USA Regulatory News

On 25 September the Colorado Department of Public Health and Environment (CDPHE) recommended to amend its existing VOC rule to align with the 2018 "Phase V" Ozone Transportation Commission (OTC) regul...

On 25 September the Colorado Department of Public Health and Environment (CDPHE) recommended to amend its existing VOC rule to align with the 2018 "Phase V" Ozone Transportation Commission (OTC) regulation. This more stringent model, whose standards were only recently passed in California, has not been adopted by any other U.S. state. Colorado air regulators put forward rigorous volatile organic compound (VOC) requirements for consumer products. By adopting the rule, the state’s limits for these goods would be strictest apart from California. 

Colorado's existing VOC rule, Regulation No. 21, conforms to the Ozone Transportation Commission's 2012 'Phase IV' model rule. To reduce ground level ozone, which is the main constituent in smog pollution, and to develop draft rules for locals, the coalition of north-eastern states in the US (i.e., OTC) is collaborating to find a solution. For a variety of goods, including carpet cleaners, dusters, odour removers, insect repellants, and glass and tyre cleaners, the proposed update includes revised definitions and new or reduced VOC limits. It does not, however, contain all phase V model rule requirements. Because of freezing and safety issues, it omits new VOC criteria for windshield water repellent as well as for some lubricants that have restrictions on reformulation. 

Additionally, the proposal forgoes stricter regulations on some aerosols due to propellant concerns. The proposed rule mentions that Colorado recently passed laws banning per- and polyfluoroalkyl substances (PFASs), which includes a deadline of 2027 for the phase-out of hydrofluoroolefins (HFOs) as propellants in cosmetics and fabric treatments. 

Manufacturers won't be permitted to utilize the current propellants in these aerosol products after that date, and they "are unsure of the ability of future products to comply with the OTC VOC content limits," the statement reads. However, the division's limitations on aerosol VOC concentration are expected to be reviewed in the future, according to the air quality commission. 

As of 19 July 2022, the U.S. Food and Drug Administration (FDA) requested information regarding uses of fluorinated polyethylene in food contact containers. This proposal is a part of ongoing efforts ...

As of 19 July 2022, the U.S. Food and Drug Administration (FDA) requested information regarding uses of fluorinated polyethylene in food contact containers. This proposal is a part of ongoing efforts to guarantee the safety of authorized food contact uses, as fluorination of polyethylene may result in the creation of per- and polyfluoroalkyl substances (PFAS). The FDA is looking for scientific evidence and information on current uses of fluorinated polyethylene in food contact, consumer dietary exposure that may arise from those uses, and safety data on chemicals that may migrate from fluorinated polyethylene food containers. 

A marketing study on fluorinated polyethylene by the Environmental Defense Fund (EDF) found that its "uses vary from packaged food and consumer goods that individuals buy to larger containers used by shops like restaurants or larger drums used by businesses to store and transport fluids." 

Following the agency's 2021 discovery of per- and polyfluoroalkyl substances (PFASs) in some fluorinated barrels, just seven comments were submitted in response to a request for information (RFI). It's unclear how the agency will move given the scant response to the data call-in, which was completed on 18 October 2022. 

In August 2022 the US Environmental Protection Agency (EPA) has stated that it intends to expand its program encouraging federal agencies to acquire materials free of per- and polyfluoroalkyl substanc...

In August 2022 the US Environmental Protection Agency (EPA) has stated that it intends to expand its program encouraging federal agencies to acquire materials free of per- and polyfluoroalkyl substances (PFASs) to include a number of product groups. 

The initiative will support the agencies' efforts to purchase PFAS-free commodities, a goal established in the Biden-Harris executive order for 2021 and confirmed in implementation guidelines published in August. With an annual procurement budget surpassing $650 billion, the government has an enormous purchasing power that will encourage a wider market transition to safer substitutes for the additional product categories. 

The EPA's Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing is intended to assist federal agencies in meeting the mandate of the executive order to acquire PFAS-free products to the maximum degree practical. 

The EPA is interested in extending" the regulations to the following industries:  

• infrastructure 

• landscaping 

• building and construction 

• laboratories, and healthcare  

• food and cafeteria services  

• clothing and uniforms 

• professional services. 

For the product classes mentioned previously, the suggestions will provide standard and ecolabel bodies that adhere to the organization's Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing. 

The update is directed at product categories that are known to contain PFASs, according to the regulator. Standard and ecolabel organizations would need to demonstrate how their criteria are addressing the problem where persistent compounds present the most significant environmental and/or human health impacts in a product's lifecycle. 
  
Additionally, the EPA will assess additional standards and eco-labels for previously established procurement categories, including: office and furniture (Including copy paper), electronics (including phones, computers, imaging devices, and televisions), cleaning goods, (Including cleaners, tissues, and trash bags), and machine shop operations (particularly parts wash solution). 

The organization continued, saying that its Environmentally Preferable Purchasing (EPP) program is actively working to assess contracts to ensure that they comply with the procurement standards. 

The US, Canada, and EU are about to start a pilot project that will test a system for exchanging data on substances and provide guidance on the potential development of a global database of informatio...

The US, Canada, and EU are about to start a pilot project that will test a system for exchanging data on substances and provide guidance on the potential development of a global database of information on chemicals led by the OECD.

Bob Diderich, head of the OECD's environmental health and safety division, said ‘’a pilot project has been agreed upon between North American countries and the EU that will test how the database and exchange of information could work internationally while speaking at Chemical Watch's Regulatory Summit Europe, held on September 26-27.’’

The International Uniform Chemical Information Database (IUCLID) of the EU will serve as its ‘core’. The OECD and ECHA together created IUCLID, an IT system that enables organizations to record, save, manage, and exchange data on the inherent and dangerous features of chemicals.

According to Mr. Diderich, IUCLID employs the OECD's harmonized templates (OHTs), which are standard data formats for reporting data used for chemical risk assessment. These have also been incorporated into the chemical information systems of other nations.

"Because IUCLID uses OECD standards for data exchange, more and more countries are interested in using IUCLID for their own regulatory processes," he said.

‘’It would therefore make sense for it to be the core of a global information system’, he added.

Mr. Diderich said, ‘the pilot project will help the OECD determine on what form its own vision for a database could take and will attempt to provide answers to questions like whether it will be a distributed system of national databases that communicate with one another or a centralized system that everyone contributes to.’

Mr. Diderich did not confirm when the project would begin.

The idea was first floated in 2018, and has support from the industry. 

On 23 August 2022, the California State Assembly passed legislation ‘AB 2771’. The bill would ban the sale in California of any cosmetics and personal care products that contain any type of PFAS (...

On 23 August 2022, the California State Assembly passed legislation ‘AB 2771’. The bill would ban the sale in California of any cosmetics and personal care products that contain any type of PFAS (per- and polyfluoroalkyl substances) by 2025. The bill, AB 2771, is backed by a coalition of consumer interest groups, public health groups, and environmental non-profit organizations. It prohibits the entire class of PFAS chemicals from being added to cosmetics and personal care products. 

PFAS are synthetic chemical compounds that are strongly resistant to degradation and, as a result, tend to accumulate in the environment. Characterized by the presence of strong carbon-fluorine bonds, these include perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), Gen X, and more. PFAS can present a diverse range of health risks, and their extensive use has resulted in frequent exposure in humans. Very low doses of PFAS in drinking water have been linked to increased risk of cancer, harm to the reproductive and immune system, and liver and thyroid disease. PFAS chemicals have been used in cosmetics products like dental floss, lotions, cleansers, shaving cream, lipstick, eyeliner and mascara to improve durability and texture and to condition or smooth skin or make it appear shiny. Cosmetics with the highest levels of PFAS are often marketed as waterproof, wear-resistant or long-lasting.

What Would AB 2247 Require?

AB 2247 requires companies that manufacture or import products (or product components) to be sold or distributed in California with "intentionally added PFAS" to publicly register the product on or before 1 July 2026. Thereafter, a manufacturer or importer must register products sold during the prior calendar year by 1 July of each year.

As states continue to consider and pass legislation regulating PFAS in cosmetics and personal care products, manufacturers and importers of these products containing PFAS will need to evaluate the scope of each state’s laws and regulations to avoid violations. Manufacturers and importers should also consider how they will comply with the regulation as the sales of these products would be banned in California by 2025.

On the 11th of July 2022, the Environmental Protection Agency (EPA) in the US notifies and seeks comment on a draft revision for trichloroethylene (TCE) risk evaluation issued under TSCA. The old d...

On the 11^th of July 2022, the Environmental Protection Agency (EPA) in the US notifies and seeks comment on a draft revision for trichloroethylene (TCE) risk evaluation issued under TSCA.

The old draft was revised to reflect the policy changes, to enhance the environment’s protection from unreasonable risks caused by chemicals. According to EPA, TCE as a whole chemical substance can cause unreasonable risks and injury to health.

This decision does not cover the assumption that all workers always wear personal protective equipment (PPE). This is because there is possibly a subpopulation of workers who might be highly exposed to TCE because they are not covered by OSHA standards or because many of OSHA’s chemical-specific permissible exposure limits are now outdated and inadequate for protecting workers’ health. OSHA standards are the rules that explain the methods employers are obligated to use to ensure their employees are protected from hazards.

When implemented, this decision will supersede the condition of use-specific no unreasonable risk determinations in the November 2020 TCE risk evaluation and will make a revised determination of unreasonable risk for TCE as a whole chemical substance.

The proposed dates of adoption and entry into force are yet to be determined. Comments for the draft revision will close on August 8, 2022.

The US Environmental Protection Agency (EPA), on July 4, 2022, notified its draft revision to the Toxic Substances Control Act (TSCA). This is for risk determination for Perchloroethylene (PCE) risk e...

The US Environmental Protection Agency (EPA), on July 4, 2022, notified its draft revision to the Toxic Substances Control Act (TSCA). This is for risk determination for Perchloroethylene (PCE) risk evaluation to reflect the announced policy changes by ensuring the public is protected from unreasonable chemical risks.

According to the draft, the US EPA after evaluation of use finds PCE as a toxic chemical substance that presents unreasonable risks to health. Although this evaluation does not consider the assumption of workers appropriately wearing personal protective equipment (PPE).

When the decision becomes final, it will override the condition of use-specific no unreasonable risk determinations in the December 2020 PCE risk evaluation and make a revised determination of unreasonable risk for PCE as a whole chemical substance.

The final date for comments on the draft revision is August 1, 2022.