Basic Measures to be taken for Activities involving Biological Agents
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1 Technical Rules for Biological Agents Basic Measures to be taken for Activities involving Biological Agents Edition: April 2012 TRBA 500 The Technical Rules for Biological Agents (TRBA) reflect the state of technology, occupational health and occupational hygiene as well as other sound scientific knowledge relating to activities involving biological agents including their classification. The Committee on Biological Agents (ABAS) establishes or adapts the rules and they are announced by the Federal Ministry of Labour and Social Affairs (BMAS) in the Joint Ministerial Gazette (GMBl). Contents 1 Scope 2 Definitions 3 Risk assessment 4 Protective measures 5 More extensive literature and information sources Annexes 1 Scope (1) The present TRBA describes basic measures to be applied during activities involving biological agents. They ensure a minimum protection for workers during activities involving biological agents with respect to their infectious, toxic and sensitising properties. (2) If the risk assessment reveals that the measures under this TRBA do not adequately ensure protection of the health of workers, more extensive protective measures will be necessary. (3) If sector-specific and process-specific measures are laid down in other TRBA (see these shall be considered as having priority. 2 Definitions 2.1 Biological agents The term biological agents is conclusively defined in BioStoffV. It concerns certain parasites and micro-organisms such as bacteria, fungi and viruses which may cause infections, or sensitising and toxic effects in human beings. Under Section 3 BioStoffV they are classified into four risk groups according to the infection risk they present.
2 2 2.2 Basic measures Basic measures within the meaning of this TRBA should be taken to mean hygienic measures intended to protect workers from biological agents. Hygienic measures include not only measures of personal bodily hygiene, but also structural, technical, organisational and personal protective measures to reduce the contamination of the air, materials, products or surfaces by biological agents with the aim of preventing infections, and sensitising and toxic effects. 2.3 Bioaerosols Bioaerosols are airborne particles and droplets of biological origin which may influence the health of humans by infectious, allergic or toxic action. 3 Risk assessment 3.1 Principle According to the Biological Agents Ordinance (BioStoffV) a risk assessment must be conducted for any activity involving biological agents. A major basic element of the risk assessment is the adequate gathering of information. Within the framework of the risk assessment infectious, sensitising and toxic effects must be considered. Specific instructions and examples are given in TRBA 400 Guidelines for risk assessment and for the instruction of employees in relation to activities with biological agents. 3.2 Risks Biological agents can cause health risks to humans (infections, and sensitising and toxic effects). The condition for this is the exposure to the relevant biological agents. Infections are normally only triggered by biological agents of risk group 2. In the case of activities involving biological agents of risk group 1 infections may occur in humans with reduced immune defence. Infections are also possible with exposure to very high concentrations of biological agents of risk group 1 or if such agents pass into the bloodstream. Sensitising and toxic effects of biological agents are not taken into account when they are classified into risk groups. The corresponding risks must be included separately in the risk assessment. The sensitising biological agents include moulds, certain bacteria (including thermophile actinomycetes) and several parasites. Toxic effects can be caused by metabolic products and cellular constituents of biological agents. Examples include endotoxins from bacteria and mycotoxins from moulds. Even if activities involving biological agents are allocated to protection level 1 because of a lack of or only low infection risk, sensitising and toxic risks may be present which render it necessary to take structural, technical, organisational or personal protective measures to minimise the corresponding risk. 3.3 Intake routes For activities involving biological agents various intake routes must be considered: Intake through the respiratory tracts Bioaerosols can be inhaled because of their size. They can become deposited in all parts of the lungs as far as the pulmonary alveoli.
3 3 Oral intake Contact between the mouth and soiled hands, gloves or objects (smear infection). Eating, drinking or smoking without prior thorough washing of the hands. Intake through the skin or the mucous membranes In particular injuries and pre-existing skin changes such as eczema enable biological agents to penetrate the body. Softened skin during wet work or dry and cracked skin as well as splashes in the eyes or on the oral mucous membrane must also be taken into account as an entry point. 3.4 Examples of activities involving possible exposure Open pouring, decanting, mixing or grading of substances or products which may be colonized or contaminated by biological agents Delivery, storage and transport of materials which may be contaminated or colonised by microbes Activities during the cleaning, servicing, inspection or maintenance in areas colonised or contaminated by microbes Cleaning of sanitary areas Street cleaning Agriculture and forestry Viticulture and horticulture Soil working Removal and disposal of materials with microbial contamination Spraying processes, high-pressure cleaning Handling industrial and circulating water Servicing of cooling lubricant systems Work on ventilation and air-conditioning systems Improper removal of protective clothing Activities involving contact with animals or vermin and their excretions (e.g. absorption via animal excreta and animal excreta dust, bite, sting and scratch wounds caused by animals) The list is not exhaustive. Depending on the operational circumstances exposures are also possible during other activities. 4 Protective measures 4.1 General (1) If it is found during the risk assessment that risks are present, the employer shall first take the necessary technical and structural measures as well as organisational measures. This also applies when the activities are allocated to protection level 1 because of a lack of or low risk of infection, but there are sensitising or toxic risks. In addition it may be necessary to use personal protective equipment. Any deviation from the priority of the protective measures must be justified in the risk assessment. (2) The required protective measures and rules of conduct and instructions on behaviour in the case of accidents and operational malfunctions, and on first aid must be laid down in the operating instructions (for an example see Annex 2) (3) The employer is obliged to give workers regular instruction with reference to the operating instructions on the potential dangers to health, the implementation of the protective measures taken and the wearing of personal protective equipment. The instruction given
4 4 must be in a form and language comprehensible to the workers. The measures taken and courses of instruction given must be documented. (4) The measures described in this TRBA must be selected and adapted in accordance with the respective sector and the operational situation. (5) In the case of activities for which there are specific TRBA these must be implemented as a matter of priority. 4.2 Technical and structural measures (1) Work equipment (machines, operating devices), floors and walls in the working area must be easy to clean. (2) State-of-the-art working procedures must be used which result in the avoidance or reduction of bioaerosols. The state of the art includes, among other things, spatial separation of polluted and unpolluted areas, room ventilation and air-conditioning measures, enclosure and extraction at the release location, binding dust using mist technique, enclosed transport routes for dust-producing bulk materials, use of vacuum cleaners of dust class H, where relevant with preseparator central vacuum cleaning systems with pipe connections into the working areas. If this does not result in adequate reduction further protective measures must be taken. (3) Easily accessible washing facilities with running water, devices for hygienic hand-drying and suitable skin protection and care agents must be kept ready. There must also be the opportunity for hygienic hand-cleaning and drying at mobile and remote workplaces. (4) Where necessary according to the risk assessment, washrooms or shower facilities must be provided. The reasons for installing a washroom may include, for example, activities involving heavy soiling or major odour pollution. (5) Changing facilities which are separate from the workplace must be provided. (6) Facilities for keeping and taking food and drinks during breaks must be created which are separate from the workplace. 4.3 Organisational measures The employer must ensure that the following measures are taken. For this purpose he must provide workers with sufficient time and opportunity. (1) The number of workers exposed to or possibly exposed to biological agents must be limited to the extent necessary to perform the task. (2) Fundamental hygienic measures must be provided for. This includes washing hands prior to commencing breaks and when ending the activities; furthermore cleaning the workplace regularly and as required and cleaning/changing work clothing and personal protective equipment. The measures taken must be recorded in a cleaning and hygiene plan (for an example see Annex 1).
5 5 Workers may not consume any food or beverages at workplaces where there is a risk of contamination by biological agents. The areas installed under number 4.2 (6) must be used for this purpose. Where disinfection measures are required according to the risk assessment they must be performed using tested disinfectants. (3) Rooms for breaks and standby purposes may not be entered wearing work clothing which is microbially contaminated. (4) Waste products involving biological agents must be collected in suitable containers. (5) Work clothing and personal protective equipment must be kept separately from personal clothing. (6) Clothing which is microbially contaminated may not be cleaned at home. (7) Where personal clothing is worn as work clothing and there is the possibility of microbial contamination at work, paragraphs (3), (5) and (6) shall apply accordingly. (8) Where vermin such as rodents, pigeons, insects and other animals are to be found in the working area, regular pest control must be carried out. (9) Storage conditions which encourage reproduction of biological agents must be avoided where this is possible given the operational circumstances. (10) In accordance with the risk assessment care must be taken to ensure adequate ventilation of the working area. 4.4 Personal protective equipment (1) In individual cases personal protective equipment must be worn as a result of the risk assessment. (2) The necessary personal protective equipment (e.g. hand protection, protective clothing, protective shoes, eye protection/face protection, particle-filtering respirator) must be used in conformity with the intended application on the basis of the instruction given. (3) It must be ensured that the wearing time limits for personal protective equipment are adhered to. (4) Personal protective equipment must be maintained after use and, if necessary, replaced in order to avoid additional exposure to microbial contamination of the personal protective equipment.
6 6 5 Further reading and information sources Acts and Ordinances Biological Agents Ordinance (Ordinance on safety and health protection at work involving biological agents BioStoffV) Ordinance on Occupational Health Care (ArbMedVV) Protection against Infections Act (IfSG) Technical Rules for Biological Agents (selection) TRBA 001 General remarks and structure of the technical regulations for the Biological Agents Ordinance Use of Technical Rules for Biological Agents (TRBA) TRBA 100 Protective measures for specific and non-specific activities involving biological agents in laboratories TRBA 120 Keeping of laboratory animals TRBA 214 Waste treatment installations including grading installations in the waste management industry TRBA 220 Safety and health for activities involving biological agents in sewage plants TRBA 230 Protective measures for activities involving biological agents in agriculture and forestry and comparable activities TRBA 240 Protective measures for activities involving microbially contaminated archive materials TRBA 250 Biological agents in health care and in welfare facilities TRBA 400 Guidelines for risk assessment and for the instruction of employees in relation to activities with biological agents TRBA/TRGS 406 Sensitising substances for the respiratory tracts BG/GUV Rules and Information sheets BGR 189 Use of protective clothing BGR 190 Use of respiratory protective equipment BGR 192 Use of eye and face protection BGR 195 Use of protective gloves BGR 206 Disinfection work in healthcare facilities BGR 208 Protecting cleaners from infection risks in healthcare facilities BGI 583 Biological agents during soil remediation BGI 762 Germ exposure from water-mixed cooling lubricants Practical guide according to the Biological Agents Ordinance BGI 805 Activities involving biological agents in the metal industry BGI 853 User instructions as specified in the Biological Agents Ordinance BGI 858 Health risks due to biological agents during the reconstruction of buildings BGI 5026 Biological agents during the handling of deceased persons BGI 5068 Practical guide to the risk assessment when providing and cleaning mobile rented toilets BGI/GUV-I 8620 General preventive guidelines for skin protection DGUV "List of regulations, rules and information relating to biological products", see: Information portals Federal Institute for Occupational Safety and Health German Statutory Accident Insurance Robert Koch-Institute
7 7 Other sources Progress report of ABAS "Significance of mycotoxins in the context of the workplacerelated risk assessment " ( Arbeitsstoffe/ABAS/aus-dem-ABAS/pdf/Bedeutung-von-Mykotoxinen.pdf ) Progress report of ABAS "Irritative-toxic effects of airborne biological agents taking the example of endotoxins" ( Arbeitsstoffe/ABAS/aus-dem-ABAS/pdf/Endotoxinpapier.pdf )
8 8 Annex 1: Example of cleaning and hygiene plan A fit-for-use cleaning and hygiene plan normally contains in tabular form all the measures of personal and object-related hygiene in an easily manageable form. All the necessary details of the agents to be used, the action times, the frequencies and the respective target group must be entered. More complex cleaning tasks can be included in addition in the form of a set of instructions. The content of the cleaning and hygiene plan must be made known to the persons affected in a suitable fashion (notice and course of instruction). The example shown can be rearranged according to the operational and personal circumstances. What Who When How With what Hand cleaning (where no hygienic hand disinfection is carried out) Skin protection and skin care Hygienic hand disinfection all all all after soiling before and after toilet use before breaks or before handling foodstuffs as required before dirty and wet jobs after washing hands several times a day Washbasin and toilet cleaning personnel responsible daily or as required Surface cleaning Floors, working surfaces (e.g. tables), other contact surfaces (e.g. door handles) Preparation of cleaning utensils (e.g. cleaning cloths, mop covers) Cleaning of work clothing personnel responsible personnel responsible hired laundry service after contact with potentially infectious or microbially contaminated material or surfaces (e.g. bodily secretions or blood, soiled toilet seats etc.) daily or as required daily or as required In the case of visible soiling at least weekly Apply liquid soap from dispenser to wet hands and rub in for approx. 20 to 30 seconds, rinse thoroughly and dry carefully with disposable towels. Massage into the skin after removal from the dispensing bottle or tube. Remove sufficient quantity of disinfectant (approx. 3.5 ml) from the dispenser and rub into dry hands for approx. 30 seconds. Do not use water. Moist wipe method, where necessary wipe off with disinfectant Moist (or wet) wipe method, where necessary wipe off with disinfectant Wash in the washing machine at at least 60 C and dry. of washing lotion of skin protection and skin care product of disinfectant concentration action time of cleaning agent concentration action time of cleaning agent concentration action time of domestic washing powder, hygienic rinse Room ventilation individual workers 4 times a day and as required inrush airing through the window
9 10 Number: Person responsible: OPERATING INSTRUCTIONS according to Section 12 BioStoffV Scope and Activities Cleaning of Buildings Annex 2: Example of Operating Instructions HAZARDS FOR WORKERS During general or special cleaning jobs in buildings workers come into contact with biological agents such as bacteria, viruses and/or moulds. The contact with biological agents may lead to infections and may have sensitising and toxic effects. The hazards may be: penetration through the mucous membranes (eye, mouth and nose mucous membranes) penetration through damaged skin (e.g. dermatitis) and wounds intake by inhalation (lung) intake by swallowing (gastrointestinal tract) hazards due to microbially infested or contaminated areas (e.g. mould-infested areas, waste bags) needle-stick and cutting injuries contact with sick adults and children or their excretions or sputum while removing waste from or cleaning sanitary installations of child day-care centres additional hazards: hazard from cleaning agent (hazardous substance), also including intake via the intake routes mentioned above, wet work, danger of slipping on wiped surfaces. PROTECTIVE MEASURES AND RULES OF CONDUCT If there is contact with biological agents during cleaning work care must be taken to ensure that the protective gloves used not only provide protection against chemicals (again cleaning agents) but also provide protection against biological agents (see pictograms on the protective glove) Before and during the work, use skin protection agents, and after the work skin care agents (skin protection plan) Before starting a break wash hands thoroughly with skin cleaning agents provided, and if necessary also disinfect them (risk assessment) Existing wounds must be adequately cared for (where relevant by cleaning, application of a plaster etc.) In the case of cleaning jobs in areas with an elevated risk of the intake of biological agents via the air breathed (e.g. when mould is released) respiratory protective equipment must be worn Soiled clothing may not be washed in the private domain Damaged personal protective equipment must be rejected and replaced immediately Work clothing must be replaced regularly and as required in accordance with the cleaning and hygiene schedule CONDUCT IN THE CASE OF DANGER In the case of injuries, tend to the wound immediately and give notification of the incident Accident telephone: FIRST AID Emergency number: 112 First Aid person: Establishment: as at: Date: Next inspection date: Signature: Employer/Company Management
10 Number: Person responsible: 11 Annex 2: Example of Operating Instructions OPERATING INSTRUCTIONS according to Section 12 BioStoffV Scope and Activities Horticultural and Soil Working HAZARDS FOR THE WORKERS During soil working workers come into contact with the micro-organisms in the soil and in substrates. Hazards for a person may be: Penetration of micro-organisms into the skin or the bloodstream (e.g. due to injuries including very small ones) Intake of micro-organisms via the mouth stomach intestine, respiratory tracts Pollution of organic fertilizers (e.g. poultry dung) by bacteria Pollution from dusts from organic fertilizers (e.g. horn shavings, dried blood) Additional hazards: glass splinters, plastics, metal from residues in, for example, composted soil which may cause injuries PROTECTIVE MEASURES AND RULES OF CONDUCT When handling soils and substrates, wear protective gloves and solid footwear Before and during the work, use skin protection agents, and after work use skin care agents (skin protection plans) Before starting breaks, wash hands In the case of existing wounds ensure safe care and dressings (dressing, plaster) Care for new injuries, including very small ones, immediately (plaster) Minimise dust developments at work by wetting During dust-intensive jobs or when using special additives, use respiratory protective equipment Indicate tetanus immunisation Ensure and use hand cleaning facilities on site CONDUCT IN THE CASE OF DANGER Replace damaged protective equipment In the case of injuries, stimulate wound to blood, care for wound In the case of injuries, if necessary consult a doctor FIRST AID Emergency number: 112 First Aid person: Establishment: as at: Date: Next inspection date: Signature: Employer/Company Management
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