By Barbara A. Christianson
On January 13, 2023, the U.S. Environmental Protection Agency (EPA) announced it is notifying pesticide registrants that EPA will send supplemental invoices to reflect the new annual pesticide registration maintenance fee for fiscal year (FY) 2023. To meet new statutory requirements in the Pesticide Registration Improvement Act of 2022 (PRIA 5), which was signed into law on December 29, 2022, the revised fee for FY 2023 for each registered pesticide product will be $4,875, increased from the $3,400 level specified in the EPA invoices provided in early December 2022.
According to EPA, PRIA 5 directs EPA to collect, to the extent practicable, an average amount of $42 million in pesticide registration maintenance fees annually for FYs 2023-2027. The previous collection target for FY 2023 under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) was $31 million. Additionally, EPA notes that maximum payment caps and small business caps are increased in PRIA 5 and will be reflected in the forthcoming reinvoicing.
By James V. Aidala and Dennis R. Deziel
On December 14, 2022, the U.S. Environmental Protection Agency (EPA) announced the removal of 12 chemicals from the current list of non-food inert ingredients approved for use in pesticide products because the inert ingredients have been identified as per- and polyfluoroalkyl substances (PFAS) and are no longer used in any registered pesticide product. 87 Fed. Reg. 76488. On September 13, 2022, EPA published a proposal to remove the 12 chemicals from the list of approved inert ingredients. In response to EPA’s request for comments, no specific information regarding those 12 chemical substances or any products that may include them was provided to EPA.
EPA is removing the following 12 chemicals from the current list of inert ingredients approved for use in pesticide products:
- 2-Chloro-1,1,1,2-tetrafluoroethane (Chemical Abstracts Service Registry Number® (CAS RN®) 2837-89-0);
- α-(Cyclohexylmethyl)-ω-hydropoly(difluoromethylene) (CAS RN 65530-85-0);
- Dichlorotetrafluoroethane (CAS N 1320-37-2);
- Ethane, 1,1,1,2,2-pentafluoro- (CAS RN 354-33-6);
- Hexafluoropropene, polymer with tetrafluoroethylene (CAS RN 25067-11-2);
- Montmorillonite-type clay treated with polytetrafluoroethylene (no CAS RN);
- Poly(difluoromethylene), α-chloro-ω-(1-chloro-1-fluoroethyl) (CAS RN 131324-06-6);
- Poly(difluoromethylene), α-chloro-ω-(2,2-dichloro-1,1,2-trifluoroethyl)- (CAS RN 79070-11-4);
- Poly(difluoromethylene), α-(2,2-dichloro-2-fluoroethyl)-, ω-hydro- (CAS RN 163440-89-9);
- Poly(difluoromethylene), α-fluoro-ω-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]- (CAS RN 65530-66-7);
- Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxy-, ether with α-fluoro-ω-(2-hydroxyethyl)poly(difluoromethylene) (1:1) (CAS RN 65545-80-4); and
- Propane, 1,1,1,2,3,3,3-heptafluoro- (CAS RN 431-89-0).
EPA states, in the PFAS Strategic Roadmap to address PFAS, it is removing these chemicals from the inert ingredient list to prevent the introduction of these PFAS into pesticide formulations without additional EPA review. This is in line with EPA’s strategic roadmap to address PFAS.
According to EPA, once an inert ingredient is removed from the list, any proposed future use of the inert ingredient would need to be supported by data, which may include studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, and genotoxicity, as well as data on environmental effects. The data must be provided to and reviewed by EPA as part of a new inert ingredient submission request.
The final notice and information on inert ingredients approved for use in pesticide products is available here.
Additional information on EPA’s action on PFAS in pesticide containers is available here.
EPA’s final removal of these ingredients from the current list of approved inert ingredients list is not surprising, although it raises important process questions that should be watched closely in future EPA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions. The removal action helps EPA meet its political commitment related to PFAS consistent with the PFAS Roadmap, and as EPA states itself, the 12 PFAS that are the subject of the notice are no longer used in any registered pesticide products. Predictably, public comments focused on general risks of PFAS and not directly on EPA’s action related to inert ingredients listing removal. It is a win for EPA related to its commitment to take action to limit PFAS.
The process EPA used to remove these 12 chemicals from the list of inert ingredients is noteworthy and potentially concerning. EPA presented no risk-based evidence for this regulatory action and instead relied on a class-based aggregation of a subset of approved inert ingredients. It will be important to continue to monitor this issue.
By Heather F. Collins, M.S.
The January 17, 2023, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental distributor registrations, which are identified by a three-element registration number.
The fee for 2023 is $3,400 for each registration up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Tuesday, January 17, 2023. Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov.
For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent, if the applicant meets the following criteria:
- The applicant has 500 or fewer employees globally;
- During the three-year period prior to the most recent maintenance fee billing cycle, the applicant has average annual gross revenue from all sources that does not exceed $10 million; and
- The applicant holds a total of five or fewer registrations subject to the maintenance fee.
There also are maintenance fee waivers for products that meet the criteria in two specific categories: minor agricultural use products and public health pesticides. The procedure for requesting a fee waiver for individual products is described in the instructions provided by EPA.
More information on the annual maintenance fees is available on EPA’s website.
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.
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.
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:
- Does routine OTT use of dicamba cause unacceptable damage to nearby commercial crops? and
- 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.
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.
By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On July 6, 2022, the U.S. Environmental Protection Agency (EPA) released a proposed consent decree intended to resolve the case, Center for Food Safety, et al. v. U.S. Environmental Protection Agency (3:21-cv-09640-JSC), brought against EPA in the United States District Court for the Northern District of California alleging that EPA has unreasonably delayed responding to a petition for rulemaking relating to the regulatory exemption of pesticide treated seed. 87 Fed. Reg. 40233.
In accordance with EPA’s March 18, 2022, memorandum entitled “Consent Decrees and Settlement Agreements to Resolve Environmental Claims Against the Agency,” EPA issued a Federal Register notice providing the proposed consent decree to resolve Center for Food Safety, et al. v. U.S. Environmental Protection Agency and providing a comment period. Comments on the proposed consent decree from persons who are not named as parties to the litigation in question are due on or before August 5, 2022. The public can submit comments at www.regulations.gov in Docket ID Number EPA-HQ-OGC-2022-0511.
This case was filed in connection with a petition (Petition) from the Center for Food Safety on or around April 26, 2017, requesting that EPA amend 40 C.F.R. Section 152.25(a) to exclude seeds for planting coated with systemic pesticides intended to kill pests of the plant, or, in the alternative, publish a formal agency interpretation in the Federal Register stating that 40 C.F.R. Section 152.25(a) does not apply to seeds for planting coated with systemic pesticides intended to kill pests of the plant, and enforce the numerous pesticide registration and labeling requirements for each separate crop seed product that is coated with a neonicotinoid or other systemic insecticidal chemical (2017 Petition Requests). EPA requested public comment on the 2017 Petition and received approximately 100 substantive comments. On December 14, 2021, Plaintiffs filed a Complaint alleging that EPA's failure to respond to the Petition constitutes an unreasonable delay under Section 706(1) of the Administrative Procedure Act (APA), 5 U.S.C. 706(1).
Under the proposed consent decree, EPA would, no later than September 30, 2022, either grant, deny, or grant in part and deny in part each of the Petition Requests. Court approval of this proposed consent decree would resolve all claims in this case except for the claim for the costs of litigation, including reasonable attorneys’ fees. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the APA or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Unless EPA or the Department of Justice determines that consent should be withdrawn, the terms of the proposed consent decree will be affirmed and entered with the court.
The treated article exemption under FIFRA, as EPA has applied it over the years, has been relevant mostly to uncontroversial products such as shower curtains (the pesticide applied to such a product is intended to preserve the shower curtain and not considered using a pesticide when one uses the shower curtain). Meanwhile, the practice of coating seeds with pesticides became more controversial in recent years about possible impacts on honeybees from fugitive dust from neonicotinoid-treated crop seeds. The concern is whether such non-target movement of pesticide residues (the dust) might be partly responsible for the apparent decline in honeybee populations. Critics view EPA’s policy about treated articles as not incorporating a sufficiently robust assessment of the impacts of this pesticide use pattern -- that is, the dust from the treated seeds and the systemic nature of neonicotinoid products used this way have impacts that EPA “ignores” due to the treated article exemption.
Interestingly, any residues remaining in the food produced using such products still must meet the Food Quality Protection Act (FQPA) safety standard of “reasonable certainty of no harm” from consuming the food -- but critics view the neonicotinoid products as causing unreasonable environmental impacts -- even if the finished food product is safe. In this view, critics of the current treated article exemption definition argue that the environmental impacts of neonicotinoid pesticides are left insufficiently regulated. One problem EPA faces, however, is that the treated article exemption applies to a much larger universe of pesticide applications than seed treatments, so changes to better evaluate the environmental impact of neonicotinoids could impact other products currently not viewed as controversial. This partly explains why EPA has delayed its response to the Petition as it considers how to respond. Changes to the current policy could result in many more products or applications needing EPA review, which would expand the pesticide registration universe at a time when EPA struggles to meet evaluation deadlines for currently registered products. EPA now will have to decide how to move forward on this issue, which will likely have more complex implications for products beyond neonicotinoid pesticides.
By Lisa R. Burchi and Barbara A. Christianson
On July 1, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2019 (2019 Report). 87 Fed. Reg. 39517. Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area. The 2019 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration. The 2019 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA. The report is available at EPA-HQ-OPP-2014-0125. Comments can be submitted on or before August 30, 2022.
EPA’s completed product reregistration actions totaled 161, short of EPA’s goal of 400 actions. The table below details the actions completed in FY 2019.
Table 1. Product Reregistration Actions Completed in FY 2019
(as of January 22, 2022)
|Product reregistration actions
|Product amendment actions
|Product cancellation actions
|Product suspension actions
EPA also states that 4,081 products had product reregistration decisions pending at the end of FY 2019, compared to 4,193 products with product reregistration decisions pending at the end of FY 2018, and 4,370 products with product reregistration decisions pending at the end of FY 2017. Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”
The number of applications for registration requiring expedited processing (i.e., “fast-track” applications) that EPA considered and approved has dropped slightly in 2019, with 2,574, 2,303, and 1,739 in 2017, 2018, and 2019, respectively.
By Lisa R. Burchi and Heather F. Collins, M.S.
On May 25, 2022, the California Department of Pesticide Regulation (DPR) announced that it will hold three public workshops to collect feedback on the next phase of design and development for DPR’s pesticide application notification system.
DPR states that the workshops will be hosted online via Zoom and facilitated by the UC Davis Center for Regional Change. Each workshop will follow the same format, including a brief overview of the proposed design for the statewide notification system and an opportunity for the public to provide input.
DPR began developing the statewide notification system in mid-2021, after the state budget allocated $10 million to DPR for system development. DPR designed the proposed system based in part on feedback from stakeholders during public focus groups and webinars. DPR states it will use the information collected during the forthcoming workshops for the next design phase of the statewide notification system.
DPR states on its website that “the tool will advance environmental justice and further protect public health by providing transparent and equitable access to information in advance of pesticide applications occurring near where people live, work or play.” DPR states further “That information will provide the public with the opportunity to make their own decisions about any additional precautions they may want to take to protect their health.”
The dates and times of the workshops are:
DPR states that registration is not required to attend. The workshops will be hosted online via Zoom. The Zoom link for each workshop is provided above on each date and time. Spanish interpretation will be provided at all workshops. A copy of materials presented during the workshops will be made available on DPR’s website following the workshops.
DPR states in its FAQs that it anticipates implementation for the system to occur in 2024. DPR states for more information and updates on statewide notification, please visit its website.
Registrants should monitor developments closely.
By Carla N. Hutton
As reported in our November 2, 2020, blog item, on October 30, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on the Agricultural Worker Protection Standard (WPS) regulation that revises the requirements on the pesticide application exclusion zone (AEZ), defined as an “area surrounding the point(s) of pesticide discharge from the application equipment that must generally be free of all persons during pesticide applications.” The final AEZ requirements were scheduled to go into effect on December 29, 2020, but on December 28, 2020, the U.S. District Court for the Southern District of New York issued an order in the case of State of New York et al. v. EPA that resulted in a stay of the requirements. Subsequent orders have extended this stay of the effectiveness.
EPA published a May 16, 2022, Federal Register notice stating that as of February 15, 2022, the effectiveness of the WPS final rule is stayed by court order until August 22, 2022. 87 Fed. Reg. 29673. According to the notice, EPA intends to publish another document in the Federal Register to address the status of the 2020 final rule if the stay of effectiveness expires or is lifted, but EPA “does not intend to publish additional Federal Register documents to announce any additional court orders entered to further stay the effectiveness of the 2020 final rule.”
By Lisa M. Campbell, James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On May 6, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and requesting comments on, data related to aquatic toxicity of chitosan salts. 87 Fed. Reg. 27059. Specifically, EPA is seeking comments on the following two aquatic toxicity reports submitted by Tidal Vision Products, LLC (Tidal Vision), the company that submitted a petition to EPA on October 10, 2018, requesting that EPA add chitosan to the list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b):
- Tidal Vision USA. (2019). Aquatic Toxicology Report by Eurofins Environmental Testing Test America. Lab I.D. No. B4345. Report Date: June 17, 2019. EPA Master Record Identification (MRID) 51861901.
- Tidal Vision USA. (2019). Aquatic Toxicology Report by Eurofins Environmental Testing Test America. Lab I.D. No. B4421. Report Date: August 28, 2019. EPA Master Record Identification (MRID) 51861902.
EPA is seeking input on how these reports may be used by EPA in its assessment of aquatic toxicity of chitosan and its salts. EPA states “chitosan may form as a salt (e.g., acetate, lactate, hydrochloride, and salicylate) when it is solubilized in acids for end use product formulation and subsequently applied in the environment” and the new information submitted by Tidal Vision pertains to these salts. Comments on the aquatic toxicity reports are due on or before June 6, 2022, in Docket EPA-HQ-OPP-2019-0701.
As background, EPA on August 20, 2020, announced that it was seeking to add chitosan to the list of active ingredients allowed in minimum risk pesticides that are exempt from pesticide registration requirements and was providing to the United States Department of Agriculture (USDA) for review a draft regulatory document titled ‘‘Pesticides; Addition of Chitosan to the List of Active Ingredients Allowed in Exempted Minimum Risk Pesticides Products.” A minimum risk product must meet six specific conditions to be exempt from pesticide registration. One of those conditions is that the active ingredient in the minimum risk pesticide be one that is listed specifically by EPA. If EPA adds chitosan to the list of minimum risk pesticide active ingredients, pesticide products containing chitosan could qualify as minimum risk pesticides provided the other conditions also are satisfied (e.g., using inert ingredients approved by EPA for use in minimum risk pesticides, not making any public health claims).
On November 2, 2020, EPA requested comments on the proposed rule to add chitosan to the list of active ingredients eligible for the exemption. In the May 6, 2022, Notice, EPA states that comments received on the proposed rule expressed concerns regarding derivatives of chitosan that are likely to be produced when chitosan is mixed with certain acids and on the potential hazard for aquatic organisms exposed to chitosan salts. Because of the concerns raised, EPA now is requesting comments on the two aquatic toxicity reports that pertain to these salts.
EPA continues to remain focused on listing this specific substance rather than address other issues related to minimum risk pesticides that have been raised by industry to EPA over many years. There is, for example, a petition filed in 2006 by the Consumer Specialty Products Association (CSPA) requesting that EPA modify the minimum risk pesticide regulations to exclude products claiming to control public health pests from the Section 25(b) exemption. Comments submitted in response to the November 2, 2020, proposed rule raise additional concerns, including but not limited to the fact that the vast majority of states now require registration of minimum risk pesticides, thus shifting the burden away from EPA with costly and potential inconsistent results.
Though this EPA list is called “minimum risk,” it more accurately could be described as -- “so safe no one could, or at least should, have any concern about toxicity.” There is long-standing reluctance for EPA to call any pesticide whatsoever as “safe” for various reasons, even to the point of an outright prohibition on using the word “safe” on registered labels. (This is the clever distinction that “minimum risk” pesticides do meet the FIFRA definition of a pesticide, but the Section 25(b) designation allows that the label not be subject to EPA review and registration of the label.)
This issue of possible risks from adding chitosan to the Section 25(b) list in light of the studies EPA seeks comment on appears to allow EPA to back away from its intended designation as minimum risk or to have the public comment reaffirm EPA’s assessment that chitosan’s safety profile is sufficiently beyond reproach to align with the other members of this category. There are many other pesticides considered of very low risk but not so low as to have made the Section 25(b) list until now. That there is a hint of debate about possible toxicity could signal that future additions to the list are being contemplated to encourage more “minimum risk” product development. Or more simply, it may signal EPA’s reaction to the comments received has triggered some reconsideration of how “minimum” any minimum risk needs to be to qualify for the Section 25(b) list.