USA Regulatory News

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).

On March 25, 2024,  the US Environmental Protection Agency (EPA) issued a fourth test order under the Toxic Substances Control Act (TSCA) to require testing for per- and polyfluoroalkyl substances (P...

On March 25, 2024,  the US Environmental Protection Agency (EPA) issued a fourth test order under the Toxic Substances Control Act (TSCA) to require testing for per- and polyfluoroalkyl substances (PFAS) as part of the National PFAS Testing Strategy. This is the latest step taken under EPA’s PFAS Strategic Roadmap. 

Test Order for NMeFOSE 

Under the terms of this action, Wacker Chemical Corporation and 3M Company are required to test 2-(N-Methylperfluoro-1-octanesulfonamido) ethanol (NMeFOSE) for physical and chemical properties, as well as potential inhalation health effects after. NMeFOSE is found in various products such as clothing, carpet treatments, furniture coatings, biosolids, and air. It can also be found in outdoor environmental media, indoor dust, and indoor air. 

After carefully reviewing available hazard and exposure data, EPA has determined that there may be an excessive risk of harm to human health or the environment from NMeFOSE. Cancer and damage to the immune and neurological systems are possible side effects of exposure to the chemical. The test order will assist EPA better understand the potential risks and exposures related to NMeFOS.                                                                                                                    
EPA encourages the companies to conduct the test together to avoid unnecessary duplication of tests. Companies covered by the test order have two options: either carry out the tests as specified in the order or provide any known information that meets the order's criteria. EPA will also consider potential combinations of tests to reduce the time, animals, and costs required.

                                                                                                             
The order goes into effect on March 25, 2024, and EPA must receive the results of all first-tier tests within one year to determine what additional tests are required. 

National PFAS Testing Strategy 

EPA is ordering tests for PFAS in categories where toxicity data are lacking to understand their potential effects on human health and the environment. The strategy aims to increase consideration of exposures and stakeholder input in determining which specific PFAS should be tested and improve their classification and universe. 

Section 4 Test Orders  

The TSCA Section 4 Order development process is complex and resource-intensive, involving a range of specialists to establish testing requirements, methodology, and financial impact estimates. EPA often covers multiple companies and their points of contact and resolves claims of confidential business information to increase transparency. This process involves identifying companies and their points of contact to ensure that EPA can effectively link the company to the chemical substance. 

The Environmental Protection Agency (EPA) is proposing Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemicals previously reviewed in premanufacture notices (PMNs...

The Environmental Protection Agency (EPA) is proposing Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemicals previously reviewed in premanufacture notices (PMNs). These chemicals have been deemed "not likely to present an unreasonable risk" under TSCA. The SNURs require notification to EPA at least 90 days before manufacturing or processing any of these chemicals for a newly proposed significant use.

Proposed Rule:

Under TSCA, EPA must make a determination and take necessary action prior to the manufacture or processing of a new chemical substance or for a significant new use. A SNUR is not a risk determination itself but requires notification for “significant new uses” so that EPA can review and assess the risk. Following EPA's review of a pre-manufacture notice (PMN), a Microbial Commercial Activity Notice (MCAN), or a Significant New Use Notice (SNUN) under TSCA Section 5, it may take appropriate action. Manufacturers must await EPA's review and decision before commencing manufacturing or processing for a significant new use.

Potentially affected entities may include manufacturers or processors of one or more subject chemical substances such as chemical manufacturing and petroleum refineries. For exporters of substances subject to SNURs, a single notification to EPA is required for the first export to a specific country.

Costs:

Submitting a Significant New Use Notice (SNUN) has an estimated cost of $26,700 for large companies and $11,000 for small companies. These costs cover preparation and submission of the SNUN, including registration on EPA's Central Data Exchange (CDX), along with payment of user fees. Large companies pay a user fee of $19,020, while small companies, as defined in 13 CFR 121.201, pay a reduced fee of $3,300 per fiscal year.

The total expenses for export notification will vary based on the requirements of the chemical and the number of countries involved.

Factors assessed while determining that the use of a chemical substance is a significant new use include:

• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the extent and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacture, processing, distribution in commerce, and disposal of a chemical substance.

Submission of Significant New Use Notifications (SNUNs) requires completion of EPA Form No. 7710-25, which is generated using e-PMN software, and compliance with the procedures outlined in 40 CFR 720.40 and 721.25. The e-PMN software can be accessed electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

This proposed rule is assigned Docket Number EPA-HQ-OPPT-2021-0228. It was notified to the World Trade Organization (WTO) on April 9, 2024. The deadline for submitting comments is May 8, 2024.