Regulation On Safety And Health At Work With Biological Agents

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

Read the untranslated law here: http://www.gesetze-im-internet.de/biostoffv_2013/BJNR251410013.html

Regulation on safety and health at work with biological agents (regulation on organic fabric - aforementioned) aforementioned Ausfertigung date: 15.07.2013 full quotation: "organic material regulation from 15 July 2013 (BGBl. I S. 2514)" footnote (+++ text detection from: 23.7.2013 +++) I of the Federal Government, the Federal Ministry of labour and Social Affairs and the Ministry of the Interior with the approval of the Federal Council and in agreement with the Federal Ministry of the Interior was the V as article 1 of the V v. 15.7.2013 , the Federal Ministry of Economics and technology and the Federal Ministry of labour and Social Affairs decided. It is according to article 3 clause 1 of this V on the 23.7.2013 entered into force.

Table of contents section 1 scope, definitions and risk groups classification article 1 scope article 2 definitions article 3 classification of organic substances into risk groups section 2 risk assessment, protection levels mapping, documentation and record-keeping obligations Article 4 section 5 risk assessment activities with protection levels of association § 6 activities without protective levels of Association § 7 documentation of the risk assessment and record keeping section 3 duties and safeguard measures article 8 § 9 duties general protection measures section 10 additional protective measures and activities at safety level 2 requirements 3 or 4 laboratories , in animal husbandry, as well as in the biotechnology section 11 additional protective measures and activities at safety level 2 requirements 3 or 4 in facilities of the health service section 12 preventative § 13 malfunctions, accidents § 14 operating instruction and training of the workforce section 4 permission and notification requirements under § 15 license requirements section 16 disclosure section 5 enforcement regulations and Committee for biological agents section 17 informing the authority of § 18 regulatory exemptions section 19 Committee for biological agents section 6 offences , Offences and transitional provisions article 20 offences section 21 offences section 22 transitional provisions annex I Biohazard sign annex II additional protective measures at activities in laboratories and similar institutions, as well as in laboratory animal husbandry Appendix III additional protective measures with activities in biotechnology section 1 scope, definitions and risk groups classification article 1 scope of application (1) this Regulation applies to activities with biological agents (organic substances). It provides for measures for the protection of the safety and health of employees from exposure through these activities. It governs also measures to protect of other persons insofar as these may be endangered as a result of using of organic substances by workers or by entrepreneur without employees.
(2) the regulation applies also to activities governed by the genetic engineering law if there no equivalent or stricter rules to protect of workers.

Definitions (1) organic substances are section 2 1 associated micro-organisms, cell cultures and endoparasites including their genetically modified forms, 2. with transmissible spongiform encephalopathy (TSE) agents that can endanger people with infections, transmissible diseases, toxin formation, effects damaging sensitizing or other, the health.
(2) the organic substances are assimilated 1 ectoparasites that cause distinct disorders in humans or sensitising or toxic effects cause technically manufactured biological units with new features that threaten the people in the same way may 2 as organic substances.
(3) micro-organisms are all cellular or non-cellular microscopic or submikroskopisch small biological units that are capable of replication or of transferring genetic material, especially bacteria, viruses, protozoa and fungi.
(4) cell cultures are in-vitro propagated cells, which have been isolated from multicellular organisms.
(5) within the meaning of paragraph 1 are products of metabolism or cell components of organic substances which as a result can cause toxic effects by inhalation, ingestion, or absorption through the skin in humans and cause acute or chronic health damage or death.
(6) organic substances of risk group 3, with (*) are marked, are organic substances, where the risk of infection for workers is limited, because a transmission over the air is not usually possible. These organic substances are 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 against exposure to biological agents at work (OJ L 262 of the 17.10.2000, p. 21), as well as the announcements according to § 19 paragraph 4 number 1 in accordance with lists.
(7) activities are professional working with people, animals, plants, products, objects, or materials, when due to this work organic substances or are released and workers in contact with can be using organic materials, in particular insulating, generate and increase closing, the GE - consuming, loading and processing, the dismantling and transfer, mixing and separation and worksite internal transporting, keeping including the storage, the disable and disposal, and 2. 1.
(8) specific activities exist if 1 the activities on one or more organic substances are directly aligned, 2. the bio or the organic substances are known at least the species according to and 3. the exposure of the workers in normal operation is sufficiently known or estimated.
Non-targeted activities exist, if at least a requirement does not exist pursuant to sentence 1. This is especially for activities under paragraph 7 number 2.
(9) workers are persons who are determined according to section 2 paragraph 2 of the occupational safety and Health Act as such. The following persons are of the same workers, if they perform activities involving organic substances: 1. pupils and students, 2. students, 3. other persons, in particular in scientific institutions and institutions of health service professionals, 4th in work at home employees to § 1 paragraph 1 of the law on homework.
On pupils and students, students and other persons referred to in point 3, the provisions of this regulation on the participation of the representatives do not apply.
(10) an employer, who is determined according to § 2 paragraph 3 of the occupational safety and Health Act as such. The entrepreneur without employees, 2. the contracting authority and the interim champion in the home work Act are the employers equal to 1.
(11) competent within the meaning of this regulation is, who is qualified to carry out a task specified in this regulation. The technical qualification requirements are dependent on the type of the task and the level of risk. The knowledge required for the technical qualification must be proved by a suitable vocational training and timely relevant professional activities. Participation in specific training activities can additionally be required depending on the task and the level of risk.
(12) State of the art is the development stand of facilities, advanced procedures or modes of operation that secured makes the practical suitability of a measure to protect health and safety of employees. In determining the State of the art are especially comparable processes to attract facilities or modes of operation which have been tried with success in practice.
(13) levels of protection based on the risk group of the respective organic substance and is a measure of the level of infection risk to an activity. According to the risk groups, four levels of protection are distinguished according to § 3. The levels of protection include the additional protective measures, which are set or recommended in annexes II and III.
(14) facilities of the health service under this regulation are workplaces, where people are stationary medically examined, treated or maintained or outpatient medically examined or treated.
(15) biotechnology for the purposes of this regulation includes the biotechnological production and biotechnology research under selective use of defined organic substances.

Article 3 classification of organic substances into risk groups (1) organic substances are classified according to the risk of infection posed by them to the State of science in one of the following risk groups: 1 risk group 1: biomaterials, that's unlikely is that; they cause a disease in humans, organic substances, which can cause disease in humans and a danger to employees represent 2. risk group 2: a spread in the population is unlikely; an effective prevention or treatment is organic substances which can cause a serious illness in humans and represent a serious threat to workers 3. risk group 3: usually possible. the risk of a spread in the population, but is usually possible, an effective prevention or treatment 4.
Risk group 4: organic substances, which cause a serious illness in humans and represent a serious hazard to workers; the risk of spread in the population is large under certain circumstances; normally, an effective prevention or treatment is 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 against exposure to biological agents at work (OJ applies for the classification of organic substances in the risk groups 2 to 4 OJ L 262 of the 17.10.2000, p. 21). This appendix in the procedure is adjusted pursuant to article 19 of this directive to technical progress, as the amended version can be applied already from its entry into force. It is to apply the fixed implementation deadline.
(3) an organic substance is not referred to in paragraph 2, the Federal Ministry of labour and Social Affairs can make the classification in a risk group with the advice of the Committee according to § 19 referred to in paragraph 1. The ratings will be announced in the joint ministerial Gazette. The employer must observe these ratings.
(4) a classification referred to in paragraph 2, nor one exists for an organic substance pursuant to paragraph 3, has the employer who proposes a targeted activity with this organic material, to classify them in one of the risk groups referred to in paragraph 1. While the employer shall observe the following: 1 come for classifying several risk groups into account, is the organic substance in the highest risk group of eligible to be classified, 2. 2 to classify viruses that were isolated, already in humans are at least in the risk group, unless, it is unlikely that these viruses in humans cause a disease, strains that are weakened or known virulence genes have lost 3. , subject to an appropriate identification and evaluation in a lower risk group can be classified as the parent strain (parentaler tribe); the parent strain in the risk group 3 or 4 is classified, a downgrade may only be based on a scientific assessment, that the Committee can carry out according to § 19.
Section 2 risk assessment, protection levels mapping, documentation and record-keeping obligations Article 4 risk assessment (1) In the context of the risk assessment pursuant to section 5 of the Labour Protection Act has to assess the risk of employees through the activities of organic substances prior to commencement of activities the employer. The risk assessment is carried out expertly. The employer has not even the knowledge, so he has consulted learned to leave.
(2) the employer shall without delay to update the risk assessment, if 1 substantial changes of in working conditions or new information, for example accident reports or findings from occupational health screening, require this, or 2. the testing of function and effectiveness of the protection measures showed that the defined protection measures are not effective.
Otherwise, the employer has to verify the risk assessment at least every second year and update if necessary. The check that an update of the risk assessment is not required, the employer has to inform date of check in the documentation according to § 7.
(3) for the risk assessment, the employer has to determine in particular the following: 1. identity, sensitizing risk group classification and transmission of organic substances, whose potential and toxic effects and recording paths, if this information for employers is available; While he's about to find out, whether by the organic materials other effects damaging to health can be caused, 2. type of activity under consideration of the operations, procedures and used work equipment, including the equipment, 3 way, duration and frequency of exposure of workers, insofar as this information for employers is available, 4. possibility of using organic materials, work methods or work equipment , which would lead to no or a reduced risk of employees (substitution test), 5 activity-based findings a) about stress and exposure scenarios, including mental stress, b) of known diseases and the countermeasures to be taken, c) from the occupational health provisions.
(4) the employer has the infection risk and the hazards of sensitizing, toxic on the basis of information obtained pursuant to paragraph 3 or to evaluate other effects of adverse health independently of each other. These single assessments are merge to an overall judgement, on the basis of which the protective measures are set, and to take. The same applies if an activity several organic substances occur simultaneously or be used.
(5) are activities with products, the organic substances, not to determine the necessary information on risk assessment such as for example the risk group classification, so employers must obtain them for the manufacturers, importers or distributors. Sentence 1 shall not apply for food in the form of finished products intended for final consumption.

§ 5 has activities with protection level assignment (1) activities in laboratories, in animal husbandry, in biotechnology as well as in institutions of health service employers in addition to section 4 paragraph 3 to determine whether targeted or non-targeted activities are carried out. He has to associate these activities with respect to their infection hazard of a protection level.
(2) the protection mapping of levels of 1. targeted activities varies according to the risk group of the identified organic material; Activities with several organic substances are exercised, so the protection mapping of levels of depends on due to a the organic material with the highest risk group, 2 not targeted activities according to the risk group of the organic substance,) the probability of its occurrence, b) the type of activity, c) the type, duration, amount and frequency of identified exposure determines the level of infection risk to workers.

Article 6 activities without protection level assignment (1) activities which do not fall under article 5, paragraph 1, must be mapped to any level of protection. This is activities within the meaning of § 2 paragraph 7 number 2. These activities include, for example, cleaning and restoration work, activities of veterinary medicine, agriculture, forestry, waste water and waste management, biogas plants and slaughterhouses.
(2) a number not be calculated 1 and 3 information referred to in section 4, paragraph 3, because the spectrum of occurring organic substances is subject to fluctuations or type, duration, amount or frequency of exposure can change in such activities, so has the employers in particular to determine the information required for the risk assessment and the determination of protective measures on the basis of 1 announcements according to § 19 paragraph 4 , 2. experiences from similar activities or 3 other safe ergonomic findings.

Section 7 has the risk assessment documentation and record-keeping obligations (1) the employer regardless of the number of employees for the first time prior to commencement of the activity, as well as after each update in accordance with sentence 2 to document the risk assessment. The documentation of the risk assessment includes in particular the following information: 1 the nature of the activity, including the exposure conditions, 2. the result of the substitution check after § 4 paragraph 3 number 4, 3. pursuant to article 5 paragraph 2 defined protection levels, 4. the protection measures, 5. a justification of the after § 19 paragraph 4 number 1 announced rules and findings will be deviated.
(2) as part of the documentation, the employer has to create a list of used or occurring organic substances (organic materials directory), insofar as these are known and relevant to risk assessment pursuant to section 4. The directory must include information on the classification of organic substances in a risk group according to § 3 and to their sensitizing, toxic and other effects damaging to health. The information must be accessible to all affected employees and their representatives.
(3) in the case of activities of protection level 3 or 4 has the employer in addition to keep a register of workers performing these activities. The nature of the activities and occurring organic substances and occurring accidents and malfunctions shall be indicated in the directory. It's personal for a period of at least ten years after the end of the activity to be kept. 1 the employer has to make information relevant to them in the directory accessible to workers; the protection of personal data is to ensure 2. at termination of employment the workers handed over a statement about the directory information relevant to him; Proof of delivery is to be kept by the employer, such as social documents.
List of workers can be done together with the organic substance directory referred to in paragraph 2.
(4) pursuant to paragraph 1 sentence 2 number 2 and 5, as well as the directory can be referred to in paragraph 2 be waived documentation of the information, if only activities with organic substances of in risk category 1 no sensitising or toxic effects are carried.
Section 3
Basic obligations and protection measures to create section 8 basic duties (1) which has an employer to incorporate the interests of occupational health and safety in relation to activities involving organic substances into its operational organisation and for this purpose the necessary human, financial and organisational conditions. While he has to involve the representatives of the employees in an appropriate manner. In particular, he has to make sure that 1 in the design of work organization, the work process and the workplace as well as in the selection and deployment of work equipment with safety and health of employees-related factors including the psychological, sufficiently be taken into account, 2. the employees or their representatives in the framework of the operational possibilities involved, when new work equipment will be introduced, which will affect the safety and health of employees.
(2) the employer has appropriate measures to take in order to create a security awareness for employees and to develop the in-house occupational safety activities with organic substances.
(3) the employer may allow only record an activity with organic substances after the risk assessment carried out pursuant to § 4 and the necessary measures taken.
(4) the employer has this before recording to replace activity 1, hazardous organic substances as a priority by those which are not or less are dangerous, as far as according to the type of activity or so to select 2. working methods and work equipment or to make that organic substances not become free at work, when the risk of employees not 1 can be excluded by a measure referred to in point is possible after the State of the art, , 3. exposure of workers through appropriate structural, technical and organisational measures to a minimum to reduce any risk to the workers through a measure after number 1 or number 2 can be prevented or the organic substances intended be released additional personal protective equipment available to 4, if the measures provided for paragraphs 1 to 3 is not sufficient to exclude the risk or adequately reduce; the employer has to restrict personal protective equipment burdening the usage to the absolutely necessary and may not provide as continuous measure they.
(5) the employer has to set the protective measures on the basis of the risk assessment after the State of the art, as well as to secure scientific knowledge and to take. He has the provisions of this regulation including the attachments to be observed and which according to § 19 paragraph 4 number 1 known rules and knowledge into account. In compliance with the rules and knowledge, it is assumed that the requirements have been met (presumption). These rules and knowledge cannot be derogated from, if other measures at least in a comparable way ensures protection of safety and health of employees. Have the State of the art or science emerged and the occupational safety through this development increases significantly, the protection measures are to adapt within a reasonable period of time.
(6) the employer has regularly the function of technical protection measures and their effectiveness at least every second year to review. The results and the date of inspection of of effectiveness of are to indicate in the documentation according to § 7. Was for a workspace, a work process or system type according to § 19 paragraph 4 a value set in a notice, which describes the accessible state of the art concentration of organic substances in the air in the workplace (technical control value), this value for the corresponding protection measures effectiveness review is to be used.
(7) the employer must be in homework exercise sensitizing only activities with organic substances of in risk category 1 or toxic effect.

§ 9 General protection measures (1) in all its activities with organic substances must be adhered to at least the basic hygiene procedures. In particular, the employer for that has to make sure that 1 workplaces and work equipment in a clean condition corresponding to the workflow regularly and kept clean, floors and surfaces of work equipment and work surfaces are easy to clean 2, 3 washing facilities available are, 4th from the workplace separate changing facilities are available, if Workwear is required; the Workwear is regularly and if necessary to change and clean.
(2) in the case of activities in laboratories, in animal husbandry, in biotechnology and in facilities of the health service the employer protection level 1 measures of paragraph 1 also has specific hygiene measures according to the according to § 19 paragraph 4 number 1 known given rules and knowledge into account.
(3) be exercised not only activities with organic substances of in risk category 1 without sensitizing and toxic effects, the employer in relation to the risk assessment has to take additional protective measures. While he has in particular to make 1 work methods and work equipment or to select that the exposure of employees to organic substances and risk of stab and cut injuries be prevented or minimized, as far as this is technically possible, 2 activities and work procedures with dust or aerosol formation, including cleaning procedures, to be replaced by those without or with reduced dust or aerosol formation as far as this state of the art is possible; This is not possible, the employer has to take appropriate measures to minimize the exposure, 3. minimise the number of exposed workers to the necessary for the carrying out of the activity, the necessary measures for disinfection, inactivation or decontamination, as well as for the proper and safe disposal of organic substances, contaminated objects, materials and equipment to take 4, provided personal protective equipment including protective clothing to clean 5 available , to wait, to maintain and properly disposed of; Employees must use the provided personal protective equipment as long as a threat, 6 the requirements to create that personal protective equipment, including safety equipment when leaving the workplace safely stored and separated from other pieces of clothing can be stored, 7 to ensure that workers in areas where organic substances can occur, take any food and beverage to be; to do this, has the employer before taking up of activities to set up separate areas, which may not be entered with personal protective equipment including protective clothing.
(4) the employer has a safe to store biomaterials, in-house safe to carry and to take precautions to prevent abuse or misuse. While he has to make sure that only containers used are the 1 with respect to their nature suitable, safe to wrap the content, 2. so marked, that are the dangers it posed in an appropriate manner clearly visible, 3. with regard to form and marking are designed so that the content can not be confused with food.
(5) if the medical examination, treatment and care of patients outside of institutions of the health service, section 11 paragraph 2 to 5 shall apply. In such activities the employer in work instructions shall set dealing with personal protective equipment and clothing, as well as the necessary measures to the hygiene and disinfection.

§ 10 additional protective measures and requirements for activities of the protection level 2, 3 or 4 in laboratories, in animal husbandry, as well as in biotechnology (1) in addition to the employer prior to the activities of the protection level has 2, 3, or 4 in laboratories, in animal husbandry or biotechnology 1 according to the protection levels of mapping a safety measures pursuant to § 9) to set appropriate spatial areas of protection levels and to identify named protection levels as well as with the symbol for biohazard annex I , b) the protective measures referred to in annex II or III to take; the protection measures referred to as recommended are to take if this can, reduce the exposure of workers to dispose of 2, used top and sharp work equipment according to the requirement pursuant to § 11 paragraph 4 3 access to organic substances of in risk category 3 or 4 to be limited to legitimate, expert and reliable employees; Activities the level of protection may be transferred these workers only 3 or 4, if they are instructed and trained on the basis of work instructions.
(2) the employer has to designate a person to 3 or 4, that is reliable and has a skill that corresponds to the high risk prior to start of activities of the protection level. He has that person with the following tasks to assign: 1 advice on a) risk assessment according to § 4, b) other issues relevant to safety, 2. support for the a) monitor of the effectiveness of protection measures, b) implementing the instruction according to § 14 paragraph 2, 3. compliance with protection measures.
The employer has to set the tasks and the powers of this person in writing. She may not be disadvantaged due to the fulfilment of its tasks. It is to provide sufficient time for the execution of tasks. Sentence 1 does not apply to activities involving organic substances of in risk category 3, the with (*) are marked.

§ 11 additional protective measures and requirements for activities of the protection level 2, 3 or 4 facilities of the health service (1) in addition to the protective measures pursuant to § 9 has set the employer before recording the activities of at safety level 2, 3 or 4 in facilities of the health service in relation to the risk assessment 1 effective disinfection and inactivation procedures, to make surfaces that need to be disinfected, 2. , that she are easy to clean and disinfection agents are resistant to the used. the requirements of annex II on surfaces apply in addition to activities protection level 4.
(2) the employer has according to section 9, paragraph 3, sentence 2 pointed and sharp medical instruments prior to commencement of activities such to replace with number 1, where no or a reduced risk of cuts and cutting is, as far as this is technically possible and necessary to avoid a risk of infection.
(3) the employer shall ensure that used needles in the protective caps are inserted back. Be exercised activities, which require the State of the art a reuse of medical instruments, and must in the cannula into the protective cap back be inserted, this is allowed if a procedure is used, which allows a secure insert back the needle into the CAP with one hand.
(4) top and sharp medical instruments are safe to dispose of after use. To do this, has the employer before starting the activities to provide waste containers that are keyword - and break-resistant and securely wrap the waste. He has to ensure that these waste containers with you through color, form, and label as waste containers are visible. Sentences 1 and 2 apply also for used medical instruments with guards against cuts and cutting.
(5) the employer has employees and their representatives about injuries caused by used pointed or sharp medical instruments, the organizational or technical reasons have to inform in a timely manner. He has to set the course of action for this purpose.
(6) the activities of the protection level may be transferred only skilled workers 3 or 4, which are instructed and trained on the basis of work permits.
(7) prior to start of activities of the protection level 4 the employer 1 to set appropriate spatial areas of protection levels and named protection levels as well as with the symbol for biohazard annex I to identify, to select the protection level 4 in annex II measures and to take, are 2. necessary and suitable to reduce the exposure of workers and other persons, 3. a person within the meaning of article 10, paragraph 2, sentence 1 to name and with the tasks according to § 10 paragraph 2 set 2 to appoint.

§ 12 preventative occupational health provision in the amended regulation also applies to the Group of persons referred to in article 2, paragraph 9, sentence 2.

§ 13 malfunctions, accidents (1) the employer has set the necessary measures prior to an activity of the protection levels 2 to 4, which are necessary in order to minimise the impact on the safety and health of employees and other persons and to restore the normal operation when operating errors or accidents. In dependency of the kind of events and used or occurring organic substances is set in particular: 1. first-aid measures and further assistance for workers in accidental transmission of organic substances, including the possibility for postexpositionellen prophylaxis, 2. measures to a carry-over of organic substances to prevent, 3. disinfection, inactivation or decontamination measures, 4 that is tested, whether at operating errors or accidents the organic material used in the work environment have reached , as far as this is technically possible and validated test methods.
The provisions are a part of the operating statement according to § 14 paragraph 1 sentence 4 number 3.
(2) the employer has to inform employees about the defined measures and their application. Occurs a malfunction or an accident within the meaning of paragraph 1 sentence 1 so the employer has immediately pursuant to paragraph 1 sentence 2 laid down measures. Thereby, only persons may remain in the danger zone, which are necessary to achieve the objectives referred to in paragraph 1.
(3) before starting activities of the Biosafety level 3 or 4 in laboratories, in animal husbandry, in biotechnology as well as prior to start of activities of the protection level 4 in facilities of the health service has the employer in addition to the provisions referred to in paragraph 1 an internal plan in to create, to fend off such threats are, that can occur when the failure of containment measure by a release of organic substances. In it, he has to set the specific hazards and the names of the persons responsible for the in-house rescue measures. The commitments are to update regularly. Sentence 1 does not apply to activities involving organic substances of in risk category 3, the with (*) are marked.
(4) in the case of activities of protection level 4, the plan has to contain information about the extent of security exercises and regular implementation, provided that such safety drills due to risk assessment are required pursuant to paragraph 3. The measures pursuant to paragraph 3 are to be agreed with the competent rescue and security services. In addition, the employer has to set up warning systems and communication opportunities through which all affected employees immediately warned and alerted the rescue and security services. The employer has to ensure that these systems are fully functional.
(5) the employer shall before recording the activities to establish a procedure for accident reports and examinations, as well as the procedure to inform the workers and their representatives. The procedure is to ensure that serious accidents and needle stick injuries possible organisational and technical causes of accidents can be identified and avoids individual blame. Workers and their representatives are operating errors and accidents with organic substances that may endanger the safety or health of employees, to inform without delay.

§ 14 has instruction and training of the employees of (1) the employer on the basis of the risk assessment pursuant to § 4 before starting the activity to create a written operating instructions arbeitsbereichs - and bio-fabric-related. Sentence 1 shall not apply when only activities with organic substances of in risk category 1 no sensitising or toxic effects are exerted. The operating instruction is to provide workers. She must be written in a language understandable form to the employees and contain in particular the following information: 1. the dangers associated with the provided activities for workers, in particular to a) the type of activity, b) the used at the work place or occurring, activity-related organic substances including the risk group, transmission and health effects, 2. information about protective measures and rules of conduct, carry out the workers for their own protection and for the protection of other workers in the workplace or to comply with have. This includes in particular: a) in-plant hygiene requirements, b) information on measures which are to take to prevent exposure, including the proper use of sharp or pointed medical instruments, c) information carrying, use and store personal protective equipment including protective clothing, 3. instructions for the behaviour and action for injuries, accidents and malfunctions as well as their internal message and first aid, 4. information to the appropriate inactivation or disposal of organic substances and contaminated objects , Materials or work equipment.
The operating instructions must be updated for each major change in working conditions.
(2) the employer shall ensure that workers on the basis of the current operating instructions be verbally instructed sentence 1 above all occurring hazards and protection measures referred to in paragraph 1. The instruction is to perform, creating a security awareness for employees. Workers are also on the requirements to inform, under which they are entitled to preventative occupational medicine according to the regulation on occupational health screening. In the framework of the training is also a general occupational health advice making remarks to specific hazards such as decreased immune system. The doctor or the doctor is if necessary advice according to § 7 paragraph 1 of the regulation on occupational health screening to participate.
(3) the training must prior employment and thereafter be performed at least annually workplace related and take place in a language understandable form to the employees. Content and timing of the training has to hold the employer in writing and signature confirmation by trained employees.
(4) for activities of the protection levels 3 and 4 are to create work instructions, which must be available at the workplace in addition to the operating instructions. Work instructions are also required for the following activities with increased infection risk: 1. maintenance, cleaning, modification or demolition work in or on contaminated equipment, 2. activities where experience has shown that increased accident risk, 3. expected activities involving an accident with serious infections is; This can be the case when the taking of samples of human or animal origin.
Section 4 permission and notification requirements under § 15 license requirements (1) the employer requires the permission of the competent authority, before activities the protection level for the first time be included 3 or 4 in laboratories, in animal husbandry or in biotechnology. The permit includes the structural, technical and organisational conditions under this regulation for the protection of employees and other persons from the hazards of these activities. Sentence 1 applies also to facilities of the health service, which are intended for activities of the protection level 4. Activities with organic substances of in risk category 3, the with (*) marked are, we need no permission.
(2) includes another regulatory decision, in particular a public approval or permission, the permission referred to in paragraph 1, as the requirements referred to in paragraph 1 by sending a copy of the official decision to the competent authority. If necessary, other documents can be requested by the competent authority.
(3) the permit referred to in paragraph 1 is in writing. The application the following documents shall be attached: 1 name and address of the employer, 2. name and qualification according to § 10 paragraph 2 or § 11 paragraph 7 designated person, 3. name of the permit holder according to § 44 of the infection Protection Act, 4. site plan, floor plan and designation of premises including escape and rescue routes, 5. Description of planned activities, 6 result of the risk assessment, stating a number 3) of used or occurring organic substances and the protection level of the activity , b) the structural, technical, organisational and personal protective measures including scheduled maintenance, and maintenance of structural and technical measures, 7 plan according to § 13 paragraph 3, 8. information about the waste and sewage disposal.
If necessary, other documents can be requested by the competent authority.
(4) the permission shall be granted if the requirements of this regulation are met, that are required to ensure the protection of employees and other persons from the hazards of organic substances.

§ 16 duty of disclosure (1) the employer has to notify the competent authority in accordance with paragraphs 2 and 3: 1 the first-time inclusion of a) a targeted activity with organic substances of in risk category 2, b) an activity with organic substances of risk group 3, as far as the activities of any license requirements are subject to ACC. to § 15, in laboratories, in animal husbandry and in biotechnology, 2nd of permitted any change or displayed activities , if these are important for the safety and health protection, such as activities aimed at increasing the virulence of the organic substance or the inclusion of activities with other organic substances of in risk category 3 or 4, 3. recording one infected patient in a patient station of protection level 4, 4. setting an activities subject to permission according to § 15.
(2) the display has to include the following: 1 name and address of the employer, 2. Description of planned activities, 3. the results of the risk assessment for section 4, 4. the nature of the organic material, 5. measures to protect of the safety and health of employees.
(3) the display referred to in paragraph 1 number 1, 2 or 4 number has no later than 30 days before recording or cessation of activities, the display referred to in paragraph 1 number 3 to immediately be carried out.
(4) the duty of disclosure can be fulfilled by the fact that within the period specified in paragraph 3 the copy of a display, approval or permission is the competent authority for other legislation, if they contain equivalent information.
Section 5 enforcement regulations and Committee for biological agents section 17 information authority (1) the employer has immediately to inform the competent authority about 1 every accident and any malfunction in activities with organic substances of in risk category 3 or 4, that can cause a health hazard workers 2. sickness and deaths of employees, attributable to activities involving organic substances are under precise indication of activity.
Is not affected (2) of section 22 of the occupational safety and Health Act of the employer of the competent authority at its request to submit the following: 1 the documentation of the risk assessment, 2. the directory after article 7, paragraph 3, sentence 1, as well as the verification according to § 7 (3) sentence 4 number 2, 3. the activities where employees actually or potentially have been exposed to organic substances, and the number of these employees , 4. the taken protective and precautionary measures including the operation and work instructions, 5. the measures laid down by article 13, paragraph 1 and 2 or taken and the according to § 13 paragraph 3 created plan.

§ 18 exceptions from the provisions of articles 9, 10, 11 and 13 including the annexes II and III to grant regulatory exceptions that competent authority may upon written or electronic request of the employer if the implementation of the provision in some cases would lead to an unreasonable hardness and the requested variance with the protection of the workers concerned is compatible.

Article 19 Committee for biological agents (1) at the Federal Ministry of labour and Social Affairs a Committee for biological agents (ABAS) is formed, in which technically suitable persons by employers, trade unions, the State authorities, statutory accident insurance and more technically suitable people, especially science, should be represented. The total number of members should not exceed 16 persons. For each Member, a substitute is appointed. The membership of the Committee is voluntary.
(2) the Federal Ministry for labour and Social Affairs appoints the Committee members and the Deputy members. The Committee adopt its rules of procedure and elects the Chairman or the Chairman from among its members. The rules of procedure and the election of presiding require the approval of the Federal Ministry of labour and Social Affairs.
(3), 1 include the tasks of the Committee expressing the State of science, technique, to identify occupational medicine and occupational hygiene, as well as other backed up findings for activities involving organic substances and corresponding recommendations including such posts, which can be used in publicly available information systems on organic substances to identify 2 to work out how it can meet the requirements provided in this regulation and to the rules corresponding to the current state of technology and medicine and insights , 3. scientific assessments of organic materials to make and to propose their classification in risk groups, 4. to advise the Federal Ministry of labour and Social Affairs in the biological safety issues.
The work programme of the Committee will be coordinated with the Federal Ministry of labour and Social Affairs. The Committee works closely with the other committees in the Federal Ministry of labour and Social Affairs.
(4) the Federal Ministry of labour and Social Affairs 1 can after examination by the Committee rules and findings identified set 1 number 2 pursuant to paragraph 3, as well as announce the classifications according to § 3 paragraph 3 in the joint ministerial Gazette, 2. recommendations pursuant to paragraph 3 sentence 1 number 1, as well as the outcome after paragraph 3 sentence 1 No. 4 in an appropriate manner publish.
(5) the federal ministries as well as the Supreme Land authorities may send representatives to the meetings of the Committee. The word is this request in the session to grant.
(6) the Federal Institute for occupational safety and Health conducts the business of the Committee.
Section 6 administrative offences, offences and transitional provisions article 20 any person within the meaning of article 25, paragraph 1 number 1 of the occupational safety and Health Act that offences (1) who intentionally or negligently exposure of employees not, incorrectly, incompletely or not timely assessed 1 contrary to article 4, paragraph 1, sentence 1, 2. contrary to article 4, paragraph 2, sentence 1 not or not timely updated risk assessment, 3. contrary to article 4, paragraph 2, sentence 2 not or not timely checks a risk assessment , 4. contrary to article 7, paragraph 1, sentence 1 a risk assessment not, incorrectly, incompletely or not timely documents, 5. contrary to article 7, paragraph 3, sentence 1 not, not properly or not takes a directory there called, 6 contrary to section 7, paragraph 3, sentence 3 stored there called a directory not or at least ten years, 7.
contrary to § 8 para 4 first half-sentence personal protective equipment not or not timely provides number 4 to 8 contrary to section 9, paragraph 1, sentence 2 number 3 for it ensures that a launderette available is, 9 contrary to section 9, paragraph 1, sentence 2 number 4 first half-sentence will not, that there is a possibility of changing, 10 contrary to article 9, paragraph 3, sentence 2 personal protective equipment provided to 5 first half-sentence not maintaining number , 11 contrary to article 9, paragraph 3, sentence 2 number not or not timely sets up areas called 7 second half sentence there, 12 contrary to article 9, paragraph 4, sentence 2 does not ensure that only known container be used, 13 contrary to article 10 paragraph 1 number number 1 not or not timely sets a protection level range 1(a) or section 11 paragraph 7 or not, not properly or in time features , 14 contrary to article 10, paragraph 2, sentence 1 or § 11 paragraph 7 point 3 not or not timely shall designate a person, 15 violates article 11 paragraph 1 a there called a not or not timely sets number 1, 16 violates article 11 paragraph 2 not or not timely replaced a there called an instrument, 17 contrary to section 11, paragraph 3, sentence 1 does not ensure that a used needle in the protective cap is plugged back , 18 contrary to section 11, paragraph 4, sentence 1, also in conjunction with 4, a there called an instrument not or not timely disposed, 19 contrary to section 13, paragraph 1, sentence 2 a there called measure not or not timely sets number 1, 2 or 3, 20th contrary to section 13, paragraph 3, sentence 1 not, incorrectly, incompletely or not in time creates an internal plan , 21 contrary to article 13, paragraph 5, sentence 1 a method for accident reports and examinations does not or not timely sets, 22 contrary to article 14, paragraph 1, sentence 1 not, incorrectly, incompletely or not in time created a written instruction, 23 contrary to article 14, paragraph 2, sentence 1 does not ensure that an employee is trained, 24 without permission in accordance with article 15, paragraph 1, sentence 1 takes a there called off , 25 contrary to article 16, paragraph 1 a display not, incorrectly, incompletely or not timely reimbursed or 26 contrary to article 17 paragraph 1 not, incorrectly, incompletely or not timely inform the competent authority.
(2) any person in the sense of article 32, paragraph 1, number 1 of the law on home work is who intentionally or negligently there called activities is contrary to article 8, paragraph 7.

Section 21 offences (1) who endangered called deliberate act by one in article 20 paragraph 1 life or health of workers, is punishable pursuant to section 26 paragraph 2 of the occupational safety and Health Act.
(2) a person who endangers workers in their labour or health through a deliberate act in home work referred to in article 20, paragraph 2, is punishable under article 32, paragraph 3 or paragraph 4 of the home work Act.

Section 22 transitional provisions for activities that are taken before entry into force of this regulation, is 1 according to § 10 paragraph 2 or § 11 paragraph 7 a competent person to call number 3 until June 30, 2014, 2. is no license requirements in accordance with article 15, paragraph 1 provided these activities the competent authority have been displayed.

Annex I Biohazard sign (site: BGBl. I 2013, 2525) annex II additional protective measures at activities in laboratories and similar institutions, as well as in laboratory animal husbandry (site: Federal Law Gazette I 2013, 2526 - 2527) A protective measures B protection levels 2 3 4 1.
The protection level range is to differentiate from other protection levels or areas of work in the same building.
recommended binding binding 2.
The protection level range must have a lock with each other interlocking doors as access.
no binding, if the transmission over the air can be made binding 3.
Access to the protection level range is limited to named employees.
mandatory for listed human pathogenic organic substances * with access control binding with access control binding with access control 4.
A constant negative pressure must be maintained in the area of protection levels.
no authentic monitored alarm, if the transmission over the air can be authentic alarm monitors 5 supply and exhaust air must through high-performance HEPA filter, or a similar device.
no binding for exhaust, if the transmission over the air can occur binding for supply and exhaust air 6.
The protection level range must be sealable to the end of the fumigation.
no binding, if the transmission over the air can be authentic 7.
A microbiological safety Cabinet or a technical equipment with equivalent level of protection must be used.
mandatory for activities with aerosol formation binding binding 8.
Each protection level range must have your own equipment.
recommended binding binding 9.
Each protection level range must have an autoclave or an equivalent sterilization unit.
recommended binding, if the transmission over the air can be authentic 10 contaminated process exhaust air must not be in the work area.
mandatory mandatory mandatory effective disinfection and inactivation are 11 to set.
binding binding binding 12.
Each of these surfaces must be water-proof and easy to clean.
Work benches work benches and floors work benches, walls, floors and ceilings 13 surfaces must be resistant against chemicals and disinfectants.
binding binding binding 14 decontamination and washing facilities for employees must be present.
mandatory mandatory mandatory 15 workers must leave the scope of the protection levels shower before.
no recommended binding contaminated solid and liquid wastes are 16 to inactivate prior to final disposal by means of proven physical or chemical procedures.
binding if no disposal of the order will be binding if the transmission over the air; otherwise in principle binding only in duly justified exceptional cases a disposal order is possible sewage are binding 17 be inactivated by means of proven physical or chemical process prior to final disposal.
no recommended for hand wash and shower water or similar effluents for hand wash and shower water binding 18.
A window or a similar device to the insight in the working area must be provided.
mandatory mandatory mandatory 19.
There is a possibility of emergency when working alone.
recommended binding binding 20 window must be open.
No; Windows must be closed during the activity binding binding 21.
For security-related facilities, an emergency power supply must be provided.
recommended authentic authentic organic fabrics are 22 to be kept under lock and key.
mandatory for listed human pathogenic organic substances * mandatory for listed human pathogenic organic substances * authentic 23.
Effective control of vectors (for example, from rodents and insects) is carried out.
recommended binding binding 24 safe disposal of infected animal carcasses, for example due to thermal inactivation, incinerators for animal carcases or other suitable devices for sterilisation/inactivation.
binding binding binding spot Note: the protection measures referred to as recommended must be in accordance with § 10 paragraph 1 then if this can reduce the risk of workers.
* In the annex I of to Regulation (EU) No. 388 / 2012 of the European Parliament and of the Council of April 19, 2012, amending Regulation (EC) no 428 / 2009 of the Council setting up a Community regime for the control of exports, transfer, the mediation and the transit of dual use goods (OJ L 129, 5, p. 12) under 1 C 351 listed human pathogens as well as listed under 1C 353 genetically modified organisms.

Appendix III additional protective measures for activities in the field of biotechnology (reference: Federal Law Gazette I 2013, 2528) the requirements referred to in annex II. Applies to activities involving organic materials in bio-engineering equipment, such as bio-reactors and separators, in addition: (A) protection measures B protection levels 2 3 4 1.
The apparatus must physically separate the process from the environment.
binding binding binding 2.
The apparatus or a comparable facility must be within an appropriate scope of protection levels.
binding binding binding 3.
The process exhaust air of the apparatus must be treated so that a release of organic substances is minimised.
prevents.
reliably prevents.
4. opening of equipment such as sampling, to add substances or the transmission of organic substances must be carried so that a release of organic substances is minimised.
prevents.
reliably prevents.
5. culture fluids may be removed for further processing only from the apparatus if the is removed in a closed system or the organic substances have been inactivated by effective physical or chemical processes.
recommended binding binding 6 seals on the apparatus shall be so designed, that an unintentional release of organic substances is minimised.
prevents.
reliably prevents.
7. the entire content of the apparatus can be absorbed.
binding binding binding note:
In accordance with § 10 paragraph 1 protective measures referred to as recommended are then to take if this can reduce the risk of workers.