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.

Verdant Law Gives Presentation on the PFAS Regulatory Landscape at Annual Product Stewardship Conference

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Verdant Law is pleased to announce that Irene Hantman gave a presentation on the PFAS Regulatory Landscape at the annual Product Stewardship Conference. Hantman presented brief case studies on how different states are regulating PFAS in their communities, including but not limited to:

  • California’s ban on food packaging containing PFAS that is intentionally added to a product or more than 100 ppm of PFAS. (Effective date January 2023)
  • Colorado’s ban on certain products containing additionally added PFAS, including carpets and rugs, cosmetics, food, packaging, children’s toys and more. (Effective date January 2024)
  • Maryland’s ban on food packaging designed for direct food contact that contains intentionally added PFAS. (Effective date January 2024)
  • North Carolina’s petition to EPA for PFAS Testing under TSCA Section 21 requesting testing on a variety of PFAS manufactured by Chemours.

Additionally, Hantman discussed PFAS regulations on the federal level. She highlighted EPA’s proposed PFAS reporting rule under TSCA (87 FR 33926), which would require all manufacturers and importers of PFAS listed on the active TSCA Inventory to report uses, volumes manufactured, environmental and health effects, worker exposure, and disposal. Hantman further detailed the reporting the comprehensive reporting standard and industry commentary on the proposed rule.

Also discussed was the National PFAS Testing Strategy released in October 2021, permitting EPA to issue test orders to manufacturers of PFAS substances and the first set of test orders EPA just recently issued. EPA’s ending of LVE exemptions for PFAS, the imposition of SNURs on approximately 150 PFAS, and the new regulation of PFAS under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was also included in Hantman’s presentation. Briefly mentioned were PFAS consumer product litigation including:

  • A lawsuit against Burger King over PFAS in Whopper Wrapping. (April 2022; voluntarily dismissed in August 2022)
  • Class action lawsuits against Burt’s Bees, L’Oreal, Cover Girl Cosmetics, and Shiseido over the use of PFAS in various cosmetic products. (2021 & 2022)
  • A class action lawsuit against REI over PFAS in “sustainable gear” including waterproof jackets. (April 2022; voluntarily dismissed in July 2022)

If you have questions about the topics of this presentation, please contact Irene Hantman.

 

Verdant Law Gives Presentation on EPA’s New PMN Review Process at Annual Product Stewardship Conference

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Verdant Law is pleased to announce that Phil Moffat gave a presentation on EPA’s new PMN review process at this year’s Product Stewardship Conference. Moffat highlighted EPA’s proposed rule (expected to be released in February 2023) updating date procedural regulation to conform with the Lautenberg amendment, which requires EPA to make affirmative determinations on whether new chemical substances present an unreasonable risk to human health or the environment under known, intended or reasonably foreseen conditions of use. The proposed rule, if implemented, would increase the quality of information initially submitted in a PMN and reduce Agency rework in the risk assessment process, and reduce the Agency’s review time for each PMN.

Additionally, in June 2020, EPA launched a series of webinars working towards its goal of increasing transparency and reducing reworks. The webinars highlight common issues that require EPA to reconduct new chemical assessments (reworks), which substantially delay the Agency in completing PMN reviews.

Moffat also discussed EPA’s recently announced effort to implement a streamlined and efficient process for risk evaluations on chemicals used in electric vehicles, semiconductor, and clean energy sectors with the goal of increasing the nation’s energy security. The effort will focus specifically on mixed metal oxides (MMOs), including new and modified cathode active materials (CAMs).

Also detailed was EPA’s recent decision to discontinue the use of exposure modeling thresholds in the new chemical review process. The change would require completing modeling for all potential exposures that may result from air releases and releases to groundwater from landfills, as opposed to only those above an established threshold under the current policy. EPA believes that the adoption of this new policy will allow for a more comprehensive accounting of all potential air and water releases to ensure any needed protections are in place before a new chemical comes to market.

Lastly, Moffat discussed EPA’s efforts to bring innovative science to the chemical review process detailed in an Agency document TSCA New Chemicals Collaborative Research Effort. The effort includes a multiyear research plan in collaboration with federal agencies such as NIH’s National Toxicology Program. The focus areas of the research include:

  • Updating and refining chemical categories.
  • Developing and expanding databases containing TSCA chemical information.
  • Developing and refining QSAR and predictive models for physical-chemical properties, environmental fate/transport, hazard exposure, and toxicokinetics.
  • Exploring was to integrate and apply New Approach Methodologies (NAMS) in new chemical assessments.
  • Developing a TSCA new chemicals decision support tool.

If you have questions about the topics of this presentation, please contact Phil Moffat.

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.