The document discusses biosafety checks and controls for work in national public health reference laboratories in Austria. It provides an overview of relevant Austrian and EU legislation and regulations regarding biological safety, including requirements for evaluating workplace risks, recording exposure to hazardous biological agents, transportation of dangerous goods, access to genetic resources, and reporting of notifiable diseases. The laws are intended to protect occupational safety and health and implement international agreements on biological safety and biosafety.

1. Biosafety checks and controls in national
public health reference laboratory work
Franz Allerberger
National Microbiology Focal Point, Austria
20 min

2. ~ Occupational Safety and
Health Administration
(OSHA)

3. 3
AUSTRIA:
94 Political Districts

4. Bundesgesetz über Sicherheit und Gesundheitsschutz bei der Arbeit
(ArbeitnehmerInnenschutzgesetz – ASchG) StF: BGBl. Nr. 450/1994 idF BGBl. Nr. 457/1995
Federal Act on Safety and Health at Work (Employee Protection Act)
The Employees Protection Act obliges employers to identify
and assess the risks to the safety and health of the contractor and,
on that basis, to adopt risk prevention measures. This process,
commonly referred to as "evaluation" in Austria, is to be comprehensively
designed, i.e. there are
• record all workplaces and work processes,
• maintenance and repair work, troubleshooting,
• emergency and rescue measures,
• and last but not least consider the employees as concrete persons
(especially young people, older people, pregnant women, invalids, constitution, qualification).
If the conditions under which the evaluation has been carried out have changed
(e.g. introduction of new work procedures, agents, etc.), if an accident has
occurred or there is a suspicion of work-related illness, the evaluation should be
reviewed and, if necessary adapted.
The results of the evaluation and the resulting prevention measures should be
recorded in the Safety and Health Document.
~ Occupational Safety and Health Administration (OSHA)

5. Replacement and prohibition of dangerous substances
§ 42. (1) Carcinogenic (hazard class 3.6 - carcinogenicity), mutagenic
(hazard class 3.5 - germ cell mutagenicity), reproductive (hazard class
3.7 - reproduction toxicity) and biological agents of group 2, 3 or 4
shall not be used if an equivalent work product can be obtained
1. with non-hazardous substances or, if this is not
possible, Second with agents that have less hazardous properties.
….
(6) The first use of biological agents of groups 2, 3 or 4 shall be
reported in writing to the Labor Inspectorate at least 30 days
before the start of work. After this period, employers may assume
that use is permitted provided they have no other knowledge. If
significant changes are made to the work processes or work
procedures that are relevant to safety or health in the workplace and
as a result of which the message is out of date, a new message must
be sent.

6. Directory of workers
§ 47. (1) If carcinogenic (hazard class 3.6 carcinogenicity),
mutagenic (hazard class 3.5 - germ cell mutagenicity),
reprotoxic (hazard class 3.7 - reproductive toxicity) or
group 3 or 4 biological agents are in use, employers
must keep a record of those workers who are
exposed to these agents
(2) In particular, this list must contain the following
information for each worker concerned : 1. name, date of birth, sex ; 2.
identification of materials, 3. type of hazard, 4. nature and duration of the activity, 5. date and result of measurements in the
work area, if any, 6. exposure information, and, 7. accidents and incidents related to them agents.
(3) The directories must always be kept up to date and in
any case kept until the end of the exposure. After the end
of the exposure, they must be forwarded to the competent
institution of the accident insurance. He has to keep these
directories for at least 40 years

7. Directive 2000/54/EC of the European Parliament and of the Council of 18 September 200
on the protection of workers from risks related to exposure to biological agents at work
(seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Official Journal L 262 , 17/10/2000 P. 0021 - 0045

8. Legal Provisions
# protection of workers from risks related to exposure
to biological agents at work
Verordnung der Bundesministerin für Arbeit, Gesundheit und Soziales über
den Schutz der Arbeitnehmer/innen gegen Gefährdung durch biologische
Arbeitsstoffe (Verordnung biologische Arbeitsstoffe – VbA)
BGBl. II Nr. 237/1998
Ordinance of the Federal Minister of Labor, Health and Social Affairs on
the Protection of Workers against Threats from Biological Agents
(Ordinance on Biological Agents - VbA)
Verordnung der Bundesregierung über den Schutz der
Bundesbediensteten gegen Gefährdung durch biologische Arbeitsstoffe
(B-VbA)
BGBl. II Nr. 415/1999
Ordinance of the Federal Government on the Protection of
Federal Employees against Threats from Biological Agents (B-VbA)

13. when intended use
Ordinance of the Federal Minister of Labor, Health and Social Affairs on the Protection of
Workers against Threats from Biological Agents (Ordinance on Biological Agents - VbA)

14. 14
Nine Federal States

15. Legal Provisions
# Regulation of Biological Agents at Work
# Regulation from the Federal Minister of Social Administration
from 2nd April 1948, with respect to the authorisation to perform
medical-diagnostic examinations as well as the precautionary
measures which are to be observed during the aforementioned work
and when working with pathogens
StF: BGBl. Nr. 63/1948
Verordnung der Bundesministerin für Arbeit, Gesundheit und Soziales über den
Schutz der Arbeitnehmer/innen gegen Gefährdung durch biologische Arbeitsstoffe
(Verordnung biologische Arbeitsstoffe – VbA) BGBl. II Nr. 237/1998
Ordinance of the Federal Minister of Labor, Health and Social Affairs on the
Protection of Workers against Danger from Biological Agents (Ordinance on
Biological Agents - VbA)
Verordnung der Bundesregierung über den Schutz der Bundesbediensteten gegen
Gefährdung durch biologische Arbeitsstoffe (B-VbA) BGBl. II Nr. 415/1999
Ordinance of the Federal Government on the Protection of Federal Employees
against Threats to Biological Agents (B-VbA)

16. Regulation from the Federal Minister of Social
Administration from 2nd April 1948, with respect to
the authorisation to perform medical-diagnostic
examinations as well as the precautionary measures
which are to be observed during the aforementioned
work and when working with pathogens
StF: BGBl. Nr. 63/1948

18. The examinations may only be carried
out in suitable rooms not used for living
purposes.

19. may only be handled and delivered by persons or institutions that
have received the authorization of the Federal Ministry for this
purpose.

20. The work must be
carried out in dedicated,
special laboratory rooms,
which can be locked by a
main door. The matching
key may only be present
in one copy and is to be
kept by the head or his
deputy.
IV. Laboratories for
bacteriological testing for
cholera, plague, yellow-
fever, smallpox, ornithosis
and for human samples in
case of rabies, tularemia,
glanders, foot- and mouth
disease and rickettsiosis

21. Legal Provisions
# Regulation of Biological Agents at Work
# Regulation from the Federal Minister of Social Administration
from 2nd April 1948, with respect to the authorisation to perform
medical-diagnostic examinations as well as the precautionary
measures which are to be observed during the aforementioned work
and when working with pathogens
StF: BGBl. Nr. 63/1948
Verordnung der Bundesministerin für Arbeit, Gesundheit und Soziales über den
Schutz der Arbeitnehmer/innen gegen Gefährdung durch biologische Arbeitsstoffe
(Verordnung biologische Arbeitsstoffe – VbA) BGBl. II Nr. 237/1998
Ordinance of the Federal Minister of Labor, Health and Social Affairs on the
Protection of Workers against Danger from Biological Agents (Ordinance on
Biological Agents - VbA)
Verordnung der Bundesregierung über den Schutz der Bundesbediensteten gegen
Gefährdung durch biologische Arbeitsstoffe (B-VbA) BGBl. II Nr. 415/1999
Ordinance of the Federal Government on the Protection of Federal Employees
against Threats to Biological Agents (B-VbA)

22. Bundesgesetz, mit dem Arbeiten mit gentechnisch veränderten Organismen,
das Freisetzen und Inverkehrbringen von gentechnisch veränderten
Organismen und die Anwendung von Genanalyse und Gentherapie am
Menschen geregelt werden (Gentechnikgesetz – GTG)
StF: BGBl. Nr. 510/1994
Federal Act regulating the use of genetically modified organisms, the release
and placing on the market of genetically modified organisms and the
application of gene analysis and gene therapy to humans (Genetic
Engineering Act - GTG)

23. Regulation from the Federal
Minister of Health with Respect
to the Electronic Reporting of
Laboratories into the Notifiable
Diseases Register

24. Laboratories are required to use
the valid version of the lab
interface description provided by
the Ministry of Health for
transmission of the data.

25. Die wichtigsten internationalen Regelungen sind:
# Europäisches Übereinkommen über die internationale Beförderung gefährlicher Güter
auf der Straße (ADR) für den Straßenverkehr für viele europäische und benachbarte
Staaten,
# Ordnung für die internationale Eisenbahnbeförderung gefährlicher Güter (RID) im
Schienenverkehr,
# Europäisches Übereinkommen über die internationale Beförderung gefährlicher Güter
auf Binnenwasserstraßen (ADN) für die Binnenschifffahrt,
# International Maritime Dangerous Goods Code (IMDG-Code) in der internationalen
Seeschifffahrt,
# Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO-TI) im
Luftverkehr, herausgegeben von der Internationalen Zivilluftfahrtorganisation (International
Civil Aviation Organization: ICAO). Diese werden vom Internationalen Verband der
Luftverkehrsgesellschaften der Internationalen Flug-Transport-Vereinigung (IATA) mit den
IATA Dangerous Goods Regulations (IATA-DGR) übernommen.
Sie gelten nach den Bestimmungen des Gefahrgutbeförderungsgesetzes
auch für rein innerstaatliche Beförderungen.
They also apply according to the provisions of the dangerous goods
transport law for purely domestic transport.
http://www.bmvit.gv.at/verkehr/gesamtverkehr/gefahrgut/
Accord européen relatif au transport international des marchandises Dangereuses par Route

26. Nagoya Protocol on Access to Genetic Resources and
the Fair and Equitable Sharing of Benefits Arising from Their
Utilization (NP)
The NP was agreed to under the Convention on Biological
Diversity (CBD; adopted by the United Nations in 1993) to provide a
transparent legal framework to implement access and benefit-sharing.
It is a supplementary agreement to the Convention on Biological
Diversity.
The NP entered into force in October 2014 after ratification by 50
countries. As of August 2017, 99 countries are parties to NP, including
China, India, Mexico, and the entire European Union.
The US did not ratify the Convention on Biological Diversity (CBD), and
by extension is not a party to the NP.

27. https://www.cbd.int/abs/about/
Tools and mechanisms to assist implementation
The Nagoya Protocol’s success requires effective implementation at the domestic
level. A range of tools and mechanisms provided by the Nagoya Protocol will assist
contracting Parties including:
Establishing national focal points (NFPs) and competent national authorities (CNAs)
to serve as contact points for information, grant access or cooperate on issues of
compliance
An Access and Benefit-sharing Clearing-House to share information, such as
domestic regulatory ABS requirements or information on NFPs and CNAs
Capacity-building to support key aspects of implementation. Based on a country’s
self-assessment of national needs and priorities, this can include capacity to
• Develop domestic ABS legislation to implement the Nagoya Protocol
• Negotiate MAT
• Develop in-country research capability and institutions
Awareness-raising
Technology Transfer
Targeted financial support for capacity-building and development initiatives
through the Nagoya Protocol’s financial mechanism, the Global Environment Facility
(GEF)

28. Hartl R, Kerschner H, Lepuschitz S, Ruppitsch W, Allerberger F, Apfalter P
Detection of the mcr-1 Gene in a Multidrug-Resistant Escherichia coli
Isolate from an Austrian Patient. Antimicrob Agents Chemother. 2017 Mar
24;61(4). pii: e02623-16. doi: 10.1128/AAC.02623-16. Print 2017 Apr.
“In submitting your manuscript to AAC, the author(s) guarantees
that a manuscript with substantially the same content has not
been submitted or published elsewhere and that all of the
authors are aware of and agree to the submission.
By publishing in the journal, the authors agree that any
DNAs, viruses, microbial strains, mutant animal strains, cell
lines, antibodies, and similar materials newly described in the
article are available from a national collection or will be
made available in a timely fashion, at reasonable cost, and in
limited quantities to members of the scientific community for
noncommercial purposes. The authors guarantee that they
have the authority to comply with this policy either directly or
by means of material transfer agreements through the owner”.

29. Von: "Lang, Elke" <ela@dsmz.de>
An: Heidrun Kerschner <heidrun.kerschner@analyse.eu>
Datum: 29.06.2017 11:54
Betreff: Re: CBD/NP compliance in Austria
Guten Tag, Frau Dr. Kerschner,
Gerade sind weltweit die Länder, Forschungsinstitutionen und Wissenschaftler dabei, sich auf das Thema und
gesetzlichen Vorgaben von Nagoya Protokoll und CBD einzurichten. Auch wir versuchen gerade, die notwendigen
Formalitäten einzurichten und müssen leider mit einigen "Krücken" leben.
Eine kurze Zusammenfassung für Österreich finden Sie unter:
http://www.biodiv-abs.at/ms/biodiv-abs/abs_home/abs_uebersicht/abs_umsetzung/
Bitte fragen Sie bei dem österreichischen Focal Point nach, ob es genügt, wenn alle Informationen zur Probenahme und
Isolierung mit dem Stamm hinterlegt werden, d.h. wenn alle Pflichtfelder in unserer Accession Form ausgefüllt sind
(außer denen, über die Sie gerade stolpern):
https://absch.cbd.int/countries/AT: Ms. Andrea H. Nouak
Description Division I/9 - International Environmental Affairs Federal Ministry of Agriculture, Forestry, Environment and
Water Management Stubenbastei 5 A-1010 Vienna
Email andrea.nouak@bmlfuw.gv.at
Telephone +43 1 71100 611616. Der Focal Point wäre auch die <national competent authority that grant(ed) sampling
access>.
Wenn dies ausreicht (in Deutschland würde es ausreichen, zumindest wenn die Klinik? einversanden ist und keine
Ansprüche erhebt), schreiben Sie bitte in unserer Accession Form die Adresse des Focal Point bzw."not applicable" in das
Feld <Provide the name of the national competent authority that granted sampling access> und laden einen pdf File, der
nur Ihren Namen enthält (also kein offizielles Schreiben), hoch unter <Upload Documentation showing Prior Informed
Consent (PIC) and/or Mutually...>.
Ich hoffe, Sie können den Sachverhalt schnell klären,
mit freundlichen Grüßen
Elke Lang
„Please ask your
National Focal Point if
it is sufficient if all the
information for
sampling and isolation
with the strain is
deposited, i. if all
mandatory fields in
our Accession form
are filled out.“

30. Foreign Trade Act 2011
RV 1073 AB 1127 p. 9.
Foreign Trade Law: Compliance with international obligations § 4.
Authorization shall be granted if the
operation is conducted on the basis
of the European Union or other
international law, in particular the
implementation of arms control and
the control of technology transfer.

32. http://www.australiagroup.net/en/controllisthandbooks.html