USA Regulatory News

On September 3, 2024, the White House Office of Science and Technology Policy (OSTP) unveiled a new federal research strategy to address per- and polyfluoroalkyl substances (PFAS), commonly referred t...

On September 3, 2024, the White House Office of Science and Technology Policy (OSTP) unveiled a new federal research strategy to address per- and polyfluoroalkyl substances (PFAS), commonly referred to as "forever chemicals." This initiative builds on the Biden-Harris Administration’s ongoing efforts to protect communities from PFAS contamination, while supporting the Biden Cancer Moonshot’s mission to reduce Americans' exposure to cancer-causing chemicals.

Per- and Polyfluoroalkyl Substances

Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals that have been used in consumer products since the 1950s. Found in items such as non-stick cookware, stain-resistant fabrics, and firefighting foam, PFAS are highly durable due to their strong carbon-fluorine bonds, making them resistant to environmental degradation.

Background:

In recent years, the Biden-Harris Administration has intensified efforts to prevent PFAS releases and expand cleanup initiatives. In March 2023, the PFAS Strategy Team (PFAS ST) released a scientific report identifying research gaps and opportunities that informed the development of a new strategic plan. The report highlighted key areas for future research, including PFAS sources and exposure pathways, toxicity, removal and destruction methods, and safer alternatives to these chemicals.

Strategy:

Building on the 2023 PFAS Report, the PFAS Strategy Team has outlined four key goals for federal research and development on PFAS. These include:

1. Improving scientific data on exposure pathways.
2. Enhancing communication with affected communities and agencies.
3. Identifying technologies to address contamination.
4. Providing information to guide procurement decisions on PFAS-containing products and alternatives to minimize health and environmental risks.

The PFAS ST has identified five key research and development strategies to address existing knowledge gaps on PFAS. These strategies focus on:

1. Understanding PFAS exposure pathways to individuals and communities.
2. Addressing current PFAS measurement challenges through the development of standards, advanced sampling and analytical methods.
3. Understanding the toxicological mechanisms, human and environmental health effects, and risks of PFAS exposure.
4. Developing, evaluating, and demonstrating technologies for the removal, destruction, and disposal of PFAS.
5. Identifying PFAS alternatives and evaluate their human health and environmental effects.

The team also aims to create a comprehensive database of alternative materials and products currently available in the market. This database will include relevant chemical and toxicological data, manufacturers’ production capacities, and performance comparisons between PFAS-containing products and their alternatives.

The successful implementation of this plan will enhance scientific progress and address regulatory, research, and mitigation gaps related to PFAS, while also addressing issues of disproportionate exposure, contamination, and toxicity.

On September 5, 2024, the U.S. Environmental Protection Agency (EPA) issued a direct final rule delaying the start of the reporting period for the October 2023 PFAS reporting rule under the Toxic Subs...

On September 5, 2024, the U.S. Environmental Protection Agency (EPA) issued a direct final rule delaying the start of the reporting period for the October 2023 PFAS reporting rule under the Toxic Substances Control Act (TSCA). Originally set to begin on November 12, 2024, the reporting period is now postponed until July 2025 due to resource constraints.

Background:

Under section 8(a)(7) of the Toxic Substances Control Act (TSCA), a reporting rule mandated by the FY2020 National Defense Authorization Act requires all manufacturers, including importers, of per- and polyfluoroalkyl substances (PFAS) and products containing PFAS since 2011 to report detailed information to EPA. This includes data on chemical identity, uses, production and processing volumes, byproducts, environmental and health effects, worker exposure, and disposal practices.

The 2023 reporting rule would have provided EPA, its partners, and the public with the largest dataset on PFAS manufactured and used in the U.S., a critical step in the agency’s PFAS Strategic Roadmap. This data will help EPA and state, local, and Tribal governments understand the uses and quantities of PFAS and support efforts to research, monitor, and regulate these chemicals. However, due to long-standing resource constraints, including a $5 million budget cut in FY 2024, EPA's program has delayed implementation of the rule and reduced its IT operating budget, impacting key initiatives and contractual support for data collection systems.

Due to delays, the agency's software application for collecting PFAS data will not be ready by the originally scheduled November 2024 opening date, making it impossible for submitters to begin submitting data by that date.

Proposed rule:

The proposed rule aims to adjust the data submission timeline by opening the submission period on July 11, 2025, when the Agency anticipates its software reporting application will be fully operational. Most reporters will be required to complete their submissions by January 11, 2026. However, small businesses that report only on the import of articles containing PFAS will have until July 11, 2026, to submit their reports.

To assist those affected by this rule, EPA has made guidance materials available on its website. EPA plans to launch a new guidance webpage on the TSCA GuideME database in the coming months, which will feature additional resources such as video tutorials, fact sheets, and other electronic reporting tools to help with compliance. EPA is also accepting public comments on both the direct final rule and the proposed rules until October 7, 2024, during a 30-day comment period.

On September 6, 2024, the U.S. Environmental Protection Agency (EPA) issued an Enforcement Alert under the American Innovation and Manufacturing Act (AIM Act), aimed at phasing down the production and...

On September 6, 2024, the U.S. Environmental Protection Agency (EPA) issued an Enforcement Alert under the American Innovation and Manufacturing Act (AIM Act), aimed at phasing down the production and consumption of hydrofluorocarbon (HFC). The Alert highlights common compliance issues with bulk HFC imports and recent enforcement actions and urges companies to follow regulations to avoid potential penalties and support efforts to address the climate crisis.

AIM Act:

The AIM Act, enacted on December 27, 2020, mandates an 85% phasedown of hydrofluorocarbons (HFCs) from historical baseline levels by 2036. EPA is authorized to limit production, consumption, and imports of HFCs; facilitate the transition to next-generation technologies; and minimize releases from equipment that uses HFCs. To implement this, EPA will issue transferable HFC production and import allowances (which producers and importers of HFCs must hold in quantities equal to the amount of HFCs they produce or import). The rule sets baselines, establishes allowance allocations, and outlines recordkeeping and compliance measures. Between 2022 and 2050, this phasedown is expected to prevent the emission of 4,560 million metric tons of HFCs in the U.S. Violations of the requirements established in the AIM Act may be subject to administrative, civil, or criminal enforcement actions. 

Hydrofluorocarbons:

Commonly used in air conditioning, refrigeration, fire suppression, solvents, foam blowing agents, and aerosols, HFCs are potent greenhouse gases with global warming potentials (GWPs) hundreds to thousands of times higher than CO2. Their global use has surged due to the phaseout of ozone-depleting substances and increasing demand for cooling. However, lower GWP alternatives, including non-fluorinated options and HFC blends, are available or under development. EPA’s efforts under the AIM Act contribute to a global HFC phasedown, which could reduce global warming by up to 0.5°C when fully implemented.

Updates:

In fiscal year 2024, EPA has completed nine civil settlements addressing unlawful imports of hydrofluorocarbons (HFCs), including recent actions against five companies. These companies imported HFCs without proper allowances, in violation of the AIM Act. The cases prevented emissions equivalent to more than 24,000 metric tons of CO2, comparable to the annual electricity use of 14,000 homes. The companies will pay a total of $115,551 in penalties. Additionally, criminal enforcement actions have been initiated this fiscal year.

If you suspect illegal HFC imports, please report them to the EPA through its Report Environmental Violations webpage.

On September 10, 2024, the Food and Drug Administration (FDA) acknowledged concerns regarding the safety of tampons after a 2024 study found metals in tampons during laboratory testing. To be legally ...

On September 10, 2024, the Food and Drug Administration (FDA) acknowledged concerns regarding the safety of tampons after a 2024 study found metals in tampons during laboratory testing. To be legally sold in the U.S., tampons must adhere to FDA standards for safety and effectiveness. Manufacturers are required to test the product and its materials at various stages of production. Additionally, biocompatibility testing, conducted by the manufacturer and reviewed by the FDA, is a crucial part of the safety evaluation before a product can be approved for market use.

Study:

Researchers at the University of California, Berkeley, have identified several toxic metals in tampons from 14 major brands across 30 different product lines. The study detected varying levels of arsenic, barium, calcium, cadmium, cobalt, chromium, copper, iron, manganese, mercury, nickel, lead, selenium, strontium, vanadium, and zinc. However, the research did not investigate whether these metals are released during tampon use, absorbed into the vaginal lining, or enter the bloodstream.

Notably, the study found lead and other toxic metals in some products, which is concerning because lead has no known safe exposure level. Further research is needed to confirm these findings and explore if these metals can leach out and affect systemic health.

Action by FDA:

All tampons currently approved by the FDA have been assessed according to the guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) and have been found to meet FDA premarket requirements.

The Biocompatibility and Toxicology Program at the FDA’s Center for Devices and Radiological Health (CDRH) ensures that medical devices are safe and effective through regulatory science research.

The FDA has launched an independent literature review and an internal laboratory study to assess metals in tampons. The laboratory study will simulate typical use conditions to gauge metal release and help the FDA evaluate potential risks. Findings will be shared publicly after peer review. The FDA will maintain oversight of tampons as part of its comprehensive total product lifecycle approach to medical devices.

On July 5, 2024, the Office of Information and Regulatory Affairs (OIRA) published the "Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions," which provides updates on various proposed r...

On July 5, 2024, the Office of Information and Regulatory Affairs (OIRA) published the "Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions," which provides updates on various proposed rules affecting cosmetics in the U.S. Two key proposed rules under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) have been delayed, with further delays possible:

• Disclosure of Fragrance Allergens in Cosmetic Labeling: MoCRA initially required the FDA to issue a proposed rule by June 29, 2024, mandating the disclosure of fragrance allergens on cosmetic labels. The Unified Agenda now indicates that this rule will be issued in October 2024.
• Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetics: The FDA was expected to propose standardized testing methods for detecting asbestos in talc-containing cosmetics by December 29, 2023. This proposal has been delayed to July 2024, but no rule has yet been released.

The Unified Agenda also updated the timeline for a proposed rule to ban formaldehyde and formaldehyde-releasing ingredients in hair straightening and smoothing products. Originally expected in October 2023, the proposal is now expected to be released in September 2024.

FDA Announces Enhancements to Cosmetics Direct Submission Portal

On July 29, 2024, the U.S. Food and Drug Administration (FDA) introduced updates aimed at helping the cosmetics industry maintain its registration and listing submissions. The most significant updates include two new features in Cosmetics Direct, the electronic submission portal established by MoCRA.

The new features allow for the discontinuation and relisting of cosmetic product listings. The discontinuation feature enables responsible persons - manufacturers, packers, or distributors of cosmetic products - to discontinue products that are no longer on the market. The relisting feature allows previously discontinued products to be reintroduced to the market.

Discontinuation is different from deletion in Cosmetics Direct. Discontinued products remain in the Structured Product Labeling (SPL) file and can be relisted, whereas deleted products are permanently removed and cannot be retrieved. For more details, please refer to the updated User's Guide to Cosmetics Direct.

On August 26, the California Senate unanimously passed the Toxic-Free Medical Devices Act (AB 2300) by a bipartisan vote of 40-0, prohibiting the use of the harmful chemical DEHP (di(2-ethylhexyl) pht...

On August 26, the California Senate unanimously passed the Toxic-Free Medical Devices Act (AB 2300) by a bipartisan vote of 40-0, prohibiting the use of the harmful chemical DEHP (di(2-ethylhexyl) phthalate) in intravenous (IV) bags and tubing manufactured, sold, or used in the state. With the passage of this legislation, California will become the first jurisdiction in the United States to ban the use of phthalates in medical devices.

Timeline for the proposed bill:

• January 1, 2030: Prohibition on the manufacture, sale, or distribution in California of certain intravenous solution containers containing intentionally added DEHP in California begins.
• January 1, 2032: Extended compliance deadline applies to companies that have pending U.S. Food and Drug Administration (FDA) approval for DEHP-free alternatives or those that lack the necessary equipment to manufacture DEHP-free containers, subject to additional requirements such as providing specified notices to consumers.

They must notify customers of their development of substitutes by July 1, 2025, and confirm compliance through a public declaration by 2028.

• January 1, 2035: Prohibition extends to the manufacture, sale, or distribution in California of certain intravenous tubing containing intentionally added DEHP.
• Other Prohibitions: The bill prohibits the manufacture, sale, or distribution of intravenous tubing or solution containers containing unintentionally added DEHP and restricts the substitution of DEHP with other specified ortho-phthalates in revised or new products.

DEHP (Di-2-ethylhexyl phthalate):

DEHP (di-2-ethylhexyl phthalate) is a chemical used to make polyvinyl chloride (PVC) plastic more flexible and is found in about 60-70% of IV bags and tubing in California and nationwide, despite its links to breast, liver, lung and testicular cancer. DEHP leaches from the plastic into medications and fluids, posing serious health risks to patients.

Companies waiting for the U.S. Food and Drug Administration (FDA) to green-light their DEHP-free alternatives would get an extra two years for the phase-out, as would companies that lack the equipment to produce them. In both cases, companies would have to notify customers by July 1, 2025, that they have begun developing substitutes, and then provide a notification and online declaration by 2028 that they will comply with the extended deadline.

The measure would also prohibit the replacement of the plasticizer with any of the other “ortho-phthalates”:

1. Benzyl-butyl phthalate (BBP) (CAS no 85-68-7)
2. Dibutyl phthalate (DBP) (CAS 84-74-2)
3. Dicyclohexyl phthalate (DCHP) (CAS 84-61-7)
4. Di-(2-ethylhexyl) phthalate (DEHP) (CAS 117-81-7)
5. Diethyl phthalate (DEP) (CAS 84-66-2)
6. Di-isobutyl phthalate (DIBP) (CAS 84-69-5)
7. Di-isodecyl phthalate (DIDP) (CAS 26761-40-0)
8. Di-isononyl phthalate (DINP) (CAS 28553-12-0)
9. Di-n-hexyl phthalate (DnHP) (CAS 84-75-3)
10. Di-n-octyl phthalate (DNOP) (CAS 117-84-0)
11. Di-n-pentyl (DnPP) phthalate (CAS 131-18-0)
12. Diisoheptyl phthalate (DIHP) (CAS 71888-89-6)

Blood bags would be exempt from all the requirements.

Maine, New Hampshire, and Massachusetts have recently advanced their efforts to phase out PFAS (per- and polyfluoroalkyl substances). PFAS are a group of synthetic chemicals widely used in consumer pr...

Maine, New Hampshire, and Massachusetts have recently advanced their efforts to phase out PFAS (per- and polyfluoroalkyl substances). PFAS are a group of synthetic chemicals widely used in consumer products for their water- and stain-resistant properties. Known as "forever chemicals," PFAS persist in the environment and are linked to various health risks, including cancer.

Maine delays most prohibitions on non-essential PFAS

Maine’s Department of Environmental Protection (DEP) issued a preliminary draft rule on August 5 to implement the state’s revised PFAS phase-out law. The update reflects legislative changes to the 2021 PFAS in products statute, delaying most prohibitions on non-essential PFAS to 2032 and narrowing reporting requirements to “currently unavoidable uses” (CUUs). The draft also exempts items such as semiconductors and motor vehicles.

The draft outlines regulations for goods and businesses, including disclosure requirements, phased-in sales restrictions, and CUU designations for products that need more time to replace PFAS. Manufacturers with CUU-designated products must provide detailed PFAS notifications and pay a $5,000 fee per notification; small businesses with 100 or fewer employees are exempt from these notifications.

The DEP plans to proceed with the rulemaking this autumn, aiming for completion early next year. Comments on the draft are due by August 30.

New Hampshire bans PFAS in 8 product categories

On August 2, New Hampshire’s Governor Chris Sununu signed a law prohibiting PFAS (per- and polyfluoroalkyl substances) in eight product categories. This law represents an ongoing effort at state level to eliminate these persistent chemicals from consumer goods.

Effective January 1, 2027, New Hampshire will ban the sale of products containing intentionally added PFAS including food packaging and containers, carpets or rugs, fabric treatments, upholstered furniture, textile furnishings, other than industrial or medical ones, juvenile products, cosmetics, and feminine hygiene products.

Unlike other states, New Hampshire's law uses the PFAS definition from the U.S. EPA's TSCA reporting rule, which covers around 1,400 compounds.

The law exempts certain products, including those with at least 85% recycled content or that were manufactured before the restrictions take effect. Manufacturers must provide certificates of compliance within 30 days if requested by the New Hampshire Department of Environmental Services (NHDES). Failure to comply could lead to misdemeanors, felonies, fines of up to $25,000 per offense, and additional penalties of up to $2,000 per violation.

Massachusetts phases out PFAS in turnout gears:

On August 15, Massachusetts Governor Maura Healey signed a law banning PFAS (per- and polyfluoroalkyl substances) in firefighter turnout gear, making Massachusetts the first state in the U.S. to phase out these chemicals in firefighting PPE by 2027. This legislation aims to protect firefighters from harmful exposures to PFAS, which are linked to serious health issues.

Starting January 1, 2025, sellers must inform buyers about the presence of PFAS in firefighting gear and provide details about the specific compounds used. Sellers and buyers must also submit these notices and related documents to state regulators within 60 days, if requested.

The law defines PFAS as "fluorinated organic chemicals containing at least one fully fluorinated carbon atom" and covers all PFAS that are intentionally added or result from manufacturing processes. The ban applies to all firefighter PPE, including jackets, trousers, helmets, gloves and respiratory equipment.