USA Regulatory News

The U.S. Agency for Toxic Substances and Disease Registry (ATSDR) has established minimum risk levels (MRLs) for 1,1,1-trichloroethane. Although the use of these substances has decreased significantly...

The U.S. Agency for Toxic Substances and Disease Registry (ATSDR) has established minimum risk levels (MRLs) for 1,1,1-trichloroethane. Although the use of these substances has decreased significantly in recent years, there is still some potential for human exposure. According to the ATSDR toxicological profile released on March 29, some production of 1,1,1-trichloroethane persists.

U.S. facilities have reported quantities of this substance to databases of the Environmental Protection Agency (EPA) such as the Toxics Release Inventory and Chemical Data Reporting. These facilities primarily handle or dispose of hazardous waste, including substantial amounts of 1,1,1-trichloroethane.

Introduction:

1,1,1-trichloroethane, a synthetic compound, does not occur naturally but is released into the environment as a result of human activities. Heating it or using it in welding can produce the toxic gas phosgene. It's commonly found in soil and water, especially at hazardous waste sites, with its vapor form being prevalent due to its high volatility. Historically, it has been widely used in both industrial and domestic settings as a solvent for dissolving substances such as glues and paints, as well as for degreasing manufactured parts and in various household products such as spot cleaners, glues, and aerosol sprays.

History:

After January 1, 2002, the U.S. Environmental Protection Agency (EPA) banned domestic use of 1,1,1-trichloroethane due to its impact on the ozone layer. Limited production for essential uses continued until 2005, with export production permitted until 2012. The phase-out of U.S. production was mandated by Section 604 of the Clean Air Act and the Montreal Protocol. Although not completely halted, production of 1,1,1-trichloroethane was scheduled to cease by 2012 under the Montreal Protocol agreements, contributing to a decline in ambient levels despite ongoing production.

Side Effects of Exposure:

Health effects observed in controlled human exposure studies include impaired cognitive skills, manual dexterity, balance and coordination. Animals show signs of central nervous system depression, such as impaired performance, ataxia, and unconsciousness, similar to humans. Neurochemical, behavioral, and physiological changes have also been observed. Case reports suggest that high concentrations of 1,1,1-trichloroethane may cause hepatic effects in humans, including changes in liver enzymes and progressive liver disease. Consistent findings in animal studies indicate hepatic effects after inhalation exposure, including increased liver weight, fatty changes, and hepatocyte swelling.

ATSDR Established Minimal Risk Levels (MRLs) for 1,1,1-Trichloroethane:

The purpose of MRLs is to serve as screening thresholds used by ATSDR health assessors and other responders. Their aim is to identify contaminants and potential health effects that may be of concern at hazardous waste sites.

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.

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.