Tag Archives: EPA

TSCA Criminal Provision Update: More Bark Than Bite

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On June 22, 2016, Congress passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, updating the Toxic Substances Control Act (TSCA).[1] Congress kept standard violations—whether done knowingly or willfully—as misdemeanors, though it increased the maximum fine from $25,000 to $50,000. Keeping even willful TSCA violations as misdemeanors distinguishes TSCA from other environmental laws, including the Clean Air and Clean Water Acts, in which negligent violations are misdemeanors but knowing or willful violations are felonies. Congress did add a felony endangerment provision [...]Read more

New EPA Facility Safety Rule Faces Uncertain Future

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On October 14, 2016, the Environmental Protection Agency (EPA) sent its final revised facility safety rule to the White House Office of Management & Budget (OMB) for pre-publication review. The rule would update EPA’s Risk Management Plan (RMP), a program established under Section 112(r) of the Clean Air Act (CAA) to improve the safety of industrial plants that use or store more than a threshold quantity of a hazardous substances. The current rule requires only that covered companies submit to EPA a plan to reduce the risk of future accidents from releases; the February 25, 2016 version of [...]Read more

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

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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 Conservation and Recovery Act (RCRA) Hazardous Waste Generator Improvements Rule this fall, and is working to finalize the Management Standards for Hazardous Waste Pharmaceuticals Rule, but appears to need additional time to do so.  While EPA states that it is focusing efforts on these rulemakings, it will also issue a Policy on Reverse Distribution and RCRA. EPA recognizes that [...]Read more

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

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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 value of robust, preventative inspections and proactive regulators in minimizing process safety incidents.  CSB, through the report, calls on California regulators to conduct preventative inspections and analyze facilities’ process safety history, including “near misses.”  CSB also calls for California to require refineries to report process safety indicators.  The conclusions [...]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

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