Question 3: To which extent does the HPTA apply to the work of the Grain Research Laboratory?
Response:
The key objective of Human Pathogen and Toxins Act (HPTA) and Regulations (HPTP) is to make working with human pathogens and toxins safer, more secure and less burdensome for those dealing with lower risk pathogens.
The HPTA does not apply to:
• a human pathogen or toxin in an environment in which it naturally occurs, as long as it has not been cultivated or intentionally collected or extracted.
• any activity that is a controlled activity within the meaning of the Assisted Human Reproduction Act.
Under the HPTA, the facility needs to develop a program and regulatory framework on the following:
• License: procedures required to engage in controlled activities.
• Biological Safety Officers: qualifications and training required and roles identified in regulations.
• Securing screening: requirements needed for access.
• Laboratory incidents: reporting on laboratory acquired infections.
I observed on the GRL website that the microbiology program of the GRL monitors and carries out surveillance of high-risk pathogenic, quarantine and toxigenic microorganisms in exported grain. Based on the limited knowledge, the microbiology laboratory operation should be regulated under the HPTA.
The GRL shall develop a program to oversee the practice. The GRL shall get a license. A biological safety officer shall be delegated. All laboratory personals who handle the pathogens/toxins must have a proper security level. They must take training sessions. A laboratory protocol could be developed to identify the hazards, and provide solutions to address these hazards.
With regard to the facility construction, the microbiology laboratory shall locate in a control area. Each person should be cleaned from contamination before leave. The labs shall maintain lower air pressure so that the labs always draw air from outside to fume hoods or ventilation systems. Eye wash stations or eyewash bottles shall be placed in the labs. The garbage bins shall have proper labels for contaminated disposals. The sink drain shall be treated properly before discharge. The lab doors shall be self-closing. The fume hoods shall maintain required face velocity. The ventilation system for the labs shall equip with HEPA filters to block the pathogens and toxins in the air.
With regard to the lab safety practice, we shall have signages on the lab doors listing pathogens and/or toxins that exceed requested storage limits. When required, glove boxes can be used in dealing with pathogens and/or toxins. The lab shall keep PSDS (Pathogens Safety Data Sheet) and/or MSDS (Material Safety Data Sheet for toxins) updated. The personals who deal with pathogens/toxins shall take training session; and wear proper PPE&C (Personal Protective Equipment and Clothing).
With regard to the lab administrative activities, we shall maintain log books of pathogens/toxins inventory. We shall assign a personal to purchase and handle them.
HPTA Application to GRL