12VAC5-90-280: Reporting of dangerous microbes and pathogens

A. Definitions. The following term when used in this part shall have the following meaning unless the context clearly indicates otherwise:

"Select agent or toxin" or "select agent and toxin" means all those biological agents or toxins as defined by federal regulations in 42 CFR Part 73, including Health and Human Services select agents and toxins and overlap select agents and toxins. "Dangerous microbes and pathogens" will be known as "select agents and toxins."

B. Items to report. Each report shall contain the following: name, source, and characterization information on select agents and toxins and quantities held and the name and address of the laboratory and the name, position, and identification information of one responsible official as a single point of contact for the organization.

C. Timing of reports. By January 31 of every year, the responsible official at a laboratory as designated by the Federal Select Agent Program shall provide a written report to the Division of Surveillance and Investigation in the Office of Epidemiology containing the information specified in subsection B of this section.

In the event of a suspected release, loss, or theft of any select agent or toxin, the responsible official at a laboratory as designated by the Federal Select Agent Program shall make a report to the department immediately by the most rapid means available, preferably by telephone. The report shall be submitted to the Division of Surveillance and Investigation in the Office of Epidemiology. The rapid report shall be followed up by a written report within seven calendar days and shall include the following information:

1. The name of the biologic agent and any identifying information (e.g., strain or other characterization information);

2. An estimate of the quantity released, lost, or stolen;

3. An estimate of the time during which the release, loss, or theft occurred;

4. The location (building, room) from or in which the release, loss, or theft occurred. The report may contain additional information as required by 42 CFR Part 73 or the department; and

5. If a release has occurred, the report shall also include the nature, environment, and location of the release; number, names, and position of exposed individuals; and actions taken as a result of the release.

D. Release of reported information. Reports submitted to the select agent and toxin registry shall be confidential and shall not be a public record pursuant to the Freedom of Information Act, regardless of submitter. Release of information on select agents or toxins shall be made only by order of the State Health Commissioner to the CDC and state and federal law-enforcement agencies in any investigation involving the release, theft, or loss of a select agent or toxin required to be reported to the department under this regulation. A person making a report as authorized in this section shall be immune from liability as provided by § 32.1-38 of the Code of Virginia.