ORDER OF THE MINISTER OF NATIONAL ECONOMY OF THE REPUBLIC OF KAZAKHSTAN

of June 6, 2016 No. 239

About approval of Health regulations "Sanitary and epidemiologic requirements to implementation of production supervision"

According to Item 6 of article 144 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", PRIKAZYVAYU:

1. Approve the enclosed Health regulations "Sanitary and epidemiologic requirements to implementation of production supervision".

2. To provide to committee on consumer protection of the Ministry of national economy of the Republic of Kazakhstan in the procedure established by the legislation:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) the direction of the copy of this order in printing and electronic type on official publication in periodic printing editions and information system of law of Ad_let within ten calendar days after state registration in the Ministry of Justice of the Republic of Kazakhstan, and also in the Republican center of legal information within five working days from the date of receipt of the registered order for inclusion in reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this order on Internet resource of the Ministry of national economy of the Republic of Kazakhstan and the intranet portal of state bodies;

4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of national economy of the Republic of Kazakhstan of data on execution of the actions provided by the subitem 1), 2) and 3) of this Item.

3. To impose control of execution of this order on the supervising vice-minister of national economy of the Republic of Kazakhstan.

4. This order becomes effective after ten calendar days after day of its first official publication.

Approved by the Order of the Minister of national economy of the Republic of Kazakhstan of June 6, 2016 No. 239

Health regulations "Sanitary and epidemiologic requirements to implementation of production supervision"

Chapter 1. General provisions

1. Health regulations "Sanitary and epidemiologic requirements to implementation of production supervision" (further - Health regulations) are developed for the purpose of implementation of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code), determine procedure for the organization and carrying out production control over observance of requirements of Health regulations, hygienic standard rates, technical regulations and are intended for individual entrepreneurs and legal entities, irrespective of their departmental accessory and patterns of ownership performing activities for production, application, storage, transportation, realization, collection, utilization and (or) destruction of products which are subject to the state sanitary and epidemiological surveillance.

2. In these rules the following terms and concepts are used:

1) objects of the state sanitary and epidemiologic control and supervision - epidemic significant objects, physical persons and legal entities, buildings, constructions, products, the equipment, vehicles, the soil, water, air, food and other objects which activities, use, the use, application and operation can do harm to the state of health of the person and the environment;

2) production supervision - complex of actions, including laboratory researches and testing of the made products, the works and services which are carried out by the individual entrepreneur or the legal entity, aimed at safety and (or) harmlessness for the person and the habitat.

3. Individual entrepreneurs and legal entities according to the activities performed by them according to item 4 of article 90 of the Code shall exercise production supervision according to the requirements provided by these Health regulations.

4. Individual entrepreneurs and legal entities develop, documentary draw up, implement and support in working order effective system of production supervision.

Ensuring production supervision is assigned to the individual entrepreneur and the head of the legal entity.

Ensuring timeliness, completeness and reliability of the exercised production supervision is assigned to the officials designated by the order of the individual entrepreneur and head of the legal entity.

5. The purpose of production supervision is safety and (or) harmlessness for the person of products, works and services, by the organization and carrying out on subject to self-checking behind observance of the requirements established in documents of the state system of sanitary and epidemiologic regulation (further - documents of regulation).

6. Subjects of production supervision are products and epidemic significant objects which lists are approved by the order of the Minister of national economy of the Republic of Kazakhstan of May 30, 2015 No. 414 "About approval of the list of products and epidemic the significant objects which are subject to the state sanitary and epidemiologic control and supervision" (it is registered in the Register of state registration of regulatory legal acts for No. 11658).

Chapter 2. Procedure for the organization and carrying out production supervision

7. Organization of events on implementation of production supervision is carried out by individual entrepreneurs and legal entities.

8. Production supervision includes:

1) development of the program of production supervision;

2) implementing (organization) of laboratory researches and measurements in the cases established by documents of regulation:

on workplaces, in the territory of industrial site, for the purpose of production impact assessment per capita and his health;

behind atmospheric air on border of the sanitary protection zone, executed according to the program of environmental production supervision, for risk assessment to health of the population and compliance of the established sanitary protection zone (further - the SPZ) to requirements of health regulations and hygienic standard rates;

raw materials, semifinished products, packaging materials, the products contacting to food products and water, control of safety of drinking water from water supply source before receipt in distribution network from distribution network, from reservoirs, finished goods and observance of hygienic requirements during engineering procedure of their production, storage, transportation, realization, collection, utilization, destruction, and also behind the gages providing necessary reliability and completeness of control;

3) control of timeliness and completeness of passing of medical examinations according to the Rules of performing obligatory medical examinations approved by the order of the Acting Minister of national economy of the Republic of Kazakhstan of February 24, 2015 No. 128 (it is registered in the Register of state registration of regulatory legal acts for No. 10634) and hygienic training according to the Rules of hygienic training of persons of dekretirovanny national group and Programs of hygienic training of persons of dekretirovanny national group approved by the order of the Minister of national economy of the Republic of Kazakhstan of June 24, 2015 No. 449 (accounting of personal medical books is registered in the Register of state registration of regulatory legal acts for No. 11714), and also;

4) control of availability of the documents confirming safety and compliance of products (including the arriving raw materials, packaging materials, products contacting to food products), behind effective periods of documents (certificates on state registration, declarations of conformity, certificates, veterinary documents), and also allowing documents (the sanitary and epidemiologic conclusion or the coupon about acceptance of the notification on the beginning of activities);

5) assessment of risk factors, the analysis of the revealed dangers, criteria of safety and (or) harmlessness of factors production both the environment and determination of control methods of safety of processes (use, collection, transportation, storage, neutralization, utilization, conversion, burial), works, services, with determination of critical points of control for ensuring management of dangers;

6) accounting of documentation connected with implementation of production supervision. Storage durations of documents - at least three years;

7) development of the scheme of informing the population, local executive bodies, bodies of the public sanitary and epidemiologic service of the Republic of Kazakhstan about emergencies, the production stops, about violations of engineering procedures, cases of origin connected with activities of object mass (3 and more cases) of the infectious and parasitic, occupational diseases and poisonings creating threat to sanitary and epidemiologic wellbeing of the population;

8) control over the implementation of the actions provided by the program of production supervision, observance of hygienic requirements during engineering procedures, timeliness of elimination and minimization of microbiological, chemical, toxicological, virologic, radiological, biological dangers and foreign inclusions. During control adjustment of the actions and implementation of measures directed to elimination of the revealed violations is carried out.

9. The program of production supervision is developed taking into account the dangers (risk factors) which are available on object.

On the objects of production of food products which implemented the HASSP system based on systematic identification, assessment and management of the dangerous factors influencing safety of products on all food chain and corresponding to the criteria established by the document of the Commission the Code Alimentarius "The international technical standards and rules. General principles of hygiene of food products. (CAC/Rcp 1-1969, rev.4 (2003). Appendix. The analysis system of dangerous factors and critical control points (HASSP) and methodical instructions for its application", implementation of the additional program of production supervision is not required.

10. Development of the program of production supervision is performed by the individual entrepreneur, the legal entity independently or with involvement of persons performing activities for carrying out sanitary and epidemiologic audit.

11. The developed program of production supervision is reviewed in case of the changes of type of activity, modification of engineering procedure, foodstuff compounding, other changes influencing stability of sanitary and epidemiologic situation and (or) creating threat to sanitary and epidemiologic wellbeing of the population.

12. Tool and laboratory researches are performed by the individual entrepreneur, the legal entity based on production laboratories or with involvement of laboratories (the test centers) having the sanitary and epidemiologic conclusion about compliance to their regulatory legal acts in the sphere of sanitary and epidemiologic wellbeing of the population and to hygienic standard rates, issued according to Item 2 of article 21-1 of the Code.

Selection and delivery of tests for carrying out production supervision is performed by the specialist of laboratory (the test center) or the trained personnel of object.

Chapter 3. Requirements to the program of production supervision

13. The program of production supervision is constituted in any form and includes the following:

1) determination of lists:

documents of regulation and regulating technical documents (state standards, techniques and control methods of factors of the habitat) according to the performed activities. This list is staticized according to the Law of the Republic of Kazakhstan of November 9, 2004 "About technical regulation";

officials (workers) to whom functions on control of carrying out production supervision at the company (object) are assigned, approved as individual entrepreneurs and legal entities;

positions of the workers who are subject to medical examinations, hygienic preparation and certification;

performed by the individual entrepreneur and the legal entity of works and services, products, and also types of activity which are constituting potential danger for the person and subject to production supervision including the list of types of activity on which are provided availability of allowing documents according to the Law of the Republic of Kazakhstan of May 16, 2014 "About permissions and notifications";

forms of accounting and the reporting established by documents of regulation, necessary for implementation of production supervision;

chemicals, biological, physical and other dangerous factors, subjects of production supervision constituting potential danger for the person and the circle of its dwelling;

control points (critical points of control) concerning which the organization of laboratory researches and measurements, with indication of control points in which sampling (measurements) for carrying out laboratory researches, and frequency of sampling (carrying out laboratory researches and testing) is performed is necessary. The list of chemicals, biological, physical and other dangerous factors, the choice of control points in which are performed sampling amount and frequency of tool and (or) laboratory researches, sanitary processing, disinfection, disinsection and deratization actions are determined by responsible persons (the technologist, the engineer and others), taking into account the characteristic of object, availability of harmful production factors (for objects of the industry), extents of their influence on health of the person and the circle of its dwelling, availability of potential dangers on production stages, turnover, packaging, marking, utilization and destruction, according to recommended amounts, criteria and frequency of laboratory and tool measurements according to appendix 1 to these Health regulations;

2) schemes of the notification of the population, local executive bodies, bodies of the public sanitary and epidemiologic service of the Republic of Kazakhstan about emergencies, the production stops, about violations of engineering procedures, cases of origin connected with activities of object mass (3 and more cases) of the infectious and parasitic, occupational diseases and poisonings creating threat to sanitary and epidemiologic wellbeing of the population according to Chapter 5 of these rules.

14. The program of production supervision includes also other actions which holding is necessary for implementation of effective control behind observance of requirements of documents of regulation.

Chapter 4. Features of production supervision when implementing separate types of activity

15. Production supervision is exercised using laboratory researches, testing on the following categories of objects:

1) objects of industrial and radiation hygiene (production facilities) - workplaces, production rooms and platforms (territory), border of the SPZ, zone of sanitary protection, raw materials for production of products, new types of industrial goods, new engineering procedures, transport, processing equipment, production wastes and consumption (collection, use, neutralization, transportation, storage, conversion and waste disposal), the polymeric, synthetic other materials intended for application in construction on transport, products, products which are source of the ionizing radiation including generating and also the products and goods containing radioactive materials, construction raw materials and materials in which hygienic standard rates regulate content of radioactive materials. Production supervision includes laboratory researches and testing of potentially dangerous factors of the production circle (physical factors: temperature, humidity, air movement speed, thermal radiation; not ionizing electromagnetic fields (further - EMP) and radiations (electrostatic field); permanent magnetic field (including hypogeomagnetic); electric and magnetic fields of industrial frequency (50 Hz); the broadband EMP created by personal computers; electromagnetic radiations of the radio-frequency range; broadband electromagnetic impulses; electromagnetic radiations of the optical range (including laser and ultra-violet); ionizing radiation; production noise, ultrasound, infrasound; vibration (local, general); aerosols (dust) mainly fibrogenny action; natural lighting (absence or insufficiency), artificial lighting (insufficient illumination, illumination pulsation, excessive brightness, high unevenness of distribution of brightness, straight line and the reflected blinding blestkost); electrically charged particles of air (aero ions); aerosols mainly fibrogenny action; chemical factors: the mixes received by chemical synthesis and/or for control of which use methods of the chemical analysis, hazardous substances with the ostronapravlenny mechanism of action, hazardous substances of 1 - 4 classes of danger). When implementing the activities connected with formation of production wastes and consumption it is necessary to provide control, including laboratory, behind collection, use, neutralization, transportation, storage, conversion and waste disposal of production and consumption with assessment of level of environmental pollution.

Information on results of the production supervision which is carried out on production facilities are represented to territorial subdivisions of department of state body in the sphere of sanitary and epidemiologic wellbeing of the population in the corresponding territory of 1 times a half-year to the 5th day of the next month in form, according to appendix 2 to these Health regulations;

2) objects of production and turnover of food products: laboratory control is established by manufacturer according to industry instructions and other regulating documents taking into account the critical control points determined by manufacturer: at technological production phases. Depending on type of the made products quality and safety of raw materials, semifinished products, auxiliary materials, finished goods, water on indicators of radiation, chemical, microbiological, toxicological, parasitological safety are controlled; sanitary and epidemiologic condition of engineering procedures and quality of disinfection, disinsection, deratization of production rooms, equipment and stock; observance of the sanitary and hygienic modes of production and the working conditions working.

On objects of trade control of storage conditions of products and frequency rate of checking of instrumentations is exercised;

3) objects of municipal hygiene: subjects to water supply, including operation of centralized, not centralized, house distributive, autonomous systems of drinking water supply of the population, system of drinking water supply on vehicles) with distribution network; the superficial and underground sources used for the purpose of drinking and economic and household water supply and the recreational purposes, materials, the equipment, substances, devices used in the sphere of economic and drinking water supply. Laboratory control is exercised behind compliance of drinking water, and also behind compliance of water object to requirements of Health regulations "Sanitary and epidemiologic requirements to water sources, places of water intake for the economic and drinking purposes, economic drinking to water supply and places of cultural and community water use and safety of water objects", approved by the order of the Minister of national economy of the Republic of Kazakhstan of March 16, 2015 No. 209 (it is registered in the Register of state registration of regulatory legal acts for No. 10774). When implementing the activities connected with release of all types of production, economic and household and surface sewage from the territories of the inhabited places, production and other facilities it is necessary to provide laboratory control of efficiency of removal of substances on ingredients on treatment facilities, composition of the dumped sewage;

treatment facilities of the economic and household sewerage, the platform and grounds for collection and storage of municipal solid waste (further - MSW): laboratory control is exercised behind quality of sewage, soils, the materials and the equipment applied in case of sewage treatment, atmospheric air. When implementing the activities connected with release of all types of production, economic and household and surface sewage from the territories of the inhabited places, production and other facilities it is necessary to provide laboratory control of efficiency of removal of substances on ingredients on treatment facilities, composition of the dumped sewage according to requirements of the Health regulations "Sanitary and epidemiologic requirements to collection, use, application, neutralization, transportation, storage and waste disposal of production and consumption" approved by the order of the Minister of national economy of the Republic of Kazakhstan of February 28, 2015 No. 176 (it is registered in the Register of state registration of regulatory legal acts for No. 10936);

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