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Comment Period Manufacturers Public Comment

Holland & Knight LLP

California's Microplastics Proposal: Impacts on the Consumer Products Supply Chain: The Proposed Listing of Microplastics Reflects...

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California's Department of Toxic Substances Control (DTSC) has proposed listing microplastics on its "Candidate Chemicals List" under the Safer Consumer Products (SCP) Program, a regulatory framework designed to reduce toxic...more

Burr & Forman

ADEM Proposes Revisions to its Recycling Rules – 15 Years in the Making

Burr & Forman on

After 15 years without significant revisions, the Alabama Department of Environmental Management (ADEM) is proposing an overhaul of its recycling rules.  The proposed regulations, which ADEM released for public notice and...more

Bergeson & Campbell, P.C.

EPA Extends Deadline for Public Comment on Manufacture of Certain PFAS during Fluorination of HDPE and Other Plastic Containers

On November 20, 2024, the U.S. Environmental Protection Agency (EPA) announced an extension to the comment period for the notice published September 30, 2024, seeking public comment on the manufacture of certain per- and...more

Bergeson & Campbell, P.C.

MPCA Requests Comments on Planned PFAS in Products Reporting and Fee Rule

On November 18, 2024, the Minnesota Pollution Control Agency (MPCA) requested comments on planned rules governing reporting and fees paid by manufacturers upon submission of required information about products containing per-...more

Bradley Arant Boult Cummings LLP

Solar Industry Group Releases New Standard for Solar Supply Chain Transparency

The Solar Energy Industries Association (SEIA), a leading solar industry group, recently published a new supply chain traceability standard, Standard 101, for public comment. The standard is intended to provide “a rubric that...more

BCLP

More Changes Under Consideration For Prop. 65 Short-Form Warnings

BCLP on

The California agency that administers Proposition 65 is considering further revisions to the regulations governing the use and format of the short-form warning....more

White & Case LLP

USTR Issues Details of the Proposed Section 301 China Tariff Increases, Seeking Public Input

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On May 22, 2024, the United States Trade Representative ("USTR") unveiled the details of the proposed increases in Section 301 tariffs on imports from China. If adopted, the action would raise tariffs on solar power products,...more

Davis Wright Tremaine LLP

EPA Seeks Comments on "Clean" Label for Construction Industry

Inflation Reduction Act pledged millions to label program intended to cut climate pollution linked to manufacturing of construction products and materials - The Environmental Protection Agency ("EPA") is seeking public...more

Akerman LLP

Updated Advanced Computing and Semiconductor Manufacturing Export Controls Take Effect

Akerman LLP on

On October 17, 2023, the Commerce Department’s Bureau of Industry and Security (“BIS”) released two interim final rules (“IFRs”) that amended the Export Administration Regulations (“EAR”) to significantly expand export...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

Holland & Knight LLP

U.S. Export-Import Bank Seeks Public Comments on Proposed Domestic Financing Program

Holland & Knight LLP on

The Export-Import Bank of the United States (EXIM) on Dec. 23, 2021, published a notice seeking public comment on a proposed expansion of its medium- and long-term buyer financing programs to include domestic transactions....more

BCLP

Federal PFAS Development: Preliminary Effluent Guidelines Program Plan 15

BCLP on

The United States Environmental Protection Agency (“EPA”) has outlined additional steps that it plans to take to investigate and in some cases regulate the discharge of per- or polyfluoroalkyl compounds (“PFAS”) in certain...more

Goodwin

Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

Goodwin on

I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more

Kilpatrick

TSCA’s Information Grab – Manufacturers and Importers Subject to Proposed Expansive Ten-Year “Look Back” PFAS Reporting...

Kilpatrick on

Did you manufacture or import a water repellant t-shirt or a nonstick cooking pan or high performance mountain wear in the past ten years? If so, you could be required to provide ten years of past data and details regarding...more

Downey Brand LLP

Proposition 65: Legal and Technical Implications of Listing PFOA as a Carcinogen

Downey Brand LLP on

On March 19, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) released a Notice of Intent (NOI) to list perfluorooctanoic acid (PFOA) as a carcinogen under Proposition 65 via the Authoritative...more

Bergeson & Campbell, P.C.

OSHA Proposes Extension to Comment Period for Amendments to the Hazard Communication Standard

On April, 12, 2021, the Occupational Safety and Health Administration (OSHA) published a Federal Register notice to extend the comment period of the notice of proposed rulemaking (NPRM) to amend the Hazard Communication...more

Smart & Biggar

Health Canada Consultation on Electronic Media in Prescription Drug Labelling

Smart & Biggar on

On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

OSHA Issues Proposed Rule to Update Its Hazard Communication Standard

Employers have been on the lookout for a temporary emergency standard for COVID-19 from the federal Occupational Safety and Health Administration (OSHA), but what they have thus far received is a proposed rule to update the...more

Jones Day

2020 Regulatory Amendments Attempt to Simplify Proposition 65 Warning Obligations

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The Situation: New regulatory amendments to Proposition 65 went into effect on April 1, 2020. These amendments: (i) allow manufacturers, distributors, and suppliers of consumer products to satisfy Proposition 65's warning...more

Akin Gump Strauss Hauer & Feld LLP

Commerce Department Extends Export Controls over Foreign-Made Items in Huawei’s Contract Manufacturing Supply Chain

- The U.S. Department of Commerce has published a highly complex and novel interim final rule extending the controls of the Export Administration Regulations (EAR) over foreign-made items in Huawei’s contract manufacturing...more

Seyfarth Shaw LLP

NDAttention – National Defense Authorization Act (NDAA) Adds Per- and Polyfluoroalkyl Chemicals to TRI

Seyfarth Shaw LLP on

Seyfarth Synopsis: On December 20, 2019, the National Defense Authorization Act for Fiscal Year 2020 (NDAA) was signed into law, including provisions for adding certain per- and polyfluoroalkyl substances (PFAS) to the EPA’s...more

Robinson+Cole Manufacturing Law Blog

PFAS Update: EPA Progress Under PFAS Action Plan

Earlier this year, we wrote about EPA’s PFAS Action Plan, the agency’s blueprint for addressing contamination and protecting public health from per- and polyfluoroalkyl substances (PFAS). ...more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Faegre Drinker Biddle & Reath LLP

NIST Unveils IoT Baseline of Core Cybersecurity Features for Comment

In a release aptly labeled “A Starting Point for IoT Device Manufacturers” the National Institute of Standards and Technology (NIST), an arm of the Department of Commerce, recently added to the discussion with the...more

Akin Gump Strauss Hauer & Feld LLP

CMS Issues Proposed Revisions to Open Payments/Sunshine Act Reporting Requirements

• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more

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