Md. Code Regs. 10.10.11.09

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.10.11.09 - Reporting Requirements

A. What to Report. Using reporting forms provided or approved by the Department, a person shall:

(1) Identify all non-exempt biological agents that the person possesses, maintains, transfers, or receives listed under:

(a) Select agents and toxins in:

(i)42 CFR § 73.3;

(ii)9 CFR § 121.3; and

(iii)7 CFR § 331.3; and

(b) Overlap select agents and toxins in:

(i)42 CFR § 73.4; and

(ii)9 CFR § 121.4;

(2) Indicate as part of the identification if a biological agent is:

(a) Viable or nonviable;

(b) Purified genomic material;

(c) Recombinant DNA;

(d) Used in small or large animal work;

(e) Used in large-scale production; and

(f) A toxin;

(3) Identify the physical location of a laboratory and storage area within a facility where a biological agent is contained;

(4) Identify the biosafety level required for the biological agent; and

(5) Identify the individual in charge of the biological agent and information needed to contact that individual.

B. When to Report. A person shall:

(1) Complete and submit a report within 30 days of receiving a request to report from the Department;

(2) Submit a report of each transfer and receipt of a biological agent within 24 hours of completing a transfer as set forth in Regulation .10D of this chapter;

(3) Respond in writing to a deficiency notice from the Department within 10 work days of receiving the notice; and

(4) Respond in writing to notice of a complaint within 10 work days of receiving notice from the Department.

C. Who Submits Reports. A person shall submit a report dated and signed by the:

(1) Individual who actually possesses, maintains, transfers, or receives and has charge of a biological agent; and

(2) Responsible official of the facility where the biological agent is located.

D. Where to Report. A person shall return all completed reports and other correspondence to the BAR Program, c/o Laboratories Administration, Department of Health and Mental Hygiene.

Md. Code Regs. 10.10.11.09

Amended effective 47:10 Md. R. 517, eff. 5/18/2020