PFAS Regulations in the United States: An Essential Guide

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PFAS Regulations United States

Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) are a group of chemicals that are added to certain consumer products to enhance their ability to resist water, stains, and flames. Examples of these products include non-stick cookware, apparel, furniture, and building materials.

In recent years, PFAS have been regulated by some federal and state regulations in the US for their toxicity to humans and the environment. In this article, we introduce PFAS regulations in the US.

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What are PFAS, PFOA and PFOS?

PFAS are a group of man-made chemicals that are defined as containing at least one fully fluorinated methyl or methylene carbon atom. It is estimated that there are more than 4,700 types of PFAS.

PFASs are referred to as “forever chemicals” because their carbon-fluorine bond is extremely strong and stable and makes them hard to break down and decompose.

In particular, PFOA (Perfluorooctanoic acid) and PFOS (perfluorooctane sulfonic acid), which belong to the PFAS group, have been widely used in the consumer product industry since the 1940s for their properties of enhancing products’ ability to resist oil, water, flame, and chemical corrosion.

Since the 2000s, some states in the United States have restricted the use of PFAS in certain consumer products for their toxicity to human beings, wildlife, and pollution to drinking water and the natural environment.

Which products and materials may contain PFAS?

In this section, we list products and materials that may contain Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS).

Food Packaging

PFAS was firstly used in the food packaging industry in the 1960s in the United States. PFAS in food packaging excels in keeping oil and moisture oozing from food such as bakery, deli, or other cooked food.

Examples of grease-resistant food packaging that might contain PFAS include:

  • Fast food containers
  • Paper wrappers
  • popcorn bags
  • Pizza boxes
  • Pet food bags

Non-stick Kitchenware

PTFE (polytetrafluoroethylene) is one member of the 4,700 types of PFAS, and it is typically used in non-stick cookware. Examples of the non-stick cookware that might contain PTFE are:

  • Frying pans
  • Grill pans
  • Pots
  • Spatulas
  • Spoons

Opinions on the toxicity of PTFE to human beings from non-sticks are unsettled. However, some studies show that non-stick cookware processed with PTFE could release toxic fumes into the air when heated to above 250°C.

The toxic fumes can cause flu-like symptoms in human beings, which are known as polymer fume fever. Users who inhale the fumes could experience chills, fever, headache, and body aches.

Furniture and Rugs

PFAS are used in the coating materials by the furniture and carpet industry, as a method to enhance the stain and water resistance ability of these products. Here we list some examples of products that might contain PFAS::

Water-Resistant Apparel

Fabrics and textiles that are treated with PFAS have outstanding ability in resisting stains and water. Examples of clothing that may contain PFAS include:

  • Gore-Tex outdoor clothing
  • Raincoat
  • Menstruation panties
  • Hiking boots
  • Camping tents

Firefighting Foam

PFAS are commonly found in Class B firefighting foams, which are used commercially to put out the fire or used in fire training in the following establishments:

  • Military installations
  • Civilian facilities
  • Airports
  • Petroleum refineries
  • Chemical storage facilities
  • Chemical manufacturing plants

Paints

Paints and coating materials of some construction materials might contain PFAS. The active ingredient of PFAS improves the glossiness of the paint and decreases bubbling and peeling on the paint surface. PFAS also enhances the stain and water resistance of the paint.

Below are examples of products that might contain PFAS-treated paints:

PFAS Lab Testing

Third-party lab testing is often necessary to determine if a certain material contains PFAS. The testing process can also determine whether the PFAS content is above or below a certain limit, which in turn may correspond to the regulations listed in this guide.

21 CFR (FDA) – Food Contact Materials

Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) are regulated by the FDA in food contact products. Only PFAS that are authorized by the FDA can be used in food contact materials. Currently, the FDA does not set maximum allowed limits on PFAS in food contact products.

Product Scope

The FDA authorized the use of PFAS in the following food contact products:

  • Non-stick cookware
  • Gaskets and O-Rings
  • Processing aids for food contact polymers
  • Paperboard or paper food packaging

Authorized Substances

The FDA has authorized the use of several types of PFAS in some categories of food contact products after reviewing the current data on their properties, health concerns, and other safety information.

According to its website, PFAS-containing coating materials in food contact products are deemed to have “negligible amount of PFAS capable of migrating to food” and PFAS used in the manufacturing of gaskets used to come into contact with food “does not pose a safety risk because they are also made of molecules that are polymerized.”

PFAS that are authorized to be used in food contact materials mainly have the following applications:

a. Coating materials of the non-stick cookware

b. Materials that are used to produce certain parts in food processing equipment that require chemical and physical durability, such as gaskets and O-Rings

c. Processing aids for manufacturing food contact polymers to reduce build-up on manufacturing equipment

d. Grease-proofing agents in paper and paperboard food packaging

Substances Notification

As explained in the previous section, the FDA authorizes the use of PFAS in certain food contact materials. However, companies selling food contact products containing PFAS must submit to the FDA a food contact substance notification, which must contain sufficient information to demonstrate that the substance is safe for the intended use.

S.3169 – Keep Food Containers Safe from PFAS Act of 2021

Even though PFAS have been authorized until now in some food contact products, there has been a growing concern about their impact on human health. In November 2021, a new bill S.3169 was introduced to Congress. The bill proposes to amend the Federal Food, Drug, and Cosmetic Act (FDCA) to prohibit the use of food packaging containing intentionally added PFAS.

Once S.3169 is passed as a law, it should be executed in all states in the United States, which will affect manufacturers, importers, or sellers of food packaging materials.

Emergency Planning and Community Right-to-Know Act (EPCRA)

The Emergency Planning and Community Right-to-Know Act (EPCRA) was created by the Environmental Protection Agency (EPA) to allow communities to plan for chemical emergencies, and it requires reporting on the use and storage of hazardous substances.

Some PFAS are listed in the Toxics Release Inventory (TRI) published under the EPCRA, including the following:

  • Perfluorooctyl iodide
  • Potassium perfluorooctanoate
  • Silver(I) perfluorooctanoate

Reporting and Recordkeeping

Manufacturers and processors of PFAS or other chemicals listed on EPCRA Section 313 are be required to report the use of the substances to the EPA, if:

a. They manufacture or process any listed chemical in an amount above a certain threshold, over a calendar year (e.g. 100 pounds for each PFAS)

b. Their facility employs 10 or more full-time employees

A wide range of facilities from multiple industries may be affected by TRI’s PFAS reporting rules. The EPA lists the industries that could be affected, which includes:

  • Food manufacturing
  • Beverage manufacturing
  • Fabric manufacturing
  • Textile manufacturing
  • Apparel manufacturing
  • Leathery goods manufacturing
  • Wood product manufacturing
  • Paper product manufacturing

Note that this is not an inclusive list. If you want to know what other industries are covered in the TRI Program, you can visit this website.

Manufacturers should also keep records of information such as the following:

  • Previous reports
  • Threshold worksheets
  • Engineering calculations and other relevant information
  • Purchase records
  • Inventory data

California Proposition 65

California Proposition 65 applies to most consumer products. This regulation sets up substance restrictions and warning label requirements for manufacturers, importers, or sellers placing their products in California in order to protect the people of California from harm caused by exposure to certain types of chemical substances.

California Proposition 65 added several PFAS to the list of chemicals known to cause reproductive toxicity to humans, including PFOA and PFOS.

Product Scope

California Proposition 65 applies to most consumer products, including the following products, which might be PFAS-treated:

  • Water/stain-resistant apparels
  • Water/stain-resistant carpets
  • Water-resistant/stain-resistant furniture
  • Leathery products
  • Paper food packaging and containers
  • Cosmetics
  • Ski waxes

Substance Restrictions

Currently, several categories of PFAS are identified to cause cancer or as being toxic to human’s reproductive systems by California Proposition 65, including:

  • Perfluorooctanoic Acid (PFOA)
  • Perfluorooctane Sulfonic Acid (PFOS) and Its Salts and Transformation and Degradation Precursors
  • Perfluorononanoic acid (PFNA) and its salts

California Proposition 65 has not specified the Safe Harbour Levels, which is the maximum exposure limit of the listed substances, for these chemicals yet. This means that importers and manufacturers are required to provide a warning statement on the product itself or the packaging to notify consumers of the potential health risks of using the products, if the product contains or might contain any amount of these substances.

Warning Label Requirements

The warning label statement for products that contain PFAS should be written as:

This product can expose you to chemicals including [Substance], which is/are known to the State of California to cause [cancer] [birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov.

Lab Testing

If you want to assess whether your products contain PFAS, you should get in touch with a laboratory that has the expertise to perform the relevant lab testing. Here is a list of companies that offer California Proposition 65 compliance test services:

  • QIMA
  • Intertek
  • SGS
  • TÜV Rheinland

California Health and Safety Code Juvenile Products: Chemicals: Perfluoroalkyl and Polyfluoroalkyl Substances

Chapter 12.5. of the Health and Safety Code requires that after July 1, 2023, manufacturers should not sell or distribute in California juvenile products that contain regulated PFAS. Manufacturers of such products should replace PFAS with the least toxic alternative.

Product Scope

According to the Health and Safety Code, juvenile products are products designed to be used by children under 12 years of age. Here are some examples of these products:

  • Baby or toddler foam pillows
  • Bedside sleeper
  • Booster seats
  • Crib mattress
  • Floor playmats
  • Highchairs
  • Highchair pads
  • Infant bouncers
  • Infant carriers
  • Infant seats

Substance Restrictions

PFAS are prohibited to be used in juvenile products as defined in the above section, starting from July 1st, 2023.

Maine – Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution

Beginning January 1, 2023, it is illegal for anyone in Maine to sell or distribute carpets or rugs that contain intentionally added PFAS.

Effective at the same time, anyone who sells or distribute other consumer products that contain intentionally added PFAS must submit to the Maine Department of Environmental Protection a notification that includes at least the following items:

a. A brief product description

b. The purpose for which PFAS are used in the product

c. The amount of each of the PFAS in the product is identified by its CAS number (reported in exact quantity or in a range)

d. The name, address, contact person, and phone number of the manufacturer

Product Scope

This act covers consumer products excluding:

a. Products for which federal law governs relating to PFAS preempts state authority and

b. Food packaging

Substance Restrictions

The prohibition of PFAS applies to rugs and carpets sold in Maine.

The notification requirement of PFAS applies to all products, excluding exceptions. The act however does not specify the permissible PFAS concentration level.

Certificate of Compliance

The Department of Environmental Protection of Maine might request a certificate of compliance from the manufacturers to attest that rugs or carpets do not contain intentionally added PFAS.

Maine – Reduction of Toxics in Packaging Law

The Reduction of Toxics in Packaging Law in Maine mainly restricts heavy metals in packaging products. However, point “§1733. Prohibitions; substitute materials, Part 3-B. Prohibition of sale of food package containing PFAS” states that it may prohibit a manufacturer, supplier, or distributor from offering for sale or for promotional purposes food packaging that contains intentionally added PFAS.

It also states that this prohibition might only be enacted once the department has determined that a safer alternative to the use of PFAS on food packaging is available.

Product Scope

This law applies to packaging, including food packaging that might contain intentionally added PFAS, such as for example:

  • Pizza cartons
  • Paper grocery bags
  • Paper wrappers
  • Bakery bags

Substance Restrictions

The law states that the sum of the concentration levels of lead, cadmium, mercury and hexavalent chromium should be < 0.01% by weight.

It also states that PFAS-contained food packaging might be banned once safer alternatives to PFAS in food packaging will become available.

Certificate of Compliance

This law requires that packaging manufacturers must provide a certificate of compliance, which is a document to attest that the packaging components meet the substance restrictions set forth in the law.

  • (USA & EU)

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    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

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