By Lisa M. Campbell and Lisa R. Burchi
On February 8, 2018, the U.S. Environmental Protection Agency (EPA) announced that it is planning to submit an information collection request (ICR), “Submission of Unreasonable Adverse Effects Information under FIFRA Section 6(a)(2)” (EPA ICR No. 1204.13, OMB Control No. 2070-0039), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act.
EPA states that information submitted under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2) “provides an important means of focusing EPA attention on key problem areas regarding the use of a particular pesticide.” EPA states that since the last ICR was approved, it is increasing by 71,778 hours the total estimated respondent burden compared with the ICR currently approved by OMB. This increased estimate is based in part on the number of Section 6(a)(2) submissions, which EPA expects to increase by 16 percent from 93,000 in the last ICR approval to approximately 108,000 for this ICR renewal. According to EPA, the increase is “due to EPA’s revised expectations regarding the number of incident reports that will be submitted to the Agency, which reflects historical information on the number of responses received.” EPA states this increase also is due to additional data requests under 40 C.F.R. Part 159, including:
- Additional standardized post-market surveillance reporting on adverse effects and submission of sales information required by EPA following a significant increase in the number of adverse incidents for spot-on domestic animal pet products from several registrants;
- Additional information required by EPA from the registrant of an herbicide to help explain circumstances for incidents of alleged tree and plant damage; and
- Additional documentation required by EPA from neonicotinoid registrants following concerns about neonicotinoid pesticides and the loss of bee colonies.
Through EPA’s notice, it is soliciting public comments on the proposed ICR. EPA states that this is a proposed extension of the ICR, which is currently approved through September 30, 2018. Comments are due by April 9, 2018. EPA has posted supporting documents in the docket for this notice, EPA-HQ-OPP-2017-0687, on www.regulations.gov:
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On February 1, 2018, the U.S. Environmental Protection Agency (EPA) announced it is publishing new guidance that sets forth a tiered approach intended to help manufacturers and EPA determine when the number of field trials necessary to register seed treatment uses can be reduced.
In its memo and attached Seed-Treatment Focus Group (STFG) Guidance Document dated January 26, 2018, EPA states that its Health Effect Divison (HED) has received “multiple waiver requests for seed-treatment field-trial residue data and has reviewed multiple field-trial datasets that indicated that there was the potential to reduce the number of field trials required to support the registration of seed-treatment uses.” EPA states that to evaluate this hypothesis, the HED Chemistry Science Advisory Council (ChemSAC), in collaboration with the Health Canada Pest Management Regulatory Agency (PMRA), in accordance with the July 11, 2017, Joint Canada/United States Field Trial Requirements “performed a retrospective analysis of all seed-treatment residue data that have been submitted to EPA/PMRA and has developed a tiered approach for determining if current crop-specific field trial data requirements are required to support new seed-treatment uses, or if a reduction in the number of required field trials is appropriate.” EPA’s announcement states that “the analysis showed that the data required to support registration could be substantially reduced and still be protective of human health.”
EPA developed two decision trees detailing the process for determining the residue chemistry field trial data requirements for seed-treatment uses: one for potato seed-piece (PSP) treatments only and another one for all remaining crops. EPA states that this case study demonstrates that application of the guidance set forth in these decision trees can, for both manufacturers and the agency, “potentially save considerable resources in terms of conducting, submitting, and reviewing the studies while still obtaining the data necessary to support seed-treatment pesticide registrations.”
The outlined procedure and memo document will supersede EPA’s previous guidance issued on October 28, 1999, entitled “Classification of Seed Treatments as Food or Nonfood Uses.”
More information is available on EPA’s Determining the Number of Field Trials Required to Register Seed-Treatment Uses webpage.
This announcement of improved review procedures allows EPA to cite both greater coordination across national borders (working with Canada), and reduce unnecessary data requirements. This would fit with the current Administration’s emphasis on reducing regulatory burdens and fostering greater innovation in regulated arenas. It also might be seen as general “good government,” as it updates guidance which is now almost twenty years old. Since seed treatment technology and associated policy issues have both evolved over the years, such a review and revision would seem timely regardless of any larger political directive.
By James V. Aidala
On January 31, 2018, Scott Pruitt, the Administrator of the U.S. Environmental Protection Agency (EPA), announced the establishment of an Interagency Working Group to Coordinate Endangered Species Act (ESA) Consultations for Pesticide Registrations and Registration Review. EPA, the U.S. Fish and Wildlife Service, and the National Marine Fisheries Service (NMFS) (the Services) signed a Memorandum of Agreement (MOA) on the establishment of the working group. The stated purpose of the working group is that it “will provide recommendations to EPA, FWS, and NMFS leadership on improving the [ESA] consultation process for pesticide registration and registration review (‘pesticide consultation process’) and will ensure that the new process is recorded and formalized as appropriate.” The working group’s action plan includes the following:
- Analyze relevant statutes, regulations, and case law. The Working Group will review the statutory requirements under ESA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the case law that has developed on the intersection of ESA and FIFRA; and existing regulations for the pesticide consultation process.
- Review past ESA pesticide consultation practices to learn lessons from recent experience and review current and previous pesticide consultation practices to identify problems and areas for improvement, as well as best practices that should be used in future pesticide consultations.
- Prepare recommendations to improve scientific and policy approaches to ESA pesticide consultations. For example, the Working Group will develop a streamlined process for identifying which actions require no consultation, informal consultation, or formal consultation. The Working Group will also help provide clarity as to what constitutes the “best scientific and commercial data available” in the fields of pesticide use and ecological risk assessment, which EPA and the Services are required to use under ESA section 7(a)(2).
- To the extent that current authorities and practices do not allow for the timely and accurate review of pesticides consistent with governing authorities, the Working Group may memorialize its recommendations for a revised regulatory framework, including addressing agency responsibilities, recommended technical approaches, and recommendations for new regulations, a memorandum of understanding, or other appropriate documentation.
Like others before them, the Trump Administration is embarking on a journey to address the problem of how to integrate ESA assessment and consultation requirements with the FIFRA registration process. This directive will help organize a senior level effort to coordinate activities of EPA and the Services and, like past efforts, at the senior management level there will likely be at least a recognition that something needs to be done to fashion a more efficient and predictable process. Currently ESA reviews add months and years to the registration review process and, to date, that process is followed by seemingly inevitable litigation challenging the EPA decision as not sufficient to meet ESA requirements.
The result has been an exhaustive, time and resource intensive initial set of “pilot” biological opinions, and a very long list of promised consultations resulting from past litigation cases. Currently, the workload already committed will be virtually unattainable for a number of years, and as EPA plans to have ESA assessments as part of the registration review process for older pesticides (as well as for future new product applications), the budget and staffing implications are staggering. Meantime, agricultural stakeholders, including pesticide manufacturers and grower groups who use pesticides, fear that the current process might result in the loss or delay in the introduction of needed pest control products.
This is the context for the current attempt to devise an integrated, more efficient process to have any realistic chance to fashion a process which meets the requirements of both statutes. We wish any and all participants good luck and constant senior political level involvement -- they will likely need much of it.
More information on ESA issues is available on our blog.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
Beginning on January 23, 2018, the European Commission (EC) opened a consultation period on the European Food Safety Authority (EFSA) risk assessment process (scientific advice). The EC states it is seeking feedback on its process both as a “follow-up to the commitments made by the Commission in reply to the European Citizens’ Initiative on glyphosate,” and in response to “citizens [that] have put into question the risk assessment based on studies provided by the industry and this in particular where the industry seeks an authorisation, e.g. for pesticides, GMOs etc.”
The General Food Law Regulation established EFSA, an independent scientific agency, to provide the risk assessment component of its risk analysis principle; the other two components are risk management and risk communication. EFSA provides its scientific opinions “which form the basis for the measures taken by the [European Union (EU)] in the food chain.” The EC states the General Food Law Regulation “is the cornerstone of the EU regulatory framework covering the entire food chain: ‘from farm to fork.’” The EC is requesting feedback to help it “look into how [the EC] can improve the current system and to address citizens’ expectations about independence and transparency of the EU risk assessment system.” The EC is specifically requesting views and experiences on the following:
- The transparency and independence of the EU risk assessment system with respect to the underlying industry studies and information on which EFSA's risk assessment/scientific advice is based;
- Risk communication; and
- The governance of EFSA, in particular the involvement of the EU Member States (MS) in the EU risk assessment system.
To contribute, interested parties must fill out the online questionnaire available here. All stakeholders and EU as well as non-EU citizens are welcome to contribute to this consultation. The consultation period will close on March 20, 2018.
This Consultation is of significant interest to stakeholders, particularly in balancing the potential need for increased transparency with the need to protect confidential business information, trade secret information, and proprietary expensive data investments. Decisions made by EFSA also could have a global impact on data protection, as any decisions made by EFSA to increase transparency could affect whether certain data can continue to be protected under other regulatory programs.
Outside of the transparency issues that are receiving much attention of late, it is important to note generally that views about risk assessment policies across governments tend to be driven by underlying political disagreements, with support or criticism somewhat predictable depending on how the resultant decisions are “for or against” the view of an interested constituency.
The transparency issue here should be considered not only on its own merits, but also within the controversy that surrounded the EU assessment approach for glyphosate, an herbicide which is widely used in production of genetically modified crops. As a stalking horse for the EU debate about biotechnology crops, the EU glyphosate assessment has, for example, become embroiled as part of the glyphosate carcinogenic classification of the International Agency for Research on Cancer (IARC). See our blog item IARC Announces Cancer Classification for Glyphosate and Other Pesticides. The IARC review concluded that glyphosate is a “probable human carcinogen,” contrary to most other assessments done by the U.S., Canada, and some EU Member States. Comments on the general EU risk assessment process can be expected to be intertwined with the perspective that any commenter has on the glyphosate assessment, even though the request is for public comment on the assessment process generally, and not only specifically about glyphosate.
More information on glyphosate is available on our blog under key word glyphosate.
By Lynn L. Bergeson and Margaret R. Graham
On January 22, 2018, the White House again delayed the effective date of revisions to the Federal Policy for the Protection of Human Subjects, referred to as the Common Rule. Final revisions were published on January 19, 2017. On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies published a Notice of Proposed Rulemaking (NPRM) proposing revisions to each agency’s codification of the Federal Policy for the Protection of Human Subjects, originally promulgated as a Common Rule in 1991. 80 Fed. Reg. 53931. On January 19, 2017, HHS and other federal departments and agencies published a final rule revising the Federal Policy for the Protection of Human Subjects. 82 Fed. Reg. 7149. The revised policy, referred to as the “2018 Requirements,” was scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018, with the exception of the revisions to the cooperative research provisions for which the compliance date is January 20, 2020.
After publication of the 2018 Requirements, representatives of industry, including organizations representing recipients of federal human subjects research awards, expressed concern regarding their ability to implement all of the 2018 Requirements by the scheduled general compliance date. Stakeholders requested a delay in the general compliance date of the 2018 Requirements with the exception of certain burden-reducing provisions of the 2018 Requirements, including certain carve-outs from the definition of “research” exemptions, elimination of the continuing review requirements for certain categories of research, and the elimination of the requirement that institutional review boards (IRB) review grant applications. The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) also recommended in August 2017 that implementation of the 2018 Requirements should be delayed. The new effective date is July 19, 2018. Comments are due by March 19, 2018.
More information on the Common Rule is available on our blog.
By Lisa M. Campbell and Margaret R. Graham
On January 10, 2018, the U.S. Environmental Protection Agency (EPA) issued its final rule to adjust the level of statutory civil monetary penalty amounts under the statutes that EPA administers, including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 83 Fed. Reg. 1190. This follows EPA’s July 2016 interim final rule adjusting penalty amounts for (FIFRA) violations by more than three times the current level, in some cases, as well as the level of statutory civil monetary penalty amounts for the other statutes that EPA administers. The adjustments in the January 10, 2018, final rule, as well as in the July 2016 rule, are mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The law prescribes a formula for annually adjusting statutory civil penalties to reflect inflation, maintain the deterrent effect of statutory civil penalties, and promote compliance with the law. The final rule is effective as of January 15, 2018.
With this rule, the new statutory maximum penalty levels listed in Table 2 of 40 C.F.R. Section 19.4 will apply to all civil penalties assessed on or after January 15, 2018, for violations that occurred after November 2, 2015, when the 2015 Act was enacted. For general civil penalties under Section 14(a)(1) of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the penalty amount is increasing to $19,446 from $19,057; for FIFRA Section 14(a)(2), which applies to private applicators and contains three separate statutory maximum civil penalty provisions, the penalty amounts are increasing from $2,795, $1,801, and $2795; to $2,852, $1,838, and $2,795.
More information on this interim final rule is available in our blog item “EPA Issues ‘Catch-Up’ Adjustments for Federal Civil Penalties.” The January 10, 2018, final rule is available online.
By Lisa R. Burchi and Lisa M. Campbell
On January 3, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-01: Expanding Use of Pesticide Products Under Reevaluation. Under Notice 2018-01, effective immediately, DPR will not act upon an Application for Pesticide Registration or an Application to Amend a Pesticide Product if it determines the registration or acceptance would potentially “expand use” of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.
DPR states that it commences a reevaluation of an existing registered pesticide when it finds, based on an investigation of all reported episodes and information received, that a significant adverse impact to human health or the environment has occurred or is likely to occur. DPR states that the policy set forth in Notice 2018-1 is needed for pesticides under reevaluation because until DPR reviews existing data for substances under reevaluation, determines whether additional data to satisfy reevaluation data requirements must be submitted, and then receives and assesses additional data applicable to the reevaluation that can mitigate the concern that prompted the initiation of the reevaluation, DPR “is not in a position to determine that an expanded use will not cause a ‘significant adverse environmental impact,’ as required under its certified regulatory program (3 CCR section 6254).” Once the reevaluation process is completed, DPR states that it will then be in a position, in light of its reevaluation determination, to consider applications for product registration or amendment.
Scope of Notice 2018-1
DPR is currently reevaluating certain pesticide products containing the following active ingredients:
- Copper-based antifouling paints (copper oxide, copper hydroxide, and cuprous thiocyanate);
- Diazinon; and
- Nitroguanidine neonicotinoids (imidacloprid, thiamethoxam, clothianidin, and dinotefuran).
This notice applies to new pesticide products that include these active ingredients, including supplemental distributor registrations (subregistrations) and amendments to currently registered pesticide products, when “expanding use” of the active ingredient relevant to the concern that prompted the reevaluation.
Specifically, DPR states in Notice 2018-1 that it interprets the following types of actions, related to a new or amended product containing the active ingredient under reevaluation, as examples of “expanding use”:
- A proposed new pesticide product, including any Special Local Needs registration or Experimental Use Permit, with a label bearing uses or exposure scenarios relevant to the concern that prompted the reevaluation. This includes any product label that is identical or substantially similar to a currently registered product in California.
- Amendment of a currently registered product to add or modify uses or exposure scenarios relevant to the concern that prompted the reevaluation, even if such use is already on other currently registered pesticide products in California. Examples of such changes include:
- New or modified uses (e.g., new crops, pests, or use sites);
- New or modified use patterns (e.g., adding aerial, aquatic, soil applications, or outdoor use);
- Significant formulation changes (unless prompted by the reevaluation);
- Increased application rates or total use amount allowed (e.g., acreage or frequency of application); and
- Other label additions or changes that may increase pesticide exposure in a manner that is relevant to the basis for the reevaluation.
This notice does not preclude expanded use of a product if the expansion is not consistent with uses or exposure scenarios relevant to the concern that prompted the reevaluation. As an example, DPR states that an application containing an active ingredient that is under reevaluation over concerns regarding exposure to wildlife would not be precluded under this notice as an expanded use is if the product is labeled solely for indoor use, with no potential wildlife exposure.
DPR also acknowledges that a pest management or public health need could arise during a reevaluation that would support the issuance of an Emergency Exemption request under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In those cases, with regard to the potential applicability of Notice 2018-1, DPR states that it “will assess the request by relying on currently available information and risk mitigation strategies.”
DPR’s reevaluation process can take years to complete, so not only are pending affected submissions for products containing the active ingredients at issue effectively frozen, but future submissions for active ingredients newly entering the reevaluation process could be halted potentially for lengthy periods of time, despite the fact that DPR may ultimately determine that any identified “expanded uses” do not cause a significant adverse environmental impact. It is an initiative that many in industry are monitoring closely.
More information on other California DPR-related issues is available on our blog under key phrase California DPR.
By Lisa R. Burchi and Lisa M. Campbell
On January 2, 2018, State Attorneys General from eleven states (Idaho, Indiana, Iowa, Kansas, Louisiana, Michigan, Missouri, North Dakota, Oklahoma, South Dakota, and Wisconsin) (collectively the States) filed a friend of the court brief in Nat’l Ass’n of Wheat Growers v. Zeise, E.D. Cal. (No. 2:17-cv-02401) (Brief), a case challenging California Office of Environmental Health Hazard Assessment’s (OEHHA) decision to list glyphosate as a carcinogen under Proposition 65 (Prop 65).
OEHHA listed glyphosate under Prop 65 on March 28, 2017, but the effective date of the listing was delayed until July 7, 2017, following a decision from the Fifth District Court of Appeals that denied Monsanto’s request for a stay of such listing. OEHHA stated that its listing was required under its Labor Code listing mechanism, which OEHHA states requires it to list under Prop 65 certain substances identified by the International Agency for Research on Cancer (IARC) as known to cause cancer. Information about Monsanto’s earlier challenge is available in our blog item California Court Tentatively Dismisses Monstano’s Lawsuit Against OEHHA to Block Addition of Glyphosate to Proposition 65 List.
On November 15, 2017, a nationwide coalition of agricultural producers and business entities (including Monsanto) filed a Complaint against OEHHA on the grounds that its listing of glyphosate as a carcinogen and the Prop 65 warning requirement triggered by that listing: (1) violate the First Amendment of the U.S. Constitution by compelling Plaintiffs and other entities to make false, misleading, and highly controversial statements about their products; and (2) violate the Due Process Clause of the Fourteenth Amendment of the U.S. Constitution because OEHHA’s actions are not rationally related to any legitimate state interest; and (3) violate the Supremacy Clause of the U.S. Constitution by conflicting with, and being preempted by, the Federal Food, Drug, and Cosmetic Act (FFDCA). Plaintiffs filed an amended Complaint on December 5, 2017.
On December 6, 2017, Plaintiffs also filed a motion for preliminary injunction (Motion), arguing that they are likely to succeed on the merits of their claim that the Prop 65 listing violates the First Amendment. The Motion argues that the warning will fail under any level of constitutional scrutiny, whether it is considered under “laws regulating commercial speech that generally receive at least intermediate scrutiny, i.e., they are prohibited if they do not directly and materially advance the government’s interest, or are more extensive than necessary,” or laws that require disclosure of information in connection with commercial transactions, which “are permissible only if the compelled disclosure is of information that is purely factual, uncontroversially accurate, reasonably related to a substantial government purpose, and not unduly burdensome or chilling. See Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985).” Motion at 23-36; Complaint at 26-28.
In agreeing with Plaintiffs that OEHHA’s Prop 65 listing of glyphosate forces businesses to issue “false and misleading” statements about their products and asking the court to grant the Plaintiffs’ motion for a temporary restraining order and preliminary injunction, the Attorneys General state in their Brief:
- The First Amendment injuries identified by Plaintiffs are heightened because they adversely impact the sovereign interests of other States in at least two ways. First, by requiring false or misleading statements about glyphosate products, California’s speech mandate imposes confusing and potentially inconsistent obligations on nonresident businesses that are bound by other States’ consumer-protection laws not to make false and misleading statements about their own products. Second, the speech mandate impairs consumer-protection efforts of the States that require sensible health-and-safety disclosures by contributing to the well-known phenomenon of disclosure fatigue.
Brief at 4-5 (emphasis in original).
The States also argue that while there may be a presumption to California’s favor that its enforcement of its duly enacted laws reflects the public interest, the Court also “should weigh heavily the fact that California’s mandate interferes with federalism and the sovereign interests of other States when assessing the public interest factor.” Brief at 10.
This case raises significant constitutional and preemption arguments in a factual context that many in industry believe compelling. It will be closely monitored.
OEHHA answered Plaintiff’s First Amended Complaint on January 9, 2018. It is expected to file its opposition to Plaintiff’s Motion for a Preliminary Injunction by January 22, 2018, and file its response to the two amicus curiae briefs filed on behalf of Plaintiffs by January 26, 2018. Following deadlines for Plaintiffs to file any reply in support of their motion for a preliminary injunction and any responses to amicus curiae briefs in support of Defendants, a hearing on Plaintiff’s motion will be held on February 20, 2018.
by James V. Aidala
Time is running out on the Pesticide Registration Improvement Act (PRIA), and it could die a natural death on January 19, 2018, absent Congressional action. Congress enacted PRIA in 2003 and in so doing established a fee schedule for pesticide registration and amendment applications and critically important specified decision time periods within which the U.S. Environmental Protection Agency (EPA) must make a regulatory decision. PRIA has been reauthorized twice, and was scheduled to expire at the end of the 2017 federal fiscal year, on September 30, 2017. A short term funding measure saved the day, but it expires on January 19.
As was the case for PRIA and its prior reauthorizations, a coalition of registrants, labor, and environmental advocates were working with Congress relatively smoothly to pass what will be “PRIA 4” before the expiration date. In May 2017, however, EPA announced that as part of its regulatory review efforts, there would be delays in implementing recent regulations making changes to worker protection standard (WPS) regulations and requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) certification and training (C&T) programs run by the states -- all Obama initiatives. Some farm advocacy groups, the American Farm Bureau in particular, raised concerns about a few elements of the WPS regulations, and the National Association of State Departments of Agriculture (NASDA) also raised concerns about some elements of the WPS and C&T programs. More information regarding the status of the WPS and C&T rulemakings is available in our blog item “EPA Signals New Rulemakings On Worker Protection Standard and Certification of Pesticide Applicators.”
When EPA announced plans to review and possibly change these regulations, farmworker advocacy groups withdrew their support for the draft PRIA legislation. Along with concerns about possible regulatory changes and delays, environmental groups also expressed concerns with the Administration’s decisions allowing the continued use of chlorpyrifos as part of a petition response announced in March 2017. The tumult fractured the PRIA coalition and a group of Democratic Senators supporting the environmental and labor advocates’ position blocked the PRIA legislation preventing changes to the current WPS regulations, and separately introduced legislation that would effectively end the use of chlorpyrifos (S. 1624).
The PRIA reauthorization has already been approved by the House of Representatives, but now there is a sufficient number of Senate Democrats to block movement of the legislation. As a result, there is currently an impasse, with discussions reportedly ongoing but with no clear path towards resolution.
As the deadline nears, it is expected that a temporary PRIA renewal will be part of any additional short extension, with a less certain outlook about the chances of being included in any comprehensive, year-long legislation to fund government operations. The expectation is that some kind of resolution will be found, but the specific parameters of any solution have not yet been identified.
PRIA has also included the authorization for the “maintenance fee” provisions first included in the 1988 amendments to FIFRA, designed as general support for the EPA pesticide program budget. Taken together, PRIA reauthorization has become a major contributor to the program budget.
Should PRIA not be reauthorized, then the current law allows for a phase-down of the current submissions which include PRIA fees and are subject to decision deadlines. The larger issue would be the potential for the elimination of approximately 200 positions from the pesticide program workforce, which is about one-third of the current staff (and is in line with the share of program costs supported by fees).
Stay tuned -- we will monitor this important topic. More information on PRIA issues is available on our blog under key word PRIA.
By Lynn L. Bergeson
Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.
Happy New Year and enjoy reading our predictions!
By Lisa M. Campbell and Timothy D. Backstrom
On December 20, 2017, the U.S. Court of Appeals for the Ninth Circuit issued an order in LULAC v. Pruitt, Case No. 17-71636, a case challenging an order denying administrative petitions to revoke the tolerances and cancel the registrations for chlorpyrifos. The court’s order includes actions concerning two pending motions. The court has denied a motion by the U.S. Environmental Protection Agency (EPA) and Administrator Pruitt (Respondents) to dismiss the case for lack of jurisdiction while granting a motion by League of United Latin American Citizens (LULAC), et al. (Petitioners) to expedite briefing and hearing in the case. More information on these two motions is available in our blog item “NGOs and Farmworkers File Motion for Expedited Briefing and Hearing in Chlorpyrifos Litigation.”
In support of their August 21, 2017, motion to dismiss the case for lack of jurisdiction, Respondents argued that the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the Petitioners to exhaust their administrative remedies by submitting formal objections to the order denying their request to revoke the tolerances for chlorpyrifos and then waiting for EPA to issue a final order before they may seek judicial review. The Petitioners argued in response that requiring exhaustion in this instance would be “futile,” and that the court should also consider reviewing the EPA order under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), because EPA has declined to cancel the registrations for chlorpyrifos. In response, Respondents argued that Petitioners have not shown that requiring exhaustion of administrative remedies would be futile, and that 21 U.S.C. § 346a(h)(5) explicitly prohibits judicial review of any order concerning pesticide tolerances under any other statute, including FIFRA.
After the motion to dismiss was fully briefed, the court summarily denied it, but also characterized that denial as “without prejudice to renewing the arguments in the answering brief.” The court also denied a motion by the Petitioners for oral argument concerning the pending motion to dismiss. These two actions indicate that the court has decided to defer argument and resolution of the jurisdictional issues presented by the motion to dismiss until briefing and argument on the merits.
The court also granted an October 13, 2017, motion by the Petitioners to expedite briefing and hearing in the case. Petitioners submitted this motion to expedite because they contend that the refusal of EPA to revoke the tolerances and cancel the registrations for chlorpyrifos is causing ongoing harm even though EPA “did not and cannot determine that chlorpyrifos is safe under the Food Quality Protection Act.” The court set the following expedited briefing schedule: Petitioners’ opening brief is due January 23, 2018; Intervenors’ brief(s) are due February 6, 2018; Respondents’ answering brief is due March 8, 2018; Petitioners’ optional reply brief is due 28 days after service of Respondents’ brief; and Intervenors’ optional reply brief(s) are due 42 days after service of Respondents’ brief. The court also directed the Clerk to “calendar this case [for argument] as soon as possible upon completion of briefing.”
The current actions of the court should be viewed in the context of the prior decision by this same court to issue a writ of mandamus that required EPA to take action on pending petitions to cancel the registrations and revoke the tolerances for chlorpyrifos after what Petitioners claimed was a quite protracted administrative delay, and the subsequent decision by EPA under Administrator Pruitt to defer final action on chlorpyrifos, after the prior Administration had proposed to take the actions sought by the Petitioners. By granting the motion to expedite, and also by deferring the ultimate disposition of the jurisdictional issues raised by EPA, the court appears to have given the Petitioners a prompt and full opportunity to explain why judicial intervention at this stage of the administrative process is warranted. Nevertheless, because the jurisdictional arguments made by EPA are supported by substantial precedent, it could prove difficult for the Petitioners ultimately to overcome these arguments.
More information on the chlorpyrifos litigation and related matters is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell and James V. Aidala
On January 3, 2018, officials with the Arkansas State Plant Board (Plant Board) voted 11 to 3 to uphold its statewide ban of dicamba. The vote came after a subcommittee of the state's legislative council asked the board to reevaluate its earlier decision. The subcommittee will revisit the Plant Board's decision again on January 16, 2018. That the subcommittee plans to revisit its decision in just two weeks is noteworthy and illustrates the controversy surrounding this and other similar state bans.
Given the panel will meet again in the next few weeks, this may indicate that the legislature is urging some greater flexibility -- that is, a longer application window that would allow some growers to use the herbicide, along with consideration of any data about the newer formulations designed to reduce the likelihood of drift.
Whether any “flexibility” or additional data will be sufficient to convince the Plant Board that the product can be used without expecting drift incidents in the future is not clear, especially since the issue has become a point of intense political debate.
More information on dicamba issues is available on our blog under key word dicamba.
By James V. Aidala, Lisa M. Campbell, and Timothy D. Backstrom
On December 14, 2017, the Missouri Department of Agriculture (MDA) announced that it issued and collected the first round of fines resulting from investigations regarding the pesticide dicamba. The news release states that the first wave of civil penalties issued to applicators, all from Dunklin County, were issued as “a result of investigations of complaints during the 2016 growing season,” and the “civil penalties, ranging from $1,500 to $62,250, were issued for pesticide misuse (off label use and drift).” Further, in 2016, “Department staff conducted and completed 121 complainant investigations. Those complainants named approximately 60 applicators, who were investigated as a result of complaints. In addition, the Department investigated nearly 100 non-Dicamba related incidents.”
This is the first group of what is anticipated to be a large number of dicamba-related enforcement cases, given the extensive number of, and publicity concerning, the reported incidents involving dicamba. Reported incidents in Arkansas were even more numerous than those in Missouri. About one-third of the reported incidents in Missouri have now been attributed to only six applicators. One applicator alone was cited for 149 discrete violations, which indicates that problems with the new dicamba formulations may be less widespread than some originally feared based on the large number of reported incidents. Moreover, some of the states where the new dicamba products were widely used have reported very few incidents. In the aggregate, this data suggests that better stewardship training accompanied by rigorous enforcement may be sufficient to greatly reduce the future incidence of unexpected off-site movement of the new dicamba formulations.
More information on dicamba issues is available in our blog.
By Lynn L. Bergeson and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) recently announced, in two separate notices, that it is initiating a process to revise (1) certain requirements in the Agricultural Worker Protection Standard (WPS) (82 Fed. Reg. 60576 (Dec. 21. 2017)); and (2) to revise the minimum age requirements in the Certification of Pesticide Applicators (C&T) rule. 82 Fed. Reg. 60195 (Dec. 19. 2017).
For the WPS rulemaking, the provisions at issue were identified as part of the public comments received in response to Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda. Three provisions in particular were the subject of public comment, and later consideration by the EPA’s Office of Pesticide Programs (OPP) Pesticide Program Dialogue Committee (PPDC) at its November 2, 2017, meeting. The three provisions are: minimum age (the 2015 WPS specifies a minimum age of 18 years, with an exemption for owners of agricultural establishments and their immediate family members); designated representative (the 2015 WPS requires employers to provide pesticide application information and safety data sheets to a designated representative of a worker or handler under specified circumstances); and application exclusion zones (AEZ) (the 2015 WPS requires the establishment of AEZs with respect to outdoor production on farms, nurseries, and forests to reduce the number of incidents where workers or others are exposed to pesticides during agricultural pesticide applications).
EPA also announced that the compliance dates in the revised WPS remain in effect and that EPA has no intent to extend them. This means that most provisions in the revised WPS went into effect on January 2, 2017, and compliance with two additional requirements will begin on January 2, 2018. The two requirements include compliance with the display of pesticide safety information, and pesticide handlers must temporarily suspend applications if workers or others enter in the application zone during pesticide applications. The only requirements in the revised WPS that will not be in effect as of January 2, 2018, are the requirements that the worker and handler pesticide safety training material cover the expanded content at 40 C.F.R. §§ 170.401(c)(3) and 170.501(c)(3). The 2015 revised WPS provided that compliance with the expanded pesticide safety content in these sections was not required until 180 days after EPA publishes in the Federal Register a notice of availability of certain training materials. While there are training materials available that meet the expanded content requirement, EPA has not yet published such a Federal Register and apparently does not intend to do so until after the rulemaking announced on December 21 has concluded.
For the C&T rule, EPA expects to “publish a Notice of Proposed Rulemaking to solicit public input on proposed revisions to the rule by the end of FY2018,” and it has no plans to change the implementation dates in the January 4, 2017, final rule. The C&T notice states that “EPA has determined that further consideration of the rule’s minimum age requirements is warranted through the rulemaking process” after it considered comments received pursuant to EO 13777, revisiting the record, and reviewing the applicable statutory.
More information on WPS issues is available on our blog under key phrase Worker Protection Standard.
By Timothy D. Backstrom, James V. Aidala, and Lisa M. Campbell
On December 18, 2017, the U.S. Environmental Protection Agency (EPA) announced it is releasing for public comment the draft human health and ecological risk assessments for glyphosate. EPA’s Draft Human Health and Ecological Risk Assessments for Glyphosate website states that the “draft risk assessments and supporting documents will be available in glyphosate’s registration review docket EPA-HQ-OPP-2009-0361 on www.regulations.gov in early 2018,” and that EPA will “open a 60-day public comment period for the draft risk assessments, evaluate the comments received, and consider any potential risk management options for this herbicide.” Many of the assessment documents, including the draft human health risk assessment, are already available on EPA’s website, but not yet posted in the docket.
The EPA announcement includes the following summary of EPA’s determinations:
- The draft human health risk assessment concludes that glyphosate is not likely to be carcinogenic to humans. The Agency’s assessment found no other meaningful risks to human health when the product is used according to the pesticide label. The Agency’s scientific findings are consistent with the conclusions of science reviews by a number of other countries as well as the 2017 National Institute of Health Agricultural Health Survey.
- EPA’s human health review evaluated dietary, residential/non-occupational, aggregate, and occupational exposures. Additionally, the Agency performed an in-depth review of the glyphosate cancer database, including data from epidemiological, animal carcinogenicity, and genotoxicity studies.
- The ecological risk assessment indicates that there is potential for effects on birds, mammals, and terrestrial and aquatic plants. EPA used the most current risk assessment methods, including an evaluation of the potential effects of glyphosate exposure on animals and plants.
EPA states the proposed interim registration review decision for glyphosate is scheduled to be published in 2019.
This latest EPA announcement is consistent with other determinations concerning glyphosate made by EPA in recent years, including statements made during the Obama Administration. EPA presented its analysis of the carcinogenic potential of glyphosate to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) in December 2016. EPA has consistently taken the position that the human health risks from glyphosate are low, and that food and water residues of glyphosate easily satisfy the requirement that they be “safe” for human consumption.
Critics of glyphosate use often focus on the widespread adoption of glyphosate-resistant bioengineered crops. If these genetically modified organism (GMO) crops were not specifically designed for use in conjunction with glyphosate, there would likely be much less discussion about the safety of the herbicide.
Because EPA’s announcement includes a statement that “there is potential for effects on birds, mammals, and terrestrial and aquatic plants,” critics of glyphosate and the associated GMO crops will likely continue to press for restrictions based on the ecological effects of glyphosate. Moreover, there is also likely to be continued controversy concerning the human health effects of glyphosate. Notwithstanding the human health safety findings in this EPA assessment and the other assessments cited in EPA’s statement, the International Agency for Research on Cancer (IARC) has classified glyphosate as “probably” carcinogenic to humans. It is thus probable that the controversy concerning glyphosate and the associated GMO crops will continue unabated.
More information on glyphosate issues is available on our blog under key word glyphosate.