NEWMOA Announces Draft PFAS Prevention Model Act

/in

In May 2023, the Northeast Waste Management Officials’ Association (NEWMOA) released a draft PFAS Prevention Model Act (Draft Model Act), model legislation for states to use in advancing the reduction of the use of polyfluoroalkyl substance (PFAS). NEWMOA is a non-profit interstate organization composed of the state environmental agency directors of hazardous waste, solid waste, waste site cleanup, emergency response, pollution prevention, and underground storage tank programs in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, and Vermont.

NEWMOA seeks to reach the goal of the “virtual elimination of the environmental releases of PFAS into the environment. NEWMOA outlined the following six main goals of this initiative:

  • Reduce/eliminate the use of PFAS in consumer products to the extent feasible.
  • Identify and implement source reduction programs.
  • Ensure that the substitutes for PFAS in products are safer and that there is no regrettable substitution.
  • Coordinate product disclosure, labeling, bans, phase-outs, source reduction, and end-of-life collection on a multi-jurisdiction basis.
  • Help consumers identify products containing PFAS and learn how to properly handle them.
  • Provide regulated entities with regulatory certainty.

To achieve these goals, NEWMOA has put forth what it refers to as a “menu of policy options” that legislators can weigh in their efforts to address PFAS contamination and exposure. By choosing from these options, NEWMOA purports states can adopt more consistent approaches to regulating PFAS-containing products.

The Draft Model Act contains 18 sections, beginning with relevant definitions developed by adapting definitions provided in the Toxics in Packaging Clearinghouse’s model legislation and existing PFAS laws.

The most unique aspect of the Draft Model Act is Section 4, which proposes the creation and implementation of a multijurisdictional clearing house. The role of the clearing house would be to “assist in carrying out the requirements of this Act and to help coordinate collection and reviews of the manufacturers’ notifications regarding PFAS-added products, applications for phase-out exemptions, the collection system plans, applications for alternative labeling/notification systems, education and outreach activities, and other related functions.” The clearinghouse would additionally be responsible for maintaining a database of “all products containing PFAS, including PFAS-added products; a file on all exemptions granted by the participating jurisdictions; a file on alternative labeling plans; and a file of all the manufacturers’ reports on the effectiveness of their collection systems.”

Additional notable provisions include:

  • Requiring PFAS-product manufacturers to provide notice to the relevant agency before the sale of the product in the relevant jurisdiction; if products are sold without the notification, a ban will be placed on the product.
  • Banning the sale of PFAS-added products in the relevant jurisdiction unless the relevant agency has determined that the use of the product is “currently unavoidable” (defined as whether the product is determined to be beneficial to the environment or protective of public health or protective of public safety; there is no technically feasible alternative that has less risk to human health or the environment to use of PFAS in the product; and there is no comparable non-PFAS-added product available at a reasonable cost”).
  • PFAS-added products that qualify for sale under a “currently unavoidable” use must have a label stating that the product contains PFAS.
  • Manufacturers must have an extended producer responsibility plan for a PFAS-containing product collection system, which will require approval from the relevant agency.

NEWMOA has accepted written public comment on the Draft Model Act and aims to finalize the model legislation by the end of summer 2023.

New Study Finds Multiple Toxic Chemicals in Consumer Products

/in , ,

This May, the American Chemical Society published a new study evaluating the presence of toxic chemicals in consumer products.  The study found use of at least one chemical known to the state of California to cause cancer, reproductive issues, and/or developmental issues in over one hundred types of consumer products.

The study’s authors used data from the California Air Resources Board’s (CARB) Consumer Product Regulatory Program, which collects data on volatile organic compounds (VOCs) in California consumer products.  They then cross-referenced this data against the list of harmful chemicals regulated under California’s Safe Drinking Water and Toxic Enforcement Act, commonly known as Proposition 65 or Prop 65, to determine the hazards posed by each product category.  It should be emphasized that the study provides only a partial picture of the use of hazardous chemicals in consumer products; only about 200 of the 865 Prop 65-listed substances are VOCs.

More than 100 product categories contained at least one VOC chemical listed under Prop 65 (a “listed chemical”).  Consumers were exposed to the greatest number of listed chemicals in categories that included personal care products, cleaners, and household products; for workers, adhesives had the greatest number of listed chemicals.  The study also determined that more than 5,000 tons of listed chemicals were released from California consumer products in 2020.

In general, the product categories with the most listed chemicals were also the categories in which exposures to especially hazardous listed chemicals were highest.  After comparing the product categories with the highest numbers especially hazardous chemicals with the categories with the highest potential exposures, the researchers assembled a list of 30 product categories and 11 especially hazardous chemicals—including formaldehyde and methylene chloride—that they believed should be prioritized for regulation.

In addition, the study noted that certain occupations put workers at particular risk of exposure to listed chemicals.  For example, janitors could be exposed to five prioritized product categories, including cleaners, detergents, and degreasers.  Construction workers, nail/hair salon employees, and automobile maintenance/repair workers were also described as particularly at-risk.

Because CARB only makes data available by product category, the study did not identify particular brands or products in their analysis.

EPA’s SBIR Program Showcases Small Businesses Developing Technologies to Test and Treat PFAS

/in , ,

This April, EPA’s Small Business Innovation Research (SBIR) Program highlighted eight companies supported by the program that are developing technologies to detect, assess, and treat PFAS in the environment.

Of the eight companies, seven are pioneering technologies to remove PFAS from water, wastewater, and/or other liquids.  They utilize a variety of technological methods: Onvector LLC developed a plasma vortex reactor-based system; Claros Technologies, Inc. uses a photochemical method; and OxByEl Technologies, Inc.’s treatment relies on an electrochemical process.  One company, RemWell Inc., is working on a sonolysis reactor that will remediate PFAS in groundwater when placed in a horizontal well.  Another, BioLargo, Inc., uses an aqueous electrostatic concentrator to capture PFAS in a membrane for further treatment or disposal.

The only highlighted company that does not specialize in PFAS water treatment, Accurate Environmental Laboratories, developed a passive sampling method that determines levels of PFAS contamination in soils and sediments using diffusion.

Many of the small businesses report impressive efficacy, and some of their technologies are being applied in real-world situations.  Aquagga’s hydrothermal alkaline groundwater treatment process will soon be used for remediation projects at airports and air force bases.  Meanwhile, Cyclopure, Inc. is in the process of constructing full-scale regeneration and PFAS destruction facilities to administer its adsorbent-based PFAS water treatment.

Every year, EPA’s SBIR Program solicits technological proposals that address specific environmental topics.  Winning proposals are awarded contracts for “proof of concept” of the proposed technology and are eligible to apply for additional funding to further develop and commercialize the technology.  In five of the last six years, the program has included a PFAS-related topic in its batch of solicitations.

EPA Releases Chemical Data Reporting National Review

/in , ,

EPA has released its first-ever Chemical Data Reporting (CDR) National Review (“Review”), which provides a comprehensive analysis of data submitted to the Agency during the 2020 CDR reporting cycle. The report presents information about chemicals that were manufactured and imported into the US from 2016 through 2019. In its press release on the Review, the Agency stated that the document will assist stakeholders in evaluating and understanding information about the types, quantities, and uses of chemicals produced domestically or imported into the U.S.

Manufacturers and importers of chemical substances listed on the Toxic Substances Control Act (“TSCA”) Inventory are required to report data to the EPA every four years if they manufacture or import substances at or above specific thresholds unless the chemical has been exempted from the reporting requirement. Typically reporting is required when an entity manufactures or imports 25,000 pounds or more of a chemical during any year in the reporting period at any single site. Companies must report how chemicals are processed or used (industrial processing and use data), and whether they are used in commercial or consumer products (commercial and/or consumer use data) in addition to manufacturing and import volumes.

According to EPA, the CDR database is the most comprehensive source of basic screening-level, exposure-related information on chemicals that is available to the Agency. EPA uses the database to screen and prioritize chemicals for further review.

The Review summarizes data from the most recent CDR reporting cycle data (2020), covering activities from 2016 to 2019, and provides trend data for reporting over the past decade. During this reporting period, more than 7.2 trillion pounds of chemicals were manufactured or imported at 5,238 sites.

The Review provides interactive trend analysis, including an interactive map of CDR sites and characteristics of the communities in which these sites are located.  It also includes maps displaying CDR reporting sites by state, and figures with production volumes. In addition, the Review contains informational charts and figures to increase understanding of a variety of CDR data elements, such as analyses of chemical use information. Environmental justice tools from EPA’s EJScreen, the Agency’s environmental justice mapping tool, are also contained in the document.

The Review’s key findings include:

  • Of the more than 8,000 chemicals reported for the 2020 CDR reporting cycle, about 54% were manufactured domestically, and 46% were imported. This is a 10% increase in imported chemicals from the 2016 CDR.
  • Two industry sectors manufactured and imported the bulk of the volume reported to the 2020 CDR: petroleum and coal products manufacturing (64%) and chemical manufacturing (14%). Although it produced less volume than the petroleum and coal products sector, the chemical manufacturing sector produced the majority of chemicals (84%) reported to the 2020 CDR and represented nearly half (43%) of all sites.
  • 180 PFAS were reported by 57 sites for a total production volume of about 678 million pounds.
  • Of the 37 Chemicals undergoing Risk Evaluation, 33 chemicals were reported to the 2020 CDR; that is, they were manufactured or imported at above threshold volumes (2,500 lbs.) in at least one year during the reporting cycle. Thirty-four Risk Evaluation chemicals were reported in both the 2012 and 2016 reporting cycles.
  • Total production volume for the 33 TSCA Risk Evaluation chemicals was about 38 billion pounds. The volume was reported across 254 sites.
  • The number of sites that manufactured and/or imported TSCA Risk Evaluation Chemicals has increased by 40% over the past 10 years, while the manufactured and imported volumes have generally remained consistent.

Supreme Court to Debate Overturning Chevron Doctrine

/in

The U.S. Supreme Court has agreed to consider overturning the Chevron doctrine in the Court’s October 2023 term. Chevron is the legal doctrine that has given federal regulators broad power to define their authority. The appeal in Loper Bright Enterprises v. Raimondo, by four New Jersey fishing companies, asks the court to overturn the watershed 1984 Chevron v. Natural Resources Defense Council ruling. In the Chevron decision, the Supreme Court held that courts should defer to administrative agencies when they offer a reasonable interpretation of an unclear statute.

The case involves a federal requirement that some fishing vessels that are fishing herring off the Atlantic coast hire monitors for conservation and management purposes. The requirement specifically mandates that the fishing companies themselves are expected to pay for the monitors. The fishing companies challenged the requirement, claiming that Congress did not authorize the National Marine Fisheries Service (Service) to require them to pay for the monitors. The fishing companies allege that they could spend as much as 20 percent of their revenues on the monitors. In August 2022, the United States Court of Appeals, District of Columbia Circuit upheld the district court’s “grant of summary judgment [upholding the monitoring requirement] to the Service based on its reasonable interpretation of its authority and its adoption of the Amendment and the Rule through a process that afforded the requisite notice and opportunity to comment” requirement relying upon the Chevron doctrine.

The fishing companies argue that the Court can simply say Chevron does not apply because the law in question (the Magnuson-Stevens Act, which governs the management of marine fisheries in federal waters) does not say anything at all about requiring the industry to fund the cost of monitors. Therefore, there is no ambiguity to be interpreted in favor of the Agency.  On May 1, the Court granted certiorari to hear Question 2 from the fishing companies’ petition, which asked: “Whether the Court should overrule Chevron or at least clarify that statutory silence concerning controversial powers expressly but narrowly granted elsewhere in the statute does not constitute an ambiguity requiring deference to the agency.”

Overturning Chevron would put more responsibility on Congress to directly address policy issues and give judges more authority to define the limit of agency powers.

EPA Releases Draft National Strategy to Prevent Plastic Pollution

/in ,

In April, EPA released the Draft National Strategy to Prevent Plastic Pollution. This strategy document, part of EPA’s Series on Building a Circular Economy for All, outlines voluntary actions aimed at eliminating plastic waste released into the environment from land-based sources by 2040. Under this plan, EPA seeks to reduce, reuse, recycle, collect, and capture plastic waste. The draft strategy comprises three primary objectives, each focusing on different aspects of plastic pollution prevention:

Objective A: Reduce pollution during plastic production

This objective emphasizes minimizing pollution throughout the life cycle of plastic products. It encourages manufacturers and consumers to implement upstream actions such as designing products for reuse and recycling, using less impactful materials, and controlling plastic production facilities. Proposed actions include reducing the production and consumption of single-use, unrecyclable, or frequently littered plastic products, as well as minimizing pollution across the entire life cycle of plastic products.

Objective B: Improve post-use materials management

While the National Recycling Strategy identified actions to enhance recycling, this objective expands the focus to other pathways of circularity, including reuse, refill, and composting. Proposed actions involve conducting a study of existing policies and incentives to evaluate their effectiveness, developing or expanding capacity for maximizing material reuse, facilitating effective composting, increasing solid waste collection, enhancing public understanding of plastic mismanagement, and exploring ratification of the Basel Convention for environmentally sound management of scrap and recyclables.

Objective C: Prevent trash and micro/nanoplastics from entering waterways and remove escaped trash from the environment

Proposed actions include implementing policies, programs, and compliance assurance measures to prevent trash and microplastics from entering waterways, improving water management to capture trash in waterways and stormwater/wastewater systems, increasing awareness of the impacts of plastic products in waterways, and coordinating research on micro/nanoplastics.

The agency aims to gauge the importance of different actions, identify key steps and milestones for successful implementation, determine the roles and actions federal agencies should lead, and evaluate potential unintended consequences on overburdened communities. EPA also seeks input on relevant metrics and indicators to measure progress and invites recommendations for additional actions to include in the strategy.

Congress Enacts Modernization of Cosmetics Regulation

/in

Last month FDA published a webinar titled Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions.  The purpose of the program was to provide an overview of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”). The Act imposes new reporting and registration requirements on cosmetic manufacturers. In addition, under MOCRA, cosmetic manufacturing facilities will be required to implement Good Manufacturing Practices (GMPs).

Under MOCRA, mandatory reporting will be required for serious adverse health events caused by cosmetic products.  Responsible persons (i.e., manufacturers, packers, and distributors) will be required to report such events to FDA within 15 business days of learning about them. MOCRA defines serious adverse health events to include infections, incapacitation, significant disfigurement (e.g., serious rashes, second or third-degree burns, significant hair loss, or alternation of appearance), or any condition of severity that requires professional medical attention. Reports of adverse events must be accompanied by a copy of the label of the product at issue. Records related to adverse events must be maintained for six years. Responsible persons shall make these records to “authorized persons’ during inspections. FDA claims the new requirement aims to help FDA identify potential safety concerns with cosmetic products more quickly and take appropriate action to protect the public.

Cosmetic manufacturing facilities will now be required to register with FDA; existing facilities must register within one year of enactment of the Act, and new facilities must register within 60 days of first beginning cosmetics manufacture. Facilities must renew their registration biennially. Registration requirements include providing all brand names under which cosmetic products manufactured or processed in the facility are sold, a list of all cosmetic products manufactured at the facility, and for each product listed, product ingredients, including ingredients in fragrances and flavors. Manufacturers must also keep records documenting ‘adequate substantiation of safety’ providing competent and reliable evidence that products are safe for use. Further, the Act tasks FDA with establishing Good Manufacturing Practices within 2 years of MOCRA’s passage.

MOCRA also mandates the labeling of fragrance allergens for all cosmetics and ingredient labeling for professional use-only products used by salon workers. Additionally, FDA is to establish a standardized testing method for detecting asbestos in talc-containing products within 1 year of MOCRA’s enactment. MOCRA also requires the FDA to assess the use and safety of PFAS in cosmetics and to publish a report of the assessment to be by December 2025.

In addition, MOCRA allows FDA to request records related to a product’s safety substantiation and ingredients and request a mandatory recall of products that are misbranded and/or adulterated.

MOCRA includes a small business exemption for businesses reporting average gross annual sales for the previous three-year period is less than $1 million. The exemption is limited to small businesses that do not make cosmetics that come in contact with eye mucus membranes, are injected, intended for internal use, or alter the appearance for more than 24 hours. Qualifying businesses are exempt from the core provisions of MOCRA, including facility registration (Section 607) and good manufacturing practice or GMP (Section 606).

MOCRA preempts states from passing more stringent laws related to registration, product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. This means that cosmetic manufacturers will be subject to a uniform set of regulations across the country.

Community Sues EPA Over Terms for Production of Petrochemical Fuel

/in , ,

Cherokee Concerned Citizens, on behalf of the Cherokee Forest neighborhood  a fenceline community in Pascagoula, Mississippi, has filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit for review of a TSCA section 5(e) consent order. The consent order covers 18 chemicals that were the subject of premanufacture notifications submitted by Chevron in 2021. In its press release announcing the litigation, Earthjustice asserted that the production of these chemicals would result in air pollution that would pose a 1 in 4 cancer risk (25 % of the residents living nearby could develop cancer over their lifetime), 250,000 times greater than what the Agency typically considers unreasonable.

TSCA requires EPA to regulate the manufacturing, processing, and distribution of substances that present an unreasonable risk of injury to health or the environment without consideration of costs or other non-risk factors. The Statute states that the Administrator shall issue consent orders and significant new use rules “to the extent necessary to protect against such risk.”

EPA identified skin and eye irritation; acute toxicity; systemic toxicity (neurotoxicity, body weight effects, and liver, kidney, blood, spleen, and other organ effects); reproductive and developmental toxicity; oral and inhalation portal of entry effects; genetic toxicity; and carcinogenicity as hazards of these New Chemical Substances. These hazards were identified based on the substance’s estimated physical/chemical properties by comparing them to compositionally analogous mixtures for which there is information on human health hazard, using available human hazard information on representative constituents of these New Chemical Substances, and other structural information. As is often the case with PMNs, there were no experimentally derived hazard data for these New Chemical Substances.  For a number of the substances, risks were identified for the general population (infants) for systemic and/or oral portal-of-entry effects via drinking water. Risks to adults for this exposure route were also identified. In addition, risks were identified for the general population for systemic and/or inhalation portal-of-entry effects via fugitive air inhalation for some of the substances at issue.

The consent order imposes worker protection and limitations on the distribution of the new chemical substances. It does not restrict air emissions or wastewater discharges of the substances. The Chevron facility called out by Earthjustice is permitted under the Clean Air and the Clean Water Acts.

EPA Improves ChemView

/in ,

EPA uses ChemView as a means for the public to access information about chemicals under the Toxic Substances Control Act (TSCA).  The web application allows searches for information such as volumes reported to the Chemical Data Reporting Rule, Premanufacture Notification determinations, section 5(e) consent orders, health and safety studies submitted under section 8(d) and section 8(e) substantial risk reports.  Only non-confidential business information is accessible.  EPA announced they have also been working to improve ChemView to reduce the delay between when the Agency receives information and when it publishes that information – EPA is trying to achieve near real-time publication.  The Agency is also working to enhance transparency in its processes for evaluating potential risks posed by different chemicals.

EPA is required to publish certain information under TSCA section 5(d), such as the list of new chemical submissions received, microbial commercial activity notices, premanufacture notices, and significant new-use notices. Throughout 2022, EPA used ChemView to make available more than 25,000 new chemical notice records that EPA has received under TSCA section 5.  The 25,000 new chemical notice records include previously unpublished records from 2014 through 2019. EPA plans to continue publishing previously unpublished records into the future and is currently publishing new records within five days of receiving them.

As noted above, EPA also uses ChemView to publish records received under TSCA section 8, including substantial risk reports.  Throughout 2022, EPA published 3,900 substantial risk reports, including over 3,300 reports received from the beginning of 2019 through the end of 2021; all of which were previously unpublished.

ASTM International Publishes Case Study on Standards for Biodegradable Plastic

/in

ASTM International, in celebration of its 125th anniversary, solicited case studies from committee members to showcase standards that have had a significant impact on society. One of the winning entries highlights a set of standards for biodegradable plastic from Committee D20 on Plastics. Two companion specification standards for compostable plastics and paper coatings have been established to promote environmentally responsible end-of-life solutions. These ASTM standards, D6400 and D6868, respectively, are crucial for gaining acceptance in the marketplace and regulatory bodies in states such as California, Washington, Minnesota, Rhode Island, and Connecticut. The plastics industry exclusively uses D6400 and D6868 for making biodegradability claims under industrial composting conditions, and these standards also serve as the basis for certifications issued by U.S. and European organizations. Many stakeholders require that compostable products meet D6400 for plastics and D6868 for coatings on paper, and industrial composters also demand adherence to these standards for the products applicable to composting