STATE INSTITUTION “O.M. MARZEIEV INSTITUTE FOR PUBLIC HEALTH” NAMSU

OCTOBER, 11 - 12

SCIENTIFIC-AND RESEARCH CONFERENCE "TOPICAL ISSUES OF PUBLIC HEALTH AND ECOLOGICAL SAFETY OF UKRAINE"
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Summary of the National Report on biocides management in Ukraine


The National Review of the current situation in the biocides (pesticides and disinfectants) management in Ukraine was carried out as a part of the Project “Strengthening Capacities for Sound Management of Biocides (Pesticides and Disinfectants) to Reduce the Impact on the Population of Ukraine” implemented by the WHO European Office, the WHO Country Office in Ukraine, and the WHO European Environmental and Health Center in collaboration with “O. M. Marzeiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine” within the framework of Quick Start Program of the Strategic Approach to the International Chemical Management (SAICM) under financial support of United Nation Environment Program.

The National Review summarizes the data on the production, import, export, transportation, use/consumption of biocides in Ukraine and the management of their waste, as well as the legal, institutional, administrative and technical aspects of biocide management in Ukraine; an expert assessment of the current state of biocide products in Ukraine was performed and suggestions and recommendations for strengthening capacities and establishing a system for sound management of biocides in Ukraine during their life cycle were formulated in order to eliminate the negative impact of biocides on the environment and human health.

The national experts’ team (who did the assessment) includes representatives from State Institution “OM Marzeiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”, State Institution “Institute of Occupational Medicine of the National Academy of Medical Sciences of Ukraine”, Kyiv City Administration (communal enterprise “Profdesinfection”), National Medical University named O.O.Bogomolets, Ministry of Ecology and Natural Resources, State Enterprise “Center for Environmental Initiatives”, State Enterprise “Cherkasy NIITEKHIM”, Kharkiv city organization “Ecopravo-Kharkiv”, “Center of Registries of the Ministry of Health of Ukraine”, Nongovernmental organizations “Ukrainian Association of Public Health”, NGO “Fumigation Association”, All-Ukrainian ecological public organization “MAMA-86”.


Country Background

Ukraine (the capital city is Kyiv) is a country in the Eastern and partly Central Europe, located in the south-western part of the Eastern European Plain. Ukraine has the common land border with Belarus in the north, with Poland in the west, with Slovakia, Hungary, Romania and Moldova in the southwest and Russia in the east, and the maritime borders with Romania and Russia.

The total area of Ukraine is 603,628 km², which is 5.7% of the European territory and 0.44% of the world, and Ukraine is the second largest among the countries of Europe.

As of June 1, 2017, the current population of Ukraine amounted to 42,481,972 people (without taking into account the temporarily occupied territory of the Autonomous Republic of Crimea and the city of Sevastopol). The urban population is 29,482,300people (69,1%); the rural population is 13,102,200 people (30.9%). The demographic situation in the country is characterized by the gradual aging of the population and significant migration (according to the International Organization for Migration in 2014-2015, the number of domestic labor migrants in Ukraine exceeded 1.6 million people and reached 9% of the economically active population).

The industrial sector plays a key role in the Ukrainian economy; its contribution to the gross domestic product (GDP) is about 20%. The share of individual industries in general industrial production is 27%, food industry - 17%, electricity - 14%, machine building - 14%, metallurgy - 7%, chemical industry - 5%, wood processing and pulp and paper industry - 5%, light industry - 3%, production of other non-metallic mineral products - 3%, refining and coke production - 2%.

Agriculture in Ukraine is one of the most important branches of the economy. By 2014 (before the beginning of the hostilities), Ukraine had 32 million hectares of black earth, accounting for 1/3 of all arable land in Europe. Due to this, Ukraine ranked third in the world for corn exports, and the fifth - in the export of wheat. The main branch of the specialization of the agro-industrial complex is plant growing, especially the technical and forage, which provides 14% of GDP and is the leading export industry in the country.

Production, Import, Export, Transportation, Use and Disposal of Biocides

Today, in Ukraine there is no legislative and regulatory framework for the definition, classification, and handling of biocides, therefore, registration and handling (which can be classified in accordance with Regulation (EC) No 528/2012 of May 22, 2012 for the third main group - pest control means) is carried out in accordance with the Law of Ukraine “About Pesticides and Agrochemicals” (as of 01.01.2016) and related normative documents.

Today, the Ukrainian market has more than 90 active substances (ASs), which are biocides and are part of pesticide products and disinfectants. Almost all of them are classified as hazardous and are toxic to the environment both in acute and chronic effects, as well as acutely toxic to humans and/or irritants in the eyes and skin.

There is no production of AS biocide products in Ukraine, except chlorine and sodium hypochlorite (disinfectant for potable water); chemical substances are also produced which can potentially be used for the production of biocides (citric, amber, dairy, acetic, hydrochloric and sulfuric acids, ethanol, etc.).

It should be noted that by November 2017 in Ukraine there had been no systematic market research on the state of the domestic commodity market of biocides. Therefore, the National Review for the first time provides information on the main cumulative indicators that characterize the state of biocides circulation in Ukraine in 2015-2016: production volumes, tons (in 2015 and 2016 – 29,745 and 26,803 tons, respectively); AS production volumes, tons (18,039 and 15,355 tons); import volumes, tons (6,126 and 6,538 tons); AS import volumes, tons (1,222 and 1,263 tons); export volumes, tons (1,937 and 2,046); AS export volumes, tons (185 and 142); consumption volumes, tons (33,929 and 31,194); AS consumption volumes, tons (19,076 and 16,475); storage volumes, tons (35,871 and 33,341); transportation volumes, tons (36,056 and 33,537); hazardous cargoes transportation volumes, tons (32,450 and 30,183); volumes of generated waste from the use of biocidal products, tons (1,746 and 1,483).

The main active ingredients of biocidal substances being in circulation in the Ukrainian market are chlorine, hydrogen peroxide, sodium salt of dichloroisocyanuric acid, aluminum phosphate, propyl alcohol, peracetic acid, formic acid, ethyl alcohol, trichlorisocyanuric acid, and others. Domestic production of biocides is based mainly on imported active substances and mixtures of active substances (except chlorine).

The branded range of registered biocides present in the Ukrainian market is about 800 - 850 trade names, in particular, the product range of biocidal products of domestic produce is 250 - 270 names.

Legal Instruments and Non-Regulatory Mechanisms for Sound Management of Chemicals, Including Biocides

A detailed analysis of the national legal instruments and non-regulatory mechanisms for the management of chemicals, including biocides, showed that today in Ukraine the regulation of chemicals is fragmented and, unfortunately, this also applies to legal instruments.

The legislation of Ukraine is devoid of a unified normative act that would regulate complex production of biocide products and their circulation at all stages of the life cycle. To the disadvantages in the part related to the management of chemicals, the unresolved issue of the division of responsibility between executive authorities and local governments should also be noted. The issue of observance of the current environmental legislation and monitoring its compliance is also relevant, which is conditional upon the Verkhovna Rada of Ukraine that adopted a moratorium on inspections of any businesses by regulatory authorities in August 2014.

Ukraine is a Party to the Chemical Conventions (Basel, Rotterdam, and Stockholm), which are the conventions of direct effect and do not require additional legislative acts. However, the quality of their implementation is very low, due to the lack of appropriate National Implementation Plans, except for the existing initial NIPs of the Stockholm Convention on Persistent Organic Pollutants. Unfortunately, for today Ukraine is not a party to the Minamata Convention, which regulates the circulation of goods with the addition of mercury.

Ukraine is also a party to a number of international agreements aimed at the proper management of chemicals for the protection of the environment and people’s health (UN Framework Convention on Climate Change, the Protocol on PRTRs to the Aarhus Convention, the Protocol on Strategic Environmental Assessment to the Convention on Environmental Impact Assessment in transboundary context), but the issue of biocide management continues to be low.

Due to coming into force of the Association Agreement between Ukraine and the EU, the country faces new challenges in harmonizing national legislation with EU legislation. Unfortunately, the Association Agreement between Ukraine and the EU did not include the main EU legislation in the field of chemicals management:

• Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals and Preparations (REACH).

• Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labeling, and packaging of substances and mixtures (CLP).

• Regulation (EC) No 528/2012 of 22 May 2012 on market access and use of biocidal products (BPR).

Also, the Global Harmonized System of Dangerous Goods and Labeling (GHS) has not been implemented in Ukraine.

Among the non-regulatory mechanisms for sound management of chemicals, including biocides, the chemical industry companies of Ukraine in the “Responsible Care” program and the existence of economic incentives can be noted. The Government of Ukraine in accordance with Art. 17 of the Law of Ukraine “On Environmental Protection” established the Procedure for the Establishment and Use of the State Fund for the Protection of the Environment and, according to the State Budget of Ukraine, approved a list of environmental protection measures.

The absence of a basic biocide law in Ukraine is hampering the introduction of a new approach to regulating biocides circulation throughout their life cycle.

Ministries, Agencies and Other State Institutions Participating in Biocides Management

The Ministry of Health of Ukraine, the Ministry of Environmental Protection of Ukraine and the Ministry of Agrarian Policy and Food of Ukraine are the main ministries that perform the control functions which determine the safety criteria for biocides at all stages of their life cycle (production, storage, transportation, use, disposal).

The mentioned ministries and departments do not have a separate unit within their organizational structure, which function only includes ensuring the rationality and safety of the biocides use. As a rule, specialists along with the above function perform other functions.

In order to increase the effectiveness of public administration activities in ensuring the safety of the use of biocidal products, achieving full coordination between various ministries and departments, providing a unified information space for the authorities at all levels, improving the skills and responsibilities of government officials and decision-makers in the field of control, it is expedient to create an interdepartmental body for the circulation of biocides, which function will be to determine the coordination of activities of public administration bodies in biocides regulation.

Activities of the Industry, Public Stakeholders and Research Centers in Terms of Biocide Management

Public associations and organizations, which activities are provided for in their charters and registered in accordance with the current legislation of Ukraine, participate in management in the field of environmental protection. The legislation of Ukraine provides for the advisory nature of the public’s ability to provide information to the government on biocide management issues, but it is not mandatory and may not be taken into account by government authorities when deciding on biocide management.

However, in the country, certain measures are being taken to establish possible cooperation between governmental and public associations in the field of environmental protection. Specially authorized state authorities, together with relevant scientific institutions and public associations, provide short-term and long-term prognostication of environmental changes that should be taken into account in the course of creating and implementing programs and measures for economic and social development and environmental and chemical safety management, including biocides.

Public control in the field of environmental protection is carried out by public environmental inspectors in accordance with the Regulation, approved by the Environmental Protection Law of Ukraine.

In Ukraine, the environmental movement has become one of the subjects of the national environmental policy, and the role of public associations in informing the public about the issues of environmental protection and the Government’s actions in this area is crucial. Today, in Ukraine there are more than 440 environmental NGOs, some of which work at the international level (about 7%).

The Law of Ukraine “On Environmental Expertise”, which was to expire by the end of 2017, provided for a public environmental expertise. And since December 16, 2017, the new Law of Ukraine “On Environmental Impact Assessment” has come into force and all types of environmental expertise have been replaced by an environmental impact assessment.

Public control in the field of environmental protection has not been adequately developed due to the lack of an experimental base and analytical laboratory studies; nevertheless, it is necessary to note the positive experience of public associations in informing the public.

Research in the field of biocide assessment, their regulation, justification of safety criteria, risk assessment for human health and the environment are carried out by scientific institutions of the National Academy of Medical Sciences of Ukraine and branch research institutions.

Interdepartmental Commissions and Coordination Mechanisms

Despite the existence in Ukraine of a coordination structure consisting of a number of interdepartmental commissions, special working groups, etc. dealing with the management of chemicals and waste, an interagency body should be urgently established to coordinate sound management of chemicals, including biocides and waste. The status and authority of this structure can be determined taking into account the needs, existing experience and the need for a synergistic approach within the framework of the implementation of chemical conventions and SAICM.


Information Management, Access, and Use

In Ukraine, a national system of access to information, which is the responsibility of central executive bodies (CEBs) and other public information providers, is developed and legally approved in accordance with the Law of Ukraine “On Access to Public Information”.

However, ensuring broad access to information has to be improved, since CEBs involved in the collection and processing of the information on chemicals safety, post incomplete data on their websites for open access, due to the lack of such data, or technical and financial problems.

In order to organize the proper exchange of information on chemicals safety for human life and health and environmental pollution, distributed between the executive authorities, it is necessary to develop an information and communication system that will enable the creation of a unified information space for all participants. The introduction of such system requires the development of appropriate sub-normative legal acts and the adoption of decisions on the financing of these measures at the state level.

A significant disadvantage in providing information about chemicals is the lack of access to international information systems. So, the information that can be obtained through internet resources in most cases is fee-based.


Technical Infrastructure

The existing environmental monitoring system in Ukraine is based on the implementation of distributed functions between entities and consists of subsystems subordinated to them. Each subsystem at the level of individual entities of the monitoring system has its own structural, organizational, scientific and methodological and technical basis.

Surveillance of the environment and its impact on the monitoring system are carried out simultaneously by several departmental networks that are not coordinated with each other; in some cases, observations are duplicated, and in some areas are insufficient.

The existing surveillance and evaluation do not fully satisfy the information needs of the monitoring system and lead to inefficient use of funds. In the existing monitoring networks, various methods are used to determine the pollution indicators, mainly using obsolete techniques and equipment that does not meet current technical and metrological requirements and most of which have already exhausted their technical resources.

Available surveillance networks are built without taking into account the recommendations of the UNECE Commission on the establishment of a European Observatory for Environmental Information, in particular, EUROWATERNET, EUROSOMNET, ICP FORESTS and others.

The level of competence of the state laboratories in many cases is confirmed by the executive authorities to whom these laboratories belong, regardless of the criteria they must have. In some cases, the executive authorities authorize performing state tests by the state-owned laboratories that do not have sufficient competence and appropriate equipment.

The level of quality of tests conducted in the state laboratories is mainly low, as evidenced by the extremely small number of the state laboratories that have passed independent accreditation (5 to 7% of the total number of the state laboratories).

In Ukraine, unlike the EU, the system of scientific and methodological coordination of the activities of the state laboratories and the system of organizations that may act as coordinators of interlaboratory comparative tests programs are not sufficiently developed. In fact, the Ministry of Health of Ukraine has not set up the reference laboratories that could guarantee the reliability of the tests. These laboratories are identified only in the system of the State Service of Ukraine on Food Safety and Consumer Protection but do not currently work to the required extent.

In addition, the information obtained during the implementation of the licensing and supervision function of the central executive bodies is an integral part of the monitoring information system. In particular, in Ukraine, at the legislative level, the requirement is made that the state trials and examinations are mandatory for a large number of licensing procedures. However, due to the deregulation of business and the introduction of monitoring during the past 3 years for certain types of control and surveillance activities, the number of laboratory studies has decreased significantly, which does not allow to obtain representative data regarding the circulation of chemicals.

Preparedness for Emergencies (Chemical Accidents), Appropriate Measures and Follow-up Activities

The analysis of the actions of the authorities and civil defense forces in emergency situations caused by the chemical factor indicates that the sequence and contents of work of the authorities do not always ensure making a reasonable decision and meeting an adequate set of conditions in the focus of the incident, as well as a number of measures to eliminate the consequences of a chemical accident.

During the preparation of the National Review, no information was found on biocides poisoning in Ukraine.

The analysis of the elimination of emergency situations caused by the chemical factor, which took place over the past decade, indicates the need for a clear and prompt response from the onset of the incident and the adequate response measures, including an understanding of the chemical processes caused by emergency situations.

When responding to a chemical accident, it is necessary to determine short-term and long-term measures both for elimination of its consequences and for carrying out health measures for people and those environmental factors which impact has been directly harmful or destructive in terms of the incident.

For the elimination of the consequences of chemical origin (including biocides), it is also necessary to involve specialized laboratories, research institutes, etc. in order to carry out appropriate instrumental research and scientific substantiation to predict their consequences for public health.

Employees’ and Public Competency and Awareness of the Issue; Training Target Groups and Professionals

The analysis of competency and training of target groups and specialists working in the field of biocidal products at all stages of their life cycle has shown the existence of two tasks related to ensuring competency and understanding of the problems, hygiene education and the preparation for the rational management of biocides and their waste.

Key elements of the information and educational policy in the field of chemicals management should be the effective implementation in Ukraine of relevant articles of the chemical conventions on information, competency raising and training and relevant sections of the Global Action Plan for SAICM, as well as national plans for the implementation of these international treaties and other national plans and programs related to environmental issues.


International Relations

On January 1, 2017, Ukraine became a member of 79 international organizations and has been cooperating with many of them with regard to rational management of chemicals and waste.

Ukraine has some positive results in the field of international cooperation on chemical management as a Party to the Chemical Conventions, and its representatives are part of several governing bodies and committees of international organizations and treaties (conventions); representatives of Ukrainian delegations take part in conferences of the Parties to conventions and other international events.

In Ukraine, with the support of international organizations, a number of technical assistance projects in the field of chemicals and waste management, which fall under the jurisdiction of chemical conventions and SAICMs, are being implemented.

At the same time, Ukraine’s level of participation in international cooperation on chemicals management is insufficient.

Due to the full entry into force on September 1, 2017, of the Association Agreement between Ukraine and the EU; the increase in the impact of technical barriers and environmental requirements on the part of the EU and other regions, first of all, at the level of environmental safety of chemical products on the domestic market (REACH, CLP, BRP, GHS), requires from Ukraine to intensify its work within the international cooperation on the rational management of chemicals.

It is also important for Ukraine to actively defend national interests both in the development of new international treaties related to the management of chemicals and in the implementation of existing relevant international agreements and programs. The country needs to use more actively the potential of cooperation with international organizations in the context of attracting technical and consultative assistance to the country to solve problems that exist in the field of chemicals management without losing national experience in these issues.

In order to further develop international cooperation in the field of chemicals management in Ukraine, it is necessary, first of all, to take measures for the establishment of coordination mechanisms at the national level that will ensure the concerted action of the relevant state administration bodies. Such a mechanism, in particular, could be the creation of the Center for the Implementation of Chemical Conventions in Ukraine and the SAICM.


Available and Required Resources for Biocide Management

The central executive authorities that ensure biocide management in Ukraine have a well-structured and skilled staff on the territory of the country. However, there is no official data on the resources available for the management of biocidal products, as there is no specific position on biocide management in the central executive authorities.

By the Resolution of the Cabinet of Ministers of Ukraine No. 348 dated March 29, 2017, the State Sanitary and Epidemiological Service of Ukraine was liquidated and its functions were transferred to the State Service of Ukraine on Food Safety and Consumer Protection. The result was a violation of intersectional relations at all stages of the biocides circulation.

In Ukraine, there is an extensive system of laboratory centers accredited in the field of hazard identification in environmental objects, agricultural products, foods, household items, but there is no clear legally-established body regulating and coordinating the effective work of these centers.

Public organizations, as a rule, do not have a laboratory base, therefore the management of biocides, which is associated with the activities of public organizations in the areas of environmental protection, health and agricultural production, is, in particular, in monitoring environmental objects, informing the public, conducting trainings and other information and training activities.

In the country, the information on environmental pollution caused by biocides, accumulation of waste, the presence of hazardous chemicals in potable water, food is published in the media and is available to the public.

So today, ensuring the safety of biocides requires not only increased resources but also the mobilization and rational use of those available. It is necessary to actively involve in the management of biocides the existing staff capacity of different departments, including academic research institutions.

State support of special professional training at different levels of government - decision-makers, laboratory experts, and state institutions, etc. – remains an urgent issue. This training should include such topics as occupational health, environmental protection, prevention of the illegal circulation of biocides, recycling hazardous waste and preventing possible harmful effects on public health.

The issue that needs to be solved is the provision of a modern technical equipment to the institutions engaged in biocides research. A prerequisite for this is the development of the state-entrepreneurial interaction between governmental institutions and representatives of businesses. International organizations and their experience should be also actively involved in cooperation in the field of biocide management.

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