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Showing 10 posts in Pharmaceuticals.

EPA Delays Effective Date of RMP Rule Amendments, Environmental Groups File Challenge

On June 14, 2017, EPA published a final rule in the Federal Register delaying the effective date of its Risk Management Program (RMP) rule amendment package for twenty months, until February 19, 2019.[1] EPA’s decision was immediately challenged by a coalition of environmental groups. Read More ›

Fourth Circuit: CWA Permit Shield Requires Compliance with Incorporated Quality Standards

A recent Fourth Circuit decision will have wastewater dischargers taking a closer look at their NPDES permits and state water quality standards. The court of appeals held, in Ohio Valley Environmental Coalition v. Fola Coal Co., No. 16-1024, that permit language incorporating state water quality standards required compliance with all such standards, including narrative standards not reflected in the permit’s effluent limits.  As a consequence, a source can only be assured that it is shielded from liability under the CWA if its discharges comply with both (a) effluent limits in the NPDES permit and (b) any water quality standards—even narrative standards—that the permit incorporates.  The decision raises questions about potential exposure and how to approach permit writers in the future. Read More ›

ICAO Bans Bulk Shipments of Lithium Batteries as Cargo on Passenger Aircraft

On February 22, 2016, the International Civil Aviation Organization (“ICAO”) Council announced an interim ban on bulk shipments of lithium ion batteries as cargo on passenger aircraft.  The ICAO Council adopted this new aviation safety measure after the ICAO’s top technical body, the Air Navigation Commission, recommended a ban on these shipments at its January 27, 2016 meeting.  The approved ban on bulk lithium battery shipments on passenger aircraft becomes effective almost immediately on April 1, 2016.  The ICAO is also implementing other significant changes to the lithium battery rules in its 2017-2018 Edition of the Technical Instructions for the Safe Transport of Dangerous Goods by Air (“ICAO-TI”).  Read More ›

Understanding New Lithium Battery Transport Requirements & Emerging Developments as Safety Concerns Mount

Growing concerns over the safety of air shipments of lithium batteries have prompted international authorities, the U.S. Federal Aviation Administration (“FAA”), and Congress to take action.  On January 19, 2016, the International Air Transport Association (“IATA”) issued an Addendum to the 57th Edition of the Dangerous Goods Regulations (“DGR”), further restricting shipments of lithium batteries by air.  The International Civil Aviation Organization’s (“ICAO”) is also planning changes to the lithium battery rules for its 2017-2018 Edition of the Technical Instructions for the Safe Transport of Dangerous Goods by Air (“ICAO-TI”), and is even considering an outright ban on bulk lithium ion battery shipments as cargo on passenger aircraft. Read More ›

Ninth Circuit Upholds Alameda Safe Drug Disposal Ordinance, Triggering Implementation of King County Secure Medicine Return Rule

On September 30, 2014, the Ninth Circuit affirmed the Northern District of California’s summary judgment that the Alameda Safe Drug Disposal Ordinance (the “Ordinance”) does not violate the dormant Commerce Clause of the United States Constitution. PRMA v. Alameda County, 2014 U.S. App. LEXIS 18737 (9th Cir. 2014). The Ninth Circuit held that the Ordinance does not discriminate against or directly regulate interstate commerce. Moreover, the Court found that, in the context of the judicially created Pike balancing test, the Ordinance does not substantially burden interstate commerce and that the Ordinance provides public benefits. Read More ›

Rite Aid to Pay $12.3 Million for Failing to Properly Manage Waste Products from its California Stores

Rite Aid Corporation has agreed to pay more than $12.3 million to settle a civil lawsuit alleging that Rite Aid improperly managed, transported, and disposed of hazardous waste at hundreds of its California stores and distribution centers.  The hazardous wastes at issue include: pharmaceuticals and over-the-counter medications, bleaches, photo processing chemicals, pool chlorine and acids, pesticides, fertilizers, batteries, electronic devices, mercury containing lamps, paints, lamp oils and other ignitable liquids, aerosol products, oven cleaners and various other cleaning agents, automotive products, and other flammable, reactive, toxic and corrosive materials.  Read More ›

King County, Washington Enacts Pharmaceutical Take-Back Program

On June 20, 2013, the King County, Washington Board of Health passed the Secure Medicine Return Rule and Regulation (“SMRRR”) establishing a product stewardship program to collect and safely dispose of unwanted household medicines. The law requires drug manufacturers to fund and implement a drug collection and disposal program. Leftover, expired, and unneeded drugs must be collected from residents free-of-charge at drop boxes located at retail pharmacies and law enforcement offices. Drug producers must transport the medicines in accordance with federal and state laws for disposal at permitted incineration facilities.   Read More ›

Safe Cosmetics and Personal Care Products Act of 2013 Mirrors TSCA Proposals, Would Greatly Expand FDA Authority Over Cosmetics

Representative Janice Schakowsky (D-IL), with fifteen co-sponsors, has introduced legislation in the House of Representatives to dramatically increase Food and Drug Administration (FDA) oversight of chemicals in cosmetics and other personal care products.[1] The Safe Cosmetics and Personal Care Products Act of 2013, H.R. 1385,[2] includes a number of provisions also included in the Safe Chemicals Act of 2013, S. 696, a bill to modernize the Toxic Substances Control Act (TSCA).[3] The bill would fundamentally transform the regulation of cosmetics and their ingredients. It expands on prior proposals in a number of respects.[4] The bill, introduced March 21, 2013, has been referred to the House Committee on Energy and Commerce and to the Committee on Education and the Workforce. Read More ›

DEA Issues Notice of Proposed Rulemaking Regarding Disposal of Controlled Substances

On December 21, 2012, the U.S. Drug Enforcement Administration (“DEA”) issued a notice of proposed rulemaking to address the disposal of unused, unwanted, or expired controlled substances by ultimate users. See Disposal of Controlled Substances, 77 Fed. Reg. 75784 (Dec. 21, 2012) (available here). The rulemaking is authorized under the 2010 Secure and Responsible Drug Disposal Act (“Disposal Act” or “Act”) (enacted October 2010), which amended the Controlled Substances Act. Prior to the Act, ultimate users had limited options for disposal of controlled substances (e.g., flushing or discarding in the trash, surrender of controlled substances to law enforcement, or seeking assistance of DEA). Prompted by public health and safety concerns arising from misuse of accumulated controlled substances within households, the Disposal Act sought to facilitate more convenient, secure, and responsible collection and disposal methods that would allow ultimate users to transfer unwanted controlled substances to authorized entities for destruction. DEA has also recognized that establishment of lawful alternative methods for disposal of unwanted pharmaceuticals may help to reduce the introduction of pharmaceuticals into the environment, particularly in water. Read More ›

Pharmaceuticals Stewardship Legislation Introduced in Congress

On September 15, 2011, Representative Slaughter (D, NY) introduced the Pharmaceutical Stewardship Act of 2011, which would create a national, producer-funded pharmaceuticals take-back program.  Read More ›