By Lisa R. Burchi
On October 7, 2021, U.S. Environmental Protection Agency (EPA) Region 2 announced a settlement with Reckitt Benckiser, LLC (Reckitt Benckiser) regarding alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The specific alleged violations relate to 239 sales and distributions of two rodenticide products in the United States that EPA asserts had misleading advertising claims on the packaging. Reckitt Benckiser has agreed to pay a civil penalty of $458,000 under the settlement to resolve these violations.
Reckitt Benckiser is a supplemental distributor of two rodenticide products that are bait stations registered under FIFRA to kill mice. EPA states that in 2019, it conducted inspections of a Home Depot in South Plainfield, New Jersey, and Reckitt Benckiser’s offices in Parsippany, New Jersey. EPA thereafter determined that Reckitt Benckiser was selling these two rodenticide products in packaging or labeling that made comparative claims as to the effectiveness of the product. Specifically, the packaging stated that the products were “10x Tastier Than Lead Competitor.” The labels EPA approved for the two products did not contain this comparative claim language, and at the time of registration, data associated with the products’ claims were never provided. EPA’s regulations at 40 C.F.R. Section 156.10(a)(5)(iv) provide that statements or representations in the labeling which constitute misbranding include a “false or misleading comparison with other pesticides or devices.” EPA states that because "the comparative claims were not subject to verification, they were ‘false and misleading comparisons’ prohibited under [FIFRA].”
This case serves as another reminder to registrants and supplemental distributors to review all labeling and advertising claims to ensure conformity with EPA-approved labels and avoidance of claims that EPA identifies as false or misleading.
By Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on May 6, 2021, that Bear River Supply Inc., based in Rio Oso, California, has agreed to pay a $50,578 penalty to resolve EPA’s findings that the Company produced pesticides in an unregistered establishment, distributed and sold misbranded pesticides, and failed to maintain equipment properly. According to EPA, the California Department of Pesticide Regulation (CDPR) and EPA discovered the violations during a series of inspections conducted at two separate facilities in Rio Oso. Inspectors found that “Vistaspray 440 Spray Oil” and “Roundup PowerMax” were being repackaged and distributed with improper labeling. In addition, EPA states, inspectors determined that Bear River Supply was producing pesticides in a facility that was not registered with EPA. While at the facilities, inspectors also found that a secondary containment unit and loading pad, both used to contain potential spills, were inadequate. The Company has since corrected the violations.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), pesticide manufacturers must register their facilities with EPA and annually report their pesticide production. EPA states that production records provide information on the quantities of pesticides produced and distributed. EPA notes that in addition, the number assigned to the establishment must appear on the label. FIFRA’s reporting and labeling requirements allow EPA and state agencies to track pesticide products back to the companies that produced them and “are necessary to ensure safe management and distribution” of pesticides.
Innovations in agricultural chemicals have revolutionized and enhanced food production, but with progress come new challenges. Agricultural chemicals can have widespread impacts on ecosystems and human health, and marginalized communities -- children and farmworkers in particular -- can be especially vulnerable. Manufacturers, regulatory agencies, public health experts, and nonprofit organizations are working to address these challenges head-on by developing new products and devising robust protective measures.
Recent changes in federal regulations include the Worker Protection Standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which expand the requirements for protecting agricultural workers from pesticide exposure. The Environmental Law Institute (ELI) presents "Pesticides, Farmworkers, Industry, and Environmental Justice," a webinar exploring the issues addressed in the new regulations and the implementation of these new obligations. James V. Aidala, Senior Government Affairs Consultant, Bergeson & Campbell, P.C. (B&C®), will moderate this discussion.
By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi
On June 22, 2020, the U.S. District Court for the Eastern District of California granted summary judgment for the Plaintiffs in National Association of Wheat Growers et. al. v. Becerra, and entered a permanent injunction against enforcement of a Proposition 65 (Prop 65) warning label for pesticide products containing glyphosate. The court found that requiring the registrants of glyphosate products to include such a warning could not be justified as a valid restriction on commercial speech and therefore is contrary to the First Amendment of the Constitution. The same District Court had previously entered a preliminary injunction against the Prop 65 warning in 2018, and the required warning has consequently never been in effect. (See our February 28, 2018, blog entitled “Eastern District of California Rules on Motion to Enjoin Prop 65 Listing and Warning on Glyphosate Products.”) The U.S. Environmental Protection Agency (EPA) also has stated that it would not allow a Prop 65 warning to be added to the labeling for any registered glyphosate product because such a warning is misleading and would cause the product to be “misbranded” under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(q)(1)(A). (See our August 15, 2019, blog entitled “EPA Issues Guidance Regarding Prop 65 Labeling Requirements for Glyphosate Products and OEHHA Responds.”)
A Prop 65 warning is required when the California Office of Environmental Health Hazard Assessment (OEHHA) determines that a product contains a substance that has been classified as a human carcinogen by certain authoritative bodies, including the International Agency for Research on Cancer (IARC). Based on an IARC determination that glyphosate is “probably carcinogenic” in humans, OEHHA listed glyphosate in July 2017 as a chemical known to the State of California to cause cancer, thereby triggering Prop 65 warning requirements. Despite the IARC determination, every other authoritative body that has considered the matter (including EPA, the European Commission, and the World Health Organization) has reached a contrary determination that glyphosate is not likely to be carcinogenic in humans. California’s imposition of a Prop 65 warning for glyphosate was challenged in 2018 by the registrant Bayer and a coalition of farming groups and industry stakeholders, who obtained a preliminary injunction against enforcement of the warning.
Before entering the new permanent injunction, the District Court considered whether California’s regulation of commercial speech should be scrutinized under the lower standard set by the Supreme Court in Zauderer v. Office of Disciplinary Counsel or the intermediate standard set by Central Hudson Gas & Electric v. Public Service Commission. The Zauderer standard only applies to mandatory disclosure of “purely factual and uncontroversial information,” and the Court found that the Prop 65 warning for glyphosate is “misleading” and therefore neither factual nor uncontroversial. Under the Central Hudson level of scrutiny, a governmental agency may only restrict commercial speech when the restriction directly advances an important governmental interest and where the restriction is not more extensive than necessary to serve that interest. The Court found that the Prop 65 warning for glyphosate is misleading, and therefore does not directly advance the interest of the state in informing consumers regarding potential cancer hazards, and that the asserted state interest could be effectively advanced by other measures that do not burden freedom of speech in the same manner.
California argued that no Prop 65 warning would actually be required for glyphosate in practice because OEHHA has set a quantitative “safe harbor” level for glyphosate exposure, but the court found that this would not prevent parties other than California from bringing separate enforcement actions to enforce the listing. Since a Prop 65 warning only needs to be “clear and reasonable,” California also proposed several alternative forms for a warning that would meet state requirements, but the court found these alternate warnings to all be misleading as well. Based on all of these factors, the court decided to enjoin permanently the enforcement of Prop 65 warning requirements for glyphosate as an unconstitutional burden on commercial speech.
Under FIFRA Section 24(b), no state may impose any labeling for a registered pesticide that differs from the labeling approved by EPA. Although EPA has sometimes been willing to accommodate state labeling requirements or preferences within the labeling approved under FIFRA, there are necessary limits to this practice. When label language sought by a state becomes misleading, approving it would also be expressly contrary to FIFRA. How much precedential effect this decision may have with respect to other state requirements for labeling in the future is an issue that registrants should monitor closely.
By Barbara A. Christianson and Heather F. Collins, M.S.
On September 24, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the premises treatment final test guideline, under Series 810, Product Performance Test Guidelines. The guideline, 810.3500 Premise Treatment, provides recommendations on how to conduct efficacy testing against invertebrate pests in premises, such as cockroaches, ticks, mosquitoes, flies and wasps in connection with registration of pesticide products for use against public health pests. This guideline does not, however, apply to efficacy testing for treatment of livestock or pets, wide-area mosquito control, structural protection from termites, or bed bug products.
EPA states that “The final guideline clarifies the original guideline published in 1998 based on public comments and recommendations from the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP).”
Revisions to 810.3500 include
- Clarifying bait product testing;
- Offering more flexibility in testing design;
- Updating the replication recommendations based on statistical modeling and ease of obtaining pests; and
- Refining the statistical analyses recommendations.
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 Number EPA-HQ-OPP-2017-0693. More information on test guidelines is available on our blog.
By Jason E. Johnston
On September 4, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ Environmental Fate and Effects Division (EFED) announced that the next Environmental Modeling Public Meeting (EMPM) will be held on October 16, 2019. The EMPM is a semi-annual public forum for EPA, pesticide registrants, and other stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for risk assessments in a regulatory context.
In a press release to the public, EPA indicates that the topics covered at the October meeting will include sources of usage data (relating to the actual application of pesticides, in terms of the quantity applied or units treated); spatial applications of usage data; model parameterization; extrapolation of usage data to fill in gaps; temporal variability of usage; and updates on ongoing topics. Presentations concerning the incorporation of pesticide usage data into environmental exposure and ecological risk assessments will also be included.
Registration is required. Requests to participate in the meeting must be received on or before September 23, 2019, as noted in the Federal Register notice.
By Lisa M. Campbell and Heather F. Collins, M.S.
On August 28, 2019, the U.S. Environmental Protection Agency (EPA) released the Frequently Asked Questions (FAQ) web resource for the Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines. As of August 28, 2019, efficacy testing should be in compliance with the following Product Performance Test Guidelines published by EPA in February 2018:
- 810.2000: General Considerations for Testing Public Health Antimicrobial Pesticides, Guide for Efficacy Testing;
- 810.2100: Sterilants, Sporicides, and Decontaminants, Guide for Efficacy Testing; and
- 810.2200: Disinfectants for Use on Environmental Surfaces, Guide for Efficacy Testing.
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. EPA states that these FAQs “provide prompt and transparent guidance to all applicants regarding commonly asked questions concerning the 810 guidelines updated in February 2018.”
With the exception of confirmatory testing (as described under OCSPP guideline 810.2000, Section (B)(7)), all studies initiated on or after August 28, 2019, should be in compliance with the 2018 revised guidelines for testing. The study initiation date is defined under 40 CFR Part 160.3 as the date the protocol is signed by the study director. Studies that were initiated prior to the implementation date but submitted to EPA for review after the implementation date may use either the previous 2012 version of the guidelines or the 2018 revised guidelines, as appropriate. EPA states that it “intends to address confirmatory testing through a separate guidance, which will be made available for public comment prior to finalization.”
The FAQs include general testing questions and questions related to each specific guideline. The appendices to the FAQs include examples of label use-directions for dilutable products, repeat testing guidance with example scenarios, and sample virucidal calculations.
There has been some concern in the regulated community regarding the need for clarification on the guidelines before they became effective. EPA’s new FAQs are intended to provide these clarifications, but the timing of their issuance may be of concern to some. Also of interest is whether additional FAQs will be issued in the future.
By Lisa M. Campbell, Timothy D. Backstrom, Lisa R. Burchi, and James V. Aidala
On August 7, 2019, EPA took long awaited action concerning the inclusion of Prop 65 warning statements for glyphosate on EPA registered pesticide labels, which will likely impact the broader ongoing debate over EPA approval of Prop 65 warnings on pesticide labels. EPA’s August 7, 2019, letter to glyphosate registrants states that EPA “will no longer approve labeling that includes the Proposition 65 warning statement for glyphosate-containing products.” EPA stated further that “[t]he warning statement must also be removed from all product labels where the only basis for the warning is glyphosate and from any materials considered labeling under FIFRA for those products.” Moreover, EPA unequivocally states that “pesticide products bearing the Proposition 65 warning statement due to the presence of glyphosate are misbranded” under FIFRA Section 2(q)(1)(A). Registrants with glyphosate products currently bearing Prop 65 warning language, where the exclusive basis for such warning is based on the presence of glyphosate, must submit draft amended labeling that removes this language by November 5, 2019.
By way of background, California’s Office of Environmental Health Hazard Assessment (OEHHA) listed glyphosate as a chemical known to the state of California to cause cancer on July 7, 2017. OEHHA’s listing of glyphosate as a substance under Prop 65 is based on the International Agency on the Research for Cancer (IARC) classifying it as “probably carcinogenic to humans.” EPA scientists subsequently completed an independent review of the available scientific data on the potential carcinogenicity of glyphosate and do not agree with the IARC classification. Additional information regarding glyphosate is available at B&C’s blog.
Also of note is a February 26, 2018, preliminary injunction issued by the U.S. District Court for the Eastern District Court of California, in response to a motion filed by a coalition including Monsanto, CropLife America, and several growers associations alleging that the IARC classification decision for glyphosate is contrary to the international scientific consensus, that the required Prop 65 warning would be misleading to the ordinary consumer, that compelling the manufacturers of glyphosate to provide such a warning would violate the First Amendment because the warning is not factual and uncontroversial, and that the applicable criteria for injunctive relief were met. The February 26, injunction precluded OEHHA from enforcing its Prop 65 warning requirements against glyphosate registrants that otherwise would have taken effect on July 7, 2018. The Court did not rule that glyphosate should be removed from the Prop 65 list as a chemical known to the State of California to cause cancer, but did state that products containing glyphosate would not be required to comply with the warning requirements. In issuing the preliminary injunction, the Court 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.” More information on that case is available at B&C’s blog. That injunction has not been appealed and remains in place.
Although the glyphosate warning that EPA has refused to allow is based on OEHHA’s recent listing under Prop 65, Prop 65 warnings on pesticide labels generally have been a significant issue since 2016 when OEHHA issued revised regulations regarding the content and transmission of Prop 65 warnings. As a result of these revisions, many registrants sought to add Prop 65 warning requirements to pesticide labels to meet Prop 65 requirements, but many registrants have not been able to obtain EPA approval for such warnings, resulting in much controversy and discussion. More information regarding the changes to Prop 65 warning requirements also are available at B&C’s blog.
In its press release announcing its guidance to glyphosate registrants, EPA Administrator Andrew Wheeler states: “It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a cancer risk. We will not allow California’s flawed program to dictate federal policy.” EPA states that its “independent evaluation of available scientific data included a more extensive and relevant dataset than IARC considered during its evaluation of glyphosate, from which the agency concluded that glyphosate is ‘not likely to be carcinogenic to humans.’” Wheeler is further quoted as stating: “It is critical that federal regulatory agencies like EPA relay to consumers accurate, scientific based information about risks that pesticides may pose to them. EPA’s notification to glyphosate registrants is an important step to ensuring the information shared with the public on a federal pesticide label is correct and not misleading.”
OEHHA immediately released its own press release on August 13, 2019, in which it “objects to US EPA’s characterization of any warning concerning glyphosate’s carcinogenicity as a false claim.’” After reiterating OEHHA’s listing glyphosate based on the IARC determination, OEHHA states that EPA’s position “conflicts with the determination made by IARC” and that “it is disrespectful of the scientific process for US EPA to categorically dismiss any warnings based on IARC’s determinations as false.”
The Court’s February 26, 2018, preliminary injunction was considered a significant development both for glyphosate specifically and perhaps for Prop 65 warning requirements generally, especially considering the recent influx to EPA of label amendments seeking EPA approval of revised Prop 65 warning language to address OEHHA’s revised regulatory changes. EPA’s guidance is equally significant, as EPA has now rejected the inclusion of a Prop 65 warning that EPA believes is misleading on a federal pesticide product label.
FIFRA Section 24(b) expressly prohibits any State from requiring any label language for a registered pesticide product beyond the labeling approved by EPA, and EPA has now declined to approve pesticide labeling that includes the Prop 65 warning for glyphosate. In some instances, EPA has been willing as a courtesy to approve labeling changes requested by a State, but the glyphosate determination demonstrates that EPA will not accept any label revisions that conflict materially with its own determinations. Although glyphosate is a fairly complex and controversial case, it will be important for registrants to monitor the evolution of EPA’s standard for when it will or will not approve a Prop 65 warning on a federal label, since this issue has been the subject of considerable controversy over the past several years.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
EPA’s Federal Register notice announcing the meeting states that the meeting will be augmented with additional experts to provide independent scientific advice on the proposed guidelines. Preceding the in-person meeting, there will be a public half-day preparatory virtual meeting to consider the scope and clarity of the draft charge questions for this peer review. The in-person meeting on June 11-14, 2019, will be held at the EPA Conference Center, Lobby Level, One Potomac Yard (South Building), 2777 South Crystal Drive in Arlington, Virginia. The meeting will also be available via webcast.
EPA’s original Product Performance Test Guidelines, OPPTS 810.3300, Treatments to Control Pests of Humans and Pets were published in March 1998. EPA’s Charge Questions state that “[t]o increase clarity and consistency in efficacy testing and to include current scientific standards, the agency is revising this product performance guideline.” Further, the proposed guidelines apply to products “in any topically applied formulation, such as a spray, spot-on, collar, shampoo, or dust, if intended to be directly applied to pets for a pesticidal purpose such as to kill, repel, or control ticks, fleas, mosquitoes, and biting flies”; do not apply “to those products exempt from FIFRA Registration under 40 CFR 152.25, products applied to humans or livestock, or product performance testing described in other agency guidelines”; and, in addition to guidance for testing efficacy against fleas, ticks, mosquitoes, and biting flies, the proposed guideline “also includes testing methods for evaluating efficacy under simulated environmental conditions.”
EPA believes the current Draft Guidelines represent the state of the science with regard to efficacy testing for these products; but is still seeking advice and recommendations from the FIFRA SAP on scientific issues related to the Draft Guidelines. EPA states that it is committed to reducing the use of animals in testing but, at this time, no reliable non-animal alternatives are available to avoid the use of animals for efficacy testing of fleas, ticks, mosquitoes, and biting flies. EPA is soliciting comment from the FIFRA SAP on approaches that may, in the future, support the replacement or reduction of animal use in efficacy testing of ectoparasitic pests on pets.
Information on attending the meeting in person and via webcast can be found on the FIFRA SAP website. EPA is requesting that written comments on the documents undergoing peer review be submitted to Docket No. EPA-HQ-OPP-2019-0161 by May 17, 2019, to provide the FIFRA SAP the time necessary to consider and review the written comments.
By Lisa M. Campbell and Lisa R. Burchi
On December 28, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-26 changing its Notice of Decision (NOD) and public report documentation for proposed registration decisions to ensure continued compliance with its certified regulatory program obligations under the California Environmental Quality Act (CEQA). The new changes to the NODs and public report documentation will be effective May 1, 2019.
These changes are as a result of a 2014 lawsuit brought by Pesticide Action Network North America (PANNA), et al. challenging DPR’s acceptance of label amendments for two previously registered dinotefuran pesticide products. The First District Court of Appeal held that DPR’s NODs and public reports supporting the dinoteferan registration actions were deficient because DPR could not demonstrate that it properly considered certain factors specified in CEQA. In essence, the court concluded that certain CEQA requirements that DPR construed as procedural in nature were actually substantive standards that DPR must meet and adequately document in its administrative record. Specifically, the court found that DPR failed to include a checklist or other documentation with meaningful analysis explaining how DPR reached its conclusion that the approval of the proposed label changes would not cause a significant adverse impact to human health, flora, fauna, water, and air.” The court also found DPR’s discussion of alternatives and cumulative impacts inadequate. Information about that case is available in our blog item California Court of Appeal Reverses Trial Court Decision Denying PANNA’s Petition Challenging Approval by DPR of Pesticides Containing Dinotefuran.
CEQA is intended to ensure projects permitted by public agencies consider the long-term protection of the environment. DPR states that CEQA “requires state and local agencies to develop an environmental impact report (EIR) for any proposed or approved project that may have a significant effect on the environment (including human health) or a negative declaration if there is substantial evidence of no significant impacts.” EIRs provide public agencies and the public “with detailed information about a proposed project’s significant effects on the environment, describe ways these effects can be minimized, and indicate alternatives to the proposed project.” CEQA and its implementing regulations set forth in Title 3, California Code of Regulations (3 Cal. Code Regs.) Sections 6254 and 6255, also require DPR to issue a weekly Notice of Proposed Decisions to Register Pesticide Products and Public Report, listing each proposed decision to register and amend pesticide products for a 30-day public comment period.
Changes to the NOD and Public Report Documentation
To address concerns raised by the court and to protect its certified program status, on January 3, 2018, DPR issued California Notice 2018-01 (“Expanding Use of Pesticide Products Under Reevaluation”), providing that, effectively immediately, DPR “will not act upon an Application for Pesticide Registration or Application to Amend Pesticide Product if DPR 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.”
With Notice 2018-26, DPR will change the documentation associated with its environmental analysis in the NODs and public reports. According to Notice 2018-26, the revised NODs and public reports will address the following areas for each pesticide product noticed for registration:
- Discussion of DPR’s certified program under CEQA;
- Relevant DPR regulations for the proposed decision and public report;
- Detailed description of the project;
- Overview of the registration program, scientific evaluation process, and continuous evaluation;
- Environmental and human health factors examined (i.e., checklist containing the following CEQA areas: human health, flora, fauna, water, and air);
- Discussion of feasible alternatives and mitigation;
- Discussion of existing environmental conditions and cumulative impacts; and
- Conclusion explaining DPR’s analysis of potential significant adverse impacts to human health, flora, fauna, water, and air.
In addition, each public report will include the proposed label. For label amendments, DPR will include both the proposed label and currently accepted label.
In summary, effective May 1, 2019, DPR “will no longer post new products and label amendments exiting the formal evaluation process as proposed to register for the 30-day public comment period until DPR completes a public report explaining why the new product or label amendment is not reasonably expected to cause a significant adverse impact to human health, flora, fauna, water, and air.” New products and label amendments that exit the formal evaluation process prior to May 1, 2019, will be posted for the 30-day public comment period using the current NOD documentation.
The impact of these changes could be substantial from a timing and DPR workload perspective and, thus, of significant concern to registrants. DPR has stated it is reviewing its internal processes and procedures and hiring additional staff to accommodate changes in workload as a result of the NOD and public report documentation changes. This is based, in part, on the fact that if current evaluation reports are not available for each CEQA checklist area (i.e., human health, flora, fauna, water, and air), DPR staff may need to review prior evaluation reports, documentation in product files, U.S. Environmental Protection Agency (EPA) risk assessments, and other available information to develop the public report. Moreover, DPR states that if it does not have adequate information to address each CEQA checklist area, the product may need to reenter DPR’s formal evaluation process. All of these factors could significantly extend the amount of time DPR takes to review a new product or amendment, as it must now develop these public reports prior to proposing registration decisions with a 30-day public comment period, and that time could be even longer in cases where DPR determines it requires additional evaluation of the product and/or data necessary to complete such public reports.