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.

CPDA’s Don Davis Briefs Conference Attendees

CPDA Director of Legislative Affairs Don Davis presided over the Legislative Policy Conference held in Washington, D.C. on March 8^th and provided attendees a snapshot of the post-election political landscape and regulatory climate under the Trump Administration.  The following is a summary of the key highlights of Don’s presentation.

CPDA Members Review Key Issues in Preparation for Congressional Visits

Across the nation, some 44 state assemblies now fall under Republican control and in 25 states, the GOP controls both the Assembly and Senate in the state legislature. The electoral map of the U.S. also shows that 33 Republicans and 16 Democrats hold the governorship.  The party breakdown at the state level is important in that it plays an important role in what happens at the federal level – especially when it comes time for Congressional redistricting.  Meanwhile in the 115^th Congress, 237 Republicans and 193 Democrats make up the House (with 5 seats currently vacant) while 52 Republicans and 48 Democrats make up the Senate.  However, the GOP’s control of 52 seats in the Senate falls short of the 60 votes needed to break a filibuster under current Senate rules.

With regard to the current regulatory climate in Washington, the Trump Administration has wasted no time in pushing forward its agenda of regulatory reform and has already signed several Executive Orders of importance to CPDA.  Every President since George Washington has used the power of the presidency to issue Executive Orders as a means of instructing federal agencies on how to implement a law but sometimes as a way of circumventing existing law.  Yet, an Executive Order can be overturned by the Judiciary if it is determined that the EO is unconstitutional or not supported by the underlying statute.  In addition, Congress can pass a new law to override an Executive Order, subject to a Presidential veto.

Among the Executive Orders that the President has signed is the directive set forth in a January 20, 2017 White House memorandum that establishes a temporary regulatory “freeze” prohibiting all federal agencies from sending any regulation to the Office of the Federal Register (OFR) for publication until a department or agency head appointed by the President reviews and approves the rule.  Rules that have been sent to the OFR but have not yet been published in the Federal Register must be immediately withdrawn pending review by the Administration.  Another EO, signed by the President on January 30^th, requires any executive department or agency that proposes a new regulation to identify two regulations to be repealed.  For fiscal year 2017, the total incremental cost of all new and repealed regulations must be no greater than zero.  Finally, the President signed an EO on February 24 which instructs each federal agency to designate an official as its Regulatory Reform Officer within sixty days of the order.  These officers would oversee the administration’s regulatory reform policy laid out in previous executive orders within their respective agencies.

In addition to these White House actions, the Republican controlled House is advancing its own agenda of regulatory reform with the introduction of several legislative initiatives supported by CPDA.  Among these are the Regulatory Accountability Act of 2017, the Congressional Review Act of 2017, and several other measures intended to instill transparency into the federal rulemaking process without imposing unnecessary cost or undue burden on the regulated community.

Before dispersing to Capitol Hill, CPDA members received the following “Lobbying 101” tips in preparation for their Congressional office visits:  1) Know the make-up of the political environment within which you are advocating your position; 2) Get to know Members of Congress who play a key role on specific bills of interest (including the majority and minority leadership who sit on the Committee of jurisdiction); 3) Acquire an understanding of the legislative process and how bills move through Congress; 4) Develop a personal relationship with the elected Representative from your Congressional district as well as his/her staff but do not contact them only when you need something; 5) Leave behind a one-page fact sheet summarizing the issue and stance along with your business card; and, 6) Follow up any Congressional office visit with a personal thank you note.

With these tips and pointers fresh in hand, Council member company representatives embarked on a very successful and productive “Rally on the Hill” relaying CPDA’s position on key legislation that will have a profound impact on the agrotechnology industry.

On February 24, 2017, President Trump signed an Executive Order (EO) directing the heads of federal agencies to designate a Regulatory Reform Officer to oversee the implementation of regulatory reform initiatives including the directives set forth in his previous EO issued on January 30^th.  As reported previously, the January 30^th EO establishes a “regulatory cap” for fiscal year 2017 and requires federal agencies that propose for public notice and comment or otherwise promulgate a new regulation to identify at least two existing regulations to be repealed.  In addition, the January 30th EO stipulates that for fiscal year 2017, the total incremental cost of all new regulations, including those that have been repealed, must be no greater than zero unless otherwise required by law or consistent with written guidance from the Office of Management and Budget (OMB).

In addition to calling for the appointment of a Regulatory Reform Officer, the February 24^th EO directs each federal agency to establish a Regulatory Reform Task Force that will have responsibility for evaluating existing regulations and making recommendations to the agency head regarding the repeal, replacement or modification of existing rules.  Federal agencies that issue few or no regulations could seek a waiver from OMB exempting them from the requirements of the EO.  A list of agencies with current waivers will be published by the OMB at least every three months.

In performing its duties, the Regulatory Reform Task Force is instructed to identify regulations that eliminate or inhibit job creation, are unnecessary or ineffective, and impose costs that exceed benefits.  In carrying out its charge, the Regulatory Reform Task Force is directed to solicit input from state, local, and tribal governments, small businesses, consumers, non-governmental organizations, and trade associations.  Within 90 days from issuance of the EO, the Regulatory Reform Task Force must provide a report to the agency detailing its progress in carrying out these obligations.