§ 13.13 — High-Containment Research Laboratories; Required Reports

§ 13.13 High-Containment Research Laboratories; Required Reports.

(a) Loss or theft of a biological agent. No later than four hours after determining that there has been a theft or loss of a biological agent from a high-containment research laboratory, the laboratory operator or a person designated on the registration form of such laboratory must notify the Department of such theft or loss at a telephone number designated by the Department. Any theft or loss must be reported even if the lost or stolen biological agent is subsequently recovered and/or the responsible parties are identified. The following information must be provided: (1) The name of the biological agent and any and all of its identifying information (e.g., strain or other characterization information); (2) The quantity or an estimate of the quantity of the biological agent that was lost or stolen; (3) The time or an estimate of the time during which the theft or loss occurred; (4) The location (building, room) from which the theft or loss occurred. (b) Exposure to or unintentional release of biological agents. Within one hour of determining that a person may have been exposed to a biological agent stored or used in a high-containment research laboratory, or of any unintentional release of a biological agent, or of an illness associated with exposure to a biological agent used or stored in a high-containment research laboratory, the laboratory operator or a person designated on the registration form of such laboratory must notify the Department of the actual or potential exposure at a telephone number designated by the Department. The following information must be provided: (1) The name of the biological agent and any and all of its identifying information (e.g., strain or other characterization information); (2) An estimate of the number of persons potentially exposed to the biological agent in or by the research laboratory and within the entity; (3) An estimate of the quantity of biological agent that was released; (4) An estimate of the time and duration of the release of the biological agent; (5) The environment into which the biological agent was released (e.g., within vs. outside building, into a waste system); (6) The location (building, room) from which the release of the biological agent occurred; (7) Identification and contact information for all persons known to be exposed to the biological agent; (8) Actions taken to respond to the release of the biological agent; and (9) Hazards posed by the release of the biological agent. (c) No requirement of this section affects any other obligation under any other law or regulation for a high-containment laboratory to report the loss, theft or release of a biological agent to any other law enforcement or regulatory agency. (d) All information, records and reports required by this section shall be kept confidential, provided that the Commissioner may disclose to a city, state or federal agency information necessary to respond to an emergency after determining such an emergency exists. (Added City Record 6/15/2016, eff. 12/12/2016)