Thông tư 05/1999/TT-BYT

CIRCULAR

GUIDING THE DECLARATION, REGISTRATION AND ISSUE OF CERTIFICATES OF ELIGIBILITY FOR USE OF SUBSTANCES SUBJECT TO STRICT LABOR SANITATION REQUIREMENTS

Pursuant to Articles 96, 185 and 186 of the Labor Code of June 23, 1994;
Pursuant to Clause 2, Article 19 of the Government’s Decree No.06/CP of January 20, 1995 defining the Ministry of Health’s responsibility for elaborating, issuing and uniformly managing the system of labor sanitation regulations;
Pursuant to Decree No.68/CP of October 11, 1993 of the Government defining tasks, functions and powers of the Ministry of Health;
The Ministry of Health hereby guides the declaration, registration and issue of certificates of eligibility for use of substances subject to strict labor sanitation requirements:

I. OBJECTS AND SCOPE OF APPLICATION

This Circular shall apply to enterprises, agencies, organizations, collectives and individuals (called establishments for short) that use, store, transport, produce and/or trade in (referred to collectively as use) substances subject to strict labor sanitation requirements, which, as defined in the Health Ministry’s list, must be declared, registered and go through the application for certificates of eligibility for use with the labor sanitation State inspectorates under the Health Ministry or Health Services of the provinces or centrally-run cities, including:

- State enterprises;

- Enterprises of other economic sectors, cooperatives, production groups, organizations and individuals;

- Foreign-invested enterprises, enterprises in export-processing zones and industrial parks;

- Foreign agencies and organizations and international institutions based in Vietnam;

- Non-business units, armed forces and other socio-political organizations.

II. DEFINITION AND PURPOSE OF MANAGEMENT OF SUBSTANCES SUBJECT TO STRICT LABOR SANITATION REQUIREMENTS

1. Definition of substances subject to strict labor sanitation requirements: They are noxious and dangerous substances, which, through the process of contact therewith, cause chronic or acute poison and may thereby lead to death, cancer or gene deformation, thus adversely affecting the reproductive process and causing occupational diseases to laborers. The list of substances subject to strict labor sanitation requirements is provided for by the Ministry of Health in Appendix 1 enclosed herewith. This list shall be supplemented when necessary. The permitted norms of such substances in the labor environment shall comply with the stipulations of the Health Ministry.

2. The management of the said substances aims to prevent in the immediate or long future chemical accidents and disasters and to protect the laborers’ health, the environment as well as the health of the community.

3. The said substances must be declared, registered and inspected periodically and extraordinarily; be used, preserved, stored and transported in accordance with the regulations on labor safety and sanitation. In the course of producing and using such substances, establishments shall have to work out optimum measures to prevent and handle accidents.

III. DECLARATION, REGISTRATION AND ISSUE OF CERTIFICATES OF ELIGIBILITY FOR USE OF SUBSTANCES SUBJECT TO STRICT LABOR SANITATION REQUIREMENTS

1. Declaration of substances subject to strict labor sanitation requirements

a/ Declaration means declaring and reporting on substances subject to strict labor sanitation requirements with the State inspection agency in charge of labor sanitation under the State Inspectorate of the Health Ministry or Health Service of the province or centrally-run city (called the Health Ministry’s Inspectorate or the Health Service’s inspectorate of the province or centrally-run city for short).

b/ Substances which must be declared: are those subject to strict labor sanitation requirements, which are used and generated in the course of production, preservation, storage and/or transport as defined in the list in Appendix 1 enclosed herewith. These substances must be declared in term of their quantity, concentration and use purposes.

c/ Declaration procedures: Establishments shall have to declare substances which are on the list of substances of categories I and II, which are subject to strict labor sanitation requirements, with the Health Services’ inspectorates of the provinces and centrally-run cities.

The Health Services’ inspectorates in the provinces and centrally-run cities shall have to report to the Health Ministry’s Inspectorate on the substances on the list of category-I substances subject to strict labor sanitation requirements.

2. Registration and issue of certificates of eligibility for use of substances subject to strict labor sanitation requirements

2.1. The registration and application for certificates of eligibility for use of substances subject to strict labor sanitation requirements (called certificates for short) are the compulsory administrative procedures for the establishments that use the substances specified on the list attached herewith.

2.2. The Health Services’ inspectorates of the provinces and centrally-run cities shall organize the registration and issue of certificates of eligibility for use of category-I and-II substances subject to strict labor sanitation requirements, which are on the list enclosed herewith.

2.3. Procedures for the issue of certificates for the first time are stipulated as follows:

The establishment shall send the dossier of registration and application for certificate to the Health Service’s inspectorate of the province or centrally-run city, which has received its declaration on the substances subject to strict labor sanitation requirements. The dossier of registration and application for certificate shall include:

- The application for registration and the certificate, sent to the Health Service’s inspectorate of the province or centrally-run city.

- The brief description of the substances subject to the application for certificate.

- The results of expertise of the substances subject to strict labor sanitation requirements, given by the competent agencies.

Within 30 days after receiving full dossiers of registration and application for certificates, the Health Services’ inspectorates of the provinces and centrally-run cities shall consider and issue certificates to the concerned establishment applicants. Such a certificate shall be valid for 36 months.

Where an establishment is not qualified for the certificate, the Health Service’s inspectorate of the province or centrally-run city shall, within 10 days after receiving the dossier, have to notify the establishment thereof, clearly stating the reasons therefor so that the latter shall overcome its errors.

2.4. Certificate extension:

One month before the certificate expires, the establishment shall have to send a dossier of application for certificate extension to the Health Service’s inspectorate of the province or centrally-run city that has granted it the latest certificate. A dossier of application for certificate extension shall include:

- The application for certificate extension

- The latest certificate

- The results of expertise of the substances subject to strict labor sanitation requirements, given by the competent agencies.

2.5. Re-issue of certificates of eligibility for use of substances subject to strict labor sanitation requirements

a/ The certificates shall be re-issued in the following cases:

- After altering the concentration of the substances in use, putting into use new substances, changing technological processes, changing the location, or upgrading workshops and/or warehouses.

- After having the certificate withdrawn.

b/ The establishment applying for the re-issue of certificate shall send a dossier to the Health Service’s inspectorate of the province or centrally-run city, which has received its declaration on the substances subject to strict labor sanitation requirements. A dossier of application for re-issue of certificate shall include:

- The application for certificate

- The latest certificate

- The brief description of the substances subject to the application for certificate

- The results of expertise of the substances subject to strict labor sanitation requirements.

c/ Procedures for the re-issue of certificates shall comply with the provisions at Point 2.3, Item 2, this Circular.

2.6. In the course of using substances subject to strict labor sanitation requirements, establishments shall annually have to conduct the labor environment assessment, periodical health check and examination for detection of occupational diseases of laborers as provided for by the current provisions of law. Establishments that fail to comply with the stipulations of this Circular shall all have their certificates of eligibility withdrawn.

Pending the granting of certificates, establishments shall have to abide by the expertizing agency’s suggestions related to the direct laborers and the community. Where factors that threaten the health of laborers as well as the surrounding community have not yet been overcome, the Health Service’s inspectorate of the province or centrally-run city shall have to report thereon to the competent agency for the temporary suspension of the establishment�s activities and notify such establishment of the non-granting of certificate.

3. Expertise of substances subject to strict labor sanitation requirements

a/ The agencies expertizing substances subject to strict labor sanitation requirements include:

- The prophylactic health centers or the labor health centers of the provinces and centrally-run cities.

- The institutes in the prophylactic health system of the Health Ministry.

- The labor health centers of the ministries, branches and other units accepted by the Health Ministry. For these units, when conducting an expertise they must coordinate with the prophylactic health centers or the labor health centers of the provinces and centrally-run cities.

b/ Where the expertise results are complained about, the regional institutes in the prophylactic health system of the Health Ministry shall conduct the re-expertise; if the re-expertise results presented by the regional institutes are still complained about, the expertise results of the Labor Medicine and Environmental Sanitation Institute under the Health Ministry shall be the final ones.

c/ A dossier of application for expertise shall include:

- The application for expertise of substances subject to strict labor sanitation requirements, sent to one of the agencies mentioned in Point a above.

- The brief description of the substances subject to the application for expertise

- The report on the results of the recruitment health check and periodical health check for workers.

- The certificates (or training contracts) of the laborers’ training in labor safety and sanitation in the use of chemicals, issued by the prophylactic health centers of the provinces or centrally-run cities.

- The establishment’s labor sanitation dossier and the results of measurement of the labor environment in the latest 12 months.

d/ Expertise duration: Within 30 days after receiving a full dossier of application for expertise, the authorized agencies shall have to complete the expertise and notify the concerned establishment of the expertise results.

e/ All costs of expertise and issue of certificates shall comply with the State’s current regulations.

4. Withdrawal of certificates of eligibility for use of substances subject to strict labor sanitation requirements.

Such certificates shall be withdrawn in the following cases:

a/ The establishment fails to strictly comply with the regulations, portending harms to the health of laborers and the community.

b/ There exists a danger of accident occurrence.

c/ The establishment has declared and registered substances not compatible to the certificates.

Agencies entitled to withdraw certificates of eligibility for use of substances subject to strict labor sanitation requirements are the People’s Committees of the provinces and centrally-run cities, the inspectorates of the Health Services of the provinces and centrally-run cities and the Health Ministry’s inspectorate.

Establishments that use substances subject to strict labor sanitation requirements, if letting accidents occur which cause human and material losses, shall have to take responsibility as prescribed by law.

IV. ORGANIZATION OF IMPLEMENTATION

1. The People’s Committees of the provinces and centrally-run cities, the ministries and branches shall have to direct establishments under their respective management to declare and register substances and apply for certificates in strict compliance with this Circular.

2. The Health Ministry’s Inspectorate and the Prophylactic Health Department shall have:

a/ To organize and guide the declaration and registration of substances and issue of certificates according to their competence defined herein.

b/ To make sum-up periodical reports on the situation of substances declaration and registration and issue of certificates throughout the country and submit them to the Health Ministry.

3. The Health Services of the provinces and centrally-run cities shall have to direct their inspectorates and prophylactic health centers in the provinces and centrally-run cities in:

a/ Organizing the substances declaration, registration and expertise as well as the issue of certificates according to their competence defined in this Circular.

b/ Guiding, urging and inspecting the substances declaration, registration by and issue of certificates for, the establishments in the localities.

c/ Submitting biannual reports before July 15 and annual reports before January 15 of the following year to the Ministry of Health (the Inspectorate and the Prophylactic Health Department) on the situation of substances declaration and registration as well as the issue of certificates in the localities.

4. Establishments using substances subject to strict labor sanitation requirements shall have to strictly comply with all the provisions of this Circular.

This Circular takes effect 15 days after its signing. If any problems arise in the course of implementation, the provincial/municipal Health Services are requested to report them to the Health Ministry (the Inspectorate and the Reserve Health Department) for study and settlement.

APPENDIX 1

LIST OF SUBSTANCES SUBJECT TO STRICT LABOR SANITATION REQUIREMENTS WHICH MUST BE DECLARED, REGISTERED AND SUBJECT TO APPLICATION FOR CERTIFICATES OF ELIGIBILITY FOR USE
(Issued together with Circular No.05/1999/TT-BYT of March 27, 1999)

I. LIST OF CATEGORY I- SUBSTANCES SUBJECT TO STRICT LABOR SANITATION REQUIREMENTS

1. 2- Acetylaminofluorene

2. 4- Aminobiphenyl (M3)

3. Arsenic and arsenic compounds (1A)

4. Asbestos (amosite and chrysotil)

5. Benzene (T1, M1)

6. Benzidine (1A)

7. Bis (chloromethyl) ether

8. 1, 4- Butanediol dimethanesufonate (M3)

9. Cyclophosphamide (T2, M2)

10. Diamino- 4,4 diphenyl

11. Diethylstilboestrol

12. 4- Dimethylaminoazobenzene

13. Naphthylamine (A and B)

14. Thorium dioxide

15. 4- Amino 10- methyl formic acid (T1)

16. Dinitrogen pentoxide (T1)

17. 2,4 DB

18. 2,4 DP

19. 2,4,5 D

20. 2,4,5 T

21. Plant protection chemicals on the list of those restricted for use in Vietnam (according to the list issued by the Ministry of Agriculture and Rural Development)

II. LIST OF CATEGORY II- SUBSTANCES SUBJECT TO STRICT LABOR SANITATION REQUIREMENTS

1. Acetothioamide

2. Acrylic amide

3. Alachlor

4. Allyl catechol methylene ether

5. 2- Aminofluorene

6. 3- Amino 1,2,4- triazole

7. Aniline and its compounds

8. Antimony and its compounds (1B)

9. Aziridine

10. Benzidine dihydro chloride

11. 2, 3- Benzofluoroethene

12. 2, 3- Benzophenanthrene

13. Benzo (a) pyrene (C2)

14. (Bis (Chloro- 2 ethyl) amino) phenyl butyric acid (T3)

15. Bis chloroethyl nitroso urea (T3 M3)

16. Benomyl                                          

17. Benzyl chloride

18. Beryllium and its compounds

19. Boric acid and borates

20. Bromodichloromethane

21. Cadmium and its compounds (1A)

22. Calcium cyanide

23. Carbondisulfide (T3, A800)

24. Carbon monoxide

25. Carbon tetrachloride

26. Chloroethyl ether

27. Chloromethyl ether

28. Chloropicrine

29. Chromium and its compounds (C1)

30. Coal tar (C1)

31. Dactinomycin

32. Daunorubicin (T3)

33. Demention (o & s)

34. Dieldrin

35. Di-sec-octyl phthalate

36. Dibez (A-H) anthracene

37. 1, 4- Dichlorobenzene

38. Diethylstilboestrol

39. Dimethylformamide

40. 1, 4- Dioxane (C1)

41. Dimethyl mercury

42. Dinitro toluene (DNT)

43. Dinitrogen pentoxide

44. Dioxin and its derivatives

45. Endosulfan

46. Epichlorohydrin (C3, 1A)

47. Epoxy 1- propanol

48. Ethylene dibromide (C2)

49. Ethylene dichloride

50. Ethylene dioxide (C2, 1A)

51. Fluorouracil

52. Formalin

53. Formaldehyde (1A)

54. Hexa methyl phosphoramide (C2)

55. Hydrazine and hydrazine hydrate, hydrazine sulfate (1A)

56. Lead and compounds containing lead

57. Mechloethamine

58. Mechloethamine hydrochloride (C2, T2, A0600, A0800)

59. Melfalan (A0600, A0800)

60. Mercury and its compounds

61. Endrine

62. Methallyl chloride

63. 2- Methyl aziridine Mercury and its compounds (1A)

64. Methylazoxy methanol B-D- Glucosite

65. Methyl bromide

66. Methyl chroride

67. Methylen chloride

68. Nickel (carbonyl, dioxide, disulfide, monoxide) (C2)

69. N- Nitrosodiisopropylamine

70. Nitrosomorpholine

71. Ortho-amino azotoluene

72. Perchloropentacyclodecane

73. Phosphine

74. Phosphorus (yellow)

75. Polychlorinated biphenyls

76. Procarbazine hydrochloride

77. Propyl thiouracil

78. Sodium cyanide

79. Stibine

80. Thallium and its compounds

81. Thionyl chloride

82. Thiophosphamide

83. Toluene (o, m, p)

84. Uracil mustard

85. Urethane (C1, M2)

86. Vinyl chloride

87. Vinyl cylohexene dioxide

88. Xylene (o, m, p)

Notes: The symbols used in attachment with the above substances are construed as follows:

C1: Found to cause cancer to human beings

C2: Found to cause cancer to animals, suspected of being able to cause harms to human beings

C3: Suspected of causing cancer to animals

M1: Found to cause gene deformation to human beings

M2: Found to cause gene deformation to animals, suspected of being able to cause harms to human beings

M3: Suspected of causing harmful gene deformation to animals

T1: Found to cause teras to human beings

T2: Found to cause teras to animals, suspected of being able to cause harms to human beings

T3: Suspected of causing teras to animals

A0600: Causing genital disorders to human beings

A0800: Causing sperm malformation

A1000: Through placentas, poisoning human embryos and ova

1A: Very poisonous material, which can lead to immediate and serious consequences

2A: Very poisonous material, which can do other harms

1B: Poisonous material, which can lead to immediate and serious consequences

2B: Poisonous material, which can do other harms.-