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.

On March 29, 2017, EPA Administrator Scott Pruitt signed an order announcing the Agency’s 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.  The order appeared in the April 5, 2017 Federal Register.  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 states:

“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.”

EPA’s denial of the petition was applauded by Sheryl Kunickis, director of USDA’s Office of Pest Management Policy who called it “a welcome decision grounded in evidence and science.”  Kunickis added, “It means that this important pest management tool will remain available to growers, helping to ensure an abundant and affordable food supply for this nation and the world.  This frees American farmers from significant trade disruptions that could have been caused by an unnecessary, unilateral revocation of chlorpyrifos tolerances in the United States.  It is also great news for consumers, who will continue to have access to a full range of both domestic and imported fruits and vegetables.”

It is very likely that the petitioners will turn to the courts in an effort to overturn EPA’s recent decision.  CPDA will report on further developments on this issue as they occur.  The Agency’s decision denying the petition may be accessed by clicking here.

An article appearing in the April 5, 2017 edition of “InsideEPA.com” details severe funding cuts expected to be proposed in the Trump Administration FY 2018 budget request for EPA that promise to impact a number of Agency programs, including the Office of Pesticide Programs.  According to the article, the proposed funding reductions are set forth in a March 21, 2017 budget memo prepared by David Bloom, EPA’s Chief Financial Officer.  The article reports that the President will propose a $5.7 million and 31.7 FTE (full-time equivalent) decrease from OPP FY 2016 enacted funding levels of $6.1 million and 324.8 FTEs for protecting human health from pesticide risk.  In addition, the article states that the President will propose a reduction of $4 million and 18 FTEs from the $4.6 million in FY 2016 funding and 207.9 FTEs for protecting the environment from pesticides.  The reduced OPP funding levels set forth in the memo are accompanied by a statement explaining that the President’s budget will include language to allow the pesticide program to use fees on a broader range of activities in the program thus preventing a reduction or slowing in pesticide reviews.  The memo further states, “The program has nearly $30 million of unspent fee carryover that can help support core work.”  Elsewhere the memo states, “Sizeable unobligated balances in EPA’s FIFRA fee accounts are to be used to offset FY 2018 funding levels.  Additionally, any potential additional fee collections from the upcoming reauthorization of PRIA could help offset reductions to the program.”

As reported previously, current FIFRA language states that in order to release funds collected by program participants, Congress must appropriate corresponding funds to support the program.  Funds are then released on a dollar-for-dollar accounting basis.  Fees that do not have a matching appropriation cannot be spent and are held by the Agency.  As a result of dwindling appropriations and hiring freezes over the years, EPA has amassed significant funds that cannot be expended on the activities for which they were intended.  CPDA is now working in an effort to secure appropriations committee report language affirming that these “frozen” funds should be released and used in support of the Agency’s pesticide product review activities.  In addition, CPDA is focusing its efforts in seeking FY 2018 OPP appropriations levels that will ensure EPA is equipped with the resources necessary to conduct product reviews under PRIA in accordance with the statutory time frames established by law.  CPDA will keep its membership apprized of further developments on this issue as they occur.