Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.
New Electronic Options for Label and CSF Submission to EPA: An update on the SmartLabel and eCSF Projects
On May 2, 2018, during the U.S. Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, EPA announced the progress of its electronic pesticide label data submission project, SmartLabel, and its electronic Confidential Statement of Formula (eCSF) submission project. The SmartLabel and eCSF will be submitted through EPA’s Pesticide Submission Portal (PSP) on the Central Data Exchange (CDX).
EPA is developing the SmartLabel program to improve efficiencies in the submission, review, and approval of pesticide label information. EPA believes creation of electronic master labels as structured data will improve the accuracy and clarity of pesticide label information and will allow it to be revised easily and efficiently.
EPA indicated that the SmartLabel program will use CDX for the creation of labels in XML format. Once uploaded through CDX’s PSP, the label will undergo an internal validation and move through an internal workflow. EPA anticipates this will aid in faster approvals of labels.
The eCSF is an electronic version of EPA’s current paper CSF (EPA Form 8570-4). This eCSF submission option will allow applicants to electronically submit product specification data and will:
The electronic form is anticipated to result in significant time savings for the applicant and the EPA reviewer. EPA stated that most submitted CSF actions are modifications to current formulations and not all fields will need to be re-entered when submitting a modification using eCSF. Additional benefits that EPA believes will result are a reduction in time and effort needed for error corrections, electronic data validation, and less reliance on paper-based processes.
The SmartLabel and eCSF teams are continuing to work with Office of Pesticide Programs (OPP) Divisions to harmonize OPP-wide vocabularies and data validation rules. The SmartLabel team and eCSF team are also working to harmonize overlapping vocabulary. Nine registrants are conducting testing on software development and most likely will participate in additional testing of the software.
EPA anticipates that the SmartLabel and eCSF programs will move EPA from a paper-based workplace to a paperless workplace. The SmartLabel and eCSF builders are anticipated to be released for voluntary submissions in Summer 2018, and EPA encourages registrants to submit labels and CSFs using the new builders.
OEHHA Proposes Regulations on Safe Harbor Warning Content as Part of Clear and Reasonable Warnings Regulations
On April 23, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced it is proposing to amend Article 6 of Title 27 of the California Code of Regulations (C.C.R.), Section 25603, specifically the safe harbor warning content for on product warnings for exposures to listed chemicals in pesticides. OEHHA states that this regulation is “intended to provide compliance assistance for businesses that cause pesticide exposures in order to reduce the potential for litigation concerning the sufficiency of warnings, while still allowing them to comply with other federal and state requirements for warnings provided on a label.” It is a part of the new Article 6 Clear and Reasonable Warnings regulations, which OEHHA adopted in August 2016 and which become effective on August 30, 2018. These new regulations include safe harbor warning methods and content for consumer product exposures (Sections 25602 and 25603) and occupational exposures (Section 25606) to listed chemicals. The Initial Statement of Reasons (ISOR) is available here and the proposed regulatory text is available here. The ISOR summarizes the proposed rulemaking:
The issue that OEHHA intends this proposal to address stems from the fact that OEHHA’s revised warning requirements require the signal word “WARNING” but the U.S. Environmental Protection Agency (EPA) “historically has not approved labels containing the terms ‘caution,’ ‘warning,’ or ‘danger,’ unless the word is the same as the [EPA]-required signal word for that label.” Thus, OEHHA is proposing the following regulatory exception from the “WARNING” requirement:
OEHHA states this is intended to be a “narrow exception” and that it is only intended to apply where EPA and California Department of Pesticide Regulation (CDPR) signal words and the Proposition 65 (Prop 65) signal word conflict. This proposal is intended to address the concerns of pesticide registrants encountering problems when they attempted to amend their EPA-approved labels to include the Prop 65 “WARNING” signal word. It remains unclear, however, whether the OEHHA proposal will fully address EPA’s concerns, and what effect it will have on EPA’s ability to approve labels that contain the language at issue. Registrants should review the proposal carefully and monitor closely EPA’s actions concerning it and this issue more generally.
Comments are due by June 11, 2018, and can be submitted to OEHHA via its website. OEHHA states that any requests for a public hearing on this proposed regulatory amendment should be submitted by May 25, 2018.
On April 30, 2018, the U.S. Environmental Protection Agency (EPA) will publish in the Federal Register a proposed rule entitled "Strengthening Transparency in Regulatory Science" (Science Rule) that EPA states is intended to “strengthen the transparency of EPA regulatory science.” EPA states in the preamble that “[t]he proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.” EPA further states that “EPA is proposing to establish a clear policy for the transparency of the scientific information used for significant regulations: specifically, the dose response data and models that underlie what we are calling ‘pivotal regulatory science.’ ‘Pivotal regulatory science’ is the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated.”
EPA intends the rule to provide this transparency “in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests.” EPA “will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments.” EPA states that its “regulatory science” should be “consistent with the Office Management and Budget’s Final Information Quality Bulletin for Peer Review,” and that “[r]obust peer review plays a critical role in independently validating key findings and ensuring that the quality of published information meets the standards of the scientific and technical community.” In addition, EPA states, the proposed rule “is designed to increase transparency of the assumptions underlying dose response models,” noting that “[t]he use of default models, without consideration of alternatives or model uncertainty, can obscure the scientific justification for EPA actions.”
EPA states: “Across EPA programs much of the science that informs regulatory actions is developed outside the Agency. It is the charge of regulators to ensure that key findings are valid and credible, as required by OMB’s Guidelines.” EPA “believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government,” and “[n]othing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections.”
The rule as proposed has ten subparts:
EPA is soliciting comments on the proposed rule and “how it can best be promulgated and implemented in light of existing law and prior Federal policies that already require increasing public access to data and influential scientific information used to inform federal regulation.” Among the issues EPA asks for comment are the following:
On April 26, 2018, EPA Administrator Scott Pruitt was a witness in a hearing before the U.S. House Committee on Energy and Commerce, Subcommittee on Environment entitled The Fiscal Year (FY) 2019 U.S. Environmental Protection Agency (EPA) Budget. Administrator Pruitt discussed the forthcoming proposed rule at this hearing, stating that the rule is an effort to make the data and methodology that underlie scientific studies, oftentimes done by third parties, more accessible and more transparent -- especially to those interested stakeholders commenting on the determinations that the studies support. Many of the Committee members were supportive of the Science Rule, stating that the transparency is long overdue. Others expressed concerns with the proposed rule, including concerns about a potential for EPA to handpick certain “public” studies and to discount other valid studies only because they did not divulge all of their confidential data; and concerns regarding the inability to protect important confidential information, such as identities of patients.
The proposed rule is controversial and will likely be the subject of significant comment. Similar to when legislative proposals offer new terminology, the establishment and use of terms such as “pivotal regulatory science” suggest some distinction between it and “not so pivotal science” not subject to the new procedures and requirements. How such distinctions will be made and what the impact may be could be significant for companies that submit “routine” data under existing Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulations concerning registration data requirements. Interest in the subject has been reported to focus especially on questions some have raised about the way EPA has utilized studies and scientific data to support initiatives and rules issued by the air program. What that raises is a fear that addressing some concerns about how air regulations are justified might have unintended consequences in other EPA media programs.
In brief, for pesticide registrants, the rule poses significant potential issues. For example, registrants spending millions of dollars on studies necessary to register products that are proprietary and protected from release to those who might use them to register their own products without compensating the owners; issues with regard to EPA’s reliance under the proposed rule on these registrant generated and FIFRA required studies will need to be carefully considered carefully. As another example, EPA’s review of epidemiology data underlying its conclusions regarding chlorpyrifos and other organophosphate pesticide requirements potentially may be subject to more stringent requirements than they previously were. Registrants should review the proposed rule carefully and monitor closely developments relating to it.
On April 24, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has updated Chapters 3, 7, and 17 of the Pesticide Label Review Manual. The three updated Label Review Manual chapters are:
General Labeling Requirements (Chapter 3) changes include:
Precautionary Statements (Chapter 7) changes include:
Net Contents/Net Weight (Chapter 17) changes include:
Each updated chapter includes a new section identifying the changes in the updated version. EPA states that it “also made editorial changes to all chapters, including updated cover pages; adding a table of contents; adding chapter editorial notes; updating hyperlinks; and reformatting text, style and layout for conciseness and readability.”
EPA directs registrants to submit questions or comments on the Label Review Manual by using its Pesticide Labeling Questions & Answers – Form.
On April 23, 2018, the California Department of Pesticide Regulation (DPR) circulated a presentation entitled “Top 10 Agricultural Pesticide Use Violations of 2017” that identifies the top ten agricultural most common pesticide use violations of 2017 in California. The violations are listed from the least common (#10) to the most common (#1):
10. Handler Training, regulated under Title 3 of the California Code of Regulations (C.C.R.) § 6724(b-e). Examples of handler training violations listed in the presentation are: not updating employee training on a new pesticide handled; and not training employees prior to them mixing, loading, or applying pesticides.
9. Availability of Labeling, regulated under 3 C.C.R. § 6602. Examples of labeling availability violations listed in the presentation are: not having relevant Special Local Needs (SLN) labeling at the site when mixing, loading, or applying; and not having the labeling booklet on-site when mixing, loading, or applying.
8. Handler Decontamination Facilities, regulated under 3 C.C.R. § 6734. Examples of these types of violations listed in the presentation are: a handler using a backpack sprayer and not carrying a pint of eyewash when the label requires eye protection; and handlers using hand sanitizer instead of soap and water.
7. Service Container Labeling, regulated under 3 C.C.R. § 6678. Examples of service container labeling violations listed in the presentation are: not including the signal word on a service container label; and only putting the name of the pesticide on the service container.
6. Hazard Communication for Fieldworkers, regulated under 3 C.C.R. § 6761. Examples of these types of violations listed in the presentation are: not completing the required fields on the displayed Pesticide Safety Information Series (PSIS) A-9 leaflet; and not providing Safety Data Sheets (SDS) for the pesticides listed on the pesticide use records.
5. Annual Registration with County Agricultural Commissioner by Anyone Who Intends to Advertise, Solicit, or Operate as a Pest Control Business in California, regulated under California Food and Agriculture Code (FAC) § 11732. An example of a violation is not registering with the county in which such a business intends to work prior to performing pest control activities.
4. Application-Specific Information (ASI) for Fieldworkers, regulated under 3 C.C.R. § 6761.1. Examples of violations listed in the presentation are: not including the start and stop times, Restricted Entry Interval (REI), or active ingredient in the displayed information; and not displaying the ASI before fieldworkers work in a treated field.
3. Emergency Medical Care Requirements, regulated under 3 C.C.R. § 6726. Examples of violations listed in the presentation are: not taking employees suspected of a pesticide illness to the doctor immediately; and not posting the name, address, and phone number of the medical facility at the worksite or in the work vehicle before employees begin handling pesticides.
2. Personal Protective Equipment (PPE) Requirements, regulated under 3 C.C.R. § 6738. Examples of violations listed in the presentation are: storing PPE in the same place pesticides are stored; and not cleaning PPE and checking for wear after each use.
1. Labeling and Permit Condition Compliance, regulated under FAC § 12973. Examples of violations listed in the presentation are: not following label-required buffer zone, set back distance, or vegetative buffer strip requirements; and applying a pesticide to a site or crop not listed on the labeling.
DPR states that it “recommends and encourages continuing education (CE) course sponsors [to] integrate this information into … future CE courses,” and asks for help “in promoting lawful pesticide use practices by encouraging [CE] attendees to review these agricultural pesticide use violations as they relate to their operations, to assure they are in compliance with federal and California pesticide use requirements.”
On April 12, 2018, House Agriculture Committee Chairman Michael Conaway (R-Texas) released the Committee’s draft Farm Bill reauthorization, the “Agriculture and Nutrition Act of 2018” (H.R. 2). The House Agriculture Committee passed the Farm Bill package on April 18, 2018, setting it up for a floor vote in the House. The 600-plus page draft legislation includes a number of provisions that will be of interest to pesticide registrants and the pesticide user community, including the following sections:
The full text of H.R. 2 and a section-by-section summary are available on the House Agriculture Committee Farm Bill webpage along with several related fact sheets. The Agriculture Committee expects to mark-up the bill this week.
On April 10, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft Science Policy document intended to reduce the use of animals in testing chemicals to evaluate whether they cause an allergic reaction, inflammation, or sensitization of the skin. According to EPA, the document, Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, “describes the science behind the non-animal alternatives that can now be used (in vitro, in silico, in chemico) to identify skin sensitization.” The draft Science Policy states that the Office of Pesticide Programs (OPP) and Office of Pollution Prevention and Toxics (OPPT) will immediately begin to accept submissions of new approach methodologies (NAM) and defined approaches (DA) as described in the draft Science Policy. EPA notes that there are multiple domestic and international activities ongoing that will allow for refinement and expansion of this draft Science Policy to other DAs and additional NAMs and support global harmonization of DAs for skin sensitization. According to the draft Science Policy, OPP and OPPT “will continue to be active participants in these activities to ensure regulatory acceptance and will continue to support cross-sector collaborations that enhance animal welfare, and accelerate the implementation of NAMs.” Comments on the draft Science Policy document must be submitted to Docket Number EPA-HQ-OPP-2016-0093 by June 9, 2018.
The draft Science Policy is the result of national and international collaboration between the Interagency Coordinating Committee on the Validation of Alternative Methods, the National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods, the European Union Reference Laboratory for Alternatives to Animal Testing, and Health Canada’s Pest Management Regulatory Agency.
On April 10, 2018, Bergeson & Campbell, P.C. (B&C®) held a complimentary webinar, “FIFRA Hot Topics.” Co-hosted with Bloomberg BNA, the webinar featured Richard P. Keigwin, Jr., Director, Office of Pesticide Programs (OPP), Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA); Daniella Taveau, former International Trade Negotiator for EPA and now Regulatory and Global Trade Strategist, King & Spalding; and William L. Jordan, former senior toxics lawyer with EPA’s OPP and Office of General Counsel. The timely and fascinating conversation was augmented by B&C’s Senior Government Affairs Consultant, James V. Aidala, and moderated by Lisa M. Campbell, Partner, B&C. More information about the webinar, including instructions on downloading a recording and related materials, is available on our Regulatory Developments page.
On March 22, 2018, the U.S. Environmental Protection Agency (EPA) released the Pesticide Registration Notice (PR Notice) 2018-1 issued by the Office of Pesticide Programs (OPP) entitled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(ll)” (PR Notice 2018-1). Notice of Availability issued on March 21, 2018. 83 Fed. Reg. 12385. The PR Notice states that it “describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment.” It “revises the method and criteria used by EPA for evaluating ‘sufficient economic incentive’ under FIFRA section 2(ll)(2),’” and it “also clarifies that minor use under FIFRA section 2(ll)(1) is based on acreage reported in the [U.S. Department of Agriculture (USDA)] Census of Agriculture.”
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll)(1) defines a minor use of a pesticide as a use on a crop grown on 300,000 acres or less in the United States. Section 2(ll)(2) of FIFRA defines a minor use of a pesticide as one that lacks sufficient economic incentive to seek or maintain a registration but has private or social value.
PR Notice 2018-1:
Previously, EPA’s interpretation of economic minor use in Section 2(ll)(2) was based on PR Notice 97-2. EPA states PR Notice 2018-1 supersedes PR Notice 97-2. EPA states that through PR Notice 2018-1, EPA “seeks to identify and encourage the registration of pesticides for minor uses to protect communities from harmful pests.” EPA states in PR Notice 2018-1 that “the existing methods for identifying an economic minor use in PRN 97-2 do not consider all relevant factors which could affect the incentives of a registrant to apply to register a minor use,” and that “use of the approach in PRN 97-2 to identify economic minor uses could prevent applicants from registering pesticides that would be beneficial to users and growers, thus limiting the availability of pesticides for certain use sites.” For this reason, “EPA revised the method to determine an economic minor use.”
PR Notice 2018-1 is significant because it can be applied to conventional pesticides, biopesticides, and antimicrobial pesticides to determine whether they meet the definition of minor use. The criteria in PR Notice 97-2 only applied to conventional pesticides.
EPA states the rationale for revising the PR Notice to consist of the following:
Additionally of note, EPA states in PR Notice 2018-1 that seeking minor use designation is not required as part of the pesticide registration process. It is an optional designation that an applicant can seek to obtain certain incentives associated with minor uses, such as:
More information on other PR Notices is available on our blog under key phrase Pesticide Registration Notice.
On February 22, 2018, the Superior Court of the State of California, County of Sacramento, issued a judgment granting petition for writ of mandate and declaratory and injunctive relief (Judgment) to suspend further chemical activities undertaken by the California Department of Food and Agriculture (CDFA) to control or eradicate pests under the Statewide Plant Pest Prevention and Management Program (the Project) until CDFA has certified a Program Environmental Impact Report (PEIR) that corrects violations of the California Environmental Quality Act (CEQA) identified in the court’s ruling.
CDFA is charged with promoting and protecting the state’s agricultural industry, and preventing the introduction and spread of injurious insect or animal pests, plant diseases, and noxious weeds. Cal. Food & Agr. Code §§ 4011 401.51 403. CDFA developed the Project to control targeted pests or pathogens, and includes activities such as pest rating (evaluation of a pest’s environmental, agricultural, and biological significance); identification, detection, and delimitation of new pest populations; pest management response (which may include eradication and/or control of new or existing pest populations); and prevention of the movement of pests into and within California.
The present case was brought after CDFA sought to comply with CEQA by preparing a single PEIR that provides a consolidated set of management practices rather than prepare Environmental Impact Reports (EIR) specific to particular pest management activities. Petitioners alleged that CDFA violated CEQA by certifying the PEIR for the Project and in related proceedings that CDFA violated CEQA by subsequently expanding the Statewide Plant Pest Prevention and Management Program to allow increased use of certain pesticides (Merit 2F and Acelepyrn) for the treatment of Japanese beetles without adequate environmental review.
The numerous CEQA violations identified by the court are set forth in a Consolidated Ruling on Submitted Matters (Consolidated Ruling) issued January 8, 2018, and attached as Exhibit 1 to the Judgment. The Consolidated Ruling discusses the following topics:
The court found multiple, broad-based issues with the PEIR, including, for example, a decision that the PEIR violates CEQA “because it adopts an unlawful tiering strategy, granting the Department authority to implement a broad range of practices without evaluating the site-specific conditions to determine whether the environmental impacts were covered in the PEIR.” The Consolidated Ruling also discusses particular failures of the PEIR. Additionally, of potential interest is the court’s opinion with regard to whether the PEIR failed to disclose and analyze impacts on sensitive biological resources, which Petitioners argued was based on several grounds: (i) an assumption that spraying “generally” will not occur near sensitive resources and fails to analyze potential impacts from pesticide drift; (ii) a conclusion, without substantial evidence, that the Project will have less-than-significant impacts on sensitive species; (iii) a conclusion, without substantial evidence, that traps and lures will not have significant impacts on non-target species; (iv) the use of improper thresholds of significance for impacts to pollinators and organic farming; and (v) a failure to define, disclose, and analyze impacts on wetlands.
The court did not find issues with the PEIR as it related to CDFA’s spraying assumptions and CDFA’s determinations of potential impacts on sensitive species, pesticide drift, or organic farming. The court likewise rejected Petitioner’s other challenges to the PEIR’s analysis of biological impacts, including the PEIR's analysis of traps/lures and of the species evaluated in the Ecological Risk Assessment (ERA).
The court did, however, agree with Petitioners that the PEIR improperly ignored potentially significant impacts to pollinators. The court stated that the PEIR considered impacts to pollinators significant only if (1) the pollinator species impacted were “special status,” or (2) the impacts would result in a secondary change in the physical environment (such as conversion of land from agricultural to non-agricultural use). The PEIR did not consider whether the Project might adversely impact non-special-status pollinators, despite acknowledging that “healthy pollinator populations are critical to protecting the environmental quality and agricultural resources of the state,” and that “Colony Collapse Disorder” and “pollinator decline” are “ongoing ... serious” problems. The court found that CDFA’s “‘voluntary’ actions to benefit pollinator species are not, by themselves, sufficient to justify the lack of analysis and enforceable mitigation measures for the potentially significant impacts to non-special-status pollinators.”
The immediate effect of this decision is the inability for CDFA to continue “chemical activities … to control or eradicate pests under the [Statewide Plant Pest Prevention and Management] Program except as authorized under CEQA independent of the PEIR.” Should this decision stand, registrants and stakeholders should be interested in whether and how CDFA modifies the PEIR to support its pest control and management activities.
On March 8, 2018, the U.S. Environmental Protection Agency (EPA) announced its release of final guidance clarifying where first aid statements should appear on the label of pesticide products. EPA also posted a response to public comments. Links to the final guidance and to the response to public comments documents are below:
EPA states that it was prompted to develop this guidance when it learned “that there was a discrepancy in how the ‘location of first aid statement,’ per [40 C.F.R. Section 156.68(d)] is interpreted by EPA and those in the pesticide registrant community.” EPA notes that its review and approval of pesticide labeling is generally of a “master” label and thus does not always include a review of the location or placement of specific language on a label.
On December 7, 2016, EPA posted a memorandum for public comment entitled “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement and Clarification on Definition of Label ‘Panel’ per 40 CFR 156.68” to clarify the interpretation of the term “panel” in the context of 40 C.F.R. 156.68 and to clarify where first aid statements must appear on pesticide labels, based on their Toxicity Category.
In its final guidance, EPA states it “will continue to require that Toxicity Category I products have the first aid statements on the front panel except in cases where a variation has been approved.” Further, based on comments received and the wide reliance by the regulated community on the interpretation that “any panel” includes inside panels, EPA is changing its position from its 2016 memorandum and now “will not require Toxicity Category II and III products to bear the first aid statements on a visible front, back or side panel.”
EPA also listed three recommendations for registrants to consider when printing their container labels:
Registrants should review this guidance carefully, as this issue has been the subject of concern and controversy for a number of registrants.
EPA Issued Proposed Rule to Add Hazardous Waste Aerosol Cans to Universal Wastes Regulated under RCRA
On March 6, 2018, the U.S. Environmental Protection Agency (EPA) issued a proposed rule (pre-publication version available here) to add hazardous waste aerosol cans to the category of universal wastes regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations (Title 40 of the C.F.R., Part 273), entitled Increasing Recycling: Adding Aerosol Cans to the Universal Waste Regulations. EPA cites as authority for this change Sections 2002(a), 3001, 3002, 3004, and 3006 of the Solid Waste Disposal Act, as amended by RCRA, as amended by the Hazardous and Solid Waste Amendments Act (HSWA). EPA states the streamlined Universal Waste regulations are expected to:
As aerosol cans are “widely used for dispensing a broad range of products” including pesticides, the proposed rule may have implications for chemical companies that create and distribute pesticide products marketed in aerosol cans. Hazardous waste aerosol cans that contain pesticides are also subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements, including compliance with the instructions on the product label. Under 40 C.F.R. Section 156.78, a flammability label statement is required for pressurized pesticide product products that states “Do not puncture or incinerate container,” but EPA’s 2004 determination (that will be posted to Docket No. EPA-HQ-OLEM-2017-0463 on www.regulations.gov for this proposed rule) allows for the puncturing of cans. The proposed rule states:
Comments will be due 60 days after the proposed rule’s publication in the Federal Register.
On February 28, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of three Group B -- Antimicrobial Efficacy Test Guidelines, under Series 810, Product Performance Test Guidelines. The guidelines provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides against public health microbial pests. 83 Fed. Reg. 8666. The three final guidelines are:
EPA states these “test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols for testing that is intended to provide data to inform regulatory decisions.”
EPA issued draft guidelines in June 2015 and solicited comments. EPA states that some comments received on those draft guidelines have been incorporated into the final versions. EPA states that the revision “is more user friendly and clarifies topics such as confirmatory data, repeat testing, hard water formulation, wetness determination testing for towelettes, and internal toilet testing … [and] also includes information on supplemental testing policies such as lower certified limits, revision of the AOAC Use Dilution Method performance standards and clarified technical details for efficacy testing.”
Documents pertaining to the revision of the product performance guidelines, including public comment submissions, and the agency’s response to comments are available at www.regulations.gov, in Docket No. EPA-HQ-OPP-2015-0276. More information on test guidelines is available on our blog.
Eastern District of California Rules on Motion to Enjoin Prop 65 Listing and Warning on Glyphosate Products
On February 26, 2018, the U.S. District Court for the Eastern District Court of California issued a memorandum and order on the plaintiff’s motion for preliminary injunction (Order) to “enjoin the listing of glyphosate under Proposition 65 (Prop 65) and the application of its attendant warning requirement pending a final judgment in this case and set a schedule for expedited final resolution of the case.” The Order (1) grants plaintiffs’ request for a preliminary injunction enjoining the warning requirement of California Health & Safety Code § 25249.6 as to glyphosate; and (2) denies the request for a preliminary injunction enjoining defendants from listing glyphosate as a chemical known to the State of California to cause cancer under California Health & Safety Code § 25249.8. Specifically, the Order states: “pending final resolution of this action, defendants … are hereby ENJOINED from enforcing as against plaintiffs … California Health & Safety Code § 25249.6’s requirement that any person in the course of doing business provide a clear and reasonable warning before exposing any individual to glyphosate.” Although this is only a preliminary injunction while the case continues further resolution, it is extremely significant that, for now, glyphosate will continue to be listed on California’s Prop 65 list as a “chemical known to the State of California to cause cancer,” but products containing glyphosate will not be required to comply with the warning requirement.
Plaintiffs’ memorandum supporting its motion for preliminary injunction states that Prop 65’s requirement for products containing glyphosate to include a warning that glyphosate is “known to the State of California to cause cancer” is unconstitutional under the First Amendment, and, if allowed to go into effect, will cause Plaintiffs’ “reputational, competitive, and economic harms for which they cannot be compensated.” Plaintiffs state that the “legal merit of their First Amendment claim is indisputable and obvious on the face of the attached documents without any need for discovery, and thus the claim is appropriate for expedited judicial resolution.” California’s Office of Environmental Health Hazard Assessment (OEHHA), the agency responsible for implementing Prop 65, listed glyphosate as a chemical known to the state of California to cause cancer on July 7, 2017, and the attendant warning requirement would have taken effect on July 7, 2018.
In support of denying the request for a preliminary injunction enjoining defendants from listing glyphosate under Prop 65, the court states that plaintiffs “have not shown a likelihood of success on the merits of their claim that the listing of glyphosate violates the First Amendment, because the listing is government speech, not private speech … [and it] is only the upcoming July 2018 deadline for providing the [Prop 65] warning that compels private speech.” The court noted further that Plaintiffs “have not shown a likelihood of irreparable harm should the court fail to enjoin the listing of glyphosate, because any harm that plaintiffs might suffer is caused by the warning requirements of [Prop 65], rather than the listing itself.” Accordingly, the court denied a preliminary injunction based on plaintiffs’ claim that the glyphosate listing violates the First Amendment.
On the other hand, in support of granting the request for a preliminary injunction enjoining the application of the attendant warning requirement, the court stated:
The court also stated that the required warnings are “false and misleading” and that plaintiffs “have shown that they are likely to succeed on the merits of their First Amendment claim, are likely to suffer irreparable harm absent an injunction, and that the balance of equities and public interest favor an injunction, the court will grant plaintiffs’ request to enjoin [Prop 65]’s warning requirement for glyphosate.”
This case, while not the end of the story, is a very significant development both for glyphosate specifically and perhaps for Prop 65 warning requirements generally. Industry should follow this case closely given the implications for glyphosate and potentially other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-regulated pesticides and chemicals generally. Some in industry have long been concerned that Prop 65 warning requirements contradict conclusions supported by the data and reached by other agencies such as the U.S. Environmental Protection Agency (EPA). This decision is a huge preliminary win for those with these concerns and, depending on the ultimate outcome of the case, could provide a precedent for additional challenges related to other substances. The potential reach of the case beyond glyphosate, however, will likely be dictated heavily by the facts of each case.
On February 15, 2018, the U.S. Environmental Protection Agency (EPA) added resources to its website regarding the Worker Protection Standard (WPS) and the Application Exclusion Zone (AEZ) requirements of the WPS. As of January 2, 2018, full compliance is required with all of the AEZ-related requirements in the WPS. The new EPA website resources include:
While many welcome EPA’s guidance on the many thorny issues presented by the WPS and AEZ requirements, some believe that in places, the newly issued guidance raises additional questions and leaves some significant questions unaddressed. Given the controversy over this rule, this new guidance should be reviewed closely.
More information on the WPS, including EPA’s December 2017 announcement of its intention to revise the AEZ and other WPS provisions, and current implementation deadlines can be found on our blog under key word WPS and key phrase Worker Protection Standard.