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

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

      1. (a) Select agents and toxins in:

         1. (i) 42 CFR §73.3;
         2. (ii) 9 CFR §121.3; and
         3. (iii) 7 CFR §331.3; and

      2. (b) Overlap select agents and toxins in:

         1. (i) 42 CFR §73.4; and
         2. (ii) 9 CFR §121.4;

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

      1. (a) Viable or nonviable;
      2. (b) Purified genomic material;
      3. (c) Recombinant DNA;
      4. (d) Used in small or large animal work;
      5. (e) Used in large-scale production; and
      6. (f) A toxin;
   3. (3) Identify the physical location of a laboratory and storage area within a facility where a biological agent is contained;
   4. (4) Identify the biosafety level required for the biological agent; and
   5. (5) Identify the individual in charge of the biological agent and information needed to contact that individual.

2. B. When to Report. A person shall:

   1. (1) Complete and submit a report within 30 days of receiving a request to report from the Department;
   2. (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. (3) Respond in writing to a deficiency notice from the Department within 10 work days of receiving the notice; and
   4. (4) Respond in writing to notice of a complaint within 10 work days of receiving notice from the Department.

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

   1. (1) Individual who actually possesses, maintains, transfers, or receives and has charge of a biological agent; and
   2. (2) Responsible official of the facility where the biological agent is located.
4. D. Where to Report. A person shall return all completed reports and other correspondence to the BAR Program, c/o Laboratories Administration, Maryland Department of Health.

Authority: Health-General Article, §§17-601—17-605, Annotated Code of Maryland

Effective date: November 25, 2002 (29:23 Md. R. 1811)

Chapter revised effective July 31, 2006 (33:15 Md. R. 1280)

Chapter revised effective January 23, 2012 (39:1 Md. R. 17)

Regulation .03B amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .04B amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .07F amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .10E amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .11A amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .12B, C amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .13 amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .14 amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .21 amended effective May 18, 2020 (47:10 Md. R. 517)

Regulation .22 amended effective May 18, 2020 (47:10 Md. R. 517)