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Regulations for Hazardous Biological Agents, 2022

Government Notice R1887 of 2022

Regulations for Hazardous Biological Agents, 2022
Citation
Government Notice R1887 of 2022
Primary work
Occupational Health and Safety Act, 1993
Date
16 March 2022
Language
English
Type
Government Notice
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South Africa
Occupational Health and Safety Act, 1993

Regulations for Hazardous Biological Agents, 2022

Government Notice R1887 of 2022

The Minister of Employment and Labour has, under section 43 of the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993), after consultation with the Advisory Council for Occupational Health and Safety, made the regulations in the Schedule.Mr TW Nxesi, MPMinister of Employment and Labour

1. Definitions

In these Regulations any word or expression to which a meaning has been assigned in the Act has the meaning so assigned and, unless the context indicates otherwise—"biohazard" means any potential laboratory source of harm caused by biological agents, microbial by-products or metabolites;"biological agent" means any microorganism, microbial by-products or metabolites, cell or organic material with plant, animal or human origin, including any which have been genetically modified;"competent person" means a person who has, in respect of the work or task to be performed, the required knowledge, training, experience and, where applicable, qualifications specific to HBAs;"control measures" means measures that remove, prevent or reduce the exposure of persons to HBAs at the workplace;"decontamination" means the procedure that eliminates or reduces biological agents to a level that does not cause harm with respect to the transmission of infection or other adverse effects;"disinfect" means to render non-viable virtually all recognised pathogenic microorganisms, but not necessarily all microbial forms;"Facilities Regulations" means the Facilities Regulations, 2004, as published in Government Notice No. R. 924 of 3 August 2004;"HBA" means a hazardous biological agent which may cause an infection, allergy or toxicity or otherwise create a risk to human health, subdivided into the following groups:(a)Group 1 HBA, an HBA that is unlikely to cause human disease;(b)Group 2 HBA, an HBA that may cause human disease and be a hazard to exposed persons, which is unlikely to spread to the community and for which effective prophylaxis and treatment is usually available;(c)Group 3 HBA, an HBA that may cause severe human disease, which presents a serious hazard to exposed persons and which may present a risk of spreading to the community, but for which effective prophylaxis and treatment is available; and(d)Group 4 HBA, an HBA that cause severe human disease and is a serious hazard to exposed persons and which may present a high risk of spreading to the community, but for which no effective prophylaxis and treatment is available;"laboratory" means a room or part of a building equipped for experimentation, research, testing or manufacture of drugs or chemicals or which may manipulate microbiological agents;"microorganism" means a microbiological entity, cellular or non-cellular, capable of replication or transferring genetic material;"monitoring" means the planning and carrying out of a measurement programme and the recording of the results thereof;"respiratory protective equipment" means a device which is worn over at least the mouth and nose to prevent the inhalation of airborne HBAs, and which conforms to a standard, acceptable to the chief inspector;"safety equipment" means equipment which is designed to prevent exposure to HBAs;"standard precautions" means a synthesis of the major features of Universal Precautions (UP) and Body Substances Isolation (BS1) and applies to all persons coming into contact with potentially infected persons, animals or animal products and potentially contaminated blood and other fluids in the workplace and—(a)apply to—(i)all blood;(ii)all body fluids, secretions and excretions, except sweat, regardless of whether they contain visible blood or not;(iii)non-intact skin;(iv)mucous membrane; and(v)tissues; and(b)are designed to reduce the risk of transmission of HBAs from both recognised and unrecognised sources of exposure to HBAs in the workplace;"the Act" means the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993);"Universal Precautions" means an approach to infection control to treat all human blood and certain human body fluids as if they were known to be infectious for HIV, HBV and other blood-borne pathogens;"ventilation" means the process of supplying or removing air to or from an indoor space for the purpose of controlling air contaminants level, humidity or temperature within the space; and"verification" means the process of establishing the accuracy or validity of something.

2. Scope of application

(1)Subject to sub regulation (2), these Regulations apply to every employer or self-employed person at a workplace where—
(a)an HBA is produced, processed, used, handled, stored or transported; or
(b)exposure to an HBA may occur.
(2)Regulations 8, 14, 15, 16 and 17 do not apply to an employer or self­-employed person at a workplace where the exposure is restricted to a Group 1 HBA.

3. Classification of biological agents

(1)Biological agents must be assigned a classification of Group 1, Group 2, Group 3 or Group 4 according to hazard and categories of contaminant by the chief inspector in consultation with the HBAs health and safety technical committee.
(2)Where a biological agent has not been assigned a classification as contemplated in subregulation (1), the employer or self-employed person must provisionally classify that biological agent in accordance with subregulation (3), having regard to the nature of the biological agent and the properties of which he or she may reasonably be expected to be aware and must without delay notify the chief inspector of the provisional classification and the reason therefor. The chief inspector may make a decision based on the recommendation of the HBAs technical committee.
(3)When provisionally classifying a biological agent, the employer or self-­employed person must conduct a risk assessment and assign that biological agent to one of the groups and if there is doubt according to its level of risk of infection as to which of two alternative groups would be most appropriate, the biological agent must be assigned to the higher of the two.

4. Information, instruction and training

(1)An employer who undertakes work which exposes an employee to HBAs must inform the relevant health and safety representative or the health and safety committee established for that workplace of the—
(a)intention to conduct—
(i)a risk assessment contemplated in regulation 6;
(ii)exposure monitoring contemplated in regulation 7;
(iii)medical surveillance contemplated in regulation 8; and
(iv)training contemplated in subregulation (2);
(b)documented outcomes of the—
(i)risk assessment contemplated in regulation 6;
(ii)exposure monitoring contemplated in regulation 7; and
(iii)medical surveillance contemplated in regulation 8.
(2)An employer must ensure that any employee at risk of being exposed or exposing others to HBAs is comprehensively informed, instructed and trained in both the practical aspects and theoretical knowledge with regard to—
(a)the contents and scope of these Regulations;
(b)the potential risks to health caused by the exposure;
(c)the measures to be taken by the employer to protect an employee against any risk of being exposed;
(d)the importance of good housekeeping at the workplace and personal hygiene requirements;
(e)the precautions to be taken by an employee to protect him or her against the health risks associated with the exposure, including the wearing and use of protective clothing and respiratory protective equipment;
(f)the necessity, correct use, maintenance and potential limitation of safety equipment, facilities and engineering control measures provided;
(g)the necessity of risk-based medical surveillance;
(h)the safe working procedures regarding the use, handling, storage, labelling, and disposal of HBAs at the workplace; and
(i)the procedures to be followed in the event of exposure, spillage, leakage, accidental release, injury or any similar emergency situation, and decontaminating or disinfecting contaminated areas.
(3)The employer must ensure that the information, instruction and training referred to in subregulation (1) are provided before an employee is potentially exposed to HBAs.
(4)The employer must conduct refresher training annually or at intervals that may be recommended by the health and safety committee or the health and safety representative.
(5)An employer or self-employed person must give instructions in writing of the procedures contemplated in subregulation (1)(a) to the drivers of vehicles carrying HBAs.
(6)Every employer or self-employed person must ensure that he or she or any person who in any manner assist him or her in the carrying out or conducting of the business duties has the necessary information and has undergone instruction and training in order for him or her to identify potential risks and the precautions that should be taken.

5. Duties of persons who might be exposed to HBAs

(1)Any person who is or might be exposed to HBAs must obey any lawful instruction given by or on behalf of the employer or a self-employed person regarding—
(a)the prevention of an uncontrolled release of an HBA;
(b)the adherence to instructions regarding environmental and health practices, personal hygiene and good housekeeping;
(c)the appropriate use of personal protective equipment and clothing as prescribed by these Regulations and the documented risk assessment;
(d)the appropriate wearing of personal samplers, when necessary, to measure personal exposure to airborne HBAs;
(e)the disposal of materials containing HBAs and the disinfection and decontamination of any workplace contaminated by an HBA;
(f)the reporting during normal working hours for such medical examination or tests as contemplated in regulation 8(1); and
(g)information, instruction and training as contemplated in regulation 4.
(2)Any person must immediately report to the employer, the health and safety representative or self-employed person any possible exposure to an HBA at the workplace.

6. Risk assessment for HBAs

(1)A self-employed person must conduct and document the risk assessment to determine if any person could be exposed to an HBA.
(2)An employer must—
(a)conduct and document the risk assessment to determine if any person could be exposed to an HBA; and
(b)ensure that the HBA risk assessment contemplated in paragraph (a) is conducted by a competent person.
(3)When conducting the risk assessment, as contemplated in subregulation (1) and (2), the employer or self-employed person must take into account, as a minimum, the following matters:
(a)The nature of the HBA and the possible route of exposure;
(b)where the HBA might be present and in what form it is likely to be;
(c)the nature of the work and work processes;
(d)current control measures in place, effectiveness of control measures and any reasonable deterioration in, or failure thereof; and
(e)what effects the HBA can have on an employee, including pregnant, immunocompromised and vulnerable employees.
(4)An employer or a self-employed person must conduct the risk assessment on the basis of all available information, including—
(a)classification of the HBA into the relevant risk group according to its level of risk of infection as contained in Annexure A;
(b)recommendations from the manufacturer, supplier or a competent person regarding additional control measures necessary in order to protect the health of persons against such agents as a result of their work;
(c)information on diseases that may be contracted as a result of the activities at the workplace;
(d)potential allergenic, infectious or toxic effects that may result from the activities at the workplace; and
(e)knowledge of diseases from which employees might be suffering and which may be aggravated by conditions at the workplace.
(5)An employer must, in terms of the risk assessment—
(a)consider the recommendations identified in the risk assessment; and
(b)develop a documented action plan for the implementation of the recommendations.
(6)An employer must review the assessment required by subregulation (1)—
(a)at intervals not exceeding 24 months;
(b)forthwith, if—
(i)the previous assessment is no longer valid;
(ii)there has been a change in a process involving an HBA;
(iii)there has been a change in the methods, plant or machinery, procedures in the use, handling, control or processing of an HBA;
(iv)an incident occurs involving an HBA; or
(vi)medical surveillance reveals an adverse health effect, where an HBA is identified as a contributing factor.[Please note: numbering as in original.]
(7)The employer must ensure that all employees, the relevant health and safety representative and health and safety committee are informed of the results of the risk assessment, who may comment thereon.

7. Exposure monitoring of HBAs

(1)An employer must establish and maintain an exposure monitoring programme at the workplace which is representative of the employees’ exposure to HBAs.
(2)The exposure monitoring programme must be—
(a)in accordance with a validated procedure, sufficiently sensitive and of proven effectiveness;
(b)conducted by a competent person;
(c)conducted at intervals determined in the risk assessment but not exceeding 24 months; and
(d)conducted when any change occurs which may affect the exposure.
(3)An employer must, in terms of exposure monitoring—
(a)consider the recommendations identified in the exposure monitoring report; and
(b)develop a documented action plan for the implementation of the recommendations.

8. Medical surveillance

(1)An employer must establish and maintain a documented system of medical surveillance of employees, which is overseen by an occupational health practitioner, if—
(a)the results of the HBA risk assessment contemplated in regulation 6 indicate that an employee is at risk of exposure to HBAs;
(b)the exposure of the employee to the HBA is hazardous to his or her health and is such that—
(i)an identifiable disease or adverse effect to his or her health may be related to the exposure;
(ii)there is a reasonable likelihood that the disease or effect may occur under the particular conditions of his or her work; and
(iii)there are techniques such as preclinical biomarkers, where appropriate, for detecting sensitisation to allergens or an inflammatory response associated with exposure to diagnose indications of the disease or the effect as far as is reasonably practicable; or
(c)an occupational health practitioner recommends that the relevant employee should be under medical surveillance, in which case the employer may call upon an occupational health practitioner to confirm the appropriateness of such recommendation.
(2)In order to comply with the provisions of subregulation (1), the employer must, after in-depth counselling and education, ensure that the medical surveillance consists of—
(a)an initial health evaluation, which should be carried out by an occupational health practitioner immediately before or within 14 days after a person commences employment where risk of exposure exists, which comprises—
(i)an evaluation of the employee’s medical and occupational history;
(ii)a physical examination; and
(iii)any biological tests and other appropriate medical tests or any other essential examination that in the opinion of the occupational health practitioner is desirable in order to enable the practitioner to do a proper evaluation;
(b)periodic medical examinations and tests which should be carried out by an occupational health practitioner at intervals specified by him or her but not exceeding 24 months and which consists of—
(i)a physical examination; and
(ii)any biological tests and other appropriate medical tests or any other essential examination that in the opinion of the occupational health practitioner is desirable in order to enable the practitioner to do a proper evaluation;
(c)exit medical examinations and tests which should be carried out by an occupational health practitioner and which consists of—
(i)a physical examination; and
(ii)any biological tests and other appropriate medical tests or any other essential examination that in the opinion of the occupational health practitioner is desirable in order to enable the practitioner to do a proper evaluation.
(3)All tests and examinations as contemplated in subregulation (2) must be conducted according to a written medical protocol following current best practice, national or international guidelines.
(4)All occupational health practitioners must submit to the employer for approval a written protocol for procedures to be followed when dealing with abnormal results.

9. Records

(1)An employer must—
(a)keep records of all training, exposure assessments, exposure monitoring reports and medical surveillance reports required by regulations 4, 6, 7 and 8 respectively;
(b)make the records contemplated in paragraph (a), excluding personal medical records, available for inspection by an inspector, a health and safety representative or a health and safety committee;
(c)make the records contemplated in regulation 8(2)(b) available to any person subject to the formal written consent of the employee concerned;
(d)keep all records of risk assessments, medical surveillance and exposure monitoring reports for a minimum period of 40 years;
(e)keep all records of the examinations and tests carried out in terms of regulation 12(c) and of any repairs resulting from the investigations and tests for a minimum period of five years;
(f)keep all records of training given to an employee in terms of regulation 4 for as long as the employee remains employed at that particular workplace; and
(g)if the employer or self-employed person ceases activities, hand over all the records to the relevant Chief Director: Provincial Operations.
(2)A self-employed person must keep records of all risk assessments for a minimum period of 40 years, and if the self-employed person ceases activities, all those records must be handed over to the relevant Chief Director: Provincial Operations.

10. Prevention and control of exposure to HBAs

(1)A self-employed person must ensure that the risk of exposure of persons to HBAs is reduced through biological containment and where this is not reasonably practicable, control the exposure to as low as possible.
(2)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 or, where this is not reasonably practicable, control the exposure to as low as possible.
(3)The employer or self-employed person must ensure that the standard precautions are implemented to reduce the risk of transmission of HBAs in a workplace, which may include—
(a)hand hygiene;
(b)gloves;
(c)face or eye protection;
(d)protective clothing;
(e)respiratory protective equipment; and
(f)other relevant process safety equipment.
(4)Where reasonably practicable, the employer or self-employed person must control the exposure to an HBA in the workplace by—
(a)implementing measurers identified in the documented risk assessment;
(b)limiting the amount of HBAs used which might contaminate the workplace to the minimum quantity required for the task;
(c)limiting the number of employees;
(d)limiting the duration of exposure of employees;
(e)introducing measures for the control of exposure, which must include any combination of the following contamination control measures:
(i)Separation of different infectious processes from each other and from persons;
(ii)barrier isolation of a process or agent;
(iii)local exhaust ventilation;
(iv)general ventilation;
(v)air and surface disinfection;
(iv)positive static air pressure differential from infectious process to human occupied zones;[Please note: numbering as in original.]
(vii)suppression of emissions of an airborne HBA;
(viii)access control to prevent unauthorised access; and
(ix)immediately accessible emergency personal or environmental disinfection;
(f)introducing appropriate work procedures that employees must follow where HBAs are handled, used and processed that could give rise to the exposure of an employee to HBAs, and such procedures must include documented instructions to ensure—
(i)the safe handling, use and disposal of HBAs;
(ii)the proper use and maintenance of machinery, installations, equipment, tools and local exhaust and general ventilation systems;
(iii)the regular cleaning of machinery and work areas with vacuum cleaners fitted with air filters with an arrestance of not less than 99,95%;
(iv)a system is in place that identifies the need for early corrective action from changes to work procedures and practices; and
(v)the decontamination and disinfection of the affected workplace;
(g)making available effective vaccines for those employees who are not immune to the biological agent to which they are exposed or are liable to be exposed;
(h)specifying procedures for taking, handling and processing samples that might contain HBAs; and
(i)displaying the biohazard sign as depicted in Annexure B and other relevant information.

11. Personal protective equipment and facilities

(1)If it is not reasonably practicable to ensure that the exposure of an employee is controlled as contemplated in regulation 10, the employer must, in the case of—
(a)airborne, ingestion and contact transmission, provide the employee with suitable protective equipment and protective clothing; and
(b)HBAs that can be absorbed through the skin, provide the employee with suitable impermeable personal protective clothing.
(2)Where respiratory protective equipment is provided, the employer must ensure that—
(a)the relevant safety equipment is capable of preventing the exposure to the HBA concerned;
(b)the relevant safety equipment is correctly selected, fitted and properly used;
(c)information, instructions, training and supervision which would be necessary with regard to the use and disposal of the safety equipment are known to the employees; and
(d)the reusable safety equipment is kept in hygienic condition and efficient working order.
(3)An employer must, as far as is reasonably practicable—
(a)not issue personal protective equipment which has been used to an employee unless it is capable of being decontaminated and disinfected prior to use;
(b)provide separate containers or storage facilities for protective equipment and protective clothing when not in use; and
(c)take steps to ensure that all protective equipment and protective clothing not in use are stored in a demarcated area with proper access control.
(4)An employer must, as far as is reasonably practicable, ensure that all contaminated reusable personal protective clothing issued is cleaned and handled in accordance with the following procedures:
(a)Where such clothing is cleaned on the premises of the employer, care must be taken to prevent contamination during handling, transporting and cleaning;
(b)where clothing is sent off the premises to a contractor for cleaning purposes, the contractor must place the clothing in impermeable, tightly sealed colour coded containers and such containers must be clearly identified with a biohazard label as depicted in Annexure B;
(c)where clothing from facilities handling HBA Risk Group 3 and Risk Group 4 agents is sent off the premises for any purposes, it must first be decontaminated; and
(d)it must be ensured that the contractor as contemplated in subregulation (4)(b) is fully informed of the requirements of these Regulations and the precautions to be taken regarding the handling of contaminated clothing.
(5)Subject to the provisions of the Facilities Regulations, an employer must, where reasonably practicable, provide employees using personal protective equipment and clothing as contemplated in subregulation (1) with—
(a)adequate washing facilities which are readily accessible and located in an area where the facilities will not become contaminated, in order to enable the employees to meet the standard of personal hygiene consistent with the adequate control of exposure, and to avoid the spread of HBAs;
(b)two separate lockers labelled "protective clothing" and "general clothing" respectively, and ensure that the general and protective clothing is kept separately in the lockers concerned; and
(c)separate "clean" and "contaminated" change rooms if the employer uses or processes HBAs to the extent that the HBA could endanger the health of persons outside the workplace.

12. Maintenance and verification of control measures, plant machinery and facilities

The employer must ensure that—
(a)documented risk-based protocols are developed, maintained by a competent person and made available at the workplace for all control measures, plant machinery and facilities provided in terms of regulations 6, 10 and 11, which include—
(i)performance parameters and minimum acceptance criteria;
(ii)performance verification methodology and intervals;
(iii)routine maintenance requirements, specifications and intervals;
(iv)relevant standards, regulations and manufacturer’s requirements; and
(v)minimum competency and training required to perform verification and maintenance activities;
(b)all control measures, plant machinery and facilities provided in terms of regulations 6, 10 and 11 are maintained in good working order and in accordance with the protocols referred to in paragraph (a);
(c)thorough examination and tests of control measures, plant machinery and facilities provided in terms of regulations 6, 10 and 11 are carried out in accordance with the protocols referred to in paragraph (a), but at intervals not exceeding 24 months;
(d)outcomes of tests of control measures are documented and available for inspection; and
(e)the protocols referred to in paragraph (a) comply with any applicable guideline issued by the chief inspector.

13. Prohibitions

(1)No person may—
(a)use compressed air to remove HBAs from any surface or person;
(b)eat, drink, smoke, keep food or beverages or apply cosmetics where an HBA is handled or require or permit any other person to eat, drink, smoke, keep food or beverages or apply cosmetics in such a workplace; or
(c)leave a controlled area without prior removal of potentially contaminated protective clothing and safety equipment.
(2)An employer or self-employed person must cause a notice and/or signage to be posted at a conspicuous place containing the provisions of subregulation (1).

14. Labelling, packaging, transporting and storage

An employer or self-employed person must, as far as is reasonably practicable, take steps to ensure that—
(a)all HBAs under his or her control in storage, transit or being distributed are properly contained and controlled to prevent the spread of contamination from the workplace;
(b)the colour coded containers in which HBAs are transported are clearly marked with a biohazard sign as depicted in Annexure B and other relevant warning signs that identify the contents;
(c)transport of HBAs is performed with due consideration of Chapter VIII of the National Road Traffic Act, 1996 (Act No. 93 of 1996), and the International Air Transport Association (IATA) Infectious Substances Shipping Regulations; and
(d)authorisations for the transport and storage of biological agents as required by the National Health Act, 2003 (Act No. 61 of 2003): Regulations Relating to the Registration of Microbiological Laboratories and the Acquisition, Importation, Handling, Maintenance and Supply of Human Pathogens, 2012, as published in Government Notice No. R. 178 of 2 March 2012, the Non­-Proliferation of Weapons of Mass Destruction Act, 1993 (Act No. 87 of 1993), the Animal Health Act, 2002 (Act No. 7 of 2002), and the Genetically Modified Organisms Act, 1997 (Act No. 15 of 1997), are adhered to where applicable.

15. Disposal of HBAs

An employer or self-employed person must—
(a)lay down written procedures for appropriate decontamination and disinfection;
(b)implement written procedures enabling infectious waste to be handled and disposed of without risk;
(c)provide sufficient hazardous waste containers for disposal of used personal protective equipment;
(d)ensure that all fixtures, plant and machinery including vehicles, reusable containers and covers which have been in contact with HBA waste are disinfected and decontaminated after use in such a manner that it does not cause a hazard inside or outside the workplace concerned;
(e)ensure that all employees involved in the collection, transport and disposal of HBA waste and who may be exposed to that waste are provided with suitable personal protective equipment;
(f)ensure that if the services of a waste disposal contractor are used, a provision is incorporated into the contract stating that the contractor must comply with the provisions of these Regulations; and
(g)ensure that HBA waste that can cause exposure is treated and disposed of only on sites specifically designated and authorised for this purpose in terms of the National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008), in such a manner that it does not cause a hazard inside or outside the site concerned.

16. HBAs health and safety technical committee

(1)The chief inspector must establish an HBAs health and safety technical committee which must consist of—
(a)a person who is to be the chairperson;
(b)two persons designated by the chief inspector from the employees of the Department of Employment and Labour;
(c)three persons designated by employers' organisations to represent employers;
(d)three persons designated by employees’ organisations representing the federation of unions;
(e)one representative of each of the professional bodies recognised by the chief inspector; and
(f)one person from the field of HBAs representing a higher educational institution.
(2)The chief inspector may—
(a)authorise the HBAs health and safety technical committee to co-­opt persons who have specialised knowledge of the matters dealt with by the HBAs health and safety technical committee; and
(b)appoint members of the HBAs health and safety technical committee for a period that he or she may determine at the time of appointment.
(3)The HBAs health and safety technical committee must—
(a)advise the chief inspector on HBA related matters, including but not limited to codes, standards and training requirements;
(b)make recommendations and submit reports to the chief inspector regarding any matter to which these Regulations relate;
(c)advise the chief inspector regarding any matter referred to the HBAs health and safety technical committee by the chief inspector;
(d)perform any other function for the administration of a provision of these Regulations that may be requested by the chief inspector; and
(e)conduct its work in accordance with the instructions and rules of conduct framed by the chief inspector.

17. Offenses and penalties

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 and, in the case of a continuous offence, 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.

18. Withdrawal of regulations

The Regulations for Hazardous Biological Substances, 2001, published as Government Notice No. R. 1390 of 27 December 2001, are hereby withdrawn.

19. Short title

These Regulations are called the Regulations for Hazardous Biological Agents.

Annexure A

Categorisation of biological agents according to risk group

Introduction

1.The attached list must be read in conjunction with the Hazardous Biological Agents Regulations, and in particular regulation 3.
2.Biological agents listed are categorised into the following risk groups on the basis of their ability to cause human disease by infection, allergy and/or toxicity, potential to cause epidemics or pandemics, endemicity in South Africa and availability of curative or prophylactic treatment:Risk group 1: a microorganism known not to or unlikely to cause human disease.Risk group 2: a pathogen that may cause human disease but unlikely to pose serious hazard to laboratory workers, the community and the environment. Specific treatment or vaccines may be available to manage or prevent infection with these pathogens.Risk group 3: a pathogen that may cause serious human disease but does not typically spread from human to human. Treatment and vaccines may be available to manage or prevent infection with these pathogens.Risk group 4: a pathogen that may cause serious human disease and may be readily transmissible from human to human. Specific treatment and preventative measures are typically not available for the diseases caused by these pathogens.
3.In allocating biological agents to a risk group, account is not taken of effects on those whose susceptibility may be affected for one or other reason such as pre­existing disease, medication, compromised immunity, pregnancy or breastfeeding. Workplace specific risk to such workers should be considered per risk assessment as in regulation 6.
4.Biological agents that have not been classified for inclusion in groups 2 to 4 of the list are not implicitly classified as Group 1. All viruses that have been isolated in humans and that have not been assessed and allocated to a group in the list are to be classified in group 2 as a minimum, except where there is evidence that they are unlikely to cause disease in humans.
5.If more than one species of any particular agent is known to be pathogenic to humans, the most prominent of these is generally named, together with the wider reference "species" (spp.) to indicate the fact that the other species of the same genus may be hazardous. If a whole genus is mentioned in this way, it is implicit that species and strains that are non-pathogenic to humans are excluded.
6.When a strain is attenuated or has lost known virulence genes, then the containment required by the classification of its parent strain need not necessarily apply, subject to risk assessment as per regulation 6, for example, when such strain is used as a product or as part of a product for prophylactic or therapeutic purposes (see point 2).
7.The requirements as to containment consequent upon the classification of parasites apply only to stages in the life cycle of the parasite in which it is liable to be infectious, allergic or toxic to humans.
8.The list also gives a separate indication where biological agents are capable of causing allergic or toxic reactions, and where a registered vaccine is available for use in the Republic of South Africa.The indications are identified by the following notations:• A: possible allergic effects;• T: toxin production; and• V: vaccine available.
9.The selection of control measures for biological agents should take into account the fact that there are no exposure limits for them. Their ability to replicate and to infect, cause allergic or toxic effects, at very low doses, means that exposure may have to be reduced to levels that are diminishingly low.For each activity the first consideration should be whether it can be carried out in a way that involves exposure to a less harmful biological agent. This may be practicable, for example, in teaching and some types of research. If there is more than one way of carrying out the activity, then the method carrying the least risk should be chosen.If the least harmful alternative still involves exposure or potential exposure to a biological agent, or the nature of the activity is such that there is no choice, and it is not reasonably practicable to prevent exposure by some other means, then exposure should be adequately controlled.
10.Agents with reduced virulence may be used at a lower than normal level of containment if the alteration has effectively changed their classification.A biological agent that falls or is treated as falling into hazard Group 1 may be a Group 3 genetically modified organism because of environmental risks associated with it or because, though now unlikely to cause human disease, it is derived by genetic modification from a pathogenic parental organism. In the latter case, the selection of containment measures appropriate to the agent’s reduced virulence and corresponding group may be permitted. Where there is a mismatch, as in the case of a genetically modified organism or biological agent that is non-hazardous to humans but environmentally harmful, the more stringent requirements should be followed.Where the rules set out lead to a particular containment level for an activity, all the measures appropriate to that level should normally be used. Some selection may be done, however, to suit individual circumstances, provided that by doing so the risk is not increased.Regulation 11 sets out additional requirements in respect of personal protective equipment used to protect employees against biological agents. The objective of these requirements is to prevent the equipment itself from acting as the means by which agents are transmitted, and they should be followed accordingly.Where workers are exposed to biological agents, the information and instruction given to them, if applicable, should be set down in the form of written instructions, outlining procedures to be followed after a serious incident involving the handling of a biological agents as well as the procedure for handling any Group 4 agent.If the nature of the workplace and the activity are such that employees may need instant access to this information, or where a reduction in risk may be expected by having the information conspicuously displayed in the workplace then it should also be set out on notices displayed in the workplace.

Table 1: Prescribed risk groups for parasitic agents (in alphabetic order)

Biological agentRisk groupBiological agentRisk group
Helminths
Ancylostoma spp.2Hymenolepis spp.2
Angiostrongylus spp.2Loa spp.2
Anisakis spp.2Mansonella spp.2
Ascaris lumbricoides2(A)Metagonimus spp.2
Brugia spp.2Necator spp.2
Capillaria spp.2Onchocerca spp.2
Clonorchis spp.2Opisthorchis spp.2
Contraceacum osculatum2Paraqonimus spp2
Dicrocoelium dendriticum2Pseudoterranova decipiens2
Dipetalonema spp.2Schistosoma spp.2
Diphyllobothrium spp.2Strongyloides spp.2
Dipylidium caninum2Taenia spp.2
Dracunculus medinesis2Taenia solium3
Echinococcus spp.3Ternidens deminutus2
Enterobius spp.2Toxocara spp.2
Fasciola gigantica2Trichinelia spp.2
Fasciola hepatica2Trichostrongylus spp.2
Fasciolopsis buski2Trichuris trichiura2
Heterophyes spp.2Wuchereria spp.2
Protozoa
Acanthamoeba spp.2Leishmania spp.2
Babesia spp.2Leishmania brasiliensis3
Balantidium spp2Leishmania donovani3
Blastocytis hominis2Linguatula spp.2
Coccidia spp.2Macracanthorhynchus spp.2
Cochliomyia hominivorax2Microsporidia spp.2
Cryptosporidium spp.2Naegleria fowleri3
Cyclospora spp.2Naegleria spp. (other than fowleri)2
Cysticerus celtulosae2Oesophagostomum dentalum2
Dientamoeba fragilis2Plasmodium spp. (human and simian)2
Encephalitozoon spp.2Plasmodium falciparum3
Entamoeba spp.2Pneumocystis carinii2
Enterocytozoon bieneusi2Sarcocystis spp2
Giardia spp.2Toxoplasma spp.2
Gnathostoma spinigerum2Trichomonas vaginalis2
Gongylonema pulchrum2Trypanosoma spp.2
Haemonchus contortus2Trypanosoma brucei gambiense3
Isospora spp2Trypanosoma brucei rhodesiense3

Table 2: Prescribed risk groups for fungal agents (in alphabetic order)

Biological agentRisk groupBiological agentRisk group
Absidia spp.2Lacazia loboi3
Acremonium spp.2Leptosphaeria spp.2
Ajellomyces spp.3Lichtheimia corymbifera2
Arthroderma spp.2Madurella spp.2
Aspergillus spp.2Malassezia spp.2
Basidiobolus haptosporus2Microsporum spp.2
Blastomyces dermatitidis3Mucor spp.2
Candida spp.2Neotestudina rosatii2
Cladophialophora bantiana3Paeciiomyces variottii2
Other Cladophialophora spp2Paracoccidioides brazilensis3
Cladosporium spp.3Penicillium marneffei3
Coccidioides and Paracoccidioides spp.3Pseudallescheria boydii2
Cryptococcus spp.2Rhinocladiella mackenziei3
Dermatophilus congolensis2Rhizomucor pusillus2
Emmonsia crescens2Rhizopus spp.2
Emmonsia parva2Saksenaea vasiformis2
Epidermophyton spp.2Scedosporium spp.2
Exophiala spp.2Scopulariopsis brevicaulis2
Filobasidiella spp.2Sporothrix schenckii2
Fonsecaea spp2Stachybotrys chartarum2
Fusarium spp.2Trichophyton spp.2
Geotrichum spp.2Trichosporon spp.2
Histoplasma spp.3Xylohypha bantiana3

Table 3: Prescribed risk groups for bacteria, rickettsiae and mycoplasmas (in alphabetic order)

Biological agent Risk groupBiological agent Risk group
Abiotrophia spp.2Kingella spp.2
Achromobacter spp.2Klebsiella spp.2
Acidaminococcus fermentans2Kluyvera spp.2
Acidovorax spp.2Koserella trabulsii2
Acinetobacter spp.2Lactobacillus spp.2
Actinobacillus spp.2Lactococcus garvieae2
Actinobaculum schaalii2Leclercia adecarboxylata2
Actinomadura spp.2Legionella spp.2
Actinomyces spp.2Leptospira spp.2
Aeromonas spp.2Levinea malonatica2
Afipia spp.2Liberobacter spp.2
Alcaligenes spp.2Listeria spp.2
Alloiococcus otitis2Mannheimia spp.2
Allomonas enterica2Megasphaera elsdenii2
Alteromonas haloplanktis2Melissococcus pluton2
Amycolata autotrophica2Microvirgula aerodenitrificans2
Anaerobiospirillum spp.2Mima polymorpha2
Anaerorhabdus furcosus2Mitsuokella multacida2
Anaplasma spp. R412Mobiluncus spp.2
Arachnia spp.2Moraxella spp.2
Arcanobacterium spp.2Morganella morganii2
Arcobacter butzleri2Morococcus cerebrosus2
Arizona spp.2Mycobacterium africanum3 (V)
Arsenophonus nasoniae2Mycobacterium avium/intracellulare2
Arthrobacter spp.2Mycobacterium bovis3 (V)
Atopobium spp.2Mycobacterium bovis (BCG strain)2
Bacillus anthracis3(V)Mycobacterium chelonae2
Bacillus cereus2Mycobacterium fortuitum2
Bacteroides spp.2Mycobacterium kansasii2
Balneatrix alpica2Mycobacterium leprae3(V)
Bartonella spp. (except B. bacilliformis)2Mycobacterium malmoense3
Bartonella pertussis2(V)Mycobacterium marinum2
Bartonella bacilliformis3Mycobacterium microti3*
Beneckea spp.2Mycobacterium paratuberculosis2
Bergeyella zoohelcum2Mycobacterium scrofulaceum2
Bifidobacterium dentium2Mycobacterium simiae2
Bilophila wadsworthia2Mycobacterium szulgai3
Bordetella spp.2Mycobacterium tuberculosis3 (V)
Borrelia spp.2Mycobacterium ulcerans3*
Brachyspira spp.2Mycobacterium xenopi2
Brevibacterium spp.2Mycoplasma spp.2
Brevinema andersonii2Myroides spp.2
Brevundimonas diminuta2Neisserria spp.2
Brucella spp.3Neisseria meningitidis2 (V)
Burkholderia spp. (except B. mallei)2Nocardia spp.2
Burkholderia mallei3Nocardiopsis dassonvillei2
Burkholderia pseudomallei3Ochrobactrum anthropi2
Calymmatobacterium granulomatis2Oligella spp.2
Campylobacter spp.2Orientia tsutsugamushi3
Capnocytophaga spp.2Pasteurella spp.2
Cardiobacterium hominis2Peptococcus spp.2
Catonella morbi2Peptostreptococcus spp.2
Cedecea spp.2Photobacterium spp.2
Cellulomonas hominis2Plesiomonas shigelloides2
Centipeda periodontii2Porphyromonas spp.2
Chlamydia spp. (except C. psittaci, avian strains)2Prevotella spp.2
Chlamydia psittaci (avian strains)3Propionibacterium spp.2
Chlamydophila spp.2Proteus spp.2
Chromobacterium violaceum2Providencia spp2
Chryseobacterium spp.2Pseudomonas spp.2
Citrobacter spp.2Pseudoramibacter alactolyticus2
Clavibacter michiganensis2Psychrobacter phenylpyruvicus2
Clostridium spp.2Rhodococcus spp.2
Clostridium botulinum2 (T, V)Rickettsia spp.3
Clostridium tetani2 (T, V)Riemerella columbina2
Clostridium diphtheria2 (T, V)Rochalimaea spp.2
Comamonas terrigena2Saccharopolyspora rectivirgula2
Corynebacterium spp.2 (T. V)Salmonella spp.2
Coxiella burnetii3Salmonella Paratyphi A3*
Curtobacterium flaccumfaciens2Salmonella Paratyphi B/java3*
Dermatophilus congolensis2Salmonella Paratyphi C/Choleraesuis3*
Dialister pneumosintes2Salmonella typhi3* (V)
Dichelobacter nodosus2Selenomonas spp2
Dolosigranulum pigrum2Serpulina spp.2
Edwardsiella spp.2Serratia spp.2
Ehrlichia spp.2Serratia liquefaciens2
Ehrlichia sennetsu3Shewanella algae2
Eikenella corrodens2Shigella spp.2
Empedobacter brevis2Shigella dysenteriae (type 1)3(T)
Enterobacter spp.2Sphaerophorus necrophorus2
Enterococcus spp.2Sphingobacterium spp.2
Eperythrozoon spp.2Sphingomonas spp.2
Erwinia spp.2Spiroplasma mirum2
Erysipelothrix spp.2Sporichthya brevicatena2
Escherichia spp.2Staphylococcus spp.2
Escherichia coli verocytotoxigenic strains (eg. O157:H7)3(T)Staphylococcus aureus2(T)
Eubacterium spp.2Stenotrophomonas spp.2
Ewingella americana2Streptobacillus spp.2
Facklamia hominis2Streptococcus spp.2
Faenia rectivirgula2Streptomyces somaliensis2
Falcivibrio spp.2Sutterella wadsworthensis2
Elizabethkingia meningoseptica2Suttonella indoIogenes2
Flexibacter spp.2Tatlockia spp.2
Fluoribacter spp.2Tatumella ptyseos2
Francisella tularensis3 (Type A. V)Tissierella praeacuta2
Fusobacterium spp.2Treponema spp.2
Gardnerella vaginalis2Tsukamurella spp.2
Gemella spp.2Turicella otitidis2
Globicatella sanguinis2Ureaplasma spp.2
Gordonia spp.2Veillonella parvula2
Haemophilus spp.2Vibrio spp.2
Hafnia alvei2Vibrio cholera2 (T. V)
Hallella seregens2Waddlia chondrophila2
Helcococcus spp.2Yersinia spp. (except Y. pestis)2
Helicobacter spp.2Yersinia pestis3(V)
Johnsonella ignava2  
Jonesia denitrificans2  
*Routine diagnosis of M. tuberculosis infection based on microscopy, PCR and primary culture can be conducted under level 2 conditions, whereas culture manipulation for identification, drug-susceptibility testing and line probe assays on cultured isolates should be conducted under level 3 conditions.

Table 4:

Prescribed risk groups for viruses. This list pertains primarily to human pathogens, but also includes other viruses that may be frequently used in experimentation (for example baculovirus for protein expression) or veterinary pathogens that will be likely processed in medical laboratories (for example BSL 4 agents) (*unassigned species refer to species not specifically listed here) (in alphabetic order per family).
Biological agent Risk groupBiological agent Risk group
Adenoviridae (human, all types)2Lymphocytic choriomeningitis (non­neurotropic)2
Alphaviridae:Machupo4
Chikungunya3Mopeia3
Middelburg3Mobala3
Ndumu3Oliveros4
O'nyong-nyong3Parana4
Semliki forest3Pichinde4
Shuni3Tamiami4
Sindbis3Sabia4
Ross river3Putative arenaviridae species or unassigned species4
Eastern equine encephalitis4Astroviridae
Western equine encephalitis4Baculoviridae2
Venezuelan equine encephalitis4Birnaviridae2
Putative alphaviridae species or unassigned species*3Bornaviridae2
Arenaviridae (mammarenaviruses):Bunyaviridae:
Amapari2Bunyamwera3
Guanarito4California encephalitis3
Flexal3Crimean-Congo Haemorrhagic fever3**
Ippy3Hanta (all species)4 
Junin4Nairobi sheep disease3 
Lassa4Rift Valley fever3 
Lujo4Sandfly fever3 
Lymphocytic choriomeningitis (neurotropic)3St Floris3 
  Putative bunyaviridae species or unassigned species (not Hanta)3 
Caliciviridae: Japanese encephalitis3 
Hepatitis E2Kadam3 
Noro2Koutango3 
Sapo2Kokobera3 
Putative caliciviridae species or unassigned species2Kumlinge4 
Coronaviridae (human):2Kyasanur Forest4 
Severe acute respiratory syndrome-2 (SARS CoV2)3*(V)   
Severe acute respiratory syndrome (SARS) (or SARS-like) Middle Eastern respiratory syndrome (MERS) (or MERS-like)3Langat4 
Putative coronaviridae species or unassigned species2Looping ill4
Filoviridae:Murray Valley encephalitis3  
Ebola4Ntaya3 
Marburg4Negishi3 
Putative filoviridae species or unassigned species4San Perlita3
Flaviviridae:Spondweni3  
Absettarov4Omsk4 
Bagaza3Uganda S3 
Banzi3Usutu3 
Bouboui3Powassan3 
Central European encephalitis4Rocio3 
Dengue3Russian spring-summer encephalitis4 
Hanzalova4St Louis encephalitis3 
Hepatitis C2Tick-borne encephalitis4 
Hepatitis G3Wesselsbron3 
Hypr4West Nile (including Kunjin)3 
Israel turkey meningoencephalitis4Yellow fever, wild typeVaccine strain3(V)2 
Zika3Human metapneumo2 
Putative flaviviridae species or unassigned species3Hendra4 
Hepadnaviridae: Measles2(V) 
Hepatitis B2(V)Menangle2 
Hepatitis D2Mumps2 (V) 
Herpesviridae: Nipah4
Cytomegalo2Parainfluenza2
Epstein-Barr2Respiratory syncytial2
Herpes simplex2Rinderpest4
Herpes 6-82Sendai2 
Herpes simiae (Herpes B)4Parvoviridae:  
Varicella-zoster2(V)Parvovirus (Human B19)2
Human B-lymphotropic2Picornaviridae: 
Pseudorabies4Acute haemorrhagic conjunctivitis2
Putative herpesviridae species or unassigned species2Coxsackie2
Orthomyxoviridae: Echo2
influenza (human)2(V)Entero2
Avian influenza3Encephalomyocarditis2
Dhori3Hepatitis A2(V)
Tick-borne orthomyxo2Polio (Type 1, 3) (Type 2)2(V)3
Thoqoto3Poxviridae:2
Papovaviridae: Buffalopox2
JC/BK2Camelpox2
Papilloma2(V)Cowpox/Milker’s nodule virus2
Polyoma2Elephantpox2
Simian virus 40 (SV40)2Horsepox2
Paramyxoviridae: Goatpox2
Avian paramyxo2  
Biological agent Risk group
Molluscum contagiosum2
Monkeypox4
Orf2
Rabbitpox2
Variola (minor and major)4
Pseudopox2
Yatapox (Tana-and Yabapox)3
Reoviridae:
Bluetongue2
Colti2
Orbi (including Colorado tick fever)3
Reo2
Rota2(V)
Putative reoviridae species or unassigned species3
Retroviridae:
Human immunodeficiency3*
Human T-cell lymphotropic3
Simian Immunodeficiency3
Rhabdoviridae:
Bovine ephemeral fever3
Rabies2 (V)
Rabies related (including new, unassigned species)3
Vesicular stomatitis3
Putative rhabdoviridae species or unassigned species3
Togaviridae:
See alphaviruses 
Rubella2 (V)
* Biosafety level 2 conditions are applicable to clinical specimens and non-culture procedures. Biosafety level 3 conditions are required for all culture procedures.** Biosafety level 3 conditions are applicable to clinical specimens and non-culture procedures. Biosafety level 4 conditions are required for all culture procedures.

Annexure B (Regulations 10(2)(f), 11(4)(b) and 14(b))

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16 March 2022 this version
Published in Government Gazette 46051
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03 March 2022
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