacturer.  CPDA also pointed out the difficulties inherent in making each product label different from other labels so as to avoid the risk of infringing on the copyright while at the same time making sure that any variations would not confuse the user.

EPA responded with a letter agreeing with these and other concerns raised by CPDA.  In its letter, the Agency affirmed the practice of the Office of Pesticide Programs (OPP) under FIFRA Section 3(c)(7)(A) to encourage me-too product labels to be identical or substantially similar to the labels of the products on which their registrations are based.  EPA emphasized that similar products need to communicate use instructions and warnings in a clear and consistent manner to ensure that the products are used appropriately.  The Agency cautioned that variations on the label for similar products could diminish EPA’s ability to enforce pesticide labeling in a consistent manner thus defeating the primary purpose of labeling.  CPDA will continue to keep a watchful eye on any further legal developments on this issue should they occur.