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Manufacturers

Williams Mullen

Environmental Notes - January 2025

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EPA late last year finalized rules banning use of trichloroethylene (TCE) in the United States and certain consumer uses of perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA). Both chlorinated chemical...more

Williams Mullen

TCE and PCE Eliminated from Most Uses

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EPA late last year finalized rules banning use of trichloroethylene (TCE) in the United States and certain consumer uses of perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA). Both chlorinated chemical...more

Hogan Lovells

Key Implications for Consumer Hardware Manufacturers

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On 28 June 2025, the key requirements of Directive (EU) 2019/882 – also known as the European Accessibility Act or “EAA” – will take effect. The EAA is expected to lift barriers to accessibility across the EU, in turn...more

White and Williams LLP

Let’s Get Specific: Rhode Island Court Asserts Jurisdiction Over Out-of-State Manufacturer

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The court granted the third-party defendant’s first motion to dismiss for lack of general jurisdiction but permitted the parties to conduct jurisdictional discovery. After the close of jurisdictional discovery, the...more

Gray Reed

Disrupted Operations – Owners Beware!

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Industrial construction is poised for continued growth in 2025, especially with incoming presidential administration and its anticipated emphasis on domestic economic production. Nowhere will this growth be seen more than in...more

DLA Piper

Maine DEP Proposes Currently Unavoidable Use Procedures for PFAS in Products Law

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Maine’s Department of Environmental Protection (DEP) recently published a proposed rule prescribing procedures and criteria for determining Currently Unavoidable Uses (CUU) of intentionally added per- and polyfluoroalkyl...more

Venable LLP

Red Dye No. 3 Ban at FDA and What's Next

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On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive...more

EPR Group Consulting Inc.

Understanding EPR is Important Across Your Company’s Departments

With the compliance process for the Extended Producer Responsibility (“EPR”) programs for packaging, paper, and food service ware in full swing in Oregon and fast approaching in Colorado and California, “producer” companies...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

Ankura

Fueling Tech Growth: New Federal Financing from the Department of Defense’s Strategic Capital Program

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Growth companies needing to scale manufacturing capacity often struggle to source adequate and affordable financing. Traditional banks usually can not take the credit risk and non-bank lenders (e.g. private equity) impose...more

White and Williams LLP

Consumer Product Safety Commission Recalls

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In subrogation cases where the insured’s damages were caused by a defective product, the fact that the product at issue is or was subject to a recall announced by the Consumer Product Safety Commission (CPSC) may help to...more

McGuireWoods LLP

FDA Bans Red Dye No. 3 in Food and Drugs, Sets Deadlines for Manufacturers to Reformulate

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On Jan. 15, 2025, the U.S. Food and Drug Administration revoked its authorization for the use of Red Dye No. 3 in food and ingested medications. Red Dye No. 3, chemically known as erythrosine, is a synthetic color additive...more

Clark Hill PLC

Red Dye No 3: Old Data Induces New Ban

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On January 16, 2025 the federal Food and Drug Administration (FDA) issued notice requiring manufacturers to reformulate their products removing Red Dye No. 3 by January 15, 2027 for food (21 CFR §74.303) and January 18, 2028...more

Bergeson & Campbell, P.C.

House Energy and Commerce Subcommittee Will Hold Hearing on Revitalizing American Innovation and Enhancing the U.S. Chemical...

On January 22, 2025, at 10:30 a.m. (EST), the House Energy and Commerce Subcommittee on Environment will hold a hearing entitled “A Decade Later: Assessing the Legacy and Impact of the Frank R. Lautenberg Chemical Safety for...more

Littler

Cal/OSHA Approves Final Respirable Crystalline Silica Regulation, While Other Potential Limits on Engineered Stone Remain Under...

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On December 19, 2024, the Cal/OSHA Standards Board unanimously approved a proposal to make permanent amendments to its regulation regarding occupational exposures to respirable crystalline silica (RCS) in the general industry...more

Davis Wright Tremaine LLP

Project W: Alumna Spotlight on Stephanie Benedetto

Stephanie Benedetto traces her entrepreneurial DNA to her great-grandfather, Pappy, who immigrated to the Lower East Side of Manhattan (the original garment district) from Austria in 1986. Pappy collected odds and ends of...more

Holland & Knight LLP

New Antidumping and Countervailing Duty Investigations May Impact Imported Lithium-Ion Batteries

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The American Active Anode Material Producers (AAAMP), an ad hoc trade association of domestic manufacturers, filed petitions on Dec. 18, 2024, with the U.S. Department of Commerce (DOC) and the U.S. International Trade...more

Ballard Spahr LLP

FHWA to Eliminate Buy America Manufactured Products Waiver for Federally-Assisted Highway Projects

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On January 14, 2025, the U.S. Department of Transportation (USDOT) Federal Highway Administration (FHWA) issued a final rule discontinuing its longstanding Buy America waiver for manufactured products used in...more

Bergeson & Campbell, P.C.

Cookware Association Files Federal Challenge to Minnesota’s Ban on PFAS in Cookware

The Cookware Sustainability Alliance (CSA) announced on January 9, 2025, that it has filed suit in the U.S. District Court for the District of Minnesota, seeking a preliminary injunction of Minnesota’s ban on the sale of...more

Perkins Coie

FDA Releases Draft Guidance on the Labeling of Plant-Based Foods

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The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

Gardner Law

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

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In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more

Pillsbury - PFAS Observer

New York and California’s Restrictions on PFAS in Apparel Takes Effect

New York and California have recently imposed sweeping prohibitions on the sale of apparel containing per- and polyfluoroalkyl substances (PFAS). These prohibitions have a broad scope and are effective and enforceable as of...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

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Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

BakerHostetler

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

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The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more

Brownstein Hyatt Farber Schreck

EXIM Launches Supply Chain Resiliency Initiative to Bolster U.S. Competitiveness

On Jan. 8, the Export-Import Bank of the United States (EXIM) announced the creation of the Supply Chain Resiliency Initiative (SCRI), a targeted financing program aimed at diversifying and strengthening critical mineral and...more

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