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

Research Compliance Offices and Websites

Governmental References