Regulations and Standards

Research conducted at UCLA is governed by numerous agencies that have guidelines and standards that we must follow.

  • The National Institutes of Health (NIH) governs many biosafety practices through funding that is received by UCLA. In order to receive NIH funding, UCLA must be in compliance with the NIH rDNA guidelines, the PHS Policy on Humane Care and Use of Laboratory Animals and other standards.

  • The Biosafety in Microbiological and Biomedical Laboratories (BMBL) is a document from the CDC and NIH that describes best practices in microbiological laboratories.

  • The CDC Select Agent Program governs all Select Agents worked on at UCLA including the 9 Select biological toxins, even when used in exempt amounts.

  • CAL/OSHA is also a regulatory body that governs UCLA as an employer.

  • Bloodborne Pathogen

  • Aerosol Transmissible Diseases Standard.

  • The California Department of Public Health (CDPH) regulates medical waste in California outlined in the Medical Waste Management Act.

  • USDA/APHIS

  • There are many more including DOT/IATA, FDA, EPA and more.

UCLA and the UC system have institutional policies as well.

While adhering to all of these regulations may seem exhausting, biosafety is here to help with any and all questions you have. Our job, in part, is to understand these regulations, know what applies and then help investigators to stay in compliance as well as UCLA as a whole. When many of these inspecting bodies come to campus for a planned or surprise visit, Biosafety is part of the inspection team that escorts inspectors from other agencies and answers questions.

Below you will find a list of many regulations and organizations that regulate research activities on UCLA campus.

Medical Waste Management Program

Medical waste is regulated by the Bloodborne Pathogen standard and the Medical Waste Act and is enforced through the California Department of Public Health (CDPH). Anyone handling medical, biohazardous or sharps waste is required to receive training. For more information on the Medical Waste program please see the Medical Waste Management page.

Select Agent Program

The Federal Select Agent Program is jointly comprised of the CDC DSAT and the USDA/APHIS. The Federal Select Agent Program oversees the possession, use and transfer of biological select agents and toxins. Select agents and toxins are biological agents and toxins that could pose a severe threat to public health and plant health, or to animal or plant products. One of the fundamental elements of the select agent regulations is to keep select agents and toxins out of the possession of individuals who might intend to misuse them.

Every individual and institution(entity) that possess, uses or transfers any select agent or toxin must be registered with CDC DSAT and be approved to work with the Select Agent. No one should be in possession or working with a select agent at UCLA unless approved by the IBC, Biosafety and the Select Agent program. Criminal penalties for non-compliance with the Select Agent Program include up to 10 years in prison and/or $250,000 fine per individual. For information regarding Select Agent toxins, including exempt quantities, check out this page. To find a list of the Select Agents click here. For more information regarding the CDC Select Agent program click here. Please feel free to contact biosafety with any question.

Bloodborne Pathogens Program

The Bloodborne Pathogen standard is part of Cal/OSHA and UCLA is in compliance with this program. In order to ensure compliance, each laboratory is responsible for creating, training and reviewing their Exposure Control Plan. Bloodborne Pathogens training is required annually for all employees or workers who are at risk for occupational exposure to bloodborne pathogens such as HIV, HBV and HCV. Personnel that may or will handle the following materials are required to receive training: human cell lines, human blood or blood components, human tissues, certain human fluids, HIV, HBV, HCV and other bloodborne pathogens.

UCLA Policies & Informational References

UCLA Policy 811
UCLA Policy 905
UCLA Policy 907
IBC policy on open flames in the BSC
IBC policy for human/NHP cells and tissues
IBC policy for reporting rDNA/Biohazardous incidents

Research Compliance Offices and Websites

UCLA Occupational Health Services (OHF)
UCLA Office of Research Administration IBC (ORA-IBC)
UCLA Office of Human Research Protection Program (OHRPP)
UCLA Division of Laboratory Animal Medicine (DLAM)
UCLA Office of Research Administration (ORA)
UCLA Office of Animal Research Oversight (OARO)
UCLA Office of Contract and Grant Administration

Governmental References

NIH-OBA
BMBL 5th Edition
CAL/OSHA AEROSOL TRANSMISSIBLE DISEASES STANDARD
Cal/OSHA BBP Standard
CDPH Medical Waste Management Act
CDC Select Agent Rule
Cal/OSHA Ventilation Requirements for Biological Safety Cabinets
Department of Transportation (DOT) Hazardous Material Shipment Requirements
The NIH Stem Cell Information Resource
Cal/OSHA Safety Needle Fact Sheet
National Institutes of Occupational Safety and Health (NIOSH) Resources on Respirators
National Institutes of Occupational Safety and Health (NIOSH) Resources on Latex Allergies
Environmental Protection Agency (EPA) Mold References
Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)
OSHA BBP Fact sheet
Animal Plant Health Inspection Service
NIH rDNA guidelines

 

 

Biological Safety Program
Email: biosafety@ehs.ucla.edu
Phone: (310) 206-3929
Fax: (310) 825-7076

Address
501 Westwood Plaza, 4th Floor
Box 951605
Los Angeles, CA 90095-1605