The regulatory environment surrounding per- and polyfluoroalkyl substances (PFAS) is continuously evolving, presenting new challenges and compliance obligations for companies across diverse sectors, including pharmaceuticals, cosmetics, and life sciences. As regulatory bodies tighten their grip on these persistent chemicals, it becomes imperative for organizations to proactively manage their PFAS footprint and ensure absolute compliance.
PFAS Regulations in the US and Canada
In the United States, the Environmental Protection Agency (EPA) has taken significant steps in addressing PFAS, including the issuance of a final rule under the Toxic Substances Control Act (TSCA), mandating PFAS manufacturers to furnish comprehensive information on PFAS production, import, and usage by May 2025. Furthermore, the EPA's Unregulated Contaminant Monitoring Rule (UCMR 5) is actively monitoring 29 PFAS in public water systems, revealing that several PFAS with health advisories were detected in nearly 14% of monitored systems.
Concurrently, Canada's federal government has proposed to classify the entire class of PFAS substances as "toxic" under the Canadian Environmental Protection Act (CEPA). This move may pave the way for broader PFAS regulations, potentially including bans or restrictions on these "forever chemicals." Certain provinces, such as Quebec, have already taken proactive measures, prohibiting the import of PFAS-containing biosolids from the United States.
Key PFAS Regulatory Updates
1. TSCA PFAS Reporting Rule: In October 2023, the EPA published a final rule under the Toxic Substances Control Act (TSCA) requiring PFAS manufacturers to report detailed information on PFAS production, import, and use by May 2025.
2. UCMR 5 PFAS Monitoring: The EPA's latest Unregulated Contaminant Monitoring Rule (UCMR 5) is tracking 29 PFAS in public water systems, with data showing that several PFAS with health advisories were detected in nearly 14% of monitored systems.
3. State-Level PFAS Product Bans: Many states are enacting laws to ban or mandate consumer notices for PFAS-containing products across various categories, necessitating companies to closely monitor developments on a state-by-state basis.
4. PFAS Litigation: The PFAS litigation scene is rapidly evolving, driven by growing public awareness, new federal and state regulations, and an expanding understanding of the environmental and health impacts of PFAS chemicals. While major settlements have been reached in the large-scale multidistrict litigation (MDL) in South Carolina federal court, experts anticipate an increase in PFAS lawsuits outside the MDL, including claims against consumer brands and personal injury cases.
Canada PFAS Regulations
Federal Regulations
- Canada has adopted limited PFAS regulations at the federal level, mirroring some U.S. federal regulations under the Toxic Substances Control Act.
- These regulations prohibit the manufacture, sale, and distribution of specific PFAS substances such as PFOA, PFOS, and long-chain perfluorocarboxylic acids (LC-PFCAs), including salts and precursors.
Proposed Broader PFAS Regulations
- In May 2023, the Canadian government released a draft "State of PFAS Report" concluding that PFAS as a class "have or may have an immediate or long-term harmful effect on the environment or its biological diversity."
- If finalized, this finding would open the door for Canada to introduce a broad, class-based ban on PFAS, like the proposed REACH restriction in the European Union.
Strategies for Maintaining PFAS Compliance
To stay ahead of the evolving PFAS regulatory landscape, organizations should consider the following strategies:
1. Understand TSCA PFAS Reporting Requirements: Prepare to submit the required data on PFAS production, import, and use by the May 2025 deadline.
2. Monitor UCMR 5 PFAS Testing Results: Track the presence of PFAS in public water systems to assess potential impacts and liabilities.
3. Closely Track State-Level PFAS Regulations: Ensure your products and operations comply with the patchwork of state-level PFAS product bans and restrictions.
4. Manage PFAS Litigation Risks: Carefully evaluate and address any potential PFAS liabilities, especially related to AFFF contamination.
5. Partner with PFAS Experts: Engage with a team of PFAS specialists to help navigate the complex regulatory landscape, conduct testing and analysis, and develop strategies for compliance and remediation.
Conclusion
As the regulatory scrutiny on PFAS intensifies, organizations must remain vigilant and proactive in adhering to evolving compliance obligations. By understanding regulatory updates, implementing robust compliance strategies, and leveraging expert guidance, companies can effectively navigate the complex PFAS regulatory landscape and mitigate associated risks.
At Neopharm our team of PFAS specialists and our optimized screening procedures enable you to detect PFAS compounds quickly and accurately at sub-ppt levels, we are ready to help you navigate the complex regulatory landscape, conduct testing and analysis, and develop strategies for compliance and remediation, to protect your brand reputation and bottom line.
Talk with our expertsSources:Sources:
Fifth Unregulated Contaminant Monitoring Rule | US EPA
Per- and polyfluoroalkyl substances (PFAS) - Canada.ca
PFAS in Canadian Provinces: Where are the environmental regulations? - The Environment Journal
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