"the 1978 Order" means the Health and Safety at Work (Northern Ireland) Order 1978;

"approved" means approved for the time being in writing;

"aerosol dispenser" means an article which consists of a non-reusable receptacle containing a gas compressed, liquefied or dissolved under pressure, with or without liquid, paste or powder and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state;

"blasting apparatus" means apparatus for cleaning, smoothing, roughening or removing of part of the surface of any article by the use as an abrasive of a jet of sand, metal shot or grit or other material propelled by a blast of compressed air or steam or by a wheel;

"CAS No." is the number assigned to a substance by the Chemical Abstract Service;

"cell culture" means the in-vitro growth of cells derived from multicellular organisms;

"diagnostic service" means any activity undertaken solely with the intention of - 

(a) testing for the presence of or identifying a biological agent,

(b) isolating or identifying other organisms from specimens or samples containing or suspected of containing a biological agent,

(c) analysing specimens or samples from a human patient or animal in which a biological agent is or is suspected of being present for purposes relating to the assessment of the clinical progress, or assistance in the clinical management, of that patient or animal,

and "diagnosis" shall be construed accordingly;

"Group" means one of the four hazard Groups specified in paragraph 3 to which biological agents are assigned.

Application
     2.  - (1) This Schedule shall have effect with a view to protecting employees against risks to their health, whether immediate or delayed, arising from exposure to biological agents except that paragraph 11 shall not apply in relation to a particular biological agent where the results of the assessment made under regulation 6 indicate that - 

(a) the activity does not involve a deliberate intention to work with or use that biological agent; and

(b) there is no significant risk to the health of employees associated with that biological agent.

    (2) Unless otherwise expressly provided, the provisions of this Schedule shall have effect in addition to and not in substitution for other provisions of these Regulations.

Classification of biological agents
     3.  - (1) The Executive shall approve for the purposes of this Schedule the document, and any revision or re-issue thereof, published by the Health and Safety Commission, entitled "Categorisation of Biological Agents according to hazard and categories of containment" containing a list of biological agents together with the classification of each agent which it has approved, and any reference in this Schedule to "approved classification" in relation to a particular biological agent shall be construed as a reference to the classification of that agent which appears in the said document.

    (2) Where a biological agent has an approved classification, any reference in these Regulations to a particular Group in relation to that agent shall be taken as a reference to the Group to which that agent has been assigned in that approved classification.

    (3) Where a biological agent does not have an approved classification, the employer shall provisionally classify that agent in accordance with sub-paragraph (4), having regard to the nature of the agent and the properties of which he may reasonably be expected to be aware.

    (4) When provisionally classifying a biological agent the employer shall assign that agent to one of the following Groups according to its level of risk of infection and, if in doubt as to which of two alternative Groups is the most appropriate, he shall assign it to the higher of the two - 

(a) Group 1 - unlikely to cause human disease;

(b) Group 2 - can cause human disease and may be a hazard to employees; it is unlikely to spread to the community and there is usually effective prophylaxis or treatment available;

(c) Group 3 - can cause severe human disease and may be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available;

(d) Group 4 - causes severe human disease and is a serious hazard to employees; it is likely to spread to the community and there is usually no effective prophylaxis or treatment available.

Assessment of health risks
     4. Without prejudice to the generality of regulation 6, every employer who intends to carry on any work which is liable to expose his employees to any biological agent shall take account of the Group into which that agent is classified when making an assessment of the risks created by that work.

Prevention of exposure to a biological agent
     5. Without prejudice to the generality of regulation 7(1), if the nature of the activity so permits, every employer shall ensure that the exposure of his employees to a particular biological agent is prevented by substituting a biological agent which is less hazardous.

Control of exposure to biological agents
     6.  - (1) Where there is a risk of exposure to a biological agent and it is not otherwise reasonably practicable to prevent that exposure then it shall be adequately controlled, in particular by the following measures which are to be applied in the light of the results of the assessment - 

(a) keeping as low as practicable the number of employees exposed or likely to be exposed to the biological agent;

(b) designing work processes and engineering control measures so as to prevent or minimise the release of biological agents into the place of work;

(c) displaying the biohazard sign shown in Part IV and other relevant warning signs;

(d) drawing up plans to deal with accidents involving biological agents;

(e) specifying appropriate decontamination and disinfection procedures;

(f) instituting means for the safe collection, storage and disposal of contaminated waste, including the use of secure and identifiable containers, after suitable treatment where appropriate;

(g) making arrangements for the safe handling and transport of biological agents, or materials that may contain such agents, within the workplace;

(h) specifying procedures for taking, handling and processing samples that may contain biological agents;

(i) providing collective protection measures and, where exposure cannot be adequately controlled by other means, individual protection measures including, in particular, the supply of appropriate protective clothing or other special clothing;

(j) where appropriate, making available effective vaccines for those employees who are not already immune to the biological agent to which they are exposed or are liable to be exposed;

(k) instituting hygiene measures compatible with the aim of preventing or reducing the accidental transfer or release of a biological agent from the workplace, including, in particular - 


(i) the provision of appropriate and adequate washing and toilet facilities, and

(ii) the prohibition of eating, drinking, smoking and application of cosmetics in working areas where there is a risk of contamination by biological agents.

    (2) In this paragraph, "appropriate" in relation to clothing and hygiene measures means appropriate for the risks involved and the conditions at the place where exposure to the risk may occur.

Special control measures for health and veterinary care facilities
     7. In health and veterinary care isolation facilities where there are human patients or animals which are, or are suspected of being, infected with a Group 3 or Group 4 biological agent, the employer shall select the most suitable containment measures from those listed in Part II with a view to controlling adequately the risk of infection.

Special control measures for laboratories, animal rooms and industrial processes
     8.  - (1) Every employer who is engaged in any of the activities specified in sub-paragraph (3) shall ensure that measures taken to control adequately the exposure of his employees to biological agents include, in particular, the most suitable combination of containment measures from those listed in Parts II and III as specified in paragraph (2), taking into account - 

(a) the nature of the activity specified in sub-paragraph (3);

(b) the minimum containment level specified in sub-paragraph (4);

(c) the assessment of risk made under regulation 6; and

(d) the nature of the biological agent concerned.

    (2) An employer who is engaged in - 

(a) any of the activities specified in sub-paragraph (3)(a) or (b) shall select measures from Part II;

(b) the activity specified in sub-paragraph (3)(c) shall select measures from Part III and, subject to sub-paragraph (4), when making that selection he may combine measures from different categories of containment on the basis of a risk assessment related to any particular process or part of a process.

    (3) The activities referred to in sub-paragraph (1) are - 

(a) research, development, teaching or diagnostic work in laboratories which involves the handling of a Group 2, Group 3 or Group 4 biological agent or material containing such an agent;

(b) keeping or handling of laboratory animals which have been deliberately infected with a Group 2, Group 3 or Group 4 biological agent or which are, or are suspected of being, naturally infected with such an agent; and

(c) industrial processes which involve the use of a Group 2, Group 3 or Group 4 biological agent.

(4) The minimum containment level referred to in sub-paragraph (1) shall be - 

(a) level 2 for activities involving the handling of a Group 2 biological agent;

(b) level 3 for activities involving the handling of a Group 3 biological agent;

(c) level 4 for activities involving the handling of a Group 4 biological agent;

(d) level 2 for laboratories which do not intentionally work with biological agents but handle materials in respect of which there exist uncertainties about the presence of a Group 2, Group 3 or Group 4 biological agent;

(e) level 3 or 4, where appropriate, for laboratories which do not intentionally work with biological agents but where the employer knows or suspects that such a containment level is necessary; except where guidelines approved by the Executive indicate that, in the particular case, a lower containment level is appropriate; and

(f) level 3 for activities where it has not been possible to carry out a conclusive assessment but concerning which it appears that the activity might involve a serious health risk for employees.

Examination and maintenance of personal protective equipment
     9.  - (1) Every employer who provides personal protective equipment, including protective clothing, to meet the requirements of these Regulations as they apply to biological agents shall ensure that it is - 

(a) properly stored in a well-defined place;

(b) checked and cleaned at suitable intervals; and

(c) when discovered to be defective, repaired or replaced before further use.

    (2) Personal protective equipment which may be contaminated by biological agents shall be - 

(a) removed on leaving the working area; and

(b) kept apart from uncontaminated clothing and equipment.

    (3) The employer shall ensure that the equipment referred to in sub-paragraph (2) is subsequently decontaminated and cleaned or, if necessary, destroyed.

Information for employees
     10.  - (1) Every employer shall provide written instructions at the workplace and, if appropriate, display notices which shall include the procedure to be followed in the case of - 

(a) an accident or incident which has or may have resulted in the release of a biological agent which could cause severe human disease;

(b) the handling of a Group 4 biological agent or material that may contain such an agent.

    (2) Every employee shall report forthwith, to his employer or to any other employee of that employer with specific responsibility for the health and safety of his fellow employees, any accident or incident which has or may have resulted in the release of a biological agent which could cause severe human disease.

    (3) Every employer shall inform his employees or their representatives - 

(a) forthwith, of any incident which has or may have resulted in the release of a biological agent which could cause severe human disease; and

(b) as soon as practicable thereafter, of - 


(i) the causes of such an accident or incident, and

(ii) the measures taken or to be taken to rectify the situation.

List of employees exposed to certain biological agents
     11.  - (1) Subject to paragraph 2(1), every employer shall keep a list of employees exposed to a Group 3 or Group 4 biological agent, indicating the type of work done and, where known, the biological agent to which they have been exposed, and records of exposures, accidents and incidents, as appropriate.

    (2) Subject to sub-paragraph (3), the list shall be kept for at least 10 years following the last known exposure of the employee concerned.

    (3) In the case of those exposures which may result in infections - 

(a) with biological agents known to be capable of establishing persistent or latent infections;

(b) that, in the light of present knowledge, are undiagnosable until illness develops many years later;

(c) that have particularly long incubation periods before illness develops;

(d) that result in illnesses which recrudesce at times over a long period despite treatment; or

(e) that may have serious long-term sequelae,

the list shall be kept for 40 years following the last known exposure.

    (4) The employment medical adviser or appointed doctor referred to in regulation 11, and any employee of that employer with specific responsibility for the health and safety of his fellow employees, shall have access to the list.

    (5) Each employee shall have access to the information on the list which relates to him personally.

Notification of the use of biological agents
     12.  - (1) Subject to sub-paragraphs (5) and (6), an employer shall not store or use for the first time one or more biological agents in Group 2, 3 or 4 at particular premises unless he has notified the Executive in writing of his intention to do so at least 30 days in advance or before such shorter time as the Executive may approve and with that notification has furnished the particulars specified in sub-paragraph (3).

    (2) Subject to sub-paragraphs (5) and (7), notification in accordance with sub-paragraph (1) shall also be made of the storage or use for the first time of - 

(a) each subsequent biological agent where that agent is specified in Part V;

(b) each subsequent Group 3 biological agent where that agent does not have an approved classification.

    (3) The particulars to be included in the notification referred to in sub-paragraphs (1) and (2) shall be - 

(a) the name and address of the employer and the address of the premises where the biological agent will be stored or used;

(b) the name, qualifications and relevant experience of any employee of that employer with specific responsibility for the health and safety of his fellow employees;

(c) the results of the assessment made under regulation 6;

(d) the Group to which the biological agent has been assigned and, if the agent is specified in Part V or is a Group 3 agent which does not have an approved classification, the identity of the agent; and

(e) the preventive and protective measures that are to be taken.

(a) that authority;

(b) an inspector appointed under Article 21 of the 1978 Order, if that inspector so requires; and

(c) where the fumigation - 


(i) is to be carried out on a sea-going ship, the Fire Authority for Northern Ireland and the officer in charge of the office of Her Majesty's Customs and Excise at the harbour, or

(ii) is the space fumigation of a building, the Fire Authority for Northern Ireland.

     2. In the case of a fumigation, other than a fumigation to which paragraph (1) applies, advance notification of fumigation shall be given to - 

(a) the sub-divisional commander of the Royal Ulster Constabulary for the sub-division in which the fumigation is to be carried out;

(b) an inspector appointed under Article 21 of the 1978 Order, if that inspector so requires; and

(c) where the fumigation is to be carried out on a sea-going ship or is the space fumigation of a building, the Fire Authority for Northern Ireland.

(a) the name, address and place of business of the fumigator and his telephone number;

(b) the name of the person requiring the fumigation to be carried out;

(c) the address and description of the premises where the fumigation is to be carried out;

(d) the date on which the fumigation is to be carried out and the estimated time of commencement and completion;

(e) the name of the operator in charge of the fumigation; and

(f) the fumigant to be used.

(a) are consistent with the provisions of - 


(i) Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (OJ No. L237, 3.12.80, p. 8),

(ii) Commission Directive 91/322/EEC (OJ No. L177, 5.7.91, p. 22) on establishing indicative limit values by implementing Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work,

(iii) Commission Directive 96/94/EC (OJ No. L338, 28.12.96, p. 86) establishing a second list of indicative limit values by implementing Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work;



(b) implement as respects Northern Ireland - 



(i) Council Directive 78/610/EEC (OJ No. L197, 22.7.78, p. 12) on the approximation of the laws, regulations and administrative provisions of the Member States on the protection of the health of workers exposed to vinyl chloride monomer,

(ii) Council Directive 88/364/EEC (OJ No. L179, 9.7.1988, p. 44) on the protection of workers by the banning of certain specified agents and/or certain work activities (fourth individual directive within the meaning of Article 8 of Directive 80/1107/EEC),

(iii) point 3 of Article 1 of Council Directive 89/677/EEC (OJ No. L398, 30.12.89, p. 19) amending for the 8th time the Marketing and Use Directive in so far as that point relates to the supply or use of benzene and substances containing benzene for such purposes,

(iv) Council Directive 90/394/EEC (OJ No. L196, 26.7.90, p. 138) on the protection of workers from the risks related to exposure to carcinogens at work (sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) insofar as it relates to carcinogens other than asbestos,

(v) Council Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work (OJ No. L374, 31.12.90, p. 1), and

(vi) that part of Commission Directive 96/55/EC (OJ No. L231, 12.9.96, p. 20) adapting to technical progress for the 2nd time Annex I to Council Directive 76/769/EEC ("the Marketing and Use Directive") (OJ No. L262, 27.9.76, p. 201) on the approximation of the laws, regulations and administrative provisions of the Member States relating to restriction on the marketing and use of certain dangerous substances and preparations which relates to supply of specified substances for use at work.

     3. In addition to minor and drafting amendments, the Regulations make the following changes of substance - 

(a) provide for the approval by the Health and Safety Executive for Northern Ireland of maximum exposure limits for substances in place of the provisions previously contained in Schedule 1 to the 1995 Regulations (regulation 2(1));

(b) include certain further definitions (regulation 2(1));

(c) require personal protective equipment provided by an employer in pursuance of these Regulations to comply with the Personal Protective Equipment (EC Directive) Regulations (regulation 7(5)); and

(d) revoke those Regulations mentioned in paragraph (1) of regulation 18 (regulation 18).

     4. Copies of the publications mentioned in the Regulations are obtainable as follows - 

(a) a list of the maximum exposure limits and occupational exposure standards which the Health and Safety Executive for Northern Ireland has approved is available in the publication "EH 40, Occupational Exposure Limits" obtainable from HSE Books, PO Box 1999, Sudbury, Suffolk CO10 6FS; and

(b) the British Standards referred to in Part II of Schedule 3 (relating to safety cabinets) are obtainable from (by personal callers only) the British Standards Institution, 2 Park Street, London W1A 2BS or (by post) from the British Standards Institution, Linford Wood, Milton Keynes, MK14 6LE.

     5. The numbers assigned to substances by the Chemical Abstract Service and referred to in Schedule 2 are given in the CAS Registry Handbook, ISSN 0093-058X, which may be inspected at the Royal Society of Chemistry, Burlington House, Piccadilly, London W1V 0BN. Details of how to obtain copies of the handbook on microfilm or microfiche may be obtained from the CAS customer website at: http://www.cas.org/Support/custserv.html.

     6. In Great Britain, the corresponding Regulations are the Control of Substances Hazardous to Health Regulations 1999 (S.I. 1999/437). Copies of the cost benefit assessments relating to those Regulations together with a Northern Ireland Supplement are held at the offices of the Health and Safety Executive for Northern Ireland at 83 Ladas Drive, Belfast BT6 9FR from where copies may be obtained on request.

     7. A person who contravenes these Regulations or any requirement or prohibition imposed thereunder, is guilty of an offence under Article 31 of the Health and Safety at Work (Northern Ireland) Order 1978 and is liable, on summary conviction, to a fine not exceeding the statutory maximum (currently £5,000) or, on conviction on indictment, to a fine.