Which workplaces fall under the Hazardous Biological Agents Regulations?

Short answer: any workplace where a hazardous biological agent (HBA) is produced, processed, used, handled, stored or transported, or where exposure to one may occur. That second test, in regulation 2(1)(b), takes the Regulations for Hazardous Biological Agents, 2022 well beyond laboratories. If your employees deal with blood or body fluids, sewage, waste, animals or animal products, assume the regulations apply.

The regulations were published in Government Gazette 46051 (Government Notice R. 1887) on 16 March 2022. Regulation 18 withdrew the earlier regulations, published as Government Notice R. 1390 of 27 December 2001, so procedures and training material that still cite the 2001 regulations need updating.

Two routes into the regulations

Regulation 2(1) applies the regulations to every employer and self-employed person at a workplace where:

• An HBA is produced, processed, used, handled, stored or transported (paragraph (a)): deliberate work with biological agents, such as diagnostic, research and quality-control laboratories, vaccine and biotechnology production, and the transport of specimens and cultures.

• Exposure to an HBA may occur (paragraph (b)): contact with the agents is incidental to the work. Typical examples are hospitals, clinics, emergency services and mortuaries; sewage works and drain maintenance; refuse collection, landfills and healthcare risk waste; farms, abattoirs and veterinary practices; food processing; and cleaning services.

The test is whether exposure may occur, not whether it has been measured. The definition of standard precautions in regulation 1 agrees: they apply to "all persons coming into contact with potentially infected persons, animals or animal products and potentially contaminated blood and other fluids in the workplace". Annexure A also lists agents that spread between people, so even an office should not assume it is outside the regulations. A documented risk assessment shows whether, and how far, they apply.

The four groups, and why they matter

Regulation 1 sorts HBAs into four groups:

• Group 1: unlikely to cause human disease.

• Group 2: may cause human disease and be a hazard to exposed persons, but is unlikely to spread to the community; effective prophylaxis and treatment are usually available.

• Group 3: may cause severe human disease, is a serious hazard to exposed persons and may spread to the community; effective prophylaxis and treatment are available.

• Group 4: causes severe human disease, is a serious hazard to exposed persons and may present a high risk of spreading to the community; no effective prophylaxis or treatment is available.

Annexure A classifies named agents: for example, Legionella species are Group 2, Mycobacterium tuberculosis and SARS-CoV-2 are Group 3, and Ebola is Group 4. An unlisted agent is not automatically Group 1. Regulation 3 requires the employer to classify it provisionally, assign the higher group when in doubt, and notify the chief inspector without delay.

Where exposure is restricted to Group 1 agents, regulation 2(2) switches off several regulations, including medical surveillance (regulation 8), labelling, packaging, transporting and storage (regulation 14) and disposal (regulation 15). Risk assessment, monitoring, training, control measures and records still apply.

What applies once you are in scope

• Risk assessment (regulation 6): documented, and covering routes of exposure, the work, existing controls and effects on pregnant, immunocompromised and vulnerable employees. Review it at intervals not exceeding 24 months, and immediately if it is no longer valid, or after a process or method change, an incident involving an HBA, or a medical surveillance finding linked to one.

• Exposure monitoring (regulation 7): a programme representative of employees' exposure, following a validated procedure, at intervals set in the risk assessment but not exceeding 24 months, and whenever a change may affect exposure.

• Medical surveillance (regulation 8): required where, among other triggers, the risk assessment shows an employee is at risk of exposure. It includes an initial evaluation immediately before or within 14 days after starting work, periodic examinations at intervals not exceeding 24 months, and an exit examination.

• Training (regulation 4): before potential exposure, with refresher training annually or at intervals recommended by the health and safety committee or representative.

• Control measures (regulations 10 and 12): standard precautions and other controls, documented protocols to maintain and verify them, and a thorough examination and test at intervals not exceeding 24 months.

• Records (regulation 9): keep risk assessments, exposure monitoring reports and medical surveillance records for at least 40 years.

Who may do the work

The risk assessment and the exposure monitoring must be done by a competent person (regulations 6(2)(b) and 7(2)(b)): someone with "the required knowledge, training, experience and, where applicable, qualifications specific to HBAs". Medical surveillance is overseen by an occupational health practitioner. The regulations do not require an approved inspection authority for any of this work; our article on approved inspection authorities and competent persons explains the difference.

A quick self-check

• List every job involving blood or body fluids, sewage, waste, animals or animal products, or close contact with people who may be ill. Treat those areas as in scope.

• Check that your HBA risk assessment is documented, was done by a competent person, is less than 24 months old and considers pregnant, immunocompromised and vulnerable employees.

• Confirm that employees at risk are under medical surveillance, and that new starters were seen within 14 days of starting.

• Check that the risk assessment sets an exposure monitoring interval, and that monitoring is up to date.

How Qualitas can help

Our biological agents assessments include HBA risk assessments and surface swab sampling, with a report written for management, SHEQ teams and auditors.

An occupational health risk assessment can cover biological agents alongside your other hazards.

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 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.