REGULATION OF MINISTER OF AGRICULTURE. NO. 88/Permentan/PP.340/12/2011 CONCERNING FOOD SAFETY CONTROL OVER IMPORT AND EXPORT OF FRESH FOOD OF

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1 REGULATION OF MINISTER OF AGRICULTURE NO. 88/Permentan/PP.340/12/2011 CONCERNING FOOD SAFETY CONTROL OVER IMPORT AND EXPORT OF FRESH FOOD OF PLANT ORIGIN WITH THE GRACE OF THE ALMIGHTY GOD THE MINISTER OF AGRICULTURE Considering: a. that, Regulation of Minister of Agriculture No. 27/Permentan/PP.340/5/2009 has stipulated provisions on food safety control over import and export of fresh food of plant origin; b. that, with the development of science and technology, and society s demand concerning food quality and safety, Regulation of Minister of Agriculture No. 27/Permentan/PP.340/5/2009 is no longer suitable and should be reviewed; c. that, based on the considerations of paragraphs a and b, it is necessary to re-stipulate Food Safety Control Over Import and Export of Fresh Food of Plant Origin by Regulation of Minister of Agriculture;

2 In view of: 1. Law No. 16/1992 on Animal, Fish, and Plant Quarantine (Statute Book of 1992 No. 56, Supplement No. 3482); 2. Law No. 7/1994 on Ratification of Agreement Establishing the World Trade Organization (Statute Book of 1994 No. 576, Supplement No. 3554); 3. Law No. 7/1996 on Food (Statute Book of 1996 No. 99, Supplement No. 3556); 4. Law No. 8/1999 on Consumer Protection (Statute Book of 1999 No. 42, Supplement No. 3821); 5. Government Regulation No. 102/2000 on National Standardization (Statute Book of 2000 No. 199, Supplement No. 4020); 6. Government Regulation No. 14/2002 on Plant Quarantine (Statute Book of 2002 No. 35, Supplement No. 4196); 7. Government Regulation No. 28/2004 on Food Safety, Quality, and Nutrition (Statute Book of 2004 No. 107, Supplement No. 4424); 8. Presidential Decree No. 84/P/2009 on Establishment of United Indonesia Cabinet II; 2

3 9. Presidential Regulation No. 47/2009 on Establishment and Organization of State Ministry; 10.Presidential Regulation No. 24/2010 on Position, Task, and Function of State Ministry and Structure of Organization, Task, and Function of Echelon I of State Ministry; 11.Regulation of Minister of Health No. 239/Men.Kes/Per/V/1985 on Certain Coloring Substances Declared as Hazardous Materials; 12.Joint Decree of Minister of Health and Minister of Agriculture No. 881/MENKES/SKB/VIII/1996 and No. 711/Kpts/TP.270/8/1996 on Maximum Limit of Pesticide Residue in Agricultural Products; 13.Regulation of Minister of Health No. 1168/Menkes/Kes/X/1999 on Additives Prohibited from Use in Food; 14.Regulation of Minister of Agriculture No. 37/Kpts/HK.060/1/2006 on Technical Requirement and Plant Quarantine Action on Import of Fresh Fruits and Vegetables to Indonesian Territory; 15.Regulation of Minister of Agriculture No. 32/Permentan/OT/140/3/2007 on Prohibition on Use of Hazardous 3

4 Chemical Materials in Paddy Milling Process, Huller, and Rice Polishing; 16.Regulation of Minister of Agriculture No. 18/Permentan/OT.140/2/2008 on Plant Quarantine Requirement and Action on Import of Live Plant Products in The Form of Fresh Bulbs; 17.Regulation of Minister of Agriculture No. 22/Permentan/OT.140/4/2008 on Organization and Work Procedure of Agricultural Quarantine Technical Operating Unit; 18.Regulation of Minister of Agriculture No. 35/Permentan/OT.140/7/2008 on Requirement and Application of Good Manufacturing Practices on Agricultural Products of Plant Origin (Good Manufacturing Practices; 19.Regulation of Minister of Agriculture No. 44/Permentan/OT.140/10/2009 on Guidelines for Good Post- Harvest Handling of Agricultural Products of Plant Origin (Good Handling Practices); 20.Regulation of Minister of Agriculture No. 09/Permentan/OT.140/2009 on Quarantine Action Requirement and Procedure on Import of Carrier of Organism Harmful to Quarantine Plants to Indonesian Territory; 4

5 21.Decree of Minister of Agriculture No. 3237/Kpts/HK.060/9/2009 on Form and Type of Document on Plant Quarantine Action and Safety of Fresh Food of Plant Origin; 22.Regulation of Minister of Agriculture No. 46/Permerntan/HK.340/8/2010 on Places of Entry and Exit of Carrier of Quarantine Animal Pests and Diseases and Organism Harmful to Quarantine Plants; 23.Regulation of Minister of Agriculture No. 56/Permentan/OT.140/9/2010 on Implementation of Quarantine Action Outside Places of Entry and Exit; 24.Regulation of Minister of Agriculture No. 61/Permentan/OT.140/10/2010 on Organization and Work Procedure of Ministry of Agriculture; Observing: 1. Principles for Food Import and Export Inspection and Certification (CAC/GL ); 2. Guidelines for Food Import and Export Control Systems (CAC/GL ); 5

6 3. Guidelines for the Design, Operation, Assessment, and Accreditation of Food Import and Export Inspection and Certification Systems (CAC/GL ); 4. Guidelines on the Judgment of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems (CAC/GL ); 5. Codex Alimentarius Joint FAO/WHO Food Standards Program Volume 2B, Pesticide Residues in Food Maximum Residue Limits, Second Edition, 2000; 6. Assuring Food Safety and Quality Guidelines for Strengthening National Food Control Systems, FAO and WHO, 2003; 7. Codex General Standard for Contaminants and Toxins in Food, CODEX STAN , Rev ; 8. Indonesian National Standard (SNI) on maximum limit of microbial contaminant in food. SNI 7388:2009; DECIDED: To stipulate: REGULATION OF THE MINISTER OF AGRICULTURE ON FOOD SAFETY CONTROL OVER IMPORT AND EXPORT OF FRESH FOOD OF PLANT ORIGIN. CHAPTER I 6

7 GENERAL PROVISIONS Article 1 Hereinafter referred to as: 1. Fresh Food of Plant Origin, hereinafter called PSAT, is food of plant origin in the form of product produced in post-harvest processing for consumption or industrial raw material and/or product which experiences minimal processing. 2. PSAT Safety is condition and attempt required to prevent PSAT from potential chemical contaminant, biological contaminant, and/or containing prohibited chemical substances that may disturb, damage, and is hazardous to human health; 3. Chemical Contaminant is chemical substances (pesticide residue, heavy metal, and mycotoxin) contained in PSAT unintentionally through agricultural practices. 4. Biological Contaminant is biological agents (virus, bacteria, microbe, mold, and yeast) that could contaminate PSAT. 5. Prohibited Chemical Substances are hazardous chemical compounds prohibited from use in PSAT. 7

8 6. Prior Notice is a statement letter in the form of a Form stating about identity of PSAT that must be filled out by PSAT producer or exporter in country of origin. 7. PSAT Safety Requirement is standard and other regulation that must be fulfilled to prevent PSAT from potential hazard due to chemical contaminant, biological contaminant and/or content of prohibited chemical substances that may disturb, damage, and is hazardous to human health; 8. Import is import of PSAT from overseas to Indonesian territory through the designated places of entry. 9. Export is export of PSAT from Indonesian territory to overseas through the designated places of exit. 10.Place of Entry/Exit is seaport, river port, airport, transshipment port, dry port, post office, inter-country cross border posts designated as places of entry/exit. 11.Recognition is acceptance of PSAT safety control system of a country producing and exporting PSAT by Indonesia s PSAT safety competent authority. 12.Equivalence Agreement is agreement between importing country and exporting country concerning different PSAT safety control system but produces equal level of PSAT safety protection. 8

9 13.Recognition of PSAT Safety System of PSAT Production Site is acceptance of PSAT safety system of PSAT production site of a country by Indonesia s PSAT safety competent authority. 14.Plant Quarantine Officer is functional officer controlling organism harmful to plants who work at Agricultural Quarantine Institution. 15.Surveillance is a series of activities performed to assess level of compliance of country of origin whose PSAT safety system has been recognized by Indonesia (Government of the Republic of Indonesia). 16.PSAT Owner or His Proxy, hereinafter called Owner or Proxy, is a person or legal entity who owns PSAT and/or is responsible for import or export of PSAT. 17.Type of PSAT is every type of PSAT that becomes subject of food safety control test. Article 2 (1)This Regulation is intended as basis for the implementation of PSAT safety control imported to or exited from Indonesian territory. 9

10 (2)The objective of this Regulation is so that PSAT imported to Indonesian territory does not contain chemical and biological contaminants that exceed the maximum limit and prohibited chemical substances so that it is safe and fit for consumption, and PSAT which is exported from Indonesian territory meets requirements of destination country. Article 3 The scope of the regulation includes import, surveillance, freeze, and re-recognition of control system of PSAT safety and PSAT export. CHAPTER II IMPORT Part One General Article 4 (1)Every person who imports PSAT shall be responsible for PSAT safety in accordance with the legislation. (2)PSAT safety as referred to in paragraph (1) is a condition of PSAT which contains chemical and biological contaminants not exceeding the maximum limit, and not containing prohibited chemical substances. 10

11 (3)Type of PSAT, maximum limit of chemical contaminants, maximum limit of biological contaminants, and prohibited chemical substances as referred to in paragraph (2), are as specified in Attachment I as an inseparable part of this Regulation. Article 5 (1)Food safety control over import of PSAT may only be performed through: a. inspection of PSAT import; b. recognition of PSAT safety control system of a country; c. equivalence agreement between Indonesia and country of origin or destination of PSAT; or d. recognition of PSAT safety control in production site. (2)Food safety control on import of PSAT shall be performed by document inspection, identity inspection, sampling, and/or laboratory test. (3)Recognition of PSAT safety control system of a country, recognition of PSAT safety control system in production site of country of origin, and/or equivalence agreement between Indonesia and country of origin shall be conducted by the Minister. 11

12 (4)The period of the recognition as referred to in paragraph (3) is 2 (two) years. (5)Procedure of recognition of PSAT safety control system of country of origin, recognition of PSAT safety control system in production site of a country, and/or equivalence agreement between Indonesia and country of origin as referred to in paragraph (2), is as specified in Attachment II as an inseparable part of this Regulation. Article 6 (1)PSAT import as referred to in Article 4 paragraph (1): a. shall be completed with PSAT safety certificate/document and prior notice from country of origin; b. shall pass through the designated places of entry; and c. shall be reported and submitted to Plant Quarantine Officer at places of entry for PSAT safety control. (2)PSAT safety certificate/document, as referred to in paragraph (1) sub-paragraph a, is a written assurance given by competent authority on food safety of country of origin stating that PSAT is safe and fit for consumption. 12

13 (3)For country of origin which does not have PSAT safety competent authority, such certificate/document as referred to in paragraph (2) shall be issued by an institution authorized to perform control and/or monitoring/surveillance over the implementation of good practices to ensure PSAT safety. (4)PSAT safety certificate/document from country of origin, as referred to in paragraph (1) sub-paragraph a, is not required for import of PSAT originating from a country or production site which is already recognized and/or already has an equivalence agreement. (5)Prior notice, as referred to in paragraph (1) sub-paragraph a, is in the form of a Form as specified in Attachment III as an inseparable part of this Regulation. Part Two Control Procedure over PSAT Import Paragraph 1 Procedure of Control over PSAT Import from Country or Production Site Whose PSAT Safety Control System is Not Recognized or Does Not Have Equivalence Agreement Article 7 13

14 (1)Owner or proxy shall report and submit PSAT safety certificate/document and prior notice from country of origin as referred to in Article 6 paragraph (1) sub-paragraph a to Plant Quarantine Officer at place of entry as referred to in Article 6 paragraph (1) sub-paragraph b within not later upon arrival of PSAT. (2)If PSAT import is not completed with PSAT safety certificate/document and/or prior notice as referred to in paragraph (1), detention shall be performed, and the owner or proxy is given a time of not later than 14 (fourteen) working days to complete the PSAT safety certificate/document and/or prior notice. (3)Detention as referred to in paragraph (2) is performed to secure PSAT by sealing and placing PSAT under control and supervision of Plant Quarantine Officer. (4)If within the time period as referred to in paragraph (2), the owner or proxy did not complete PSAT safety certificate/document and/or prior notice, rejection shall be performed. (5)All costs arising as a result of detention shall be imposed on the owner or proxy. 14

15 Article 8 (1)If PSAT import is completed with PSAT safety certificate/document as referred to in Article 7 paragraph (1), Plant Quarantine Officer shall perform identity inspection to identify compliance between information on the PSAT safety certificate/document and prior notice with PSAT identity on the package and physical condition of PSAT. (2)In case that result of PSAT identity inspection as referred to in paragraph (1) proves: a. non-compliance between information on PSAT safety certificate/document and prior notice with PSAT identity on the package and/or physical condition of PSAT, rejection shall be performed; or b. compliance between information on PSAT safety certificate/document and prior notice with PSAT identity on the package and/or physical condition of PSAT, collection of PSAT sample shall be performed to be followed with laboratory test. (3)During the laboratory test, as referred to in paragraph 2 sub-paragraph b, PSAT shall be under control and supervision of Plant Quarantine Officer. 15

16 (4)Sampling procedure for laboratory test, as referred to in paragraph (2) sub-paragraph b, is as specified in Attachment IV as an inseparable part of this Regulation. Article 9 (1)Laboratory test as referred to in Article 8 paragraph (2) sub-paragraph b shall be performed at an accredited or appointed laboratory. (2)For performance of laboratory test, as referred to in paragraph (1), selection of test laboratory shall be performed by the owner or proxy. (3)Cost of the laboratory test, as referred to in paragraph (2), shall be borne by the owner or proxy. (4)The appointed laboratory, as referred to in paragraph (1), is as specified in Attachment V as an inseparable part of this Regulation. Article 10 In case that result of the laboratory test, as referred to in Article 9 proves that: a. chemical and biological contaminants exceed the maximum limit and/or containing prohibited chemical substances, as referred 16

17 to in Article 4 paragraph (3), rejection shall be performed; or b. chemical and biological contaminants equal or do not exceed the maximum limit and containing prohibited chemical substances, as referred to in Article 4 paragraph (3), plant quarantine action shall be performed in accordance with the legislation. Article 11 (1)Rejection of PSAT import, as referred to in Article 7 paragraph (4), Article 8 paragraph (2) sub-paragraph a, or Article 10 paragraph a, shall be done by exporting PSAT from Indonesian territory. (2)Rejection of PSAT import, as referred to in paragraph (1), shall be conveyed to the owner or proxy by Plant Quarantine Officer in the form of letter of rejection along with the reasons. (3)Concerning rejection of PSAT import, as referred to in paragraph (1), Head of Quarantine Agency Technical Operating Unit shall submit notification of non-compliance to PSAT safety competent authority of country of origin with a copy submitted to Head of Agricultural Quarantine Agency. 17

18 (4)All costs required for the implementation of rejection, as referred to in paragraph (1), shall be borne by the owner or proxy. Article 12 (1)If after 14 (fourteen) working days since date of rejection, as referred to in Article 11 paragraph (1), PSAT is not exported from Indonesian territory, destruction shall be performed. (2)In the implementation of destruction, as referred to in paragraph (1), Plant Quarantine Officer shall issue a destruction report. (3)All costs required for the implementation of destruction, as referred to in paragraph (2), shall be borne by the owner or proxy. Paragraph 2 Procedure of Control of PSAT Import from Country or Production Site Whose PSAT Safety Control System is Recognized or Has an Equivalence Agreement Article 13 18

19 (1)Owner or proxy importing PSAT from a country or production site whose PSAT safety control system is recognized or a country who has an equivalence agreement, shall report and submit prior notice, as referred to in Article 8 paragraph (1), to Plant Quarantine Officer at place of entry within not later than upon arrival of vehicle transporting PSAT. (2)Upon arrival of PSAT at place of entry, Plant Quarantine Officer shall perform identity inspection to identify compliance between prior notice and identity on PSAT package and physical condition of PSAT. (3)In case that result of identity inspection, as referred to in paragraph (2), proves: a. non-compliance between information on prior notice with PSAT identity on the package and/or physical condition of PSAT, rejection shall be performed; or b. compliance between information on prior notice with PSAT identity on the package and/or physical condition of PSAT, plant quarantine action shall be performed in accordance with the legislation. Article 14 19

20 (1)Rejection of PSAT import, as referred to in Article 13 paragraph (3) sub-paragraph a, shall be done by exporting PSAT from Indonesian territory. (2)Rejection of PSAT import, as referred to in paragraph (1), shall be conveyed to the owner or proxy by Plant Quarantine Officer in the form of a letter of rejection along with the reasons. (3)Concerning rejection of PSAT import, as referred to in paragraph (1), Head of Agricultural Quarantine Agency Technical Operating Unit shall submit a notification of noncompliance to PSAT safety competent authority of country of origin with a copy submitted to Head of Agricultural Quarantine Agency. (4)All costs required for the implementation of rejection, as referred to in paragraph (1), shall be borne by the owner or proxy. Article 15 (1)If after 14 (fourteen) working days since date of rejection, as referred to in Article 13 paragraph (3) sub-paragraph a, PSAT is not exported from Indonesian territory, destruction shall be performed. 20

21 (2)In the implementation of destruction, as referred to in paragraph (1), Plant Quarantine Officer shall issue a destruction report. (3)All costs required for the implementation of destruction, as referred to in paragraph (2), shall be borne by the owner or proxy. CHAPTER III SURVEILLANCE Article 16 (1)To prove compliance of a country or production site whose food safety system has been recognized and/or country who has had an equivalence agreement with Indonesia s food safety requirements, surveillance shall be performed. (2)Surveillance, as referred to in paragraph (1), shall be performed at any time upon import of PSAT through test of content of chemical contaminants, biological contaminants, and prohibited chemical substances. (3)To perform surveillance, as referred to in paragraph (1), Plant Quarantine Officer shall collect PSAT samples during 21

22 performance of PSAT identity inspection, as referred to in Article 13 paragraph (2). Article 17 (1)Surveillance, as referred to in Article 16 paragraph (2), shall be performed at the laboratory, as referred to in Article 9 paragraph (1). (2)During laboratory test, as referred to in paragraph (1), PSAT shall be under control and supervision of Plant Quarantine Officer. (3)Cost of the laboratory test, as referred to in paragraph (1), shall be borne by Agricultural Quarantine Agency. (4)Procedure of surveillance, as referred to in Article 16, is as specified in Attachment VI as an inseparable part of this Regulation. Article 18 (1)In case that result of the laboratory test, as referred to in Article 17 paragraph (1), proves that: a. chemical contaminants and biological contaminants exceed the maximum limit and/or containing prohibited chemical 22

23 substances, as referred to in Article 4 paragraph (3), rejection shall be performed; b. chemical contaminants and biological contaminants are equal to or do not exceed the maximum limit and do not contain prohibited chemical substances, as referred to in Article 4 paragraph (3), plant quarantine action shall be performed in accordance with the legislation. (2)Rejection of PSAT import, as referred to in paragraph (1) sub-paragraph a, shall be done by exporting PSAT from Indonesian territory. (3)Rejection of PSAT import, as referred to in paragraph (1), shall be conveyed to the owner or proxy by Plant Quarantine Officer in the form of a letter of rejection along with the reasons. (4)Concerning rejection of PSAT import, as referred to in paragraph (1), Head of Agricultural Quarantine Agency Technical Operating Unit shall submit notification of noncompliance to PSAT safety competent authority with a copy submitted to Head of Agricultural Quarantine Agency. 23

24 (5)All costs required for the implementation of rejection, as referred to in paragraph (1), shall be borne by the owner or proxy. Article 19 (1)If after 14 (fourteen) working days since date of rejection, as referred to in Article 18 paragraph (1), PSAT is not exported from Indonesian territory, destruction shall be performed. (2)In the implementation of destruction, as referred to in paragraph (1), Plant Quarantine Officer shall issue destruction report. (3)All costs required for the implementation of destruction, as referred to in paragraph (2), shall be borne by the owner or proxy. CHAPTER IV FREEZE AND RE-RECOGNITION OF PSAT SAFETY CONTROL SYSTEM Article 20 Freeze of recognition of food safety control system of PSAT of a country, recognition of PSAT safety control in production site, 24

25 or equivalence agreement, shall be perfdormed by the Minister of Agriculture in the case of 3 (three) times of: a. non-compliance in PSAT identity inspection, as referred to in Article 13 paragraph (3) sub-paragraph a; or b. result of laboratory test, as referred to in Article 18 paragraph (1), shows that chemical contaminants and biological contaminants exceed the maximum limit and/or containing prohibited chemical substances as referred to in Article 4 paragraph (3). Article 21 (1)Re-recognition of food safety control system on PSAT type of a country, PSAT safety control system in production site, equivalence agreement, or the frozen one, as referred to in Article 20, can be granted by the Minister after performance of review and re-verification in country of origin. (2)In performing review and verification, as referred to in paragraph (1), the Minister shall be assisted by a Team. (3)The Team, as referred to in paragraph (2), shall be established by a separate Decree. Article 22 25

26 Concerning import of PSAT originating from a country or production site whose recognition is frozen, as referred to in Article 20, provisions on procedure of PSAT import, as referred to in Articles 7 to 12, shall be applied. CHAPTER V PSAT EXPORT Article 23 (1)PSAT export shall be in accordance with regulations on PSAT safety of destination country, if required. (2)PSAT export, as referred to in paragraph (1), from Indonesian territory: a. shall be completed with certificate or document stating about condition of PSAT safety in accordance with requirements of destination country issued by an accredited laboratory, accredited certification institution, or PSAT safety competent authority; b. shall pass through the designated places of exit; and c. shall be reported to Plant Quarantine Officer. (3)Plant Quarantine Officer at place of exit shall perform inspection of completeness and correctness of the documents 26

27 required by destination country as referred to in paragraphs (1) and (2). (4)If result of inspection shows fulfillment of the requirement, as referred to in paragraph (3), PSAT can be delivered to destination country. CHAPTER VI TRANSITORY PROVISIONS Article 24 (1)Concerning PSAT which has been loaded to transportation vehicle in country of origin within not later than 30 (thirty) days since the application of this Regulation, PSAT safety control shall be performed based on the provisions of Regulation of Minister of Agriculture No. 27/Permentan/PP.340/5/2009 juncto Regulation of Minister of Agriculture No. 38/Permentan/PP.340/8/2009. (2)Existing recognition of PSAT safety control system shall be valid until its expiry date. CHAPTER VII CLOSING PROVISIONS 27

28 Article 25 Implementation of safety control over PSAT import and export shall be done integrally with the implementation of plant quarantine action. Article 26 With the enactment of this Regulation, Regulation of Minister of Agriculture No. 27/Permentan/PP.340/5/2009 juncto Regulation of Minister of Agriculture No. 38/Permentan/PP.340/8/2009 is revoked and declared inapplicable. Article 27 This Regulation shall be effective 3 (three) months since date of enactment. For public cognizance, this Regulation is enacted by placing it in the State Gazette of the Republic of Indonesia. Stipulated in Jakarta December 14, 2011 MINISTER OF AGRICULTURE Sgd SUSWONO Enacted in Jakarta Date: MINISTER OF JUSTICE AND HUMAN RIGHTS OF THE REPUBLIC OF INDONESIA 28

29 AMIR SYAMSUDDIN STATE GAZETTE OF THE REPUBLIC OF INDONESIA OF 2011 NO. ATTACHMENT I OF REGULATION OF MINISTER OF AGRICULTURE NO: 88/Permentan/PP.340/12/2011 DATED: December 14, 2011 FRESH FOOD OF PLANT ORIGIN (PSAT), MAXIMUM LIMIT OF CHEMICAL CONTAMINANT, BIOLOGICAL CONTAMINANT, AND PROHIBITED CHEMICAL In the separate file ATTACHMENT II OF REGULATION OF MINISTER OF AGRICULTURE NO: 88/Permentan/PP.340/12/2011 DATED: December 14, 2011 PROCEDURE OF RECOGNITION OF PSAT SAFETY CONTROL SYSTEM OF COUNTRY OF ORIGIN, RECOGNITION OF PSAT SAFETY CONTROL SYSTEM IN A PRODUCTION SITE AND/OR EQUIVALENCE AGREEMENT ON PSAT SAFETY CONTROL SYSTEM BETWEEN INDONESIA AND COUNTRY OF ORIGIN A. PROCEDURE OF RECOGNITION OF PSAT SAFETY CONTROL SYSTEM OF COUNTRY OF ORIGIN I. REQUIREMENT Requirement of PSAT safety control system in a country so it can be given recognition: 29

30 1. applying good agricultural practices (GAP) on the PSAT type; 2. applying good handling practices (GHP) on the PSAT type. II.PROCEDURE The process of grant of recognition of PSAT safety control system in a country shall follow the following procedure: 1. Application Submission Application shall be submitted in writing by PSAT producer/his proxy in a country to the Minister of Agriculture through Agricultural Quarantine Agency by filling out Form of Application for Recognition accompanied with documents and information concerning safety control system of PSAT type in a country. 2. Assessment a. Assessment shall be performed on the application submitted. b. Assessment shall be performed by a Team appointed by the Minister of Agriculture. c. If the application, document and information, as referred to in point 1, have been received, the Team shall 30

31 perform assessment within not later than 3 (three) months since receipt of application. d. If the documents and information as referred to in point 1 are incomplete and/or during assessment process it is found that the documents are incomplete, the applicant shall be given an opportunity to complete it within not later than 3 (three) months since letter of notification on document incompletion to the applicant. e. If the document is not completed, the application for recognition shall be deemed null and void, and if the applicant wanted to continue with process of application for recognition, he is required to re-submit application for recognition. f. Result of assessment will be followed-up with on-site verification on the production site. 3. On-Site Verification a. Verification shall be performed by a Team appointed by the Minister of Agriculture. b. Before performance of verification, the Team shall arrange planning that includes place and time of performance of verification and other matters concerning 31

32 performance of verification and will be first discussed with the applicant or his proxy. c. The Team shall perform verification to country of origin to evaluate compliance between regulation/document/information given by the applicant with food safety control system practices performed on PSAT type in country of origin to be requested for recognition. d. Result of on-site verification shall be written on a work document. e. The work document shall record result of verification consisting of: - elements of PSAT safety control system; - non-compliance with authentic proofs on documentation and facts. f. Based on the work document, as referred to in letter e, the Team shall arrange Report on Verification Result. 4. Evaluation a. Verification result shall be reported by Chairman of the Team to the Minister of Agriculture in Agricultural Ministry meeting. 32

33 b. Submission of report, as referred to in letter a, is intended to obtain assessment on Report on Verification Result. c. Assessment on Report on Verification Result shall be contained in Verification Report Evaluation. d. Verification Report Evaluation shall have been implemented within not later than 3 (three) months since completion of On-Site Verification activity. e. On-Site Verification Evaluation shall be followed-up with discussion at Team level within not later than 6 (six) months since presentation of Report on Verification Result. f. Result of discussion at Team level shall be conveyed in writing to the applicant. g. If the result, as referred to in letter f, shows noncompliance of PSAT safety control system in production site requested for recognition with Indonesia s PSAT safety requirement, the applicant is advised to perform corrective action. h. If the applicant has performed corrective action, the process of grant of recognition can be followed-up with further on-site verification. 33

34 i. Further verification shall be performed on noncompliances found in the previous verification. j. If the result, as referred to in letter i, is considered in accordance with Indonesia s PSAT safety requirement, process of grant of recognition shall be followed up with Stipulation of Recognition. 5. Recognition a. Recognition shall be stipulated by the Minister of Agriculture in the form of a Decree within not later than 6 (six) months since performance of Verification Report Evaluation. b. The Recognition, as referred to in letter a, shall be valid for a period of 2 (two) years. c. Extension of validity period of the Recognition, as referred to in letter b, can be given after producer/his proxy re-submits application for recognition and will be followed-up with assessment and repeat verification. III.SCOPE OF RECOGNITION Types of commodity that can obtain recognition are PSAT type produced by a country which has been granted recognition. 34

35 IV. APPLICATION FORM OF RECOGNITION Sample of application form of recognition as mentioned in Part II point 1 is as follow: APPLICATION FOR RECOGNITION OF FFPO IN A COUNTRY In the separate file B. PROCEDURE OF GRANT OF RECOGNITION OF PSAT SAFETY CONTROL SYSTEM IN A PRODUCTION SITE I. REQUIREMENT PSAT safety control system requirement in a production site in a country so it can be given recognition: 1. Applying good agricultural practices (GAP) in production site. 2. Applying good handling practices in production site. 3. Being a registered and certified production site. II.PROCEDURE Process of grant of recognition of PSAT safety control system in a production site shall follow the following procedure: 35

36 1. Application Submission Application is submitted in writing by PSAT producer/his proxy in a production site to the Minister of Agriculture through Agricultural Quarantine Agency by filling out Form of Application for Recognition accompanied with documents and information concerning safety control system of PSAT type in a production site. 2. Assessment a. Assessment shall be performed on submitted application. b. Assessment shall be performed by a Team appointed by the Minister of Agriculture. c. If the application, document, and information, as referred to in point 1, have been received, the Team shall perform assessment within not later than 3 (three) months since receipt of application. d. If the documents and information as referred to in point 1 are incomplete and/or during assessment process it is found that the documents are incomplete, the applicant is given an opportunity to complete it within not later than 3 (three) months since letter of notification on document incompletion to the applicant. 36

37 e. If the document is not completed, the application for recognition shall be deemed null and void, and if the applicant wishes to continue with process of application for recognition, he is required to re-submit application for recognition. f. Result of assessment will be followed-up with on-site verification on the production site. 3. On-Site Verification a. Verification shall be performed by a Team appointed by the Minister of Agriculture. b. Before performance of verification, the Team shall arrange planning consisting of place and time of performance of verification and other matters concerning performance of verification and will be first discussed with the applicant or his proxy. c. The Team shall perform verification in production site to evaluate compliance of regulation/document/information given by the applicant with food safety control system practices performed on PSAT type in production site to be requested for recognition. 37

38 d. Result of on-site verification shall be written on a work document. e. The work document shall record result of verification consisting of: - elements of PSAT safety control system; - non-compliance with authentic proofs on documentation and facts. f. Based on the work document, as referred to in letter e, the Team shall arrange Report on Verification Result. 4. Evaluation a. Verification result shall be reported by Chairman of the Team in meeting of Agricultural Quarantine Agency and the related institutions. b. Submission of report, as referred to in letter a, is intended to obtain assessment on Report on Verification Result. c. Assessment on Report on Verification Result shall be contained in Verification Report Evaluation. 38

39 d. Verification Report Evaluation shall have been implemented within not later than 3 (three) months since completion of On-Site Verification activity. e. On-Site Verification Evaluation shall be followed-up with discussion at Technical Commission level within not later than 6 (six) months since presentation of Report on Verification Result. f. Result of discussion at Team level shall be conveyed in writing to the applicant. g. If the result, as referred to in letter f, shows noncompliance of PSAT safety control system in production site requested for recognition with Indonesia s PSAT safety requirement, the applicant is advised to perform corrective action. h. If the applicant has performed corrective action, process of grant of recognition can be followed-up with further on-site verification. i. Further verification shall be performed on noncompliances found in the previous verification. j. If the result, as referred to in letter i, is considered in accordance with Indonesia s PSAT safety requirement, 39

40 process of grant of recognition shall be followed up with Stipulation of Recognition. 5. Recognition a. Recognition shall be stipulated by the Minister of Agriculture in the form of a Decree within not later than 6 (six) months since performance of Verification Report Evaluation. b. The Recognition, as referred to in letter a, shall be valid for a period of 2 (two) years. c. Extension of validity period of the Recognition, as referred to in letter b, can be given after producer/his proxy re-submits application for recognition and will be followed-up with assessment and repeat verification. III.SCOPE OF RECOGNITION Types of commodity that can obtain recognition are PSAT type produced by a production site which has been granted recognition. IV. APPLICATION FORM OF RECOGNITION Sample of application form of recognition as mentioned in Part II point 1 is as follow: 40

41 APPLICATION FOR RECOGNITION OF PRODUCTION SITE In the separate file C. PROCEDURE OF EQUIVALENCE AGREEMENT ON PSAT SAFETY CONTROL SYSTEM BETWEEN INDONESIA AND COUNTRY OF ORIGIN I. REQUIREMENT Requirement of equivalence agreement on PSAT safety control system between Indonesia and country of origin: 1. Being an initiative of two or more countries that have PSAT trade relations with Indonesia; 2. Both countries have Food Safety Competent Authority who prepares/submits information, gives opportunity for verification performance on PSAT safety control system II.PROCEDURE Process of preparation of equivalence agreement on PSAT safety control system is as follows: 1. Application shall be submitted in writing by Food Safety Competent Authority of a country who will apply for equivalence agreement to the Minister of Agriculture through Head of Agricultural Quarantine Agency by filling out Form of Application for Equivalence Agreement 41

42 accompanied with documents and information concerning safety control system of the PSAT type. 2. The Minister of Agriculture shall form an Assessment and Verification Team on PSAT Safety Control System to assess preparedness of Indonesia s PSAT safety control system and its scope which will be set forth in equivalence agreement and to perform verification on PSAT safety control system in exporting country. 3. The Minister of Agriculture shall give an opportunity to Food Safety Competent Authority of country of origin to cooperate in preparing and following up and process of consultation and negotiation of conditions in PSAT safety control system of each country. 4. Equivalence agreement can be stipulated if both parties objectively accept different sanitary actions/conditions in PSAT safety control system of each country, but achieving appropriate level of protection (ALOP). 5. Stipulation of equivalence agreement on sanitary actions/conditions in the framework of inspection and certification shall be based on the following principles: a. Both parties are entitled to stipulate ALOP in each country; 42

43 b. Sanitary conditions in the stipulation of equivalence agreement shall not be discriminative to WTO member countries and shall not create hidden barriers to international trade. c. Both parties may recognize different sanitary actions/conditions but achieving ALOP. d. Country of origin shall be responsible to objectively show that the sanitary actions applied by the country concerned have achieved ALOP of importing country. e. Upon demand of country of origin or importing country or both, consultation and negotiation shall be performed to determine equivalence of sanitary actions applied by both countries within a rational time. f. Evaluation shall be conducted objectively on sanitary actions performed in both countries. g. Risk analysis in stipulation of equivalence agreement, each country shall be consistent in using internationally accepted technique and methodology. h. In determining equivalence, the importing country in accordance with its knowledge and experience, will review, 43

44 assess, and evaluate PSAT inspection and certification in country of origin. i. Country of origin shall give access, upon demand of the importing country, to review, assess, and evaluate its PSAT inspection and certification system. j. Stipulation of equivalence agreement shall consider methods to maintain sustainability in the implementation thereof. k. Countries who arrange agreement shall ensure transparency in consultation and negotiation in the stipulation of equivalence agreement. l. Equivalence agreement can be made by two or more countries. III.SCOPE OF RECOGNITION 1. Equivalence agreement on PSAT safety control system consists of, amongst others, work frame, legislation, control and procedure, inspection and certification services, legislation enforcement, laboratory services, place of production/packaging, and information exchange. 44

45 2. Equivalence agreement shall cover review procedure and regular perfection to settle differences arising in the framework of equivalence agreement. III.CONTENT OF EQUIVALENCE AGREEMENT Equivalence agreement shall at least contain information concerning the following matters: a. type of agreement (bilateral or multilateral); b. title of agreement; c. parties engaged in agreement; d. objective of agreement; e. scope of agreement; f. definition of terms; g. substance of obligations; h. competent authority responsible for agreement; i. equivalence findings; j. provisions on assessment/verification; k. sample collecting; l. methodology, analysis, and other methodology; m. administrative procedure; n. information exchange and cooperation; o. transparency; p. notification; 45

46 q. dispute settlement; r. liaison officer; s. effective date; t. review, modification, and termination; and u. signature. E. PROCEDURE FOR DETERMINING EQUIVALENCE 1. Importing country shall provide detailed information concerning sanitary conditions applied, upon demand of country of origin (exporter). 2. Country of origin shall review all sanitary conditions applied by importing country to identify sanitary actions required in the framework of equivalence agreement. 3. Both countries shall perform exchange of information, especially concerning matters required for equivalence agreement. F. EQUIVALENCE DECISION 1. Equivalence decision of importing country shall be based on transparent, objective, and consistent analysis process and shall incorporate consultation with all related parties. 46

47 2. Equivalence decision of importing country on sanitary actions shall consider: a. experience, knowledge, and confidence on food inspection and certification system of country of origin; b. supporting data submitted by country of origin; c. analysis on sanitary actions of country of origin, and objective achievement of ALOP; d. the parameter shall be stated as far as it is possible quantitatively; e. diversity and source of uncertainty of other data; f. identified benefit for human health which is expected of a sanitary action in exporting country; g. Codex rules concerning food safety. 3. Exporting and importing countries should immediately notify about changes in program and recommendation that may affect equivalence decision. Procedure for determining and equivalence decision shall basically be in accordance with CAC/GL and CAC/GL

48 V. APPLICATION FORM OF EQUIVALENCE AGREEMENT Sample of application form of recognition as mentioned in Part II point 1 is as follow: APPLICATION FOR EQUIVALENCE AGGREEMENT OF FFPO In the separate file ATTACHEMENT III OF REGULATION OF MINISTER OF AGRICULTURE NO: 88/Permentan/PP.340/12/2011 DATED: December 14, 2011 REMARK ON PSAT (PRIOR NOTICE) In the separate file ATTACHMENT IV OF REGULATION OF MINISTER OF AGRICULTURE NO: 88/Permentan/PP.340/12/2011 DATED: December 14, 2011 SAMPLING PROCEDURE FOR LABORATORY TEST A. SAMPLING PROCEDURE FOR LABORATORY TEST Plant Quarantine Officer at place of entry shall collect samples and shall pack test samples in such a way so they will not experience damage/degradation during shipment. Afterwards, the test samples shall be handed to PSAT safety test laboratory. 48

49 1. Sampling shall be performed by Plant Quarantine Office who already received sampling training. 2. In performing sampling, Plant Quarantine Officer shall fill out Sampling Report in accordance with the format in Form 1 Sampling Report and attach it to the Letter of Application for Laboratory Test from Head of Agricultural Quarantine Technical Operating Unit (UPT) concerned and hand it to PSAT safety test laboratory chosen by the owner or proxy as specified in Form 2 together with PSAT samples to be tested. 3. The Letter of Application for Laboratory Test shall mention test parameter expected, for example: for pesticide residue test, type of pesticide s active material to be tested must be mentioned. Format of Letter of Application for Laboratory Test is as specified in Form PSAT sample to be sent to the test laboratory shall be packed by Sampling Officer (PPC) in accordance with expected requirement for PSAT safety test. 5. PSAT samples can be delivered personally by Plant Quarantine Officer to PSAT safety test laboratory or through courier service or by coordination with PST safety test laboratory. 6. The PSAT safety test laboratory shall perform test in accordance with the expected test parameter such as the one 49

50 in Form 3 within not later than 1 (one) working day since receipt of PSAT samples. 7. The test laboratory shall submit report on test result to Agricultural Quarantine UPT who submitted test application within not later than 1 (one) working day since completion of test. 8. Plant Quarantine Officer shall inspect test result on chemical contaminants in PSAT tested with maximum limit of contaminants stipulated and contained in Report on Performance/Control Result*) Physical/Health Examination of Carrier/Identity Inspection and PSAT Safety Test (DP-7) within not later than 1 (one) working days since receipt of test result. B. SAMPLING 1. SAMPLING METHOD There are two (2) sampling methods, namely lottery and car methods. Lottery method is used to select samples from the population which is in packed form, while car method is used to select samples from the population which is in bulk form Lottery Method Using Slips of Paper 50

51 1. If we have lot of items consisting 36 boxes and wish to take 6 boxes as samples. 2. Prepare paper slips with a size equal to lot size. Give numbers according to lot size (N), in this case 1 to Place the paper slips in a box. 4. Shake the box. 5. Take a paper slip and write down the number on the slip. 6. Put the slip back to into the box, shake the box again, and repeat this procedure until there are 6 different numbers selected. This method is called random as each number has an equal chance of being selected, provided that after number picking, the slips must be placed back into the box Using Random Table 1. If the lot size is equal to 300 boxes and 20 boxes are taken as samples. 2. Each pack or unit shall be given sequence number, for example 1, 2, 3, etc

52 3. As number of packs consists of 3 digits (200), a random number is required consisting of a sequence of 3 random numbers and 3 random columns selected, for each pack to be taken as samples. 4. To determine starting point, point randomly (for example by a pencil) a number on the first page of the random table (Table 6), in this case for example pointing at line 48 column 10. On line 48, write down 4 numbers starting from column 10 to the right (columns 10, 11, 12, 13), namely The first two numbers for line number and the following two numbers for column number of starting point. As starting point, line 32 and column 3 are selected. 5. Write down 3 numbers each starting from the starting point to the right direction until 20 pairs of numbers are obtained. Number 592 is obtained, and it is greater than 300 so it is not used. And, numbers which are not greater than 300 are: 126, 236, 163, 189, 278. As there are only 2 numbers left, reading is continued to the next line (line 33) and to make it easy, take the left direction, numbers 70, 210, etc until 20 different pairs of numbers are obtained. Units whose numbers are picked are selected as samples. I.2. Car Method 52

53 Random sampling can also be performed on bulk products in form of grains which are commonly carried in container or in ship s hold and shall be collected by using a special device. Car sampling method diagram can be seen in Figure 1. Samples taken from a car shall consist of at least 5 probes taken from the following points: a. Middle point of a ship s hold. b cm from rear door/wall of the ship s hold and 0.5 to the inside of one of the ship s hold side. c m from the same point of the ship s hold, but 0.5 m from the opposite side, such as in collection of samples (2) and (5) such as in collection of samples (2) and (3), but from opposite point and side of ship s hold. 0.5 m from side 0.5 m from side O O 1 1.5m from rear point Door O middle m from door O O 0.5 m from side 0.5 m from side Figure 1. Car sampling diagram This method can also be applied on packed products, if sampling is performed directly in the car, commonly in the port or on inter-country border. 53

54 2. PSAT SAMPLING PROCEDURE 2.1.Preparation of Sampling Kits and Equipment Sampling kits and equipment required for sample collection that shall be prepared consist of: - sampling kits (for example, gloves, shovel, double-headed spear, single-headed spear, vacuum, etc.) - sample containers (for example, plastic bags, aluminum foil bags) - shipping tools (refrigerated containers, frozen containers) - identification kits (for example, label, marker pen, ballpoint pen, glue) 2.2. Sampling Procedure PSAT package is divided into 3 (three) types, namely bulk package, large package (sack/large container), and small package (commonly of less than 5 kg per primary package). Sampling system for the three package types is different. Total samples for each type of package are as specified in Table Bulk Package Sampling 54

55 Sampling of PSAT whose package is in form of bulk shall be in accordance with the procedure based on SNI s Solid Sampling. And, sampling points shall be determined based on random sampling car method. Sampling procedure is as follows: 1. Collect samples from a car consisting of at least 5 (five) probes. 2. From On each point, at least 1 kg or 5 units are taken. 3. All samples are mixed and collected according to Table Separate samples for each different test by special handling, depending on the type of test to be performed Large Package Sampling Sampling of PSAT with large package shall be in accordance with the procedure based on SNI s Solid Sampling. Sampling points (containers to be used as samples) shall be determined based on random sampling, whether lottery method by using paper slips or Random Table (Table 6) Small Package Sampling Product without Secondary Package Sampling procedure to determine status of acceptance or rejection commonly refers to Codex AQL 65. If Codex procedure is adopted it becomes very expensive as all samples must be 55