What must a biological agents risk assessment cover?
Short answer: at least the five matters listed in regulation 6(3), from the agent and its route of exposure to its effects on employees, including those who are pregnant, immunocompromised or vulnerable. It must be documented, done by a competent person and reviewed at intervals not exceeding 24 months.
The Regulations for Hazardous Biological Agents, 2022 were published in Government Gazette 46051 (Government Notice R. 1887) on 16 March 2022 and took effect on publication. Regulation 18 withdrew the 2001 regulations (Government Notice R. 1390 of 27 December 2001), so update any assessment that still cites them. For scope, see which workplaces fall under the regulations.
Who does it, and when
The employer arranges it: regulation 6(2)(a) requires the employer to "conduct and document the risk assessment to determine if any person could be exposed to an HBA" (a hazardous biological agent). A self-employed person has the same duty (regulation 6(1)).
A competent person carries it out (regulation 6(2)(b)): regulation 1 defines one as a person with "the required knowledge, training, experience and, where applicable, qualifications specific to HBAs". No approved inspection authority is required. The Explanatory Notes (guidance) add that the employer should be able to justify that choice.
Representatives are informed: the employer must tell the health and safety representative or committee of its intention to conduct the assessment and of its documented outcomes (regulation 4(1)). All employees, the representative and the committee must be told the results and may comment (regulation 6(7)).
Timing: regulation 6 sets no deadline for the first assessment. Good practice is to complete it before work starts: it shows who is at risk, and they need an initial health evaluation immediately before or within 14 days after starting (regulation 8(2)(a)).
What it must consider
Under regulation 6(3), the assessment must take into account, "as a minimum":
the nature of the HBA and the possible route of exposure;
where the HBA might be present, and in what form;
the nature of the work and work processes;
the controls in place, their effectiveness and any reasonable deterioration in, or failure of, them;
the effects the HBA can have on an employee, "including pregnant, immunocompromised and vulnerable employees".
Regulation 6(4) requires it to be based on all available information, including:
the HBA's risk group in Annexure A;
recommendations from the manufacturer, supplier or a competent person on additional controls;
diseases that may be contracted as a result of the work activities;
potential allergenic, infectious or toxic effects;
diseases employees might be suffering from that conditions at work may aggravate.
Annexure A explains why this matters: its risk groups take no account of effects on people whose susceptibility may be affected by factors such as pre-existing disease, medication, compromised immunity, pregnancy or breastfeeding, and says their risk "should be considered" in the regulation 6 assessment.
Regulation 6 prescribes no format or method; good practice is to record agents, exposure routes, people exposed, controls and a risk rating per area and task, with the assessor's name and date.
When it must be reviewed
Regulation 6(6) requires a review at intervals not exceeding 24 months, and "forthwith" if:
the previous assessment is no longer valid;
a process involving an HBA changes;
the methods, plant or machinery, or procedures for using, handling, controlling or processing an HBA change;
an incident involving an HBA occurs; or
medical surveillance reveals an adverse health effect, where an HBA is identified as a contributing factor.
What the results trigger
An action plan: the employer must consider the recommendations and develop a documented action plan to implement them (regulation 6(5)).
Controls: where reasonably practicable, the measures the assessment identifies must be implemented (regulation 10(4)(a)), maintained under documented protocols, and thoroughly examined and tested at intervals not exceeding 24 months (regulation 12). Surface swab sampling can help verify cleaning and disinfection.
Vaccines: where reasonably practicable, effective vaccines must be made available to employees who are not immune to an agent they are, or may be, exposed to (regulation 10(4)(g)). Annexure A marks agents with a registered vaccine "V", hepatitis B for example.
Exposure monitoring: by a competent person, at intervals set in the risk assessment but not exceeding 24 months (regulation 7(2)).
Medical surveillance: overseen by an occupational health practitioner where the results indicate an employee is at risk of exposure (regulation 8(1)(a)), unless exposure is restricted to Group 1 agents (regulation 2(2)).
Training: for every employee at risk of being exposed, or of exposing others (regulation 4(2)).
Records: keep risk assessments for at least 40 years (regulation 9(1)(d)).
A quick self-check
Check that your HBA risk assessment is documented, names the competent person and was reviewed within the last 24 months.
Work through the five matters in regulation 6(3), and confirm that each agent's risk group is recorded, with unlisted agents provisionally classified (regulation 3).
Check that it sets the exposure monitoring interval and identifies who needs medical surveillance, training and vaccines.
Find the documented action plan, and evidence that employees and their representatives were told the results.
List changes and incidents since the last review; each may require a review now.
How Qualitas can help
Our biological agents assessments cover your work activities and environments, exposure routes and existing controls, with swab sampling where needed. The report, written for management, SHEQ teams and auditors, gives practical recommendations for your regulation 6(5) action plan.
Not sure what your site needs? Start with our free Compliance Gap Analysis, request a quote, or call or WhatsApp 082 649 6599.
This article summarises regulation 6 of the Regulations for Hazardous Biological Agents, 2022 (Government Notice R. 1887, Government Gazette 46051, 16 March 2022) for general guidance. It is not legal advice; refer to the regulations and Annexure A for the full requirements.
Christo de Wet is a SAIOH-registered occupational hygienist with 15 years' experience and the founder of Qualitas Occupational Consulting.
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