USA Regulatory News

The US Environmental Protection Agency (EPA) has opened a 60-day public comment period on the draft Toxicological Review of Inorganic Arsenic under the Integrated Risk Information System (IRIS). This ...

The US Environmental Protection Agency (EPA) has opened a 60-day public comment period on the draft Toxicological Review of Inorganic Arsenic under the Integrated Risk Information System (IRIS). This draft, prepared by the Center for Public Health and Environmental Assessment (CPHEA) within EPA's Office of Research and Development, evaluates the toxicological effects of inorganic arsenic. The public comment period, which opened on October 16, 2023, will remain open until December 15, 2023.

BACKGROUND:

Inorganic arsenic is used in various industrial applications, including the hardening of copper and lead alloys, glass manufacture, and as a catalyst in the production of ethylene oxide. Given its widespread use, understanding its potential health risks is of paramount importance. The draft IRIS assessment, if finalized, could lead to stricter federal regulations on the use of inorganic arsenic in these industries.

KEY ASPECTS:

The latest evaluation introduces an overall reference dose of 0.031 µg/kg per day, which is well-supported by evidence that links inorganic arsenic to circulatory system disorders. The potential adoption of this reference dose has significant implications for the regulation of inorganic arsenic in various products and processes. While the EPA's Integrated Risk Information System program previously classified arsenic as carcinogenic, this classification remains unaltered in the latest draft.

However, the draft assessment looks more closely at the risks beyond cancer, including new data on noncancerous effects. These include effects on the cardiovascular system, neurodevelopment, pregnancy, and diabetes. The draft assessment conveys a high level of confidence in the role of inorganic arsenic compounds in the development of cardiovascular disease and diabetes, and a moderate level of confidence in their association with pregnancy, birth, and neurodevelopmental effects.

This comprehensive evaluation of the health effects of inorganic arsenic underscores the critical importance of regulating the use of this compound in various industries. To participate in the public comment process and have your say on these proposed regulations, visit the IRIS website or the public docket, with Docket ID No. EPA–HQ–ORD–2012–0830. The EPA welcomes input from stakeholders, scientists, and the public to help shape the future regulation of inorganic arsenic.

PFDA Review

The EPA also published a report detailing an external peer review of its preliminary IRIS assessment of perfluorodecanoic acid (PFDA), a long-chain PFAS. The reviewers generally agreed with the EPA's initial findings on the effects of PFDA on the immune system and development, but also provided additional perspectives. In the preliminary draft, a provisional overall reference dose of 4*10-10 mg/kg/day was established, based on considerations of immunotoxicity and developmental toxicity. However, the report underscores that the information currently available is insufficient for a comprehensive evaluation of the risks associated with PFDA.

On September 29, 2023, the U.S. Environmental Protection Agency (EPA) expanded the Safer Chemical Ingredients List (SCIL) by adding ten chemicals. The SCIL is a dynamic compilation of chemicals that m...

On September 29, 2023, the U.S. Environmental Protection Agency (EPA) expanded the Safer Chemical Ingredients List (SCIL) by adding ten chemicals. The SCIL is a dynamic compilation of chemicals that meet the safety criteria of the Safer Choice program and now includes 1,071 chemicals that are considered the safest for their intended purposes.

Background

The Safer Chemical Ingredients List (SCIL) is a comprehensive compilation of chemical ingredients classified according to functional-use categories. These ingredients have been assessed by the Safer Choice Program and have been deemed to be safer alternatives to conventional chemical ingredients. The primary objective of this list is to assist manufacturers in identifying and adopting chemical alternatives that meet the exacting standards of the Safer Choice Program.

Selection Criteria

Prior to the inclusion of a chemical on the Safer Chemical Ingredients List (SCIL) by the Safer Choice program, an independent third-party profiler, such as NSF International, or ToxServices, is responsible for collecting hazard information. This process involves a comprehensive examination and assessment of all available data on the chemical's toxicological properties and environmental behavior. Subsequently, the third-party profiler compiles a detailed report for submission to Safer Choice, together with a recommendation as to whether the chemical meets the criteria for Safer Chemical Ingredients. Additionally, Safer Choice may conduct supplementary literature reviews and consider data from confidential sources, such as the Environmental Protection Agency's New Chemicals Program.

The Safer Choice program certifies products containing ingredients that meet the program’s criteria for human health and environmental safety and allows companies to use its label on products that meet the Safer Choice Standard. EPA encourages manufacturers to submit their safer chemical formulations for EPA evaluation and potential listing on the SCIL, which the EPA revises at least once annually to reflect advances in the field of safer chemistry.

The latest additions to the SCIL are: 

• Fats and Glyceridic oils, vegetable, hydrogenated; 
• Tocopherols; 
• Sulfuric acid, dimethyl ester, compd. with .alpha.,.alpha.',.alpha.'',.alpha.'''-[1,6-hexanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)]; 
• Glycolipids, sophorose-contg., Candida bombicola-fermented, from D-glucose and mahua Madhuca longifolia fats and glyceridic oils; 
• 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,2-ethanediol, .alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) and 1,2-propanediol, ester with .alpha.-methyl-.omega.-hydroxypoly(oxy-1,2-ethanediyl); 
• Dodecanoic acid, ester with 1,2-propanediol; 
• Diisopropyl succinate; 
• Diisopropyl sebacate;  
• Methyl propanediol; and 
• Methyl ethyl ketone. 

You can access a downloadable spreadsheet of the Safer Chemical Ingredients List (xls). Additionally, the U.S. EPA has initiated efforts to eliminate per- and polyfluoroalkyl substances from the program and to explore the possibility of expanding the scope of the program to include categories that are presently outside its scope.

On 28 September 2023 the U.S. Environmental Protection Agency (EPA) finalised a rule that will result in the most comprehensive collection of data on per- and polyfluoroalkyl substances (PFAS) produce...

On 28 September 2023 the U.S. Environmental Protection Agency (EPA) finalised a rule that will result in the most comprehensive collection of data on per- and polyfluoroalkyl substances (PFAS) produced and used in the United States. This rule is the culmination of more than two years of progress on the Government's initiative to tackle PFAS pollution, protect public health, and promote environmental justice, and is a major step in the EPA's PFAS Strategic Roadmap.

Per- and Polyfluorinated Substances

Per- and Polyfluorinated Substances (PFAS) are a class of manufactured chemicals that are widely used in industrial and consumer products. They have been manufactured since the 1940s and have properties that allow them to be used in a wide range of products, from non-stick cookware to waterproof clothing and firefighting foam. They are also used in some manufacturing processes.

PFAS are known as 'forever chemicals' as they are extremely persistent in our environment and bodies. They can lead to health problems such as liver damage, thyroid disease, obesity, fertility issues and cancer.

EPA’s Final Rule

The final rule expands the scope of the proposed rules definition of PFAS to include 41 additional PFAS identified as being of concern. The Environmental Protection Agency (EPA) has determined that a minimum of 1,462 PFAS have been produced or manufactured in the United States since 2011 will be subject to the final rule. It is important data to protect human health and the environment from these chemicals.

The Toxic Substance Control Act (TSCA) reporting rule is part of the FY2020 National Défense Authorization Act (NDAA), which requires all manufacturers (including importers) of PFAS-containing products in a given year from 2011 to submit information to the Environmental Protection Agency (EPA) including chemical identity, volume of products manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal.

This rule will provide the ability to understand and effectively protect people from PFAS and to conduct research on who is using the substances and in which quantity.  This rule will produce actionable data that can be used by the EPA and governments to craft policies and laws to protect people and the environment from PFAS.

Timeline

Companies will have 18 months from the effective date of the final rule (30 days after publication in the Federal Register) to report data online. Small companies that only report data on the import of PFAS in articles will have an additional 6 months to complete their online submissions.

On June 13, 2024, the U.S. Environmental Protection Agency (EPA) published a final rule entitled "Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Polic...

On June 13, 2024, the U.S. Environmental Protection Agency (EPA) published a final rule entitled "Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program in Commercial and Industrial Refrigeration”, also known as Significant New Alternatives Policy Program (SNAP) Rule 26. 

The SNAP program implements Section 612 of the amended  Clean Air Act of 1990. This section mandates EPA to assess alternatives to substances that deplete the ozone layer in order to minimize risks to human health and the environment. As a result of these assessments, SNAP creates lists of acceptable and unacceptable substitutes for several major industrial sectors. The goal of the SNAP program is to facilitate a seamless transition to safer alternatives. 

Proposed Rule and Final Rule 

Substitutes that are deemed either unacceptable or acceptable with use restrictions will be subject to a comment period before being formally published as a rule. A 'Proposed Rule' includes proposed lists of substances that are considered either acceptable with restricted conditions or completely unacceptable. Typically, there is a 60-day period for public comments starting from the date of publication in the Federal Register. 

After receiving public feedback on its proposed rules, EPA reviews the comments and finalizes a 'Final Rule' that formalizes the provisions as law. The SNAP rules and notices can be accessed online here. 

List of Substances under SNAP Rule 26: 

 
This action outlines new substitution guidelines for the refrigeration and air conditioning sector. The details are: 

• List nine refrigerants as acceptable, subject to use conditions, for use in commercial ice machines. 

• List nine refrigerants as acceptable, subject to use conditions, for use in industrial process refrigeration. 

• List seven refrigerants as acceptable, subject to use conditions, for use in cold storage warehouses. 

• List six refrigerants as acceptable, subject to use conditions, for use in ice skating rinks. 

• List eight refrigerants as acceptable, subject to use conditions, for use in retail food refrigeration systems. 

• Revise use conditions for one refrigerant, for use in self-contained commercial ice machines and stand-alone retail refrigeration equipment. 

• Adopt the current versions of three industry standards by incorporating them by reference into the relevant use conditions; and 

• Exempt R-290 from the Clean Air Act section 608 prohibition on releases of refrigerant during installing, maintaining, repairing, or disposing of refrigerated food processing and dispensing equipment on the basis of information that such releases are not expected to pose a threat to the environment. 

On June 13, 2024, the U.S. Environmental Protection Agency (EPA) announced that its Science Advisory Committee on Chemicals (SACC) will conduct a peer review of two key assessments: the Draft Risk Eva...

On June 13, 2024, the U.S. Environmental Protection Agency (EPA) announced that its Science Advisory Committee on Chemicals (SACC) will conduct a peer review of two key assessments: the Draft Risk Evaluation for 1,1-dichloroethane and the draft hazard assessment supporting the Draft Risk Evaluation for 1,2-dichloroethane (commonly referred to as ethylene dichloride). Additionally, EPA is seeking public comments on potential candidates for ad hoc reviewer roles to support the SACC in this review process. 

Comprehensive Review of Industrial Solvent Risk Assessment Documents under TSCA 
 
EPA is conducting risk evaluations for two solvents, 1,1-dichloroethane and 1,2-dichloroethane, under the Toxic Substances Control Act (TSCA). 1,1-dichloroethane is used in industrial settings, mainly for chemical production and laboratory work, with no consumer applications. In contrast, 1,2-dichloroethane is primarily used in the production of vinyl chloride. 

EPA originally planned to gather feedback on the draft risk evaluation for 1,1-dichloroethane through a letter peer review but has now opted for a more thorough review by convening the SACC. 

EPA is also seeking input on the draft hazard assessment for 1,2-dichloroethane, which provides crucial toxicity data to help understand the toxicity of 1,1-dichloroethane due to their structural similarities. This assessment will inform the upcoming draft risk evaluation for 1,2-dichloroethane that EPA will release for public comment and peer review in the future. 

The SACC will conduct its peer review in a public meeting, preceded by a virtual session to discuss draft charge issues and review scope. Registration details for these meetings will be posted on EPA’s peer review website in the coming months. 

Public Comments on Ad Hoc Peer Reviewers 

EPA is seeking public input on potential candidates to serve as ad hoc peer reviewers for the risk evaluations of 1,1-dichloroethane and 1,2-dichloroethane. Following a previous call for nominations in March 2024, no new nominations will be accepted. EPA will proceed with the previously identified candidates for the SACC review, which will replace the originally planned letter peer review. 

Biographies of these candidates can be accessed in docket EPA-HQ-OPPT-2024-0114  and on EPA’s peer review website. Public comments on the candidates must be submitted to www.regulations.gov by June 28, 2024. Commenters should avoid including confidential business information or sensitive personal data, as this information may be publicly posted online. 

During the selection process, candidates will be required to submit confidential financial disclosures detailing their employment, investments, and research funding sources. These disclosures will be reviewed by EPA to ensure that there are no conflicts of interest, biases, or prior involvement with the documents under review. 

Feedback from the SACC will be crucial in guiding EPA's final risk evaluations and influencing its risk management decisions under TSCA. 

Maine law 32 MRS §1733(3-B) requires the Department of Environmental Protection to initiate rulemaking to ban PFAS in food packaging as soon as safer alternatives are available. On April 18, 2024, th...

Maine law 32 MRS §1733(3-B) requires the Department of Environmental Protection to initiate rulemaking to ban PFAS in food packaging as soon as safer alternatives are available. On April 18, 2024, the Board of Environmental Protection approved Chapter 80 Section 5, which bans per- and polyfluoroalkyl substances (PFAS) in specific food packaging sold in Maine. This prohibition will become effective May 25, 2026, two years after the rule's official adoption by the Secretary of State. 

This new rule is the first major update to Maine's 1992 regulations to reduce toxics in packaging. The ban is based on a 2019 state law that has been delayed due to concerns about the cost and availability of non-PFAS alternatives. 

Types of Food Packaging Affected: 

Bags and Sleeves: Flexible, foldable containers for transporting food, including bags with sealed ends such as pinch-bottom bags. 

Bowls: Open-topped, wide-rimmed containers designed for serving foods with significant liquid content, including portion cups. 

Closed Containers: Fully enclosed containers with interlocking or overlapping walls for secure transport. Examples: clamshells, food pails, bakery boxes, deli containers. 

Flat Service ware: Shallow, flat-bottomed containers with large surface areas or compartments for serving and transporting food. Examples: trays, cafeteria trays, plates. 

Food Boats: Tray-like containers with high sides and no compartments. 

Open-Top Containers: Containers that enclose food on all but one side and are used for serving or transporting food. Examples: paper cones, cups, bowls, food boats. 

Pizza Boxes: Folded boxes for holding and transporting various sizes of pizza or calzones. 

Plates: Flat service ware, either single-piece or with compartments, used for serving or holding food. 

Wraps and Liners: Sheets used to wrap food or line other service ware to provide an additional barrier. 

Exemptions 

The prohibition does not apply to manufacturers with annual national food and beverage sales of less than $1 billion. This applies to any manufacturer of a food or beverage product that comes in a food package or to which a food package is applied. 

Chemicals of High Concern List 

The new regulations (32 MRSA, Chapter 26-B) require the Department to create and publish a list of up to 10 "Chemicals of High Concern" associated with food contact materials. This list will help track the use of these chemicals in food packaging. To qualify, a substance must meet these criteria: 

• Listing: Included on the Maine Chemicals of Concern list (Title 38, section 1693); or  

• Governmental Recognition: Recognized by an authoritative entity as: 

  •  A carcinogen, or a reproductive/developmental toxicant, or an endocrine disruptor; 

  • Persistent, bioaccumulative, and toxic (PBT); or 

  • Very persistent and very bio accumulative (vPvB). 

• Scientific Evidence: Credible scientific evidence that the chemical is a reproductive or developmental toxicant, endocrine disruptor or human carcinogen.  

• Exposure criteria: The chemical must also meet at least one of these criteria based on strong scientific evidence: 

  • Detected in human blood, breast milk, urine, or other body tissues or fluids. 

  • Found in food or beverage products through analysis.  

  • Added to or present in a food package. 

On 20 September 2023 the US Consumer Product Safety Commission (CPSC) published a request for information on per- and polyfluoroalkyl substances (PFAS) that are in commerce or may be used in consumer ...

On 20 September 2023 the US Consumer Product Safety Commission (CPSC) published a request for information on per- and polyfluoroalkyl substances (PFAS) that are in commerce or may be used in consumer products, potential exposures linked to such use, and potential adverse consequences on human health from the use of PFAS in consumer products. The request was notified to the World Trade Organisation (WTO) on 21 September. The notification is open for comments until 20 November 2023.  

Information requested  

The request for information is open to all stakeholders, including consumers, manufacturers and importers, government and non-government groups, and researchers. Stakeholders are asked to focus the information on consumer products considering the data that the CPSC already has access to in the contract report and related supporting materials. The report from the contractor is not a risk assessment and does not list all potential data sources that might be used in a risk assessment. 

The Consumer Product Safety Commission (CPSC) is specifically seeking information regarding the presence and use of per- and polyfluoroalkyl substances (PFAS) in consumer products, the potential human exposure to PFAS associated with the consumer product use, the potential exposure of highly exposed populations, and the potential adverse effects on human health derived from toxicological data sources. 

The CPSC seeks comment on all significant aspects of this issue. More details can be found here:  https://www.govinfo.gov/content/pkg/FR-2023-09-20/pdf/2023-20332.pdf