News & Analysis as of

Manufacturers Final Rules

Jones Day

Federal PFAS Reporting Deadline Extended as Biden Administration Announces New PFAS Strategic Plan

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The White House revealed its latest strategy to address PFAS, and the EPA extended the reporting deadline for its PFAS reporting rule....more

Venable LLP

Food and Color Additives - Is the Patchwork Here?

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State legislatures are actively pursuing bans on food and color additives.  California’s landmark Food Safety Act (Act), effective January 2027, bans the manufacture and sale of products containing brominated vegetable oil...more

Wilson Sonsini Goodrich & Rosati

FDA Signals to Industry to Prepare for Compliance with the LDT Final Rule Despite Looming Legal Challenge

The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more

Williams Mullen

Communication is Key: OSHA’s Amended Hazard Communication Standard

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OSHA is amending its Hazard Communication Standard (HCS) regulations which require chemical manufacturers and importers to classify the hazards of chemicals they produce or import and to provide their employees information...more

Troutman Pepper

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

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After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more

Fisher Phillips

Snapshot on Manufacturing Industry: A Survival Guide to OSHA’s Regulation Allowing Union Walkthroughs of Union and Non-Union...

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Welcome to this edition of the FP Snapshot on Manufacturing Industry, where we take a quick snapshot look at a recent significant workplace law development with an emphasis on how it impacts employers in the manufacturing...more

Conn Maciel Carey LLP

[Webinar] Major Updates to OSHA's Hazard Communication (Chemical Right-to-Know) Standard - June 20th, 1:00 pm ET

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On May 20, 2024, OSHA published its long-in-the-making revision to the Hazard Communication Standard (HCS). OSHA’s revised its standard to better align with the United Nations’ Globally Harmonized System of Classification...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

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The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

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Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more

Holland & Knight LLP

DOE Expands ATVM Eligibility to Include Ultra Efficient and Other Types of Vehicles: Also Now Included: Trains, Maritime Vessels,...

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The U.S. Department of Energy (DOE) published a direct final rule (DFR) on April 29, 2024, to amend and align the Advanced Technology Vehicles Manufacturing Incentive Program (ATVM) implementing regulations1 with its...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

McDermott+

FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices

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On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as...more

Holland & Knight LLP

EPA Designates 2 PFAS Compounds as Hazardous Substances

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The U.S. Environmental Protection Agency (EPA) on April 19, 2024, announced its Final Rule designating two per- and polyfluoroalkyl substances (PFAS) compounds – perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid...more

BCLP

EPA Designates PFOS and PFOA as CERCLA Hazardous Substances

BCLP on

On April 19, 2024, the United States Environmental Protection Agency (“EPA”) announced that it is designating perfluorooctanoic acid (“PFOA”) and perfluorooctanesulfonic acid (“PFOS”) as Hazardous Substances under the...more

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

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In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on

On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

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

PFOA/PFOS/CERCLA: U.S. Environmental Protection Agency Final Rule Designating as Hazardous Substances

The United States Environmental Protection Agency (“EPA”) issued a prepublication version of a Final Rule that would designate two of the Per-and polyfluoroalkyl substances (“PFAS”) as Comprehensive Environmental Response,...more

Holland & Knight LLP

Treasury Department, IRS Release Final Regulations on Direct Pay Under CHIPS Act Section 48D

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The Chips and Science Act of 2022 (CHIPS Act) added Section 48D to the Internal Revenue Code to incentivize the production of semiconductors and semiconductor manufacturing equipment in the United States. The credit is equal...more

Clark Hill PLC

EPA Releases Final Rule on Vehicle Emission Limits for 2027 and Later

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On March 20, the U.S. Environmental Protection Agency (“EPA”) released its final rule on Multi-Pollutant Emissions Standards for Model Years 2027 and Later Light-Duty and Medium-Duty Vehicles (the “Final Rule”). The Final...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

Perkins Coie

USDA Issues Final Rule on Voluntary “Product of USA” Claims

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On March 18, USDA’s Food Safety and Inspection Service (FSIS) published its Final Rule on Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims (Final Rule). The Final Rule covers meat, poultry, and egg...more

Jones Day

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

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Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...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

Alston & Bird

EPA Finalizes Sweeping New Safety Standards and Public Disclosure Requirements for Chemical Accidents

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Our Environment, Land Use & Natural Resources Group examines the Safer Communities by Chemical Accident Prevention Rule’s stringent requirements for accident prevention, response, and public disclosure of information....more

Pillsbury Winthrop Shaw Pittman LLP

DoD Publishes Final Rule Implementing Executive Order 14005

The rule conforms applicable DFARS clauses to the final FAR rule that was published on March 7, 2022. Contractors must comply with increasing U.S. and qualifying country content thresholds for manufactured end products—65...more

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