News & Analysis as of

Manufacturers Risk Management

Keller and Heckman LLP

January 2025 Bounty Hunter Plaintiff Claims

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Exploring Trends in California’s Proposition 65: Claims, Chemicals, Products, and More - California’s Proposition 65 (“Prop. 65”), the Safe Drinking Water and Toxic Enforcement Act of 1986, requires, among other things,...more

Goodwin

EU Updates its Product Liability Regime: Important Considerations for Providers of AI Systems and Software

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The European Union has significantly overhauled its product liability regime with a new directive concerning liability for defective products (Product Liability Directive). EU member states have until December 9, 2026, to...more

Warner Norcross + Judd

Lessons from CES 2025: The Legal Side of Product Innovation — What Every Manufacturer and Supplier Needs to Know

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The 2025 Consumer Electronics Show (CES) — one of the world’s most influential tech events — once again showcased groundbreaking innovations that are shaping the future of technology. I was among the over 141,000 attendees of...more

McGlinchey Stafford

Defending Manufacturers Against PFAS Claims: Legal Strategies and Challenges

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As litigation involving per- and polyfluoroalkyl substances (PFAS) continues to rise, manufacturers of PFAS-containing products face significant legal and financial risks. Plaintiffs, including individuals, communities,...more

Bennett Jones LLP

Driving Compliance: Updates to Canada’s Motor Vehicle and Equipment Safety Regulations

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Regulations Amending Certain Regulations Made Under the Motor Vehicle Safety Act (Recall Information), SOR/2024-274 (Regulations) came into force on January 1, 2025.  The Regulations amend...more

Miller Nash LLP

What the U.S. Cyber Trust Mark Means for IoT Security and How to Prepare

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This year’s Data Privacy Week theme is “take control of your data.” That can be really challenging to do. Data is collected from everywhere—whether online or offline—and can be stored and used indefinitely (even if the...more

Gray Reed

Manufacturing Matters: Controlling Construction Costs

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Manufacturing construction is anticipating an uptick in 2025 with expected domestic economic protections and the continued consumer demand. Texas will remain a hotbed for this activity with continued business relocations,...more

Bergeson & Campbell, P.C.

GAO Recommends EPA’s New Chemicals Program Develop a Systematic Process to Manage and Assess Performance Better

The U.S. Government Accountability Office (GAO) publicly released a report entitled “New Chemicals Program: EPA Needs a Systematic Process to Better Manage and Assess Performance” on January 22, 2025. GAO states that it was...more

Wiley Rein LLP

[Webinar] Chemical Regulation: 2025 Outlook - February 5th, 12:00 pm - 1:00 pm EST

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As the second Trump Administration begins, significant shifts in the federal government’s approach to chemical regulation appear imminent. The main forces of change include the ongoing legal challenges to the Toxic Substances...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

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

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

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

Hogan Lovells

FDA Draft Guidance Addresses Management of Environmental Pathogen Hazards for Low-Moisture Ready-to-Eat Foods

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On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Vaccination Program

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more

Bricker Graydon LLP

[Webinar] Fast Facts, Big Impacts: The Manufacturing Lightning Round - January 16th, 9:00 am - 11:45 am ET

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Join Bricker Graydon attorneys and distinguished experts as we cover a myriad of topics in a 2-hour, rapid-fire format webinar designed to provide you with valuable information that you can put to immediate use. See the...more

Vorys, Sater, Seymour and Pease LLP

EPA Releases Final Rules for TCE and PCE Under the Toxic Substances Control Act

The U.S. EPA recently announced that it released new risk management rules under the Toxic Substances Control Act (TSCA) for TCE and PCE.1 Manufacturers and other industrial clients need to be cognizant of these new rules...more

Beveridge & Diamond PC

EPA Finalizes TSCA Risk Management Rules for PCE and TCE

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Two more chlorinated solvents have been wholly or partially banned by the U.S. Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA). Following the May 8, 2024 final rule on methylene chloride,...more

Alston & Bird

D-Day for the EU Cyber Resilience Act

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Our Privacy, Cyber & Data Strategy Team discusses the new Cyber Resilience Act (CRA) that affects manufacturers and distributors of connected devices that are in use anywhere in the European Union....more

Bergeson & Campbell, P.C.

EPA Releases Final Supplement to the Risk Evaluation and Revised Unreasonable Risk Determination for 1,4-Dioxane

On November 13, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of its final supplement to the risk evaluation and revised unreasonable risk determination for 1,4-dioxane under the Toxic Substances...more

Akin Gump Strauss Hauer & Feld LLP

Three Questions with Sedgwick’s Jeremy Schutz

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

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On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more

Holland & Knight LLP

EPA Issues a Final Revised Risk Determination for 1,4-Dioxane

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The U.S. Environmental Protection Agency (EPA) concluded its risk evaluation of 1,4-Dioxane under the Toxic Substances Control Act (TSCA) and issued a Notice of Availability of its Final Supplement to the Risk Evaluation and...more

Bergeson & Campbell, P.C.

EPA Issues ANPRM under TSCA Section 6 on 6PPD and 6PPD-Quinone

On August 1, 2023, Earthjustice filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) asking the U.S. Environmental Protection Agency (EPA) to establish regulations prohibiting the manufacturing,...more

Goodwin

The NIS 2 Era Is Here: Are You Compliance-Ready?

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With the deadline for Member States to transpose the European Union’s updated Network and Information Systems Directive (Directive (EU) 2022/2555) (NIS 2 or Directive) into national law, with the Directive having passed on 18...more

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