Regulation On Safety And Health At Work 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 at work with biological agents (Biochemical Ordinance-BioStoffV)

Non-official table of contents

BioStoffV

Date of expend: 15.07.2013

Full quote:

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

Footnote

(+ + + Text evidence from: 23.7.2013 + + +)

The V was defined as the 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 for Economic Affairs and technology and the Federal Ministry of Labour and Social Affairs. She's gem. Art. 3 sentence 1 of this V entered into force on 23.7.2013. unofficial table of contents

content overview

section 1
Scope,
definitions and risk group classification
§ 1Scope
§ 2 Definitions
§ 3Classification of biosubstances in risk groups
Section 2
Risk Assessment,
Protection Level Mapping,
Documentation and Recording obligations
§ 4 Risk assessment
§ 5Activities with protection level assignment
§ 6 Activities without a protective level map
§ 7Risk assessment documentation and Recording
Section 3
Basic obligations and protection measures
§ 8 Basic Obligations
§ 9General Protections
§ 10 Additional protective measures and requirements for protection level 2, 3 or 4 activities in laboratories, in experimental animals and in biotechnology
§ 11Additional protective measures and requirements in the activities of protection level 2, 3 or 4 in health service facilities
§ 12occupational health care
§ 13Operating Disruptions, Accidents
§ 14Operating instruction and instruction of
Section 4
Permission and display requirements
§ 15permission to permission
§ 16 Display
Section 5
Enforcement Regulations and
Committee for Biological Work Materials
§ 17Authority information
§ 18Authorities exceptions
§ 19Committee on Biological Work
Section 6
Irregularities,
offences and transitional rules
§ 20Administrative Offences
§ 21 offenses
§ 22Transitional rules
appendix I icon for biohazard
Appendix IIAdditional protections for activities in laboratories and comparable facilities as well as in experimental animals
Annex IIIAdditional protective measures in the case of activities in the Biotechnology

Section 1
Scope, definitions, and risk group classification

unofficial table of contents

§ 1 Scope

(1) This regulation applies to activities with biological agents (biomaterials). 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, insofar as these can be endangered by the use of biomaterials by employees or by entrepreneurs without employees.(2) The Regulation shall also apply to activities which are subject to genetic engineering, provided that there are no equivalent or stricter rules on the protection of employees. Non-official table of contents

§ 2 Definitions

(1) Biomaterials are
1.
Microorganisms, cell cultures and endoparasites, including their genetically modified forms,
2.
with transmissible spongiform encephalopathy (TSE) associated agents,
which make people aware of infections, communicable diseases, toxins, sensitising or other health effects which may cause adverse health effects.(2) The equivalent of biofuels is
1.
Ectoparasites, which cause disease in humans or cause sensitising or toxic effects. ,
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 which are capable of propagating or passing on genetic material, in particular bacteria, viruses, protozoa and fungi.(4) Cell cultures are in vitro-propagated cells, which have been isolated from multicellular organisms.(5) Toxins referred to in paragraph 1 are metabolic products or cell constituents of biosubstances which, as a result of inhalation, swallowing or uptake of the skin, cause toxic effects in humans, and thereby become acute or chronic can cause health damage or death.(6) Biomaterials of the risk group 3, which are identified by (**), are those which limit the risk of infection for employees, because transmission via the airway cannot normally be carried out. These biosubstances are listed 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 C 327, 28.12.2000, p. 21) and in the notices referred to in Article 19 (4) (1).(7) Activities are
1.
The use of biomaterials, in particular the isolation, production and increase, the closing, the consumption and processing, the processing, the refilling and refilling, mixing and separation as well as the intra-company transport, storage, including storage, deactivation and disposal, as well as
2.
professional work with humans, animals, plants, products, objects or materials, when biomaterials occur or are released on the basis of these works and employees
(8) Targeted activities are available when
1.
directly aligns the activities to one or more biosubstances ,
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 well known or estimable.
Non-targeted activities are available if at least one requirement after sentence 1 is not available. This is in particular given in the case of activities referred to in paragraph 7 (2).(9) Employees are persons who are designated as such in accordance with Section 2 (2) of the German 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, especially in scientific institutions and institutions of the Health Service,
4.
in homework Employees according to § 1 paragraph 1 of the Heimarbeitsgesetz.
On pupils, students and other Persons referred to in point 3 shall not apply the provisions of this Regulation concerning the participation of the representations.(10) Employers are those who are designated as such in accordance with Section 2 (3) of the Employment Protection Act. The employer is the same as
1.
of the entrepreneurs without employees,
2.
the client and the intermediate master within the meaning of the Home Work Act.
(11) It is a specialist within the meaning of this Regulation who is competent to perform a task defined in this Regulation. 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 vulnerability, it may also be necessary to participate in specific training activities.(12) The state of the art is the state of development of advanced procedures, facilities or modes of operation which makes 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 with success in practice.(13) Protection levels are based on the risk group of the respective bioactive substance 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 protection levels shall include the additional protective measures set out or recommended in Annexes II and III.(14) Health service facilities provided for in this Regulation are workplaces where people are medically examined, treated or cared for, or where they are medically examined or treated in an outpatient manner.(15) Biotechnology within the meaning of this Regulation shall include biotechnological production and biotechnological research under the targeted use of defined biosubstances. Non-official table of contents

§ 3 Classification of biosubstances in risk groups

(1) Biomaterials will be produced according to the Risk of infection according to the state of science in one of the following risk groups:
1.
Risk group 1: Biomaterials, where it is unlikely that they will in humans, causing a disease,
2.
Risk group 2: Biomaterials that can cause disease in humans and pose a risk to employees The population is unlikely to be spread in the population; effective prevention or treatment is normally possible
3.
Risk group 3: Biomaterials, which can cause a serious disease in humans and may pose a serious risk to workers; there may be a risk of spread in the population, but effective prevention or treatment is normally possible,
4.
Risk group 4: Biomaterials that cause a serious illness in humans and pose a serious risk to employees; the danger of a Distribution in the population may be large; normally, effective prevention or treatment is not possible.
(2) For the classification of the biosubstances in risk groups 2 to 4, Annex III to Directive 2000 /54/EC of the European Parliament and of the Council of the European Union 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 C 327, 28.12.2000, p. 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 shall be applied at the end of the period of transposition laid down.(3) If a biosubstance is not classified in accordance with paragraph 2, the Federal Ministry of Labour and Social Affairs may, after consultation by the Committee according to § 19, make the classification into a risk group as referred to in paragraph 1. The ratings will be announced in the Joint Ministerial Gazan. The employer has to comply with these steps.Where a biosubstance does not have a classification as referred to in paragraph 2, or in accordance with paragraph 3, the employer who intends to carry out a specific activity with that biosubstance shall have to classify it in one of the risk groups referred to in paragraph 1. In doing so, the employer has to consider the following:
1.
For the classification of several risk groups, the biosubstance is in the highest eligible risk group. To classify a 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 to be that these viruses cause a disease in humans,
3.
strains that have been weakened or have lost known virulence genes may be subject to a appropriate identification and evaluation to be classified in a lower risk group than the parent strain (parentaler strain); if the parent strain is classified in the risk group 3 or 4, a downgrade can only be based on a scientific evaluation, which may in particular be carried out by the Committee according to § 19.

Section 2
Risk assessment, protection level assignment, documentation and Recording requirements

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§ 4 Risk assessment

(1) Within the scope of the risk assessment according to § 5 The employment protection act has the employer to assess the risks to the employees of the activities with biomaterials prior to the commence of the activity. The risk assessment shall be carried out expertly. If the employer does not have the appropriate knowledge himself, he/she has to be advised with expert advice.(2) The employer shall immediately update the risk assessment if
1.
significant changes in working conditions or new information, on the Example of accident reports or findings from occupational health check-ups, this requires or
2.
the examination of the function and effectiveness of the The employer has provided that the protective measures laid down are not effective.
Otherwise, the employer shall check the risk assessment at least every other year and update it if necessary. If the examination reveals that an update of the risk assessment is not necessary, the employer shall note this in the documentation provided for in § 7, indicating the date of the review.(3) For the risk assessment, the employer shall identify in particular the following:
1.
Identity, risk group classification and transmission routes of the biosubstances, of which: Possible sensitising and toxic effects and reception paths where such information is available to the employer, including information on whether the bio-substances other health-damaging effects ,
2.
Type of activity, taking into account operational procedures, working methods and tools used, including Operating systems,
3.
The nature, duration and frequency of exposure of employees, as far as this information is available to the employer,
4.
The possibility of using biomaterials, working methods or work equipment that would lead to no or a lower hazard for employees (substitution check),
5.
Activity-related insights
a)
on stress and Exposure situations, including mental stress,
b)
about known diseases and the countermeasures to be taken,
c)
from occupational health care.
4) On the basis of the information determined in accordance with paragraph 3, the employer has the risk of infection and the To assess risks, independently of each other, by sensitising, toxic or other harmful effects on health. 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 the case of an activity.(5) If, in the case of activities with products containing biosubstances, the necessary information on risk assessment, such as risk group classification, is not to be determined, the employer shall be required to do so by the manufacturer, importer or Get on the market. The first sentence shall not apply to food products in the form of finished products intended for final consumption. Non-official table of contents

§ 5 Activities with a protective level assignment

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

(1) Activities not covered by Section 5 (1) do not have to be protected shall be assigned. These are activities within the meaning of Section 2 (7) (2). These activities include, for example, cleaning and refurbishment work, veterinary medicine, land, forestry, sewage and waste management, as well as in biogas plants and slaughterhouses.(2) In these activities, one of the information referred to in Article 4 (3) (1) and (3) may not be determined because the range of biosubstances occurring is subject to fluctuations or changes in the nature, duration, height or frequency of exposure , the employer shall, in particular, determine the information required for the risk assessment and the determination of the protective measures, based on
1.
Notices according to § 19 paragraph 4,
2.
Experience from comparable activities or
3.
Other trusted work science.
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§ 7 Documentation of risk assessment and recording obligations.

(1) The employer has the risk assessment regardless of the number of To document, for the first time, before the start of the activity, and thereafter every update according to sentence 2. The documentation of the risk assessment shall include, in particular, the following information:
1.
the type of activity, including exposure conditions,
2.
the result of the substitution check in accordance with § 4, paragraph 3, point 4,
3.
determined in accordance with § 5, paragraph 2 Protection levels,
4.
the protection measures to be taken
5.
a justification when the (
)
part of the documentation, the employer has to draw up a list of the biosubstances used or occurring (list of biosubstances), insofar as these are known and are relevant for 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 accessible to all employees concerned and to their representations.(3) In the case of the 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 malfunctions which have occurred. It shall be kept for a period of at least ten years after the end of the activity. The employer has
1.
to make the information in the directory accessible to the employees; the protection of the personal data is to be made available to the employer. ensure,
2.
when the employment relationship is terminated, an excerpt of the information in the list concerning him or her; the person concerned shall be responsible for the Proof of delivery must be kept by the employer, such as personnel records.
The list of employees may be kept together with the biochemical list 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 the risk group 1 without sensitising or toxic effects

Section 3
Basic obligations and protections

Non-official Table of contents

§ 8 Basic requirements

(1) The employer has to include the concerns of occupational safety and health in relation to activities with biomaterials in his company organisation and for this purpose the necessary human, financial and organisational requirements. In doing so, it shall involve the representations of the employees in a suitable form. In particular, he has to ensure that
1.
in the organization of work organization, work and workplace, and in the selection and Provision of work equipment all factors related to the safety and health of workers, including psychic, sufficiently taken into account
2.
The employees or their representatives are involved in the operational possibilities when new work equipment is to be introduced, the impact on security and Employees ' health.
(2) The employer has to take appropriate measures to ensure safety awareness among employees and to provide occupational health and safety in the case of activities with biomaterials. to develop.(3) The employer shall not be allowed to start an activity with biomaterials until the risk assessment in accordance with § 4 has been carried out and the necessary measures have been taken.(4) Before taking up the activity, the employer shall replace
1.
with the priority of replacing dangerous biosubstances by those which are not or less dangerous, to the extent that this is done by the Type of activity or state of the art is possible,
2.
Working methods and work equipment to be selected or designed in such a way that biosubstances in the workplace are not if the risk to the employees cannot be excluded by means of a measure according to point 1,
3.
the exposure of the employees by appropriate to reduce structural, technical and organisational measures to a minimum if a hazard to workers cannot be prevented by a measure referred to in paragraph 1 or point 2 or if the biosubstances are released in accordance with their intended purpose ,
4.
additional personal protective equipment shall be made available if the measures referred to in points 1 to 3 are not sufficient to exclude the risk The employer shall limit the use of personal protective equipment to the extent strictly necessary and shall not provide them as a permanent measure.
(5) The employer shall have the following: To establish and take protective measures on the basis of the risk assessment according to the state of the art as well as on the basis of scientific knowledge. To that end, it shall 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 secured scientific knowledge has been developed and the safety of work is considerably increased by this further development, the protective measures must be adapted within a reasonable period of time.(6) The employer shall regularly review 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 shall be used for the verification of effectiveness of the corresponding safeguard measures.(7) In the case of home work, the employer shall only be able to carry out activities with biomaterials of the risk group 1 without sensitizing or toxic effects. Non-official table of contents

§ 9 General protection measures

(1) In all activities with biosubstances, at least the general hygiene measures must be taken shall be complied with. In particular, the employer has to ensure that
1.
keeps jobs and work equipment in a clean state corresponding to the work schedule and regularly cleaned,
2.
floors and surfaces of work equipment and working surfaces are easy to clean,
3.
washbasins are available,
4.
there are separate changing options from the workplace where working clothes are required, the work clothes shall be regularly and, if necessary, to be changed and cleaned.
(2) In the case of activities in laboratories, in experimental animals, in biotechnology and in establishments of the In addition to the measures provided for in paragraph 1, the employer has to take into account specific hygiene measures in accordance with the rules and findings announced in accordance with Article 19 (4) (1) of the health service.(3) Where there are not exclusively activities carried out with biomaterials of the risk group 1 without sensitizing and toxic effects, the employer shall take further protective measures as a function of the risk assessment. In particular, he has to design or select
1.
working methods and work equipment in such a way that the exposure of the employees to biomaterials and the danger are prevented or minimized by stitching and cutting injuries, as far as this is technically possible,
2.
Activities and working methods with dust or Aerosol formation, including purification procedures, 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; if this is not possible, the employer shall take appropriate measures to: To minimise exposure,
3.
the number of workers exposed to the level of exposure required to carry out the activity
4.
The necessary measures for disinfection, inactivation or decontamination, as well as for the proper and safe disposal of biomaterials, contaminated objects, materials and equipment,
5.
personal protective equipment made available, including protective clothing, Clean, maintain, maintain and properly dispose of; employees must use the personal protective equipment provided as long as there is a risk,
6.
creating the conditions to ensure that personal protective equipment, including protective clothing, is safely deposited when leaving the workplace and separated from others items of clothing can be stored,
7.
to ensure that employees do not have food and drink in work areas where biomaterials may occur. For this purpose, before taking up the activities, the employer shall set up separate areas which must not be entered with personal protective equipment, including protective clothing.
(4) The employer shall have: To safely store biomaterials, to transport them safely within the company and to take precautions to prevent misuse or misuse. In doing so, it has to ensure that only containers that
1.
are suitable for their quality are used to ensure that the contents are safe to use.
2.
so that the hazards are clearly visible in a suitable way,
3.
in terms of shape and marking, designed to ensure that the content cannot be confused with food.
(5) In the medical examination, treatment and Care of patients outside of healthcare facilities is subject to § 11 (2) to (5). In the case of such activities, the employer shall determine in working instructions the handling of personal protective equipment and working clothes, as well as the necessary hygiene and disinfection measures. Non-official table of contents

§ 10 Additional protection measures and requirements for protection level 2, 3 or 4 activities in laboratories in which Experimental animal husbandry and 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 animals or in biotechnology.
1.
corresponding to the
a)
protection level map
appropriate spatial protection level ranges and to identify with the protection level designation as well as the biohazard symbol referred to in Annex I,
b)
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 risk to workers
2.
used
3.
Access to the biomaterials of risk group 3 or 4 on the basis of the requirement laid down in Article 11 (4) of the requirement to be safely disposed of,
3.
competent, competent and reliable employees; the activities of protection level 3 or 4 may only be entrusted to these employees if they have been instructed and trained on the basis of work instructions.
(2) An employer must designate a person who is reliable and has a technical customer who is in high risk, prior to the inclusion of the activities of protection level 3 or 4. He has the following tasks to do:
1.
Consulting at
a)
Risk assessment according to § 4,
b)
other safety-related issues
2.
Support at
a)
Control effectiveness control,
b)
Implementation of the instruction in accordance with § 14 paragraph 2
3.
Review 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 shall be available for sufficient time to carry out the tasks. The first sentence shall not apply to activities involving the biomaterials of the risk group 3, which are marked with (**). Non-official table of contents

§ 11 Additional protection measures and requirements for protection level 2, 3, or 4 activities in facilities of the Health service

(1) In addition to the safeguard measures in accordance with § 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 set effective disinfection and inactivation procedures,
2.
surfaces that must 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 protection level 4.
(2) In accordance with Article 9 (3), second sentence, point 1, employers shall replace sharp medical instruments prior to taking up the activity by means of which there is no or lesser risk of stitch and cut injuries, to the extent that this is not the case. is technically possible and is required to avoid infection.(3) The employer shall 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 , which permits a safe return of the cannula into the protective cap with one hand.(4) Tip and sharp medical instruments are safe to dispose 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 devices against stitch and cut injuries.(5) The employer shall inform the employees and their representatives in a timely manner of injuries caused by used pointed or sharp medical instruments, which have organisational or technical causes. It has to determine the procedure for doing so.(6) The activities of protection level 3 or 4 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 protection level 4, the employer
1.
shall set appropriate spatial protection level ranges and shall have the protection level designation as well as with to mark the biohazard symbol referred to in Annex I,
2.
to select and take the measures of protection level 4 from Annex II, which are necessary and appropriate , to reduce the risk to employees and other persons,
3.
to name a person within the meaning of § 10 (2) sentence 1 and to carry out the tasks according to § 10 the second sentence of paragraph 2.
Non-official table of contents

§ 12 occupational health care provision

The Regulation on occupational health and safety Provision in the current version shall also apply to the group of persons referred to in Article 2 (9) sentence 2. Unofficial Table Of Contents

§ 13 Operating Disruptions, Accidents

(1) The employer has before commend an activity of protection levels 2 to 4 to take the necessary measures to minimise the impact on the safety and health of workers and other persons in the event of malfunctions or accidents, and to restore the normal operating procedure. In particular, depending on the type of possible event and used or occurring biofuel, the following shall be determined:
1.
First aid and Further assistance for employees in the event of accidental transfer of biosubstances, including the possibility of post-exposition prophylaxis,
2.
Measures to prevent a spilling of biosubstances,
3.
Disinfection, inactivation, or Decontamination measures,
4.
that it is tested as to whether the biosubstances used have reached the working environment in the event of malfunctions or accidents, to the extent that this is not the case. is technically possible and there are validated test procedures.
The specifications are part of the operating instructions in accordance with Section 14 (1) sentence 4, point 3.(2) The employer shall inform the employees of the measures defined 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 experimental animals, in biotechnology and prior to taking up the activities of protection level 4 in health service facilities, the employer has to supplement the To establish, in accordance with paragraph 1, an internal plan on how to repel risks which may arise in the failure of a containment measure to be caused by the 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 activities involving the biomaterials of the risk group 3, which are marked with (**).(4) In the case of activities of level 4 of protection, the plan referred to in paragraph 3 shall contain 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 possibilities, which will immediately alert all the employees concerned and alert the rescue and security service. The employer has to ensure that these systems are functioning.(5) Before taking up the activities, the employer shall establish a procedure for the reporting and investigation of accidents, as well as the procedure for informing the employees and 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 organisational and technical causes of accidents 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. Non-official table of contents

§ 14 Operating instruction and instruction of the employees

(1) The employer has based on the Risk assessment according to § 4 prior to the start of the activity a written instructions for the production of the work area and biosubstance related. The first sentence shall not apply if only activities with biomaterials 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, it must contain the following information:
1.
which shall be provided with the intended Activities related risks to the employees, in particular to
a)
the type of activity,
b)
the activity-relevant biomaterials used or occurring in the workplace, including the risk group, transmission routes and health effects
2.
Information on protective measures and behavioural rules that employees have on their own protection and the protection of other employees Perform or have to comply with; in particular,
a)
Incorporate hygiene preferences,
b)
Information about measures to be taken to prevent exposure, including the correct use of sharp or pointed medical Tools,
c)
Information about wearing, using, and placing personal protective equipment, including protective clothing
3.
Instructions on behavior and action in case of injury, accident and operational malfunction, and their internal reporting and first help,
4.
Information on the proper deactivation or disposal of biomaterials and contaminated objects, materials or equipment.
The operating instruction must be any significant change in working conditions.(2) The employer shall ensure that the employees are instructed orally on the basis of the current operating instructions provided for in the first sentence of paragraph 1 above all hazards and the necessary protective measures. 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 consultation in accordance with § 7 (1) of the Ordination on occupational health care.(3) The training must be carried out before the start of employment and thereafter at least annually in terms of employment, and must 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 undersigned employees by signing.(4) In addition to the operating instructions, work instructions must be drawn up for the activities of protection levels 3 and 4, which must be available at the workplace. Work instructions are also required for the following activities with increased risk of infection:
1.
Maintenance, cleaning, modification, or demolition work in or contaminated work equipment,
2.
Activities where there is an increased risk of accident,
3.
Activities that are likely to be affected in an accident with serious infections; this may be the case in the removal of samples of human or animal origin.

Section 4
Permission and Display Obligations

Unofficial Table Of Contents

§ 15 

(1) The employer requires the authorisation of the competent authority before the first inclusion in laboratories, in experimental animals or in biotechnology of the activities of protection level 3 or 4. 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 stage 4. Activities with biomaterials of the risk group 3, marked with (**), do not require any permission.(2) In the event that a different official decision, in particular a public service authorization or permission, has been granted permission in accordance with paragraph 1, the requirement referred to in paragraph 1 shall be sent by sending a copy of that official decision the competent authority. If necessary, the competent authority may request further documentation.(3) The permission referred to in paragraph 1 shall be requested in writing. The application must be accompanied by the following documents:
1.
The name and address of the employer,
2.
Name and empowerment of the person named in accordance with § 10 (2) or § 11 (7) (3),
3.
Name of the Permission holder according to § 44 of the Infection Protection Act,
4.
Site plan, layout and designation of the premises including escape and Rescue paths,
5.
Description of scheduled activities,
6.
Result of the Risk assessment, specifying
a)
of the used or occurring biomaterials and the level of protection of the activity,
b)
the constructional, technical, organizational and personal protective measures, including the information on the planned maintenance and maintenance of the building and technical equipment Measures
7.
Plan according to § 13, paragraph 3,
8.
Information about the waste and Waste water disposal.
If required, the competent authority may request further documentation.(4) permission shall be granted if the requirements of this Regulation are met, which are necessary to ensure the protection of employees and other persons from the hazards of biosubstances. Non-official table of contents

§ 16 Display obligation

(1) The employer must show the competent authority in accordance with the provisions of paragraphs 2 and 3:
1.
first-time recording
a)
a targeted activity with risk group biomaterials 2,
b)
an activity with biomaterials of the risk group 3, in so far as the activities are not subject to a permission requirement in accordance with § 15,
in laboratories in which: Animal testing and biotechnology,
2.
any change in the permitted or displayed activities, if they are intended for safety and health protection are significant, for example, activities that aim to increase the virulence of the biosubstance or to take up activities with other biomaterials of the risk group 3 or 4,
3.
the inclusion of an infected patient in a patient station of protection level 4,
4.
setting 1.
(2) The display shall include the following information:
1.
employer name and address,
2.
Description of the activities envisaged,
3.
the result of the risk assessment according to § 4,
4.
the nature of the biosubstance,
5.
the safety and security measures provided for
(3) The ad referred to in points 1, 2 or 4 of paragraph 1 shall take place no later than 30 days before the date on which the activities are carried out, or the notification referred to in paragraph 1 (3) shall be notified without delay.(4) The obligation to notify may also be satisfied by the fact that, within the time limit specified in paragraph 3, the competent authority shall be sent a copy of an ad, authorisation or authorisation in accordance with another piece of legislation, where that provision is

Section 5
Full Enforcement Regulations and Committee on Biological Agents

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§ 17 Information to the authority

(1) The employer must immediately inform the competent authority of
1.
any accident or malfunction in the activities of risk group 3 or 4 biomaterials, which may lead to a health hazard for employees,
2.
Health and death cases related to activities related to biomaterials, specifying the activity.
(2) Without prejudice to § 22 of the The employer of the competent authority shall, at its request, submit the following to the employer:
1.
the documentation of the Risk assessment,
2.
the list according to § 7 (3) sentence 1 as well as the proof in accordance with § 7 paragraph 3 sentence 4, point 2,
3.
the activities where employees have actually or may have been exposed to biomaterials and the number of these employees,
4.
the protection and precautionary measures taken, including the operating and operating instructions,
5.
the measures defined or taken pursuant to § 13 (1) and (2) and the plan drawn up in accordance with § 13 paragraph 3.
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§ 18 exceptions to the authorities

The competent authority may, on the written or electronic request of the employer, make exceptions to the provisions of § § 9, 10, 11 and 13, including Annexes II and III, where the implementation of the provision would lead to a disproportionate degree of hardship in individual cases and the derogation requested is compatible with the protection of the employees concerned. Non-official table of contents

§ 19 Committee on Biological Agents

(1) At the Federal Ministry of Labour and Social Affairs, a committee shall be set up for Biological agents (ABAS), in which technically appropriate persons on the part of the employers, the trade unions, the national authorities, the statutory accident insurance and other persons, in particular the scientific community, are suitable for the benefit of the public. to 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 voluntary.(2) The Federal Ministry of Labour and Social Affairs shall convene 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 or the Chairperson shall require the approval of the Federal Ministry of Labour and Social Affairs.(3) The tasks of the Committee include:
1.
The state of science, technology, occupational medicine and hygiene, as well as other secured findings for identify and make recommendations for activities with biomaterials, including those that can be used in publicly available information systems on biosubstances,
2.
to determine how the requirements set out in this Regulation can be met and the rules and findings corresponding to the state of technology and medicine ,
3.
To make scientific assessments of biomaterials and to propose their classification in risk groups,
4.
the Federal Ministry of Labour and Social Affairs to advise on biological safety issues.
The work programme of the Committee will be discussed with the Federal Ministry of Labour and Social vote. 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.
may adopt the rules and findings determined by the Committee in accordance with the first sentence of paragraph 3, point 2, and the Classification according to § 3 (3) of the Joint Ministerial Gazan,
2.
the recommendations referred to in paragraph 3, first sentence, point 1, as well as the consulting results referred to in paragraph 3 Article 1 (4) shall be published in a suitable manner.
(5) The Federal Ministries and the competent national authorities may send representatives to the meetings of the Committee. The latter shall be given the floor at the request at the request.(6) The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) conducts the business of the committee.

Section 6
Administrative Offences, Crime and Transitional Regulations

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§ 20 Administrative Offences

(1) Administrative Offences within the meaning of Section 25 (1) (1) of the German Labor Protection Act (Arbeitsschutzgesetz) Intentionally or negligently
1.
contrary to § 4, paragraph 1, sentence 1, the risk to employees not, not correct, not complete or not in good time ,
2.
contrary to § 4, paragraph 2, sentence 1, a risk assessment is not updated or updated in time,
3.
contrary to § 4, paragraph 2, sentence 2, a risk assessment is not reviewed or not checked in time,
4.
contrary to § 7, paragraph 1, sentence 1, a risk assessment not, not correct, not complete or not documented in good time,
5.
contrary to § 7, paragraph 3, sentence 1, a directory named there is not, not correct, or not complete,
6.
contrary to § 7, paragraph 3, sentence 3, a directory named there not or not at least ten years,
7.
contrary to § 8, paragraph 4, point 4, first half-sentence, personal protective equipment is not available or is not available in time,
8.
contrary to § 9, paragraph 1, sentence 2, point 3, it does not make sure that a washing facility is available,
9.
contrary to § 9, paragraph 1, sentence 2, point 4, first half-sentence does not ensure that there is a locker room,
10.
contrary to § 9, paragraph 3, sentence 2, sentence 5, first half-sentence, personal protective equipment is not maintained,
11.
contrary to § 9, paragraph 3, sentence 2, second sentence, second half-sentence, do not set up areas in time or do so in a timely manner,
12.
contrary to § 9, paragraph 4, sentence 2, it does not ensure that only containers named therein are used,
13.
contrary to § 10 (1) (1) (a) or § 11 (7) (1), a level of protection is not or is not fixed in time or not, not correct or not in good time
14.
contrary to § 10, paragraph 2, sentence 1 or § 11, paragraph 7, point 3, a person shall not be named or not named in due time,
15.
contrary to § 11, paragraph 1, point 1, a procedure referred to there is not set or not fixed in time,
16.
contrary to § 11, paragraph 2, an instrument referred to there is not replaced or not replaced in time,
17.
§ 11 Paragraph 3 sentence 1 does not ensure that a used cannula is not reinserted into the protective cap,
18.
contrary to § 11, paragraph 4, sentence 1, also in connection with with the fourth sentence, the instrument referred to therein, not disposed of or not disposed of in due time,
19.
contrary to § 13 (1) sentence 2, point 1, 2 or 3, a measure not referred to there or not in a timely manner,
20.
contrary to § 13, paragraph 3, sentence 1, an intra-company plan, not correct, not complete or not in good time
21.
contrary to § 13, paragraph 5, sentence 1, a procedure for accident reporting and investigation is not or not fixed in time,
22.
contrary to § 14, paragraph 1, sentence 1, a written instruction manual, not correct, not complete, or not created in time,
23.
contrary to § 14, paragraph 2, sentence 1, not ensuring that an employee is instructed,
24.
without Permission in accordance with § 15 (1) sentence 1 to take up an activity mentioned there,
25.
contrary to § 16, paragraph 1, an advertisement not, not correct, not complete or not in a timely manner, or
26.
contrary to § 17 (1), the competent authority does not, not properly, not fully or not informed in good time.
(2) In the sense of Section 32 (1) (1) of the Heimarbeitsgesetz (Home Work Act), the person who intentionally or negligently makes an activity referred to in paragraph 8 (7) is acting in a manner contrary to § 8 (7). Non-official table of contents

§ 21 offenses

(1) Who, by means of an intentional act referred to in § 20, paragraph 1, of a life or health of a Employees at risk shall be punishable in accordance with Section 26 (2) of the German Employment Protection Act (Arbeitsschutzgesetz).(2) Anyone who endangers employees in their work force or health by means of an intentional act referred to in § 20 (2) in homework shall be punishable under Article 32 (3) or (4) of the Heimarbeitsgesetz (Home Work Act). Non-official table of contents

§ 22 Transitional rules

For activities that have been included before the entry into force of this Regulation,
1.
is an expert person up to the age of 30, in accordance with § 10 (2) or § 11 (7) (3). June 2014,
2.
does not require a permit pursuant to § 15 (1), provided that these activities have been indicated to the competent authority.
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Appendix I icon for biohazard

(found: BGBl. I 2013, 2525)Non-official table of contents

Annex II Additional protective measures in the case of activities in laboratories and comparable facilities as well as in experimental animals

(Fundstelle: BGBl. I 2013, 2526-2527)A
Protection Action B
Protection Levels234
1.
The protection level range is to be delisted from other protection levels or workspaces in the same building.
recommended mandatory mandatory
2.
The protection level area must have access to a lock with mutually lockable Doors have.
no mandatory if the transmission can be carried out over the air mandatory
3.
The access to the protection level area is to be restricted to designated employees.
binding on listed human pathogenic biomaterials * with access control mandatory with Access control mandatory with access control
4.
A continuous vacuum must be maintained in the protective stage area
.
no Compulsory alarm if transmission can be carried out over the air mandatory alarm monitoring
5.
Too-and Exhaust air must be guided by high-capacity suspended-air filters or a comparable device.
no Compulsory for exhaust air, if the transmission can be done via the air Compulsory for supply and exhaust air
6.
The protective stage area must be sealable for the purpose of gassing.
no mandatory if the Transmission over the air can be done mandatory
7.
A microbiological safety cabinet or a technical Device with an equivalent level of protection must be used
Compulsory for activities with aerosol formation mandatory mandatory
8.
Each protection level range must have its own equipment.
recommended mandatory mandatory
9.
Each protection level range must have an autoclave or equivalent sterilization unit.
recommended mandatory if the transmission is over the air can mandatory
10.
Contaminated Process Exhaust must not be delivered to the workspace
.
mandatory Compulsory mandatory
11.
Effective disinfection and inactivation procedures are to be set.
mandatory mandatory mandatory
12.
The areas mentioned must be waterproof and easy to clean
Werkbenke Workbenches and FloorsWorkbenches, walls, floors, and ceilings
13.
Surfaces must be resistant to the used chemicals and disinfectants.
mandatory mandatory mandatory
14.
Dekontaminations-und WaschFacilities for the employees must be present.
mandatory mandatory mandatory
15.
Employees must be employees before leaving Shower protection range
no recommended mandatory
16.
Contaminated solid and liquid wastes are before the final Disposal by means of proven physical or chemical processes
mandatory if there are no appropriate Order disposal is done mandatory if the transmission can be carried out via the air; otherwise binding in principle, only in Appropriate order disposal is possible mandatory
17.
Abwaters are using tested physical or chemical methods before final disposal
no for hand washing and Shower water or comparable waste water recommended for hand-washing and shower water mandatory
18.
A viewing window or similar device to view into the workspace is to be provided
mandatory Compulsory mandatory
19.
An emergency call option should be provided for single work.
recommended mandatory mandatory
20.
Window must not be opened.
nein; window must be closed during the activity Compulsory mandatory
21.
For security-related devices, there is an emergency power supply to be provided
recommended Compulsory mandatory
22.
Biomaterials are to be kept under wraps.
Compulsory with listed human pathogenic biomaterials* Compulsory with listed human pathogenic biomaterials* mandatory
23.
An effective control of vectors (for example, of rodents and insects) is to be carried out.
recommended mandatory mandatory
24.
Safe disposal of infected animal bodies, for example by thermal inactivation, incinerators for animal carcasses or other appropriate facilities for Sterilization/Deactivation.
mandatory mandatory mandatory on
Note:
In accordance with § 10 Paragraph 1 shall be taken as the recommended protective measures, if it may reduce the risks to employees.
*
In Annex I to Regulation (EU) No 388/2012 of the European Parliament and of the Council of 19 June 2012. Amending Council Regulation (EC) No 428/2009 setting up a Community regime for the control of exports, transfer, broking and transit of dual-use items (OJ L 145, 31.5.2009, p. 1). 12) under 1C351 listed human pathogenic agents and genetically modified organisms listed in 1C353.
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Annex III Additional protective measures for activities in biotechnology

(Fundstelle: BGBl. I 2013, 2528) The requirements set out in Annex II shall apply. For activities with biomaterials in bio-engineering equipment, for example bioreactors and separators, the following applies: A
protection-measure-B
protection levels234
1.
The apparatus must physically separate the process from the environment
mandatory mandatory mandatory
2.
The apparatus or a comparable asset must be within a corresponding protective stage area lie.
mandatory Compulsory mandatory
3.
The process exhaust of the apparatus must be treated in such a way that a release of Biochemicals
minimized. Prevented. reliably prevented.
4.
The opening of the device, for example, for sampling, adding Substances or for the transfer of biomaterials must be carried out in such a way that release of biomaterials
minimized . Prevented. reliably prevented
5.
Culture liquids may only be removed from the apparatus for further processing if the removal is carried out in a closed system or when the biosubstances are carried out in an effective way. physical or chemical methods have been inactivated.
recommended mandatory mandatory
6.
gaskets on the apparatus must be such that an unintentional release of biomaterials
minimized. Prevented. reliably prevented.
7.
The entire contents of the apparatus must be collected
mandatory mandatory
Note:
In accordance with § 10, paragraph 1, the recommended measures should be taken to reduce the risks to workers.