Author Archives: Elise Paeffgen

Elise Paeffgen is an associate in the Environment, Land Use & Natural Resources Group. Her practice focuses on environmental enforcement defense; RCRA, CERCLA and SDWA financial assurance; chemicals management; carbon regulation; and shale gas extraction.  Read More

EPA and NHTSA Finalize Stringent Emission and Fuel Efficiency Standards

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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 medium- and heavy-duty engines and vehicles.  This “Phase 2” rule, applies to: 1) combination tractors; 2) trailers pulled by combination tractors; 3) heavy-duty pickup trucks and vans; and 4) vocational vehicles, such as buses, garbage trucks and concrete mixers, as well as engines that power combination tractors and vocational vehicles, and covers model years 2021 through [...]Read more

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

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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 should reduce NOx emissions by up to 90 percent:  the expected lower standard is 0.02 grams per brake horsepower hour (g/bhp-hr), a significant decrease for the current 0.2 g/bhp-hr.  Under the Clean Air Act (CAA), California may issue emission standards that are more stringent than federal standards.  While California is the only state with such authority, other states [...]Read more

EPA Extends Comment Period for Proposed RCRA Rules

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EPA announced this morning that it extended the comment period for both the Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule and the Hazardous Waste Generators Improvements Proposed Rule until December 24, 2015, according to the pre-publication notices here and here.  All healthcare facilities, pharmaceutical reverse distributors and other hazardous waste generators should read the proposed rules, and each should analyze the impacts it will have on its operations and waste management practices.  The proposed rules have broad-reaching implications, and generators should provide [...]Read more

EPA Released its Proposed Management Standards for Hazardous Waste Pharmaceuticals Rule

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Today, EPA released its proposed Management Standards for Hazardous Waste Pharmaceuticals Rule.  A pre-publication copy is available here. The proposed rule, if finalized, will add a subpart P under 40 CFR part 266, which applies to the management of hazardous waste (HW) pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors.  All pharmaceutical reverse distributors will be required to manage HW pharmaceuticals under this subpart, not 40 CFR part 262.  Subpart P creates a new category of hazardous waste entities, pharmaceutical reverse distributors – such entities [...]Read more

The Floodgates Are Open for EPR Laws

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Last week, the United States Supreme Court denied industry’s petition for certiorari in Pharmaceutical Research and Manufacturers of America (PhRMA), et al. v. County of Alameda. The petitioners contended that Alameda’s Safe Drug Disposal Ordinance violated the dormant commerce clause by requiring pharmaceutical companies to finance a drug take-back program. The impact of the Court’s denial—which lets stand a Ninth Circuit ruling upholding the ordinance—will be widespread, both for the pharmaceutical industry, and more broadly, for extended producer responsibility (EPR) laws and ordinances [...]Read more

RCRA Regulation of Hazardous Waste Pharmaceuticals –Proposed Rule Forthcoming this Summer

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On March 19, 2015, EPA sent its proposed rule, “Management Standards for Hazardous Waste Pharmaceuticals,” to the White House Office of Management and Budget (OMB) for pre-publication review.  This review may take up to 90 days (barring a one-time 30-day extension).  Unless OMB returns the rule to EPA for reconsideration, we expect the proposed rule to be released this summer.  This rule will have major implications for the pharmaceutical reverse distribution industry and the management of non-dispensable pharmaceuticals at health care facilities. The fall 2014 Unified Agenda states that [...]Read more

Update on Pharmaceutical “Take-Back” Legislation: Counties Forge Ahead; California Waits for Direction from the Supreme Court

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Between Washington and California, the West Coast once again pushes the envelope in drug take-back legislation, while state action – which may level the playing field – has taken a backseat, waiting for the United States Supreme Court to determine whether to grant certiorari in Pharmaceutical Research and Manufacturers of America (PhRMA), et al. v. County of Alameda. At the end of December, the pharmaceutical industry petitioned the Supreme Court to reverse a September 30, 2014 Ninth Circuit appellate ruling that mandates that the industry pay for the County’s take-back program. On January [...]Read more

EPA to Begin Enforcing New Low Sulfur Fuel Standards for Vessels

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EPA is increasing enforcement of vessel pollution cases—specifically violations of fuel sulfur standards—in the North American and U.S. Caribbean Emissions Control Areas ("ECAs"), as demonstrated through its recent release of the “EPA Penalty Policy for Violations by Ships of the Sulfur in Fuel Standard and Related Provisions.”  This policy outlines how EPA will calculate penalties assessed for violations of Act to Prevent Pollution from Ships, the law that implements MARPOL, Annex VI.  The release of this policy coincides with the December 31, 2014 significant reduction in fuel sulfur [...]Read more

DEA Releases Regulations Implementing the Secure and Responsible Drug Disposal Act

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The Department of Justice (DOJ), Drug Enforcement Administration (DEA) released a final rule that implements the Secure and Responsible Drug Disposal Act of 2010, also referred to as the “Disposal Act.” The new regulations take effect on October 9, 2014. They provide additional options for ultimate users to dispose of controlled substances, and create a voluntary role for industry registrants, i.e. “collectors,” which are entities that ultimate users can transfer controlled substances to for disposal. An “ultimate user” includes a person a controlled substance is prescribed to; [...]Read more

EPA Opens Environmental Crimes Office in North Dakota

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The Environmental Protection Agency (EPA) opened a Criminal Investigation Division (CID) office in North Dakota at the end of July. North Dakota has seen its oil production increase to over 1 million barrels a day over the last decade. The Bakken shale, located in the western part of the state, holds almost 11 billion barrels of oil, and production is increasing. EPA’s office is staffed by four agents who plan to investigate operations in the state’s western oil patch, ranging from drilling rigs to disposal sites and everything in between. EPA’s closest offices have been in Montana and Colorado [...]Read more