USA Regulatory News

In October 2021, US EPA removed the confidentiality status for 377 substances, making their chemical status available to the public. According to the TSCA inventory, these chemicals make up about 8,00...

In October 2021, US EPA removed the confidentiality status for 377 substances, making their chemical status available to the public. According to the TSCA inventory, these chemicals make up about 8,000 of the 42,000 chemicals listed there.

In April, EPA listed 390 substances that will be moved to the public section of the inventory. Industries were given a period to raise concerns about the declassification of these chemicals. Of the 390 substances, 13 were found on the public inventory, and some were reported for having invalid accession numbers. This warranted a few changes before US EPA published the 377 substances to lose confidentiality status.

This list includes substances reported by companies as non-confidential in a CDR submission and those flagged during the inventory reset proceed from 2017 to 2018. As released by EPA, it will also be included in the next TSCA inventory update this year.

Last Update: 2021-10-26

To get ahead of problems that can impact those who make and use PFAs, the US EPA has issued a 26-pages roadmap to set an approach for research, restricting, and remediating these chemicals. Accordi...

To get ahead of problems that can impact those who make and use PFAs, the US EPA has issued a 26-pages roadmap to set an approach for research, restricting, and remediating these chemicals.

According to the EPA Administrator, Michael Regan, "This comprehensive, national PFAS strategy will deliver protections to people who are hurting, by advancing bold and concrete actions that address the full lifecycle of these chemicals." 

This new roadmap includes the following:

• Imposes new testing and reporting requirements, strengthening the TSCA review of new PFAs

• Tightens restrictions on existing ones.

• Adopts an enforceable drinking water limit for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS)

• Applies hazardous substance designations for certain substances.

• For substances not yet on the market, EPA will apply a rigorous premanufacture notice review process for new PFAS to ensure these substances are safe before they enter the market.

All these changes are in addition to the earlier revised assumptions about proper usage of personal protective equipment (PPE) and the lack of approval for PFASs submitted through a low volume exemption (LVE). 

Furthermore, to review and tighten restrictions on existing PFAs, EPA plans to issue TSCA section 5(e) orders and impose rigorous safety requirements as a condition of allowing the use of PFAs. You can download a copy of the roadmap here.

Last Update: 2021-10-21

On the 22nd of July 2021, the US House of Representatives passed H.R. 2467, the PFAS Action Act of 2021. This is a comprehensive framework for regulating 9,252 per-and polyfluoroalkyl substan...

On the 22nd of July 2021, the US House of Representatives passed H.R. 2467, the PFAS Action Act of 2021. This is a comprehensive framework for regulating 9,252 per-and polyfluoroalkyl substances (PFAS). Unlike a similar bill (H.R. 535) which was never considered by the Republican-controlled Senate in the last Congress, this bill was passed by a vote of 241-183.

The bill sets requirements and incentives, in a bid to limit the use of PFAs in the environment. All PFAS are to be tested by EPA for toxicity to human health and the environment.

Furthermore, the bill provides the following:

• Designation of PFOA and PFOS as hazardous substances under CERCLA. They are also designated as hazardous air pollutants under the Clean Air Act.
• EPA must decide within five years if the other PFAS should be labelled hazardous substances.
• Unsafe burning of PFAs wastes will be prohibited and incentives are to be provided for helping community water systems that are contaminated by PFAS.

On the 10th of June, EPA proposed a new Per- and polyfluoroalkyl substances (PFAS) reporting rule after the White House Office of Management and Budget clea...

On the 10th of June, EPA proposed a new Per- and polyfluoroalkyl substances (PFAS) reporting rule after the White House Office of Management and Budget cleared it. For producers and importers, this new rule means that they have to supply extensive information on 1,300 plus substances that have been used in the US over the last 10 years.  

Producers and importers of substances need to take note, as this is vital to future regulatory actions. The rule encompasses by-products, impurities, and articles that contain compounds. And affected parties are expected to disclose information regarding their use of any of the compounds. This information should include by-products, chemical identity, use classifications, quantity generated and processed, environmental and health impacts, worker exposure counts and lengths, and disposal.  

EPA said it verified 1,346 PFASs on the TSCA inventory as of April 2021, and 669 are active in the US commerce. A one-year reporting timeline has been suggested by EPA, which will follow the enactment of a final rule by 1 January 2023. This is following the National Defense Authorization Act (NDAA) of the US. 

According to the agency, this effort is targeted at collecting detailed information and having a comprehensive dataset on PFAS manufactured in the US. Producers and importers of substances should take note, as this is vital to future regulatory actions. Furthermore, it will help reduce potential risks caused by these chemicals.  

For the next 60 days (following publication in the Federal Register), EPA is open to comments about this proposal with a particular interest in the following: 

1. identifying PFASs for reporting and whether imported articles containing them should also be covered 

1. issues for economic assessment, especially regarding implicated small businesses and other manufacturers or importers of these compounds or articles containing them 

1. the six-month submission period’s start date and duration, partially based on the CDR submission period 

1. requirements possibly repeating what the agency has gathered under TSCA or other laws 

1. the extent and format of collected environmental and health details 

1. proposed data elements’ scope and whether the agency should ask for additional ones 

1. how else it may utilize or publicize received information 

1. whether it should permit joint submissions when the supplier, producer, or importer is unaware of a substance’s identity or ingredients; and 

1. how the agency could facilitate small firms’ compliance, such as through outreach or adjusted reporting timelines. 

You can access the comment section via: www.regulations.gov 

Sources: United States Environmental Protection Agency  

Date: July 5, 2021 

Significant New Use Rules (Snur) draft guidance was released on 10 December 2020 to help businesses understand and comply with a TSCA Snur. This is the guid...

Significant New Use Rules (Snur) draft guidance was released on 10 December 2020 to help businesses understand and comply with a TSCA Snur. This is the guidance that defines what qualifies as ‘surface coating’ under the rule and the entities subject to the rule’s requirements. So far, no substantive change has been made to the guidance. 

However, alongside the new reporting rule proposed by EPA, the Snur guidance issued earlier this year was revoked. This guidance was released in the final weeks of Trump’s administration. According to the agency, it has “inappropriately narrowed the scope and weakened the prohibitions included in the Snur.”  

Most importantly, the rule is still in effect as only the guidance was revoked. The Significant New Use Rules (SNURs) says: 

• Companies must get the EPA approval before they can recommence the use of more than a dozen long-chain perfluoroalkyl carboxylate (LCPFAC) substances and perfluorooctanoic acid (PFOA). 

This rule also applies to imported articles containing compounds in a surface coating; this includes automotive parts, carpet, furniture, and electronic components. EPA also noted, during its announcement, that three PFAS have been added to the Toxics Release Inventory (TRI) in the early month of June. Also, the release of these chemicals will be reported by 1 July 2022 for 2021 calendar year data. The addition of these PFAS is made towards implementing the vitasl PFAS requirement of the NDAA. The NDAA, in line with the TRI Reporting Year 2021 directly added these three PFAS to the TRI list because they are subject to a SNUR under TSCA.  

Sources: United States Environmental Protection Agency 

Date: July 5, 2021 

Proposition 65, known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The proposition protects California's drinking water so...

Proposition 65, known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The proposition protects California's drinking water sources from being contaminated with chemicals known to cause cancer, birth defects, or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals. 

On December 2, 2020, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705. In this amendment, a proposition 65 No Significant Risk Level (NSRL) of 23 micrograms per day for the chemical p-chloro-α,α,α-trifluorotoluene (PCBTF) (CAS 98-56-6) was adopted. The regulation will be effective on April 1, 2021.  

Update: 2021-02-21

The 2020 Chemical Data Reporting (CDR) submission period begins on June 1, 2020 and runs through November 30, 2020. The CDR rule requires manufacturers (including importers) of certain chemical substa...

The 2020 Chemical Data Reporting (CDR) submission period begins on June 1, 2020 and runs through November 30, 2020. The CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Inventory to report data on chemical manufacturing, processing, and use every four years. This information helps EPA understand exposure to these chemicals and screen and prioritize chemicals to identify and evaluate potential human health and environmental effects.

Materials to help CDR submitters prepare for and report information during the 2020 CDR cycle can be found at https://www.epa.gov/chemical-data-reporting, including:

• how to access e-CDRweb starting June 1, the electronic reporting tool used to submit CDR data in EPA’s Chemical Data Exchange (CDX);
• instructions for reporting during the 2020 cycle;
• topic-specific guidance like information on imported products and specific industries, with guidance on additional topics planned for release in the coming weeks;
• transcripts and recordings from overview webinars; and
• important dates and reminders.