Tag: consumer products

Colorado PFAS Act Likely Just the Beginning of New PFAS Chemical Regulation

Key Takeaways

  • How does the recent increase in state regulation of PFAS chemicals in consumer products impact your business?
  • Potential federal regulations of PFAS chemicals
  • Need for implementation of quality control practices
  • How best to identify and correct improper use of PFAS chemicals in consumer products

Introduction

Colorado has become the most recent state to regulate the use of PFAS chemicals in consumer products. It is important that manufacturers and retailers become aware of these restrictions now to avoid future compliance issues since the state regulations of PFAS chemical use are not the same state to state. Further the compliance issues imposed by state regulations will be compounded if the federal government fulfills its promise to regulate PFAS chemicals. Multiple federal agencies have indicated that such federal regulations may be forthcoming in the near future.

Definition of PFAS

Per- and polyfluoroalyyl substances (PFASs, CnF2n+1–R) are a group of man-made chemicals that includes PFOA, PFOS and GenX chemicals.1 These chemicals are widely used, long lasting chemicals that contain components that break down very slowly over time. PFAS chemicals are used to make fluoropolymer coatings and products that resist heat, oil, stains, grease, and water. These can include clothing, furniture, adhesives, food packaging, and many other products.2 Because of their widespread use and persistence in the environment, many PFAS are found in the blood stream of people and animals all over the world and are present at low levels in a variety of food products and in the environment.

Colorado Joins a Growing List of States to Implement PFAS Regulations for Consumer Products

Colorado recently adopted into law the Perfluoroalkyl and Polyfluoroalkyl Chemcials Consumer Protection Act (the “Colorado PFAS Act”)3, which regulates the use of perfluoroalkyl and polyflupralkyl substances (“PFAS chemicals”) in certain consumer products. The Colorado General Assembly concluded that such regulation is necessary upon the determination that “PFAS chemicals pose[] a significant threat to the environment of the state and the health of its residents.”4 Accordingly, by its terms, the Colorado PFAS Act was implemented into law in order “to create a regulatory scheme that phases out the sale or distribution of certain products and product categories in the state that contain intentionally added PFAS chemicals.”5 In furtherance of this goal, the Colorado PFAS Act will phase out the sell and distribution of certain consumer products that contain “intentionally added PFAS chemicals” from January 1, 2024 through January 1, 2027.6

These phase out regulations within the Colorado PFAS Act are consistent with a national trend of states regulating the sale and distribution of consumer products containing PFAS chemicals. For example, the Colorado PFAS Act establishes that Colorado is now one of at least 8 states that will regulate the sale and distribution of “food packaging” that contains intentionally added PFAS chemicals.

Beyond the differing timeline in the above chart, it is important to note these regulations are not synonymous since the term “food packaging” is defined differently by each regulating state.

Ignorance Is No Defense

The Colorado PFAS Act also does not allow ignorance on the contents of a commercial product as prohibiting the enforcement of its regulations. It is true that the Colorado PFAS Act prohibits the sell and distribution of certain products that contain “intentionally added PFAS chemicals.”7 However, the Colorado PFAS Act defines “intentionally added PFAS chemicals” as “PFAS chemicals that a manufacturer has intentionally added to a product and that have a functional or technical effect on the product.”8 Here the “intent” element necessary to trigger the regulations of the Colorado PFAS Act is the intent to add any chemistry which includes any listed PFAS chemicals. The Colorado PFAS Act defines “product” to “include” any product components.”9 Thus, a “manufacturer” of consumer goods must understand all additive materials to its products through each stage of the supply chain.

Likely Federal regulation by the end of the year (2022)10

The EPA is expected to propose a regulation for groups of PFAS in drinking water in the Fall of 2022 before the Agency’s statutory deadline in March 2023. A final rule is anticipated in Fall 2023 after considering public comments on the proposal. In a new health advisory, EPA reduced the acceptable levels for two PFAS (perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA)) in drinking water from 70 parts per trillion down to just 0.004 parts per trillion for PFOA and 0.02 parts per trillion for PFOS.11 Issuing a health advisory is generally considered to be a preliminary step in the process of setting maximum contaminant levels.12 Some states have set their own enforceable drinking water standards for PFOA and PFOS. Vermont, Michigan, and New Jersey have all set limits ranging from 8 to 20 parts per trillion for both chemicals.13 The issuance of the health advisory by the EPA will have States reevaluating their own regulations to conform with the standards set by the Agency.14

By Winter 2022 the EPA plans to leverage federally-issued NPDES permits to reduce PFAS discharges and will propose monitoring requirements at facilities where PFAS are expected or suspected to be present in wastewater and storm water discharges, using its recently published analytical method 1633, which covers 40 unique PFAS. EPA will issue new guidance recommending that state-issued permits that do not already include monitoring requirements for PFAS use the method 1633 at facilities where PFAS is expected or suspected to be present in wastewater and storm water discharges. In addition, the new guidance will recommend the full suite of permitting approaches that EPA will use in federally-issued permits. The EPA expects to publish a multi-laboratory validation method to detect up to 40 specific PFAS compounds in eight environmental matrices with the Department of Defense online by Fall 2022.

Discussion of Proposed RCRA and CERCLA changes

a. Proposed RCRA Changes15

In recent months, EPA has set the stage for greater regulation and firm federal standards PFAS chemicals that could significantly impact cleanup requirements. In October of 2021, the EPA responded to a petition from Governor Michelle Lujan Grisham of New Mexico to tackle PFAS contamination under the Resource Conservation and Recovery Act (RCRA). EPA outlined plans to initiate rulemaking process for two new actions under the hazardous waste law. The first rulemaking effort will initiate the process to propose adding four PFAS chemicals as RCRA Hazardous Constituents under Appendix VIII, by evaluating the existing data for these chemicals and establishing a record to support a proposed rule. The four PFAS chemicals EPA will evaluate are: perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorobutane sulfonic acid (PFBS), and GenX. Adding these chemicals as RCRA hazardous Constituents would ensure they are subject to corrective action requirements and would be a necessary building block for future work to regulate PFAS as a listed hazardous waste. The second rulemaking effort will clarify in EPA regulations that the RCRA Corrective Action Program has the authority to require investigation and cleanup for wastes that meet the statutory definition of hazardous waste, as defined under RCRA section 1004(5). This modification would clarify that emerging contaminants such as PFAS can be cleaned up though the RCRA corrective action process.

b. Proposed CERCLA Changes16

In June 2021, EPA restarted the process to designate PFOA and PFOS as Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) hazardous substances. A proposed rule was expected in the Spring of 2022, no such rule has been proposed. According the EPA’s “PFAS Strategic Roadmap” a final rule is expected in the Summer of 2023 and EPA is currently developing a Notice of Proposed Rulemaking to designate PFOA and PFOS as CERCLA hazardous substances. Such designations would require facilities across the country to report on PFOA and PFOS releases that meet or exceed the reportable quantity assigned to these substances. The hazardous substance designations would also enhance the ability of federal, Tribal, state, and local authorities to obtain information regarding the location and extent of releases. EPA or other agencies could also seek cost recovery or contributions for costs incurred for the cleanup.

The designation PFOA and PFOS as a hazardous substance under CERCLA could substantially impact existing and new cleanup sites. Site owners and responsible parties who release PFOA or PFAS, and possibly other PFAS chemicals will be obligated to report releases, quantify the location and amounts released to stakeholders, and may be liable for partial or total cleanup. Regulatory changes may also delay cleanup and add significant analytical costs for companies who need to evaluate PFAS in various media prior to releases of any kind to waste streams. The designation of PFAS as hazardous substances has not yet been ratified at a federal level. However, several states (e.g., Washington DOE) have enacted Public Health Goals for surface and drinking waters and cleanup standards – several that incorporate federal hazardous substances lists, ensuring that the impending PFAS regulations will extend beyond federally designated cleanup sites.

The Importance of Following the Discussion Leading up to New TSCA Regulations17

The Toxics Release Inventory (TRI) helps the EPA compile data and information on releases of certain chemicals and supports decisions by companies, regulatory agencies, and the public. The EPA intends to implement a rulemaking in 2022 to categorize the PFAS on the TRI list as “Chemicals of Special Concern” and remove the de minimis eligibility from supplier notification requirements for all “Chemicals of Special Concern.” It is expected for the EPA to continue to update and add to the list of PFAS subject to the TRI. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. There is still opportunity for public comments as the rule is not set to finalize until January of 2023.

Industries Should Take Protective Measures

Both the implementation of the Colorado PFAS Act and the recent actions of the EPA establish that the time for manufacturers and retailers to act is now. Specifically, manufacturers and retailers should implement quality control practices directed towards identifying—and where necessary altering—the chemical contents of their consumer products.

To implement such quality control practices, manufacturers and retailers should review their wastewater handling processes and insurance policies for periods of past PFAS chemicals use. These previous processes and insurance policies likely identify the specific components of PFAS chemicals that were deemed to violate state waste water regulations, as well as the internal changes implemented to eliminate the use of such chemicals. Similar practices can likely be implemented in the sale and distribution of consumer products that include PFAS chemicals. Manufacturers and retailers should implement practices now to limit exposure and costs once regulation of PFAS consumer products become both effective and more prevalent. If you have any questions regarding PFAS regulations, please contact the authors of this article.

ENDNOTES

1 Zhanyun Wang et al., A Never-Ending Story of Per- and Polyfluoroalkyl Substances (PFASs)?, 51 ENV’L SCI. TECH. 2508.

2 CTR. FOR DISEASE CONTROL AND PREVENTION, https://www.cdc.gov/biomonitoring/PFAS_FactSheet.html (last visited June 24, 2022).

3 C.R.S.A. § 25-15-601 et seq.

4 C.R.S.A. § 25-15-602(1)(a).

5 C.R.S.A. § 25-15-602(2).

6 C.R.S.A. §§ 25-15-604(1), (3)-(4).

7 C.R.S.A. § 25-15-604(1), (3), and (5).

8 C.R.S.A. § 25-15-603(12)(a).

9 C.R.S.A. § 25-15-603(20)(b).

10 All information gathered in this section coms from: ENV’L PROT. AGENCY https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf (last visited June 24, 2022).

11 Juan Carlos Rodriguez, 3 Takeaways from EPA’s Guidance on PFAS in Drinking Water, Law360 (June 22, 2022, 8:48 PM EDT).

12Id.

13Id.

14Id.

15 Information on RCRA changes comes from: EPA Press Release, responding to New Mexico Governor’s petition to tackle PFAS contamination under RCRA (Oct. 26, 2021).

16 All information gathered in this section coms from: EPA, PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024 (Oct. 2021).

17 Information comes from: EPA (last visited June 24, 2022).

 

Article By Daniella D. Landers, Michael J. Sullivan, and Brendan H. White of Womble Bond Dickinson (US) LLP. Audrey Capra, Summer Associate, also contributed to this alert.

Copyright © 2022 Womble Bond Dickinson (US) LLP All Rights Reserved.

California Announces Initial Draft Priority Products Under California Safer Consumer Products Regulations

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On March 13, 2014, the California Department of Toxic Substances Control (“DTSC”) announced the first set of draft priority products that, if finalized, will be subject to the requirements of the California Safer Consumer Products (“SCP”) Regulations.

Notably, while DTSC had legal authority to identify up to five products, it chose to identify only three draft priority products at this time. The three products are:

  1. Children’s Foam Padded Sleeping Products containing the flame-retardant chemical, Tris (1,3-dichloro-2-propyl phosphate) or (“TDCCP”). Such products include nap mats and cots, travel beds, bassinet foam, portable crib mattresses, play pens, and other children’s sleeping products. In its press release announcing the draft priority products, DTSC asserted that TDCCP is a known carcinogen, is released from products into air and dust where it can be absorbed, inhaled, or transferred from hand to mouth, and has been found in California waters and sediments. DTSC also noted that there is no legal requirement applicable to these products that would require them to be made with flame retardants. For more information on DTSC’s selection of this draft priority product, click here.
  2. Spray Polyurethane Foam (“SPF”) Products containing Unreacted Diisocyanates. SPF products are used for home and building insulation, weatherizing and sealing, and roofing. DTSC asserted in its press release that exposure to wet or “uncured” SPF materials can contribute to occupational asthma and noted that unreacted diisocyanates are a “suspected” carcinogen. DTSC expressed its concern for populations using these products that are not protected by Occupational Safety & Health Administration regulations, such as independent contractors and people performing their own home repairs. In its press release, DTSC noted that currently there are no alternatives to unreacted diisocyanates for spray-foam applications. For additional information from DTSC on this draft priority product, click here.
  3. Paint and Varnish Strippers containing Methylene Chloride. Methylene chloride is a well-known and widely used solvent in paint strippers. According to DTSC, when metabolized, methylene chloride converts to carbon monoxide, which is acutely toxic to the brain and nervous system. DTSC claimed that alternative products without methylene chloride are readily available. For more information on this draft listing, click here.

In announcing the “draft list” of proposed priority products, DTSC emphasized that the naming of these products does not constitute a ban on the products, but rather the initiation of process to examine whether the chemicals of concern used in these products are “necessary” or may be replaced with safer alternatives. To put the draft priority products announcement in context, this announcement begins the second of four steps established by California’s SCP Regulations for identifying, prioritizing, and evaluating the use of chemicals and their alternatives in consumer products. The four steps include:

  1. Identification of Candidate Chemicals. The final SCP Regulations promulgated by DTSC include an initial list of candidate chemicals (~1,200), which DTSC later pared down to an informational “initial” list of fewer than 200 candidate chemicals that exhibit a hazard trait and/or environmental or toxicological endpoint.
  2. Identification of Priority Products. The SCP Regulations require DTSC to evaluate and prioritize product/candidate chemical combinations and to develop a list of priority products for which alternatives analyses must be conducted. Once a candidate chemical is the basis for a priority product listing, it is considered a chemical of concern. March 13’s announcement identifies the first product/candidate chemical combinations that DTSC is proposing to subject to the procedural process outlined in the SCP Regulations.
  3. Alternatives Analysis. Responsible entities of a product listed as a priority product must perform an alternatives analysis to determine how best to limit exposures to, or the level of adverse public health and environmental impacts posed by, the chemicals of concern in the product.
  4. DTSC Regulatory Response. The SCP Regulations provide a range of potential regulatory responses that DTSC may require after review of the alternatives analysis. These include provision of information for consumers (such as safe handling or instructions to limit exposure), restrictions on the use of chemicals of concern in the products, sales prohibition, engineered safety measures, and end-of-life management requirements. DTSC may require regulatory responses for a priority product (if the responsible entity decides to continue producing and distributing the priority product to the California market), or for an alternative product selected to replace the priority product.

Applicability

The SCP regulatory requirements apply to businesses (“responsible entities”) that manufacture, import, distribute, sell or assemble consumer products[1] identified by DTSC as priority products that are placed into the stream of commerce in California. Responsible entities are defined to include manufacturers, importers, retailers and assemblers. The SCP Regulations assign the principal duty to comply with the requirements to manufacturers. If a manufacturer does not comply with its obligations with regard to a priority product, DTSC may notify an importer, retailer or assembler of its duty to meet the requirements with respect to the priority product. Even if not called on to conduct an alternatives analysis, importers, assemblers and/or retailers of priority products may be impacted by regulatory responses selected by DTSC after the manufacturer’s completion of the alternatives analysis (e.g., if DTSC imposes a sales prohibition or requires additional information to be provided to the consumer at the point of sale) .

Requirements for Responsible Entities

Once the draft priority products are formally proposed and finalized through a public rulemaking process (which may take up to one year), responsible entities will be required to:

  • Within 60 days after finalization of the final priority products list, notify DTSC that the responsible entity makes or sells a priority product (DTSC will post information obtained from notifications, including the names of the responsible entities as well as the product names, on its web site);
  • Within 180 days after finalization of the final priority products list, prepare a Preliminary Alternatives Analysis[2] to determine how best to limit exposures to, or the level of adverse public health and environmental impacts posed by, the chemicals of concern in the product; and
  • Within one year after DTSC issues a Notice of Compliance for the Preliminary Alternatives Analysis, prepare a Final Alternatives Analysis.

Next Steps

Those that manufacture, sell, use, or otherwise have an interest in the draft priority products may wish to submit comments to DTSC as part of the priority product listing process. DTSC will follow a formal rulemaking process to finalize the draft priority products, which will take up to a year after the products are formally proposed. DTSC plans to hold several workshops in May and June of 2014 before publishing the notice of proposed rulemaking and opening the public comment period. Stakeholders will then have the opportunity to weigh in on whether, and how, the proposed priority products will be regulated by DTSC.

If your products were not among the three proposed priority products,stay tuned: By October 1, 2014, DTSC is required to issue a Priority Product Work Plan that identifies and describes the product categories that DTSC will evaluate to select priority products for the three years following the issuance of the Work Plan (roughly from 2015 to 2017). DTSC intends the Work Plan to serve as a signal to consumers and the regulated community as to the categories of products it will examine next.

Once DTSC finalizes the initial priority product listings (anticipated late summer or early fall of 2015), responsible entities will be required to meet a series of deadlines for notification and submission of alternatives analysis reports outlined above. Manufacturers of draft priority products should engage their supply chain partners to evaluate options prior to finalization of the priority product listings. Note that manufacturers that choose to reformulate products prior to finalization of the priority product listing will not be subject to the DTSC notification or alternatives analysis requirements.

[1] “Consumer product” is defined for purposes of the California Safer Consumer Products regulations to mean “a product or part of the product that is used, brought, or leased for use by a person for any purposes.” Cal. Health & Safety Code § 25251(e). Certain limited products, such as dental restorative material or its packaging, prescription drugs or devices and their packaging, medical devices and their packaging, food, and federally registered pesticides, and mercury containing lights are excluded from the definition of consumer product.

[2] DTSC is currently developing an alternatives analysis guidance document to assist responsible entities in carrying out their obligations under the SCP Regulations. As of March 13, 2014, the guidance is still in development. DTSC anticipates that it will be released sometime before the first set of priority products is finalized.

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