Audit, Compliance and Risk Blog

This post continues my discussion of the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” which was adopted in June to revise the 1976 Toxic Substances Control Act (TSCA). In the last post I summarized changes made to accelerate testing of chemical substances that are already in use in the U.S., and for which evidence developed since their introduction suggests they may pose an “unreasonable risk” to health or the environment. This “grandfathering” of never-evaluated and potentially hazardous chemicals has been seen as a major weakness. The 2016 Amendments also strengthen the process of evaluation for new chemicals offered for distribution in the U.S. This note addresses changes to these new chemical reviews.

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On June 22, President Obama signed the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” which revises the 1976 Toxic Substances Control Act (TSCA) extensively. TSCA was enacted 40 years ago to empower the Environmental Protection Agency (EPA) to acquire and evaluate data regarding the effects of chemical substances and mixtures on human health and the environment, and to prevent unduly hazardous chemicals from entering commercial use. Although TSCA was a huge step forward at the time, its limitations became ever clearer in subsequent years, and compounded to leave important gaps in protective regulation of chemicals. (I summarized basic provisions here). The late Senator Lautenberg spent many years trying to thread the political needle between chemical companies and health and environmental advocates. He died without achieving this goal, but is honored by the new legislation – which I refer to from now on as “the 2016 Amendments.” (I summarized an earlier version of this new legislation here)

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On May 17, the Environmental Protection Agency (EPA) issued a proposed order registering the pesticide sulfoxaflor, using authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). This proposal is the latest action in a long-running and controversial review of that potential pesticide, and continues to consider how toxic this active ingredient is to bees, and therefore how and if it can be used. Coming after a recent court decision vacating EPA’s previous attempt to register sulfoxaflor, the answer is not clear (I provided a basic discussion of FIFRA registration here).

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Section 404 of the Clean Water Act (CWA) authorizes the U.S. Army Corps of Engineers (Corps) to regulate the “discharge” of “dredged material” or “fill material” into “navigable waters.” Section 404 provision applies if someone wants to dredge a waterway, put fill (or a constructed feature such as a pier or berm) into a waterway, or fill a wetland that occupies a waterway, if that waterway is regulated by CWA as a “water of the United States.” That definition is subject to extreme controversy at the moment – several U.S. Supreme Court decisions struck down a century of agency interpretations, which the Corps and the Environmental Protection Agency (EPA) sought to readjust by changing rules that have now been stayed pending litigation that’s certain to reach the Supreme Court again (I blogged about the rules here).

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Most of the laws and regulations discussed in these blogs exist to ensure proper management of hazardous chemicals and products, in ways designed to minimize environmental and human exposures. Pesticide management provides important variations on these themes, since pesticides are used for the very purpose of killing targeted organisms in the environment … and are regulated to target those uses to protect humans and other non-target species. Within the United States, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) provides the national framework for regulation of pesticides, including registration of active ingredients and mixtures, licensing of applicators, and requirements for the application and use of these hazardous materials. FIFRA provides the U.S. Environmental Protection Agency (EPA) with overall responsibility, although different elements of pesticide regulation are subject to different balances of federal (EPA) and state control.

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When it comes to hospitals we all expect the highest standard of cleanliness and yet, we want every part of our lives to be more sustainable. Of course, when hospitals are faced with a choice that puts hygiene up against sustainability, hygiene always wins. But I wonder if it’s possible to find ways for both to win?

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The Clean Water Act’s (CWA’s) national water quality purview includes National Pollutant Discharge Elimination system (NPDES) provisions for “stormwater” that may contain pollutants such as oil, industrial contaminants, and sediment. This means run-off of rain or snow melt containing pollutants from manufacturing, processing, or raw material storage areas at an industrial site, that passes through a “conveyance” (such as a storm drain) into waters of the United States. The Environmental Protection Agency (EPA) administers or delegates permit programs covering discharges from the following:

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The Occupational Safety and Health Administration (OSHA) recommends that all employers create and maintain plans for dealing with emergency conditions. In particular, some OSHA standards require employers to create an emergency action plan (EAP) as part of their compliance programs.

Even if your organization is not required to do so, you should consider the benefits or being prepared to conduct emergency responses and evacuations. Well-developed emergency plans and proper employee training (so employees understand their roles and responsibilities) likely will result in fewer and less severe employee injuries and less structural damage to the facility during emergencies. A poorly prepared plan, on the other hand, likely will lead to a disorganized evacuation or emergency response, exacerbating confusion, injury, and property damage.

Which Employers Require An EAP?

The following OSHA Standards require you to prepare an EAP as part of your compliance with their requirements:

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Efforts to prevent and respond to chemical disasters are undergoing their first thorough review since many were created decades ago after December 1984’s catastrophe in Bhopal, India. President Obama triggered these reviews in August 2013, when he issued an Executive Order directing federal regulatory agencies to review specified regulatory programs that are designed to prevent such disasters: Occupational Safety and Health Administration’s (OSHA) Chemical Process Safety Management Standard (PSM); Environmental Protection Agency’s (EPA) Accidental Release Prevention (ARP) program and Emergency Planning and Right-to-Know Act (EPCRA) program; and Department of Homeland Security’s (DHS) Chemical Facility Anti-Terrorism Standards (CFATS) program (I blogged about the EO here, OSHA’s consideration of PSM changes here, EPA’s call for comments on possible ARP revisions here, one of the agencies’ joint reports here, and about subsequent revisions to CFATS here and here). On February 25, 2016 EPA proposed ARP revisions, which I describe below.

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Federal laws (commonly referred to as RCRA, after the Resource Conservation and Recovery Act of 1976) provide comprehensive management requirements for parties involved in hazardous waste management, from “cradle to grave” covering generators, transporters, and offsite management facilities. Among these many provisions are requirements that “large quantity generators (LQGs)” submit biennial reports to the Environmental Protection Agency (EPA) or delegated states in March of every even-numbered year. March 2016 is the next such deadline, so now is a good time to review biennial report requirements.

Who Must File Biennial Reports?

A facility that was an LQG during calendar year 2015 must file a biennial report. LQGs are defined as a facility that generates either of the following during a calendar month:

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