In a significant move to protect public health, the U.S. Environmental Protection Agency (EPA) issued orders on December 1, 2023, directing Inhance Technologies LLC (Inhance) to cease the production of per- and polyfluoroalkyl substances (PFAS). These chemicals, which are integral to the manufacture of fluorinated high-density polyethylene (HDPE) plastic containers, have been identified as posing health risks by leaching into various consumer, industrial, and agricultural products.

PFAS

Known for their persistence in the environment and in the human body, PFAS accumulate over time, contributing to long-term health risks even at low exposure levels. Studies, including those by the Centers for Disease Control, reveal that nearly all individuals tested already have traces of PFAS in their blood. The substances can enter the human body through drinking water, consumption of contaminated fish, and exposure to PFAS-contaminated groundwater.

HISTORY

The Environmental Protection Agency (EPA) is intensifying efforts to address per- and polyfluoroalkyl substance (PFAS) contamination following a series of incidents. In 2019, Easton, Massachusetts, struggled with perfluorooctanoic acid (PFOA) contamination in its drinking water, which was traced back to a mosquitocide. EPA investigations revealed that the PFAS in the mosquitocide originated from fluorinated high-density polyethylene (HDPE) plastic containers manufactured by Inhance. These containers, when fluorinated, release various PFAS, including PFOA, which can migrate into liquid products like pesticides.

The regulatory process gained momentum in March 2022 when EPA issued a Notice of Violation to Inhance, for failing to disclose its PFAS manufacturing activities. With a single company historically producing up to 200 million containers annually, EPA recognized the substantial risk to drinking water supplies. Legal action ensued forcing the company to submit, albeit belatedly, significant new use notices (SNUNs) for the nine PFAS it produces.

The release of just 2.2 Kg of the nine PFAS could contaminate vast quantities of water, surpassing the proposed maximum contaminant level of 4 parts per trillion for PFOA in drinking water. Consequently EPA, under the Toxic Substances Control Act (TSCA), is prohibiting the continued manufacture of three highly toxic PFAS—PFOA, perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA)— which are produced during the fluorination of HDPE. For the remaining six PFAS (PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA, and PFODA), EPA mandates Inhance to cease production and conduct additional testing before potential restart, acknowledging the inherent risks to health and the environment.

WAY FORWARD

Starting February 28, 2024, EPA's recent orders emphasize its commitment to addressing PFAS-related risks. The regulatory action not only signals EPA's dedication to mitigating the risks of PFAS exposure but also highlights the Agency's commitment to protecting public health and the environment from the harmful effects of persistent chemical contaminants. Importantly, alternative processes to the current fluorination method offer industries the opportunity to meet product packaging standards without compromising public safety.

In a recent development, the U.S. Food and Drug Administration (FDA) has announced a six-month extension of the enforcement deadline for cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The previous deadline of December 29, 2023, has been pushed back to July 1, 2024, providing the cosmetics industry with additional time to comply with these regulatory obligations.

This decision comes in the wake of the FDA's commitment to facilitating a smooth transition for industry stakeholders in complying with the new regulatory landscape mandated by MoCRA. The Agency recognizes the importance of ensuring that cosmetic manufacturers and processors have adequate time to submit facility registration and product listing information.

Background and Timeline:

1. Suspension of Voluntary Cosmetic Registration Program (VCRP): In March 2023, the FDA announced the suspension of submissions to the Voluntary Cosmetic Registration Program (VCRP) due to the imminent implementation of the facility registration and product listing authorities mandated by MoCRA.
2. Draft Guidance on Cosmetic Product Regulations: By August 2023, the FDA issued draft guidance on cosmetic product facility registration and product listing, aligning with the requirements set forth by MoCRA. This draft, once finalized, will offer crucial recommendations and instructions for individuals submitting cosmetic product facility registrations and product listings to the FDA.
3. Introduction of Electronic Submission Portal: In September 2023, the FDA introduced an opportunity for public comment on its newly developed draft electronic submission portal named "Cosmetics Direct," along with the paper forms (Forms FDA 5066 and 5067). Emphasizing the importance of electronic submissions for efficiency, the Agency anticipates the availability of electronic submission options and supporting documentation in early December 2023.

Details of the Delayed Enforcement:

The FDA's decision to delay enforcement aims to provide regulated industries with the necessary time to comply with MoCRA's new authorities, which include facility registration and product listing requirements. Specifically, the delay extends to July 1, 2024, for both the statutory deadline of December 29, 2023, and specific registration and listing requirements.

This extension also includes a grace period for owners or operators of facilities that commenced manufacturing or processing a cosmetic product after December 29, 2022, and for cosmetic products first marketed after that date.

MoCRA Authorities and Exemptions:

Cosmetic product manufacturers and processors are required to register their facilities, update information promptly, and renew registrations every two years. Responsible persons, such as manufacturers, packers, or distributors, must list each cosmetic product marketed, including ingredients, and provide annual updates.

Exemptions are granted to certain small businesses. However, such exemptions do not apply to facilities that manufacture or process, or to responsible persons for, the following cosmetic products:

• Products that regularly come into contact with the mucus membranes of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use. 

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

As the FDA extends the MoCRA implementation deadline, industry stakeholders are encouraged to take advantage of the additional time granted to ensure a seamless transition to compliance with the new regulations.