On February 14, 2023, the Maine Department of Environmental Protection (MDEP) announced a much anticipated proposed rule intended to provide additional guidance on the notification requirements and sales prohibitions for products and product components containing intentionally added per- and polyfluoroalkyl substances (PFAS). MDEP will hold a public hearing on April 20, 2023. Comments are due May 19, 2023, by 5:00 p.m. (EDT).

Background

Maine enacted “An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution” in July 2021. Under the bill, manufacturers of products with intentionally added PFAS must report the presence of the intentionally added PFAS in those products to MDEP beginning January 1, 2023. The law also prohibits the sale of carpets or rugs, as well as the sale of fabric treatments, that contain intentionally added PFAS beginning on January 1, 2023. Beginning January 1, 2030, any product containing intentionally added PFAS may not be sold in Maine unless the use of PFAS in the product is specifically designated as a currently unavoidable use by MDEP.

As reported in our September 30, 2022, blog item, pending clarification of the January 1, 2023, reporting requirements, reporting entities had to request an extension of time to notify MDEP of any products for sale in the State of Maine that contain intentionally added PFAS. Manufacturers had to obtain information from many industry sectors and upstream suppliers to determine if PFAS was intentionally added to the product or is a component of the product. The frequently asked questions (FAQ) on MDEP’s website list information that will be required, “at a minimum,” but the website states that “[t]hese requirements will be further clarified as part of the rulemaking.”

Proposed Rule

Applicability

The proposed rule would apply to all new products and product components sold, offered for sale, or distributed for sale in the State of Maine that contain intentionally added PFAS.

Definitions

The proposed rule defines several terms, including:

• Intentionally added PFAS: “Intentionally added PFAS” means PFAS added to a product or one of its product components in order to provide a specific characteristic, appearance, or quality or to perform a specific function. Intentionally added PFAS also includes any degradation byproducts of PFAS serving a functional purpose or technical effect within the product or its components. Products containing intentionally added PFAS include products that consist solely of PFAS. Intentionally added PFAS does not include PFAS that is present in the final product as a contaminant.

• Manufacturer: “Manufacturer” means the person that manufactures a product or whose brand name is legally affixed to the product. In the case of a product that is imported into the United States where the person that manufactured or assembled the product or whose brand name is affixed to the product does not have a presence in the United States, manufacturer includes either the importer or the first domestic distributor of the product, whichever is first to sell, offer for sale, or distribute for sale the product in the State of Maine.

  • MDEP notes that certain online retail platforms may allow for purchase of products directly from a producer. When no other person meets the definition of manufacturer under the proposed rule, and the product is sold, offered for sale, or distributed for sale in the State of Maine, MDEP will consider the importer to be the manufacturer.

  • MDEP also notes that when it is possible to consider both entities the manufacturer, MDEP will consider the party who controls the formulation of the product and its PFAS content to be the manufacturer.

• Perfluoroalkyl and polyfluoroalkyl substances (PFAS): “Perfluoroalkyl and polyfluoroalkyl substances” or “PFAS” means substances that include any member of the class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.
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  • MDEP notes that the U.S. Environmental Protection Agency (EPA) maintains a web page of chemicals that have been identified as PFAS (available at https://comptox.epa.gov/dashboard/chemical-lists/pfasmaster) that “provides clarity on what is considered a PFAS.” MDEP states that any product sold, offered for sale, or distributed for sale in the State of Maine that contains intentionally added PFAS must be reported to MDEP regardless of whether the substance is found on any list.

  • MDEP also notes that 38 M.R.S. Section 1614 requires notification of intentionally added PFAS by Chemical Abstracts Service Registry Number^® (CAS RN^®), therefore chemicals that do not have CAS RNs assigned are not subject to the proposed rule. MDEP states that chemicals that do have CAS RNs assigned but are withheld by other persons or are otherwise unavailable are subject to the proposed rule, however.

• Product: “Product” means an item manufactured, assembled, packaged, or otherwise prepared for sale to consumers, including its product components, that is sold or distributed for personal, residential, commercial, or industrial use, including for use in making other products. Product includes packages, packaging components, and food packaging as defined in 32 M.R.S. [Section] 1732, when sold individually or in bulk and not used in marketing, handling, or protecting a product.

• Product component: “Product component” means an identifiable part of a product, regardless of whether the manufacturer of the product is the manufacturer of the product component.

Notification

Beginning January 1, 2023, a manufacturer of a product for sale in Maine that contains intentionally added PFAS must notify MDEP. Under the proposed rule, the reporting notification must include:

• A brief description of the product, including at minimum:

(i) Global Product Classification (GPC) brick category and code, if available;

(I) If GPC is not applicable to the product or product component, the United States International Trade Commission’s Harmonized Tariff System (HTS); or

(II) Unless an alternative category is approved below, if neither GPC code nor HTS number is applicable, products or product components must be registered individually by name and with sufficient information, such as stock keeping unit (SKU), to differentiate them from similar items or items with different compositions;

(ii) The general type of the product; and

(iii) Its intended use.

• The purpose for which PFAS are used in the product, including PFAS in any product component;

• The amount of each of the PFAS as a concentration, identified by name and its CAS RN, of each PFAS in the product or any product component reported as an exact quantity determined using commercially available analytical methods, or as falling within a range approved by the Department; and

(i) If reporting PFAS as falling within an MDEP-approved range, found in MDEP’s online notification system, the manufacturer may rely on calculations specific to the inputs and outputs of their manufacturing process or that of a product component’s manufacturer to determine the amount of PFAS present.

For product components for which MDEP has previously received notifications, that are used in more complex products containing the reported components, the manufacturer of the more complex product shall either report PFAS in the product, including its components, or refer to the notifications for product components and any PFAS in the remainder of the product.

• The name and address of the reporting manufacturer, and the name, address, e-mail address, and phone number of a responsible official for the manufacturer. The responsible official provided must have the authority to execute or direct others to execute the steps in Section 8 below.

  • MDEP notes that claims of confidential business information may be made at the time of notification. MDEP will handle such claims in accordance with Maine’s Freedom of Access Act Title 1, Chapter 13, subchapter 1, M.R.S. and related policies and procedures; in particular 1 M.R.S. Section 402(3)(B) excludes information from public disclosure that the courts would find to be privileged.

For notifications submitted to the Department under the statutory requirement and prior to the effective date of this rule and/or the availability of the digital reporting system, the notification must be submitted into the digital database within 90 days of the effective date of this rule.

Exemptions

The proposed rule includes the following exemptions:

• A product for which federal law or regulation controls the presence of PFAS in the product in a manner that preempts state authority. For this purpose, the provisions of this Chapter are severable, and if any phrase, Section or Subsection is preempted by federal law or regulation, the validity of the remainder of this Chapter shall not be affected.

  • MDEP notes that federal preemption involves a determination that the intent of federal laws is to limit or eliminate overlapping programs at the state level; the intent can be expressly written into the enabling statute or implicit where the structure and scope of the federal law reflects the intent to preempt.

MDEP will treat as exempt products where an applicable federal law is written with language that explicitly preempts parts of this program. MDEP will also treat as exempt any products where an applicable opinion from a court having jurisdiction in Maine finds that preemption of parts of this program is implied.

In the absence of explicit statutory language or an applicable court finding, MDEP does not have the authority to make independently a finding of law or accept an assertion that implied preemption exists.

For more information on preemption. see https://crsreports.congress.gov/product/pdf/R/R45825/2.

• A product subject to Title 32, Section 26-A, Reduction of Toxics in Packaging.

• A product subject to Title 32, Section 26-B, Toxic Chemicals in Food Packaging.

  • MDEP notes that the statutory exemption of products subject to Title 32, Section 26-A, Reduction of Toxics in Packaging, and Title 32, Section 26-B, Toxic Chemicals in Food Packaging, applies to all packing, packing components, and food packaging as defined in 32 M.R.S. Section 1732, regardless of whether MDEP has specifically regulated such items.

These exemptions apply only when items are actually used as packaging, packing components, or food packing, intended for marketing, handling, or protection of products.

Commentary

The proposal offers some much-needed guidance, but not as much as is needed. We appreciate MDEP is working hard to address the many open-ended issues its notification requirements inspired, but it (not industry) set into motion the program that seemed to have been launched prematurely.

Stakeholders should read the proposal carefully, comment as necessary, and seek additional guidance on much needed aspects of the program. Many questions remain unanswered. The MDEP program could well serve as a template for other states.