By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda. The U.S. Environmental Protection Agency’s (EPA) Agency Rule List included several pesticide rulemakings in the proposed rule stage, as well as the Certification of Pesticide Applicators rulemaking that is in the final rule stage. The five items in the proposed rule stage are:
- RIN 2015-AA00: Revision of Procedural Rules for Hearings on Cancellations, Suspensions, Changes in Classifications, and Denials of Pesticide Registrations. The agenda states that this proposed rulemaking is a “revision of the Rules of Practice governing the conduct of licensing adjudications under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).” The issuance of the proposed rule is scheduled for January 2018.
- RIN 2070-AK00: Pesticides; Technical Amendments to Data Requirements. The agenda states that to satisfy one of the commitments in a settlement agreement reached with the American Chemistry Council (Docket ID Number EPA-HQ-OPP-2008-0110-0139), EPA is proposing a correction pertaining to the 200 parts per billion (ppb) level described in 40 C.F.R. Section 158.2230(d) that was originally used by the U.S. Food and Drug Administration with respect to the “concentration of residues in or on food for tiering of data requirements for indirect food use biocides.” Through this rulemaking, the agenda states that EPA intends to “clarify that the 200 ppb level is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food.” The issuance of the proposed rule is scheduled for July 2017.
- RIN 2070-AK06: Pesticides; Procedural Rule Amendment; Requirement for Certain Pesticide Actions to Publish Notices in the Federal Register. In the agenda, EPA states that as the as the Federal Register is “no longer the most cost effective or efficient way for providing notice or sharing information with the public,” it is considering changing the way that it provides notice on or shares information with the public -- specifically, by no longer publishing certain information in the Federal Register, but instead providing the same information on a consolidated website which the agenda states “will be more accessible to the public and other interested parties, as well as a more cost effective and efficient mechanism for providing timely updates.” The agenda lists the following kinds of notification it is considering making this change regarding: (1) reregistration of a pesticide product with a new active ingredient or new use; (2) announcing approvals of specific, quarantine and public health exemptions; and (3) Summaries of certain state registrations. For Registration Review, the agenda state that EPA “intends to announce availability of the documents that are currently announced in the Federal Register on the EPA's Registration Review Website.” For notices of availability announced in the Federal Register, the agenda states that “EPA intends to direct the public to a case-specific docket on Regulations.gov to view pertinent registration review documents and provide comment.” The issuance of the proposed rule is scheduled for April 2018.
- RIN 2070-AK40: Extension of Compliance Date(s); Agricultural Worker Protection Standard. As reported in our memoranda summarizing the Worker Protection Standard (WPS) final rule, EPA Publishes Worker Protection Standard Final Rule, the WPS final rule was issued on November 2, 2015, but has not yet been made effective. More information on the delay of its effective date is available in our blog item EPA to Delay Agricultural WPS Indefinitely; Cites Issues with Guidance and Training. This proposed rulemaking will adjust the compliance date. The issuance of the proposed rule is scheduled for July 2017 and the issuance of the final rule is scheduled for November 2017.
- RIN 2080-AA13: Updates to 40 C.F.R. § 26 Subpart K to reflect recent changes to 40 C.F.R. Subpart A (The Common Rule). As reported in our blog item Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects, on January 19, 2017, EPA, together with a host of other federal agencies, released a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991, and is now codified in 40 C.F.R. § 26, Subpart A. These revisions, scheduled to become effective on January 19, 2018, will create a conflict within some of the EPA-specific subparts, in particular, Subpart K of 40 C.F.R. 26 (Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intention Exposure of Non-Pregnant, Non-Nursing Adults) which regulates third party pesticide research. The agenda states that this proposed rulemaking is “intended to resolve proposed rulemaking discrepancies created by the recent revision to Subpart A, and will not alter the fundamental protections for human subjects, including vulnerable populations.” The issuance of the proposed rule is scheduled for January 2018.
The two items in the final rule stage are:
- RIN 2070-AJ20: Pesticides; Certification of Pesticide Applicators. As reported in our memoranda summarizing the Certification of Pesticide Applicators’ final rule, Final EPA Rule Requires Stronger Standards for Applying Riskiest Pesticides, the final rule was issued on January 4, 2017. More information on the delay of its effective date is available in our blog item EPA Delays Effective Date of Certification of Pesticide Applicators Final Rule. On June 2, 2017, a Federal Register publication was issued that delayed the effective date until May 22, 2018.
- RIN 2070-AK13: Procedural Rule to Remove Obsolete Information. The agenda states that this final rule will remove information from EPA’s existing pesticide regulations that is now out of date or obsolete and will “provide clearer and more reliable information to those seeking to register a pesticide product.” The agenda further states that as rulemaking is intended to be a non-substantive, procedural rulemaking “since the EPA does not intend to make any substantive changes to the existing requirements,” EPA is considering issuing this as a final rule and not going through the notice and comment period. The issuance of the final rule is scheduled for January 2018.
Much of the work noted emphasizes potential procedural efficiencies and clarifications. The potential move to more announcements on the websites and away from the Federal Register is, at least in part, likely intended as a cost-saving measure. It is also a change that will be closely watched. For example, in recent years, EPA has seen registrations challenged based on assertions of an alleged lack of appropriate notice concerning the receipt or processing of registration applications, and these past challenges will likely influence any new procedures that EPA may adopt.
Of more interest is the new Administration’s call for suggestions of what rules or policies should be changed as part of a broader push for economic growth and less regulatory costs, which may result in more substantive regulatory changes and some likely controversial decisions about what rules or programs will be modified or eliminated -- but that exercise is not part of this announcement. The delay in the compliance date for the WPS regulation is more substantive, but changes that may be proposed have not yet been announced.
By Lisa R. Burchi, Timothy D. Backstrom, and James V. Aidala
On June 30, 2017, the U.S. Court of Appeals for the D.C. Circuit issued its opinion in Center for Biological Diversity (CBD), et al. v. U.S. Environmental Protection Agency (EPA), Case No. 14-1036, resolving jurisdictional and substantive issues following complaints alleging that EPA violated Section 7(a)(2) of the Endangered Species Act (ESA) by failing to make an effects determination or to consult with the U.S. Fish and Wildlife Service (FWS) or the National Marine Fisheries Service (NMFS) before registering cyantraniliprole (CTP) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Regarding the jurisdictional issue and the appropriate court in which to bring such a challenge, the U.S. District Court for the District of Columbia on May 14, 2015, had dismissed the ESA complaint of CBD, the Center for Food Safety, and the Defenders of Wildlife (Conservation Groups), finding that the Conservation Groups’ “Complaint gives rise to an ‘actual controversy as to the validity’ of the FIFRA Registration Order and is therefore governed by that Act’s jurisdictional grant.” The D.C. Circuit affirmed the U.S. District Court’s ruling to dismiss the ESA petition on jurisdictional grounds, concluding that FIFRA “grants the court of appeals exclusive jurisdiction to review an ESA claim that is ‘inextricably intertwined’ with a challenge to a pesticide registration order.”
The D.C. Circuit also, however, granted the Conservation Groups’ FIFRA petition, finding that EPA registered CTP without having made an effects determination or consulting with the FWS and/or the NMFS as required under ESA Section 7(a)(2). The court remanded the case to EPA for further proceedings, but allowed the CTP registration order to remain in effect until it is replaced by an order consistent with the court’s opinion.
Considering the growing number of complaints that allege a failure to consult with the FWS and/or the NMFS under the ESA, this decision could have broad reaching implications for how these complaints are filed and reviewed.
On February 29, 2012, EPA announced that it had received applications to register pesticide products containing CTP under FIFRA. On June 6, 2013, EPA announced its proposal to register CTP as a pesticide under FIFRA. As part of its review, EPA prepared an “Environmental Fate and Ecological Risk Assessment for the Registration of the New Chemical Cyantraniliprole” in which EPA states that CTP is “highly toxic or very highly toxic” to multiple taxonomic groups, including terrestrial invertebrates such as butterflies and beetles.
On January 24, 2014, EPA registered CTP as a pesticide under FIFRA and approved fourteen end-use products containing CTP. At issue in this case was EPA’s decision to register CTP without having made an effects determination or consulting with the FWS and/or the NMFS as required by ESA Section 7(a)(2) and implementing regulations (50 C.F.R. § 402.13-14).
Under the ESA citizen-suit provision, “any person” may “commence a civil suit on his own behalf … to enjoin any person, including the United States and any other governmental instrumentality or agency … who is alleged to be in violation of any provision of this chapter or regulation issued under the authority thereof.” 16 U.S.C. § 1540(g)(1). “The district courts … have jurisdiction” of ESA citizen suits, id., but no action may be commenced “prior to sixty days after written notice of the violation has been given to the Secretary, and to any alleged violator.” Id. § 1540(g)(2)(A)(i).
FIFRA’s citizen-suit provision at 7 U.S.C. § 136n(b) provides the federal circuit court with exclusive jurisdiction to affirm or set aside an EPA pesticide registration order following a public hearing, provided a challenge is filed within 60 days of the registration decision.
With potentially conflicting statutory provisions regarding the court in which to file a complaint and the timing to do so, the Conservation Groups initiated two actions: a complaint against EPA in D.C. District Court under the ESA’s citizen-suit provision; and a petition for review in D.C. Circuit Court pursuant to FIFRA’s citizen-suit provision.
The D.C. Circuit first addressed the jurisdiction issue, which involved a determination of standing and a resolution of the “dueling jurisdictional provisions of the ESA and of FIFRA.”
On the issue of standing, the D.C. Circuit found that petitioners did in fact have standing, as not only did EPA make procedural omissions through “its failure to make an effects determination and to consult,” but the plaintiffs show that EPA’s failure affected the plaintiffs’ members’ “concrete aesthetic and recreational interests.”
With regard to the appropriate court in which to bring this claim, the D.C. Circuit found that “FIFRA vests the courts of appeals with exclusive jurisdiction over controversies arising from an EPA pesticide registration, so long as, inter alia, registration follows a public hearing.” The court thus also found:
- Because FIFRA’s grant of exclusive jurisdiction to the court of appeals to review registration orders is more specific than the ESA’s citizen-suit provision, we believe the Conservation Groups must bring their ESA section 7(a)(2) challenge to us if 7 U.S.C. § 136n(b) is satisfied. And the Conservation Groups do satisfy the requirements of 7 U.S.C. § 136n(b): they are adversely affected by the registration of CTP; they challenge the validity of the CTP registration order based on the EPA’s failure to make an effects determination and to consult; and their challenge comes after a “public hearing” by way of three notice and comment periods. We therefore have “exclusive jurisdiction” to review their claim under FIFRA and the district court correctly dismissed their ESA citizen suit. (citations omitted).
While the ESA citizen suit was dismissed, the FIFRA citizen suit remained under the D.C. Circuit’s exclusive jurisdiction and review. The court found that EPA violated ESA Section 7(a)(2) by registering CTP before making an effects determination or consulting with the FWS or the NMFS.
Significantly, the court decided to remand the case to EPA for further proceedings without vacating the CTP registration. The court stated that remand without vacatur is appropriate in this case because “[n]otwithstanding the EPA’s failure to make an effects determination and to engage in any required consultation, it did not register CTP in total disregard of the pesticide’s potential deleterious effects; indeed, the Conservation Groups themselves rely heavily on the EPA’s ‘Ecological Risk Assessment for the Registration of the New Chemical Cyantraniliprole.’” The court further stated that “allowing the EPA’s CTP registration order to remain in effect until it is replaced by an order consistent with our opinion will maintain ‘enhanced protection of the environmental values covered by the CTP registration order.’”
This case is significant in at least two respects and should have implications in other cases being brought under ESA and FIFRA citizen suit petitions. First, the court provides the same answer concerning the “dueling jurisdictional provisions of the ESA and of FIFRA” as prior decisions in the Ninth Circuit, finding that FIFRA’s jurisdictional grounds take precedence and that the Courts of Appeal have exclusive jurisdiction to review cases claiming ESA violations in the context of an approved FIFRA pesticide registration. The court found the Conservation Groups’ arguments to the contrary “unavailing,” including but not limited to their argument that the public notice and comment periods that were provided did not constitute a “public hearing” under FIFRA Section 16(b) as well as their argument that the ESA challenge was not “inextricably intertwined” with FIFRA, even though the Conservation Groups were challenging the CTP registration order itself. It also is significant that the court, while remanding the registration order to EPA for further actions under the ESA, did not immediately vacate the existing CTP registration order.
Some observers of the extensive ESA-FIFRA litigation over recent years wondered whether the CTP registrations would be vacated once challenged for conformity to ESA requirements. EPA effectively admitted that it did not follow the full consultation process with FWS and NMFS, in this case substituting a relative risk argument that CTP was an improvement that would provide more species protection compared to the compounds it is expected to replace in the marketplace. The remand without vacatur does not resolve what some have called the “train wreck” scenario, where the need to complete ESA consultation, combined with time and resource constraints at the respective agencies, will result in a virtual freeze on new pesticide product registrations. The court makes it clear that, if EPA makes an affirmative ESA effects determination for CTP, consultation with the FWS and/or the NMFS must follow.
By Lynn L. Bergeson and Margaret R. Graham
In June 2017, the U.S. Environmental Protection Agency (EPA) issued a draft Office of Chemical Safety and Pollution Prevention (OCSPP) National Program Manager Guidance for Fiscal Year (FY) 2018-2019, which sets forth the strategies and actions that EPA and its state and tribal partners will undertake to protect human health and the environment via six key programmatic activities. EPA uses an Annual Commitment System (ACS) to track annual regional performance information and results. Below is a listing of the six programmatic activities and their ACS measures, if applicable:
- Strengthening state and tribal partnerships through continued effective management of pesticide cooperative agreements. The guidance states that the “National Pesticide Program depends on cooperative agreements with states and tribes to implement many of the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and to help ensure [EPA’s] regulatory decisions and programs achieve intended protections. For the ACS measure, the commitment target is 100 percent of pesticide program required activities included in grantee work plans completed under pesticide program portion of the FIFRA Grant Guidance. More information on the activities is listed in the guidance.
- Assisting in national, regional, and local pollinator protection efforts. EPA states that “through risk assessment, mitigation, education, and outreach, EPA’s Office of Pesticides Programs’ goal for pollinator protection is to ensure all pollinators, including managed pollinators such as honey bees, and native pollinator including Monarch Butterflies, are protected from adverse effects of pesticide exposure.” More information on the activities is listed in the guidance. EPA is not proposing any ACS measures to be associated with this area of focus for FY2018-2019.
- Effectively implementing the revised pesticides worker protection standard rule. More information on this rule is available on our blog under key phrase Worker Protection Standard. EPA states that no ACS measure is proposed to be associated with this area of focus for FY2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.”
- Effectively implementing the revised certification of pesticide applicators rule. Same as above, EPA states that no ACS measure is proposed to be associated with this area of focus for FY2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.” More information on this rule is available on our blog under key phrase pesticide applicators.
- Focusing region-specific pesticide priorities on those areas of greatest need nationally. EPA states that region-specific pesticide priority areas “support the agency’s national pesticide program efforts. In addition, these projects support one or more of the agency’s Strategic Plan goals and strategies, and directly benefit states and/or tribes. The region-specific pesticide priority areas to choose from are: (1) promotion of state and tribal pesticide program coordination and communication; (2) bed bug outreach and assistance; (3) promotion, development or support of integrated pest management efforts; (4) support of water quality risk assessment and mitigation; (5) spray drift outreach and incident data collection; and (6) support of emerging public health pesticide issues. The ACS measure commitment target is one project or initiative contributing to the implementation and enhancement of the region-specific pesticide program priority areas.
- Toxics Release Inventory (TRI). For the TRI program, EPA includes three ACS measures on the number of TRI data quality checks:
- The TRI-1 measure allows EPA to track performance of the TRI program, and aid in improving the accuracy and reliability of environmental data. This measure will provide valuable information as more than 21,000 facilities report to the TRI program annually.
- For FY2018, TRI-1 is a non-commitment measure of data quality calls and emails to 600 facilities in total across all regional offices.
- For FY2019, TRI-1 will be a commitment measure of data quality calls and email to 600 facilities in total across all regional offices.
By Lisa M. Campbell and Margaret R. Graham
On June 14, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. 82 Fed. Reg. 27254. EPA states that this test guideline provides “guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA,” and “recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products intended to repel, attract, and/or kill the common bed bug (Cimex lectularius) in connection with registration of pesticide products under the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” EPA states that this guidance applies to products “in any formulation such as a liquid, aerosol, fog, or impregnated fabric, if intended to be applied to have a pesticidal purpose such as to attract, repel, or kill bed bugs.” This guideline provides appropriate laboratory study designs and methods for evaluating the product performance of pesticides against bed bugs and includes statistical analysis and reporting.
EPA issued the draft guideline on February 14, 2012. This original document was the subject of FIFRA Scientific Advisory Panel (SAP) review conducted on March 6-7, 2012. EPA indicates that the final version of the guideline reflects revisions to the original draft based on comments from the SAP and the public. EPA states that the revisions include the following:
- Decreasing the number of individuals and replicates tested;
- Rescinding the recommendation to test each field strain for its resistance ratio; and including a resistance management statement;
- Clarifying the agency's Good Laboratory Practices (GLP) requirements;
- Reducing the recommended length of time individuals are exposed to insecticides;
- Recommending individuals to be observed up to 96 hours after treatment; and
- Revising the statistical analyses recommendations.
EPA has also placed two other relevant documents in the docket:
By Lynn L. Bergeson and Carla N. Hutton
On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of a nanosilver pesticide product and vacated the conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC) as well as the Center for Food Safety (CFS) and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named NSPW-L30SS (NSPW). The court vacated the conditional registration because, according to the court, “EPA failed to support its finding that NSPW is in the public interest.”
When EPA granted the conditional registration, EPA did so on the basis that NSPW had a lower application rate and a lower mobility rate when compared to conventional-silver pesticides, and thus had the potential to reduce environmental loading and risk caused by silver release. Petitioners disputed these facts. While the court found that substantial evidence supports EPA’s findings that NSPW has lower application and mobility rates, the court agreed that the third premise, that current users of conventional-silver pesticides will switch to NSPW and/or that NSPW will not be incorporated into new products, “impermissibly relies on unsubstantiated assumptions.” According to the court, EPA cites no evidence in the record to support its assumption that current users of conventional-silver pesticides will switch to NSPW (“the substitution assumption”), but contends that it will occur as a “logical matter.” The court states that the lack of evidence supporting the substitution assumption is problematic in light of EPA’s other unsupported assumption, that there will be no new products. The court notes that EPA assumes current users of conventional-silver pesticides will switch to NSPW because of its benefits, but that these same benefits will not prompt manufacturers to incorporate NSPW into new products. EPA could have proved these assumptions, but without evidence in the record to support the assumptions, the court states that it “cannot find that the EPA’s public-interest finding is supported by substantial evidence as required by [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” According to the court, the public interest finding is an “essential prerequisite to conditional registration,” and EPA failed to support that finding for NSPW with substantial evidence. The court vacated the conditional registration in whole, and did not consider the remaining issues raised by petitioners.
More information will be available in Bergeson & Campbell, P.C.’s memorandum Appellate Court Vacates Conditional Nanosilver Registration.
By Lynn L. Bergeson and Margaret R. Graham
In a May 11, 2017, letter from U.S. Environmental Protection Agency (EPA) Acting Assistant Administrator Wendy Cleland-Hamnett to the CEO of the National Association of State Departments of Agriculture (NASDA) posted by Bloomberg’s BNA Daily Environment Report, Cleland-Hamnett states that it is appropriate to grant NASDA’s request to delay implementation of all revised provisions to the agricultural Worker Protection Standard (WPS) “until the necessary guidance and training have been completed which would allow state lead pesticide agencies to successfully implement the rule changes.” EPA has not yet issued any formal delay notifications.
The May 11, 2017, letter was sent in response to a February 17, 2017, letter from NASDA (February 21, 2017, per the NASDA website) that requested EPA to extend the WPS “until at least January 2, 2018, or until adequate enforcement guidance, educational materials, and training resources have been completed and the state lead agencies have the tools, time, and resources necessary to effectively implement the rule changes and assist the regulated community with compliance activities.” This letter was not submitted in the WPS docket in response to a request for comment, but pursuant to a NASDA membership decision. NASDA states in the letter that the new WPS regulations require “significant additional staff time to provide sufficient outreach to workers, handlers, applicators, agricultural employers, trainers and other stakeholders,” and that “the enhanced compliance and record keeping requirements require a robust delivery and understanding of educational resources and training materials to assist [state lead agencies] and the regulated community in understanding, complying, and enforcing the new requirements.”
The WPS final rule including updates and revisions to the existing worker protection regulations for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) became effective on January 1, 2016, and on January 4, 2017, agricultural employers and handler employers were required to comply with all of the new requirements set forth in the final rule – with the exception of two requirements that would be implemented not before January 2018. More information on the final rule is available in our blog item EPA Publishes Worker Protection Standard Final Rule.
By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham
On April 27, 2017, Senator Elizabeth Warren (D-MA) and Representative Frank Pallone (D-NJ) sent a letter to Inspector General Arthur Elkins, Jr. at the Office of Inspector General (OIG) at the U.S. Environmental Protection Agency (EPA) requesting the OIG to conduct an investigation into EPA’s March 29, 2017, order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos. The letter refers to the March 29, 2017, order as “Administrator Scott Pruitt’s order,” and asks OIG to address questions specifically targeting the rationale, communications, and consideration that Administrator Pruitt took prior to reaching the decision.
The letter states that Administrator Pruitt's “hasty reversal of this decision … appears not to be based on EPA’s existing recent scientific findings about the risk, or any new information that contradicts the findings about the health and safety risks of chlorpyrifos.” Further, the letter asserts that “it does not appear to be consistent with the law, which requires that pesticide products cannot be used unless ‘there is reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical residue.’”
- How did Mr. Pruitt reach the decision he announced on March 29, 2017? What was the timeline leading up to this decision? With whom did he communicate within EPA, the White House, or elsewhere in the Administration? With which outside entities did he communicate? Specifically, did Mr. Pruitt have any communication with staff or representatives of Dow Chemical or any pesticide industry trade groups including CropLife America?
- What was the rationale for Mr. Pruitt's decision, and why did he reverse an agency decision that had been years in the making? How was this rationale developed? Was it based on any new information or evidence?
- Was Mr. Pruitt's decision consistent with the requirements of the Administrative Procedures Act? Did he provide appropriate notice and comment and appropriately consider all relevant comments and information?
- Was Mr. Pruitt's decision consistent with the requirements of the FFDCA, which establishes a standard that, to maintain a pesticide tolerance, there must be "reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical petitition to revoke tolerances.pdf residue"? Has the EPA met the "reasonable certainty [of] no harm" standard in the law? Why did Mr. Pruitt note that chlorpyrifos was "widely used" when he announced his decision? Was this "wid[e] use" a factor in Mr. Pruitt's decision, and, if so, was this appropriate under the law? What other factors were taken into consideration by Mr. Pruitt?
- Is the EPA accurately and transparently presenting information to the public with regard to previous EPA actions concerning chlorpyrifos? For example, the EPA website for chlorpyrifos on January 2, 2017 contained information indicating that EPA "proposed to revoke all chlorpyrifos tolerances," and contained a link with detailed information about the health risks and the reasons for the EPA action. This reference to the proposed ban, and the link to the detailed EPA analysis are no longer available on the chlorpyrifos web page, and the link to the analysis (as of April 3, 201 7) now gives a "Page Not Found" error.
This letter not surprisingly continues the debate over the appropriate regulatory status of chlorpyrifos. Those disappointed by the recent EPA decision, apparently including Senator Warren and Representative Pallone, want to press EPA to explain in more detail not only the reasons for the decision not to revoke chlorpyrifos tolerances at this time, but also the rationale EPA used to rebut what they believe to be the decision-making record that EPA had accumulated over the last two to three years.
The explanation that the arrival of new leadership at EPA with the Administration led to a change in position is perhaps only part of the answer. The change in Administration did not change the underlying statutory requirements governing EPA’s registration, reregistration, and tolerance decisions, and EPA relied on these requirements as the basis for its decision not to make a decision at this time, as discussed in EPA Denies Petition to Ban Chlorpyrifos.
EPA’s response to any investigation initiated by this letter, as well as the OIG response, will be watched closely by all stakeholders.
By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham
In a two-page order issued on April 10, 2017, the U.S. District Court for the Middle District of North Carolina granted in part a motion for summary judgment filed by “me-too” registrants, Willowood, LLC, Willowood USA, LLC, Willowood Azoxystrobin, LLC, and Willowood Limited (Defendants), regarding Syngenta Crop Protection, LLC’s (Plaintiff) claims of copyright infringement. Syngenta Crop Protection, LLC v. Willowood, LLC, Case No. 1:15-CV-00274. The claims at issue (Counts V and VI of Plaintiff’’s complaint) were based on the Defendants’ use of Syngenta’s label. The court stated that it was granting this part of Defendants’ motion “because the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) precludes copyright protection for the required elements of pesticide labels . . . of me-too registrants.”
Counts V and VI of Plaintiff’s complaint stated that Defendant copied and used substantial portions of Syngenta’s copyrighted work, and that this infringement is “willful and knowing.” The Defendants’ motion for summary judgment stated with regard to the copyright infringement counts of the complaint:
- Counts V and VI fail as a matter of law because Defendants’ labels comply with applicable federal regulations and contain language that is mandated by federal law. Moreover, under settled law, the portions of Plaintiff’s labels that Plaintiff asserts Defendants have copied are not entitled to federal copyright protection. Finally, to the extent that any portions of Plaintiff’s labels are entitled to copyright protection, Defendants’ copying is permitted under the fair use doctrine.
The order states that “in enacting FIFRA, Congress intended narrow exception to copyright protection for the required elements of pesticide labels as against me-too registrants.” The court expressly rejects the lengthy 2005 decision issued by the District Court for the Eastern District of Pennsylvania, which reached a different conclusion in a similar case, stating that it finds the analysis in that decision “unconvincing.” FMC Corp. v. Control Solutions, Inc., 369 F. Supp. 2d 539, 555-71 (E.D. Pa. 2005). The court states: “FIFRA contemplates that a ‘me-too’ applicant will copy from the original pesticide label in ways that would otherwise infringe a copyright.”
Of interest, the court states that its grant of the summary judgment motion with respect to the copyright claims does not need to take into account an expert report or declarations by, among others, former EPA Office of Pesticide Programs (OPP) officials Debra Edwards and Lois Rossi, filed by Defendants because “the Court is granting the summary judgment motion on legal grounds unrelated to the proffered evidence.”
Plaintiff filed its complaint on March 27, 2015. The complaint included seven counts against Defendants: the infringement of four patents in violation of 35 U.S.C. § 271(a) (Counts I-IV), the two copyright infringement counts (Counts V-VI), and a violation of the Unfair and Deceptive Trade Practices Act (N.C. Gen. Stat § 75-1.1) (Count VII). Count VII of the complaint was dismissed on August 12, 2016, and on March 24, 2017, the court granted Plaintiff’s motion for summary judgment regarding the infringement of two of the four patents; a decision on the infringement of the remaining two patents is still pending.
This opinion, which squarely rejects the 2005 conclusion of another district court, is likely to be of controversy and is the most recent decision in a long-standing debate on this issue between basic registrants and me-too registrants. EPA in the past has appeared to side with the me-too registrants. For example, in an August 3, 2005, letter to the Chemical Producers and Distributors Association (CPDA), written in response to the FMC decision, EPA stated that it “has been the practice of [OPP] since the enactment of FIFRA section 3(c)(7)(a) in 1978 to strongly encourage ‘me-too’ product labels to be identical or substantially similar to the labels of the products on which their registrations are based.” In that letter, EPA stated further: “Conveying application instructions and safety messages for similar products in different ways increases the likelihood that the product will be misused.” EPA at the time noted that there were over 650 mostly “me-too” products for just one herbicide (2,4,-D) -- and that having 650 products each having to say some of the required use instructions differently would be impossible.
Nonetheless, some elements of the label might be viewed as proprietary -- the “look and feel” of a product label, perhaps certain fonts, and trademarked product name (as opposed to the active ingredient name). It remains to be seen whether the April 10, 2017, order is the last judicial word on this subject or whether the issue will continue to be litigated. It is an issue that all registrants should monitor closely.
By Lisa M. Campbell and James V. Aidala
On April 5, 2017, Petitioners Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) filed a Motion for Further Mandamus Relief in the Ninth Circuit Court of Appeals proceedings regarding the chlorpyrifos tolerances. In the motion, Petitioners respond to the U.S. Environmental Protection Agency’s (EPA) order signed on March 29, 2017, which denied the petition to revoke tolerances. Petitioners state that EPA’s response to the petition (the order) is “no response at all and not what this Court ordered EPA to do,” and asks the court to “grant further mandamus relief, giving EPA 30 days to act on its findings that chlorpyrifos exposures are unsafe and to establish deadlines for the next steps in the revocation and cancellation processes for chlorpyrifos.” Specifically, Petitioners request that the court order EPA to:
- Take regulatory action within 30 days on its finding that chlorpyrifos is unsafe and “make it abundantly clear that what is required within 30 days is final regulatory action based on the neuro-developmental and other risks posed by chlorpyrifos exposures”;
- Resolve objections to its final regulatory action within 60 days, as opposed to “as soon as practicable after receiving the arguments of the parties,” because, Petitioners assert, EPA otherwise may put off their response for a long period of time;
- Require EPA to issue a notice of intent to cancel all chlorpyrifos uses within 60 days, “consistent with its risk assessments and findings that chlorpyrifos is unsafe,” as it has “found drinking water contamination from all chlorpyrifos uses, including nonfood uses, and will need to take regulatory action to end such uses in addition to stopping food uses”; and
- File six-month status reports until the tolerance revocation process and the cancellation proceedings are complete.
It is no surprise that the Petitioners who were disappointed by EPA’s denial of the petition one week ago have now continued their advocacy against the use of chlorpyrifos. As we note in our previous blog item EPA Denies Petition to Ban Chlorpyrifos, EPA articulated its reason for the denial as of this time, but this in itself did not articulate its determination that the registration and associated tolerances met the requirements of the Food Quality Protection Act (FQPA). EPA’s response to this latest legal skirmish will be of interest, as will the court’s response to it. .
More information on the proceedings is available on our blog under key word chlorpyrifos.
By Lynn L. Bergeson, James V. Aidala, and Margaret R. Graham
On February 14, 2017, in the House of Representatives, Rep. Rodney Davis (R-IL) introduced H.R. 1029, the “Pesticide Registration Enhancement Act of 2017,” which reauthorizes the Pesticide Registration Improvement Act (PRIA). H.R. 1029 was immediately referred to the Agriculture Committee and to the Energy and Commerce Committee; it was passed by the Agriculture Committee on February 16, 2017. Per Agriculture Committee Chair Michael Conaway’s opening statement at the Business Meeting markup of H.R. 1029, changes to PRIA include “reasonable increases in registration fees, funding for Good Laboratory Practices, and a seven year reauthorization as opposed to the five-year reauthorizations of the past.” H.R. 1029 would allow the U.S. Environmental Protection Agency (EPA) to collect up to 31 million in registration fees (up from 27.8 million) per year from fiscal years (FY) 2017-2023. It also includes the following registration increases for FY2017 through FY2023:
- The maximum annual fee for registrants holding 50 pesticide registrations or less would be $129,400 (up from $115,500);
- The maximum annual fee for registrants holding over 50 pesticide registrations would be $207,000 (up from $184,800);
- The maximum annual fee payable for a small business registrant holding 50 pesticide registrations or less would be $79,100 (up from $70,600); and
- The maximum annual fee payable for a small business registrant holding over 50 pesticide registrations would be $136,800 (up from $122,100).
PRIA represents a commitment by the pesticide registrants to help with the continued resource issues of the pesticide regulatory program. This has become an issue of increased concern with the arrival of the Trump Administration after campaign rhetoric about eliminating EPA and cutting budgets. Fees are seldom a popular topic, but an essential program component. Without staff and resources to approve pesticide registrations, registrants would be left with new products destined to pile in EPA in-boxes. PRIA is designed to help maintain some certainty and predictability to the review process.
Of some note is that in recent years Congress has appropriated funds at a level below the statutory minimum that originally was a line in the sand which, if breeched, would de-authorize EPA’s authority to charge application fees. The regulated community has reluctantly supported Congressional action to lower this “minimum” level of funding to hold onto the programmatic progress which has been made since the first PRIA authorization. This appears to be an uneasy acceptance of the budget realities surrounding federal spending on discretionary, non-defense expenditures.