Frequent Questions

Does the medical exclusion apply to chemicals at doctors' offices and pharmacies?

Sections 311 and 312 require facility owners or operators to file inventory reports detailing the name, amount, and location of hazardous chemicals present at a facility in excess of the established threshold quantities.  Hazardous chemicals are defined by OSHA's Hazard Communication Standard, found at 29 CFR §1910.1200(c), which requires facility owners or operators to maintain material safety data sheets for all hazardous chemicals present at the facility.  Section 311(e)(4) and 40 CFR §370.66 exclude from the definition of hazardous chemical, "any substance to the extent that it is used in a research laboratory or a hospital or other medical facility under the direct supervision of a technically qualified individual."  The EPCRA program has adopted the definition of a technically qualified individual from the Toxic Substances Control Act (TSCA) regulations found at 40 CFR §720.3(ee); the term includes any person who, because of education, training, or experience is capable of understanding the health and environmental risks associated with the chemical under the individual's supervision.  Does the EPCRA medical exclusion apply to chemicals stored and used at doctors' offices and pharmacies?

In order to be excluded from the definition of hazardous chemical, a substance must be both under the supervision of a technically qualified individual and present at a medical facility.  EPA interprets technically qualified individual to refer to those persons who are adequately trained in the research or medical fields, including doctors, nurses, and pharmacists.  Further, both doctors' offices and pharmacies are considered medical facilities.  When a substance is used by a physician or a pharmacist at either a doctors' office or a pharmacy, it does not meet the definition of a hazardous chemical and therefore should not be included in threshold determinations under Sections 311 and 312.  The exclusion also applies to the storage of chemicals at these facilities prior to their use.  The medical exclusion applies only to the specific substances meeting the above criteria, and does not exempt the facility from the requirements of Sections 311 and 312.  Any hazardous chemical not meeting the exclusion must be applied toward the inventory threshold.  Other exclusions commonly applicable to doctors' offices and pharmacies include those found at Section 311(e)(1) and (3) exempting chemicals which are present in consumer form or which are regulated by the Food and Drug Administration.

Have more questions? Submit a request