EPA Releases Draft Toxicological Review of Hexavalent Chromium

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EPA recently released its draft Integrated Risk Information System (IRIS) toxicological review of hexavalent chromium (also known as chromium-6). Hexavalent chromium is used in pigment manufacturing, metal finishing and chrome plating, stainless steel production, leather tanning, and wood preservatives. It has various other industrial applications as well. The metal is also emitted into the air when fossil fuels are burned.

The metal gained significant attention in 2000 with the release of the movie Erin Brokovich. The film detailed the story of a class action lawsuit by Californians against Pacific Gas & Electric Company for dumping wastewater containing chromium into ponds, subsequently polluting groundwater supplies.

Hexavalent chromium is a known carcinogen in humans when inhaled, including increased lung cancer rates found in workers exposed at higher than normal levels in industries that process or use chromium or chromium compounds. The metal is also known to cause nasal and sinus cancers, kidney and liver damage, nasal and skin irritation, and other adverse health effects.

Less information has been known about the effects of ingesting hexavalent chromium. EPA’s current standard for the metal in drinking water is a maximum contaminant level of 100 parts per billion. The draft IRIS reports that ingestion through drinking water is likely carcinogenic, and once finalized, EPA will use the IRIS review to make assessments of risk related to ingestion exposure.

The draft is currently open for public comment until December 19, 2022. EPA Scientific Advisory Board will hold a hearing to discuss hexavalent chromium following the closing of the comment period.

EPA Evaluation of PFAS Leaching in Fluorinated Containers

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On September 8, 2022, EPA announced findings of the Agency’s evaluation of PFAS leaching in fluorinated containers.  Specifically, the evaluation assessed the extent to which PFAS that are present in the packaging leach into the contents of the containers.  The study tested the leaching potential of PFAS over a 20-week test period into water, methanol and similar solutions that were packaged in different brands of HDPE fluorinated containers.  EPA undertook this evaluation after learning of PFAS contamination in some mosquitocide products, and after conducting a study of other pesticides stored in fluorinated high-density polyethylene containers.   In both cases the Agency found varying levels of PFAS in the contents of the containers.

The announcement reported that EPA has determined that any liquid products packaged in HDPE containers that have been treated with fluorination technology could be contaminated with PFAS, including water-based products.  The Agency also reported that the amount of PFAS that leach into the products could increase over time.   EPA noted that the Agency does not know if all fluorinated containers will leach PFAS because the Agency’s analysis did not test all the different fluorination technologies.

The announcement included a reminder that pesticide registrants must notify the Agency if they discover PFAS in any of their products.  Under FIFRA §6(a)(2) and 40 CFR §159.179, “additional factual information on unreasonable adverse effects, including metabolites, degradates and impurities (such as PFAS)” must be reported to EPA within 30 days after the registrant “first possesses or knows of the information.”  Note that the Agency considers any level of PFAS to be potentially toxicologically significant and therefore reportable.

The announcement also noted that in many cases, the manufacture of PFAS from the fluorination of polyolefins is subject to the Agency’s significant new use rule  for long-chain perfluoroalkyl carboxylates (LCPFACs) under the Toxic Substances Control Act (TSCA).  Companies must notify EPA at least 90 days before starting manufacturing or processing of these chemical substances for this significant new use.  TSCA requires significant new use notification in these situations to allow EPA review any associated risks and impose any needed protections.

Implementing Statutory Addition of Certain PFAS Substances to the Toxics Release Inventory Reporting

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In July 2022, EPA released a final rule adding five PFAS to the list of chemicals required to be reported to the Toxics Release Inventory (TRI) under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). TRI tracks the management of certain toxic chemicals that may pose a threat to human health or the environment and provides this information to the public. Pursuant to the National Defense Authorization Act (NDAA), EPA is required to automatically add PFAS to the TRI whenever it takes one of the following actions:

  • EPA finalizes a toxicity value for a PFAS or class of PFAS;
  • EPA determines that a PFAS or a class of PFAS is covered by a TSCA Significant New Use Rule (SNUR);
  • EPA adds PFAS or a class of PFAS to an existing SNUR; or
  • EPA finds that a PFAS or class of PFAS is active in commerce (under TSCA Section 8).

Under this rule, facilities in specific industry sectors that manufacture, process, distribute, or use any of the five PFAS added to the TRI, must submit a TRI report if they exceed the PFAS reporting threshold of 100 pounds. Four of the substances are added to the list effective January 1, 2022, and the remaining substance is effective January 1, 2021, meaning TRI reporting due in 2023 must account for these substances.

EPA Proposes to Stop Authorized Use of Certain PFAS in Pesticide Products

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EPA is proposing to remove 12 PFAS substances from the current list of inert ingredients approved for use in pesticide products. Under EPA’s 2021 PFAS Strategic Roadmap the Agency is reviewing substances approved as inert ingredients in pesticides and potentially taking action to limit their use. Inert ingredients in pesticides serve to increase effectiveness and product performance including improving the ease of pesticide application and extending shelf life.

The 12 chemical substances proposed for removal are no longer in any registered pesticide product, but EPA believes it is important to remove these chemicals.  This means that a review of available information for these chemicals would be required for their future use in pesticide products. In discussing the proposal Michal Freedhoff, EPA’s Assistant Administrator for the Office of Chemical Safety and Pollution Prevention stated, “ensuring that these 12 chemicals can no longer be used in pesticides is an important step to protect workers, the public, and our planet from unnecessary PFAS exposure.”

CoverGirl Cosmetics and Coty Inc PFAS Suit

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CoverGirl Cosmetics and Coty Inc. are facing a class action lawsuit for marketing their TruBlend Pressed Powder as sustainable and safe while allegedly it contained PFAS.  The complaint was filed in the U.S. District Court for the Southern District of California.  According to the complaint, independent lab testing found that the product contained increased fluorine levels, an indicator of the presence of PFAS.   The complaint also notes that defendants misrepresent the product in their marketing materials which state that they hold themselves to the highest quality standards when it comes to safety and efficacy of their products.  Plaintiffs argued that these acts violate the California Unfair Competition Law and the California False Advertising Law, and constitute fraud and negligent misrepresentation.

The plaintiff asserts that the presence of PFAS is a concern because PFAS exposure through inhalation, ingestion, and skin contact can result in PFAS entering the body. The makeup in question is applied directly to the face and is prolonged skin contact.  Plaintiff contends that PFAS are present at a greater concentration than recommended by the current EPA health advisory limit for safe consumption.

EPA Issues First Test Order for PFAS in Commercial Firefighting Foam

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EPA recently issued a test order under TSCA section 4 to select companies requiring that they develop and submit certain information on 6:2 fluorotelomer sulfonamide betaine, a PFAS. The order is part of the Agency’s National PFAS Testing Strategy which will evaluate a large number of PFAS for potential human and ecological effects as “most PFAS lack data for robustly characterizing their potential toxicity.

The test order was issued to Chemours Company, DuPont De Nemours Inc., National Foam Inc., and Johnson Controls Inc.  6:2 fluorotelomer sulfonamide betaine is used to make commercial firefighting foam and certain floor finishes.  The test order explains that EPA found insufficient data on 6:2 fluorotelomer sulfonamide betaine to determine or predict the effects on human health specifically by the inhalation route.  The order applies a tiered testing strategy.  EPA has ordered the companies to generate of data on certain physical-chemical properties (e.g., density, particle size, hydrolysis as a function of pH).  The Agency will use those data to determine whether further testing (e.g., inhalation toxicokinetic study, acute inhalation study) is needed.  Under TSCA section 4(a)(4), EPA is required to employ a tiered screening and testing process under which the results of screening-level tests or assessments of available information inform the decision as to whether additional tests are necessary.

EPA intends to issue additional test orders to other PFAS manufacturers in the coming months. A detailed overview of the activities involved in issuing a TSCA Section 4 order can be found here.

EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

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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

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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

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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

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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.