EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

On September 21, 2022, EPA announced settlements with two New Jersey companies for the sale and distribution of the pesticide Zoono Microbe Shield. The companies made false and misleading claims stating that the registered pesticide was suitable for use as a disinfectant or sanitizer against the virus which causes COVID-19. The companies’ claims were a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) which prohibits false and misleading claims of registered pesticide products.

The two companies, Zoono USA and Zoono Holdings, advertised and sold the Zoono Micro Shield product on their own company websites as well as on Amazon. The product’s labeling contained public health claims that EPA stated differ substantially from statements submitted to the Agency in connection with its pesticide registration; in other words, the companies were committing misbranding under FIFRA, The product’s registration allows only for labeling claims related to effectiveness against odor-causing bacteria, bacteria that cause staining and discoloration, fungi, and algae. The product is not registered for use as a disinfectant or sanitizer, nor is it registered for any public health purpose. Therefore, it was a violation of the statute to make such claims. The settlements included civil penalties in the amounts of $205,000 and $120,000.

EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

On September 21, 2022, EPA announced settlements with two New Jersey companies for the sale and distribution of the pesticide Zoono Microbe Shield. The companies made false and misleading claims that the registered pesticide was suitable for use as a disinfectant or sanitizer against the virus which causes COVID-19. The companies’ claims were a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) which prohibits false and misleading claims of registered pesticide products.

The two companies, Zoono USA and Zoono Holdings, advertised and sold the Zoono Micro Shield product on their companies’ websites as well as on Amazon. The product’s labeling contained public health claims that EPA found to differ substantially from statements approved by the Agency in its review of the product label. The approved label allows only for statements regarding the product’s effectiveness against odor-causing bacteria, bacteria that cause staining and discoloration, fungi, and algae.  EPA did not approve the use of the product as a disinfectant or sanitizer or make any public health claims. The settlements included civil penalties in the amounts of $205,000 and $120,000.

Amendments to SNUR Requirements

On July 5, 2022, EPA finalized the rule Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (87 FR 39756).  EPA made changes to SNUR requirements in the following sections 40 CFR §§ 721.11, 721.63, 721.72, and 721.91. In addition, the Agency has changed when 40 CFR 721.80(j) will be used.  Most amendments only apply to SNURs issued after the rule’s effective date, September 6, 2022. However, retrospective changes are flagged throughout this report.  The amendments in this Federal Register notice will also require the submission of SDS(s) with PMNs, SNUNs, and Low Volume Exemptions (LVEs).

Changes to 40 CFR § 721.63, Protection in the Workplace

EPA updated this regulation so that it will be consistent with NIOSH and OSHA requirements.  For example, the amendment to 40 CFR § 721.63(a)(4) references the updated NIOSH regulations for respirator use, testing, and certification.  EPA believes that most manufacturers and processors are already subject to and complying with the NIOSH regulations. This change will be retroactive and thus will apply to all previously issued SNURs that contain significant new use requirements pertaining to respiratory protection. The amended rule allows manufacturers and processors that are subject to SNURs to follow updated respiratory protection requirements without triggering a SNUN requirement.

EPA has also updated to the NIOSH-certified respirator language in 40 CFR § 721.63(a)(5). Notably, individuals will be allowed to continue using any of the fifteen older-style respirators listed under 40 CFR § 721.63(a)(5)(i-xv) to avoid triggering a SNUN requirement.  In addition, EPA amended 40 CFR § 721.63(a)(6) to update the language for when the airborne form of a chemical substance implicates the respiratory requirements in 40 CFR § 721.63(a)(4).

The amendments to the SNUR regulations also include new paragraphs 40 CFR § 721.63(a)(7) and 40 CFR § 721.63(a)(8).  When implicated by a SNUR, these new requirements make it a significant new use not to implement a hierarchy of controls to protect workers. These changes will require any person subject to a SNUR that calls out these requirements to identify and implement appropriate engineering and administrative controls for respiratory protection before using PPE for workers protection.

Changes to 40 CFR § 721.72, Hazard Communication Program

EPA updated the language in 40 CFR § 721.72(a) through (h) to be consistent with current OHSA requirements and the United Nations’ Globally Harmonized System of Classification and Labeling (GHS). The amendments will apply retroactively to previously issued SNURs that cite 40 CFR § 721.72(a), (c), or (d).

Paragraphs (g) and (h) were amended to include new hazard and precautionary statements to make these provisions consistent with OSHA requirements and GHS recommendations.  EPA also added two new paragraphs to 40 CFR § 721.72, (i) and (j).  These new paragraphs impose new hazard communication requirements. Paragraph (i) requires a written hazard communication program to be developed and implemented for the SNUR substance in each workplace. The written hazard communication program would need to meet OSHA requirements in 29 CFR 1910.1200, OSHA’s Hazard Communication Standard (HCS). Paragraph (j) provides specific statements and warnings that could be incorporated in hazard communications.

Under the revisions to § 721.72, whenever the statements in paragraphs (g), (h), and (j) are required, manufacturers and processors subject to the SNUR will also need to consider if they trigger any other corresponding hazard communication under the OSHA HCS.  Any hazard and/or precautionary statements required by the SNUR would need to include a minimum set of hazard warnings.

Changes to 40 CFR § 721.80, Industrial Commercial and Consumer Activities

EPA has changed the circumstance in which it will cite 40 CFR § 721.80(j) which defines a significant new use as, “[u]se other than as described in the premanufacture notice references in subpart E of this part for the substance.” No language would be changed.  Instead, the Agency is clarifying when it will identify a new use using this verbiage.  The Federal Register notice explains that “To better identify the significant new use, EPA has changed this procedure to only cite 40 CFR 721.80(j) when the use described in the PMN is confidential.”

 Changes to 40 CFR § 721.91, Computation of Estimated Surface Water Concentrations: Instructions

EPA has modified the instructions in 40 CFR § 721.91 for computation of estimated surface water concentrations to allow for a certain percentage of removal of a chemical substance from wastewater after undergoing control technology in accordance with the requirements in 40 CFR § 721.90.

Changes to 40 CFR § 721.11, Applicability Determination When a Specific Chemical Identity is Confidential

The amendments to 40 CFR § 721.11 subpart A modify the bona fide procedure so that it applies to all SNURs containing any CBI, including the significant new use.

Changes for Submission of SDS(s) with PMNs, SNUNs, Low Volume Exemptions (LVEs), Low Release, and Exposure Exemptions (LoREXs), and Test Marketing Exemption (TME) Applications

EPA has amended sections 40 CFR § 720.38, 40 CFR § 720.45, and 40 CFR § 723.50 to require that any safety data sheets (SDSs) that has been developed, even if it is in draft form, be submitted as part of any notification or exemption application (PMN, SNUN, LVE, LoREX, or TME).  Submitters are not required to develop an SDS if one does not already exist.

 

PFAS From Certain Plastic Can Violate Chemicals Law, EPA Says

Earlier this year, EPA released a letter to manufacturers, processors, distributors, users, and those that dispose of fluorinated high-density polyethylene (HDPE), informing them of possible violations of the Toxic Substances Control Act (TSCA).  EPA determined through recent testing that certain PFAS have unintentionally formed during or following the process of fluorinating polyolefins. Manufacturers and processors of fluorinated polyolefins modify polymers with fluorine to create high-performance barriers.  These barriers are then used in the storage and transport of various products to keep the product inside the container without notable permeation.  During some methods of fluorination, such as in the presence of oxygen, PFAS can occur as a byproduct.

EPA first noticed the unintentional formation of PFAS in containers used in storing and transporting pesticides, and it is researching whether this problem occurs in other HDPE products. This effort to restrict human health and environmental exposure to PFAS is one of many steps the Agency has outlined in its PFAS Strategic Roadmap.

EPA’s letter reminds the HDPE industry that certain long-chain PFAS are subject to a TSCA Significant New Use Rule (SNUR) (See 40 CFR § 721.10536). Generally, chemical substances created during the manufacturing process that does not have a separate commercial purpose are considered byproducts and are exempt from SNUR requirements under 40 CFR § 721.45(e). But certain long-chain PFAS byproducts produced during the manufacture of fluorinated polyolefins do not meet the requirements of the byproducts exemption and therefore require a SNUR. These rules require the manufacturer to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemicals for significant new use.

The Agency encourages the industry to review the relevant regulations at 40 CFR § 721. Any questions on the topic can be directed to the Existing Chemicals Risk Management Division in the Office of Pollution Prevention and Toxics at TSCA_PFAS@epa.gov.

Chlorpyrifos Food Tolerance Revoked  

Earlier this year, EPA denied all objections to and hearing requests for a rule that terminates the use of the chlorpyrifos pesticide on food crops. As a result of the new rule, producers may no longer apply any chlorpyrifos to food or feed products, although there is an exemption for farmers to use the pesticide on certain exported food products.

Following its registration in 1965, farmers have used chlorpyrifos as an insecticide on food crops such as soybeans, corn, fruit and nut trees, and vegetables. It has also been used for agricultural purposes such as cattle ear tags, poultry houses, turkey, swine, and dairy barns.

There is significant potential for the pesticide to cause neurological effects, particularly in pregnant women and children. Children who are exposed to chlorpyrifos may experience lifelong intellectual disabilities and lowered IQ levels. Farmworkers who use the pesticide or work in fields where the pesticide has been used are also at increased risk of adverse health effects from exposure with including effects on the nervous system such as headaches, blurred vision, muscle weakness, and seizures. The chemical has been the focus of environmental advocacy groups because of its toxicity to wildlife, particularly birds, fish, aquatic vertebrates, and bees. For example, these groups argue that the chemical impacts the health and existence of nearly 1,400 animals and plants protected under the Endangered Species Act.

In 2000, the EPA banned chlorpyrifos for residential indoor use but continued allowing the use of these chemicals on food products. In 2014 and 2016, the EPA published data confirming that all toddlers were being exposed to chlorpyrifos at levels 140 times greater than the Agency had determined was safe.  However, the Agency did not take actions to limit chlorpyrifos pesticide use at that time. In 2017, the EPA again failed to take action to ban chlorpyrifos. The Agency decision argued that additional scientific evidence was needed. Meanwhile, beginning in 2019, some states banned or restricted the use of chlorpyrifos, including California, Maryland, New York, and Hawaii. In recent years, many toxic torts lawsuits have been filed against chlorpyrifos manufacturers and distributors. Many of these cases are still ongoing.

The EPA’s current final rule banning chlorpyrifos in food was issued in response to the Ninth Circuit Court of Appeals’ order directing the EPA to issue a final rule after the Natural Resources Defense Council and the Pesticide Action Network North America filed a petition with the Court. These organizations had previously petitioned the Agency for a ban, which was denied under the Trump administration in 2017 and again in 2019, leading to its Ninth Circuit challenge. EPA administrator Michael S. Regan addressed the delay in EPA’s action against the chemical, stating, “[t]oday EPA is taking an overdue step to protect public health. Ending the use of chlorpyrifos on food will help to ensure children, farmworkers, and all people are protected from the potentially dangerous consequences of this pesticide.”

EPA Launches Stakeholder Outreach Effort to Help Speed New Chemical Reviews

On June 27, 2022, EPA announced its TSCA New Chemical Engineering Initiative.  EPA seeks to increase efficiency and transparency in the new chemical review process by inviting stakeholders to learn more about how the agency evaluates submitted information.  EPA plans to focus the initiative specifically on issues surrounding “engineering” information, including, but not limited to, occupational exposures and environmental releases.

The initiative has been launched in response to significant delays in new chemical reviews.  Frequently, submitters will provide additional information after the safety review process of a chemical under Section 5 of the Toxic Substances Control Act (TSCA) has already begun.  When EPA receives this additional information, it must revise its risk assessment (known as a “rework”) which causes delays in completing its review process and finalizing its risk assessment.  In an analysis of previous cases, EPA determined that an individual case may be reworked anywhere from one to five times, delaying the process at least several months.

EPA will be conducting a series of webinars providing an in-depth look at how the Agency analyzes submissions, including EPA’s written methodology of how its conducts analysis.  EPA intends to present case studies to stakeholders to further demonstrate what it considers acceptable in submissions.  Webinars will also communicate EPA’s considerations in evaluating qualitative claims or quantitative data, particularly in circumstances in which they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER).  Webinars will also discuss EPA’s considerations in evaluating information about sites that are not controlled by the submitter.

The kick-off meeting for the series was held on July 27, 2022.  The meeting detailed background on rework analysis, causes of reworks, examples of rework cases, and general observations.  EPA will be releasing information including the dates for two additional webinars in this fall.

Flame Retardant Rule Do-Over Sought By EPA Granted in Federal Case

On June 23, 2022, the Ninth Circuit Court of Appeals granted EPA a request for voluntary remand on a risk management rule for decabromodiphenyl ether (decaBDE).  This allows EPA to reconsider the rule at issue and make changes they deem necessary.  DecaBDE is a flame retardant added to the plastics used in many products on the market, such as televisions, computers, and upholstered articles. The January 2021 risk management rule prohibits manufacturing or importing decaBDE for all products after February 28, 2022, 60 days after the publication of the final rule.  The rule gives the hospital curtain industry 18 months to come into compliance, and 3 years for new aerospace vehicles. Replacement parts for motor and aerospace vehicles were granted an exclusion from the prohibition of manufacturing, processing, and distribution of decaBDE.

Petitioners opposing EPA in this matter are a coalition consisting of the Alaska Community Action on Toxics, Yurok Tribe, the Consumer Federation of America, Learning Disabilities Association of America, and the Center for Environmental Transformation.  the coalition, argues that EPA has had more than a year to review unidentified provisions of the final rule.  The coalition also asserts that EPA’s Final Rule is inadequate because it lacks 1) risk management measure to reduce exposure of decaBDE generally, 2) an exclusion for unrestricted recycling of plastics containing decaBDE, and 3) restrictions on releases of the chemical to the air, water, or land.

In 2021, the Ninth Circuit Court of Appeals had also granted EPA’s request to revisit two other chemical risk evaluations, including the one for hexabromocyclododecane (HBCD which is also a flame retardant).  Along with granting EPA’s request to reconsider the rule, the Ninth Circuit denied the petitioners request to impose deadlines on the reconsideration and potential amendment of the rule.

EPA orders e-commerce platform Wish to stop selling illegal disinfectants

On July 5, 2022, EPA ordered the e-commerce platform Wish (ContextLogic Inc.) to stop selling a variety of unregistered disinfectants on its website, including disinfectant sprays, tablets, and air sterilization cards. EPA’s “Stop Sale” order prevents the company from selling unregistered disinfectants, which is a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Under FIFRA, all disinfectants must be registered with the Environmental Protection Agency which requires testing and determination that the product will not pose an unreasonable risk to human health when used according to the label directions. Violations of this nature have increased during the Covid-19 pandemic. Allowing products like this to stay on the market is particularly concerning as unregistered products make be harmful to human health and may not be effective against the spread of germs. The EPA Pacific Southwest Regional Administrator Martha Guzman commented on the Stop Sale order and the overall issue stating, “As our nation continues to grapple with Covid-19, today’s stop sale order is critical to protecting Americans from misleading and harmful claims from a large e-commerce platform. EPA remains vigilant and will keep removing these illegal disinfectants from circulation.”

EPA Takes Steps to Regulate PFAS in Commerce

On March 16, 2022, EPA announced that the Agency would be taking two steps to further regulate PFAS in commerce. First, EPA notified manufactures of high-density polyethylene (HDPE) that they are obligated to comply with existing TSCA requirements to prevent unintentional PFAS contamination. Second, EPA stated that the Agency will remove two types of PFAS from the Safer Chemical Ingredients List (SCIL).

EPA provided notice that manufacturers, importers, processors, distributors, users, and other entities who engage in the disposal of HDPE containers and other plastics containing fluorinated polyolefins must adhere to the significant new use notice requirement under TSCA. This notice was provided via an open letter to the HDPE industry that was initially posted on March 16, 2022, and then reissued with minor revisions on March 24, 2022.  Here, EPA reminded the HDPE industry that the process of fluorination can lead to the unintentional manufacture of PFAS (e.g., byproducts).  Furthermore, EPA stated that the manufacture of certain PFAS, including long-chain perfluoroalkyl carboxylates, via fluorination of polyolefins is considered a significant new use under TSCA because the byproducts exemption provided at 40 CFR § 721.45(e) does not apply. Specifically, this exemption does not apply because these PFAS are not “used only by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes.” Therefore, a significant new use notification (SNUN) must be submitted to EPA at least 90 days before initiating such use so that the Agency can review the potential risks of this new use before industry can place the product into the stream of commerce.

The two PFAS that EPA will be removing from the SCIL, CASRN 449177-94-0 and 452080-67-0, were initially placed on the list in 2012.  In October of 2021, EPA began revisiting its previous PFAS endorsements pursuant the PFAS Strategic Roadmap. These two chemicals were subsequently removed from the list based on “a growing understanding of the toxicological profiles for certain PFAS, and incomplete information on the potential health and environmental effects of these substances.” Henceforth, these products that contain these PFAS will not be eligible Safer Choice certification. In addition, existing products containing these substances, that have received the Safer Choice certification, must be reformulated to maintain said certification.

EPA Releases Draft Revised Risk Determination for PV29

On March 7, 2022, EPA released a draft revision to the risk determination for C.I. Pigment Violet 29 (PV29).  Manufacturers and commercial clients use PV 29 as a weather fast and heat stable pigment in paints and coatings.  These paints and coatings are primarily used in automobiles and industrial carpeting.  The draft revision comes as part of the path forward EPA released in June 2021 for the first 10 risk evaluations under TSCA.

Risk evaluations are conducted under TSCA section 6.  TSCA requires the Agency to conduct risk evaluations to determine whether high priority substances present an unreasonable risk of injury to health or the environment.  EPA has determined that PV29, presents an unreasonable risk of injury to health.  This determination regarding PV29, evaluated the substance as a “whole chemical,” replaces previous determinations which were based on evaluations of individual conditions of use.

The draft revision risk determination for PV29 does not include an assumption of personal protective equipment (PPE) for workers. Instead, EPA stated that the Agency would consider the use of PPE, and any other potential mitigating factors, during its determination of risk management measures.  Note that the January 2021 risk evaluation for PV29found an unreasonable risk to workers, even when proper use of PPE is assumed.  The January 2021 risk evaluation identified 14 categories of use and found unreasonable risk exists in 10 of those categories including:

  • manufacture,
  • processing,
  • paints/coatings and merchant ink for commercial printing categories of Industrial/commercial use, and
  • disposal.

The draft revision states these same conditions of use will continue to drive EPA’s determination of unreasonable risk for PV 29.  The categories of use that were not found to present an unreasonable risk are: distribution in commerce, industrial/commercial use in plastic and rubber products, and consumer uses.