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, Lisa R. Burchi and Barbara A. Christianson
On April 3, 2020, the California Department of Pesticide Regulation (DPR) announced it would allow enforcement discretion by County Agricultural Commissioners (CAC) for licensing and certification requirements for pesticide applicators who perform sanitization services to control the spread of COVID-19.
DPR states in its announcement that, under normal circumstances, a “Pest Control Business (PCB) must always have a Qualified Applicator License (QAL) holder to supervise pest control services. Generally, where a PCB performs sanitization services, the QAL must also be certified in Category A, P, or K” described as follows:
- Category A allows PCBs to perform sanitization or disinfection in residential, industrial, or institutional (RII) use settings such as hospitals, schools, or prisons;
- Category P allows PCBs to perform microbial pest control in RII use settings; and
- Category K allows PCBs to perform health related pest control services under a government-sponsored program.
DPR acknowledges that due to Governor Newsom’s March 4, 2020, “Stay at Home” Executive Order, DPR cannot proctor in-person licensing examinations to certify licensees. DPR thus announced that it will use enforcement discretion by allowing “licensed and registered PCBs to perform sanitization services for the control of COVID-19 if they have a designated individual at each business location with a valid QAL in any category” (emphasis added by DPR). DPR specifies that enforcement discretion applies when all of the following conditions are met:
- The professional sanitization service is performed for COVID-19 control and only during the next 90 days.
- The PCB without the specific QAL license category notifies the CAC in writing with an explanation for why the sanitization work is necessary.
- Examples of necessary work may include situations in which the PCB is the only licensee registered to do business in the county or where other properly licensed PCBs are unavailable to perform COVID-19-related work.
- The QAL holder ensures that all applicators applying antimicrobials are properly trained and are in strict compliance with label directions and all other applicable laws and regulations.
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 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.
By Lisa R. Burchi and Kelly N. Garson
EPA recently released the Consent Agreement and Final Order (CAFO) for the October 31, 2019, settlement discussed in our blog post “EPA Settles Two Cases Regarding Unregistered and Misbranded Pesticides.” This October 31, 2019, settlement between U.S. Environmental Protection Agency (EPA) Region 3 and AFCO C&S, LLC (AFCO), a chemical company located in Chambersburg, Pennsylvania, to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Pursuant to the CAFO, AFCO agreed to pay a $1,489,000 penalty to settle the alleged violations that involved the use of 12 products to clean and sanitize food and beverage processing facilities.
The CAFO provides more information on the violations Region 3 alleged. The CAFO allegations state that AFCO sold and distributed 10unregistered pesticide products on at least 1,031 separate occasions in violation of FIFRA Section 12(a)(1)(A). The CAFO also alleges that AFCO sold and distributed a product that made claims beyond those permitted by its FIFRA registration on at least five separate occasions. It additionally alleges that AFCO sold or distributed a misbranded pesticide on 41 separate occasions.
EPA initially collected the information during an inspection of AFCO’s establishment in Chambersburg, Pennsylvania on June 20, 2016. The settlement also addresses violations of a Stop Sale, Use or Removal Order (SSURO) that EPA issued to AFCO on July 13, 2018, requiring AFCO to immediately cease all sales and distributions of the 12 products. The CAFO alleges that AFCO engaged in sales and distributions that violated this order, having sold or distributed the products from at least January 1, 2015, through either August 8 or August 9, 2019. AFCO has since discontinued sales of all of the involved products, except for one registered product, for which EPA issued an Order Modification letter on March 4, 2019, allowing AFCO to recommence sales.
AFCO will pay the civil penalty within one year in 12 equal monthly installments, plus interest payment of $7,954.96, totaling $1,496,954.96.
By Heather F. Collins, M.S.
The January 15, 2020, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is fast approaching. The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires that 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 registrations of distributors which are identified by a three-element registration number.
The fee for 2020 is $4,000 for each registration up to the maximum fees which can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and mail the response to EPA by Wednesday, January 15, 2020. Registrations for which the fee is not paid will be canceled, by order and without a hearing.
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 3-year period prior to the most recent maintenance fee billing cycle the applicant has average annual gross revenue from all sources that do not exceed $10,000,000; and
- The applicant holds a total of 5 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 M. Campbell, Timothy D. Backstrom, and James V. Aidala
On November 21, 2019, the U.S. Department of Justice announced a settlement with Monsanto Company (Monsanto) in which Monsanto agreed to plead guilty to a misdemeanor count of illegally using the pesticide Penncap-M, a methyl parathion product that was cancelled by the U.S. Environmental Protection Agency (EPA) on July 27, 2010. This settlement of several criminal counts by Monsanto followed an investigation by the EPA Criminal Investigation Division. Under the existing stocks provision in the EPA cancellation order, continued use of Penncap-M became unlawful after December 31, 2013. In the settlement documents, Monsanto admits that its employees knowingly violated this order by using Penncap-M on July 15, 2014, to treat corn seed research crops at Monsanto’s Valley Farm research facility in Maui, Hawaii. Monsanto also admits that Monsanto employees directed other employees to re-enter the treated site seven days after the July 15, 2014, application, although the re-entry period established for this pesticide prior to its cancellation was 31 days. Monsanto further admits that it stored stocks of Penncap-M after December 31, 2013, when unused stocks of this product became an acute hazardous waste under the Resource Conservation and Recovery Act (RCRA), at several locations in Hawaii without obtaining the required permits.
As part of the settlement, Monsanto agreed to pay a total of $10.2 million in fines and penalties, which includes a maximum fine of $200,000 for illegal use of a cancelled pesticide, $6 million in fines for the hazardous waste violations, and $4 million in community service payments to Hawaii governmental entities for various environmental remediation programs. Monsanto also agreed to be sentenced to two years of probation. If Monsanto adheres to all of its obligations under this settlement, at the end of the two-year period of probation, the criminal felony counts for the RCRA hazardous waste violations will be dismissed with prejudice.
Although the agreement reached with Monsanto will allow Monsanto to escape any felony convictions, it is clear from the stiff penalties imposed (which include the maximum fine permissible for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violation) that EPA considers the violations at issue to be very serious. Pesticide research facilities often handle dangerous pesticides, and EPA typically affords such research facilities wide latitude to use unregistered active ingredients in small-scale research projects, but Monsanto has admitted that its personnel deliberately violated a FIFRA cancellation order, and did not comply with the restrictions on re-entry that were in place before the product in question was cancelled. Monsanto also has admitted that it stored stocks of a cancelled pesticide at several sites after they became acute hazardous waste without obtaining the required permits. The substantial penalties imposed may not seem surprising to some given those admissions.
By Lisa R. Burchi and Kelly N. Garson
The U.S. Environmental Protection Agency (EPA) recently settled two cases involving allegations of non-compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Although the Consent Agreement and Final Orders (CAFO) and Stop Sale, Use or Removal Orders (SSURO) issued in these cases are not yet available online, the penalty amounts at issue -- $200,000 and $1,489,000 -- reflect increased enforcement in targeted areas and EPA’s willingness to seek and obtain heroic penalties.
On November 18, 2019, EPA Region 9 announced that Decon7 Systems LLC (Decon7) would pay a $200,000 civil penalty in a settlement related to FIFRA violations. Specifically, EPA found that Decon 7:
- Sold and distributed two products that were not registered with EPA. These products, “D7 Part 1” and “D7 Part 2,” combined to disinfect hard nonporous surfaces. EPA regulations (40 C.F.R. § 152.15) set forth the conditions under which EPA will consider a product to be a pesticide product required to be registered, including but not limited to products containing certain “active” ingredients and/or making claims to kill, repel, or “disinfect” certain pests (e.g., germs, bacteria, viruses).
- Sold and distributed pesticides that were labeled with false and misleading claims regarding safety and efficacy. In addition to misleading efficacy claims to kill all bacteria, viruses, and fungi, EPA states:
The products also had false and misleading safety claims, which created the incorrect impression that the products were noncorrosive and nontoxic. The products’ formulations in fact could have caused skin burns and irreversible eye damage. The products’ labeling also claimed the products were used by various federal government agencies to clean up buildings following anthrax attacks, implying that the federal government recommends or endorses their use.
- Exported unregistered pesticides that did not include necessary notifications and failed to comply with reporting obligations following a SSURO issued to the company in 2018.
On October 31, 2019, EPA Region 3 announced that it reached an agreement with AFCO C&S, LLC (AFCO), a chemical company located in Chambersburg, Pennsylvania, to resolve alleged FIFRA violations. AFCO agreed to pay a $1,489,000 penalty to settle the alleged violations that involved the use of 12 products to clean and sanitize food and beverage processing facilities. EPA alleges that AFCO sold and distributed ten unregistered pesticide products, a misbranded product, and a product that made claims beyond those permitted by its FIFRA registration.
The settlement also addresses violations of a SSURO that EPA issued to AFCO on July 13, 2018. AFCO engaged in sales and distributions that violated this order. AFCO has since discontinued sales of all of the involved products, except for one registered product.
By Heather F. Collins, M.S.
On October 17, 2019, the U.S. Environmental Protection Agency (EPA) released the Spanish Translation Guide for Pesticide Labeling resource for use by all, including pesticide registrants that choose to display parts of their pesticide product label in Spanish. The purpose of the guide is to be a resource for the translation of the health and safety sections on pesticide labeling from English to Spanish. EPA states that the “guide is written in a universal form of Spanish to reach as many Spanish speakers as possible.”
While translating pesticide labels is not a requirement, EPA generally allows pesticide registrants to translate their product labels into any language so long as there is an EPA-accepted English version of the label and the translation is true and accurate. The guide is not intended to substitute for or eliminate the pesticide labels in English. An English version of all required labeling text is needed for all pesticide products in accordance with 40 C.F.R. Section 156.10(a)(3).
The guide provides translations for standard language typically used in the health and safety sections of pesticide product labels such as the:
- First aid and precautionary statement label language;
- Signal words;
- Misuse statements;
- Storage and pesticide container disposal instructions;
- Personal protection equipment label statements; and
- Worker Protection Standard agricultural use requirements.
EPA states that it “developed the Spanish translation guide in response to feedback from stakeholders who believe that having bilingual pesticide labeling is critical to the well-being of pesticide handlers, applicators, and farmworkers, many of whom do not speak English as a first language.”
The English statement appears in the left-hand column and the corresponding Spanish translation is available in the right-hand column of the guide. EPA states that the “guide will help registrants maintain accurate, consistent translations on product labels and ease their burden when adding Spanish translations.”