Understanding PFAS

Let’s begin with a short introduction to PFAS. PFAS (per- and polyfluoroalkyl substances) are a group of synthetic chemicals resistant to heat, oil, stains, grease, and water. They are used in a wide range of industrial and consumer products like non-stick cookware, waterproof clothing, food packaging, firefighting foams, and many other products. However, they do not break down easily and contaminate soil and water, earning them their name ‘forever-chemicals.’ Due to their prevalent use and persistence, many PFAS have been found in the blood of humans and animals worldwide and are also present at low levels in our environment. The occurrence of PFAS in the environment through industrial release, discharges from sewage treatment plants, and landfills can contaminate water bodies, which cannot be reversed easily.

Exposure to certain types of PFAS in humans can lead to health problems such as:

• Risk of Cancer
• Development delays in Children
• Fertility issues in women
• Liver damage
• Thyroid disease
• Risk of obesity
• Asthma

In response to the growing risk posed to both humans and the environment, regulations have been implemented to minimize their prevalence in the environment and minimize human exposure.

Regulations surrounding PFAS.

Let’s explore how PFAS are being regulated worldwide:

European Union

1. REACH Regulation: Under the EU's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, PFAS are subject to strict registration and evaluation requirements.
2. Persistent Organic Pollutants (POPs) Regulation: PFAS, such as perfluoro octane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA), are listed as POPs and are subject to strict restrictions on their production, use, and disposal.
3. Water Framework Directive (WFD): The EU's Water Framework Directive sets standards for the quality of surface waters, groundwater, and coastal waters in the EU, and PFAS are included in the list of priority substances.
4. Food Contact Materials Regulation: The EU's Food Contact Materials Regulation sets strict limits on the use of PFAS in food products due to their potential health risks.
5. ECHA Restrictions: ECHA has proposed restrictions on the use of certain types of PFAS, including perfluorohexane sulfonic acid (PFHxS), perfluorononanoic acid (PFNA), and perfluorooctanoic acid (PFDA).

The United States:

1. EPA's Lifetime Health Advisory: The U.S. Environmental Protection Agency (EPA) has set up a health advisory level for two PFAS compounds, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), at 70 parts per trillion (ppt) in drinking water.
2. Clean Water Act: The Clean Water Act regulates the discharge of pollutants into U.S. waterways, including PFAS.
3. Toxic Substances Control Act (TSCA): In 2019, the EPA added 172 PFAS compounds to the TSCA's list of chemicals that are subject to reporting requirements.
4. Food and Drug Administration (FDA) Guidance: The FDA has issued guidance to the food industry on the use of PFAS in food contact materials.
5. National Primary Drinking Water Regulation (NPDWR): By March 2023, EPA proposed the (NPDWR) a set of standards and techniques to limit the level of contaminants in the public water system for the protection of human health. The proposal will be finalized by the end of 2023.

Ensuring PFAS compliance as manufacturers:

With these many regulations in place and still more to come (as the effect of PFAS is still under study), it is evident that manufacturers of products containing PFAS substances are required to comply with the regulations. Non-compliance could result in violation notification, hefty penalties, and the banning of products altogether as in the state of Maine, USA

1. Understanding the regulations: Familiarize oneself with the relevant regulations and guidelines regarding PFAS compliance. This includes understanding the legal limits, reporting requirements, and any specific regulations applicable to specific industries or regions.
2. Conduct a Compliance Assessment: Evaluate the operations, processes, and products to assess compliance with PFAS regulations. This may involve site visits, inspections, and audits. Consider the following areas:

a. Input Materials: Determine if any materials used in the product contain PFAS. Any changes to substances for example using an alternative material which was used earlier in the manufacturing process could drive capital investments for new equipment. Obsolescence of materials using PFAS could initiate product redesign or recertification.
b. Production Processes: Evaluate the manufacturing processes to identify any potential points of PFAS contamination or release. This may include examining equipment, chemicals, waste management practices, and wastewater treatment systems.
c. Testing and Monitoring: Determine if you have established a testing and monitoring program to detect and quantify PFAS levels in the products, emissions, and wastewater.
d. Disposal and Recycling: Evaluate the procedures for handling, storing, disposing, and recycling materials containing PFAS. Ensure they comply with proper waste management regulations and guidelines.
e. Reporting and Documentation: Maintain accurate records, documentation, and reporting of their PFAS-related activities, such as testing results, monitoring data, and regulatory filings. Be transparent about the efforts.

3. Supply Chain: Communicate with your suppliers to inquire about their PFAS compliance practices. Ask specific questions about their processes, testing methods, and waste management procedures related to PFAS. Seek clarification on any areas where you have concerns or require more information.
4. Third-Party Verification: Consider engaging a third-party auditor or consultant with expertise in PFAS compliance to conduct an independent assessment of the manufacturer's compliance efforts. They can provide an unbiased evaluation and offer recommendations for improvement if necessary.
5. Stay Updated Always: Keep track of any updates or changes in PFAS regulations to ensure ongoing compliance. Regularly review your relationship with the manufacturer to ensure they maintain compliance over time.

How APA can help you achieve PFAS compliance!

Yes, manufacturers can adhere to the above to comply with PFAS regulations. However, they are easier said than done as they involve time, money, and resources. Here is how we can help you be compliant. With more than 20 years in the field of compliance, our experts can provide you with the regulatory insights you need, give you intelligible information from your suppliers, drive your market growth and stay updated anywhere, anytime.

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3. EPA requires Toxicity Data for PFAS
4. PFAS banned in Maine, USA