Laboratory Regulations and Zoning Ordinance in Baltimore, MD

1. Zoning
2. Building Requirements & Bio Safety
3. Use and Occupancy Permit
4. CLIA and State Laboratory Licensing

Building a research lab in Baltimore City is not an easy task. Many hurdles must be crossed to comply with state, federal and local regulations. Luckily, the 31 Light Street building already complies with the necessary requirements to run a laboratory in Baltimore City. The 3rd floor is already being used as a laboratory space by a biotech startup and several more floors are available.

1. Zoning

According to the Baltimore City Zoning Ordinance, Article 32, Page 434, Research and Development Facilities are only allowed in the following zones:

• Zone C-5: Downtown District, Campus Zoning District, BSC Bio-Science Campus Zoning District, IMU-1 Industrial Mixed-Use Zoning District, IMU-2 Industrial Mixed-Use Zoning District, I-1 Light Industrial Zoning District, I-2 General Industrial Zoning District, MI Maritime Industrial Zoning District, EC-2: Educational Campus, H: Hospital and PC-1, 2, 3,4: Port Covington.

Baltimore City Zoning Maps

• CityView Map Application
• Baltimore City Zoning Map
• CodeMap

2. Building Requirements & Bio Safety

Laboratories in Baltimore City must comply with International and National building codes, as well as comply with fire safety, HVAC, plumbing and other laws.

• ASHRAE: The American Society of Heating, Refrigerating and Air-Conditioning Engineers
• International Code Council
  • Ventilation Code
• National Fire Protection Association (NFPA)

3. Use and Occupancy Permit

For a building situated in a zone that permits laboratories by right (see above), and which complies with all the laboratory building laws, a use and occupancy permit can be requested from Baltimore City Department of Housing & Community Development and  Baltimore City Department of Planning.

4. Clinical Laboratory Improvement Amendments (CLIA) and State Laboratory Licensing

Sometimes, research clinical laboratory testing is exempt from CLIA and state laboratory licensing.

In most cases of research testing where patient-specific results are not reported from the laboratory, and those results are not used “for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” they are not presumed to be subject to CLIA.

In cases where patient-specific test results are reported to a patient or another entity like a business with employees, or maintained by a statistical research center for possible use by investigators in which the results are reported out as patient-specific and could be potentially used “for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” CLIA and state lab licensure would then apply.