Tag Archives: EPA

US EPA Announces its Implementation Plan for TSCA Reform

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TSCA Reform was signed into law just one week ago on June 22, 2016, but a mere one week later, on June 29, U.S. EPA has published its implementation plan, which sets an aggressive schedule to get into place the basic rulemaking frameworks to implement its vast new authorities. U.S. EPA is proposing to establish its regulatory framework for implementation of its new authorities into four main rulemakings, and propose three of them by mid-December 2016 in the twilight days of the Obama Administration. The four main rulemakings are: 1) prioritization process rule, 2) risk evaluation process [...]Read more

Historic TSCA Reform Signed Into Law

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The outdated Toxic Substances Control Act (TSCA) has just received the most significant update in decades. On Wednesday, June 22, President Obama signed into law sweeping reforms, which had bi-partisan support in both houses. Last month, the U.S. House of Representatives voted overwhelmingly to approve a revised version of the Toxic Substances Control Act (TSCA) reform bill, H.R. 2576, originally approved by the House last year. The Senate passed the bill on June 7. The newly signed bill was a compromise following House and Senate negotiations to reconcile differences between last year’s House [...]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

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

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