USA Regulatory News

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 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.