USA Regulatory News

The state of Colorado has updated its legislation regarding products with intentionally added PFAS, with phased implementation beginning in January 2025. On May 1, 2024, the Governor signed SB 24-081 ...

The state of Colorado has updated its legislation regarding products with intentionally added PFAS, with phased implementation beginning in January 2025. On May 1, 2024, the Governor signed SB 24-081 which makes significant revisions to the existing regulations. This amendment makes several key changes to the current regulatory framework. 

Previous PFAS Legislation 

In 2022 the State of Colorado passed legislation (the "Perfluoroalkyl and Polyfluoroalkyl Chemicals Consumer Protection Act") to establish a regulatory scheme that prohibits the sale or distribution of certain products (i.e. carpets, fabric treatments, food packaging, oil/gas products) that contain intentionally added perfluoroalkyl and polyfluoroalkyl chemicals (PFAS chemicals). “Intentionally added PFAS chemicals” are defined as "PFAS chemicals that a manufacturer intentionally adds to a product and that have a functional or technical effect on the product” and also include any “intentional breakdown products” of added PFAS chemicals. 

New PFAS Legislation 

The new bill titled the “Perfluoroalkyl and Polyfluoroalkyl Chemicals Protection Act” includes the following restrictions on the use of intentionally added PFAS in consumer products:  

• January 1, 2025: The sale or distribution of certain outdoor apparel meant for prolonged or intensive use in extremely wet conditions (outdoor apparel for extremely wet condition) that contains intentionally added PFAS chemicals will be prohibited unless the product is accompanied by a disclosure stating that it contains PFAS chemicals (disclosure requirement). 

• January 1, 2026:  The sale and distribution of cleaning products, cookware, dental floss, menstrual products and ski wax that contain intentionally added PFAS chemicals will be prohibited as part of the product phaseout timeline. However, floor maintenance products used in hospitals or medical settings are exempted until January 1, 2028. 

• July 1, 2026: It will be illegal for anyone to install artificial turf containing intentionally added PFAS chemicals on any part of property in the state. 

• January 1, 2028: The disclosure requirement will be repealed, and the sale or distribution of outdoor apparel intended for extreme wet condition that contains intentionally added PFAS chemicals will be prohibited. In addition, the sale and distribution of textile articles and food contact equipment intended primarily for use in commercial settings that contain intentionally added PFAS will also be prohibited. 

• January 1, 2032: The product phaseout timeline will be repealed and the sale or distribution of any non-exempted product containing intentionally added PFAS chemicals will be prohibited.  

The full text of SB 24-081 can be found here. 

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has announced a final rule to update the Hazard Communication Standard (HCS). This update aligns the HCS primarily...

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has announced a final rule to update the Hazard Communication Standard (HCS). This update aligns the HCS primarily with the seventh revised edit of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS 7). Published on May 20, 2024, the rule will take effect on July 19, 2024.

This final rule aims to address issues that have arisen since the implementation of the 2012 standard, as well as improve alignment with other federal agencies and Canada.

History:

The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) has been adopted worldwide to standardize the handling and labeling of hazardous chemicals. In 2012, the Occupational Safety and Health Administration (OSHA) revised its Hazard Communication Standard (HCS), 29 CFR 1910.1200, to align with the third revision of the GHS (GHS 3) (77 FR 17574). The GHS is updated every two years to incorporate improvements and clarifications. Since OSHA adopted GHS 3, there have been seven updates, the most recent being Revision 10, published in 2023. The current rulemaking primarily aligns the HCS with GHS 7, which waspublished in 2017.

Established in 1983, the HCS aims to standardize the communication of workplace hazards associated with hazardous chemicals. It mandates chemical manufacturers and importers to classify the hazards of the chemicals they produce or import. The latest amendments do not alter the basic structure of the HCS.

OSHA has determined that these updates will improve the effectiveness of the HCS, ensuring that employees are better informed about the chemical hazards they may encounter. This, in turn, is expected to reduce the incidence of chemical-related occupational illnesses and injuries. The revisions include updated criteria for classifying certain health and physical hazards, new provisions for updating labels and labeling small containers, changes related to trade secrets, technical amendments concerning the contents of safety data sheets (SDSs), and updates to definitions used in the standard.

Major changes to the Hazard Communication Standard:

• Hazard Classification: Provides specific criteria for classifying health and physical hazards and classifying of mixtures.

• Labeling: Chemical manufacturers and importers must now include a harmonized signal word, pictogram and hazard statement for each hazard class and category on their labels. Precautionary statements are also mandatory. Additionally, labels on shipped containers must display the date the chemical is released for shipment. There are new, detailed labeling requirements for small containers, specifically those with a capacity of 100 ml or less.

• Safety Data Sheets: The format for Safety Data Sheets (SDS) is now standardized to a specified 16-section layout.

• Information and Training: Employers are required to train their workers on the new label elements andupdated Safety Data Sheets format to facilitate recognition and understanding.

• Trade Secrets: When claiming a specific concentration of a substance as a trade secret, prescribed concentration ranges must now be used, adding a layer of transparency and safety.

Manufacturers, importers and distributors must comply with the new requirements by January 19, 2026, for substances and by July 19, 2027, for mixtures. Employers have until July 20, 2026, for substances and January 19, 2028, for mixtures tocomply with the new standards.

Please see the Federal Register Notice for more information.

On May 10, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend Title 27, Section 25705(c)(2) of the California Code of Regulations to establish a Propositio...

On May 10, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend Title 27, Section 25705(c)(2) of the California Code of Regulations to establish a Proposition 65 No Significant Risk Level (NSRL) for titanium dioxide (airborne, unbound respirable particles). The proposal is open for public comment until June 24, 2024, and comments may be submitted electronically through OEHHA’s website (https://oehha.ca.gov/comments).

Background:

The Safe Drinking Water and Toxic Enforcement Act of 1986, known as “Proposition 65,” mandates that businesses provide clear warnings before knowingly exposing individuals to chemicals identified as carcinogens or toxic to reproduction. It also prohibits the discharge of these chemicals into water sources or onto land where they may contaminate drinking water.

The Office of Environmental Health Hazard Assessment (OEHHA) oversees the implementation of Proposition 65 and may adopt regulations to further its goals. Safe harbor levels, which include No Significant Risk Levels (NSRLs) for carcinogens and Maximum Allowable Dose Levels (MADLs) for reproductive toxicants, have been established for many listed chemicals. Exposures and discharges below these levels are exempt from the requirements of Proposition 65.

The proposed NSRL for titanium dioxide specifies that no warning is needed if the average daily exposure is at or below the following levels:

• For airborne, unbound particles with diameters of 10 micrometers (µm) or less, the proposed NSRL is 440 micrograms (µg); and
• For airborne, unbound particles with diameters of 0.8 µm or less, the proposed NSRL is 44 µg.

Other forms of titanium dioxide, such as non-airborne particles or those bound within a product matrix (e.g., rubber, ink, or paint), are not on the Proposition 65 list and thus do not require a warning.

History:

OEHHA maintains the Proposition 65 list of carcinogens and reproductive toxicants, including chemicals identified as human or animal carcinogens by the International Agency for Research on Cancer (IARC). A chemical is listed if IARC has classified it as carcinogenic to humans or possibly carcinogenic with sufficient evidence of carcinogenicity in animals.

IARC has classified titanium dioxide (TiO2) as a Group 2B carcinogen, which means that it is "possibly carcinogenic to humans." Consequently, OEHHA listed titanium dioxide (airborne, unbound particles of respirable size) as a carcinogen on September 2, 2011. The National Institute for Occupational Safety and Health (NIOSH) also determined in 2011 that ultrafine TiO2 is a potential occupational carcinogen.

Anticipated Benefits of the Proposed Regulation:

Regulated businesses using the NSRL will find it easier to determine if their products' exposure to titanium dioxide (airborne, unbound particles of respirable size) poses no significant cancer risk. This simplifies compliance, reduces over-warning, and supports the statute's goal of promoting the health and safety of Californians. Additionally, while the NSRL doesn't mandate reduced exposures, it may encourage businesses to reduce exposures to non-significant risk levels, thereby benefiting public health.

On April 30, 2024, the U.S. Environmental Protection Agency (EPA) implemented a ban on most uses of methylene chloride, a hazardous substance linked to several cancers, neurotoxicity, liver damage, an...

On April 30, 2024, the U.S. Environmental Protection Agency (EPA) implemented a ban on most uses of methylene chloride, a hazardous substance linked to several cancers, neurotoxicity, liver damage, and even death. This action, taken under the Toxic Substances Control Act (TSCA), aims to protect public health while permitting essential uses by enhancing worker protection measures.

Methylene Chloride:

Methylene chloride is widely used by consumers for products such as aerosol degreasing and paint and coating brush cleaners, as well as in commercial and industrial applications, including the production of environmentally friendly refrigerants. Despite an EPA ban on one consumer use in 2019, methylene chloride remains prevalent and has led to numerous deaths, particularly among workers in the paint stripping and refinishing industries, even when equipped with protective gear.

EPA’s Final Rule:

EPA's final risk management rule mandates a swift reduction in the production, processing, and distribution of methylene chloride for consumer, industrial, and commercial uses, including its use in home renovations. Consumer uses will be phased out within one year, while most industrial and commercial uses will be banned within two years. Additionally, the rule establishes comprehensive worker protections through a Workplace Chemical Protection Program that ensures strict exposure limits, monitoring, and training to protect against health hazards such as cancer from exposure to methylene chloride.

The uses that will continue under the Workplace Chemical Protection Program are highly industrialized and important to national security and the economy. These activities, backed by data and evidence, demonstrate that workplace safety measures can effectively mitigate any unreasonable risks. They include:

1. Use in the production of other chemicals, including refrigerant chemicals that are important in efforts to phase down climate-damaging hydrofluorocarbons under the bipartisan American Innovation and Manufacturing Act.
2. Production of battery separators for electric vehicles.
3. Use as a processing aid in a closed system.
4. Use as a laboratory chemical.
5. Use in plastic and rubber manufacturing, including polycarbonate production.
6. Use in solvent welding.

In highly specialized settings such as those mandated by the National Aeronautics and Space Administration (NASA), the Department of Defense, and the Federal Aviation Administration, strict workplace controls will continue for specific applications of methylene chloride.

Under the Workplace Chemical Protection Program, workplaces that continue to use methylene chloride will have 18 months after the risk management rule is finalized to align with the program's guidelines. They will need to conduct regular monitoring of their premises to guarantee that workers aren't exposed to levels of methylene chloride that pose unreasonable risks.

For more information, please refer to the Risk Management for Methylene Chloride page.

The California Department of Public Health (CDPH) has revised its fragrance allergen reporting guidance for cosmetic products. This revision comes after the inclusion of 155 new substances, including ...

The California Department of Public Health (CDPH) has revised its fragrance allergen reporting guidance for cosmetic products. This revision comes after the inclusion of 155 new substances, including 56 fragrance allergens, to the state’s Reportable Ingredient List (RIL) in late 2023.

Background:

For nearly twenty years, companies in California have been obligated to reveal carcinogenic or reproductive toxic chemicals in their products under the California Safe Cosmetics Act (CSCA) of 2005. The 2020 Cosmetic Fragrance and Flavor Ingredient Right to Know Act (CFFIRKA) expanded this requirement to include fragrances and flavors. A recent update to the reporting guidelines distinguishes fragrance allergens from general "fragrance ingredients” that are added to enhance or neutralize odors. The CSCA and CFFIRKA require disclosure of such ingredients to the California Department of Public Health. The CSCP compiles all ingredients that are reportable under both the CSCA and CFFIRKA in its CSCP Reportable Ingredient List [​Excel], which is updated twice a year. When the list is updated, companies are given a six-month window to ensure compliance.

Recent update:

In the CFFIRKA report, ingredients labeled as "fragrance allergens" have specific reporting guidelines. Unlike other fragrance components, these allergens must be reported regardless of their purpose in the product, even if they're not intended to provide fragrance or odor control. Moreover, they must be disclosed in rinse-off cosmetics if their concentration is at or above 0.01 percent (100 parts per million) and in leave-on cosmetics if their concentration is at or above 0.001 percent (10 parts per million). The CSCP Reportable Ingredients List clearly identifies fragrance allergen ingredients. All other listed ingredients must be reported regardless of their concentration in the product.

As of March 27, 2024, the Summary of Updates tab of the Reportable Ingredient List will now mark all newly listed fragrance allergens from the European Union (EU) with an asterisk. This indicates that cosmetic product manufacturers in California must report each of these allergens, as specified in Annex III of the EU Cosmetics Regulation No. 1223/2009, to the California Department of Public Health (CDPH) by either 2026 or 2028, in accordance with EU law. However, they have the flexibility to submit this information before the deadlines. Additionally, cosmetic manufacturers, packers, and distributors are required to notify the CDPH of any ingredients known or suspected to be harmful as outlined in one or more of 23 designated lists created by various authoritative bodies.

On April 19, 2024, the US Environmental Protection Agency (EPA) published a rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), along with their salts and structura...

On April 19, 2024, the US Environmental Protection Agency (EPA) published a rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), along with their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as Superfund. This amendment to Title 40 of the Code of Federal Regulations will become effective 60 days after publication in the Federal Register.

Background

PFOA, PFOS, their salts, and structural isomers are considered hazardous substances under CERCLA due to their prolonged accumulation and persistence in the human body. Studies on both laboratory animals and human populations have revealed a correlation between exposure to these substances and adverse health effects including cancer, immune system disruption, cardiovascular issues, liver damage, and harm to developing fetuses. Failure to address these contaminants will lead to continued migration, increased exposure risks and potential cleanup expenses.

CERCLA aims to identify and prioritize sites that pose unreasonable risks to human health, ensure the prompt cleanup of contaminated areas and hold responsible parties accountable for significant pollution. This approach aligns with CERCLA's core objectives of cleaning up contaminated sites and enforcing the "Polluter Pays" principle, which enables EPA to require responsible parties to cover the costs for cleanup.

Reporting Requirements

The direct effects of the rule require:

• All releases of PFOA and PFOS surpassing the one-pound Reportable Quantity (RQ) within a 24-hour period must be reported to the National Response Center (NRC). A subsequent written report should be submitted to the State Emergency Response Commission (SERC) or Tribal Emergency Response Commission (TERC), as well as the Local Emergency Planning Committee (LEPC) or Tribal emergency planning committee (TEPC), at the earliest opportunity after the release.
• Federal entities that transfer or sell property must notify storage, release, or disposal of PFOA or PFOS. They must also include a covenant in the deed, committing to clean up any resulting contamination as per CERCLA 120(h).
• The U.S. Department of Transportation must list and regulate these substances as hazardous materials under the Hazardous Materials Transportation Act.

• Vessel or facility owners/operators must give reasonable notice of any release of these substances to potentially affected parties by publication in local newspapers about.

This rule may impact various entities including, but not limited to:

1. Manufacturers (including importers) of PFOA and/or PFOS, and articles containing these substances.
2. Processors of PFOA and/or PFOS.
3. Manufacturers of products containing PFOA and/or PFOS.
4. Downstream users of PFOA and PFOS.
5. Downstream users of products containing PFOA and/or PFOS.
6. Waste management facilities.
7. Wastewater treatment facilities.

The pre-publication of final rule can be accessed here. 

On April 9, 2024, the U.S. Environmental Protection Agency (EPA) issued an updated "Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) and Materia...

On April 9, 2024, the U.S. Environmental Protection Agency (EPA) issued an updated "Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) and Materials Containing PFAS" as part of its PFAS Strategic Roadmap.

The revised guidance incorporates the latest scientific advancements to help PFAS waste managers determine the most suitable methods for destruction, disposal, or storage. It advises decision makers to prioritize technologies with minimal potential for environmental release to protect individuals and communities from PFAS exposure. Notably, the interim guidance does not impose specific requirements for the destruction or disposal of PFAS materials.

Updates from the Guidance document:

The updated interim guidance continues to focus on three primary D&D (destruction and disposal) technologies:

1) Underground injection (UIC)

2) Landfills

3) Thermal treatment under certain conditions, which includes incineration.

It incorporates public feedback on EPA’s 2020 Guidance, integrates years of governmental and private sector technological advances, and outlines new EPA testing methods and improved screening tools to identify and prioritize protections for communities residing near D&D facilities, particularly those already burdened by pollution. By addressing key data gaps and uncertainties, ongoing research aims to improve the efficient destruction of PFAS while minimizing their release into the environment.

Key Findings in 2024:

The new EPA guidance emphasizes the importance of selecting destruction and disposal (D&D) technologies that minimize the potential for PFAS release to the environment. The interim guidance outlines several preferred options in different categories:

• Interim storage with controls, though not a definitive D&D solution, could be considered temporarily. Its suitability depends on the type of PFAS materials involved. For instance, EPA recommends interim storage for containerized or high PFAS-content materials. However, materials that are continuously produced or have low PFAS content and high volume may not be suitable for storage. Effective controls during interim storage can help manage PFAS migration.

• UIC-Permitted Class I non-hazardous industrial or hazardous waste injection wells: Designed to isolate liquid wastes deep underground and protect drinking water sources, these wells are a viable option for managing PFAS-containing fluids, although availability may vary.

• Permitted Hazardous Waste Landfills: Hazardous waste landfills, especially when PFAS concentrations in the waste are high, are recommended for landfill disposal because they protect against leachate emissions that help control PFAS releases to the environment.

• Thermal Treatment–Permitted hazardous waste combustors that operate under certain conditions: Recent research suggests that certain thermal treatment units are more effective at destroying PFAS and minimizing releases or exposures. However, uncertainties remain regarding potential harmful byproducts or air emissions of PFAS, particularly for units operating at lower temperatures.

EPA has introduced a new analytical test method, OTM-50, to gather additional data and address inquiries, particularly regarding incomplete combustion products. The revised interim guidance advises thermal treatment facilities to use various test methods before accepting significant volumes of PFAS-containing materials.

Further Action:

EPA welcomes feedback on the interim guidance for 180 days following its publication in the Federal Register. Comments can be submitted to the public docket at Regulations.gov, Docket ID: EPA-HQ-OLEM-2020-0527. EPA will then assess public comments, advances in research, and new scientific findings to update the interim guidance within three years, as required by the National Defense Authorization Act (NDAA).