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Manufacturers Risk Assessment

Pillsbury Winthrop Shaw Pittman LLP

The EU’s AI Act: A Review of the World’s First Comprehensive Law on Artificial Intelligence and What This Means for EU and Non-EU...

The agreed text of the AI Act was published on July 12, 2024, essentially starting the clock on the legal deadlines contained in it. Its obligations will apply in tiered phases, with the first key obligations being enforced...more

Downey Brand LLP

EPA’s Final Rule Enhances Risk Evaluations Process For Scrutiny of TSCA Chemicals

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On May 3, 2024, the Environmental Protection Agency (EPA) published its Final Rule that amends the risk evaluation process for chemicals under the Toxic Substances Control Act (TSCA) and the steps chemical manufacturers and...more

K&L Gates LLP

Brussels Regulatory Brief: April 2024

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Antitrust and Competition - European Commission Charges Company with Providing Incorrect, Incomplete, and Misleading Information During a Merger Control Proceeding - On 19 March 2024, the European Commission (Commission) sent...more

Wiley Rein LLP

[Webinar] EPA Risk Evaluations Under TSCA: What’s at Stake and How to Prepare - May 16th, 12:00 pm - 1:00 pm EDT

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On May 3, 2024, the U.S. Environmental Protection Agency’s (EPA) final rule on procedures for chemical risk evaluation under the Toxic Substances Control Act (TSCA) was published in the Federal Register. In the words of EPA’s...more

Dorsey & Whitney LLP

AI regulation introduced in Europe - setting the way forward for the rest of the world or slowing down the adoption of new tech?

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The EU AI Act, which was passed by the European Parliament on 13 March and is set to become law later this year, will probably be the world’s first legislation to introduce a general regulatory framework for artificial...more

Downey Brand LLP

EPA Adds Extensive New Amendments to its Risk Management Program in Final Rule

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On March 11, 2014, the Environmental Protection Agency (EPA) published in the Federal Register amendments to the Risk Management Program (RMP) rule (Final Rule). Going into effect on May 10, 2024, EPA’s Final Rule, named the...more

Goldberg Segalla

EPA’s Final EtO Rule Finally Finalized

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The Environmental Protection Agency on March 14 announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) applicable to 90 large commercial sterilization facilities that use ethylene...more

K&L Gates LLP

Brussels Regulatory Brief: February 2024

K&L Gates LLP on

Antitrust and Competition - The European Commission Carried Out Unannounced Inspections in the Tires Sector - On 30 January 2024, the Commission conducted dawn raids at the premises of several companies active in the tires...more

Beveridge & Diamond PC

Get Ready for Higher TSCA Fees

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The U.S. Environmental Protection Agency (EPA) has substantially raised its fees for most actions under the Toxic Substances Control Act (TSCA). In a final rule published on February 21, 2024, 89 Fed. Reg. 12961, EPA...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Wiley Rein LLP

EPA Eliminates De Minimis Exemption for PFAS Under TRI Reporting, Proposes Changes to Chemical Risk Evaluations Under TSCA

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The U.S. Environmental Protection Agency (EPA or Agency) has issued two pre-publication announcements on notable regulatory actions that may affect your business. The first one will increase the amount of information that...more

Foley & Lardner LLP

The Importance of Risk Audits for PFAS in the Automotive Industry

Foley & Lardner LLP on

The automotive industry continues to grow a record of sustainability, improving fuel efficiency and proliferating electric vehicles, and adopting eco-friendly manufacturing processes. Along with these important sustainability...more

Foley Hoag LLP - Global Business and Human...

A Human Rights Impact Assessment of Microsoft's Enterprise Cloud and AI Technologies Licensed to U.S. Law Enforcement Agencies

Microsoft is one of the world’s leading technology companies. Its products and technologies are in offices, classrooms, and homes. Additionally, governments use them to help conduct vital public services. Microsoft is also...more

Mitchell, Williams, Selig, Gates & Woodyard,...

U.S. EPA Proposed NSPS/NESHAP for Synthetic Organic Chemical Manufacturing Industry: American Chemistry Council/Fuel and...

The American Chemistry Council, American Fuel & Petrochemical Manufacturers, U.S. Tire Manufacturers Association, and Vinyl Institute (collectively “ACC”) submitted July 7th comments to the United States Environmental...more

King & Spalding

FDA’s Much Anticipated New Cell and Gene Therapy Guidance Outlines a Conservative Approach to Manufacturing Changes

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Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and post-change products are comparable. This...more

Bergeson & Campbell, P.C.

UK Calls for Evidence to Support RMOA for Formaldehyde and Formaldehyde Releasers

The United Kingdom’s (UK) Health and Safety Executive (HSE) issued a call for evidence on April 26, 2023, to gather information and evidence that will support HSE and the UK Health and Security Agency (UKHSA) with the...more

Gould + Ratner LLP

Bringing Manufacturing Back: Tips for Planning a Successful Factory Construction

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If you think that there is a lot of talk about new factory construction in the United States in recent months, you are correct. Ryan Beene, a writer for Bloomberg News, noted last year that some in financial circles had...more

Jackson Lewis P.C.

How Modern Manufacturing Plants Can Protect Against Ransomware, Cyberattacks

Jackson Lewis P.C. on

To help protect against criminal ransomware and cyberattacks, modern manufacturing plants should ensure they have reasonable physical, administrative, and technical safeguards in place....more

Beveridge & Diamond PC

TSCA Sticker Shock: EPA Proposes Large Fee Increases

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Does your company manufacture domestically or import chemicals that the U.S. Environmental Protection Agency (EPA) is reviewing under section 6 of the Toxic Substances Control Act (TSCA)? Does your company submit applications...more

Beveridge & Diamond PC

China Sets out a Regulatory Roadmap to Control New Chemicals

On May 24, 2022, China State Council issued an Action Plan on New Pollutants Governance (“Plan”) to set out a regulatory roadmap to control new chemicals and outline an enhanced enforcement framework for compliance. The Plan...more

Hogan Lovells

Strengthening toy safety in Europe: Consultation on revisions to the Toy Safety Directive

Hogan Lovells on

The European Commission (“EC”) gets started with its plans to improve toy safety in Europe with a Public Consultation leading the way to a new legislative proposal envisaged for Q4 2022. The new legislation is expected to put...more

Tucker Arensberg, P.C.

Biden Warns of Imminent Cyberattacks and New Regulations– Is Your Business Prepared?

Tucker Arensberg, P.C. on

Our clients in financial services, technology, and manufacturing industries, take note of this important new piece of legislation. On March 21, 2022, President Biden warned American businesses to prepare for imminent...more

Bergeson & Campbell, P.C.

EPA Publishes Final Scope of D4 Risk Evaluation, Seeks Comment on Draft Revision to PV29 Risk Determination

On March 7, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of the final scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4), a chemical substance for which EPA...more

Oberheiden P.C.

FDA Warning Letter Response Strategies (Step-By-Step)

Oberheiden P.C. on

FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more

Bergeson & Campbell, P.C.

OECD Publishes Report on Important Issues on Risk Assessment of Manufactured Nanomaterials

The Organization for Economic Cooperation and Development (OECD) published a February 2022 report entitled Important Issues on Risk Assessment of Manufactured Nanomaterials. The report provides the current practices,...more

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