Category Archives: Federal Policy/Programs

EPA Facility Safety Rule (and Others) Delayed until March 21, 2017

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Yesterday, EPA posted a pre-publication version of a new final rule (the Delay Rule) delaying the effective date of the Risk Management Program (RMP) Facility Safety Rule until March 21, 2017.[1]  The RMP Rule is one of 30 regulations listed in the Delay Rule that have been published in the Federal Register but have not yet taken effect—so-called “Midnight Rules” promulgated at the end of the Obama administration.  As a result of the Delay Rule, the new effective date for all 30 Midnight Rules is now March 21, though EPA left open the possibility that effective dates could be further delayed. The [...]Read more

EPA Final Facility Safety Rule Still Faces Uncertain Future

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Yesterday, EPA Administrator Gina McCarthy signed the agency’s final Facility Safety Rule.[1]  The rule, which contains some significant changes from the draft version, will be published in the Federal Register within the next few weeks and will take effect 60 days after publication.  That is, if it is not somehow blocked. The final rule codifies many of the safety requirements in the draft rule, including consideration of inherently safer technology and third party audits after reportable releases.  It also includes notable changes to address security concerns raised both by industry and [...]Read more

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

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

TSCA Reform Passes Senate Unanimously

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Historic overhaul of the primary law governing the safety of chemical products in the U.S.—the Toxic Substances Control Act (“TSCA”)—has, after long delay, passed in the Senate. With agreement from all sides that the law is long overdue for modernization and reform, lawmakers have been working for years to update and reform TSCA.  Enacted in 1976, TSCA has never been significantly amended and the current legislation is poised to massively overhaul U.S. EPA’s authority over chemicals in commerce. In June 2015, the House of Representatives passed the bipartisan TSCA Modernization Act [...]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

Bipartisan TSCA Reform Bill Sails Through House

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Last night, the U.S. House of Representatives passed the TSCA Modernization Act of 2015 (H.R. 2576) with a near-unanimous vote of 398-1. The bipartisan bill now heads to the Senate, where a competing bill (S. 697) advanced last month. Lawmakers will have to resolve key differences between the bills before sending to President Obama. H.R. 2576 would update the 40-year old Toxic Substances Control Act for the first time. The bill’s key provisions remove cost as a factor in EPA’s chemical safety assessments, afford EPA more power to order new chemical safety data, and aim to create a more uniform [...]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