researchers contemplating work with PCBs (including environmental studies with PCB-contaminated media) should consult their institution’s EHS officer because of the stringency of these regulations.

11.D REGULATION OF BIOHAZARDS AND RADIOACTIVE MATERIALS USED IN LABORATORIES

As explained in Chapter 4, sections 4.H, and Chapter 6, section 6.E.2, most radioactive materials that are used in laboratories are regulated by the U.S. Nuclear Regulatory Commission (USNRC). Rules most pertinent to laboratories are in Title 10 of the Code of Federal Regulations, Parts 20 and 30. The USNRC licenses the use of radioactive materials. Many institutions and firms obtain a broadscope license from the NRC, which provides flexibility but requires an institutional Radiation Safety Officer and Radiation Safety Committee.

As explained in Chapter 4, section 4.G, and Chapter 6, section 6.E.1, the most widely accepted standards for using biohazards in laboratories can be found in Biosafety in Microbiological and Biomedical Laboratories (BMBL; HHS/CDC/NIH, 2007a). The Foreword explains that, “the BMBL remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories, from a biosafety perspective and is not intended as a regulatory document.” However, many accrediting bodies, grant-making organizations, and state regulators expect laboratories that use biohazards to adhere to the BMBL.

Select agents are regulated by CDC and the Department of Agriculture’s APHIS.

11.E ENVIRONMENTAL REGULATIONS PERTAINING TO LABORATORIES

Federal and state environmental regulations apply to laboratory waste, air emissions, and discharges to the sewer. Of these, EPA’s rules for chemical hazardous waste may be the most demanding.

11.E.1 Management of Chemical Hazardous Waste

Chapter 8 covers the regulation of chemical hazardous waste in laboratories, while this section covers the regulation of that waste at an institutional level.

RCRA was enacted by Congress in 1976 to address the problem of improper management of hazardous waste. Subtitle C of that Act established a system for controlling hazardous waste from generation to disposal, often referred to as “cradle to grave.” Under RCRA, EPA is given great responsibilities in promulgating detailed regulations governing the generation, transport, treatment, storage, and disposal of hazardous (chemical) waste. RCRA and EPA regulations apply to laboratories that use chemicals.

11.E.1.1 Definitions and Types of Hazardous Waste Generators

A generator is any firm or institution whose processes and actions create hazardous waste. There are three categories of generator:

1.   Large-quantity generators are those whose facilities generate 1,000 kg or more per month (about four 55-gal drums of hazardous waste) or over 1 kg of “acutely hazardous waste” per month. By this measure, most large research organizations, including the larger universities, are large-quantity generators.

2.   Generators of more than 100 but less than 1,000 kg of hazardous waste per month, and less than 1 kg of “acutely hazardous waste” per month (and accumulate less than 1 kg at any one time). This category may not accumulate more than 6,000 kg at any one time.

3.   Conditionally exempt small-quantity generators of 100 kg or less of hazardous waste per month and less than 1 kg of “acutely hazardous waste.” The special requirements applicable to conditionally exempt small-quantity generators can be found in 40 CFR § 261.5.

11.E.1.2 Implications of EPA’s Definition of On-Site

Federal and state definitions of on-site have bearing on the generation category of each site, and how laboratory hazardous waste is transported and managed. This is particularly important for firms, colleges, universities, and other organizations that are transected by public roads.

“Individual generation site” is defined by RCRA regulation as a contiguous site at or on which hazardous waste is generated. A firm or institution located in one geographic area may be viewed as a single generator with a single EPA generator identification number or, if it is transected by public roads, may be viewed as multiple generator sites requiring multiple EPA generator identification numbers. Multisite facilities are required to have separate EPA identification numbers for each site.

Note that each individual laboratory generating waste is not itself a RCRA “generator,” but instead is part of the “generator” site. Each laboratory therefore



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