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.

• Email This
• Print
• Comments

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):

1. 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.
2. 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.

Commentary

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.

• Email This
• Print
• Comments

By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson

On November 2, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  85 Fed. Reg. 69307.

The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting that chitosan be added to the list of active ingredients eligible for EPA’s minimum risk exemption, followed by an April 4 2019, amended petition seeking also to add chitosan to the list of inert ingredients eligible for the minimum risk exemption.  EPA on August 20, 2020, issued a Federal Register notice stating that a draft regulatory document on this issue had been forwarded to the U.S. Department of Agriculture (USDA).  EPA states that no comments were submitted on that notice by USDA or any other person.  EPA also forwarded the draft to the FIFRA Scientific Advisory Panel for review, but according to EPA, the Panel “waived review of this proposed rule, concluding that the proposed rule does not contain scientific issues that warrant scientific review by the Panel.”  On October 8, 2020, EPA again announced it was considering adding chitosan to the list of active ingredients allowed for use in minimum risk pesticides and provided a pre-publication version of the proposed rule.

EPA states in the November 2, 2020, Federal Register notice regarding the proposed rule: “Based on all the information available to the Agency, there are low risk concerns for human health or the environment if chitosan is intended for use as a minimum risk pesticide.”  According to EPA, adding chitosan to this list may save stakeholders time and money through waived FIFRA registration requirements for certain products containing chitosan.  Specifically, EPA estimates the cost savings of avoiding the application process (e.g., guideline studies, registration fees) to be up to $116,000 initially and approximately $3,400 per year thereafter for each new product.

Comments on EPA’s proposal to add chitosan to its list of active ingredients for use on minimum risk pesticides are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2019-0701.   EPA states that it is currently deferring a decision regarding the amended petition to add chitosan to the list of inert ingredients permitted in minimum risk pesticides.

Additional information on chitosan is available on our blog.

• Email This
• Print
• Comments

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

On August 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking to add chitosan to the list of active ingredients allowed for in minimum risk pesticides exempted from pesticide registration requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  A minimum risk product must meet six specific conditions to be exempted 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 added to the list of minimum risk pesticide active ingredients, pesticide products containing chitosan could qualify as minimum risk pesticides provided the other conditions are also satisfied (e.g., using inert ingredients approved by EPA for use in minimum risk pesticides, not making any public health claims).

Chitosan is a naturally occurring polymer that is derived from the shells of crustaceans.  It is currently registered as a fungicide, antimicrobial agent, and plant growth regulator that boosts the ability of plants to defend against fungal infections.  For uses as a plant growth regulator, chitosan is applied to treat field crops, ornamentals, turf, home gardens, and nurseries.  Target pests include early and late blight, downy and powdery mildew, and gray mold.  As an antimicrobial agent, chitosan is used on textiles to protection the fabric from bacterial and fungal growth.  Chitosan is exempt from the requirement for a pesticide tolerance.

History -- The Caesar Salad Chemicals

The origin of the Section 25(b) list came from an effort by EPA to deregulate products which, while meeting the definition of being a pesticide (a product with the intended purpose of being sold or distributed to kill or repel a pest as defined under FIFRA), were common products of established safety.  More precisely, products with a lack of toxicity such that it was a “waste of resources” for EPA to subject such products to the bureaucratic requirements of FIFRA registration.

In particular, at an oversight Congressional hearing on the lack of progress being made at the time on EPA’s attempt to complete re-registration (now referred to as registration review), the EPA witness was asked about some most recently released re-registration assessments.  These referred to the four registered pesticides:  garlic, capsicum, acetic acid, and citric acid.  These are pesticides formulated into various products, and in the hearing were referred to by more common names: garlic, pepper, vinegar, and lemon juice.  This led to a famous oversight question to the EPA witness:  “Are you making progress or Caesar Salad?”

This led, in part, to the Office of Pesticide Programs (OPP) allowing very low risk pesticides to be exempt from registration.  It eventually issued the original Section 25(b) list to conserve review resources.  At the same time, since these products no longer had to be registered, it allowed label language such as “natural,” “non-toxic,” and “safe around children and pets,” which are disallowed registered product label claims.  Not surprisingly, label language allowing the word “safe” has proven to be a popular marketing claim for products that meet the exemption requirements.

At the same time, the fine print of the Section 25(b) exemption did not allow health and safety claims on such products even if they were made from Section 25(b) ingredients.  In particular, this led to concerns about insect repellents that could be made from Section 25(b) ingredients and were labeled as repelling mosquitoes or ticks or other public health pests; they could include the word “safe” as long they did not also mention any disease or other public health claims.  The average consumer, however, likely does not distinguish between insect repellents (or other products) that fit EPA’s definition of public health claims and those simply listing the target pest (e.g., mosquitoes, ticks, or rodents).  The average consumer is unlikely to realize the distinction between a product labeled as “XX insect repellent -- repels mosquitoes -- all natural and safe,” which may not have evidence of efficacy, and another product that says “YY insect repellent -- made from natural ingredients and repels mosquitoes, which may carry West Nile Virus” -- which is required to be registered and include proof of efficacy for any public health claims.

This possible consumer confusion was the subject of a FIFRA petition filed in 2006 by the Consumer Specialty Products Association (CSPA).  The petition suggests that EPA modify the Section 25(b) regulation to exclude products claiming to control public health pests from the Section 25(b) exemption -- which would then require registration, including data proving efficacy (Docket: EPA-HQ-OPP-2006-0687-0002).

EPA responded to the CSPA petition in 2007, essentially agreeing about the problem of possible consumer confusion.  In a letter to CSPA, EPA stated:

…. whether we decide to pursue rulemaking or some other avenue, we intend to move as expeditiously as possible to identify the most efficient approach to protect the public from unknowingly relying on products that target public health pests and have not been shown to work.

EPA later announced that it would embark on rulemaking to address this possible consumer confusion.  It is, however, unclear whether this is still a pending matter on EPA’s agenda.  No docket materials have been added in many years.  As part of its Semiannual Regulatory Agenda in fall 2011, EPA included an entry that stated a Section 25(b) proposed rule would be issued before February 2013.  It is not clear if EPA continues to have plans to issue such a proposal.

Commentary

EPA’s August 20 proposal is an interesting development, as EPA’s other revisions and proposals for minimum risk pesticides trend toward adding restrictions to the conditions to be satisfied, thus limiting exemptions.  The current proposal would expand the exemptions by adding another active ingredient to the otherwise limited approved list.  Since changes to the Section 25(b) list will require a rulemaking, it is unclear what happened to the earlier plan to issue a proposed rule addressing the long-ago CSPA petition response.

EPA states that it has forwarded to the Secretary of the United States Department of Agriculture (USDA) a draft regulatory document concerning “Pesticides; Addition of Chitosan to the List of Active Ingredients Allowed in Exempted Minimum Risk Pesticides Products.”  EPA will not make this draft regulatory document available to the public until after it has been signed.  When it is available, that document and additional information will be available in docket EPA-HQ-OPP-2019-0701.

• Email This
• Print
• Comments