Uncertified Facility (BSL 2 plus): Its Journey through Life for Preparations and Setting up, Compliance with Biosafety Regulations, Implementation, and Registration of the Facility with the Ministry of Health, Singapore

Abstract

An uncertified facility is a facility not certified, as defined in the Biological Agents and Toxins Act (BATA) in Singapore, but has met the requirements of the Ministry of Health to possess First and Fifth Schedule biological agents and toxins. This type of facility is also known as a Biosafety Level 2 Plus (BSL 2+) facility. Registration as an uncertified facility or a BSL 2+ facility requires a certain process and procedure to be sought with the Biosafety Branch of the ministry. This review, shares first-hand knowledge on the journey to achieving registration of the authors’ facility. The procedure involved considerable preparation, setting up facility requirements, biosafety precautions, procedures and practices, and training and competence of laboratory users. The ministry conducted a thorough onsite facility audit to ensure that the facility requirements and biosafety procedures and practices were in place. It then issued an approval letter of possession for the first-time use of biological agents and registered the laboratory as an uncertified facility. The expectation is that the comprehensive information shared may be of great benefit to other facilities with similar interests.