Biological Safety

Regulations governing labs in Boston

There are currently three regulations governing labs in the city of Boston:

1. Biological Laboratory Regulation (passed September 19, 2006) with accompanying Guidelines.

Registration of facilities and agents
In accordance with Disease Surveillance and Reporting Guidelines and the Biological Laboratory Regulation the Boston Public Health Commission's Environmental Health Office (EHO) is responsible for the registration of all Boston based research laboratory facilities that work with high risk agents  (BSL-3 and BSL-4).

2. Disease Surveillance and Reporting Regulation (passed March 30, 2004) with accompanying Guidelines.

3. Recombinant DNA Technology: Use Regulations (passed March 22, 1994)

RDNA Permit Application and Project Registration.DOC

A research laboratory is any laboratory that possesses, produces, stores or otherwise works with any high risk agents. Contact the Boston Public Health Commission to register for access to an on-line application process for your BSL-3 or BSL-4 facility.

Related Links:

Boston Ordinance:

• Boston Fire Deparment:  Laboratory Registration Guide and Form

Massachusetts State Regulations:

• 105 CMR 480.000:  Minimum Requirements for the Management of Medical or Biological Waste (state sanitary code chapter VIII).
  
• 105 CMR 300.000:  Reportable Diseases, Surveillance, and Isolation and Quarantine Requirements
  
• 105 CMR 120.000:  Radiation Control Program
  

Federal Regulations:

• Biosafety in Microbiological and Biomedical Laboratories (BMBL) – Current edition (CDC/NIH) – 5th Edition in 2006
  

  NIH Guidelines for rDNA
• OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030)
  
• OSHA Laboratory Standard (29 CFR 1910.1450). AKA. Occupational Exposure to Hazardous Chemicals in the Laboratory
  
• OSHA Hazard Communication (29 CFR 1910.1200)
  
• Department of Health and Human Services (DHHS):

        - 42 CFR Parts 72 and 73 (Possession, use, and transfer of select agents and toxins; final rule)

        - 42 CFR Part 1003 (civil money penalties, assessments, and exclusions ) 
          http://www.selectagents.gov/selagentRegulation.htm
         

• Department of Agriculture Animal and Plant Health Inspection Service (APHIS)

- 7 CFR Part 331 and 9 CFR Part 121 (Possession, use, and transfer of biological agents and toxins; final rule)
  http://www.selectagents.gov/selagentRegulation.htm