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Medical Products Supply Chain Week in Review – August 2021 #2

Last week, the Administration’s COVID-19 Response Team reported that the case numbers continue to rise in low-vaccination states, with most infections as a result of the Delta variant. Vaccination rates, however, are starting...more

Medical Products Supply Chain Week in Review – August 2021 #1

Last week, the Centers for Disease Control and Prevention (CDC) revised its mask guidance for fully vaccinated individuals. Also, while the Administration and several health care institutions evaluate the possibility of...more

Medical Products Supply Chain Week in Review – July 2021 #4

Last week, FDA Acting Commissioner Janet Woodcock testified before Congress on the role of the agency in the COVID-19 response and the way forward. The Administration reaffirms its commitment to combat the national and global...more

Medical Products Supply Chain Week in Review – July 2021 #3

Last week, six U.S. agencies updated an advisory to urge businesses to conduct human rights due diligence for supply chain links to Xinjiang, China. In addition, the Pfizer/BioNTech COVID-19 vaccine received Priority Review...more

Medical Products Supply Chain Week in Review – July 2021 #2

Last week, President Biden signed a comprehensive pro-competition Executive Order with various requirements affecting medical product supply chains, such as the ability to import prescription drugs from Canada and banning...more

COVID-19 Medical Products Supply Chain Week in Review – July 2021 #1

Last week, the White House released a framework for U.S. leadership in the global COVID-19 response. In addition, the FDA is revoking the emergency use authorizations (EUAs) of all non-NIOSH-approved disposable respirators...more

COVID-19 Medical Products Supply Chain Week in Review – June 2021 #5

Last week, the FDA added new heart health risk information to mRNA vaccines’ fact sheets. In addition, the U.S. seized unauthorized COVID-19 drugs en route from Bangladesh and India to Mexico. ...more

45Q Regulations Will Spur Carbon Capture and Storage Investment

Carbon capture and storage could play a major role in a Biden Administration eager to rejoin the Paris Agreement. Our Federal Tax Group provides a brief overview of the 45Q credit and key takeaways from the IRS’s new final...more

At Long Last, EPA Releases Protocol for Registering Long-Lasting Disinfectants

Our Environment, Land Use & Natural Resources Group explains how companies can benefit from the Environmental Protection Agency’s new interim guidance expediting the product registration process for long-lasting antimicrobial...more

Cleaning Up After COVID-19? What You Need to Know Before You Manufacture, Import, or Sell Sterilizers, Sanitizers, Purifiers, and...

Whether your products are used for medical purposes or used in homes and offices, our Food, Drug & Device/FDA and Environment, Land Use & Natural Resources teams highlight the key regulatory requirements that apply, what has...more

Now Effective: EPA’s Sewer Ban and (in some states) Management Standards for Hazardous Waste Pharmaceuticals

On August 21, 2019, EPA’s Final Management Standards for Hazardous Waste Pharmaceuticals takes effect federally. The sewer ban component of the new rule applies in all states....more

Final Management Standards for Hazardous Waste Pharmaceuticals Released

On December 12, 2018, the EPA released its long-awaited Management for Hazardous Waste Pharmaceuticals Rule. The EPA addressed industry concerns by amending the hazardous waste listing for nicotine to exclude nicotine...more

California’s Drug and Sharps Takeback Bill Triggers Statewide Obligations

All entities selling drugs and sharps in California should be aware of California’s pharmaceutical and sharps waste stewardship bill, SB 212, which recently passed both houses of the state Legislature. ...more

Food Packaging Alert: Increasing State Scrutiny of PFAs, BPA and BPS

Washington recently passed legislation that will examine and possibly lead to a ban on perfluorinated chemicals (PFAs) in food packaging. Under Washington’s Healthy Food Packaging Act (H.B. 2658/S.B. 6396), which takes...more

Major Change in DOJ Environmental Penalty Policy

On June 5, 2017, Attorney General Jeff Sessions issued a memo prohibiting DOJ from including payments to third party non-government entities in civil and criminal settlements. This memo will have far reaching consequences...more

Forthcoming California Phase 2 GHG Emission Regulations Foreshadow Compliance Challenges

Last August, the U.S. Environmental Protection Agency (EPA) and the National Highway Traffic Safety Administration (NHTSA) finalized the more stringent “Phase 2” greenhouse gas (GHG) emission standards and fuel efficiency...more

EPA Confirms Vehicle Emission Standards for 2022-2025

As expected, on January 12, 2017, the U.S. Environmental Protection Agency (EPA) issued its Final Determination affirming the greenhouse gas (GHG) emission standards for model year 2022-2025 light-duty vehicles. While EPA...more

EPA Releases CERCLA Financial Assurance Rule

EPA has released its long-awaited proposed CERCLA financial assurance regulations for the hardrock mining industry. When finalized, these regulations will serve as a model for financial assurance regulations for other...more

EPA Provides Early Affirmation of Vehicle Emission Standards for 2022-2025

Through its Proposed Determination, EPA has concluded that the model year 2022-2025 GHG standards should remain as promulgated, despite automotive industry evidence demonstrating the need for less stringent standards. ...more

CARB Launches Rulemaking for Heavy-Duty Engine Low NOx Standard

On November 3, the California Air Resources Board (CARB) announced plans for a new low-nitrogen oxide (NOx) standard for heavy-duty engines sold in the state. CARB intends to adopt the new NOx standard—of 0.02 grams per...more

EPA's Latest Truck Rule Has Broader Effect on Mobile Source Compliance and Environment

Originally published in Bloomberg BNA's Daily Environment Report, 209 DEN B-1, 10/28/16. On Oct. 25, the Environmental Protection Agency and the National Highway Traffic Safety Administration published more stringent...more

EPA Commits to Hazardous Waste Retail Strategy, Policy Expected to Address Point of Generation Issues

On September 12, 2016, the U.S. Environmental Protection Agency (EPA) issued its Strategy for Addressing the Retail Sector under RCRA’s Regulatory Framework. As part of this strategy, EPA will finalize the Resource...more

CSB Report calls for Preventative Inspections at Petroleum Refineries, Bolstering EPA and OSHA Efforts

Earlier this month, the U.S. Chemical and Safety Hazard Investigation Board (CSB) issued a report calling for preventative inspections at petroleum refineries to prevent accidents and injuries. The report highlights the...more

EPA and NHTA Finalize Stringent Emission and Fuel Efficiency Standards

Yesterday, the U.S. Environmental Protection Agency (EPA) and the National Highway Traffic Safety Administration (NHTSA) finalized more stringent greenhouse gas (GHG) emission standards and fuel efficiency standards for...more

NOx Emission Reductions for Medium- and Heavy-Duty Trucks Forthcoming

The timeline for federal NOx emission reductions for medium and heavy-duty trucks is uncertain, but expected in California in 2017. The California Air Resources Board (CARB) is expected to issue a NOx standard in 2017 that...more

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