Current aspects on Biosafety and Biosecurity

in the Republic of Moldova

Olga Burduniuc - MD, PhD, associate profesor, Greta Bălan - MD, PhD, associate profesor, Natalia Caterinciuc - MD, PhD
Maria Bivol - microbiologist, Cătălina Croitoru - MD, PhD, associate profesor, Elena Ciobanu - MD, PhD, associate profesor
Oana Iaconi - medical student
National Agency for Public Health State University of Medicine and Pharmacy “Nicolae Testemitanu”

OBJECTIVE: Situational analysis of the biosafety and biosecurity issues and development of set of comprehensive measures focused on protection
of public health and environment from the pathogenic biological agents.

SUMMARY
Biosafety and biosecurity issues remain a major concern for the country
because of the alarming rise of biological threats to public health across the
globe, including increased concerns on proliferation of biological weapons,
potential for bioterrorism, emerging and reemerging infectious diseases.
The international scientific community developed a common approach to
guarantee biosafety and biosecurity while working with pathogenic
biological agents, based on the concept of management of the biological
risks, which is reflected in the leading international &national documents.
This study highlighted the current situation on biosafety and biosecurity in
the Republic of Moldova and underlies the importance for improving
endorsement of legal framework in order to ensure national health security.
Country is working on updating regulatory framework in the field of
biosafety and biosecurity measures to assure implementation of a
coordinated multi-agency approach, creation and maintenance of the
functionality of the National Biosafety and Biosecurity Committee;
creation and management of a national registry of laboratories. In Moldova
there is Biosafety and Biosecurity Association, that represent the interests
and needs of practitioners of biological safety internationally. The
objectives of the association are: strengthening of knowledge in the field of
biosecurity and developing biosafety and biosecurity culture and
promoting knowledge in this field within professional groups, students, etc.
METHODS
The conducted assessment of the biosecurity and biosafety legislative
framework allowed to conduct mapping of stakeholders and institutions
involved in implementing biosecurity and biosafety activities. Within other
sources of information was statistical reports on morbidity in the Republic
of Moldova. Statistical methods of retrospective analysis were used. All the
items of the study are analyzed and included in a radar graphical
representation. Were analyzed multiple parameters and this methods helps
us highlighted strengths and weaknesses of the analyzed items. This
graphical method of displaying multivariate data in the form of a two-
dimensional chart of three or more quantitative variables represented on
axes starting from the same point. The relative position and angle of the
axes is typically uninformative.
RESULTS AND DISCUSSION
The Republic of Moldova has acceded to, ratified and is implementing the following international
documents on biosafety and biosecurity issues: the International Health Regulations (WHO 2005);
United Nations Security Council Resolution 1540 (United Nations Security Council 2004); and the
Biological Weapons Convention (Biological and Toxin Weapons Convention 1975); Convention
on Biodiversity Conservation (Rio-de -Janeiro, 1992); Pan-European Strategy for Biodiversity and
Landscape Conservation (Sofia, 1995); In January 2001 signed the Cartagena Protocol on
Biosafety. In 2007 Republic of Moldova adopted and is implementing the International Health
Regulations (2005), which purpose is to prevent, protect against, control and provide a public
health response to the international spread of disease, increasing the safety of laboratory workers
etc.
The comparison of the national versus international biosecurity and biosafety legislative
framework, underline various strength areas of activities that can have been considered, such as:
§ Well-functioning national epidemiological surveillance system of infectious diseases and
public health events;
§ Reorganized public health laboratory network (laboratory classification, procedures and
equipment to ensure safe working conditions, etc.);
§ Quality management system in place;
§ Present equipment, methods and procedures for appropriate utilization of biological waste;
§ Requirements and conditions for the transport of hazardous biological substances etc.
Republic Moldova represents a country in SE Europe with rather good transposition of
international practices in national legislation but besides this progress institutions need to work on
implementation of different items both in terms of biosafety and biosecurity. Moldova has used as
model, the European Union Directive 2000/54 on the protection of workers against the risks related
to exposure to biological agents and WHO biosafety guide. This directive established the
foundations of biosafety, including conducting risk analysis prior to the handling of a biological
agent, definition and classification of biological agents in risk group and definition of different
protection levels for biological laboratories (BSL -1 to -4). Directive 94/55/EC (European
Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR) has also
transpose in national regulation.

The provisions related to export control is the subject of a regulation incorporating the traceability of
exchanges, the need to obtain a license and the ability to control exports.
However, biosecurity is not limited only to the verification of export of biological agent. Biosecurity refers
to all measures and practices to prevent the risk of loss, theft, misappropriation or misuse of all or part of
micro-organisms or toxins in order to cause disease or death of human beings.
Therefore, the legislative documents do not stipulate provisions related to :
• Physical protection and access control measures based on level of risk for institutions holding highly
pathogenic micro-organisms (group 3 and 4, mentioned in the European legislation)
• Measurement traceability of exchanges between laboratories and stocks held of these biological agent
• Criminal records verification of persons having access to highly pathogenic micro-organisms
• Measures for establishing the list of establishments authorized to hold and use highly pathogenic
microorganisms
• Inspection or control for preview items.
These objectives traceability of microorganisms and toxins, individuals and laboratories are not explicitly
mentioned in the European regulations, but are present in different national regulations of European
countries (including France, Netherlands and Switzerland). In addition, the WHO biosecurity guideline
promotes the same goals.
The population migration and refugee movements started in 2015, especially in the European Region
maintaining the continue risk of transmission of communicable diseases from endemic areas. The regular
tourist and economic change ways between countries increases the risk of import of dangerous infectious
diseases, including in the Republic of Moldova
The periodic risks assessment of occurring communicable disease will offer evidence-based information to
consider the effectiveness of existing or revising of countermeasures, such as disease surveillance,
diagnostics, vaccines, and drugs supply mechanisms. Early disease detection of diseases, especially caused
by bacterial resistance to antibiotics and surveillance systems are crucial for effective preparedness and
response measures of health sector.
The national surveillance system over the past 10 years present qualitative information, based on
standard case definition, related to sporadic cases of anthrax (from 1 to 10 cases), tularemia (single cases),
and leptospirosis (from 4 to 19 cases), mainly transmitted from animals or throughout the contact with
contaminated environment. In the Republic of Moldova, there are telluric foci of anthrax, in certain
restricted areas, the circulation of various pathogens of tularemia and leptospirosis pathogens, etc., as well
as in different types of vectors (tick, mosquitoes) for Lyme borreliosis, tick-borne encephalitis, etc. Routine
sentinel sites monitoring of vector-borne diseases such as monitoring of diversity and geographical
distributions of vectors (ticks, mosquitoes), reservoirs (rodents) and different types of infectious agents
have been established for evidences collection and analysis.

CONCLUSIONS
1.The implementation of legislative framework needs permanent and continues attention in order to assure appropriate update rules, standards,
guidelines and instructions for public health security.
2.The existing National Commission for Biosafety, established in accordance with the Biosafety Act 755/2001, authorizes and controls the
production, testing, use and sale of GMO.
3.The national epidemiological surveillance system is structured and collects data on infectious diseases and unusual or unexpected public health
events need permanent support and continuous maintenance.
4.Along with state bacteriological laboratories, there are a significant number of private laboratories. According to national procedures, licensing of
private laboratory activities and accreditation (every 5 years) does not ensure proper monitoring of biosafety and biosecurity requirements.
5.The introduction of a single National Register for laboratories, both public and private, will assure appropriate monitoring of activities from the
tracking of procedures and SOPs, devices and consumables to admission of specialists in laboratories with different levels of biosafety and handling of
microorganisms types.
6.The safe disposal / inactivation of biological waste from laboratories and other medical institutions include following methods: autoclaving,
chemical disinfection, incineration in special devices and outdoors.
To strengthen and improve biosafety and biosecurity activities, an important component is the strengthening of human resources and the
modernization of educational programs in the field of biosafety and bioethics in accordance with the latest recommendations of the WHO

NEXT STEPS AND RECOMMENDATIONS

In the framework of the EU CBRN Center of Excellences Initiative, the Republic of Moldova cooperates with EU and
non-EU states to mitigate CBRN risks of criminal, accidental or natural origin. Moldova has participated in EU
CBRN CoE Project 3 “Knowledge Development And Transfer Of Best Practice On Bio-Safety/Bio-Security/Bio-Risk
Management” ; EU CBRN CoE Project 7: Guidelines, procedures and standardization on biosafety/biosecurity, EU
CBRN CoE Project 18 “International Network of universities and institutes for raising awareness on dual-use
concerns in bio-technology”; EU CBRN CoE Project 36 “Further development and consolidation of the
Mediterranean Programme for Intervention Epidemiology Training (MediPIET)”; EU CBRN CoE Project 44
“Strengthening CBRN first response capabilities and regional cooperation in South East Europe, Southern Caucasus,
Moldova and Ukraine” that have contributed to the increase of national capacities in the field of biosafety and
biosecurity.
1.Development of legislative, normative and methodological documents regulating the actions for handling of infectious agents.
2.In order to assure protection of working personnel, general population and environment from the pathogenic biological agents it is necessary further
development and improvement of medical-biological, organizational, engineering and technical measures;
3.To create and ensure the functionality of the National Committee responsible for biosecurity and biosafety and National registry of laboratories;
4.Improve educational programs in the field of biosafety and bioethics in accordance with the latest WHO recommendations;
5.To develop / continue international cooperation with interested countries, institutions and services
ACKNOWLEDGMENTS
We would like to express our deep and sincere gratitude to the following specialists for all their effort, technical support and contribution to conduct
this research;
1. Christiane Scimar, Scientific Expertise & QHSE, France
2. Dr. Werner Gielsdorf, Healthcare Services & Consulting, Germany
3. Col. Mariana Grama , head of the department for Logistics, Ministry of Defence of RM