This regulation specifies under what circumstances it will be applicable to you.

Compliance Obligations?

This regulation is applicable to every employer or self-employed person at a workplace where -

• an HBA is produced, processed, used, handled, stored or transported or;
• exposure to an HBA may occur.

Regulations 8, 14, 15, 16 and 17 do NOT apply to an employer at a workplace where the exposure is restricted to a Group 1 HBA.

This regulation regulates the classification of biological agents.

Compliance Obligations?

Biological agents must be assigned a classification of Group 1, Group 2, Group 3 or Group 4 according to hazard and categories of contamination by the chief inspector in consultation with the HBAs health and safety technical committee.

In the event that a biological agent has not been assigned a classification, an employer and self-employed person shall provisionally classify that agent in accordance with Regulation 3(3) of these Regulations.

If a biological agent is provisionally classified in terms of Regulation 3(3), the employer and self-employed person must conduct a risk assessment and assign that biological agent to one of the groups. If there is doubt according to the level of risk of infection as to which of the two alternative groups would be appropriate, the biological agent must be assigned to the higher of the two.

Where an employee does work which exposes them to HBAs, then the employer must comply with this regulation.

Compliance Obligations?

Employers must ensure that employees who are at the risk of being exposed or exposing others to HBA have been comprehensively informed, instructed and trained in both practical aspects and theoretical knowledge. This training must be provided before an employee is potentially exposed to HBAs. The training must cover the factors listed in regulation 4 (1) (a) – (j).

An employer must give instructions in writing to the drivers of vehicles carrying HBA’s, which explain the procedures that must be followed in the event of exposure, spillage, leakage, injury or any other emergency situation.

You must ensure that you, as well as any person who assists in the conducting of your business has the necessary information and has undergone sufficient training in order for him/her to identify the potential risks and precautions that should be taken.

This regulation sets out what the duties are for persons who might be exposed to HBA’s.

Compliance Obligations?

Any person who is or might be exposed to a HBA must obey any lawful instruction given by or on behalf of the employer with regard to the factors listed in regulation 5 (1) (a) – (g), the most important being the:

• prevention of an uncontrolled release of a HBA;
• adherence to instructions regarding environmental and health practices, personal hygiene and good housekeeping;
• the wearing of personal protective equipment,
• the disposal of materials containing HBA and the decontamination of a site;
• undergoing medical examinations; and
• information and training as per regulation 4 above.

Where there has been a possible accidental exposure to a HBA at the workplace, the person involved must immediately report the incident to the employer and the employer must ensure that the incident is investigated and recorded.

This regulation specifies what the duties are of the employer with regard to the conducting of a risk assessment.

Compliance Obligations?

An employer must conduct and document the risk assessment to determine if any person could be exposed to an HBA and it must be ensured by the employer that the HBA risk assessment is conducted by a competent person.

When making the assessment, you must keep a record of the assessment and take into account the matter listed in regulation 6 (3) (a) – (e).

You must also cause the risk assessment to be conducted on the basis of all available information including the matters listed in regulation 6 (4) (a) – (e), the most important being:

• the classification of the HBA into the relevant risk group, according to the level of risk of infection;
• recommendations from the manufacturer, supplier or a competent person regarding the control measures that are necessary in order to protect the health of persons against such agents as a result of their work;
• information on diseases that may be contracted;
• potential allergenic or toxic effects;
• knowledge of diseases from which an employee might be suffering and which may be aggravated by conditions at the workplace.

You must review the risk assessment at intervals not exceeding 24 months, if there is reason to suspect that the previous assessment is no longer valid or there has been a change in process involving HBA or in the methods, equipment or procedures in the use, handling, control or processing of HBA.

Health and safety representatives and health and safety committee must be informed of the results of the risk assessment and given an opportunity to comment thereon.

This regulation stipulates that monitoring must be done in workplaces that have or may have HBA.

Compliance Obligations?

An employer must establish and maintain an exposure monitoring programme at the workplace which is representative of the employee’s exposure to HBAs.

The exposure monitoring programme must include the items in regulation 7(2)(a -d). Importantly, it must be conducted by a competent person.

This regulation stipulates under what circumstances employees must be placed under medical surveillance.

Compliance Obligations?

Employees must be placed under medical surveillance, which is overseen by an occupational health practitioner, if:

• after having conducted a risk assessment, it is evident that an employee may be exposed to HBA;
• the exposure of the employee to any HBA that is hazardous to his/her health is such that an identifiable disease may be related to exposure and there is a reasonable likelihood that the disease may occur under the conditions of his/her work; and there are techniques for detecting sensitisation to allergens or inflammatory response associated with exposure to diagnosis; or
• an occupational health practitioner recommends that the employee should be under medical surveillance in which case the employer may call upon an occupation medical practitioner to confirm the recommendation.

All tests and examinations must be conducted according to a written medical protocol following current best practice, national or international guidelines.

This regulation stipulates what the duties of the employer are with regard to keeping records.

Compliance Obligations?

The employer must comply with the requirements listed in regulation 9 (1) (a) – (g) with regards to the keeping of records, the most important requirements being:

• keep records of all assessments, monitoring results and medical surveillance reports. Personal medical details must only be available to an occupational health practitioner;
• make the records of all risk assessments and monitoring results available for perusal;
• keep all records or risk assessments and monitoring results for a minimum of 40 years.

This regulation stipulates what measures must be taken by the employer to control the exposure of persons to HBA.

Compliance Obligations?

An employer must ensure that the risk of exposure of persons to HBAs is reduced through biological containment and medical fitness restrictions in the workplace. If this is not reasonably practicable, control exposure as low as possible.

Standard precautions must be implemented to reduce the risk of transmission of HBAs in the workplace which may include hand hygiene, gloves, face or eye protection.

This regulation stipulates under what circumstances PPE is required.

Compliance Obligations?

If you have an airborne HBA and/or and HBA that can be absorbed through the skin, ingested or transmitted through contact, and the exposure cannot be adequately controlled as per regulation 10 above, you must ensure that employees are provided with suitable PPE and impermeable PPE if it can be absorbed through the skin.

If respiratory equipment is provided, it must:
• be capable of preventing exposure to the HBA concerned;
• the equipment must be correctly selected, fitted and properly used;
• information, instructions, training and supervision with regard to the use and disposal of the equipment must be provided to the employees; and
• reusable safety equipment must be kept in hygienic condition and efficient working order.

This regulation seeks to ensure that control measures, plant machinery, and facilities are maintained and verified.

Compliance Obligations?

As employer you must ensure that all control measures, equipment and facilities provided in terms of regulations 6, 10 & 11 are in good working order and that thorough examination and tests are carried out at intervals no exceeding 24 months.

This regulation specifies what the prohibitions are with regard to HBA.

Compliance Obligations?

No person is allowed to:
• use compressed air to remove HBA from any surface or person;
• eat, drink, smoke, keep food or beverages or apply cosmetics in an area that contains HBA; or
• leave a controlled area without prior removal of protective or contaminated clothing and equipment.

You must ensure that a notice is put up in a conspicuous place that forbids the abovementioned prohibitions.

This regulation details what the requirements are with regard to labelling, packaging, transporting and storage of HBA.

Compliance Obligations?

All HBA that is in storage, transit or being distributed must be properly contained and controlled in order to prevent the spread and contamination of HBA from the workplace.

The colour coded containers in which the HBA are transported in must be clearly marked with a big hazard sign as depicted in Annexure B of these regulations.

The driver must be trained and equipped with a certificate in emergency procedures.

This regulation details what the requirements are with regard to the disposal of HBA.

Compliance Obligations?

You must:
• lay down written procedures for appropriate decontamination and disinfection,
• implement written procedures enabling infectious waste to be handled and disposed of without risk;
• all fixtures and equipment that have been in contact with HBA waste must be disinfected and decontaminated after use;
• all HBA waste that can cause exposure must be disposed in such a manner that it does not cause a hazard;
• HBA waste that can cause exposure must be disposed of only on sites specifically designated to accept the hazardous waste;
• If the services of a waste disposal contractor is used then there must be a provision in the contract stating that the contractor will comply with the provisions of these regulations.

Any person who contravenes or fails to comply with any provision of regulations 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 will be guilty of an offence and liable on conviction to a fine or to imprisonment for a period not exceeding 12 months.

For a continuous offence, such person will be liable to an additional fine of R200 for each day on which the offence continues or additional imprisonment of one day for each day on which the offence continues, provided that the period of such additional imprisonment shall in no case exceed 90 days.

Compliance Obligations?

You must comply with the provisions of the regulations.