By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson
On April 3, 2020, the U.S. Environmental Protection Agency (EPA) hosted an interactive telephone call with U.S. retailers and third-party marketplace platforms to discuss imposter disinfectant products and those that falsely claim to be effective against the novel coronavirus, SARS-CoV-2, the cause of COVID-19. EPA hosted the call due to recent complaints on the availability of products with unsubstantiated and potentially dangerous claims of protection against SARS-CoV-2 and has enlisted the help of the retail community to prevent these products from coming to market.
EPA Administrator Andrew Wheeler described the call as “informative and productive,” and stated that “together, we will work diligently to ensure that consumers have access to EPA-approved and verified surface disinfectant products; products that we know to be effective against the novel coronavirus.”
Participants included the Retail Industry Leaders Association (RILA), the National Retail Federation, Walmart, Amazon, and eBay. All expressed commitment to “work closely with trusted suppliers to ensure that all products that they sell meet or exceed all applicable U.S. safety standards and legal requirements” and to “work closely with EPA to remove fraudulent products from the marketplace as soon as possible.” EPA is also coordinating with the U.S. Department of Justice and other federal partners to bring the full force of the law against those selling fraudulent or unregistered products.
Based on tips, complaints, and research, EPA has identified illegal products that are claiming anti-viral, antibacterial, disinfectant, sterilizing, or sanitizing properties but have not gone through EPA’s robust registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and are not legal for sale in the United States. EPA only registers disinfectants that can be used effectively against the novel coronavirus on surfaces. Non-registered products may not effectively eliminate the virus or reduce the spread of the virus and could even be harmful to consumers’ health. Consumers are urged to refer to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N) for EPA-registered disinfectants that EPA has determined to be safe and effective against the novel coronavirus.
The following is a list of some of the unregistered products that have been identified. EPA typically enforces FIFRA through stop-sale orders and penalty actions. EPA provided the following information to ensure that Americans have as much information as possible to help them protect themselves from COVID-19:
- Lanyards that illegally claim to protect wearers from coronavirus:
- Unregistered disinfectant tablets:
- “Epidemic prevention Chlorinating Tablets Disinfectant Chlorine Tablets Swimming Pool Instant Disinfection Tablets Chlorine Dioxide Effervescent Tablet Chlorine Disinfectant 100g Cozy apposite Fun Suit”
- “The Flu Virus Buster, CLO2 Disinfection Sticker, Removable sterilize air purifier, Anti COVID-19, Stop Coronavirus disease infection /Influenza Buster Disinfectant 1 Box/10 Tablets”
- Unregistered disinfectant sprays:
- “Fullene silver antibacterial solution/24 Hour Defense Hand Sanitizer Disinfectant Spray Against Corona Virus COVID- 19 Kills 99.99% of Germs Bacteria 24 Hours of Lasting Protection Alcohol Free 50ml (1.7 fl. oz.)”
- Unregistered disinfectant wipes:
- “99.9% Sterilization Wipes/16/32/48/64/96pcs Sterilization Rate of 99% Disinfection Wet Wipes and Paper Napkin Prevention of Coronavirus”
Additional information on the recent telephone conference is available here.
By Lisa M. Campbell and Lisa R. Burchi
On March 30, 2020, the U.S. Environmental Protection Agency (EPA) issued a Press Release to clarify its Temporary Policy released on March 26, 2020, regarding EPA’s enforcement of environmental legal obligations during the COVID-19 pandemic. A discussion of the Temporary Policy is available on our blog.
The impetus for the Press Release was based, according to EPA, on the “reckless propaganda” by certain news outlets that provided erroneous or exaggerated information about the Temporary Policy, particularly that the Temporary Policy is providing a blanket waiver of environmental requirements or is creating a presumption that the COVID-19 pandemic is the cause of noncompliance.
EPA’s Press Release outlines certain elements of the Temporary Policy that should not be overlooked:
- The Temporary Policy states that EPA will not seek penalties for noncompliance with routine monitoring and reporting requirements, if, on a case-by-case basis, EPA agrees that such noncompliance was caused by the COVID-19 pandemic. The Policy is not intended to cover:
- Exceedances of pollutant limitations in permits, regulations, and statutes.
- Cases which may involve acute risks or imminent threats, or failure of pollution control or other equipment that may result in exceedances, except in possible circumstances where the facility contacts the appropriate EPA region, or authorized state or tribe, and allows regulators to work with that facility to mitigate or eliminate such risks or threats.
- Normal operations and maintenance of public water systems and required sampling of vital drinking water supplies.
- Regulated parties must document the basis for any claim that the pandemic prevented them from conducting that routine monitoring and reporting and present it to EPA upon request. EPA states that it is using this approach to allow EPA to prioritize its resources and respond to acute risks and imminent threats, rather than making up-front case-by-case determinations regarding routine monitoring and reporting requirements.
EPA notes that it expects regulated facilities to comply with regulatory requirements, where reasonably practicable, and to return to compliance as quickly as possible, once the COVID-19 threat is over. EPA states that it plans to lift the measures of the Temporary Policy as soon as normal operations can resume, which may occur sooner in some locations than others.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on March 26, 2020, a temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic. EPA states that its temporary enforcement discretion policy applies to civil violations during the COVID-19 outbreak. The policy addresses different categories of noncompliance differently. For example, according to EPA, it “does not expect to seek penalties for noncompliance with routine monitoring and reporting obligations that are the result of the COVID-19 pandemic but does expect operators of public water systems to continue to ensure the safety of our drinking water supplies.” The policy describes the steps that regulated facilities should take to qualify for enforcement discretion. To be eligible for enforcement discretion, the policy requires facilities to document decisions made to prevent or mitigate noncompliance and demonstrate how the noncompliance was caused by the COVID-19 pandemic.
EPA notes that its policy does not provide leniency for intentional criminal violations of law and that it does not apply to activities that are carried out under Superfund and Resource Conservation and Recovery Act (RCRA) Corrective Action enforcement instruments. EPA states that it will address these matters in separate communications. The policy states that it does not apply to imports. According to the policy, EPA is “especially concerned about pesticide products entering the United States, or produced, manufactured, distributed in the United States, that claim to address COVID-19 impacts.” EPA “expects to focus on ensuring compliance with requirements applicable to these products to ensure protection of public health.”
The policy will apply retroactively beginning on March 13, 2020. EPA will assess the continued need for and scope of this temporary policy on a regular basis and will update it if EPA determines modifications are necessary. To provide fair and sufficient notice to the public, EPA states that it will post a notification on its website at least seven days prior to terminating the temporary policy.
By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson
On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a new web portal that is available to the public to search for EPA guidance documents. The EPA Guidance Portal (Portal) was created under Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents,” where agencies are to develop a central web portal for the public to review active guidance documents and the ability to request for modification or withdrawal of the guidance documents.
Information available about each guidance document listed on the Portal includes:
- A concise name for the guidance document;
- The date on which the guidance document was issued;
- The date on which the guidance document was posted to the web portal
- An agency unique identifier;
- A hyperlink to the guidance document;
- The general topic addressed by the guidance document; and
- A summary of the guidance documents’ content.
EPA states that the “guidance documents lack the force and effect of law, unless expressly authorized by statute or incorporated into a contract” and EPA “may not cite, use, or rely on any guidance that is not posted on this web area, except to establish historical facts.”
The portal is broken down by office, including regional offices:
- Office of Air and Radiation (OAR)
- Office of Chemical Safety and Pollution Prevention (OCSPP)
- Office of Enforcement and Compliance Assurance (OECA)
- Office of General Counsel (OGC)
- Office of International and Tribal Affairs (OITA)
- Office of Land and Emergency Management (OLEM)
- Office of Mission Support (OMS)
- Office of Research and Development (ORD)
- Office of Water (OW)
- All EPA Regional offices
Currently, there are a total of 1,735 guidance documents listed under OCSPP. Within the 1,735 documents, 117 appear to be specific to FIFRA. Examples of guidance documents included in the portal are:
- Inert Ingredients Overview and Guidance;
- Exporting Unregistered Pesticides: Foreign Purchaser Acknowledgement Statements;
- EPA's Regulation of Biotechnology for Use in Pest Management;
- CPARD USER GUIDE: For State Lead Agency (SLA) and Tribal Representatives with Certification Plans (CPs);
- Frequent Questions for the 2018 Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines;
- Pesticide Registration Manual;
- Guidance on FIFRA 24(c) Registrations;
- Design for the Environment Logo for Antimicrobial Pesticide Products;
- Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants;
- Structured Product Labeling (SPL) Draft Implementation Guide with Validation Procedures and User Guide;
- Reregistration and Other Review Programs Predating Pesticide Registration Review;
- FIFRA Pesticides Export Policy: Questions & Answers Issue: Research and Development Pesticides; Active Ingredient Concentrations;
- State FIFRA Issues, Research, and Evaluation Group Final Guidance for State Lead Agencies for the Development and Implementation of Managed Pollinator Protection Plans; and
- E-FAST, Down the Drain Assessment Model.
Under OECA, there are six documents specific to FIFRA. The guidance documents included in this portal are:
- Compliance Advisory: High Number of Complaints Related to Alleged Misuse of Dicamba Raises Concerns;
- Good Laboratory Practices - Questions and Answers;
- EPA and Association of American Pesticide Control Officials (AAPCO) Advisory Notice on Pesticide-related E-Commerce;
- Fact Sheet on Pesticides Sales in E-Commerce;
- Documents with Questions and Answers on FIFRA Pesticides Export Policy; and
- FIFRA Pesticide Export Policy: Interpretive Guidance: Multilingual Labeling.
Of note, the portal sets forth an option for petitioning EPA to modify or withdraw a guidance document from the Portal by completing an online form. The required information to submit using the online form is name, email address, unique identifier of the guidance document, the office and/or region, and comments related to the withdrawal or modification of the guidance document.
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 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 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 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 Lynn L. Bergeson
Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.
Happy New Year and enjoy reading our predictions!