Law 31/1995 of 8 November. In the case of the prevention of occupational hazards, the basic body of guarantees and responsibilities is determined to establish an adequate level of protection of the health of workers in the face of the risks arising from working conditions, in the the framework of a coherent and effective policy. According to Article 6 of the Directive, the regulatory standards will be those which will be laid down and the most technical aspects of preventive measures.

Thus, it is the regulatory development rules that should set the minimum measures to be taken for the proper protection of workers. These include those aimed at ensuring the protection of workers from the risks related to exposure to biological agents during work.

In the same sense, it must be borne in mind that, at the level of the European Union, criteria of a general nature on health and safety measures in the institutions have been set out in the relevant Directives. as well as specific criteria for measures to protect against accidents and situations of risk. In particular, Directive 90 /679/EEC of 26 November on the protection of workers from the risks related to exposure to biological agents at work lays down the minimum specific provisions in this field; This Directive was subsequently amended by Directive 93 /88/EEC of 12 October and adapted to technical progress by Directive 95 /30/EC of 30 June. This Royal Decree provides for the transposition into Spanish law of the content of the three Directives mentioned above.

In its virtue, pursuant to Article 6 of Law 31/1995. On 8 November, on the proposal of the Ministers of Labour and Social Affairs and of Health and Consumer Affairs, the most representative employers ' and trade unions were consulted. the National Committee on Health and Safety at Work, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 9 May 1997,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object and scope of application.

1. This Royal Decree aims, in the framework of Law 31/1995, of 8 November, on the Prevention of Occupational Risks, the protection of workers from the risks to their health and safety arising from exposure to workers. biological during work, as well as the prevention of such risks.

2. This Royal Decree lays down the minimum requirements for the activities in which workers are or may be exposed to biological agents due to the nature of their work.

3. The provisions of Royal Decree 39/1997 of 17 January 1997 on the Regulation of the Prevention Services shall apply in full to the whole of the field referred to in the preceding paragraph, without prejudice to the provisions rigorous or specific provisions of this Royal Decree.

4. This Royal Decree shall apply without prejudice to the provisions of Law 15/1994 of 3 June establishing the legal system for the contained use, voluntary release and placing on the market of modified organisms in order to prevent risks to human health and the environment.

Article 2. Definitions.

For the purposes of this Royal Decree:

(a) Biological agents: micro-organisms, including genetically modified organisms, cell cultures and human endoparasites, susceptible to any type of infection, allergy or toxicity.

(b) Microorganism: any microbiological entity, whether cellular or not, capable of reproducing or transferring genetic material.

c) Cell culture: the result of "in vitro" growth of cells obtained from multicellular organisms.

Article 3. Classification of biological agents.

1. For the purposes of this Royal Decree, biological agents are classified, depending on the risk of infection, in four groups:

a) Group 1 biological agent: the one that is unlikely to cause a disease in man.

b) Group 2 biological agent: the one that can cause a disease in man and can pose a danger to the workers, being unlikely to spread to the community and existing generally prophylaxis or effective treatment.

c) Group 3 biological agent: the one that can cause a serious disease in man and presents a serious danger to workers, with the risk of spreading to the community and generally existing prophylaxis or effective treatment.

d) Group 4 biological agent: the one causing a serious illness in man poses a danger to workers, with many chances of spreading to the community and without there being generally a prophylaxis or effective treatment.

2. A list of biological agents, classified in groups 2, 3, or 4, is presented in Annex II to this Royal Decree, following the criterion set out in the previous section. Additional preventive utility information is also provided for certain agents.

For the correct use of this list, the introductory notes contained in that Annex shall be taken into account.

CHAPTER II

Obligations of the employer

Article 4. Identification and risk assessment.

1. In accordance with the provisions of Article 2 of Royal Decree 39/1997 of 17 January on the Regulation of the Prevention Services, identified one or more risks related to exposure to biological agents during the course of the work will be carried out, for those who have not been able to avoid, to evaluate the same by determining the nature, degree and duration of the workers ' exposure.

In the case of work involving exposure to several categories of biological agents, the risks shall be assessed on the basis of the danger posed by all biological agents present.

2. This assessment shall be repeated periodically and in any case whenever a change in conditions which may affect the exposure of workers to biological agents occurs.

A new risk assessment shall also be carried out when an infection or disease suspected to be a result of exposure to biological agents at work has been detected in any worker.

3. The assessment referred to in the preceding paragraph shall be carried out taking into account all available information and in particular:

(a) The nature of the biological agents to which the workers and the group they belong may be exposed, in accordance with the table and classification criteria set out in Annex II. If an agent does not appear in the table, the employer shall, after consulting the employees ' representatives, estimate his risk of infection taking into account the definitions laid down in the first paragraph of Article 3 of this Royal Decree, for the purposes of provisionally assimilating it to those included in one of the four groups provided for therein. In case of doubt between two groups it must be considered in the higher hazard.

(b) The recommendations of the health authorities on the desirability of controlling the biological agent in order to protect the health of workers who are or may be exposed to such an agent by reason of their work.

(c) Information on diseases likely to be contracted by workers as a result of their professional activity.

d) The potential effects, both allergic and toxic, that may result from the professional activity of the workers.

e) The knowledge of a disease that has been detected in a worker and is directly linked to his or her work.

f) The additional risk for those workers especially sensitive according to their personal characteristics or known biological status, due to circumstances such as previous pathologies, medication, disorders immune, pregnancy or breast-feeding.

4. If the results of the assessment show that the exposure or possible exposure relates to a group 1 biological agent which does not present a known risk to the health of workers, Articles 5 to 15 of the Directive shall not apply. This Royal Decree. However, the provisions of paragraph 1 of the preliminary remark in Annex V shall be observed.

5. If the results of the assessment reveal that the activity does not involve the deliberate intention to manipulate biological agents or to use them at work but may lead to the exposure of workers to such agents, the provisions of Articles 5 to 13 of this Royal Decree, unless the results of the assessment make it unnecessary.

6. Annex 1 to this Royal Decree contains an indicative list of activities in which the provisions of the previous paragraph might apply.

Article 5. Replacement of biological agents.

Taking into account the available technical and scientific information, the employer shall, where the nature of the activity so permits, avoid the use of dangerous biological agents by replacing them with three agents which, depending on the conditions of use, they are not hazardous to the safety or health of workers, or to a lesser extent.

Article 6. Risk reduction.

1. If the results of the assessment referred to in Article 4 show a risk to the safety and health of workers from exposure to biological agents, that exposure shall be avoided. Where this is not feasible for technical reasons, taking into account the activity carried out, the risk of exposure to the lowest possible level shall be reduced to adequately ensure the safety and health of the workers concerned, By means of the following measures:

a) Establishment of appropriate work procedures and use of appropriate technical measures to prevent or minimize the release of biological agents in the workplace.

b) Reduction, to the minimum possible, of the number of workers who are or may be exposed.

c) Adoption of safe measures for the reception, handling and transport of biological agents within the workplace.

(d) Adoption of collective protection measures or, failing that, individual protection, where the exposure cannot be avoided by other means.

e) Use of secure means for the collection, storage and disposal of waste by workers, including the use of safe and identifiable containers, after appropriate treatment if necessary.

f) Use of hygiene measures that prevent or hinder the dispersion of the biological agent outside the workplace.

g) Use of a biological hazard signal as indicated in Annex III to this Royal Decree, as well as other relevant warning signs.

h) Establishment of plans to deal with accidents that may result from exposures to biological agents.

i) Verification, where necessary and technically possible, of the presence of the biological agents used in the work outside the primary physical confinement.

2. The risk assessment referred to in Article 4 shall identify those workers for whom special protective measures may be necessary.

Article 7. Hygienic measures.

1. In all activities where there is a risk to the health or safety of workers as a result of work with biological agents, the employer shall take the necessary measures to:

a) Prohibit workers from eating, drinking or smoking in areas where such a risk exists.

(b) Provide appropriate protective clothing workers or other appropriate special garments.

c) Dispose appropriate and appropriate toilet toilets and rooms for the use of workers, including eye cleaning and skin antiseptic products.

d) Dispose of a particular location for the proper storage of protective equipment and verify that they are cleaned and checked for good operation, if possible before and, in any case, after each using, repairing, or replacing defective equipment before new use.

e) Specify the procedures for obtaining, handling and processing samples of human or animal origin.

2. Within the working day, the workers will have ten minutes for their personal grooming before the meal and another ten minutes before leaving the job.

3. When leaving the work area, the worker must remove the work clothes and personal protective equipment which may be contaminated by biological agents and must keep them in places which do not contain other garments.

4. The employer shall be responsible for the washing, decontamination and, if necessary, destruction of the work clothes and protective equipment referred to in the previous paragraph, and it shall be strictly prohibited for the workers to take the at his home for that purpose. When you engage in such operations with businesses that are suitable for this purpose, you will be obliged to ensure that your clothes and equipment are sent in closed containers and labelled with the precise warnings.

5. In accordance with Article 14 (5) of the Law on the Prevention of Occupational Risks, the cost of measures relating to the safety and health at work established by this Royal Decree must not, in any way, be borne by the workers.

Article 8. Monitoring the health of workers.

1. The employer shall ensure adequate and specific surveillance of the health of workers in relation to risks from exposure to biological agents, carried out by competent health personnel, as determined by the health authorities in the guidelines and protocols to be drawn up, in accordance with the provisions of Article 37 (3) of Royal Decree 39/1997 of 17 January 1997 on the Regulation of the Prevention Services. Such surveillance shall be offered to workers on the following occasions:

a) Before exposure.

(b) At regular intervals thereafter, with the periodicity of the medical knowledge, considering the biological agent, the type of exposure and the existence of effective early detection tests.

(c) When necessary because it has been detected in a worker, with similar exposure, an infection or disease that may be due to exposure to biological agents.

2. Workers may request the review of the results of their health surveillance.

3. Where there is a risk of exposure to biological agents for which effective vaccines are available, they shall be made available to workers, informing them of the advantages and disadvantages of vaccination. When entrepreneurs offer the vaccines they must take into account the practical recommendations contained in Annex VI to this Royal Decree.

The provisions of the preceding paragraph shall also apply in relation to other effective pre-exposure measures for the proper prevention of primary prevention.

The offer to the worker of the corresponding measure, and its acceptance thereof, must be stated in writing.

4. The doctor responsible for the supervision of the health of workers must be familiar, as far as possible, with the conditions or circumstances of exposure of each of the workers. In any case, it may propose individual prevention or protective measures for each individual worker.

5. An individual medical record of the workers subject to health surveillance must be taken.

6. Workers shall be advised and informed as regards any relevant medical checks to be carried out after the cessation of the exposure. In particular, it shall apply to those workers as laid down in Article 37 (3) (e) of Royal Decree 39/1997 of 17 January 1997. approving the Regulation of the Prevention Services, in the field of health surveillance beyond the end of the employment relationship.

Article 9. Documentation.

1. The employer is obliged to have:

(a) The documentation on the results of the assessment referred to in Article 4, as well as the evaluation criteria and procedures and the methods of measurement, analysis or test used.

(b) A list of workers exposed in the undertaking to biological agents in groups 3 and 4, indicating the type of work carried out and the biological agent to which they have been exposed, as well as a record of the corresponding exposures, accidents and incidents.

2. The employer must take the measures necessary for the preservation of a record of the individual medical records provided for in Article 8 (5) of this Royal Decree, without prejudice to the provisions of Article 22 of the Law Occupational Risk Prevention.

3. The list of exposed workers and medical records shall be kept for a period of at least 10 years after the end of the exposure; this period shall be extended to 40 years in the case of exposures which may give rise to a infection in which one of the following features is present:

a) Debit to biological agents with a known ability to cause persistent or latent infections.

b) That it is not diagnosable with current knowledge, until the manifestation of the disease many years later.

c) The incubation period, prior to the manifestation of the disease, is especially prolonged.

d) That results in a disease with recurrence phases for an extended period of time, despite treatment.

d) That it can have important long-term sequelae.

4. The documentation referred to in paragraph 1 (b) shall be additional to that which the employer shall draw up in accordance with Article 23 of the Law on the Prevention of Occupational Risks and shall be subject to the same legal regime as it is. (a) special provisions concerning the making available to the labour and health authorities, and access and confidentiality of information.

5. The automated processing of personal data can only be carried out in accordance with the terms of the Organic Law 5/1992, of October 29, of Regulation of Automated Treatment of Personal Data.

Article 10. Notification to the employment authority.

1. The use, for the first time, of biological agents in groups 2, 3 or 4 must be notified in advance to the labour authority at least 30 days in advance at the beginning of the work.

In addition, the use, for the first time, of any other biological agent in group 4, as well as any new biological agent which has been provisionally assimilated by the employer to those of the Group 3, in accordance with the provisions of Article 4 (3) (a).

2. However, laboratories carrying out diagnostic services related to group 4 biological agents shall be required only for the initial notification of such purpose.

3. The notification referred to in this Article shall

:

a) The name and address of the company or job center.

b) The name and training of the person or persons with responsibility for prevention in the enterprise.

(c) The result of the assessment referred to in Article 4.

d) The species of the biological agent.

e) The intended prevention and protection measures.

4. A new notification shall be made whenever substantial changes are made to the work processes or procedures whose impact on safety and health conditions invalidate the previous notification.

Article 11. Information to the competent authorities.

1. The employer shall have at the disposal of the labour and health authorities the documentation relating to the results of the assessment referred to in Article 4 of this Royal Decree, including the nature, degree and duration of the exposure, not the assessment criteria and procedures and the methods of measurement, analysis or test that have been used.

2. Where such assessment shows that there are risks to the safety or health of workers, the employer shall inform the working or health authorities at his request of:

(a) Activities where workers have been or could be exposed to biological agents.

b) The number of workers exposed.

c) The name and training of the person or persons with responsibility for prevention in the company.

d) The prevention and protection measures taken, including procedures and methods of work.

e) An emergency plan for the protection of workers against exposure to a biological agent of groups 3 or 4, in the event of failure of physical containment.

3. The employer shall immediately inform the working and health authorities of any accident or incident which may have caused the release of any biological agent and which may cause serious infection or disease in man.

4. All cases of disease or death that have been identified as resulting from a professional exposure to biological agents shall be communicated to the labour and health authorities.

5. The list referred to in Article 9 (1) (h) and the medical records referred to in Article 8 (5) shall be sent to the labour authority in the event that the undertaking ceases to work.

The medical records will be submitted by the health care authority, who will keep them, guaranteeing, in any case, the confidentiality of the information contained therein. In no case shall the employment authority keep a copy of these records.

Article 12. Information and training of workers.

1. Without prejudice to Article 18 of the Law on the Prevention of Occupational Risks, the employer shall take appropriate measures to ensure that workers 'representatives and workers' representatives are informed of any safety and security measures. the health to be adopted in compliance with this Royal Decree. The employer will also take appropriate measures to ensure that workers and workers ' representatives receive sufficient and adequate training and accurate information based on all available data, in particular in form of instructions, in relation to:

a) Potential health risks.

b) The precautions to be taken to prevent exposure.

c) The hygiene provisions.

d) The use and use of personal protective clothing and equipment.

e) The measures to be taken by workers in the event of incidents and for the prevention of incidents.

2. Such training shall:

a) To be imparted when the worker is incorporated into a job that involves contact with biological agents.

b) Adapting to the emergence of new risks and their evolution.

c) Repeated periodically if necessary.

3. The employer shall give written instructions at the place of work and, if appropriate, place notices containing at least the procedure to be followed:

(a) In the event of an accident or serious incident involving the handling of a biological agent.

b) In case of manipulation of a group 4 biological agent.

4. Workers shall immediately communicate any accident or incident involving the handling of a biological agent to their direct hierarchical superior and to the person or persons with responsibility for prevention within the undertaking.

5. The employer shall immediately inform the workers and their representatives of any accident or incident which has resulted in the release of a biological agent capable of causing serious infection or disease in man.

In addition, the employer shall inform, as soon as possible, the workers and their representatives of any major accident or incident, their cause and the measures taken, or to be taken, to remedy such a situation.

6. Workers shall have access to the information contained in the documentation referred to in Article 9 (1) (b) where such information concerns them.

Also, workers ' representatives or, failing that, workers themselves will have access to any anonymous collective information.

At the request of the workers ' representatives or, failing that, the employer shall provide the employer with the information provided for in Article 11 (1) and (2

.

Article 13. Consultation and participation of workers.

The consultation and participation of workers or their representatives on the matters referred to in this Royal Decree shall be carried out in accordance with the provisions of Article 18 (2) of the Law on the Prevention of Occupational Risks.

CHAPTER III

Multiple Provisions

Article 14. Sanitary and veterinary establishments other than diagnostic laboratories.

1. Without prejudice to the provisions of the preceding chapters of this Royal Decree, in the case of medical and veterinary establishments other than diagnostic laboratories, the assessment referred to in Article 4 shall be in particular in view of the risks inherent in the activities carried out on them and, in particular, the uncertainty about the presence of biological agents in the body of human patients, animals, or materials or samples from these, and the danger that such a presence might suppose.

2. Appropriate measures shall be taken in such services to ensure adequate health protection and the safety of the workers concerned.

Such measures shall include in particular:

a) The specification of appropriate decontamination and disinfection procedures, and

(b) The application of procedures to allow contaminated waste to be handled and disposed of without risk.

3. In isolation services where patients or animals that are or are suspected to be contaminated by biological agents of groups 3 or 4 are found, containment measures shall be selected from among those listed in column A of the Annex. Annex IV to this Royal Decree, in order to minimise the risk of infection.

Article 15. Special measures applicable to industrial processes, to laboratories and to premises for animals.

1. Without prejudice to the provisions of the preceding chapters of this Royal Decree, in laboratories, including diagnostic and research laboratories, and in premises intended for laboratory animals, deliberately contaminated by biological agents of groups 2, 3 or 4, or which are or are suspected to be carriers of such agents, appropriate measures shall be taken in accordance with the following paragraphs:

(a) Laboratories undertaking work involving the manipulation of biological agents of groups 2, 3 or 4 for the purpose of research, development, teaching or diagnosis must establish measures for the containment of compliance with Annex IV to this Royal Decree in order to minimise the risk of infection.

(b) Depending on the outcome of the assessment referred to in Article 4, measures shall be made in accordance with Annex IV to this Royal Decree, after the level of physical containment required for that purpose has been established. biological agents according to the degree of risk.

Activities involving the manipulation of a biological agent will be executed:

1. Only in areas of work corresponding to at least 2 containment level, for a group 2 biological agent.

2. ° Only in working areas corresponding to at least 3 containment level, for a biological agent, group 3.

3. Only in areas of work corresponding to at least 4 containment level, for a group 4 biological agent.

(c) Laboratories handling materials for which there is uncertainty about the presence of biological agents that may cause disease in man, but which do not aim to work with They should, at least, adopt a level 2 of containment, either by growing or concentrating them. Levels 3 and 4, where appropriate, should be used whenever they are known or suspected to be necessary, except where the guidelines established by the health authorities indicate that, in some cases, a level of containment is appropriate. less.

2. Without prejudice to the provisions of the preceding chapters of this Royal Decree, in industrial processes using biological agents of groups 2, 3 or 4, appropriate measures shall be taken in accordance with the provisions of this Regulation. The following sections:

(a) The containment principles set out in the second subparagraph of paragraph 1 (b) should be applied on the basis of the appropriate measures and procedures set out in Annex V to this Royal Decree.

b) Depending on the outcome of the risk assessment linked to the use of biological agents in groups 2, 3 or 4, the labour and health authorities, within their respective powers, may decide on the measures appropriate to be applied for the industrial use of such biological agents.

(c) All activities covered by this Article in which it has not been possible to carry out a conclusive assessment of a biological agent, but whose intended use may appear to be a serious risk for the health of workers, they may only be carried out at work premises where the level of containment corresponds to at least level 3.

Single additional disposition. Referral of documentation and information to the health authorities.

The labour authorities shall send to the health authorities a copy of the documentation and information received from the companies in accordance with the provisions of Articles 9, 10 and 11 of this Royal Decree.

Single transient arrangement. Notification to the employment authority.

Companies or workplaces which at the time of the entry into force of this Royal Decree use biological agents of groups 2, 3 or 4 shall notify the employment authority of such use within three months of the date of entry into force of this Regulation. from the entry into force of this Royal Decree.

Single repeal provision. Regulatory repeal.

As many provisions of equal or lower rank are repealed, the provisions of this Royal Decree and expressly Articles 138 and 139 of the General Ordinance on Safety and Hygiene at Work, adopted by Order, are hereby repealed. of 9 March 1971, as regards the risks related to exposure to biological agents during work.

Final disposition first. Elaboration and updating of the Technical Risk Guide.

The National Institute of Safety and Hygiene at Work, in accordance with the provisions of Article 5 (3) of Royal Decree 39/1997 of 17 January, approving the Regulation of the Prevention Services, develop and keep up to date a non-binding Technical Guide for the assessment of risks related to exposure or biological agents during work.

Final disposition second. Application and development powers.

The Minister of Labor and Social Affairs is authorized, after a favorable report from the Ministry of Health and Consumer Affairs, and prior to the report of the National Commission on Safety and Health at Work, to make the necessary provisions for the implementation and development of this Royal Decree, as well as for adaptations of a strictly technical nature to its annexes in the light of technical progress and the evolution of international regulations or specifications knowledge in the field of biological agents.

Final disposition third. Entry into force.

This Royal Decree will enter into force two months after its publication in the "Official Gazette of the State".

Given in Madrid to May 12, 1997.

JOHN CARLOS R.

EI First Deputy Prime Minister

and Minister of the Presidency,

FRANCISCO ALVEZ-HELMETS FERNANDEZ

ANNEX I

Indicative of activities list

1. Work in food production centers.

2. Agricultural work.

3. Activities in which there is contact with animals or products of animal origin.

4. Health care work, including those developed in isolation and pathological anatomy services.

5. Work in clinical, veterinary, diagnostic and research laboratories, excluding microbiological diagnostic laboratories.

6. Jobs in waste disposal units.

7. Work in wastewater treatment plants.

ANNEX II

Classification of biological agents

1. A list of biological agents, classified in groups 2, 3 or 4, is presented in the attached table, following the criterion set out in Article 3.1 of this Royal Decree. Additional indications are provided for certain agents, using the following symbology for this purpose:

A: Possible allergic effects.

D: the list of workers exposed to the agent should be kept for more than ten years after the last exposure.

T: toxin production.

V: Effective vaccine available.

(*): normally not infectious through the air.

"spp": other species of the genus, in addition to those explicitly indicated, may constitute a health risk.

2. The classification of the listed agents has been carried out in view of their possible effects on healthy workers. No account has been taken of the particular effects that may have on workers whose sensitivity is affected by causes such as previous pathology, medication, immune disorders, pregnancy or breast-feeding.

3. For the correct classification of the agents, on the basis of that list, it should be noted that:

a) Non-inclusion in the list of a given agent does not mean its implicit and automatic classification in group 1.

(b) The list has not included genetically modified micro-organisms, subject to specific regulation.

(c) In the case of agents for which only gender is indicated, species and strains that are not pathogenic to humans shall be considered excluded from the classification.

(d) All viruses not included in the list that have been isolated in humans shall be considered to be classified as a minimum in group 2, except where the health authority has estimated that it is unnecessary.

4. When a strain is attenuated or has lost well known virulence genes, the containment required by the classification of its parent strain shall not necessarily be applicable. For example, when that strain is to be used as a product or part of a product for prophylactic or therapeutic purposes.

5. For the normally non-infectious biological agents through the air. marked with an asterisk on the list of biological agents: certain containment measures designed to prevent their transmission by air may be dispensed with unless otherwise indicated by the health authority to which the information is to be provided; prior to such a circumstance.

6. The containment imperatives resulting from the classification of the parasites shall be applied only to the different stages of the parasite cycle which may be infectious to persons in the workplace.

3

Coxiella burnetii

Enterobacter spp

2

Francisella tularensis (type A)

Listeria monocytogenes

Mycobacterium malmoense

Mycobacterium paratuberloc

Nairovirus:

Virus

     Human lymphotropic virus B (HBLV-HHV6)

3

Echinococcus granulosus

Strongyloids spp

2

pebrofti

3 neoformans var. neoformans (Filobasidiella neoformans var. neoformans

Madurella grail

Penicillium marneffei

Agent	Classification	Notes
	Bacteria and
2		2	2
2			2		2
2		2	2
	Actinomyces israi	2		2
	Actinomyces pyogenes	2
Actinomyces spp	2
	Arcanobacterium haemolyticum (Coryne-bacterium haemoyticum)	2
anthracis	3
Bacteroides fragilis
Bartonella bacilliformis	2
	Bordetella bronchiseptica	2
	Bordetella parapertussis
	Bordetella pertussis	2	V
	Borrelia burgdorferi	2
	Borrelia duttonii
Borrelia recurrents	2
	Borrelia spp	2
	abortus brucella
3
			3
	Suis Brucella	3
	Campylobcater fetus	2
	Campylobacter jejuni	2
2		2	2
Cardiobacterium hominis	2
	Chlamydia pneumoniae	2
Chlamydia trachomatis	2
Chlamydia psittaci (avian strains)	3
	Chlamydia psittaci (non-avian strains)	2
Clostridium botulinum	2	T
	Clostridium perfringens	2
	Clostridium tetani	2	T. V.
	Clostridium spp	2
2		T. V.
	Corynebacterium minutissimum	2
2
2	Corynebacterium spp	2
3
	Edwardsiella	2
Ehrlichia sennetsu (Rickettsia sennetsu)	2
	Ehrlichia spp	2
	Eikenella corrodens	2
2		2	2
2
	Enterococcus spp	2
	2	2
	Escherichia coli (except non-pathogenic strains)	2
	Flavobacterium meningosepticum	2
	Fluorbacter bozemanae (Legionella)
3
Francisella tularensis (type B)	2
Futacterium necrophorum	2
	Gardnerella vaginalis	2
	Haemophilus ducreyi	2
Haemophilus influenzae
Haemophilus spp	2
Helicobacter	2
Klebsiella oxytoca
Klebsiella pneumoniae	2
	Klebsiella spp	2
	Legionella pneumophila
	2	2
Leptospira interrogans (all serotypes)	2
2
	ivanovii Listeria	2
	Morganella morganii	2
	Mycobacterium africanum	3	V
Mycobacterium avium/intracellulare	2
	Mycobacterium bovis (except BCG strain)	3
Mycobacterium chelonae	2
	Mycobacterium fortuitum
	Mycobacterium kansasii	2	2
	Mycobacterium leprae	3
2
	Mycobacterium marinum	2
	Mycobacterium microti
2
	Mycobacterium scrofulaceum	2
	Mycobacterium simiae
	Mycobacterium szulgai	2	2
	Mycobacterium tuberculosis	3	V
Mycobacterium ulcerans
Mycobacterium xenopi	2	2
	Mycoplasma pneumoniae	2
	Neisseria gonorrhoeae
	Neisseria meningitidis	2	2	V
	Nocardia asteroids	2
Nocardia brasiliensis
	2	2
	Nocardia nova	2
Nocardia otitidiscavarum
2	2
	Pasteurella spp	2
	Peptostreptococcus anaerobius
	Plesiomonas shigelloids	2	2
	Porphyromonas spp	2
Prevotella spp
	Proteus mirabilis	2
	Proteus penneri	2
	Proteus vulgaris
	Providencia alcalifacens	2	2
Providencia rettgeri	2
	spp
	aeruginosa Pseudomonas	2
	Mallei Pseudomonas	3
	Pseudomonas pseudomallei	3
Rhodococcus equi	2
	Rickettsia akari	3 (*)
	Ricketsia canada	3 (*)
	Rickertsia conorii	3
	Rickettsia	3 (*)
Rickettsia typhi (Rickettsia mooseri)	3
	Rickettsia prowazekii	3
	Rickettsia rickettsii	3
Rickettsia tsutsugamushi	3
Rickettsia spp	2
		2
arizonae
enteritidis	2	2
typhimurium	2
paratyphi A, B, C
V
typhi	3 (*)	V
(other serologic varieties)	2
	Serpulin spp
	Shigella boydii	2
Shigella dysenteriae (type 1)	3 (*)	T
Shigella flexneri
	Shigella sonnei	2
	Staphylococcus aureus	2
Streptobacillus moniliformis
	Streptococcus pneumoniae	2	2
	Streptococcus pyogenes	2
Streptococcus suis
	Streptococcus spp	2
	Treponema careteum	2
	Treponema pallidum
2
	Treponema spp	2
	Vibrio cholerae (including The Tor)
	Vibrio parahaemolyrticus	2
	Vibrio spp	2
	Yersinia enterocolitica
	Yersinia pestis	3
Yersinia pseudoTB	2
Yersinia spp
	Adenoviridae	2
Arenaviridae:
Virus Junin	4
Lassa Virus	4
lymphocytic coriomenyngitis (neurotropic strains)	3
lymphocytic coriomeningitis (other strains)	2
Virus Machupo	4
Virus Mopeia and other Tacarbe viruses	2
	Astroviridae	2
	Bunyaviridae:
Virus Bunyamwera	2
Oropouche Virus	3
California encephalitis	2
Hantavirus:
Hantaan (Fever Korea hemorrhagic),	3
Virus Seoul	3
Virus Puumala	2
Virus Prospect Hill
	Other hantavirus	2
	4
Virus Hazara	2
Flebovirus:
fence Rift	3	V
Virus
Virus	2
Other known pathogenicity bunyavirus
Virus Norwalk
Virus	2
Other Caliciviridae	2
2
2
Ebola Virus	4
Marburg Virus	4
Flaviviridae:
Encefalitis of Australia (Murray Valley Encefalitis)	3
European tick encephalitis virus Central	3 (*)	V
Absettarov	3
Hanzalova	3
Hypr	3
Kumlinge	3
Dengue Virus types 1-4	3
hepatitis C	3 (*)	D
Encephalitis B Japanese	3	V
Forest Kyasamur	3	V
Louping Evil			Ormsk (a)
3	V
Powassan	3
Rocio	3
	3
Encefalitis	3
Wesssbron Virus	3 (*)
Virus West Nile	3
Yellow Fever	3	V
Other flavivirus known pathogenicity	2
Hepadnaviridae:
(*)		3 (*)	3 (*)
Hepatitis D Virus (Delta) (b)	3 (*)	V.
	Herpesviridae:
			Virus
2		Virus	2
3		3 Types 1 and 2 viruses	2
Herpesvirus variceila-zoster
2
	Orthomyxoviridae:
Influenza viruses types A, B, and C	2	V (c)
Tick-borne Ortomixovirus: Dhori and Thogoto Virus	2
Papovaviridae:
Virus BK and JC	2	D (d)
human papilloma	2	D (d)
Paramyxoviridae:
measles Virus	2
Pumps Virus
Newcastle disease virus.	2
Types 1 to 4 parainfluenza virus	2
respiratory syncytial virus
Parvoviridae:
Human Parvovirus (B 19)	2
	Picornaviridae:
Hemorrhagic Conjunctivitis Virus (AHC)	2
Virus Coxsackie	2
Echo Virus	2
Hepatitis A Virus (human enterovirus type 72)	2	V
Poliovirus	2	V
Rhinovirus	2
Poxviridae:
Buffalopox virus (e)	2
Cowpox virus	2
Elephant virus (f)	2
Computer node virus
Molluscum contagiosurn virus	2
Monkeypox virus	3	V
Orf virus	2
Rabbitpox virus (g)	2
Vaccinia virus	2
Variola (major & minor) virus	4	V
"Whitepox" virus (virus variola)	4	V
Yatapox virus (Tana & Yaba)	2
	Reoviridae:
Coltivirus	2
Human Rotavirus	2
2
Reovirus		Reovirus
Retroviridae:
Human Immunodeficiency Virus	3 (*)	D
Human leukemias of T cells (HTLV) types 1 and 2	3 (*)	D
Virus SIV (h)	3 (*)
	Rhabdoviridae:
rabies virus	3 (*)	V
vesicular stomatitis virus	2
Togaviridae:
Alfavirus:
Eastern American Encephalomyelitis	3	V
		2
Chikungunya Virus	3 (*)
Virus Everglades	3 (*)
Virus Mayaro	3
Virus Mucambo	3 (*)
Virus Ndumu	3
Virus Onyong-yong	2
Ross River Virus	2
Semliki Forest Virus	2
Virus Sindbis	2
Virus Tonate	3 (*)
	V
	3	V
2		Rubivirus (rubella)	2	V
	Toroviridae	2
Unclassified virus:
Hepatitis hepatitis virus blood transmission, yet to be identified	3 (*)	D
Hepatitis E virus	3 (*)
Unclassified agents associated with (i):
Creutzfeldt-Jakob disease	3 (*)	D (d)
Gerstmann-Straussler-Scheinker	3 (*)	D (d)
Kuru	3 (*)	D (d)
	Acanthamoeba castellani	2
	Ancylostoma duodenale
Angiostrongylus cantonensis	2
Angiostrongylus costaricensis	2
Ascaris lumbricoides	2	A
Asaris suum	2	A
Divergens Babesia	2
	Microti Babesia	2
Balantidium coli	2
	Brugia malayi
	2	2
Capillaria philippinensis	2
Capillaria spp	2
	Clonorchis sinensis	2
	Clonorchis
	Cryptosporidium parvum	2	2
	Cryptosporidium spp	2
	Cyclospora cayetanensis
		2
	Diphyllobothrium latum	2
Dracunculus medinensis
3 (*)
	Echinococcus multilocularis	3 (*)
	Echinococcus vogeli
	histolytica	2	2
	2	2
Fasciola
	Fasciolopsis buski	2
	Giardia lamblia (Giardia interinalis)	2
	Hymenolepis diminuta
Hymenolepis nana	2
	Leishmania brasiliensis	3 (*)
Leishmania donovani		2
2	2
Leishmania	2
	Leishmania Peruviana
	Leishmania	2		2
Leishmania major	2
Leishmania spp
Loa loa	2
Mansonella ozzardi	2
Mansonella perstans	2
	Naegleria fowleri	3
	Necator americanus	2
Onchocerca volvulus	2
	Opistorchis felineus	2
	Opisthorchis spp	2
2	Paragonimus westermani		2
	Plasmodium falciparum	3 (*)
Plasmodium spp (human and symbolic)	2
2		2	Sarcocystis suihominis
	Schistosoma haematobium	2
	Schistosoma intercalatum	2
2		2	2
	Schistosoma mansoni	2
	Schistosoma mekongi	2
2		2	2
2
	Taenia saginata	2
Taenia solium	3 (*)
	Toxocara canis	2
2	2
	spiralis	2
2
	Trypanosoma brucei brucei	2
	Trypanosorna brucei gambiense
(*)
2
	Aspergillus fumigatus	2	A
Blastomyces dermatitidis (Ajellomyces dermatitidis)	3
Candida albicans	2	A
2	A
Cryptococcus neoformans var. gattii (Filobasidiella bacillispora)	2	A
	Emmonsia parva var. parva	2
	Emmonsia parva var. crescens	2
	Epidermophyton floccosum
	2
	Fonsecaea pedrosoi	2
	Histoplasma capsulatum var capsulatum (Ajellomyces capsulatus)	3
	Histoplasma capsulatum duboisii	3
2
	Madurella mycetomatis	2
	Microporum spp	2	A
Neotestudine roatii	2
Paracoccidioides brasiliensis	3
2	A
	Sporothrix schenckii	2
Tricophyton rubrum
2	2	2	2	Centro_table_body ">

(a) Encefalitis vehiculada by the tick.

(b) The hepatitis D virus requires another simultaneous or secondary infection to that caused by the hepatitis B virus to exercise its pathogenic power in the workers.

The hepatitis B virus vaccine will therefore protect workers affected by the hepatitis B virus, against the hepatitis D virus (Delta).

(c) Only for types A and B.

(d) Recommended for jobs involving direct contact with these agents.

(e) Two different viruses can be identified under this heading: a genus "buffalopox" virus and a variant of "vaccinia" virus.

(f) Variant of " cowpox".

(g) "vaccinia" variant.

(h) There is currently no evidence of human disease caused by another retrovirus of seismic origin. As a precautionary measure, your recommends a level 3 of containment for jobs that assume an exposure to these retroviruses.

(i) There is still no evidence of the existence in humans of infections caused by the argents responsible for bovine spongiform encephalitis. However, level 2 of containment is recommended, at least, as a protective measure in lab work.

ANNEX III

Biological hazard signal

ANNEX IV

Indications regarding containment measures and containment levels

Preliminary observation: The measures set out in this Annex shall apply according to the nature of the activities, the risk assessment for the workers and the characteristics of the biological agent concerned.

	Containment measures	B. Containment
		2	3	4
1. The workplace will be separated from any activity that is developed in the same building.	No.	Recommended.	Yes.
	2. The air introduced and removed from the workplace will be filtered by using high-efficiency filters for airborne particles (HEPA) or similarly.	No.	Yes, for air output.	Yes, for air input and output
3. Only designated personnel will be allowed access.	Recommended.	Yes.	Yes, with air exclusionary.
4. The workplace should be able to be sealed to allow disinfection.	No.	Recommended.	Yes.
5. Disinfection procedures specified.	Yes.	Yes.	Yes.
6. The workplace will be maintained with a negative pressure on atmospheric pressure.	No.	Recommended.
7. Efficient vector control, for example, of rodents and insects.	Recommended.	Yes.	Yes.
8. Water-impermeable and easy-to-clean surfaces.	Yes, for the test bench or worktable.	Yes, for the test bench or table of work and the floor.	Yes, for the test bench or table of work, floor, walls, and ceilings
9. Surfaces resistant to acids, alkalis, solvents, and disinfectants.	Recommended.	Yes.	Yes.
10. Security storage for biological agents.	Yes.	Yes.	Yes, storage.
11. An observation window or alternate device will be installed in the zones so that its occupants can be seen.	Recommended.	Yes
12. Lab with own equipment.	No.	Recommended.	Yes.
13. The infected material, including animals, must be handled in a biological safety booth or in an insulator or other appropriate containment.	Where applicable.	Yes, when the infection spreads through the air.	Yes.
. Incinerator for destruction of dead animals.	Recommended.	Yes (available)	Yes, in the same place

ANNEX V

Indications regarding containment measures and containment levels for industrial processes

Preliminary Observation

1. Group 1 biological agents: When working with group 1 biological agents, including live attenuated germ vaccines, the principles of correct safety and professional hygiene shall be observed.

2. Group 2, 3 and 4 biological agents: It may be appropriate to select and combine, based on a risk assessment related to any particular process or part of a process, containment requirements for the different categories which are expressed below.

Containment measures

Containment
2	3	4
1. Viable microorganisms should be manipulated into a system that physically separates the environment process:	Yes.	Yes.	Yes.
	2. The closed system exhaust gases must be treated for:	Minimize the release.	Prevent release.	Prevent Release.
3. Sampling, adding materials to a closed system, and transferring viable organisms to another closed system must be performed in a way that allows:	Minimizing the release.	Prevent Release.	Prevent Release.
4. Large crop fluids should not be removed from the closed system unless the viable micro-organisms have been:	Inactivated by means of proven efficacy.	Inactivated by physical or chemical-efficient media.	Inactivated by physical or chemical means of proven efficacy
5. Seals must be designed for the purpose of:	Minimizing Release.	Prevent Release.	Prevent the release.
6. Closed systems must be located in a controlled zone:	Optional.	Optional.	Yes, expressly built
) You must place biological hazard tokens.	Optional.	Yes.	Yes.
b) Only Access to designated personnel must be allowed.	Optional.	Yes.	Yes, using air locks.
c) Personnel should wear protective clothing.	Yes, workwear.	Yes.	Change completely.
d) You must have the decontamination and washing facilities personnel available.	Yes.	Yes.	Yes.
) Workers must shower before leaving the controlled zone.	No.	Yes.
	.
Yes. Table_table_izq"> f) The scrubbing and shower effluents must be collected and inactivated prior to their release.	No.	Optional.	Yes.
g) The controlled zone must be properly ventilated to minimize air pollution.	Optional.	Optional.	Yes.
) In the controlled zone, a negative air pressure must be maintained with respect to the atmosphere.	No.	Optional.	Yes.
) You must treat with "HEPA" filters the input and output air of the zone controlled.	No.	Yes.
j) The controlled zone must be designed to prevent leakage of the contents of the closed system.	No.	Optional.	Yes.
k) Power must be seal the controlled zone for fumigation.	No.	Yes.
.
l) Treatment of effluents before their final spill.	Inactivated by physical media or proven efficacy chemicals.	Inactivated by means of proven efficacy.	Inactivated by means of proven efficacy.	Proven efficiency chemicals or chemicals

ANNEX VI

Practical recommendations for vaccination

1. Where the assessment referred to in Article 4 demonstrates the existence of a risk to the safety and health of workers by exposure to biological agents against which effective vaccines are available, the employer shall provide such vaccination.

2. Workers should be informed of the advantages and disadvantages of both vaccination and non-vaccination.

3. The vaccination offered to the workers will not entail any such expenditure.

4. A vaccination certificate may be drawn up to be issued to the worker concerned and, where requested, to the health authorities.

5. The provisions of the preceding paragraphs shall apply to the measures referred to in the second subparagraph of Article 8 (3

.