Regulation on safety and health protection in the case of activities with biological agents

Original Language Title: Verordnung über Sicherheit und Gesundheitsschutz bei Tätigkeiten mit Biologischen Arbeitsstoffen

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Regulation on safety and health protection in the case of activities with biological agents (Biosubstance Ordinance-BioStoffV)

Unofficial table of contents

BioStoffV

Date of completion: 15.07.2013

Full quote:

" Biostoffverordnung vom 15. Juli 2013 (BGBl. I p. 2514) "

Footnote

(+ + + Text proof: 23.7.2013 + + +) 

The V was referred to as Article 1 of the V v. 15.7.2013 I of the Federal Government, the Federal Ministry of Labour and Social Affairs and the Federal Ministry of the Interior with the consent of the Federal Council and in agreement with the Federal Ministry of the Interior, the Federal Ministry of Economics and Technology and the Federal Ministry of Labour and Social Affairs decided. She's gem. Art. 3 sentence 1 of this V entered into force on 23.7.2013. Unofficial table of contents

Content Summary

Section 1
the scope,
Definitions and risk group classification
§ 1 Scope
§ 2 Definitions
§ 3 Classification of biosubstances in risk groups



Section 2 Risk assessment, Protection level mapping, Documentation and recording obligations
§ 4 Risk assessment
§ 5 Activities with protection level allocation
§ 6 Activities without a protection level assignment
§ 7 Documentation of the risk assessment and recording obligations

Section 3 Basic obligations and safeguard measures
§ 8 Basic duties
§ 9 General protection measures
§ 10 Additional protective measures and requirements in the case of activities of protection level 2, 3 or 4 in laboratories, in experimental animals and in biotechnology
§ 11 Additional protective measures and requirements in respect of the activities of protection level 2, 3 or 4 in health service facilities
§ 12 Occupational health care
§ 13 Malfunctions, accidents
§ 14 Operating instructions and training of employees

Section 4 Permission and disclosure requirements
§ 15 Authorisation
§ 16 Notification duty


Section 5 Enforcement arrangements and Committee on Biological Working Materials
§ 17 Information to the Authority
§ 18 Exceptions to the Authority
§ 19 Committee on Biological Working Materials


Section 6 Irregularities, Offences and transitional provisions
§ 20 Irregularities
Section 21 Offences
Section 22 Transitional provisions
Annex I Symbol for Biohazard
Annex II Additional protective measures in the case of activities in laboratories and comparable facilities and in the conservation of animals
Annex III Additional protective measures for activities in biotechnology

Section 1
Scope, definitions and risk group classification

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§ 1 Scope

(1) This Regulation shall apply to activities with biological agents (biosubstances). It regulates measures to protect the safety and health of workers from the risks associated with these activities. At the same time it also regulates measures for the protection of other persons, in so far as these can be jeopardised by the use of biomaterials by employees or by entrepreneurs without employees. (2) The Regulation also applies to activities which are If there are no equivalent or more stringent regulations for the protection of employees, genetically engineered plants are subject to genetic engineering. Unofficial table of contents

§ 2 Definitions

(1) Biomaterials are
1.
micro-organisms, cell cultures and endoparasites, including their genetically modified forms,
2.
Agents associated with Transmissible Spongiform Encephalopathy (TSE),
that may pose a risk to humans through infections, communicable diseases, toxins, sensitising or other health-related effects. (2) Biomaterials are considered to be the same as those of the
1.
ectoparasites, which can cause human diseases or cause sensitising or toxic effects in humans,
2.
technically produced biological units with new properties that can endanger humans in the same way as biosubstances.
(3) Microorganisms are all cellular or non-cellular microscopically or submicroscopically small biological units capable of propagating or passing genetic material, in particular bacteria, viruses, protozoa and Fungi. (4) Cell cultures are in vitro propagated cells isolated from multicellular organisms. (5) Toxins referred to in paragraph 1 are metabolic products or cell components of biosubstances, which are caused by inhalation, swallowing or Exposure to human skin causing toxic effects and thereby acute or chronic damage to health or death. (6) Biomaterials of the risk group 3 which are identified by (**) are those which have a limited risk of infection for employees, because transmission via the Air travel usually cannot be done. These biosubstances are set out in Annex III to Directive 2000 /54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from the risks related to exposure to biological agents at work (OJ L 327, 22.12.2000, p. 21) as well as in the notices referred to in Article 19 (4) (1). (7) Activities are
1.
the use of biomaterials, in particular the isolation, production and distribution, the closing, the consumption and processing, the filling and refilling, the mixing and separation, and the intra-company promotion, storage and storage of biomaterials, including storage, deactivation and disposal as well as
2.
professional work with humans, animals, plants, products, objects or materials, if, on the basis of these works, biosubstances occur or are released and employees can come into contact with it.
(8) Targeted activities shall be carried out if:
1.
the activities of one or more biosubstances are directly oriented,
2.
the biosubstance or the biosubstances of at least the species are known, and
3.
the exposure of the employees in normal operation is sufficiently known or estimable.
Non-targeted activities shall be carried out if at least one of the conditions set out in sentence 1 is not available. This is particularly the case in the case of the activities referred to in paragraph 7 (2). (9) Employees are persons who are designated as such in accordance with Article 2 (2) of the Employment Protection Act. The persons employed shall be equal to the following persons, provided that they carry out activities with biomaterials:
1.
Pupils,
2.
Students,
3.
other persons, in particular in scientific institutions and in health service facilities,
4.
in homework employees in accordance with Article 1 (1) of the Home Work Act.
The provisions of this Regulation concerning the participation of the representations are not applicable to pupils, students and other persons under point 3. (10) Employers are those who, according to § 2 (3) of the German Labour Protection Act (Arbeitsschutzgesetz), as such is determined. The employer shall be equal to
1.
the trader without employees,
2.
the adjudicating entity and the intermediate master within the meaning of the Home Work Act.
(11) For the purposes of this Regulation, subject-matter skilled in the exercise of a task in this Regulation shall be the competent person. The requirements for the subject matter are dependent on the respective type of task and the level of the hazard. The knowledge required for the subject-matter is to be demonstrated by appropriate vocational training and a timely relevant professional activity. Depending on the task and the level of risk, participation in specific training measures may be required. (12) The state of the art is the state of development of advanced procedures, facilities, or Modes of operation which make it possible to ensure the practical suitability of a measure to protect the safety and health of workers. In the determination of the state of the art, comparable methods, devices or modes of operation are to be used in particular, which have been tested successfully in practice. (13) Protection levels are based on the risk group of the particular Biosubstance and are a measure of the level of infection risk of an activity. In accordance with the risk groups according to § 3, four protection levels are distinguished. The levels of protection include the additional protective measures laid down or recommended in Annexes II and III. (14) Health service facilities provided for in this Regulation are workplaces where people are hospitalised. (15) Biotechnology within the meaning of this Regulation includes biotechnological production and biotechnological research under targeted use. defined biosubstances. Unofficial table of contents

§ 3 Classification of biosubstances in risk groups

(1) Biomaterials shall be classified in one of the following risk groups in accordance with the risk of infection according to the state of the scientific community:
1.
Risk group 1: Biomaterials, which are unlikely to cause disease in humans,
2.
Risk group 2: Biomaterials which may cause disease in humans and which could pose a risk to employees; population spread is unlikely; effective prevention or treatment is normally possible,
3.
Risk group 3: Biomaterials which can cause a serious disease in humans and pose a serious risk to employees; the risk of spreading in the population may exist, but effective prevention is normally or may not be effective. Treatment possible,
4.
Risk group 4: Biomaterials which cause a serious disease in humans and pose a serious risk to employees; the risk of spreading among the population may be large; normally, effective prevention or Treatment not possible.
(2) Annex III to Directive 2000 /54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from the risks related to exposure to biological agents is applicable to the classification of biosubstances in risk groups 2 to 4; at work (OJ L 327, 22. OJ No L 262, 17.10.2000, p. 21). Where this Annex is adapted to technical progress in the procedure referred to in Article 19 of this Directive, the amended version may already be applied as from its entry into force. It is to be applied at the end of the specified implementation period. (3) If a biosubstance is not classified in accordance with paragraph 2, the Federal Ministry of Labour and Social Affairs, after consulting the Committee according to § 19, may be classified into a risk group according to (1). The ratings will be announced in the Joint Ministerial Gazan. The employer has to comply with these classifications. (4) If there is no classification in accordance with paragraph 2 or one under paragraph 3 for a biosubstance, the employer who intends to carry out a specific activity with this biosubstance shall have it in one of the following: To classify risk groups as referred to in paragraph 1. In doing so, the employer must comply with the following:
1.
for the classification of a number of risk groups, the biosubstance shall be classified in the highest possible risk group;
2.
Viruses that have already been isolated in humans must be classified at least in the risk group 2, unless it is unlikely that these viruses will cause disease in humans,
3.
Strains that have been attenuated or have lost known virulence genes may be classified in a lower risk group than the parent strain (parentaler strain), subject to appropriate determination and evaluation; is the parent strain in the Risk group 3 or 4 may only be downgraded on the basis of a scientific evaluation, which may in particular be carried out by the Committee according to § 19.

Section 2
Risk assessment, protection level allocation, documentation and recording obligations

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§ 4 Risk assessment

(1) In the context of the risk assessment in accordance with § 5 of the Occupation Protection Act, the employer must assess the risks to the employees by the activities with biomaterials prior to the commencing of the activity. The risk assessment shall be carried out expertly. If the employer does not have the appropriate knowledge himself, he has to be consulted professionally. (2) The employer has to update the risk assessment immediately if:
1.
relevant changes in working conditions or new information, such as accident reports or findings from occupational health check-ups, which require or
2.
the assessment of the function and effectiveness of the safeguard measures has shown that the protective measures laid down are not effective.
Otherwise, the employer has to check the risk assessment at least every other year and update it if necessary. If the examination shows that an update of the risk assessment is not necessary, the employer must note this, stating the date of the review in the documentation in accordance with § 7. (3) For the risk assessment, the employer has the following information: In particular, employers shall identify:
1.
the identity, risk group classification and transmission routes of the biosubstances, their possible sensitising and toxic effects and reception paths, to the extent that such information is accessible to the employer, including: find out whether the biosubstances may cause other health-damaging effects,
2.
type of activity, taking account of operational procedures, working methods and equipment used, including operating facilities,
3.
the nature, duration and frequency of exposure of employees to the extent to which such information is available to the employer;
4.
the possibility of using bio-materials, working methods or work equipment which would lead to no or lesser danger to employees (substitution test),
5.
Activity-related findings
a)
on situations of stress and exposure, including psychological stress,
b)
about known diseases and the countermeasures to be taken,
c)
from occupational health care.
(4) The employer shall, on the basis of the information determined in accordance with paragraph 3, assess the risk of infection and the hazards of sensitising, toxic or other adverse health effects, independently of each other. These individual assessments shall be combined to form an overall assessment on the basis of which the safeguard measures shall be determined and taken. This also applies if several biosubstances occur or are used simultaneously in one activity. (5) In the case of activities with products containing biosubstances, the necessary information on the risk assessment, such as the one for example, is the If risk group classification is not to be determined, the employer must obtain it from the manufacturer, importer or placing on the market. The first sentence shall not apply to food products in the form of finished products intended for final consumption. Unofficial table of contents

§ 5 Activities with a protection level assignment

(1) In the case of activities carried out in laboratories, in experimental animals, in biotechnology and in health service facilities, the employer shall, in addition to Article 4 (3), determine whether targeted or non-targeted activities are carried out. He has to assign these activities to a protection level with regard to their risk of infection. (2) The protection level assignment is directed at
1.
in the case of specific activities carried out in accordance with the risk group of the identified bioactive substance; if activities are carried out with several biosubstances, the level of protection shall be determined by the biosubstance with the highest risk group,
2.
in the case of non-targeted activities carried out in accordance with the risk group of the biosubstance,
a)
the probability of its occurrence,
b)
the nature of the activity,
c)
the nature, duration, height and frequency of the exposure determined
the degree of risk of infection of the employees.
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§ 6 Activities without a protection level assignment

(1) Activities other than those referred to in Article 5 (1) do not have to be assigned to a protection level. These are activities within the meaning of Section 2 (7) point 2. These activities include, for example, cleaning and remediation work, activities in veterinary medicine, agriculture, forestry, sewage and waste management as well as in (2) In these activities, one of the information referred to in Article 4 (3) (1) and (3) may not be determined because the spectrum of the biosubstances occurring is subject to fluctuations, or because of the nature, duration, height or The frequency of exposure may be changed, the employer shall have the To identify, in particular, the information required on the basis of risk assessment and the definition of protective measures.
1.
Notices pursuant to Article 19 (4),
2.
experience of comparable activities or
3.
other established scientific evidence.
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§ 7 Documentation of the risk assessment and recording obligations

(1) The employer shall, for the first time, document the risk assessment, irrespective of the number of persons employed, prior to the commencing of the activity, and thereafter every update as set out in the second sentence. The documentation of the risk assessment shall include, in particular, the following information:
1.
the nature of the activity, including exposure conditions,
2.
the result of the substitution test in accordance with Section 4 (3) (4),
3.
the protection levels laid down in accordance with Article 5 (2);
4.
the protective measures to be taken,
5.
an explanatory statement if the rules and findings announced in accordance with Article 19 (4) (1) are deviated from.
(2) As part of the documentation, the employer shall draw up a list of the biosubstances used or occurring (list of biosubstances), insofar as they are known and relevant to the risk assessment in accordance with § 4. The list shall include information on the classification of the biosubstances in a risk group in accordance with § 3 and on their sensitising, toxic and other harmful effects on health. The information must be available to all the employees concerned and their representations. (3) In the case of activities of protection level 3 or 4, the employer shall also have a list of the employees who carry out these activities. The list shall indicate the nature of the activities and the biosubstances occurring, as well as the accidents and disruptions of operation which have occurred. It shall be kept for a period of at least ten years after the end of the activity. The employer shall:
1.
to make the information in the list accessible to the employees; whereas the protection of personal data must be guaranteed;
2.
in the case of termination of the employment relationship, an extract of the information in the list relating to him shall be issued to the employee; proof of the suspension shall be kept by the employer, such as staff records.
The list of employees may be kept together with the list of biosubstances referred to in paragraph 2. (4) The documentation of the information referred to in the second sentence of paragraph 1, points 2 and 5, and the list referred to in paragraph 2, may be waived if: only activities with biomaterials of risk group 1 are carried out without sensitising or toxic effects.

Section 3
Basic obligations and safeguard measures

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§ 8 Basic obligations

(1) The employer shall involve the interests of occupational safety and health in relation to activities with biomaterials in his/her operational organisation and shall create the necessary human, financial and organisational conditions for this purpose. In doing so, it shall involve the representations of the employees in a suitable form. In particular, it shall ensure that:
1.
in the organisation of work organisation, the working process and the workplace, as well as in the selection and provision of work equipment, all the factors related to the safety and health of workers, including those relating to: psychological, sufficiently taken into account,
2.
the employees or their representations will be involved in the operational possibilities of the introduction of new means of work which have an impact on the safety and health of workers.
(2) The employer shall take appropriate measures to establish a safety awareness among the employees and to develop the internal occupational safety and health protection in the case of activities with biomaterials. (3) The employer shall be allowed to carry out an activity with After the risk assessment has been carried out in accordance with § 4 and the necessary measures have been taken. (4) The employer has to do so before commencing the activity
1.
to replace, as a matter of priority, dangerous biosubstances by those which are not, or are less dangerous, as far as possible according to the nature of the activity or the state of the art,
2.
to select or design work methods and equipment in such a way as to prevent the free use of biomaterials at the workplace where the risk to workers cannot be excluded by means of a measure referred to in point 1;
3.
reduce the exposure of workers to a minimum by means of appropriate structural, technical and organisational measures where a hazard to workers cannot be prevented by means of a measure referred to in point 1 or 2; or the biosubstances are released as intended,
4.
provide additional personal protective equipment if the measures referred to in points 1 to 3 are not sufficient to prevent or sufficiently reduce the risk; the employer has the use of incriminating personal to limit protective equipment to the degree strictly necessary and shall not be used as a permanent measure.
(5) The employer shall establish and adopt the protective measures on the basis of the risk assessment in accordance with the state of the art as well as on the basis of the scientific knowledge. To that end, it must comply with the provisions of this Regulation, including the Annexes, and shall take account of the rules and findings referred to in Article 19 (4) (1). If the rules and findings are complied with, it must be assumed that the requirements are met (presumption of presumption). These rules and findings may be dismissed if, at least in a comparable way, the protection of the safety and health of workers is ensured by other measures. If the state of the art or scientific knowledge has been developed further and the safety of work is considerably increased by this development, the protective measures must be adjusted within a reasonable period of time. (6) The The employer shall regularly check the function of the technical safeguard measures and their effectiveness at least every other year. The results and the date of the effectiveness test are to be noted in the documentation provided for in § 7. If, for a working area, a working method or a type of investment, a notice in accordance with Article 19 (4) has been established, a value which describes the concentration of the biosubstances in the air at the workplace, which can be achieved according to the state of the art (technical control value), this value should be used for checking the effectiveness of the corresponding protective measures. (7) The employer may only work in homework with risk group 1 biosubstances without sensitising or toxic substances. Exercise effect. Unofficial table of contents

§ 9 General protection measures

(1) At least the general hygiene measures must be complied with in all activities with biosubstances. In particular, the employer shall ensure that:
1.
Jobs and work equipment are kept in a clean state corresponding to the working process and cleaned regularly,
2.
Floors and surfaces of work equipment and working surfaces are easy to clean,
3.
the washing facilities are available,
4.
there are separate changing possibilities from the workplace, provided that work clothes are required; the work clothes must be changed and cleaned regularly as well as if necessary.
(2) In the case of activities carried out in laboratories, in experimental animals, in biotechnology and in health services, the employer shall, in addition to the measures provided for in paragraph 1, have specific hygiene measures in accordance with the measures referred to in paragraph 1. to take account of the rules and findings made known in accordance with Article 19 (4) (1). (3) The employer shall not be engaged exclusively in the activities of risk group 1 biomaterials without sensitising and toxic effects. Depending on the risk assessment, further protective measures to be taken . In particular, it shall:
1.
to design or select working methods and equipment in such a way as to prevent or minimise the exposure of workers to biomaterials and the risk of stab and cut injuries, to the extent that this is technically possible,
2.
Activities and working methods with dust or aerosol formation, including purification processes, to be replaced by those without or with less dust or aerosol formation, to the extent that this is possible according to the state of the art; is this not possible, the employer has to take appropriate measures to minimise exposure,
3.
to limit the number of workers exposed to the level necessary for carrying out the activity;
4.
take the necessary measures for disinfection, inactivation or decontamination, and for the proper and safe disposal of bio-materials, contaminated objects, materials and work equipment,
5.
to clean, maintain, maintain and dispose of personal protective equipment, including protective clothing, made available; employees must use the personal protective equipment provided, as long as a vulnerability,
6.
create the conditions to ensure that personal protective equipment, including protective clothing, can be stored safely when leaving the workplace and stored separately from other items of clothing,
7.
ensure that workers in work areas where biomaterials may appear do not take on food and drink; in this connection, before taking up the activities, the employer has to set up separate areas which do not include: Personal protective equipment, including protective clothing, may be entered.
(4) The employer has to store biomaterials safely, to carry them safely within the company, and to take precautions to prevent abuse or misuse. In doing so, he has to ensure that only containers are used which
1.
be able to safely enclose the content in terms of their nature,
2.
be marked in such a way that the risks emanating from them are clearly identifiable in a suitable manner,
3.
with regard to form and labelling, the content cannot be confused with food.
(5) § 11 (2) to (5) shall apply in the medical examination, treatment and care of patients outside health-care institutions. In the case of such activities, the employer shall determine the handling of personal protective equipment and working clothes, as well as the necessary hygiene and disinfection measures, in working instructions. Unofficial table of contents

§ 10 Additional protection measures and requirements in the case of activities of protection level 2, 3 or 4 in laboratories, in experimental animals and in biotechnology

(1) In addition to the protective measures referred to in § 9, the employer shall, before taking up the activities of protection level 2, 3 or 4, in laboratories, in experimental animal husbandry or in biotechnology
1.
according to the protection level assignment
a)
to define appropriate spatial protection level areas and to identify them with the protection level designation and the biohazard symbol referred to in Annex I,
b)
take the protective measures referred to in Annex II or III; the protective measures referred to as recommended are to be taken in order to reduce the risks to workers;
2.
to safely dispose of used tip and sharp work equipment in accordance with the requirement laid down in Article 11 (4),
3.
limit access to risk group 3 or 4 biomaterials on authorized, competent and reliable employees; the activities of protection level 3 or 4 may be transferred to those employees only if they are based on: Work instructions have been instructed and trained.
(2) The employer shall designate a person who is reliable and has a technical customer who is in high risk, prior to the inclusion of the activities of the protection level 3 or 4. He shall assign this person to the following tasks:
1.
Advice on
a)
the risk assessment in accordance with § 4,
b)
other issues relevant to safety,
2.
Support for the
a)
to monitor the effectiveness of the safeguard measures;
b)
Implementation of the instruction in accordance with § 14 (2),
3.
Verification of compliance with the safeguard measures.
The employer shall set out the tasks and powers of that person in writing. It shall not be penalised because of the performance of the tasks assigned to it. It is necessary to provide sufficient time for the performance of the tasks. The first sentence shall not apply to the activities of the biomaterials of the risk group 3 which are marked with (**). Unofficial table of contents

Section 11 Additional protective measures and requirements in the case of activities of protection level 2, 3 or 4 in health-service facilities

(1) In addition to the protective measures referred to in § 9, the employer shall, before taking up the activities of the protection level 2, 3 or 4, in health service facilities as a function of the risk assessment
1.
to establish effective disinfection and inactivation procedures,
2.
Surfaces which have to be disinfected in such a way that they are easy to clean and are resistant to the disinfectants used; in addition, the requirements of Annex II to surfaces shall apply to the activities of the protection level 4.
(2) The employer shall, in accordance with Section 9 (3), second sentence, point 1, point 1 pointed and sharp medical instruments to replace the activity by those in which there is no or lesser risk of stitch and cut injuries, as far as this is technically possible and necessary to avoid any risk of infection. (3) The employer has to ensure that used cannulas are not put back into the protective caps. Where activities are carried out which require a multiple use of the medical instrument according to the state of the art, and the needle must be put back into the protective cap, this shall be permitted if a procedure is applied (4) tip and sharp medical instruments can be safely disposed of after use. To this end, before taking up the activities, the employer has to provide waste containers which are resistant to sticking and breakage and which safely enclose the waste. It has to ensure that these waste containers can be clearly identified as waste containers by colour, form and labelling. Sentence 1 and 2 also apply to used medical instruments with protective equipment against stab and cut injuries. (5) The employer has the employees and their representations about injuries caused by used pointed or sharp injuries. medical instruments that have organizational or technical causes, to be informed in a timely manner. (6) Protection level 3 or 4 activities may only be entrusted to skilled workers who have been instructed and trained on the basis of work instructions. (7) Before taking up the activities of the Protection level 4 has the employer
1.
to define appropriate spatial protection level areas and to identify them with the protection level designation and the biohazard symbol referred to in Annex I,
2.
select and take the measures of protection level 4 from Annex II, which are necessary and appropriate to reduce the risks to workers and other persons;
3.
to appoint a person within the meaning of Article 10 (2) sentence 1 and to carry out the tasks in accordance with § 10 (2) sentence 2.
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§ 12 Occupation of occupational health

The Regulation on occupational health care in the current version shall also apply to the persons referred to in § 2 (9) sentence 2. Unofficial table of contents

§ 13 Operating disturbances, accidents

(1) The employer shall, before taking up an activity of protection levels 2 to 4, lay down the necessary measures which are necessary in the event of malfunctions or accidents, with a view to the effects on the safety and health of workers and to minimize other people and to restore normal operations. Depending on the nature of possible events and used or occurring bio-substances, the following shall in particular be established:
1.
First-aid measures and further assistance to workers in the event of accidental transfer of biosubstances, including the possibility of post-exposition prophylaxis,
2.
measures to prevent the disappearance of bio-substances,
3.
disinfection, inactivation or decontamination measures,
4.
testing is carried out as to whether the biosubstances used have reached the working environment in the event of malfunctions or accidents, to the extent that this is technically possible and that validated test procedures are in place.
In accordance with Section 14 (1) sentence 4, point 3, the stipulations are a component of the operating instructions. (2) The employer shall inform the employees of the measures and their application. If an operational disturbance or an accident occurs within the meaning of the first sentence of paragraph 1, the employer shall immediately take the measures laid down in accordance with the second sentence of paragraph 1. In the area of danger, only those persons who are required to achieve the objectives set out in paragraph 1 may remain in the area of danger. (3) Before taking up the activities of protection level 3 or 4 in laboratories, in the conservation of animals, in which: In addition to the provisions of paragraph 1, the employer shall draw up, in addition to the provisions laid down in paragraph 1, an internal plan to be drawn up in order to prevent the risks of such risks, which occur in the event of failure of a containment measure by release of biosubstances . It shall specify the specific hazards and the names of persons responsible for the internal rescue operations. The provisions shall be updated on a regular basis. The first sentence shall not apply to the activities of the biomaterials of the risk group 3 marked with (**). (4) In the case of activities of level 4 of protection, the plan referred to in paragraph 3 shall provide information on the scope of safety exercises and their regular implementation. provided that such safety exercises are necessary on the basis of the risk assessment. The measures referred to in paragraph 3 shall be coordinated with the relevant rescue and security services. In addition, the employer has to set up warning systems and to create communication opportunities, by which all the employees concerned can be immediately alerted and the rescue and security service can be alerted. The employer must ensure that these systems are functional. (5) The employer shall have a procedure for the reporting and investigation of accidents, as well as the procedure for informing employees, prior to the start of the activities. of their representations. The procedure shall be designed in such a way that, in the event of serious accidents, as well as in the event of needlestick injuries, possible organizational and technical accident causes can be identified and individual recrimination instructions are avoided. The employees and their representatives shall be informed without delay of any malfunctions and accidents involving biomaterials which may endanger the safety or health of workers. Unofficial table of contents

Section 14 Operating instructions and training of employees

(1) On the basis of the risk assessment according to § 4 prior to the commencing of the activity, the employer shall draw up a written operating instruction in relation to the work area and biosubstance related. The first sentence shall not apply if only activities with biosubstances of the risk group 1 are carried out without sensitising or toxic effects. The operating instructions shall be made available to the employees. It must be written in a form and language which is comprehensible to the employees and, in particular, must contain the following information:
1.
the risks associated with the activities envisaged for the employees, and in particular:
a)
the nature of the activity,
b)
the active substances used or occurring in the workplace, including the risk group, transmission routes and health effects,
2.
information on protective measures and codes of conduct to be carried out or to be observed by employees in their own protection and the protection of other employees in the workplace, in particular:
a)
in-company hygiene requirements,
b)
information on measures to be taken to prevent exposure, including the right use of sharp or pointed medical instruments,
c)
Information on the wearing, use and deposition of personal protective equipment, including protective clothing,
3.
instructions on behaviour and measures in the event of injuries, accidents and malfunctions, and their internal reporting and first aid,
4.
Information on the factual inactivation or disposal of biomaterials and contaminated objects, materials or work equipment.
The operating instructions must be updated at any significant change in working conditions. (2) The employer shall ensure that the employees are informed of the current operating instructions as referred to in the first sentence of paragraph 1 above. all hazards arising and the necessary protective measures are to be referred orally. The training must be carried out in such a way as to create a safety awareness among the employees. The employees must also be informed of the conditions under which they are entitled to occupational health care in accordance with the Regulation on occupational health care. In the course of the instruction, a general medical consultation is also to be carried out with references to special hazards, for example in the case of reduced immune defences. To the extent necessary, the physician or the physician must be involved in the provision of occupational health care in accordance with § 7 (1) of the Regulation on the provision of occupational health care. (3) The training must be carried out before the start of the employment and thereafter at least annually. , and shall be carried out in a form and language which is comprehensible to the employees. The content and date of the instruction must be recorded by the employer in writing and can be confirmed by the signed employees by signing. (4) For the activities of the protection levels 3 and 4, in addition to the operating instruction Create work instructions that must be in the workplace. Work instructions are also required for the following activities with increased risk of infection:
1.
Maintenance, cleaning, alteration or demolition work in or on contaminated work equipment,
2.
activities in which there is an increased risk of accidents,
3.
activities in which serious infections are to be expected in the event of an accident; this may be the case in the collection of samples of human or animal origin.

Section 4
Permission and disclosure requirements

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§ 15 permit

(1) The employer shall require the authorisation of the competent authority prior to the first inclusion in laboratories, in experimental animals or in biotechnology of the activities of Level 3 or 4 of protection. The permit shall include the structural, technical and organisational conditions laid down in this Regulation for the protection of employees and other persons from the risks related to such activities. The first sentence shall also apply to health service facilities provided for the activities of the protection level 4. Activities with biomaterials of the risk group 3, which are marked with (**), do not require any permission. (2) A other decision by the authorities, in particular a public authorisation or permission, shall be subject to the authorization referred to in paragraph 1. , the requirement referred to in paragraph 1 shall be fulfilled by sending a copy of that official decision to the competent authority. If necessary, the competent authority may request further documents. (3) The permission referred to in paragraph 1 shall be requested in writing. The application shall be accompanied by the following documents:
1.
the name and address of the employer;
2.
Name and qualification of the person named in accordance with § 10 (2) or § 11 (7) (3),
3.
the name of the holder of the authorisation pursuant to § 44 of the Infection Protection Act,
4.
Site plan, ground plan and name of the premises, including escape and rescue routes,
5.
description of the activities envisaged,
6.
Result of the risk assessment under indication
a)
the used or occurring bio-materials and the level of protection of the activity;
b)
the structural, technical, organisational and personal protective measures, including the information on the planned maintenance and maintenance of the structural and technical measures;
7.
Plan pursuant to Article 13 (3),
8.
Information on waste and waste water disposal.
If necessary, the competent authority may request further documents. (4) permission shall be granted if the requirements of this Regulation are met, which are necessary to protect the employees and other persons from the To ensure the risk of biosubstances. Unofficial table of contents

§ 16 Display obligation

(1) The employer shall indicate to the competent authority in accordance with paragraphs 2 and 3:
1.
the first-time reception
a)
a targeted activity with biomaterials of risk group 2,
b)
an activity with biomaterials of the risk group 3, in so far as the activities are not subject to a permit requirement in accordance with § 15,
in laboratories, in experimental animals and in biotechnology,
2.
any change in the permitted or displayed activities where they are relevant to safety and health protection, such as activities aimed at increasing the virulence of the biosubstance or the inclusion of activities with further biomaterials of the risk group 3 or 4,
3.
the inclusion of an infected patient in a patient station of protection level 4,
4.
the setting of an activity according to § 15.
(2) The ad shall include the following information:
1.
the name and address of the employer;
2.
description of the activities envisaged,
3.
the result of the risk assessment in accordance with § 4,
4.
the nature of the biosubstance,
5.
the measures envisaged for the protection of the safety and health of workers.
(3) The ad referred to in points 1, 2 or 4 of paragraph 1 shall be notified without delay at the latest 30 days before the date of inclusion or cessation of the activities, the notification referred to in paragraph 1 (3) shall be made without delay. the competent authority shall, within the time limit laid down in paragraph 3, send a copy of a notification, authorisation or authorisation in accordance with any other legislation, provided that such equivalent information is included.

Section 5
Implementation rules and Committee on Biological Work Materials

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Section 17 Information to the Authority

(1) The employer shall inform the competent authority immediately of:
1.
any accident or malfunction in the case of activities involving a risk group 3 or 4 of the risk group, which may lead to a health risk for the workers;
2.
Occupational diseases and deaths attributable to activities carried out with bioactive substances, with a precise indication of the activity.
(2) Without prejudice to § 22 of the German Labour Protection Act (Arbeitsschutzgesetz), the employer shall, at the request of the competent authority, forward the following:
1.
the documentation of the risk assessment,
2.
the list referred to in the first sentence of Article 7 (3) and the proof referred to in Article 7 (3), sentence 4, point 2,
3.
the activities in which employees have actually or may have been exposed to biosubstances and the number of such employees,
4.
the protective and preventive measures taken, including operational and operational instructions,
5.
the measures laid down or taken in accordance with Article 13 (1) and (2) and the plan drawn up pursuant to Article 13 (3).
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§ 18 Government exemptions

The competent authority may, on a written or electronic request from the employer, grant exemptions from the provisions of Sections 9, 10, 11 and 13, including Annexes II and III, if the implementation of the provision is to be carried out on a case-by-case basis. would lead to disproportionate hardship and the deviation applied for is compatible with the protection of the employees concerned. Unofficial table of contents

Section 19 Committee on Biological Work Materials

(1) At the Federal Ministry of Labour and Social Affairs, a Committee for Biological Agents (ABAS) is set up, in which technically suitable persons from the employers, the trade unions, the national authorities, the statutory accident insurance and other suitably qualified persons, in particular science, should be represented. The total number of members shall not exceed 16 persons. An alternate member shall be designated for each Member. The membership of the Committee is honorary. (2) The Federal Ministry of Labour and Social Affairs convenes the members of the Committee and the alternates. The Committee shall adopt its rules of procedure and elect the chairman or chairman from his centre. The Rules of Procedure and the election of the chairman require the approval of the Federal Ministry of Labour and Social Affairs. (3) The tasks of the Committee include:
1.
to identify the state of science, technology, occupational medicine and hygiene and other established findings for activities with biosubstances and to make appropriate recommendations, including such contributions, which shall be published in public usable information systems on bio-materials,
2.
to determine how the requirements set out in this Regulation can be met and to draw up the rules and findings of the relevant state of technology and medicine,
3.
carry out scientific assessments of biosubstances and propose their classification in risk groups;
4.
advise the Federal Ministry of Labour and Social Affairs on questions of biological safety.
The work programme of the Committee shall be coordinated with the Federal Ministry of Labour and Social Affairs. The committee works closely with the other committees at the Federal Ministry of Labour and Social Affairs. (4) After examination, the Federal Ministry of Labour and Social Affairs
1.
announce the rules and findings established by the Committee pursuant to paragraph 3, first sentence, point 2, as well as the classification in accordance with Article 3 (3) of the Joint Ministerial Gazan,
2.
publish the recommendations referred to in paragraph 3, first sentence, point 1, and the results of the consultations referred to in paragraph 3, first sentence, point 4, in an appropriate manner
(5) The Federal Ministries and the competent supreme state authorities may send representatives to the meetings of the Committee. The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) is responsible for carrying out the business of the committee.

Section 6
Administrative offences, criminal offences and transitional provisions

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§ 20 Administrative Offences

(1) In the sense of Section 25 (1) (1) of the German Labor Protection Act (Arbeitsschutzgesetz), who intentionally or negligently acts in accordance with the law of the law
1.
Contrary to § 4 (1) sentence 1, the risk to employees does not, not properly, be assessed in full or in time,
2.
, contrary to § 4 (2) sentence 1, a risk assessment shall not be updated or updated in good time;
3.
, contrary to the second sentence of Article 4 (2), a risk assessment shall not be reviewed or not reviewed in good time
4.
Contrary to the first sentence of Article 7 (1), a risk assessment shall not be documented, not correct, in full or in good time,
5.
contrary to § 7 (3), first sentence, a list referred to in the first sentence of this paragraph does not lead to the right or not
6.
the third sentence of Article 7 (3) of this Regulation shall not, or not be kept for at least ten years,
7.
, contrary to § 8 (4) (4), first half-sentence, personal protective equipment shall not be made available in time,
8.
Contrary to Article 9 (1), second sentence, point 3, it is not ensured that a washing facility is available,
9.
Contrary to § 9 (1) sentence 2, point 4, first half-sentence, it is not ensured that there is a possibility of changing over,
10.
does not maintain personal protective equipment provided for in the first half sentence of the first subparagraph of Article 9 (3), second sentence, point 5,
11.
, contrary to the second sentence of Article 9 (3), second sentence, point 7, the second half-sentence does not or does not establish in time
12.
Contrary to Article 9 (4), second sentence, it does not ensure that only containers referred to therein are used,
13.
, contrary to Article 10 (1) (1) (a) or Article 11 (7) (1), a protective stage area shall not be established or not identified in time, not properly or in time,
14.
, contrary to § 10 (2) sentence 1 or § 11 paragraph 7, point 3, a person shall not be appointed or not appointed in good time,
15.
, contrary to Article 11 (1) (1), the procedure referred to in paragraph 1 shall not or shall not
16.
Contrary to Article 11 (2), a so-called instrument shall not be replaced or replaced in due time;
17.
Contrary to Article 11 (3), first sentence, it does not ensure that a used cannula is not put back into the protective cap,
18.
contrary to Article 11 (4), first sentence, also in connection with sentence 4, the instrument referred to therein shall not be disposed of or shall not be disposed of in good time,
19.
shall not, contrary to the second sentence of Article 13 (1) (2), (2) or (3), establish a measure referred to therein, or
20.
Contrary to § 13 (3) sentence 1, an internal plan shall not be drawn up, not correctly, in full or in good time,
21.
, contrary to Article 13 (5), first sentence, a procedure for reporting and investigating casuals shall not be established or shall not be established
22.
Contrary to the first sentence of Article 14 (1), a written instruction manual shall not be drawn up, not correctly, in full or in time,
23.
Contrary to Article 14 (2), first sentence, it does not ensure that an employee is instructed,
24.
shall take up any activity referred to in paragraph 15 (1), first sentence, without the authorisation,
25.
Contrary to § 16, paragraph 1, an advertisement is not, not correct, not fully or not reimbursed in good time, or
26.
Contrary to § 17, paragraph 1, the competent authority does not, not correct, not fully or not informed in good time.
(2) An administrative offence within the meaning of Section 32 (1) (1) of the Heimarbeitsgesetz (Home Work Act) acts as a person who, intentionally or negligently, can carry out a specified activity in accordance with § 8 (7). Unofficial table of contents

Section 21 Crime

(1) Anyone who endangers the life or health of an employee by means of an intentional act referred to in § 20, paragraph 1, is liable to prosecution in accordance with Section 26 (2) of the German Occupation Protection Act. (2) Who by a deliberate act referred to in § 20 (2)) in Homework at risk of workers in their work force or health is punishable under Article 32 (3) or (4) of the Heimarbeitsgesetz (Home Work Act). Unofficial table of contents

Section 22 Transitional provisions

In the case of activities which have been included before the entry into force of this Regulation,
1.
in accordance with Article 10 (2) or Article 11 (7) (3), a competent person shall be appointed by 30 June 2014;
2.
shall not be subject to authorisation pursuant to Article 15 (1), provided that such activities have been indicated to the competent authority.
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Annex I, symbol for biohazard

(Fundstelle: BGBl. I 2013, 2525) Unofficial table of contents

Annex II Additional protective measures in the case of activities in laboratories and similar establishments and in the holding of experimental animals

(Fundstelle: BGBl. I 2013, 2526-2527)

A Protective measures B Protection levels 234
1.
The protection level area shall be demarcted from other protection levels or working areas in the same building.
recommended mandatory mandatory
2.
The protective step area must have as access a lock with doors that can be locked in relation to each other.
No mandatory if the transmission can be carried out via the air mandatory
3.
Access to the level of protection shall be restricted to designated employees.
binding on listed human pathogenic biomaterials * with access control mandatory with access control mandatory with access control
4.
A constant vacuum must be maintained in the protective stage area.
No shall be subject to a binding alert if the transmission can be carried out via the air Mandatory alarm monitoring
5.
Air and exhaust air must be passed through high-performance suspended particulate filters or a similar device.
No mandatory for exhaust air, if the transmission can be carried out via the air mandatory for supply and exhaust air
6.
The protective step area must be sealable for the purpose of gas treatment.
No mandatory if the transmission can be carried out via the air mandatory
7.
A microbiological safety cabinet or a technical facility with an equivalent level of protection must be used.
Mandatory for activities with aerosol formation mandatory mandatory
8.
Each protection level area must have its own equipment.
recommended mandatory mandatory
9.
Each protective stage area must have an autoclave or equivalent sterilization unit.
recommended mandatory if the transmission can be carried out via the air mandatory
10.
Contaminated process waste air must not be delivered to the workspace.
mandatory mandatory mandatory
11.
Effective disinfection and inactivation procedures should be established.
mandatory mandatory mandatory
12.
The areas mentioned above must be water-impermeable and easy to clean.
Workbenches Workbenches and floors Workbenches, walls, floors and ceilings
13.
Surfaces must be resistant to the chemicals used and disinfectants used.
mandatory mandatory mandatory
14.
Decontamination and washing facilities for the employees must be present.
mandatory mandatory mandatory
15.
Employees have to shower before leaving the protective stage area.
No recommended mandatory
16.
Contaminated solid and liquid waste must be deactivated prior to final disposal by means of proven physical or chemical processes.
shall be binding if appropriate order management is not carried out binding if the transmission can be carried out via the air; otherwise, in principle binding, only in duly substantiated individual cases an appropriate order disposal is possible mandatory
17.
Waste water is to be deactivated before final disposal by means of proven physical or chemical processes.
No for hand washing and shower water or comparable waste water recommended for hand washing and shower water mandatory
18.
Provision should be made for a viewing window or similar device for inspection of the working area.
mandatory mandatory mandatory
19.
In the case of single work, an emergency call should be provided.
recommended mandatory mandatory
20.
Windows must not be open.
no; windows must be closed during activity mandatory mandatory
21.
Emergency power supply shall be provided for safety-relevant installations.
recommended mandatory mandatory
22.
Biosubstances must be kept under closure.
binding on listed human pathogenic biomaterials * binding on listed human pathogenic biomaterials * mandatory
23.
An effective control of vectors (for example of rodents and insects) must be carried out.
recommended mandatory mandatory
24.
Safe disposal of infected animal carcasses, for example by thermal inactivation, incinerators for animal carcasses or other suitable sterilisation/inactivation devices.
mandatory mandatory Mandatory on site
Note:
In accordance with Article 10 (1), the protective measures referred to as recommended are to be taken when the risks to the workers can be reduced.
*
In Annex I to Regulation (EU) No 388/2012 of the European Parliament and of the Council of 19 April 2012 amending Council Regulation (EC) No 428/2009 setting up a Community regime for the control of exports, the shipment, the Transfer and transit of dual-use items (OJ L 196, 27.7.2001, p. 12) under 1C351 listed human pathogens as well as genetically modified organisms listed in 1C353.
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Annex III Additional protective measures in respect of activities in biotechnology

(Fundstelle: BGBl. I 2013, 2528) The requirements set out in Annex II shall apply. In addition, the following applies to activities with biochemical substances in biochemical equipment, such as bioreactors and separators:

A Protective measures B Protection levels 234
1.
The apparatus must physically separate the process from the environment.
mandatory mandatory mandatory
2.
The apparatus or a comparable installation shall be within a corresponding protective stage range.
mandatory mandatory mandatory
3.
The process waste air of the apparatus must be treated in such a way that release of biosubstances
is minimized. is prevented. is reliably prevented.
4.
The opening of the apparatus, for example for sampling, adding substances or for the transfer of biosubstances, must be carried out in such a way that the release of biosubstances
is minimized. is prevented. is reliably prevented.
5.
For further processing, culture liquids may only be removed from the apparatus if the removal is carried out in a closed system or if the biomaterials have been inactivated by effective physical or chemical processes.
recommended mandatory mandatory
6.
Seals on the apparatus must be such that an inadvertent release of biosubstances
is minimized. is prevented. is reliably prevented.
7.
The entire contents of the apparatus must be able to be collected.
mandatory mandatory mandatory
Note:
In accordance with Article 10 (1), the protective measures referred to as recommended are to be taken when the risks to the workers can be reduced.