“reproductive toxins,” and “substances with a high degree of acute toxicity.”

   A select carcinogen is defined in the standard as any substance (1) regulated by OSHA as a carcinogen; (2) listed as “known to be a carcinogen” in the Report on Carcinogens published by the National Toxicology Program (HHS/CDC/NTP, 1995); (3) listed under Group 1 (“carcinogenic to humans”) by the International Agency for Research on Cancer (IARC) Monographs; or (4) in certain cases, listed in either Group 2A or 2B by IARC or under the category “reasonably anticipated to be carcinogens” by NTP. A category (4) substance is considered a select carcinogen only if it causes statistically significant tumor incidence in experimental animals in accordance with any of the following criteria: (1) after inhalation exposure of 6 to 7 hours per day, 5 days per week, for a significant portion of a lifetime to dosages of less than 10 mg/m3; (2) after repeated skin application of less than 300 mg/kg of body weight per week; or (3) after oral dosages of less than 50 mg/kg of body weight per day.

   “Reproductive toxins” are defined as those chemicals that affect reproductive capabilities, including chromosomal damage (mutations) and effects on fetuses (teratogenesis).

   Chemicals with a “high degree of acute toxicity” are highly toxic noncarcinogenic or highly volatile toxic materials that may be fatal or cause damage to target organs as a result of a single exposure or exposures of short duration. Examples include hydrogen sulfide, nitrogen dioxide, hydrogen cyanide, and methylmercury.

Although “select carcinogens” are specifically identified through reference to other publications, “reproductive toxins” and chemicals with a ‘’high degree of acute toxicity” are not specified further, which has made it difficult to apply these categories. Some organizations have chosen to adopt the OSHA Hazard Communication Standard definition of “highly toxic” (LD50 < 50 mg/kg oral dose) as a workable definition of high degree of acute toxicity. There is little agreement on how to determine reproductive toxins.

The OSHA-mandated special provisions for work with carcinogens, reproductive toxins, and substances that have a high degree of acute toxicity include consideration of “designated areas,” use of containment devices, special handling of contaminated waste, and decontamination procedures. The OSHA requirement is for evaluation, assessment, and implementation of these special controls, when appropriate. These special provisions are to be included in the Chemical Hygiene Plan.

11.C.3 Chemical Facility Anti-Terrorism Standards

In 2007, Congress authorized DHS to “establish risk-based performance standards for security chemical facilities.” In response, DHS issued the Chemical Facility Anti-Terrorism Standards (CFATS). According to the agency, the standards identify high-risk facilities based on the likelihood of an attack, the consequences of an attack, and the threat of an attack based on the intent and capability of an adversary. The standards are concerned with

   EPA Risk Management Plan chemicals,

   highly toxic gases,

   chemical weapons convention chemicals, and

   explosives.

The specific “Chemicals of Interest” are listed in Appendix A of the CFATS rule. (See Chapter 10, section 10.E.4.2 for examples.) The standard applies to any institution that meets or exceeds the threshold quantity established for these chemicals. All facilities, including those with laboratories, are expected to survey their site for the presence of the chemicals of interest and compare the inventory to the threshold screening quantities established in Appendix A of the standard. If the facility meets or exceeds the threshold quantity for any chemical of interest, the facility must report the inventory to DHS.

On the basis of the report, chemical facilities are categorized into risk-based tiers. Each facility is assigned a tier ranging from tier 1 (highest risk) to tier 4 (lowest risk). Facilities that fall into risk tiers 1–3 must prepare a security vulnerability assessment (SVA) to identify facility security vulnerabilities, and develop and implement site security plans. Should a facility fall into tier 4, circumstances may allow for submission of alternate security programs in lieu of an SVA, a site security plan, or both.

For more information about SVAs and CFATS, see Chapter 10, sections 10.F and 10.E.4.2

11.C.4 Regulations Covering Polychlorinated Biphenyls (PCBs)

Regulations pursuant to the Toxic Substances Control Act (TSCA) apply to the use of PCBs and monochlo-robiphenyls in laboratories. Although the rules except the use of “small quantities for research and development” and use “as an immersion oil in microscopy,”



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