By Lisa R. Burchi, James V. Aidala, and Barbara A. Christianson

On November 15, 2022, the California Department of Pesticide Regulation (DPR) made two announcements: an enforcement action relating to 1,3-Dichloropropene (1,3-D) and chloropicrin and an announcement on a proposed rule on additional use restrictions on 1,3-D. These actions may have significant impacts on registrants and growers who use soil fumigants.

Enforcement Action

DPR issued a licensing action against TriCal, a company that performs field fumigations, primarily using chloropicrin and 1,3-D. DPR found that TriCal had numerous violations that resulted in serious illness and injury and dozens of other violations. During a licensing action, DPR can seek civil penalties or seek to revoke or suspend the license of a company that is licensed to do pest control work, sell pesticides, or advise on pest control in California.

DPR states that TriCal has been subject to past enforcement actions dating back to 2014. These past violations include a combined 40 incidents -- four of which were “priority episodes” (i.e., incidents involving serious illness or injury, or an episode involving five or more people). Specifically, TriCal paid over $125,000 in administrative civil penalties to County Agricultural Commissioners and a $44,275 fine to the U.S. Environmental Protection Agency (EPA).

DPR’s press release states that nine episodes were cited in the most recent licensing action, including the following:

• In October 2020, DPR alleged 20 residential bystanders and three members of the Salinas Fire Department experienced symptoms of pesticide exposure from a TriCal misapplication.
• In October 2019, DPR alleged 39 fieldworkers were exposed to 1,3-D and chloropicrin due to TriCal’s misapplication. Thirty-two fieldworkers experienced symptoms of pesticide exposure, and three people sought medical care for their symptoms.
• In October 2018, DPR alleged TriCal misapplied a product containing 1,3-D and chloropicrin and, as a result, 13 residential bystanders experienced symptoms of pesticide exposure.

This licensing action comes as DPR announces proposed regulatory requirements to strengthen use restrictions on 1,3-D to protect public health. In its proposed regulation, DPR 22-005 Health Risk Mitigation and Volatile Organic Compound Emission Reduction for 1,3-Dichloropropene, DPR states its “broad objectives of the proposed regulations are to mitigate the potential 72-hour acute risk and 70-year lifetime cancer risk to non-occupational bystanders from the use of 1,3-D, and to reduce [volatile organic compound] VOC emissions from 1, 3-D field soil fumigations.” This proposal is based in part on a health-protective regulatory target established last year after consultation with state and local agencies. Specifically, the proposed action, if issued in final, would:

1. Allow the use of 1,3-D only for the production of agricultural commodities, effectively prohibiting other uses that are not currently registered;
2. Establish mandatory setbacks (distances from occupied structures where 1,3-D cannot be applied);
3. Set limits on the application rate and acres treated for individual field soil fumigations;
4. Place restrictions on multiple field soil fumigations that do not meet distance or time separation criteria;
5. Limit the allowed methods to apply 1,3-D, including establishing criteria for acceptable types of tarpaulins that can be used;
6. Require an annual report from DPR that includes evaluations of 1,3-D use and air monitoring results; and
7. Require the inclusion of certain information in existing pesticide use records and pesticide use reports.

Comments are due on or before January 18, 2023. DPR will accept written comments that are submitted via U.S. mail and postmarked no later than January 18, 2023. Comments also may be transmitted via e-mail to .(JavaScript must be enabled to view this email address) or by facsimile at 916-324-1491 and must be received no later than 5:00 p.m. (PST) on January 18, 2023.

DPR will conduct a public hearing to accept comments on these amendments. The public hearing is scheduled for January 18, 2023, starting at 9:30 a.m. (PST). The hearing will be in a hybrid format with both a physical location and an option to participate remotely:

Physical Location:

CalEPA Headquarters Building

Byron Sher Auditorium

1001 I Street, 2nd Floor

Sacramento, CA 95814

Remote Location:

Zoom

Webinar ID: 826 1358 3257

Password: 045724

Direct link to join the meeting from a web browser or Zoom client:

https://us02web.zoom.us/j/82613583257?pwd=UGJ0WkxtbFlFYUdrQmJYb3V3QyszUT09

One tap to join from a mobile phone: +16699009128,,82613583257#,,,,*045724#

Or call from a landline: +1-669-900-9128 and enter the Webinar ID and Password (above) when prompted

The hearing also will be accessible via public webcast for persons who would like to watch this hearing without participating. The public webcast can be accessed by visiting the following web address: https://video.calepa.ca.gov/#/

Commentary

These actions add many new restrictions on the use of these pesticides. Growers who rely on these products will have to comply with the new restrictions and hope that they address the state’s concerns or face additional restrictions or even a decision by DPR to not register the pesticides regardless of what EPA’s federal label allows. The state actions may in turn raise new issues for EPA. DPR’s justification for greater controls mentions the possible impact on local communities, which may cause greater focus on environmental justice matters, and the evolution of this issue should be monitored.

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By James V. Aidala, Dennis R. Deziel and Heather F. Collins, M.S.

On November 16, 2022, the U.S. Environmental Protection Agency (EPA) announced it released an Endangered Species Act (ESA) Workplan Update (Workplan Update) that outlines major steps to increase protections for wildlife and regulatory certainty for pesticide users. The Workplan Update details how EPA will pursue protections for nontarget species, including federally listed endangered and threatened (i.e., listed) species, earlier in the process for pesticide registration review and other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions. According to EPA, these early protections will help EPA comply with the ESA, thus reducing its legal vulnerability, providing farmers with more predictable access to pesticides, and simplifying the ESA-FIFRA process that, left unchanged, creates both significant litigation risk and a workload far exceeding what EPA has the resources to handle.

EPA states this update is a follow-up to EPA’s April 2022 ESA Workplan that addresses the complexity of meeting its ESA obligations for thousands of FIFRA actions annually. The ESA Workplan prioritizes certain FIFRA actions for ESA compliance, outlines how EPA will pursue early mitigation for listed species under FIFRA, and describes directions for expediting and simplifying the current pesticide consultation process.

As part of registering new pesticides or reevaluating pesticides during registration review, EPA has a responsibility under the ESA to ensure certain pesticide registrations do not jeopardize the continued existence of listed species or adversely modify their designated critical habitats. EPA states that it has seen in the past few decades an increase in litigation due to EPA’s failure to meet its ESA obligations when taking FIFRA actions. Over the next six years, existing court-enforceable deadlines will require EPA to complete ESA reviews for 18 pesticides -- the most EPA estimates it can handle during this period based on its current capacity and processes. Ongoing litigation and settlement discussions for other lawsuits cover dozens of additional pesticides and will likely fill the EPA’s ESA workload well beyond 2030. According to EPA, if its ESA efforts continue at this pace, a future court may decide to curtail drastically pesticide use until EPA meets its obligations. EPA believes this situation would be unsustainable and legally tenuous and provide inadequate protection for listed species and create regulatory uncertainty for farmers and other pesticide users.

The Workplan Update is EPA’s first update to the ESA Workplan and covers four main goals:

1. Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.
2. Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for many future conventional and biological pesticide registration and registration review actions to protect nontarget species. For each FIFRA action, EPA will consider this menu and propose, based on the risks and benefits of the particular pesticide, which specific measures to include on the pesticide label.
3. Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture. Where needed, EPA may develop these measures to complement the generic FIFRA ecological mitigation described above.
4. Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.

The first strategy described in EPA’s ESA Workplan is to “meet ESA obligations for FIFRA actions.” EPA states as part of its work to execute this strategy, it has identified a menu of Interim Ecological Mitigation measures it will use as a starting point to address pesticide risks to nontarget species during registration and registration review.

The menu of Interim Ecological Mitigation will include measures to reduce pesticide spray drift and pesticide runoff and will be considered as part of EPA’s upcoming proposed interim registration review decisions. While EPA intends for this set of Interim Ecological Mitigation measures to apply widely to many pesticides, EPA will consider the menu of options for any given pesticide depending on the level of risk that it poses to species and the exposure route.

EPA anticipates that this approach will more efficiently establish protections for nontarget species, including listed species, and standardize the protections across similar pesticides, in contrast to identifying mitigation measures pesticide by pesticide or species by species, as EPA has typically done in the past.

EPA states it will also work with registrants to add language on pesticide incident reporting, advisory language to protect insect pollinators, and language to most outdoor-use pesticide labels that directs users to reference Bulletins Live! Two, a website where pesticide users can find endangered species protection bulletins. These bulletins describe geographically specific use limitations to protect threatened and endangered species and their designated critical habitat.

EPA expects that once consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service is completed for any given outdoor-use pesticide, endangered species protection bulletins may be necessary for at least one listed species.

EPA also expects that working with registrants proactively to add the reference to Bulletins Live! Two to pesticide labels in advance of consultation will ultimately save EPA, state partners, and registrants time and resources by minimizing the number of amendments to labels.

The ESA Workplan Update also describes initiatives that, according to EPA, will help it and other federal agencies improve approaches to mitigation under the ESA and improve the interagency consultation process outlined in the ESA Workplan. These initiatives include EPA’s work to identify ESA mitigation measures for pilot species, incorporate early ESA mitigation measures for groups of pesticides (e.g., herbicides), and develop region-specific ESA mitigations.

Comments on the proposed set of interim mitigation measures and the proposed revisions to label language included in the Workplan Update appendix are due on or before January 30, 2023. Comments can be submitted at EPA-HQ-OPP-2022-0908.

Commentary

This next phase of the ESA Workplan provides more detail about how EPA plans to impose various mitigation measures to meet its ESA obligations when registering a pesticide. The most favorable view of what EPA has presented is that it continues the march toward ESA compliance, which is long overdue, and provides more detail about the kinds of mitigation approaches it will place on pesticide labels to meet ESA requirements. The less favorable view here is that EPA has outlined a number of “off the shelf” mitigation options (buffers to reduce pesticide drift and water runoff), and EPA might impose such conditions in many instances where more careful analysis of usage data and site- or use-specific considerations might lessen the areas where such mitigation measures are needed.

EPA has stated previously as part of its earlier Workplan document, issued in April 2022, that using the present approaches EPA would complete only 5 percent of the ESA required reviews in about 18 years -- implying that the current approach would take about 360 years to complete. This next iteration of the Workplan, describing “early mitigation” strategies, is designed to reduce this unacceptable timeframe (360 years), but is likely to lead to fears among some stakeholders that in a “rush” to complete this work, EPA will make overly conservative label restrictions and reduce availability of the pesticide without increased species protections. Such concerns raise immediate ancillary concerns about stakeholder involvement in decision-making, compliance with what might be complicated label requirements, and enforcement of what is already typically a long list of label requirements for many current products. An example of such issues: one mitigation option example discussed is “do not use when rain is expected in the next 48 hours” -- which could raise issues concerning what or how compliance might be proven or enforced.

Again, to be sure, this next document about how EPA plans to make significant progress in meeting its ESA obligations continues the effort to convince courts that it is meeting its ESA obligations. As such, it represents a large step forward where in the past EPA was left with little progress or plans to present in court as part of litigation over ESA compliance. As it continues to reveal its plans and options, however, stakeholders will need to follow closely and consider the possible impacts of the Workplan and the resulting label proposals to follow.

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By Lisa R. Burchi, James V. Aidala, and Dana S. Lateulere

On November 8, 2022, the U.S. Environmental Protection Agency (EPA) issued a final rule adding chitosan (Poly-D-Glucosamine), a naturally occurring substance found in the cell walls of all crustaceans, many fungi, and the exoskeletons of most insects, to its minimum risk pesticide exemption list. 87 Fed. Reg. 67364. EPA states that the listing also includes those chitosan salts that can be formed when chitosan is mixed with the acids that are listed as active or inert ingredients eligible for use in minimum risk pesticide products.

According to EPA’s announcement of the final rule, the purpose of the exemption list is to eliminate the need for EPA to expend significant resources to regulate products deemed to be of minimum risk to human health and the environment. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b) minimum risk exemption, products that contain only those active and inert ingredients allowed by the exemption and that meet certain requirements are exempt from the normal FIFRA registration requirements. Approximately a decade has passed since a substance was added to the list of ingredients eligible for the minimum risk pesticide exemption.

Chitosan is currently registered with EPA under FIFRA as a fungicide, antimicrobial agent, and plant growth regulator that boosts the ability of plants to defend against fungal infections. EPA’s decision was based on a review of an October 10, 2018, petition requesting that chitosan be added to the list of active ingredients allowed in exempted minimum risk pesticide products. In November 2020, EPA requested public comment on the proposed rule to add chitosan to the list of active ingredients eligible for the exemption. Additionally, in November 2021, EPA requested information from the petitioner on chitosan salts and their potential effect on the environment.

EPA states that after reviewing the latest available science and comments on the proposed rule and the Notice of Data Availability, it has determined to add chitosan to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption. EPA’s analysis of the available data suggests that chitosan and chitosan salts are of low toxicity to humans and that no environmental risks of concern have been identified. As a result of this final rule, products that contain chitosan and that comply with all the other requirements applicable to minimum risk pesticides will no longer need to be registered under FIFRA. Products containing chitosan that cannot meet all minimum risk pesticide requirements may still require registration.

The final rule is available here. Additional information on chitosan is available on our blog.

Commentary

As the first change to the list in many years, this may represent EPA’s attempt to communicate further about “safer” or reduced risk products to the public. These Section 25(b) products are allowed to make pesticidal claims without EPA review and approval and can make certain claims that are not permitted for registered pesticides (e.g., “safe for use around children and pets,” “all natural”). Based on EPA’s determination, these products will not be subject to EPA review, thus reducing workload for which program resources may be used on other products that possibly pose greater risks.

At the same time, this current effort to issue regulation changes to communicate better information to the public does not address past commitments to clarify important safety information about possibly misleading or often misunderstood claims for products already exempted from registration requirements under Section 25(b). Specifically, in response to a 2006 petition (see Petition of the Consumer Specialty Products Association to Modify EPA’s Exemption from FIFRA Regulation for Minimum Risk Pesticides under 40 C.F.R. § 152.25(f) (Mar. 15, 2006)) about health and safety claims for Section 25(b) products making implied public health label claims, EPA agreed to issue regulations to make requirements for insect repellents more clear for Section 25(b) products and to ensure that insect repellent products are safe and effective.

Regarding insect repellents, the 2006 petition argued that the average consumer would not distinguish between labeling claims to “repel mosquitoes,” which are allowed for minimum risk pesticides, and labels that make public health claims by linking a mosquito with a specific disease (e.g., “repel mosquitoes which may cause West Nile Virus”), which are not allowed for minimum risk pesticides.

In response to the 2006 petition, EPA pledged to ensure that insect repellents actually repelled insects. To date, little progress has been made, and no change to the Section 25(b) situation regarding repellents has been proposed or made final. The commitment to clarify and ensure effectiveness of insect repellents has not been addressed and does not appear to be on any announced regulatory agenda for the pesticide program.

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By Lisa R. Burchi and Barbara A. Christianson

On November 3, 2022, the California Department of Pesticide Regulation (DPR) announced it reached a settlement agreement with Amazon.com Services, LLC (Amazon) regarding the illegal sale of pesticides in California. According to DPR, its review of Amazon uncovered multiple violations. Among them, it sold unregistered pesticides in California, failed to report and pay required mill assessment fees associated with the sale of registered pesticides in California, and failed to hold a valid pesticide broker’s license.

Under the terms of the agreement, Amazon will pay DPR a total of $4.97 million -- $3.69 million in unpaid pesticide sales assessment fees and related late penalties, and $1.28 million in civil penalties associated with retail sales of unregistered pesticides into California. DPR states that Amazon also agreed to register as a pesticide broker and report and pay the mill assessment fees associated with all future retail sales of registered pesticides into California.

Under California law, pesticides that are registered by EPA also must be registered by the state before they are used, possessed, or offered for sale in California. Based on DPR’s evaluation of a product’s potential human health and environmental risks and efficacy, DPR may impose state-specific requirements, including additional data requirements or label use restrictions.

California also has its own state requirements for mill assessments, which is a fee to be paid for sales of pesticides that are registered with DPR and sold into California. Specifically, a mill assessment is charged at the first point of sale of a pesticide in California. Generally, the registrant is responsible for reporting sales and paying the mill assessment when it has knowledge, at the time of sales, that the pesticide is being sold in California. If the registrant does not have knowledge at the time of sale, the party that is the first to sell the pesticide in California is responsible for reporting and paying the mill assessment. If a party other than the registrant is the first to sell a pesticide into or within California, this first seller party must obtain either a pesticide broker or a pest control dealer license (whichever is appropriate) from DPR.

Additional information on DPR’s programs is available here.

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By Dana S. Lateulere and Barbara A. Christianson

On October 19, 2022, the U.S. Environmental Protection Agency (EPA) announced that it activated its emerging viral pathogen (EVP) guidance in support of the Centers for Disease Control and Prevention’s (CDC) response to the Ebola virus cases in western Uganda. With EPA’s EVP guidance, additional disinfectants, for which EVP claims have been approved, can be used against the Ebola virus.

According to EPA’s press release, EPA developed its EVP guidance to aid in the availability of EPA-registered disinfectants for use against EVPs. EPA states that it divides viruses into three tiers based on how difficult they are to kill. The Ebola virus falls into Tier 1, the category of viruses that are easiest to kill. EPA expects disinfectants qualified for use against any EVPs in Tiers 1, 2, and 3 to be effective against the Ebola virus when used according to the label use directions.  To find these products, EPA recommends searching its list of disinfectants and filter for products for use on Tier 1 viruses.

EPA states the use of products with EVP claims supplements but does not replace other infection control practices. Individuals should follow CDC, state, and local public health guidelines.

According to EPA, EPA’s website “provides the list of products registered for use against Ebola, and list of disinfectants for emerging viral pathogens.”

Additional information on EVP guidance is available on our blog.

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October 26, 2022
12:00 p.m. - 1:00 p.m. (EDT)

The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to outbreaks to preventing them. FSMA consists of seven major rules, each meant to improve the safety and sustainability of the nation’s food supply, regardless of its country of origin, and identify clear, specific actions to achieve enhanced food safety.

This webinar will focus on FSMA and discuss the incremental progress the law has achieved in assuring food safety.  In addition, the webinar will include a look at the New Era of Smarter Food Safety, a 2020 initiative meant to enhance FSMA, and improve food safety outcomes by leveraging technology. Register now to join Thomas J. Dunn, Karin F. Baron, and Lynn L. Bergeson for the Bergeson & Campbell, P.C. (B&C^®) sponsored webinar, “Food Safety Issues in the United States.”
 
Topics Covered:

• Review of FSMA
• Discussion on food safety over the past decade
• New Era of Smarter Food Safety

Speakers Include:
 
Thomas J. Dunn, Managing Director, Flexpacknology llc, has been an active practitioner in the flexible packaging industry since 1979, with significant responsibilities as an associate with the Flexible Packaging Association and Printpack Inc. He supplemented his professional accomplishments with leadership roles in industry associations (FPA, RadTech NA) and professional societies (TAPPI, SPE, IFT). Dunn has authored peer-reviewed papers, served on U.S. Department of Agriculture (USDA) grant proposal review panels, and contributed content to major technical publications in the industry.
 
Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, has more than 20 years’ experience developing, implementing, and managing complex chemical regulatory compliance matters for some of the largest industrial and specialty chemical companies in the world. Her primary areas of practice include hazard and risk assessment and communication, industrial hygiene and environmental health and safety (EHS) programs, FDA regulations pertaining to food contact materials, and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), including compliant safety data sheets (SDS).
 
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

REGISTER NOW

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By Carla N. Hutton

On September 2, 2022, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published an advance notice of proposed rulemaking (ANPR) seeking input from stakeholders about how to update its organic regulations on inert ingredients in pesticides used in organic production. 87 Fed. Reg. 54173. AMS seeks comments on alternatives to its existing regulations that would align with the Organic Foods Production Act of 1990 (OFPA) and the U.S. Environmental Protection Agency’s (EPA) regulatory framework for inert ingredients. According to the ANPR, information from public comments would inform AMS’s approach to this topic, including any proposed revisions of the USDA organic regulations. On October 11, 2022, AMS extended the comment period to December 31, 2022. 87 Fed. Reg. 61268.

According to AMS, the ANPR seeks input from stakeholders about how to rectify the USDA organic regulations’ references to outdated EPA policy on inert ingredients used in pesticide products. AMS states that the outdated references are inconsistent with current EPA requirements and that this causes problems in the organic industry and for AMS’s administration of the USDA organic regulations.

AMS notes that inert ingredients, also identified as “other ingredients” on pesticide labels, are substances other than the “active” (i.e., pesticidal) ingredients included in formulated pesticide products. Inert ingredients may function as adjuvants, solvents, diluents, stabilizers, or preservatives. AMS states that pesticide labels do not typically disclose the identity (common or chemical name) of the inert ingredients in the product.

For organic crop and livestock production, current USDA organic regulations allow EPA List 3 and List 4 inert ingredients to be used in pesticide products when the product includes active ingredients permitted by the organic regulations. According to AMS, together, EPA List 3 and List 4 include more than 2,700 inert ingredients. AMS states that it does not know how many of these inert ingredients are included in products used in organic production, “but it is likely a relatively small subset of these 2,700 ingredients.” Because the Food Quality Protection Act of 1996 (FQPA) mandated that EPA develop tolerances (or tolerance exemptions) for inert ingredients used in food-contact products, new and existing inert ingredients are approved for use through EPA’s rulemaking process. As a result, EPA no longer updates the EPA lists referenced in the USDA organic regulations.

Commentary

AMS’s National Organic Program (NOP) seeks comments that will assist in assessing the feasibility of alternatives that could replace the references to the outdated EPA lists. Information submitted in response to the ANPR will inform AMS’s approach to this topic, including any proposed revisions of the USDA organic regulations. AMS seeks comments to identify alternatives, as well as to receive information about obstacles and the costs and benefits of options. According to AMS, stakeholders that may be affected by future actions on this topic include pesticide manufacturers, certified organic operations, consumers, certifying agents, and other interested parties.

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By James V. Aidala and Dennis R. Deziel

The U.S. Environmental Protection Agency (EPA) announced on August 18, 2022, it released its draft ecological risk assessment for dicamba for a 60-day public review. 87 Fed. Reg. 50854. The 287-page assessment examines the potential ecological risks associated with currently registered uses of dicamba on non-target, non-listed species. Risks to federally listed threatened and endangered species are not evaluated in the assessment. EPA is reevaluating the risks of dicamba as part of a routine review process for pesticides that occurs every 15 years. Comments are due October 17, 2022. EPA expects to propose an interim decision regarding the reregistration of dicamba in 2023.

Dicamba is a systemic benzoic acid used primarily to control annual, biennial, and perennial broadleaf weeds. First registered in the United States in 1967, it is currently registered for use on a wide variety of agricultural crops, such as soybeans, cotton, corn, grains, and sorghum, as well as for non-agricultural uses, such as rangeland, fallow fields, turf, and residential premises.

The draft assessment focuses on areas where there have been updates since the most recent national-level risk assessments of dicamba by EPA (2005 and 2020) to examine if the risk picture has changed based on new data and analysis. The 2005 risk assessment was for dicamba’s Registration Eligibility Decision (RED) based on use patterns registered at that time, which were applications to non-dicamba-tolerant plants. The 2020 risk assessment was exclusively to evaluate risk associated with relatively new uses of applications to dicamba-tolerant plants (i.e., soybeans and cotton).

In general, the risk conclusions of the draft assessment are consistent with those identified in past national-level risk assessments for dicamba with a few notable exceptions:

• Lower Risks to Birds. The risk assessment incorporates recently submitted toxicity data (chronic toxicity to birds), information that eases previously identified chronic risk concern for birds in dicamba-tolerant plants.
• New Risks to Bees. Recently submitted toxicity data indicate a previously unidentified potential chronic risk concern for honeybees from all uses on non-dicamba-tolerant plants. EPA used application rates higher than those EPA evaluated in its 2020 assessment, and potential chronic risks to bees are based on weight-of-evidence and maximum single application rates. The uses with the greatest potential chronic bee risks are asparagus, soybean, dicamba-tolerant cotton, and any registered uses on unmaintained non-agricultural areas.
• Risks to Fish. Updated exposure estimates accounting for the combined residues of dicamba indicate a previously unidentified potential chronic risk concern for non-listed fish. Updated exposure estimates accounting for the combined residues of dicamba (dichlorosalicylic acid (DCSA) and 6-CSA, degradates of dicamba) indicate a previously unidentified potential chronic risk concern for non-listed fish from one use scenario.

Also of significance, there are thousands of reported incidents allegedly caused by dicamba exposure occurring at or near a wide variety of agricultural and non-agricultural use sites and affecting a wide variety of plant species. According to EPA, a pronounced increase in the overall number of reported dicamba incidents associated with damage to non-target plants started around 2016 and appears to link to the introduction of dicamba-tolerant plants and “over-the-top” (OTT) applications to those crops. The combined evidence from field studies and incident data indicates that there may be off-site movement of dicamba via runoff, spray drift, and volatility from the use of dicamba, particularly for OTT application on dicamba-tolerant plants.

Damage to plant species near areas of application presents two separate issues of concern that will have to be addressed in EPA’s eventual decisions:

1. Does routine OTT use of dicamba cause unacceptable damage to nearby commercial crops? and
2. Does any tendency to injure nearby plants represent a possible concern about possible impacts on threatened and endangered species when EPA eventually includes Endangered Species Act (ESA) assessments as part of its review?

In 2020, EPA concluded that its 2020 label restrictions of dicamba-tolerant plants would significantly reduce incident reports about damage to nearby crops. Despite the new control measures, EPA received nearly 3,500 incident reports for the 2021 growing season of damage to non-dicamba-tolerant soybean, numerous other crops, and a wide variety of non-target plants in non-crop areas, including residences, parks, and wildlife refuges. EPA continues to monitor and evaluate new incident report submissions, and the analysis will be updated as new information becomes available. Dicamba also continues to be an important issue of discussion at State FIFRA [Federal Insecticide, Fungicide, and Rodenticide Act] Issues Research and Evaluation Group (SFIREG) meetings where data, analysis, and recommendations for dicamba continue to be discussed.

Commentary

This is the first time dicamba has been identified to pose risks to bees and fish. Worth noting, the identified chronic risks to honeybees, which could indicate that dicamba affects the larvae stage as well as the adult stage of bees, in a time of increased attention to bee health, throws dicamba into another arena of controversy previously unidentified and could garner significant attention in the environmental community, industry, and EPA.

Still, the most significant risk continues to be to possible impacts on non-target terrestrial plants from spray drift and volatilization. Almost 3,500 incident reports for a single growing season are hard to ignore. EPA has received numerous complaints about dicamba damaging non-target plants since EPA allowed the herbicide OTT application on genetically modified soybeans and cotton in 2016. Spraying dicamba over the top of crops after they have emerged is typically done later in the growing season, when temperatures are hotter and other crops/plants are maturing in nearby areas. In warmer temperatures, the herbicide is more likely to volatilize from target application areas and drift, also because of the warmer temperatures. Environmental groups sued EPA to halt the approval, and a federal appeals court ordered EPA in June 2020 to cancel all registrations for use on dicamba-tolerant crops.

In October 2020, EPA issued new registrations with new controls intended to reduce and prevent dicamba movement from volatilizing and drifting onto neighboring properties. Based on the most recent incident reporting, however, the measures did not stop the complaints about harm to nearby crops, plants, and trees.

This draft ecological risk assessment puts dicamba under scrutiny once again and may signal important registration challenges for the herbicide in 2023.

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By Lynn L. Bergeson and Carla N. Hutton

On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340:

• “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics such as what microorganisms are regulated, permit requirements, permit exemptions, and how to contact APHIS and what information to provide; and
• Updated Confirmation Request Guidance: The updated guidance provides clarification on preparing and submitting requests to APHIS to confirm a modified plant qualifies for an exemption and is not subject to the regulations in 7 C.F.R. Part 340, including information on how APHIS treats off-target modifications when considering confirmation requests.

These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS at .(JavaScript must be enabled to view this email address). For questions regarding confirmation requests, contact APHIS at .(JavaScript must be enabled to view this email address).

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By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi

On July 12, 2022, the U.S. Court of Appeals for the Eleventh Circuit (Court) issued an opinion in Carson v. Monsanto that reverses a ruling by the U.S. District Court for the Southern District of Georgia (District Court) that the Plaintiff’s failure to warn claim under Georgia law was preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Plaintiff alleged that Monsanto’s label for its product Roundup^®, which contains the active ingredient glyphosate, did not have adequate warning of the “harmful nature of glyphosate under Georgia law.” The District Court ruled that FIFRA preempts Georgia law and Plaintiff’s failure to warn claim because the U.S. Environmental Protection Agency (EPA) classified glyphosate as not likely to be carcinogenic to humans and approved the Roundup label. Plaintiff appealed.

The Court found that the District Court erred in concluding that the Plaintiff’s failure to warn claim was preempted under FIFRA. In its Opinion, the Court stated that a common-law cause of action, such as the failure to warn claim under Georgia law, would be preempted “if two conditions are met: 1) the state requirement must be for ‘labeling or packaging’ under the language of the statute; and 2) the state requirement is ‘in addition to or different from’ requirements derived from FIFRA.” The Court found that EPA’s registration process “is not sufficiently formal to carry with it the force of law” and instead “at most creates a rebuttable presumption of compliance with FIFRA’s registration process and nothing more.” In addition, with regard to FIFRA’s labeling provisions, the Court found that the Georgia law failure to warn claim is not in addition to or different from FFIRA requirements. Instead, the Court states that the Georgia failure to warn claim “simply enforces the FIFRA cause of action, so it is not expressly preempted.”

The Court also responded to Monsanto’s argument providing several EPA documents indicating that it could not label Roundup as carcinogenic. These included various registration reviews and reregistration eligibility decisions regarding glyphosate products, an EPA paper written about the EPA Scientific Advisory Panel’s independent review of the effects of glyphosate, and “[v]arious papers involving scientific analysis where the EPA concluded that glyphosate did not cause cancer.” Monsanto additionally provided evidence regarding the August 2019 letter from EPA to glyphosate registrants that it would not permit label amendments to include warnings under California’s Proposition 65 that glyphosate is known to the State of California to cause cancer. In that letter, EPA stated that it would consider such language to be “false or misleading,” and thus would not approve of such language on any label and further that registrants were to remove such statements from any approved labels.

The Court found, however, that none of these documents had the “indicia of formality” necessary to meet their standard of review. The Court noted that none of the documents identified were the product of notice and comment rulemaking or formal adjudication, and they did not “‘bespeak the legislative type of activity that would naturally bind’ Monsanto.”  The Court thus remanded this case back to the District Court for further proceedings on the failure to warn claim.

This case potentially places glyphosate registrants in the position of defending themselves for not warning about the potential carcinogenicity of glyphosate despite past EPA statements that any such warning would be considered a violation of FIFRA. Registrants should pay attention to the potential implications of this case, and others like it, particularly with regard to label claims that EPA has approved. More information on other glyphosate issues is available on our blog.

Commentary

Regardless of the outcome of this decision, the long and tortured history of the FIFRA preemption issue was expected to, and certainly will, continue. For many years, the debate over the implications of the FIFRA requirement that the EPA label cannot have conflicting (“different from”) language that would be needed, as the argument goes, to comply with state requirements to provide adequately warnings. To a casual observer, the FIFRA label and EPA review should take care of imposing the necessary conditions to avoid harms since it is axiomatic that “the label is the law,” and, if label directions are followed, EPA expects there would be no “unreasonable adverse effects” caused by the pesticide application. But the case law has evolved over the years not only about the confines of FIFRA but also regarding other “failure to warn” cases involving label instructions and warnings approved by other federal agencies (e.g., the U.S. Food and Drug Administration). The result has been a continued series of cases where the courts, state and federal, have to determine where federal requirements end and freedom for state requirements are allowed. 

In this case, the outcome was a disappointment to the registrant community but is unlikely to stop the flow of litigation on both sides of the preemption arguments. And the recent announcement in April 2022 by the Biden Administration EPA to reverse effectively the 2019 letter to California about FIFRA labels and California’s Proposition 65 requirements (Letter from California’s Office of Environmental Health Hazard Assessment on California Proposition 65 |to EPA) might further muddy the water of what a FIFRA label really does imply regarding state warnings, “right-to-know” requirements, and the like.

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