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.
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.
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.
Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another. Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
In September 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) plans to convene a Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting to discuss New Approach Methodologies (NAM) for organophosphate (OP) pesticides. EPA states that these NAMs could reduce reliance on default uncertainty factors for human health risk assessment and also reduce animal testing.
Under Administrator Wheeler’s directive to prioritize efforts to reduce animal testing, EPA is developing NAMs based on in vitro techniques and computational approaches that will also provide the opportunity to incorporate information relevant to humans. OPP states that it is evaluating use of “in vitro data for 16 organophosphate compounds to reduce potentially reliance on default risk assessment uncertainty factors in favor of more refined data-derived factors.” Human health risk assessment for OP pesticides has recently been focused primarily on potential developmental neurotoxicity, and the Office of Research and Development (ORD) has been working to develop a NAM to evaluate developmental neurotoxicity. Initial analyses of data derived from neuron cell models have been completed for specific OP pesticides as a case study and, when possible, compared to in vivo results (an in vitro to in vivo extrapolation).
This case study of a NAM for developmental neurotoxicity using OP pesticides will be presented to the FIFRA SAP at the September meeting for its consideration and advice. EPA will request external review and public comment on this research before implementing NAMs in human health risk assessments. Additional details, including dates, times and agenda, will be forthcoming at www.epa.gov/sap.
EPA has for some time had a general policy that it will try to develop and to implement alternatives to in vivo animal testing. These alternatives to animal testing are typically based on new in vitro assays and modeling methodologies. It is interesting that OPP has selected an in vitro NAM to assess developmental neurotoxicity of OP pesticides as a case study, given the controversy surrounding EPA’s use of the default Food Quality Protection Act (FQPA) uncertainty factor for all OP pesticides, which was based primarily on epidemiology data that EPA claimed may suggest a link between chlorpyrifos exposure and developmental neurotoxicity. Prior to this determination, human health risk assessment for OP pesticides was generally based on expert judgments by EPA that neurotoxicity would not be expected below the established threshold for acetylcholinesterase (AChE) inhibition, and that infants and children are not likely to be more sensitive to neurotoxic effects than adults. OPP adopted the FQPA determination for all OP pesticides even though it could not determine or propose a mechanism for the presumed developmental neurotoxicity of chlorpyrifos below the threshold for AChE inhibition, or evaluate whether other OP pesticides might share a similar mechanism. Since the 2015 release of the Literature Review, additional epidemiology studies have become available and a number of concerns regarding the reliability of the epidemiology data have been raised. EPA has also expressed concerns with the availability and reliability of the epidemiology studies. These developments bring into question the accuracy and reliability of the Literature Review.
In its announcement, OPP states that the new NAM is intended “to reduce potentially reliance on default risk assessment uncertainty factors,” although it does not state which uncertainty factors may be supplanted or modified. Standard uncertainty factors which may be implicated include the factor for extrapolating from animal data to human effects (“interspecies variation”), the factor for human variability (“intraspecies variation”), and the default uncertainty factor for potential increased sensitivity of infants and children (“FQPA uncertainty factor”). The issues may spark additional controversy. Additionally, even if OPP and the FIFRA SAP conclude that the proposed NAM for developmental neurotoxicity is a viable approach to human health risk assessment for OP pesticides, there are likely to be many related policy issues. For example, it is unclear whether OPP would be sufficiently confident in the reliability of such an assay to propose cancellation or suspension of affected pesticide products based on a resultant human health risk assessment.
By Lynn L. Bergeson and Carla N. Hutton
As reported in our February 13, 2020 blog item, the U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear. The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration. According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles. According to a February 27, 2020, memorandum placed in Docket ID EPA-HQ-OPP-2020-0043, EPA received a request to extend the comment period 30 days to allow additional time to review the documentation contained in the docket. The memorandum states that EPA “feels that 15 additional days should be sufficient to allow for adequate review of the Proposed Decision and supporting documentation.” Comments are now due March 30, 2020.
By Lisa M. Campbell and Lisa R. Burchi
On March 2, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on EPA’s procedures for conducting on-site civil inspections. This final rule applies to on-site inspections conducted by EPA civil inspectors, federal contractors, and Senior Environmental Employment employees conducting inspections on behalf of EPA.
This rule is effective March 2, 2020.
This rule explains how EPA inspectors should conduct on-site civil administrative inspections and addresses common elements applicable to on-site civil inspections for compliance with environmental laws.
The elements of the process for conducting on-site civil inspections, and some EPA guidance regarding each element, is as follows.
- Timing of Inspections and Facility Notification -- EPA inspectors should generally conduct inspections during the facility's normal work hours and take reasonable steps to work with the facility to agree on a workable schedule for accessing areas for the inspection.
- Inspector Qualifications -- EPA inspectors must hold a valid credential to perform the inspection, which are issued to inspectors that have completed relevant training.
- Obtaining Consent to Enter -- Upon arrival at a facility, EPA inspectors shall present their valid EPA Inspector Credentials to a facility employee, describe the authority and purpose of the inspection, and where possible seek the facilities' consent to enter. Inspectors are required under certain statutes to advise facility personnel that they can deny entry, but EPA may then seek a warrant for entry.
- Opening Conference -- The EPA inspector shall request an opening conference with available facility representatives or employees, where practicable. The EPA inspector shall discuss the overall objectives of the inspection and may request access to/copies of facility records and request to interview facility employees, as necessary.
- Physical Inspection -- EPA inspectors shall inspect the areas, units, sources and processes relevant to the scope of the inspection. The inspectors will generally document their observations with photos and notes.
- Managing Confidential Business Information (CBI) -- Pursuant to existing statutory and regulatory requirements, inspectors shall complete appropriate, statute-specific, CBI training before managing CBI. The EPA inspectors shall manage all CBI claims made by a facility during an inspection in accordance with 40 CFR part 2, subpart B.
- Interview Facility Personnel -- EPA inspectors may conduct interviews of facility personnel as appropriate. Interviews may include, but are not limited to, the environmental contacts, process operators, contractors, maintenance personnel, process engineers, control room operators, and other employees working in the area(s) of interest.
- Records Review -- Once the records requested by the EPA inspector are assembled, the EPA inspector shall review any records relevant to the facility inspection/field investigation. EPA inspectors may request copies of many different types of records (paper, electronically scanned, downloaded or recorded through other digital storage devices), when appropriate, and record copies of records taken from the facility. An EPA inspector may request records before, during, or after an inspection.
- Sampling -- EPA inspectors may take samples when appropriate. Where applicable and practicable, during the opening conference, the inspector shall offer facility personnel the opportunity to obtain split samples or to collect duplicate samples.
- Closing Conference -- EPA inspectors shall offer a closing conference with available facility employees, as practicable, to discuss any outstanding questions or missing documents and the process for follow up. EPA inspectors may also discuss next steps and how the facility will be contacted on the results of the inspection and identify the appropriate point of contact for further communication and coordination. EPA inspectors may also summarize any potential “areas of concern” identified in the inspection.
- Inspection Reports -- After an inspection, EPA shall share an inspection report with the facility. The content and format of the report may vary depending on the facility, type of the inspection, and the statutory authority upon which the inspection is based.
EPA states this rule was issued to fulfill the objectives outlined in Executive Order 13892 (Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication). In addition to this rule, companies can find more detailed information in EPA’s FIFRA Inspection Manual, most recently updated in August 2019, and available here.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear. The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration. According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles. EPA invites public comment on its proposal and preliminary findings. Comments are due March 13, 2020. More information is available in Docket ID EPA-HQ-OPP-2020-0043.
EPA notes that NSPW Nanosilver was the active ingredient in a previous conditional registration that it granted in 2015, for use as a materials preservative in textiles and plastics. As reported in our May 31, 2017, memorandum, that decision was challenged, and the U.S. Court of Appeals for the Ninth Circuit “vacated it on grounds that EPA’s public interest finding for granting the registration was without support in the record.” EPA states that the currently proposed product “is solely for use in specified textiles; therefore, Polyguard will have a more limited use authorization than the previously vacated conditional registration.” EPA notes that Polyguard will be formulated as a master batch, meaning that NSPW Nanosilver would be embedded within plastic beads or pellets, in contrast to the previous product registration, which was in the form of a liquid suspension.
By Kelly N. Garson and Carla N. Hutton
On January 27, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a notification for Project Number OA&E-FY20-0095, announcing that it will begin fieldwork to audit EPA’s adherence to pesticide registration risk assessment regulations, policies, and procedures. In a memorandum addressed to EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), OIG stated that its objective is to evaluate EPA’s ability to address human health and environmental risks prior to pesticide product registration. OIG will conduct the audit from EPA headquarters. According to the memorandum, the anticipated benefits of this audit include determining whether EPA has adequate controls to address human health and environmental risks prior to pesticide product registration.
OIG is an independent office created by the Inspector General Act of 1978, as amended. Though located within EPA, Congress funds OIG separately to ensure independence as it conducts activities such as audits and investigations to determine the efficiency and effectiveness of EPA’s operations and programs. Following the audit, OIG will prepare a report that may include recommendations for corrective actions OCSPP should take based upon OIG’s findings. More information on OIG’s previous reports and audit system is available on OIG’s website. Recent OIG reports regarding the implementation of FIFRA include:
By Timothy D. Backstrom
On February 3, 2020, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of an interim registration review decision for glyphosate. EPA previously issued a proposed interim registration review decision (PID) for glyphosate for comment in April 2019. At the time EPA issued the glyphosate PID for comment, EPA also issued a draft human health risk assessment and a preliminary ecological risk assessment for glyphosate. After reviewing the comments received concerning these assessments, EPA has not made any revisions to either assessment. EPA has determined that there are no dietary, residential, bystander, or occupational human health risks of concern associated with glyphosate use. EPA has also determined that there are some potential risks to plants, birds, mammals, and invertebrates from glyphosate use, but that these can be appropriately mitigated by label changes requiring enforceable spray drift management measures and adding a warning concerning the potential hazards to non-target organisms. EPA also has proposed some new measures to manage the development and spread of herbicide-resistant weeds. EPA has generally retained the proposed labeling changes identified in the PID, except for some modest adjustments to the proposed language concerning droplet size restrictions and swath displacement restrictions for aerial applications, and removal of spray drift advisory language for airblast application.
Despite considerable publicity recently concerning purported carcinogenic risks for glyphosate, including allegations that human exposure to glyphosate can be linked to non-Hodgkin's lymphoma, EPA has determined that glyphosate is not likely to be a human carcinogen and has steadfastly adhered to this basic conclusion. EPA made this determination for glyphosate after convening a meeting of the FIFRA Scientific Advisory Panel (SAP) to evaluate the carcinogenic potential of glyphosate in 2016.
The general purposes of the PID process are to allow EPA to move forward with aspects of the registration review process that are essentially complete, and to adopt interim risk mitigation measures, even though some of the actions required prior to a final registration review decision are not yet complete. As in the case of most recent PIDs, EPA states that it has not yet made a complete determination concerning potential effects or any required consultation for glyphosate under the Endangered Species Act (ESA), nor has it made a determination for glyphosate under the Endocrine Disruptor Screening Program (EDSP). In addition, EPA is considering a pending petition to prohibit preharvest use of glyphosate on oats, and to reduce the tolerance for glyphosate in oats, that was filed in 2018 by the Environmental Working Group and others. This petition is predicated on the potential carcinogenicity of glyphosate. Finally, EPA is still evaluating the question of whether additional data will be needed to evaluate properly the potential effects of glyphosate use on pollinators.
More information on glyphosate and EPA’s interim registration review decision is available here.
EPA's interim registration review decision for glyphosate is predicated on EPA's prior determination that the best available scientific data do not substantiate the claims that glyphosate may be a human carcinogen. As discussed above, the potential carcinogenicity of glyphosate was thoroughly evaluated by the FIFRA SAP in 2016. EPA's determination after that review that glyphosate is not a carcinogen has also been supported by other pesticide regulatory authorities. Nonetheless, EPA's view conflicts with a cancer classification decision for glyphosate by the World Health Organization (WHO), and with some recent tort case decisions that were based on the premise that there is a credible linkage between glyphosate exposure and human cancer. EPA recently announced that it would not permit or approve any cancer warning statements for inclusion in glyphosate labeling (including any statements that may be required pursuant to California's Prop 65) because EPA believes that such statements are false or misleading and would therefore cause the pesticides to be "misbranded."
It appears probable there will be continued litigation based on the purported carcinogenicity of glyphosate, along with various proposals to ban or restrict glyphosate use. The pending petition to restrict use of glyphosate on oats that was filed by EWG, et al., is expressly predicated on the potential carcinogenicity of glyphosate, so it appears probable that this petition will ultimately be denied by EPA. Nonetheless, unless WHO decides to reverse or modify its classification determination, or the courts determine that the recent tort awards for glyphosate users cannot be scientifically substantiated, the battles over the claimed carcinogenicity of glyphosate may persist for years.
More information on glyphosate issues is available on our blog under keyword glyphosate.
By Heather F. Collins, M.S.
The March 1, 2020, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2019 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7 (7 U.S.C. § 136e), “any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”
Reports must be submitted on or before March 1 annually for the prior year’s production. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed.
EPA has created the electronic reporting system to submit pesticide producing establishment reports using the Section Seven Tracking System (SSTS). Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports. Electronic reporting is efficient, it saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics.
Link to EPA Form 3540-16, as well as instructions on how to report, and how to add and use EPA’s SSTS electronic filing system are available below.
Further information is available on EPA’s website.