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REGULATION OF THE MINISTER OF AGRICULTURE
No. 62/PERMENTAN/OT140/12/2006

CONCERNING
OBSERVATION AND QUARANTINE ACTION TO THE ENTRY OF PATHOGEN MATERIAL
AND/OR VETERINARY MEDICINE BIOLOGIC PREPARATION TYPE

THE MINISTER OF AGRICULTURE,

Considering :

• a. whereas carrier of quarantine animal disease which pertained as other object has potency to destroy continuity of natural resources which endanger health of animal and human;
• b. whereas pathogen material and veterinary medicine of biologic preparation type is carrier media of animal disease pertained as other object, which enter from outside country and traffic between areas therefore it need to be done observation through action of quarantine;
• c. whereas based on things as referred to in point a and b above, and to follow up Article 7 paragraph (3) of Government Regulation Number 82 year 2000 about animal quarantine hence considered necessary to arrange observation and action of quarantine for the entry of pathogen material and/or veterinary medicine of biologic preparation type;

In view of :

• 1. Law No. 6 of 1967 concerning Main Provisions for Livestock and Animal Health (State Gazette year 1967 Number 10, Supplement to State Gazette 2824);
• 2. The Law Number 16 of 1992 concerning Animal, Fish and Plant Quarantine (The State Gazette/Governmental Gazette of 1992 Number 56, Supplement to State Gazette Number 3482);
• 3. Government Regulation number 78 year 1992 about Animal, Fish, and Plant Quarantine (State Gazette year 1992 Number 129, Supplement to State Gazette 3509);
• 4. The Governmental Regulation Number 82 of 2000 concerning Animal Quarantine (The State Gazette of 2000 Number 161, Supplement to State Gazette Number 4002);
• 5. The Governmental Regulation Number 49 of 2002 concerning Tariff on Type of State Income derived from Non Tax prevailing to Ministry of Agriculture (The State Gazette of the Republic of Indonesia of 2002 Number 92, The Additional State Gazette Number 4224);
• 6. Presidential Decree of the Republic of Indonesia Number 187/M Year 2004 regarding United Indonesia Cabinet Formation;
• 7. Presidential Regulation of the Republic of Indonesia Number 9 Year 2005 regarding The Status, Tasks, Functions, Structure of Organizations, and Working-System of Administration for the State Ministers of the Republic of Indonesia as amended by Presidential Regulation Number 62 Year 2005;
• 8. Presidential Regulation of the Republic of Indonesia Number 10 Year 2005 regarding The First Echelon Organizational Units and Duties of the State Minister of the Republic of Indonesia as already amended by Presidential Regulation of the Republic of Indonesia Number 80 Year 2005;
• 9. Decree of the Minister of Agriculture No. 422/Kpts/LB720/6/1988 about Animal Quarantine Regulation; in conjunction with the Decree of The Minister of Agriculture Number 471/ Kpts/LB730/8/2001;
• 10. Decree of the Minister of Agriculture Number 695/Kpts/TN260/8/96 about Clauses and Procedures of Registration and Observation of Animal Medicine;
• 11. Decree of the Minister of Agriculture Number 206/Kpts/TN530/3/2003 about Classification of pest and Quarantine Animal Disease Types and Classification of Carrier Media;
• 12.Decree of the Minister of Agriculture Number 299/Kpts/ OT140/7/2005 concerning Organization and Work-Procedure of the Department of Agriculture;
• 13. Decree of the Minister of Agriculture Number 341/Kpts/OT140/9/2005 about Comprehensiveness of Organization and Work-Procedure of the Department of Agriculture;

Pays attention to :

• 1. Terrestrial Animal Health Code – Office International Des Epizooties;
• 2. World Trade Organization (WTO) Notification Number G/SPS/N/IDN/29;

HAS DECIDED :

To Promulgate :

REGULATION of THE MINISTER OF AGRICULTURE ABOUT OBSERVATION AND QUARANTINE ACTION TO THE ENTRY OF PATHOGEN MATERIAL AND/OR VETERINARY MEDICINE BIOLOGIC PREPARATION TYPE

CHAPTER I
GENERAL PROVISION

Article 1

In this Government Regulation, the interpretation of:

• 1. Quarantine animal disease pest carrier Media hereinafter referred to as carrier media is animal, material of animal, result of material of animal and or other object of which can bring pest and quarantine disease.
• 2. Animal quarantine pest and disease hereinafter referred to as quarantine animal disease ( HPHK) shall be mean as all pests, diseases and animal disease affecting national social - economy and world commerce and causes health trouble of veterinary society which can be classified according to its risk level.
• 3. Other Object shall be mean as carrier media which do not pertained as animal, material of animal and result of material of animal which having spreading potency of animal quarantine pest and disease.
• 4. Pathogen Material is material coming from biologic of which potency can generate animal health trouble.
• 5. Veterinary Medicine of Biologic Preparation type which hereinafter referred as Biologic material shall be mean as material yielded through biologic process at animal or animal network to generate impenetrability, diagnoses an animal disease, or heals animal disease with immunology.
• 6. Entry is activity of input carrier media from outside country into territory of Republic of Indonesia or to an area from other area in Republic of Indonesia.
• 7. Exit/Excretion is activity of output carrier media exit from territory of Republic of Indonesia or from one area to other area in territory of Republic of Indonesia.
• 8. Area shall be mean as area of an island, an island, or group of island in Republic of Indonesia which related to prevention of the spreading of animal quarantine pest and disease.
• 9. Observation was activity which executed to know the traffic of pathogen material and/or biologic which having potency propagates HPHK.
• 10. Action of Quarantined Animal was activity which executed to know the traffic of pathogen material and/or biologic which having potency propagates HPHK.
• 11. Packaging is material use to place and/or wraps pathogen material and/or biologic material either coming into direct contact with and also indirect one.
• 12. Business Entity is State or Regional-owned Enterprises for public ownership or area, private sector or co-operation.
• 13. Entry Approval Letter later on hereinafter referred as SPP is decision of giving approval (permit) which given by The Minister of Agriculture to certain Business Entity before executing entry activity of pathogen material and/or biologic material.
• 14. Installation of animal Quarantine hereinafter referred to as installation of quarantine shall be mean as building including equipments, land, facilities and other support which is required as place of executing action of quarantine.
• 15. Animal Quarantine Officer hereinafter referred to as quarantine officer is certain public servant given duty to conduct action of quarantine.

Article 2

(1) This regulation meant as basis law for quarantine officer in executing observation and action of quarantine to inclusion of pathogen material and/or biologic material.

(2) Purpose of this arrangement to prevent the entry and spreading of HPHK through pathogen material and/or biologic material.

Article 3

This regulation Scope covers Entry Observation, Quarantined Action, and Traffic between Areas, Action Service of Quarantine and Reporter.

CHAPTER II
Entry Observation

Part One
Entry Clauses

Article 4

(1) Inclusion/Entry of pathogen material and/or biologic material from outside country can be done by business entity.

(2) Inclusion/Entry of pathogen material and/or biologic material as referred to in paragraph (1) can only be done if the diseases already exist in Indonesia.

(3) Business Entity as referred to in paragraph (1) which will input pathogen material and/or biologic material from outside country must have Entry Approval Letter (SPP) which published by the Minister.

(4) SPP as referred to at paragraph ( 3), contains:

• a. Corporate name;
• b. License number for veterinary medicine;
• c. Address/location of business entity;
• d. Name and producer country;
• e. Purposes and objectives;
• f. Number and types;
• g. Place of excretion;
• h. Place of inclusion;
• i. Description of product;
• j. Report;
• k. Sanction and implementation period of SPP;

(5) For inclusion of biologic material besides having SPP as referred to in paragraph (3) also must have animal medicine registration number;

Article 5

(1) Pathogen material as referred to in Article 4 paragraph (1) can be in the form of blood, system, organ, carcass (cadaver) or embryo.

(2) Biologic material as referred to in Article 4 paragraph (1) can be in the form of vaccine, sera, anti sera or biologic diagnosed material.

Article 6

(1) Rule as referred to in Article 4 paragraph (2) not applicable to inclusion of biologic material for the purpose of research, examination of diagnose or education, and is not be obligated to have animal medicine registration number.

(2) Business entities which will input biologic material for the purpose of research, examination of diagnose or education as referred to in paragraph (1) must get permit from The Minister.

Article 7

Inclusion of biologic material for the purpose of examination quality and spacious test for the agenda of registration shall not be obligated to have animal medicine registration number.

Part Two
Inclusion/Entry Procedures

Article 8

(1) Business entities to be able to input pathogen Material and/or biologic material as referred to in Article 4 must apply in written application to The Minister of Agriculture.

(2) Application of Inclusion as referred to in paragraph (1) shall be enclosed with description:

• a. Name and address/location of business material;
• b. Taxpayer Fundamental Number;
• c. Business License number for animal medicine;
• d. Name and address/location of producer;
• e. Description of product;
• f. Number and pathogen material types and/or biologic material;
• g. Place of excretion;
• h. Place of inclusion.

Article 9

(1) The Minister after receiving application as referred to in Article 8, at least within 10 (ten) workday have to issued SPP.

(2) Application as referred to in Article 8 paragraph (1) which complete and fulfills clauses as referred to in Article 8 paragraph (2) have to be issued SPP with carbon copy to Director-General of Customs and Excise and Head of Technical Implementation Unit of animal quarantine in place of inclusion.

(3) Application which has not fulfilled clauses as referred to in Article 8 paragraph (2) shall be delayed, and will be advised to applicant in writing with the reason for soon can complement the inadequacy.

(4) If during 7 (seven) workday commencing from date of receiving of notification as referred to in paragraph (3) the application has not or cannot complement inadequacy of application clauses, it is assumed revocable.

(5) Application refused as referred to in paragraph (1) shall be advised to applicant in writing with the reason of rejection.

CHAPTER III
QUARANTINE ACTION

Article 10

The entry of Pathogen material and/or biologic material as referred to in Article 4 paragraph (2), shall be obligated to:

• a. Be Equipped with origin letter published by producer, place of gathering or management from its country of origin;
• b. Be Equipped with SPP;
• c. Enter through place of inclusions which has been specified;
• d. Be reported and delivered to quarantine officer place of inclusion;
• e. Be executed security method to guarantee pathogen material and/or biologic material doesn't propagate HPHK and prevents the happening of damage, leakage and contamination.

Article 11

Report and delivery as referred to in Article 10 point d shall be done 1 (one) day before arrival by showing original SPP for preparation of action of quarantine.

Article 12

(1) Place of inclusions of pathogen material and/or biologic material from outside country as referred to in Article 10 point c, that is:

• a. Soekarno-Hatta Cengkareng Airport, Jakarta.
• b. Port of Tanjung Priok, Jakarta.
• c. Juanda Airport, Surabaya.
• d. Port of Tanjung Perak, Surabaya.

(2) Place of inclusions as referred to in paragraph (1) alterable based on technical consideration and maximum security for example covering facilities and infrastructure, laboratory and Human resource.

(3) Change of place of inclusions as referred to in paragraph (2) will be specified with separate decision.

Article 13

(1) Every inclusion of pathogen material and/or biologic material is conducted quarantine action in the form of inspection that is checking authenticity, truth and conformity between document enclosed with packaging of pathogen material and/or biologic material which written in Air Way Bill or Bill Lading.

(2) Result of inspection as referred to in paragraph (1) which is met the standard and trustworthy, shall be issued certificate of quarantine by local quarantine officer.

(3) Publication of certificate of quarantine as referred to in paragraph (2) shall be done at least within 2 (two) hour commencing from completed of inspection.

Article 14

(1) If result of inspection as referred to in Article 13 paragraph (1) found existence of unconformability or questionable the truth and the authenticity or there is packaging damage, shall be continued with physical examination of packaging contents or pallet in sampling.

(2) If result of physical examination as referred to in paragraph (1) is not found deviation, shall be issued certificate.

(3) If result of physical examination as referred to in paragraph (1) found existence of deviation shall be done rejection or destruction as according to regulation applied.

Article 16

If result of inspection as referred to in Article 14 paragraph (1) found existence of unconformability or questionable the truth and the authenticity or deviation as referred to in Article 15 paragraph (3) then quarantine officer at least within 2 x 24 hours must report to Head of agriculture agency through head of local TIU of animal quarantine.

CHAPTER IV
TRAFFIC BETWEEN AREAS

Article 17

(1) Pathogen material and/or biologic material coming from within country and/or from outside country can be trafficked between areas by owner/its proxy.

(2) Pathogen material and/or biologic material as referred to in paragraph (1) which can be trafficked between areas only valid for animal disease which has been specified by The Minister.

(3) Owner/Its Proxy as referred to in Paragraph (1) to be able to trafficked pathogen material and/or biologic material between areas must apply to quarantine officer in place of excretion by enclosing origin letter.

Article 18

(1) Quarantine officer as referred to in Article 17 paragraph (3) shall does inspection of document and physical concordance of packaging.

(2) If result of inspection of document and physical concordance of packaging as referred to in paragraph (1) in place of excretion is already met the standard and not been found deviation, during at least 2 (two) hour must has been published Exit Letter by quarantine officer.

(3) If result of inspection of document and physical concordance of packaging as referred to in paragraph (1) in place of inclusion is already met the condition and has not been found deviation, during at least 2 (two) hour must has been published Exit Letter by quarantine officer.

Article 19

(1) If result of inspection of document and physical concordance of packaging as referred to in Article 18 paragraph (2) in place of excretion is found any deviation or document unconformability, then shall be done rejection.

(2) If result of inspection of document and physical concordance of packaging as referred to in Article 18 paragraph (2) in place of inclusion is found any deviation or document unconformability with contents of packaging, then shall be done detention

(3) Detention as referred to in paragraph (2) shall be done for execution of further animal quarantine action.

CHAPTER V
ANIMAL QUARANTINE ACTION SERVICE TO PATHOGEN MATERIAL AND/OR BIOLOGIC MATERIAL

Article 20

(1) To obtain release certificate or exit letter as referred to in Article 13, Article 14, Article 17 and Article 18 then owner/proxy is obligated to pay action service of quarantine based on government regulation concerning Tariff on Type of State Income derived from Non Tax prevailing to Ministry of Agriculture, juncto government regulation Number 7 year 2004.

(2) Calculation of action service of inclusion quarantine as referred to in paragraph (1) based on number of packaging which written in air way bill for air transportation or bill of loading for sea transportation.

(3) Packaging as referred to in paragraph (2) shall be expressed in a score or pallet.

CHAPTER VI
REPPORTER

Article 21

Every inclusion of pathogen material and/or biological sample as referred to in Article 4 paragraph (1) must be periodically reported once 1 (one) in a month by Head of TIU place of inclusions as referred to in Article 12 to Head of agriculture quarantine agency with carbon copy to Director-General of Husbandry.

CHAPTER VII
OTHERS

Article 22

Inclusion of veterinary medicine in the form of Pharmaceutics and premix preparation as referred to in Government regulation Number 78 year 1992 about Veterinary medicine is not executed quarantine, because not including as carrier media of HPHK.

CHAPTER VIII
CLOSING

Article 23

This regulation shall put into effect since the date of stipulation.

Ratified in Jakarta
On December 7, 2006
THE MINISTER OF AGRICULTURE,
signed
ANTON APRIYANTONO