By Lisa M. Campbell, Heather F. Collins, M.S., and Barbara A. Christianson
On June 1, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a compliance advisory on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19.
EPA states that the advisory was issued because it has received tips and complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices. EPA says it is actively reviewing these claims and is working to identify others. EPA states that it intends to pursue enforcement for those products making false and misleading claims regarding SARS-CoV-2. EPA has made available a webpage where tips can be reported.
The advisory reiterates EPA’s message that disinfectant products that claim to kill viruses must be registered with EPA before they can be sold and that pesticide products cannot legally make claims that they kill a particular pathogen, such as SARS-CoV-2, unless EPA has authorized the claim during the registration process.
In the advisory, EPA emphasizes that it will not register a product claiming to be effective against SARS-CoV-2 until it has determined that the product will not pose an unreasonable risk and will be effective when used according to the label directions. EPA notes that it maintains List N, which is a list of disinfectants that meet EPA’s criteria for use against the virus that causes COVID-19. While surface disinfectant products on List N have not been tested specifically against SARS-CoV-2, EPA expects them to kill the virus because they demonstrate efficacy against a harder-to-kill virus or another human coronavirus similar to the one causing COVID-19.
The advisory also discusses devices that claim to kill SARS-CoV-2. It states that a pesticidal device is an instrument or other machine that is used to destroy, repel, trap, or mitigate any pests, including viruses (i.e., ozone generators, UV lights). EPA notes that unlike registered pesticide products, the safety and efficacy of pesticidal devices are not routinely reviewed by EPA. EPA states that it therefore cannot confirm whether, or under what circumstances, such products might be effective against SARS-CoV-2. The advisory states that consumers should be aware that pesticidal devices making such claims have not been reviewed and accepted by EPA. It further states that while pesticidal device labels must have an EPA establishment number (which identifies where a product was produced), they will not have an EPA registration number because pesticidal devices are not subject to the same registration requirements as pesticides.
According to the advisory, pesticidal devices are subject to certain regulatory requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), one of which is a prohibition of false or misleading labeling claims. The advisory specifically states:
Making false or misleading labeling claims about the safety or efficacy of a pesticidal device may result in penalties under FIFRA. Please note that ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses. In addition, because EPA does not review these data as part of a registration review process, these claims are not supported by any government review.
Because EPA does not review or register pesticide devices, these products are not included on List N.
It is important for pesticide device producers to review carefully the data supporting the claims made for their devices to ensure that they comply with the regulatory requirements under FIFRA.
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.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On October 13, 2017, the U.S. Environmental Protection Agency (EPA) announced that it had reached an agreement with Monsanto, BASF, and DuPont on measures “to further minimize the potential for drift to damage neighboring crops from the use of dicamba formulations used to control weeds in genetically modified cotton and soybeans,” and “new requirements for the use of dicamba ‘over the top’ (application to growing plants) will allow farmers to make informed choices for seed purchases for the 2018 growing season.”
EPA states that in a series of discussions, it “worked cooperatively with states, land-grant universities, and the pesticide manufacturers to examine the underlying causes of recent crop damage in the farm belt and southeast,” “sought extensive input from States and [U.S. Department of Agriculture (USDA)] cooperative extension agents from across the country, as well as the pesticide manufacturers, on the underlying causes of damage,” and “reviewed all available information carefully and developed tangible regulatory changes for the 2018 growing season.”
The label changes that certain registrants of dicamba products have agreed to impose additional requirements for "over the top" use of these products next year. These new requirements include:
- Classifying products as "restricted use," permitting only certified applicators with special training, and those under their supervision, to apply them; dicamba-specific training for all certified applicators to reinforce proper use;
- Requiring farmers to maintain specific records regarding the use of these products to improve compliance with label restrictions;
- Limiting applications to when maximum wind speeds are below 10 mph (from 15 mph) to reduce potential spray drift;
- Reducing the times during the day when applications can occur;
- Including tank clean-out language to prevent cross contamination; and
- Enhancing susceptible crop language and recordkeeping with sensitive crop registries to increase awareness of risk to especially sensitive crops nearby.
This announcement follows two compliance advisories issued by EPA in August 2016 and July 2017 on what EPA described as the high number of complaints received regarding crop damage from the alleged misuse of herbicides containing the active ingredient dicamaba. EPA’s August 2016 compliance advisory stated that the Missouri Department of Agriculture received 117 complaints alleging misuse of pesticide products containing dicamba, and Missouri growers estimated that more than 42,000 acres of crops had been adversely affected. Further, that similar complaints alleging misuse of dicamba products were received by Alabama, Arkansas, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Tennessee and Texas. In the spring of 2016, EPA issued a proposal to register dicamba to control weeds in cotton and soybean that have been genetically engineered to tolerate dicamba. In November 2016, EPA issued a conditional registration for dicamba on dicamba-tolerant cotton and soybean to Monsanto for its Xtendimax product; and EPA recently approved a label amendment made by Monsanto for Xtendimax which includes “additional restrictions further minimizing off-field movement of the active ingredient dicamba.”
EPA’s July 2017 compliance advisory states that by early July, EPA had received reports of hundreds of complaints to state agencies in Arkansas, Missouri, and Tennessee, a significant increase from 2016; lists the three new conditional registrations issued late last year (including Xtendimax); and states that only these new registered products may be lawfully applied over-the-top of growing soybeans and cotton. It discusses what it describes as unlawful applications of dicamba products, and states that “[e]xcept for the new conditionally registered dicamba products, application of a dicamba product during either the cotton or soybean crop growing season is unlawful under FIFRA.”
EPA’s July 2017 compliance advisory further states that each of the conditionally approved dicamba herbicide products has labeling that provides mandatory directions for use, restrictions, and special precautions that must be followed, and that the labels of the new products require specific and rigorous drift mitigation measures to further reduce the potential for exposure from spray drift including:
- No application from aircraft;
- No application when wind speed is over 15 mph;
- Application only with approved nozzles at specified pressures; and
- Buffer zones to protect sensitive areas when the wind is blowing toward them.
The reports of and concerns about potential damage to crops in connection with the application of dicamba illustrate a problem that has long been discussed, which is the potential for unintended impact when a pesticide that has been specifically designed for use with one or more crops that have been genetically engineered to be tolerant to the pesticide is applied in close proximity to other crops that do not share these tolerant characteristics.
The dicamba case also illustrates the differing views on potential misuse issues. Some observers have questioned whether all of the reported dicamba incidents were due to misuse or misapplication of the product. Although the 2018 label changes are designed to mitigate the potential for damage to sensitive crops, some question whether some unanticipated or as yet not completely understood factor may be at play in some of the incident reports. One issue raised by some researchers concerns potential unexpected volatility of the product even when applied according to the label directions by well-trained applicators. The registrants have disputed this suggestion, but it is an area which will likely be more thoroughly researched over the next few growing seasons.
More information on EPA’s regulatory action on dicamba is available on EPA’s website.