USA Regulatory News

On March 15, 2024, Bill ESHB 1097, ‘An act relating to the sale of cosmetics tested on animals’, was signed into law in Washington State. It will take effect on January 1, 2025. The legislation pr...

On March 15, 2024, Bill ESHB 1097, ‘An act relating to the sale of cosmetics tested on animals’, was signed into law in Washington State. It will take effect on January 1, 2025. The legislation prohibits manufacturers from selling or offering for sale in Washington any cosmetic product that has been developed or manufactured through cosmetic animal testing, whether conducted directly or contracted for by the manufacturer or its supplier.

Exceptions:

Manufacturers may market a cosmetic that has undergone cosmetic animal testing, either conducted by the manufacturer or on its behalf, under the following conditions:

• If the testing is carried out outside the United States to adhere to the regulations of a foreign regulatory authority, provided that the results of such testing were not used to confirm the safety of the cosmetic ingredient or product sold by a manufacturer in Washington.
• If the testing is conducted for a cosmetic or cosmetic ingredient subject to regulation under applicable portions of the Federal Food, Drug, and Cosmetic Act (FDCA).

• If the testing is performed on a cosmetic ingredient intended for non-cosmetic applications and conducted under the regulation of federal, state, or foreign authorities, provided that the results of the testing are not used to validate the safety of a cosmetic sold in Washington, except in cases where:
  • There is documented evidence of the non-cosmetic intent of the test.
  • There is a history of non-cosmetic use of the ingredient for at least 12 months prior to reliance.

• Where the testing is requested, mandated, or carried out by a federal or state regulatory authority, provided that the following additional criteria are met:
  • There is no non-animal alternative method or strategy recognized by any federal or state agency or organization.
  • The cosmetic ingredient or non-functional constituent poses a risk of causing a specific human health problem that is substantiated and the need for animal testing is justified and supported by a detailed research protocol; and
  • The cosmetic ingredient is in widespread use and cannot be replaced by another cosmetic ingredient that can perform a similar function.

The restriction on the sale of cosmetics developed or manufactured through cosmetic animal testing organized by the manufacturer, or its supplier will be waived under two conditions:

• If a cosmetic or its ingredient was tested on animals before January 1, 2025, and no additional testing was performed after that date, and
• if a cosmetic manufacturer reviews, evaluates, or retains evidence of cosmetic animal testing.

Enforcement:

Manufacturers in violation of these regulations commit a civil violation, punishable by a fine of up to $5,000 for each violation. Washington State will be the twelfth on the growing list of U.S. states banning animal testing for cosmetics. The others are California, Hawaii, Illinois, Louisiana, Maine, Maryland, Nevada, New Jersey, New York, Oregon and Virginia. 42 other countries have banned cosmetic testing on animals, including the European Union.

The U.S. Environmental Protection Agency (EPA) is introducing a rule under Section 8(d) of the Toxic Substances Control Act (TSCA), mandating manufacturers (including importers) of 16 chemicals to sub...

The U.S. Environmental Protection Agency (EPA) is introducing a rule under Section 8(d) of the Toxic Substances Control Act (TSCA), mandating manufacturers (including importers) of 16 chemicals to submit to the Agency data from unpublished health, safety, environmental, as well as occupational, general population and consumer exposure studies. These submissions will help in EPA's prioritization, risk evaluation, and management of chemicals under TSCA, reinforcing its commitment to protecting human health and the environment.

Chemicals Covered by the Proposed Rule

The proposed rule includes 13 chemicals listed in the 2014 TSCA Work Plan, curated by EPA for additional assessment based on their identified hazards and potential exposures. To effectively prioritize, evaluate risks, and manage these chemicals, EPA needs information on their hazards and potential exposure pathways.

Priority Chemicals Identified for Risk Evaluation

EPA proposed to prioritize five of the chemicals included in the proposed rule for risk evaluation in December 2023, all of which have been linked to cancer and used to make plastics: 

• 4,4’-Methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4), 
• Acetaldehyde (CASRN 75-07-0), 
• Acrylonitrile (CASRN 107-13-1), 
• Benzenamine (CASRN 62-53-3), and 
• Vinyl chloride (CASRN 75-01-4). 

Additional Chemicals Covered by the Proposed Rule

The proposed rule additionally covers 10 chemicals that EPA initially identified as candidates for prioritization but did not include in its prioritization action initiated in December 2023. However, these chemicals are currently under consideration for inclusion in the prioritization action scheduled to begin in December 2024:

• 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CASRN 140-66-9), 
• Benzene (CASRN 71-43-2), 
• Bisphenol A (CASRN 80-05-7), 
• Ethylbenzene (CASRN 100-41-4), 
• Hydrogen fluoride (CASRN 7664-39-3), 
• N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8), 
• Naphthalene (CASRN 91-20-3), 
• Styrene (CASRN 100-42-5),  
• Tribomomethane (Bromoform) (CASRN 75-25-2), and 
• Triglycidyl isocyanurate (CASRN 2451-62-9). 

EPA’s Response to Specific Concerns

In November 2023, EPA responded to a petition from certain tribes regarding the use of the chemical 6PPD in tires. 6PPD reacts with ozone air pollution, to form a compound known as 6PPD-quinone (2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione)(CASRN: 2754428-18-5), which has been shown to be lethal to coho salmon when present in stormwater. As a result, EPA finalized a rule to collect additional data on 6PPD. This proposed rule now includes provisions for 6PPD-quinone.

On February 21, 2024, the Alameda Superior Court approved a settlement between the Center for Environmental Health (CEH) and 28 leather footwear and glove companies. This settlement is a result of CEH...

On February 21, 2024, the Alameda Superior Court approved a settlement between the Center for Environmental Health (CEH) and 28 leather footwear and glove companies. This settlement is a result of CEH's issuance of ‘Notices of Violation’ (NOVs) to over 100 companies in 2023 for allegedly failing to provide Prop 65 warnings regarding hexavalent chromium exposure from ‘skin contact components’ of their leather products. As part of the settlement, these companies have agreed to only use leather from tanneries that have adopted advanced protocols to eliminate hexavalent chromium, also known as hex chrome, from the surface of the leather.

Chromium 6

Chromium 6, also known as hexavalent chromium, is the most toxic form of chromium. It occurs naturally in rocks and can leach into groundwater through rock weathering or industrial pollution. It has been listed as a carcinogen under California’s Proposition 65 since 1987 and as a reproductive and developmental toxicant since 2008. Chromium 6 is used in textile dyes, paints, chrome plating and stainless-steel production. It's also found in trace amounts in certain leather goods and building materials.

Tanneries can prevent the formation of hexavalent chromium in leather by implementing protocols such as adding antioxidants, controlling fat levels, limiting oxidizing agents and monitoring pH levels, among others.

How the industry can comply

The legal agreement requires defendants to source leather from tanneries that follow strict protocols to prevent hexavalent chromium formation. Alternatively, compliance can be achieved by sourcing leather exclusively from tanneries that have received a Gold rating in Leather Working Group (LWG) audits, indicating adherence to such protocols. Full compliance is required by the end of 2025, with an option to label certain products with a Prop 65 label if sourcing from a certified tannery is not feasible.

Opt-in

The court settlement introduces a process that allows any company that sells leather footwear or gloves in California to “opt in”. This includes defendants in settlement negotiations with CEH and previously uninvolved leather companies. Opting in allows companies to adopt the same commitments as the settled defendants to ensure compliance with Prop 65. The initial opt-in period is 90 days, ending on May 21, 2024.

Opted-in companies will receive immunity from Prop 65 liability for pre-existing products and must meet compliance targets by specific deadlines. 

A company may opt-in to the settlement if it:

(i) has 10 or more employees; and

(ii) manufactures, distributes, or sells one or more covered products that it knows or has reason to believe will be or has been sold or offered for sale in the State of California.

CEH invites leather footwear and glove companies concerned about hexavalent chromium exposure to visit http://www.prop65hexchromesettlement.com for details on opting in.

The Environmental Protection Agency (EPA) has opened a 60-day public comment period on the draft Integrated Risk Information System (IRIS) Toxicological Review of Perfluorononanoic Acid (PFNA, CASRN 3...

The Environmental Protection Agency (EPA) has opened a 60-day public comment period on the draft Integrated Risk Information System (IRIS) Toxicological Review of Perfluorononanoic Acid (PFNA, CASRN 375–95–1) and Related Salts. This draft document prepared by the Center for Public Health and Environmental Assessment (CPHEA) within EPA's Office of Research and Development (ORD), precedes a contracted peer review. Comments received will be shared with the external peer reviewers. A public meeting organized by ERG, an EPA contractor, will be held during Step 4 of the IRIS Process to discuss the draft report. Public comments and feedback from the meeting will be considered by the external peer reviewers. The deadline for submitting comments is May 7, 2024.

Background and Proposed Reference Doses

In 2018, EPA announced its intention to assess five members of the per- and polyfluoroalkyl substance (PFAS) class using IRIS. The Agency had previously established Reference doses (RfDs) for perfluorobutanoic acid (PFBA) and perfluorohexanoic acid (PFHxA) and proposed RfDs for perfluorohexane sulfonate (PFHxS) and perfluorodecanoic acid (PFDA).

EPA has now proposed an RfD for perfluorononanoic acid (PFNA), that is in the mid-range compared to the other PFAS assessed by IRIS. The proposed RfD for PFNA, set at 7x10^-9 milligrams per kilogram per day (mg/kg per day), is significantly more stringent than the final RfDs for PFBA and PFHxA established in 2022 and 2023.

While RfDs generated by IRIS do not have direct legal implications, EPA may use them for regulatory risk assessments.

Concerns

Perfluorononanoic acid (PFNA) and its related salts are part of the group of per- and polyfluoroalkyl substances (PFAS). These synthetic compounds, which do not occur naturally, have found widespread use in consumer goods and industrial processes over the past several decades due to their resistance to heat, oil, stains, grease, and water. Concerns regarding PFNA and other PFAS arise from their resistance to hydrolysis, photolysis, and biodegradation, which leads to their persistence in the environment.

PFNA, commonly used in the production of fluoropolymers, can be found in various products such as carpets, food contact papers, cleaning and polishing products.

Health Effects of PFNA Exposure

Human epidemiologic studies have examined connections between PFNA exposure and several health outcomes, including fetal growth restriction, liver serum biomarkers, antibody responses, infectious diseases, sensitization and allergic responses, semen parameters, reproductive hormones, pubertal development, thyroid hormones, neurodevelopment, serum lipids, cardiovascular disease, metabolic effects, time to pregnancy, female reproductive responses, and urinary effects.

However, with the exception of reduced birth weight and increased serum ALT in adults, the ability to make conclusive judgements about these associations based on human evidence is limited.

Available evidence suggests potential immune, thyroid, neurodevelopmental, and cardiometabolic effects from oral exposure to PFNA under specific exposure conditions but is not sufficient to draw definitive conclusions. Medium-reliability epidemiological studies indicate potential immunosuppression, primarily related to prenatal and childhood exposures, resulting in reduced antibody responses following vaccinations. The evidence is insufficient to conclude that PFNA can cause immunotoxicity.

On February 20, 2024, the U.S. Environmental Protection Agency (EPA) announced the latest update to the Toxic Substances Control Act (TSCA) Inventory.    Key Findings of the Update  The TS...

On February 20, 2024, the U.S. Environmental Protection Agency (EPA) announced the latest update to the Toxic Substances Control Act (TSCA) Inventory. 

Key Findings of the Update 

The TSCA Inventory includes all existing manufactured, processed, or imported chemicals in the United States. As part of its regular release of non-confidential TSCA Inventory data, EPA updates the public TSCA Inventory every two years. 

The most recent TSCA Inventory contains a total of 86,741 chemical substances, with 42,293 substances classified as active. Updates to the TSCA Inventory also include data on unique identifiers, commercial activities, and regulatory flags including test orders and significant new use requirements (SNURs). 

Transition from Confidential to Public Information 

Furthermore, as part of EPA's ongoing review of TSCA confidential business information, certain substances remain on the list with their unique chemical identities after being moved from the confidential part of the Inventory to the public part. Since the last update of the TSCA Inventory in August 2023 EPA has moved approximately 900 chemicals from the confidential part to the public part of the Inventory.  

For more information on the TSCA Inventory, please visit: https://www.epa.gov/tsca-inventory. 

The Food and Drug Administration (FDA) has initiated an investigation into the cause of benzene contamination in certain drugs, raising concerns about potential health risks associated with the presen...

The Food and Drug Administration (FDA) has initiated an investigation into the cause of benzene contamination in certain drugs, raising concerns about potential health risks associated with the presence of this carcinogenic compound. Benzene contamination has prompted recalls of certain hand sanitizers and aerosol drug products and prompted the FDA to issue warnings to drug manufacturers regarding the dangers posed by benzene in drug components.

Benzene:

Benzene, a known human carcinogen, has been linked to leukemia and other blood disorders. Contamination can occur from inactive ingredients such as carbomers (thickening agents) or isobutane (a spray propellant), as well as other drug components derived from hydrocarbons. More than 60% of FDA-approved small molecule drugs contain at least one benzene ring motif. These include acetylsalicylic acid (Aspirin), acetaminophen (Tylenol), and ibuprofen (Advil) which are all painkillers sold over the counter. It is used primarily as a solvent in the chemical and pharmaceutical industries, as a starting material, and as an intermediate in the synthesis of numerous chemicals.

Action taken:

In light of these findings, the FDA emphasizes the need for drug manufacturers to establish scientifically sound specifications and testing procedures to ensure that both active and inactive ingredients, as well as finished drug products, meet appropriate quality standards. This includes rigorous testing of raw materials and finished product batches prior to release, to ensure conformity to specified criteria for identity, strength, quality, and purity.

Manufacturers are encouraged to use risk assessments to identify potential sources of contamination and implement appropriate risk mitigation measures. Specifically, the FDA has worked with manufacturers to conduct risk assessments focusing on ingredients derived from hydrocarbons or manufactured with benzene or other related compounds. Additionally, the FDA recognizes the potential for benzene formation from interactions between certain ingredients, such as sodium benzoate and antioxidants, which requires thorough testing throughout the shelf life of a drug product.

The International Conference on Harmonization (ICH) Q3C Impurities: Residual Solvents guidance and its companion document Q3C Tables and List provide guidance on limited cases where the presence of benzene may be tolerated. 

To address concerns regarding benzene contamination, drug manufacturers are advised to conduct testing and not release any product batch containing benzene levels above 2 parts per million (ppm). Manufacturers that identify batches that exceed this threshold must immediately initiate a recall and communicate with the FDA for further guidance.

Furthermore, manufacturers are urged to provide the FDA with comprehensive test results and information concerning the potential sources of benzene contamination to facilitate ongoing investigations.

On February 28, 2024, the U.S. Food and Drug Administration (FDA) made a significant announcement, declaring that manufacturers have ceased selling grease-proofing substances containing Per- and Polyf...

On February 28, 2024, the U.S. Food and Drug Administration (FDA) made a significant announcement, declaring that manufacturers have ceased selling grease-proofing substances containing Per- and Polyfluoroalkyl Substances (PFAS) for food contact coatings in the U.S. market. The completion of the voluntary market phase-out marks a critical step in eliminating the primary source of dietary exposure to PFAS from authorized food contact uses.

History:

In 2020 in an effort to protect public health, the FDA secured commitments from manufacturers to discontinue the sale of grease-proofing substances containing specific types of PFAS for food contact uses in the United States. The recent announcement signals the fulfilment of these voluntary commitments. Additionally, the FDA has confirmed that other manufacturers have voluntarily stopped selling various food contact grease-proofing substances containing different types of PFAS in the U.S.

PFAS In Food Packaging:

Grease-proofing substances are essential for preventing grease and oil leakage and providing water-resistant properties to paper and paperboard packaging. These PFAS-containing substances were commonly used in fast food wrappers, microwave popcorn bags, take-out containers, pet food bags, and similar packaging materials.

Most companies have exited the market ahead of the expected phase-out, despite an 18-month timeline. The FDA is also developing a validated analytical method to monitor the market for PFAS-containing food contact materials in packaging.

The FDA reaffirms its commitment to food chemical safety and the ongoing re-evaluation of authorized chemicals for use in food. Post-market safety evaluations will continue to ensure that risk determinations remain accurate and based on current scientific knowledge.