Mar-13-2024
On February 28, 2024, the U.S. Food and Drug Administration (FDA) made a significant announcement, declaring that manufacturers have ceased selling grease-proofing substances containing Per- and Polyfluoroalkyl Substances (PFAS) for food contact coatings in the U.S. market. The completion of the voluntary market phase-out marks a critical step in eliminating the primary source of dietary exposure to PFAS from authorized food contact uses.
History:
In 2020 in an effort to protect public health, the FDA secured commitments from manufacturers to discontinue the sale of grease-proofing substances containing specific types of PFAS for food contact uses in the United States. The recent announcement signals the fulfilment of these voluntary commitments. Additionally, the FDA has confirmed that other manufacturers have voluntarily stopped selling various food contact grease-proofing substances containing different types of PFAS in the U.S.
PFAS In Food Packaging:
Grease-proofing substances are essential for preventing grease and oil leakage and providing water-resistant properties to paper and paperboard packaging. These PFAS-containing substances were commonly used in fast food wrappers, microwave popcorn bags, take-out containers, pet food bags, and similar packaging materials.
Most companies have exited the market ahead of the expected phase-out, despite an 18-month timeline. The FDA is also developing a validated analytical method to monitor the market for PFAS-containing food contact materials in packaging.
The FDA reaffirms its commitment to food chemical safety and the ongoing re-evaluation of authorized chemicals for use in food. Post-market safety evaluations will continue to ensure that risk determinations remain accurate and based on current scientific knowledge.
Feb-28-2024
On February 8, 2024, the Environmental Protection Agency (EPA) finalized amendments to the 2018 Toxic Substances Control Act (TSCA) Fees Rule, which will increase fees and double the cost of new substance applications. The final rule aims to recover more program costs through industry-submitted fees. The agency cites the need for funding due to expanded TSCA responsibilities. Increased fees will increase resources for efficient chemicals, allowing for better protection of communities and supporting American innovation.
The final rule will become effective 60 days after its official publication in the Federal Register.
Key Changes
The final rule sets a fee of $37,000 for filing a Pre-Manufacture Notice (PMN) or Significant New Use Notice (SNUN), and $10,870 for filing a new chemicals exemption notice under TSCA Section 5. The EPA-initiated risk evaluation fee will increase from $1.605 million to $4.287 million which will be shared among responsible companies. Meanwhile, test orders will be priced at $25,000. Small businesses are eligible for an 80% fee reduction in each category. Some fees were reduced from the 2022 supplemental proposal due to adjustments in program costs.
Comparison to Previous Proposals
Exemptions
The new rule adds exemptions not included in the 2018 fee rules:
(1) An exemption for research and development activities
(2) An exemption for companies that manufacture less than 2,500 pounds (lbs) of a chemical subject to an EPA-initiated risk evaluation, or 1,100 lbs for TSCA Section 4 test rules.
(3) An exemption for manufacturers of chemical substances produced as non-isolated intermediates.
(4) Exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, manufactured as a by-product, or manufactured or imported as an impurity.
Companies that fall into the first three categories must certify to the agency that they meet the exemption criteria.
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