1

Resolution SENASA N° 816 BUENOS AIRES, 4 October 2002 HAVING SEEN File No. 1218/2002 of the register of the NATIONALA GRI

- FOOD HEALTH AND QUALITY SERVI CE, and WHEREAS: The Quarantines, Borders and Certifications Coordination Office proposes review an d updating of the stan dards regulating imports of animals; reproductive material; precursory life forms; zoothera

peutics; biologicals; fertilizers; animal feed; plants; plant parts; soil dressings; organic support and/or growth media; biological control organisms; products, by products and deriv atives of animal and/or plant origin; and goods and/or inputs whose components consist of or include ingredients of animal or plant origin; that fall under the respons ibility

of the above

- mentioned office. The terms of Laws Nos. 3959, 4084, 17,160 and 18,284; Decrees Nos. 83732 dated 3 June 1936, 6704 dated 12 August 1963, 4238 dated 19 July 1 968, 2126 dated 30 June 1971, 1812 dated 29 September 1992, 1585 dated 19 December 1996, 815 dated 26 July 1999 and 394 dated 1 April 2001; Resolutions Nos. 202 dated 1 April 1992 and 668 dated 10 Au gust 1994, both issued by

the former Ministry

o f Agriculture, Livestock and Fisheries]; Resolutions Nos. 758 dated 13 October 1997 and 292 dated 10 December 1998 issued by the former M inistry

of Agriculture, Liv e stock, Fisheries and Food; Resolution No. 69 dated 15 January

1 999 issued by

the NA TI ONAL AGRI

- FOOD HEALTH AND QUALITY SERVI CE; and Resolution No. 228 dated 8 July 1 999 and its amendment No. 782 dated 23 November 1999 issued by the former MI NI STRY OF AGRICULTURE, LIVESTOCK, FISHERIES AND FOOD, make it feasible to implement procedures for imports of goods of animal or plant origin that, while ensuring quality and safeguarding public, plant and animal health in the above

- mentioned pro cedures, adapt to the changes required for marketing at the world level. The purpose of this proposal is to combine various standards relating to imports of goods of animal or plant origin, thereby e stablishing clear procedures for each modal ity in an e ffort to streamline control. Based on experience acquired, it has been deemed appropriate to intro duce these changes while maintaining the quality r equirements and sanitary criteria that help minimize the risk of introducing diseases or pests through goods that endanger public health as well as the zoosani tary

and/or phytosanitary

status of our territory

. In this regard, the proposed amendments consist of actions that must be taken in matters of human and animal health by the National Administration and/or the National Plant Health Protection O rganization, and, along these lines, included in international agreements, in cluding those in effect within the framework of the (ME RCOSUR. The structural changes to the NA TIONAL AGRI

- FOOD HEALTH AND QUALITY SERVI CE as of the entry into force of Decree No. 1585 dated 19 December 1996 make it advisable to introduce the proposed amendments, including those that facil i tate verification of compliance with applicable identity, hygiene and sanitary , phy tosanitary , zoosani tary , quality , purity, stability , packing and transport stan dards, prior to the entry o f goods or authorization of their use. The ARGENTINE REPUBLIC has adhered to the Sanitary and Phy

tosani tary ( SPS)2

Agreements and Technical Barriers to Trade (TBT) of the WORLD TRADE ORGANIZA TI ON (WTO) and to the concepts and principles resulting there from. Resolution No. 32 dated 4 May 2 001 of the NATIONAL AGRI

- FOOD HEALTH AND QUALITY SERVICE confers upon the Quarantines, Borders and Certifications Coo rdination Office respon sibilities for preventing the risk of introduction and spread of emergent and/or high risk exotic diseases in animals and regulated quarantine and non quarantine pests in plants, entrusting that office with streamlining import proc e dures and preserving animal, plant and public health without hin dering trade. SENASA File No. 13,428/2001 consti tutes an agreement between the various offices of this body with respect to auditing procedures to be used abroad for purposes of their implementation. The various comp etent technical areas have issued opinions with respect to the proposed amendments. The Legal Affairs Directorate has been involved in the process in keeping with its a uthorities. It is appropriate to issue this ruling in accordance with the terms of Artic le 8 e) of D e cree No. 1585 dated 19 December 1996, which was replaced b y similar Decree No. 394 dated 1 April 2001. THE PRESIDENT OF THE NATIONAL AGRI

- FOOD HEALTH AND QUALITY SE RVICE THEREFORE RESOLVES: ARTI CLE 1.

- When presented with a request for impo rt authorization and for pur poses of carrying out the corresponding risk analysis from the point of view of plant or animal health, as applicable, the NATIONAL AGRI

- FOOD HEALTH AND QUA L IT Y SERVI CE may

o rder an audit of the entire health system of origin or a specific audit, as it deems nece s sary , based on available information, including in that audit a review of the structure and eff

i ciency o f services, control systems, quarantine procedures, epidemiological monitoring sys tem, import control, prevention me asures, inspection of production establishments, manufac turing plants, warehouses, breeding centres, etc., reference and diagnostic laboratories, residue control pro grams, among others, according to the procedures that appear in Annex I , which forms part o f this Res o lution. ARTI CLE 2.

- Any individual, corporation or de facto company that wishes to carry out imports of live animals; reproductive material; precursory l ife forms; plants; plant parts; pro d ucts, by products or derivatives of animal or plant origin; or goods and/or inputs whose components consist of or contain ingredients of animal or plant origin, that fall under the responsibility

o f this National Service and require prior authoriz ation, must be previously entered in the register kept by the Quarantines, Borders and Certifications Coordination Office, in compliance with Resolution No. 492 dated 6 November 2001 of the NA TI ONAL AGRI

- FOOD HEALTH AND QUALITY SE RVICE. ARTI CLE 3.

- The competent authority in public and animal health matters, and/or the n ational plant health protection organization of the country of origin and/or shipment, when the NATIONAL AGRI

- FOOD HEALTH AND QUALITY SERVI CE so re quests, must guarantee auditable traceability s ys tems for animals; reproductive material; pre cursory l ife fo rms; zootherapeutics; biologicals; fertilizers; animal feed; plants; plant parts; soil dressings, o rganic support and/or growth media; biological control organisms; products, by products and deriv atives of animal or plant origin; or goods and/or inputs whos e3

components consist of or contain ingredients of animal or plant origin; throughout the production and marketing chain from the place of origin through to shipment to the ARGENTINE REPUBLIC. The NA TI ONAL AGRI

- FOOD HEALTH AND QUALITY SERVI CE reserves the right to audit that traceability and the documentation pertaining thereto where it deems necessary , as established in this Resolution. ARTI CLE 4.

- All new requests for the importation of products, by products and deriv atives of animal origin or goods and/or inputs whose components consist of or contain ingredients of animal ori gin, that fall under the responsibility o f the NATIONAL AGRI

- FOOD HEALTH AND QUALITY SERVI CE and come from a new plant in a country e xporting to ours, or from a new plant in any c ountry , shall be subject to prior inspection of same, though excep tions may

b e granted where deemed appropriate by this National Service. In addition, plants that manufac ture goods for industrial use may b e exempted provided that such goods are not intended for human or animal use in any o f their forms and that importation of those goods does not involve a health risk ari s ing from their origin or place of shipment, product or i ntended use. In such cases, prior approval of the plant could be a condition for autho rizing the import. Authoriz ations shall have a term of TWO (2) ye ars. If the Service is unable to re - inspect such plants once that term has expired, the authorization may be e xtended where deemed necessary

. Countries with which there is a mutual agreement to authorize plants (pre

- listing) or official agreements b etween the parties, or establishments therein, are exempt. In the case of plants already a uthorized on the date of entry into effect of this Resolution, said authorization shall be deemed to have expired once TWO (2) years have transpired from the time of their authorization to export to our country , and a new authoriz ation shall be required. An extension to that authorization may b e granted by

the NATIONAL

AGRI

FOOD HEALTH AND QUALITY SERVICE at it s discretion. Those plants or the countries in which they

are l o cated shall request, once the TWO (2) year term has expired, or prior to that time, a visit to ensure continuity o f exports to our country
. SENASA may , where it deems appropriate, extend the a uthorization without fulfilling this requirement. ARTI CLE 5.

- Slaughtering establis hments, manufacturing establishments and/or warehouses for products, by products, and derivatives of animal origin, animal inputs and goods with animal comp o nents from any c o untry , from which imports have been previously

a uthorized may

b e inspected where the NAT IONAL AGRI

- FOOD HEALTH AND QUALITY SERVICE so rules. Countries whose establishments are not authorized on the date of public ation of this ruling and who export their products to our country , are given ONE HUNDRED AND EIGHTY (180) calendar days to request inspection of those establishments. If requests to that effect are not obtained from the countries or interested parties within that period, once the latter has tran spired, suspension of imports from establishments in that country m ay b e ordered. The Service shall, when presented with requests, stipulate a date for conducting the visit to that country
. The inspections carried out in any

s uch case may

b e accompanied by

an audit by

the NAT IONAL AGRI

- FOOD HEALTH AND QUA L ITY SERVI CE that includes, among other aspects, the structure and efficiency o f the Health Services, manufacturing and control processes, animal health aspects, certification and residue control systems, laborato ries, etc., for purposes of issuing a ruling on the feasibility of authorizing those plants. ARTI CLE 6.

- Where reasons of a public or animal health nature so warrant, any establis hment from amongst those authorized to export to the ARGENTINE REPUBLIC may be inspected, and that authorization may b e revoked where the stipulated condi tions4

are not met, including establishments authorized by p re - listing or official agreements between parties. ARTI CLE 7°.

- Fruit and vegetable packing plants shall be authorize d in the place of origin for exporting to the ARGENTINE REPUBLIC, where the NATIONAL AGRI

- FOOD HEALTH AND QUA L ITY SERVI CE deems necessary

. ARTI CLE 8o.

- Where required or deemed necessary , all expenses generated by inspe c tion in the place of origin by

p erso nnel of this organization as established in this Resolution for purposes of anal yz ing the feasibility o f exporting products to the ARGEN TI NE REPUBLI C shall be for the account of the exporting country , requesting party and/or interested party in the commerc ial procedure. The same shall appl y where the NATIONAL AGRI

- FOOD HEALTH AND QUALITY SERVI CE considers it nece s sary to conduct a visit to a country

f or purposes of in situ verification of all matters related to exports headed for the ARGEN TI

NE REPUBLIC. ARTI CLE 9.

- Approval is hereby ordered of the Procedure for the approval and notif i cation of phy

tosanitary and zoosanitary requirements for imports of animals; reproductive m aterial; precursory l ife forms; zootherapeutics; biologicals; fertilizers; animal fe ed; plants; plant parts; soil dressings; organic support and/or growth media; biolog i cal control organisms; products, by products and derivatives of animal or plant origin; or goods and/or inputs whose components consist of or contain ingredients of animal or plant origin that appear in Annex II, which forms part of this Resolution. ARTI CLE 10.

- Approval is hereb y ordered of the administrative procedure for pro c essing imports of products, by

products or derivatives of animal origin, or goods and/or inputs who se components consist of or contain ingredients of animal origin as it appears in Annex III, which forms part of this Resolution. ARTI CLE 11.

- The Quarantines, Bo rders and Certifications Coordination Office is hereb y authorized to establish and amend phy to sanitary and zoosanitary

requirements for imports of animals; reproductive material; precursory l ife forms; zootherapeutics; biologicals; fertilizers; animal feed; plants; plant parts; soil dressings; organic support and/or growth media; biological control organisms; products, byproducts and derivatives of animal or plant origin; or goods and/or inputs whose components consist of or contain ingredients of animal or plant origin. That office shall also generate the mechanisms and procedures necessary f or the establishment of phy tosanitary and zoosanitary requirements as well as the administrative pro cedures for authorizing the corresponding imports in each case, and may p rohibit or suspend the entry into the National Territory o f goods under the responsibility of the NA TI ONAL AGRI

- FOOD HEALTH AND QUALITY SERVI CE where technical or emergency condi tions so warrant. ARTI CLE 12.

- Resolutions Nos. 1354 dated 27 October 1994 and 1415 dated 17 N o vember 1994, both issued by the former NATIONAL ANIMAL HEALTH SERVICE, in the Administrative procedure for processing imports of live animals and reproductive mat erial, are to remain in effect. ARTI CLE 13.

- Approval is hereb y ordered of the Administrative Procedure for proces s ing imports of plants; plant parts; organic support and/or growth media [issuance of the Autorización Fitosanitaria de Importación (Phy tosanitary Import Authoriz ation)] (AFID I); pro d ucts, by products, derivatives of plant origin or goods and/or inputs whose components consist of or contain ingredients of p lant origin; that appears in Annex IV, which forms part of this Res o lution. ARTI CLE 14.

- Provision No. 165 dated 20 March 1986, Resolution No. 630 dated 23 May5

1994 of the former NATIONALA NIMAL HEALTH SERVI CE, Res o lution No. 416 dated 4 November 1994 of the former INSTITUTO ARGENTINO DE SANIDAD and CALIDAD VEGETAL [Argentine In stitute of Plant Health and Quality] and Resolution No. 1508 dated 21 September 2000 of the NAT IONAL AGRI

- FOOD HEALTH AND QUALITY SERVI CE are hereby

revoked. ARTI CLE 15.

- The scope o f Articles 1, 2, 4 and 5 of Resolution No. 202 dated 1 Au gust 1992 and Articles 1, 2 and 4 of Resolution No. 668 dated 10 August 1994, both of the former MI

NI STRY OF AGRI CULTURE, LIVESTOCK AND FISHERIES, is hereb y restricted. ARTI CLE 16.

- The scope of Reso lution No. 758 dated 13 October 1997 of the former MI NI STRY OF AGRI CULTURE, LIVESTOCK AND FI SHERIES AND FOOD is hereby re stricted. ARTI CLE 17.

- The terms of Resolution No. 492 dated 6 November 2001 of the NA TI ONALA GRI

- FOOD HEALTH AND QUALITY SERVI CE are to be expanded to include biological co ntrol organisms. ARTI CLE 18.

- This Resolution shall enter into effect as of the day f ollowing its public ation in the Official Gazette. ARTI CLE 19.

- Non

- compliance with any of the procedures set out in this standard shall re sult in application of the penalties set out in Chapter VI , Article 18 and thereafter, of D e cree No. 1585 dated 19 December 1996. ARTI CLE 20.

- Be it known, published and forwarded to the National Official Registry f or filing. RESOLUTION NO.8166

Annex I PROCEDURALSTANDARDS FOR THE AUDITING OF COUNTRIES EXPORTI NG PRODUCTS AND BY

- PRODUCTS OF ANIMAL OR PLANT ORIGIN TO THE ARGEN TI

NE REPUBLIC In the context of products and by

-products of animal or plant origin, on - site audits refer to the monitoring and inspection measures required to verify guarantees that the existing sanitary

and phy tosanitary s tandards, and sanitary

and public health policy are being implemented.

These guarantees must, at a minimum, be those agreed to between a non member country

and the Argentine Republic, or those established in multilateral agreements. The Argentine health authorities will notify in advance the country

that they wish to audit, and request an agreement to set a date for the visit. The agreement will include the ty

p e of products and the program to be followed. Under no circumstance may the information and comments collected during the audit mission or its conclusions be used for personal ends, or communicated to persons not associated with SENASA the state Agri

- Food Health and Quality Service. SENASA will certify

the findings of the mission in a written report that it will submit within thirty

( 30) business days, provided that the country v isited provides any addi tional information requested during the mission.

Should a significant risk to public, animal or plant health have been uncovered during the mission, the report will be presented as soon as possible, and in any case, within ten (10) business days of the end of the mission.

Once the report with the findings of the mission has been delivered to the a udited country , the audited country will have twenty

( 20) business days in which to make any necessary

comments and suggest corrections. Any c omments and corrections proposed will be anal yz ed by S ENASA and will be incorporated into the final report if they are considered pertinent. I f they are not in corporated, they

will be included in a footnote as the opinion of the audited country

. SENASA will use the corrections received to write the final report.

A. PROTOCOL FOR ANIMALHEALTH AUDITS
INDEX The final written report should include the titles and page numbers for the fo l lowing:7

1. INTRODUCTION a) Country

. b) Date of mission. c) Argentine experts on the mission. d) Accompanying officials from the country visited. e) Program wi th audit schedule. 2. OBJECTIVES Describe the objectives of the animal health mission (FMD/CSF/BSE, etc.). a) Name the competent authorities to be interviewed (central, regional and l o cal levels). b) Visits and technical meetings in the corresponding areas at the central level. c) Visits to local and/or regional offices (provincial/state, etc.). d) Visits to:

- reference laboratories;

- public diagnostic laboratories;

- private diagnostic laboratories. e) Visits to slaughterhouses, processing and/or packaging plants and warehouses, that e xport to the Argentine Republic. f) Other visits:

- establishments that supply animals for slaughtering, whose meat is to be exported to the Argentine Republic;

- insemination centres whose semen, embryos or eggs are exported to the Argentine Republic ;

- establishments that prepare livestock feed;

- inspection post at sanitary barrier;

- border sanitary

inspection post;

- livestock markets. 3. LEGAL FRAMEWORK FOR MI SSI ON List the standards that must be met by the products exported to the Argentine Republic by the country

that is the subject of the inspection mission. 4. CONTEXT OF THE MI SSI ON 4.1. History

of the disease (under inspection) during recent years: Provide a brief summary of its onset, measures taken to control it, use of vaccines (ty pe, applicatio n), disease eradication, serologic testing, methods used, restricted animal movement, control and eradication programs. 4.2. Summary

of the last mission undertaken in the country : To be completed at a later date. S tate observations made and give address for the web page where the complete report for the mission can be read. 4.3. Evolution of the disease, since the last visit: To be completed at a later date. 4.4. Production and marketing information:8 Record the volumes produced by the audited country

( i f relevant, by

r egions or zones) and the tonnes of product exported to the Argentine Republic (please provide ONE multi

- ye ar cycle). 5. OBSERVATIONS 5.1. Competent authorities: 5.1.1. Organization of Veterinary Services. 5.1.1.1. Central competent auth orities: describe the ty pe of organization and its position in the national organization chart; s tructure and jurisdictions, both technical and administrative, with their legal framework. Proc e dures manuals at the different levels. 5.1.1.2. Regional autho rities: describe their jurisdiction and autonomy

. Clearly describe this point for those countries (like Spain and Germany) where the regi o ns are very independent from the central government. 5.1.1.3. Lo cal authorities: describe the jurisdiction and respons ibilities of the l o cal authority; their knowledge of the standards for which they are re sponsible; record

- keeping of activities and animals; reporting and noti fication to their superiors (provincial, re gional and central) of having taken the actions for which they are re sponsible. The same applies to cases involving a slaughterhouse or food

-processing plant. 5.1.2. Financial and human resources. How does it obtain its resources and how are they distributed (equipment, ed ucation and training courses, salari es, maintenance of operating capacity , etc.). 5.1.3. Transparency

policy

. Notification of the onset of the disease that is being audited (whether the Office international de é pizooties (OIE) and the Argentine Republic are notified; whether the information is posted on its web page, etc.); whether the microo rganisms are sent to an international or regional reference laboratory for ty ping. 5.2. Animal registration: Animal identification system used in the country
. Registration of livestock establis hments. 5 .3. Control of animal movements. Animal transit document. How are changes in animal ownership verified and recorded, both internall y and for imported animals. 5.4. National Epidemiological Surveillance S ys tem 5.4.1. Notification and management of outbreak s (FMD/CSF/BSE, etc.)9 5.4.1.1. Rules in force before the onset of the disease; who gives notice of a su spected outbreak; implementation period for the competent authority

. 5.4.1.2. Measures taken before the onset of the disease: samples taken, mov ement of animals and animal

- derived products. 5.4.1.3. Epidemiological survey : management of the epidemiological inform ation in the findings. 5.4.2. Components and Structure of the National System 5.5. Measures taken in the outbreak area and surrounding area: 5 .5.1. Immobilization period for animals and animal

- derived products, as well for all the materials at risk for the disease. 5.5.2. Restrictions on animal movements and animals sent for slaughter whose pro d ucts could be exported to the Argentine Republic. 5.6. Vaccination: 5.6.1. Characteristics of the vaccines used (ty pe of microorganisms, inactivators used, adjuvants, duration of immunity) processed by p rivate or public corporations; who performs quality control, etc. 5.6.2. National or regional vaccination programs: Monitoring of animals subjected to vaccination programs, frequency , doses; who monitors the storage and transport of the vaccine; who administers it (pub lic or private); who certifies the inoculation; identification of vaccinated animals. 5. 7. L aboratories: 5.7.1. National reference laboratory : budget, condition of building and laboratories, equipment, organization, personnel, records and protocols for sampling and re sults; management of information and results. 5.7.2. Network laboratories: rating systems and audit records. Condition of the buil ding and of the laboratories, diagnostic methods used (with their procedures manuals), time lapsed between receipt and return of results. Systems for co mmunicating with the person returning the samples and with the officials who must be sent the info r mation. 5.8. Establishments for the slaughter, processing and/or packaging and warehousing of animal

- derived products: 5.8.1. Special rating, if required. 5.8.2. Competent authority : identification of off icial, knowledge of the pertinent legi s lation, records of sanitary c ertificates, animal movement certificates, “ante

- mortem" appraisals (identification of animals, records of animals that arrived with sy

mptoms or lesions caused by disease) and “post

- mortem "10 appraisals (r e cords of observations of lesions or confiscation). Records of compliance with specific requirements for exports to the Argentine Republic. Risk

- mitigation manuals for the diseases being audited. 5.8.3. Traceability

f rom the animal's arrival to the packaged products in the warehouse. 5.8.4. Waste treatment: manner in which waste is destroyed in order to prevent the cont amination and spread of the disease. 5.8.5. Certification: system used to guarantee the veracity of the information entered o n the certificate and the use of the model certificates approved by SENASA that set the requirements for entry into the Argentine Republic. 6. CONCLUSIONS 6.1. Competent authority: must describe the outcome of the audit at the different levels of the org anization of the responsible authority. 6.2. Record

- keeping by e stablishments: analysis of observations with regard to knowledge of the establishments where animals are kept. 6.3. Animal identification: opinion on the system used to guarantee the origin of the animals that will supply

the products for exportation. 6.4. Monitoring of farm movements: appraisal of the system that guarantees animal mov ements and the immobilization of diseased animals. 6.5. Notification and management of outbreaks or diseased animals (BSE): Comments on the system used for the notification of a disease or of suspected cases. Inaddition, actions implemented to contain the disease and to avoid contaminating other susceptible animals or their products. 6.6. National disease program: comments on the plan implemented to control the disease. 6.7. Laboratories: level of training, management of samples and the protocols of the n ational reference laboratory . Comments on the network laboratories. 6.8. Certification: comments on the manner in which the country guarantees the veracity of the sanitary

certificates. 7. FINAL MEETING Once the on - site inspection has been completed, the SENASA experts will provide the country's official authorities with an oral report on their conclusions from the audit, and if appropriate, on corrective measures that should be implemented, as well as their degree of urgency

. A mission report will be drawn up based on all the information collected under the proto col, and must include:

- Conclusions,

- Recommendation s:  for the official authorities of the country visited
 for SENASA authorities. 8. RECOMMENDATIONS11

8.1. For the authorities of the country visited: In this case, state any observations made during the audit that should be corrected in order to continue to allow entry o f the product(s) originating in the inspected country
. 8.2. For SENASA audits Provide any suggestions for SENASA to:
 strengthen the controls over this product
 raise the requirements for accepting the product, or
 suspend entry

o f the product until the [exporting] country guarantees to correct the problems observed
 suspend the establishment that produced the product. 9. APPENDIXES Comments issued by

the official authorities of the audited country f or the draft mission report submitted by

S ENA SA must be included. If there are corrections to be made directly or clarifications, if appropriate, these are recorded in the footnotes. Similarly, maps, charts, and statistics may also be included.

B

- PROTOCOLFOR AUDITING MEAT

- PROCESSING ESTABLI SHMENTS.
INDEX 1. INTRODUCTION. 2. MI SSI ON OBJECTIVES. 3. LEGAL FRAMEWORK FOR THE MISSION. 4. CONTEXT OF THE MI SSI ON. 4.1. Summary

of findings from previous missions. 4.2. Reasons for current mission. 4.3. Production and marketing information. 5. OBSERVATIONS. 5.1. The competent authorities. 5.2. Ranking procedures for establishments. 5.3. Separation of national production from production for export to the Argentine Repu b lic (including animal traceability and identification). 5.4. Certification. 5.5. Securi ty of production controls. 5.5.1. Official monitoring of production conditions.12

5.5.2. “Ante

- mortem” inspection. 5.5.3. “Post

- mortem” inspection. 5.5.4. Structure and maintenance of establishments. 5.5.5. Self

- inspection of establishments. 5.5.6. Traceabi lity

of meat. 5.5.7. Training programs for personnel at the establishments. 5.5.8. Medical certificate for workers. 5.5.9. Water quality

. 5.6. Animal well

-being. 5.7. Monitoring of animal health. 5.8. L aboratory

service. 6. CONCLUSIONS 6.1. Structure and powers of the competent authority

. 6.2. Procedures for approving establishments. 6.3. Monitoring of food security. 6.4. Certification. 6.5. Separation of production for export (including animal traceability and identification). 6.6. Animal well

-being. (i f considered necessary) 6.7. Final exportation controls. 6.7.1 Controls at border or at shipping plants for embarkation. 6.7.2. Controls at loading point: processing plants, other locations, or port or air loading terminals, etc. 7. FINAL MEETING. 8. REC OMMENDATIONS. 8.1. To the competent authorities of the inspected country

. 8.2. To SENASA authorities. 9. APPENDIXES Lists of establishments authorized to export by the official health agency

.
C. PROTOCOLFOR AUDITING RESIDUE

- MONITORING PROGRAMS.
INDEX 1. INTRODUCTION. 2. MI SSI ON OBJECTIVES.13

3. LEGAL FRAMEWORK FOR THE MISSION . 4. CONTEXT OF THE MI SSI ON . 4.1. Summary

of findings from previous missions. 4.2. Reasons for current mission. 4.3. Production and marketing information. 5. OBSERVATIONS. 5.1. The competent authorities, structure and power. 5.2. Residues monitoring program. 5.2.1. L egal framework for residues monitoring program. 5.2.2. Coverage of the residues monitoring program. 5.2.3. General sampling (monitoring) and sampling of suspic ious animals. 5.2.4. Information on test results under the national residue monitoring plan. 5.2.5. Procedures for implementing the national residue monitoring plan. General crit eria of the plan (size of sampling and statistical basis) and risk analysis. C riteria for drafting annual plans. 5.2.6. Database of infractions, corrective measures for irregularities and their legal framework. 5.3. Availability of veterinary drugs. 5.3.1. L egal framework. 5.3.2. Veterinary

drugs prohibited for use in animal feed. 5.3.3. Growth hormones (GHs). 5.3.4. Restrictions on the use of GHs in livestock establishments registered for slaughter operations. 5.3.5. Prescription and over

- the

- counter drugs. 5.3.6. Drug ingredients used for purposes other than those indicated. 5.4 . Control of the production and distribution of GHs and veterinary drugs. 5.6. Maximum residue limit (MRL) for pesticides and heavy metals. 5.7. In - depth investigation. 5.7.1. In - depth investigation in case anabolic substances were used, in compliance wi th Resolution 397/97 5.7.2. In

- depth investigation in case of MRL violations, in compliance with Resolution 125/98. 5.8. Animal identification. 5.9. L aboratory

performance. 5.9.1. Quality

management

– Quality

Security (QS). 5.9.2. Analy

tical performance.14 5.9.3. Direction from SENASA's national reference laboratory for network laborato ries. 6. CONCLUSIONS 6.1. Structure and jurisdiction of the competent authority

. 6.2. Residues monitoring program. 6.3. Availability

of veterinary

drugs. 6.4. Control of th e production and distribution of GHs and veterinary drugs. 6.5. Maximum residue limit (MRL) for veterinary drugs and levels of administrative ac tion. 6.6. Maximum residue limit (MRL) for pesticides and heavy metals. 6.7. In - depth investigation. 6.8. Animal identification. 6.9. L aboratory

performance. 6.10. Overall conclusion. 7. FINAL MEETING. 8. RECOMMENDATIONS. 8.1. For the competent authorities of the inspected country 8.2. For SENASA authorities 9. APPENDIXES
D. PROTOCOLFOR AUDITING DAIRY

- PRODUCT PROGRAMS.
INDEX 1. INTRODUCTION. 2. MI SSI ON OBJECTIVES. 3. LEGAL FRAMEWORK FOR THE MISSION . 4. CONTEXT OF THE MI SSI ON. 4.1. Summary

of findings from previous missions. 4.2. Reasons for current mission. 4.3. Production and marketing information. 4. 3.1. Milk production. 4.3.2. Dairy

products exported to Argentina. 4.3.3. Dates of the last ten (10) exportations (if available) 4.3.4. National livestock herd15

4.3.5. Dairy

herd, dominant breeds. 4.3.6. Number of milking yards. 4.4. Health information. 4. 4.1. Animal health status. 4.4.2. Animal diseases covered in OIE Li sts A and B, their control s ys tems. 4.4.3. Foodborne illnesses and zoonoses caused b y dairy products. 4.3.3.1. Control agencies. 5. OBSERVATIONS. 5.1. Standards regarding the collection, treatment and processing of milk, for products e xported to the Argentine Republic. 5.1.1. Program on operational procedures. 5.1.2. EEC Directive 92/46 or directive required by SENASA. 5.1.3. National legislation. 5.2. Organization of the competent autho rity

. 5.2.1. Structure of the National Service. 5.2.1.1. Competent central authority

. 5.2.1.2. Competent regional authority

. 5.2.1.3. Competent provincial authority

. 5.2.2. Coordination of the different levels. 5.2.3. Program for monitoring milking yard s and establishments receiving, treating and processing milk. 5.2.3.1. Inspection s ys tem for primary production. 5.2.3.2. System for monitoring the collection and transport of the raw material. 5.2.3.3. System and frequency o f inspection at the treatment, processing and warehousing establishments for dairy products for expo rtation. 5.2.4. Inspector training courses. 5.3. Official s ys tem for monitoring export production. 5.3.1. National residues plan. 5.3.2. Sampling program for milk and dairy products. 5.3.2.1. Ty

pe of tests and parametres used. 5.3.3. Official program for water testing. 5.4. Network of officially recognized laboratories16 5.4.1. Description. 5.4.2. National reference laboratory

. 5.4.3. Coordination of laboratory network. 5.4.4. Offici all y authorized private laboratories. 5.4.5. Inside laboratories at dairy plants. 5.5. System for issuing official export certificates 5.6. Primary

production (milking yards). 5.6.1. Structure 5.6.2. Equipment 5.6.3 Sanitary

controls 5.7. System for monitoring raw

- milk quality

. 5.7.1. L evel of quality values 5.7.2. Basis for raw

- milk pay ment system 5.7.3. L aboratory

that carries out the controls 5.7.3.1. Laboratory

location 5.7.3.2. Methods used 5.7.3.3. Frequency

of controls. 5.8. Establishment for receiving, treating and processing milk. 5.8.1. Documentation for official use. 5.8.2. Documentation for use in industry that includes traceability of production. 5.8.3. Controls for production sy stem. 5.8.4. Use of the HAACP system. 5.8.5. Self

- monitoring sy stem. 5.8.6. Use of other s ys tems. 5.8.7. General condition of building structures. 5.8.7.1. Sector divisions of the different facilities. 5.8.7.2. Planimetry 5.8.8. Use and approval of additives 5.8.9. Approval of products 5.8.10. Records 5.8.11. Ef fluent 6. CONCLUSIONS 6.1. Hygiene standards for milk and dairy p roducts applied to products exported to Argentina. 6.2. Organization of the competent authority

.17

6.3. Sampling program for exported products. 6.4. Network of official laboratories. 6.5. Off icial certification for exportation. 6.6. Milking yards. 6.7. Quality

s ys tem for raw milk. 6.8. Milk processing plants. 7. FINAL CONCLUSION. 8. RECOMMENDATIONS. 8.1. For the competent authorities of the inspected country 8.2. For SENASA authorities 9. APPENDIXES
E. PROTOCOLFOR PHYTOSANITARY AUDITS INDEX 1. INTRODUCTION. 1.1. Country 1.2. Date of the mission 1.3. Argentine experts on the mission. 1.4. Officials from the audited country accompanying the Argentine mission. 2. MI SSI ON OBJECTIVES. De scribe the reasons for which the audit is carried out, which in general are to verify vari ous phy

tosanitary and/or quarantine issues. 3. LEGAL FRAMEWORK FOR THE MISSION. National standards, bilateral agreement, regional standards, international standards that e s tablish the conditions that the exporting country must meet for products to be exported to Argentina. 4. CONTEXT OF THE MI SSI ON. 4.1. Summary

of findings from previous missions, if available. 4.2. Production and marketing information. Description of crops in area, detailed description of the products that are to be exported, production volumes, volumes for export to the Argentine Republic. 4.3. Brief description of the pest or disease being studied. Monitoring s ys tems, status, economic importance in the region.18

5. PROGRESS OF THE MI SSI ON. 5.1. GENERAL ASPECTS 5.1.1. The competent authorities 5.1.1.1. Organization of the phy tosanitary protection services. 5.1.1.2 Central competent authorities: describe the ty pe of organization and its position in the national organization chart; structure and jurisdictions, both technical and administrative, with their legal framework . Proc e dures manuals. 5.1.1.3. Regional authorities: describe their jurisdiction and autonomy

. Clearly describe this point for th ose countries where the regi o ns are very independent from the central government. 5.1.1.4. Lo cal authorities: describe their jurisdiction and responsibilities; their knowledge of the standards for which they are responsible; record

keeping of activities an d monitoring performed; notification to their s u periors (provincial, regional and central) of actions taken. 5.1.2. Financial and human resources. How does it obtain its resources and how are they distributed (equipment, ed ucation and training courses, s alaries, operating capacity , etc.). How does it fund its activities, organizational structure, personnel and administration unit. 5.1.3. Inthe case of audits of systems or protocols covered under the standards of the South Cone Plant Protection Committee [ COSAVE

- Comité de Sanidad Vegetal del Cono Sur] (pest

- free areas, multi

- stage risk

- mitigation measures systems, etc.), all the points in the standards must be verified. 5.1.4. Pest identification laboratories: organization, recognition or rating, infrastruc ture available, personnel and training, methodology u sed, records of findings, traceability , management of information and findings, system for communicating findings, monitoring or audit systems, finalizing the methodologies to be used. 5.1.5. Trac eability : of pest monitoring programs, official monitoring performed in the country

. 5.2. SPECIFIC ASPECTS 5.2.1. For rating nurseries. 5.2.1.1. Certification program for propagation material. Pests covered. S ys tem for obtaining initial material. Pre

-propagation establishments. Monito ring of nurseries for mother plants. Monitoring of certified material (traceability). 5.2.1.2. Laboratories that take part in the certification program, laboratories that perform tests for the official monitoring of nurserie s, laboratories that perform tests on material for export: organization, recognition or19 rating, infrastructure available, personnel and training, pests identified, meth odology used, records of findings, traceability , management of the in formation and of th e findings, system for communicating the findings, monitoring and audit systems, finalizing the methodologies to be used. 5.2.1.3. Official monitoring system for nurseries, mother plants, initial material and plants destined for production: inspections pro gram, records. Sampling, record

- keeping. Record

- keeping and monitoring of the quantity

and ty pe of material produced by the nurseries. Traceability

. 5.2.1.4. Pest control programs, if applicable: Notification and management of pest outbreaks requiring quarantine b y the Argentine Republic. 5.2.1.5. Description of the nursery : Organization, infrastructure, production, certified material production system. Production and sale of standard material. Traceability . Region producing material. Record

- keeping of offi cial inspections: of nursery m aterial, basic monitoring and soil tests. Experience as export nursery : list the destinations and describe under what phy tosanitary conditions the nursery

e xports or has exported. Potential for meeting the phy tosani tary requir ements of the Argentine Republic. 5.2.1.6. Official monitoring and certification for pests for which quarantine is required by

importing countries. Possibility f or monitoring and certific ation for pests for which quarantine is required by the Argentine Repub lic. 5.2.2. For quarantine

- treatment facilities. 5.2.2.1. Chambers for fumigation with methyl bromide. 5.2.2.1.1. Documentation that confirms the ranking of the fumigation

chamber, current instrument calibration (scales, chimney sen sor, system for rec ording temperature and events, portable thermometer) and personnel training (managers and operators) in charge of the chamber. 5.2.2.1.2. Tests: manual calibration of sensors and thermometer

(mixture of crushed ice and distilled water), pressure (drop of f ifty ( 50) millimetres of mercury c olumn in a period of one hundred twenty (120) seconds), vacuum test (injection of thirty

- two (32) grams per cubic metre of methyl bromide in the empty

chamber). 5.2.2.1.3. Le ak detection (instrument panel, pipes, dumpers, door,

cei l ing, walls). 5.2.2.1.4. Reading of the fumiscope (measurement of methyl bromide

concentration (front, middle and rear)) thirty ( 30) minutes a f ter injection and with the recirculation fans stopped. 5.2.2.2. Centres for cold

- treatment application.20 5.2.2.2.1. Documentation that confirms rating of cold chamber,

current instrument calibration (s ys tem for recording temperature and events, portable thermometer) and personnel training (mana g ers and operators) responsible for the chamber. 5.2.2.2.2. Manu al calibration of sensors and thermometer (mixture of

crushed ice and distilled water). 5.2.2.2.3. Report on system
- test software for temperature recording

and monitoring. 5.2.2.3. Hot

- water treatment plant. 5.2.2.3.1. Documentation that confirms the ranking of the hydrothermal treatment plant, current instrument calibration (system for r e cording temperature and events, portable thermometer) and personnel training (managers and operators) responsible for the plant. 5.2.2.3.2. Report on system
- test softwar e for temperature recording

and monitoring. 5.2.3. Miscellaneous. 6. CONCLUSIONS Opinion on audit at government level. Opinion on audit in private sector. Certification: comments on the need for phy tosanitary import authorization ( autorización fitosanita ria de importación

- AFIDI) in order to issue phy tosanitary c ertificates for the Argentine Repu b lic, its significance and relevance. Equivalencies of rate measurements required for each pest and guarantees of their performance. 7. FINAL MEETING Once the v isit is completed, SENASA experts will provide the country's phy tosanitary a uthorities with an oral report of their preliminary c onclusions on the audit, and if appropri ate, any corrective measures that should be implemented. P roposals for quarantine guarantees or certification may also be discussed by

the phy tosanitary authorities of the exporting country with regard to phy

tosanitary requirements in Argentina. 8. RECOMMENDATIONS. List any suggestions for SENASA to:
 approve/not approve the importation of new products, or  approve/not approve an inspected nursery , or  modify

the controls for the importation of the product, or21

 modify

the requirements for accepting the product, or  request that the exporting country t ake additional measures or modify i ts control system for products exported to the Argentine Republic. or  suspend entry

o f the product, until the country p rovides guarantees regarding the prob lems uncovered, or  other. 9. APPENDIXES. Maps, charts and any other information provided by the audited country during the visit.22

Annex 2 PROCEDURE FOR APPROVALAND NOTIFICATION OF PHYTOSANITARY AND ZOOSANITARY REQUIREMENTS FOR IMPORTS OF ANIMALS; REPRODU C TIVE MATERIAL ; PRECURSORY LIFE FORMS; ZOOTHERAPEUTICS; BIOLOGICALS; FERTILIZERS; ANIMAL FEED; PLANTS; PLANT PARTS; SOIL DRESSI NGS; O RGANIC SUPPORT AND/OR GROWTH MEDIA; BIOLOGICAL CONTROL ORGA N ISMS; PRODUCTS, BYPRODUCTS AND DERIVATIVES OF ANIMAL AND/OR PLANT ORIGIN; OR GOODS AND/OR I NPUTS WHOSE COMPONENTS CONSI ST OF OR INCLUDE INGREDIENTS OF ANIMAL AND/OR PLANT O RI GI N 1. The Coordinación de Cuarentenas, Fronteras and Certificaciones [Quarantines, Borders and Certifications Coordination Office] shall establish or amend the phy tosanitary and zoosanitary

requirements for authorizing imports of products under the respon sibility

o f SENASA in keeping with the Risk Anal ys is, basing itself on assessment, in keeping with the circum stances, of existing risks to the life and health of people and animals or the preservation of plants and their health, in accordance with the term s of the Sani tary

and Phy tosanitary M easures Agreement of the WORLD TRADE ORGANIZAT ION and fo l lowing the notification and consultation procedures established herein. 2. The Quarantines, Borders and Certifications Coordination Office may p rohibit or su spend entry

into the national territory o f products under its responsibility where technical evaluations or emergency conditions so warrant. 3. Functions performed by S ENASA may

include the following: o fficial recognition of countries, areas, zones or regions fre e of or with a low prevalence of diseases or pests, as applicable; establis hments or farms free of diseases or pests; equivalence of measures for risk reduction; and equivalence of inspection procedures of exporting countries. The Quarantines, Borders and Certifications Coordination Office shall, through the Animal and Plant Quarantine Directorates, establish the procedures necessary f or each recogni tion, based on the recommendations and principles of international bodies (INTERNA TI ONAL OFFI CE OF EPIZOOT IC S , WORLD TRADE ORGAN IZAT ION, Codex, CIPF, among others) and taking into account the national or regional legislation in effect. The applicant official service shall provide the information requested by

S ENASA for each case and facilitate the conducting of in spection visits by SENASA officials where deemed necessary . The cost of these actions shall be borne by the interested party

. 4. The Animal and Plant Quarantine Directorates shall be the sole parties responsible for issuing technical reports from the quarantine point of view for all phy tosanitary o r zoosanitary

requirements pertaining to import authorization for products under the re sponsibility

of SENASA. 5. The areas of the Quarantines, Borders and Certifications Coordination Office authorized to generate import requirements, as applicable, shall be those responsible for conducting the necessary prior consultations with the various SENASA offices with the23

authority to establish other technical sanitary requirements (quality, residues, l a bels or other). 6. Th e responsible offices shall forward the requirements drafted as a result of the respe c tive Risk Anal ys is, technical reports and other technical requirements to the Quarantines, Borders and Certifications Coordination Office for review. 7. The draft requirement may b e sent for technical and scientific comments by the comp etent bodies and/or technical advisory commissions or reference bodies. 8. This period for comments shall be established for each case and may v ary according to the characteristics of the produc t, with a minimum term of SIXTY (60) days esta b lished. 9. The Quarantines, Borders and Certifications Coordination Office may f ormally open a consultation period at the national level where it deems necessary , so as to obtain opinions on draft sanitary , phy tosanitary and zoosanitary

import requirements from institutions competent in such areas. The method and times for the above

- mentioned consult ation period shall be established for each specific case. 10. Once the period established for the various consultatio ns has expired, the Quarantines, Borders and Certifications Coordination Office shall, after considering the comments and proposals received, proceed to finalize the draft requirement, amend it or extend the co n sultation period, and may m ake public a report anal yz ing the relevant comments re ceived in which it states the reasons for rejection or accep tance of the various points of view. The Final Regulation shall be initialled by all participating technical in stitutions and signed by the Coordinator of the Q uarantines, Borders and Certifications Coordin ation Office. 11. The above

- mentioned Coordination Office shall forward the requirements to the Coo rdinación de Relaciones Intern a cionales e Institucionales [International and Institutional Relations Coordination Office] in order that the latter might so inform the country o f ori gin of the product within the preesta b lished deadlines, or the SPS, where applicable. 12. The external consultation period set out in Point 11 shall consist of a minimum of sixty (60) days. C omments received shall be considered by the Animal and Plant Quarantine Directo r ates, as applicable. 13. If no comments are received within the preestablished period, the Quarantines, Borders and Certifications Coordination Office shall consider the import re quest approved subject to the established conditions. 14. Where there are comments on the part of the exporting country(ies), the Quarantines, Borders and Certifications Coordination Office shall conduct the corresponding evaluation of same within a minimum p eriod of SIXTY (60) days. If applicable, the necessary amendments shall be made and the exporting country advised thereof for24

purposes of f

inal confirmation or acceptance of new comments. Once this period has tran spired and the comments received have been evaluated, the Animal and Plant Quarantine Directo rates shall draft the final import requirement, of which notification shall be given as esta

b lished in Point 11 of this Annex. 15. Sanitary , phy

tosanitary o r zoosanitary

r equirements may

b e amended by

o rder o f the Quarantines, Borders and Certifications Coordination Office through recommendations by the Animal and Plant Quarantine Directorates, where emergency risk

- generating sani tary , phy

tosanitary o r zoosanitary

c ircumstances are in effect. S uch measures may go so far as to include suspension of import authorizations. The suspension set out in this point shall be formalized through a ruling handed down by the Coordinator of the Quarantines, Borders and Certifications Coordination Office (this responsibility may be delegated to responsible parties in the Animal and Plant Quarantine Directorates, where nece s sary). 16. A database of zoosanitary and phy tosanitary import requirements shall be available for consultation. 17. SENASA offices shall be advised by reliable m eans of any amendment or new requirements, including border offices involved in complying with the new sanitary requirements. 18. Entry into the country

shall only

be authorized for those goods mentioned in article one of this Resolution that have the corresp onding import authorization in accordance with the terms of the standards in effect. 19. Final confirmation of the model sanitary , phy tosanitary , or zoosanitary r equirements, as appl i cable, shall constitute part, but not all, of the requirements for import authorization. P rior to authorization, compliance with all necessary t echnical and administrative re quirements must be ensured, including, among others, audits and authorization in the place of origin.25 PART 1 ESTABLISHMENT OF ZOOSANITARY REQUIREMENTS C riteria of the Animal Quarantine Directorate with respect to determination of zoosanitary requirements for imports of products of animal ori gin under the responsibility of SENASA. a) The primary

role of quarantine procedures and decisions is both keeping und esirable di s eases outside the territory o f the ARGENTINE REPUBLIC and facilitating the intern ational flow of persons and goods under the responsibility of this National Serv i ce. b) Quarantine policy

i s based on a concept of reasonable and accep t able risk man agement based on scientific support. c) The definitions contained in the Zoosanitary C ode of the INTERNATIONAL OFFI CE OF EPIZOOTICS (OIE) shall be used in all cases and shall take into account the pre ex i stence of national or regional regulations in effect, not onl y those issued by SENASA, but also by

other bodies with jurisdiction in this area. Presentation by

the interested party . A file shall be opened by the Entry , Exit, Archives and Public In formation Desk of SENASA on forms pro vided for that purpose by the competent areas. 1. Preliminary

evaluation: there are two (2) possible scenarios: 1.1. Requirements are in place for products of equivalent or greater risk or specific prohibitions in that regard are in effect, in which case a direct ruling shall be handed down at the level of the operating area involved. 1.2. Faced with the non - existence of and need for a feasibility analysis, the Animal Quarantine Directorate shall prepare a work schedule which shall specify both the need for resources for the abo ve - mentioned analysis as well as the probable time required to rule on the case. The schedule must include details as to personnel resources, particularl y if the need arises for consultation of other permanent or ad hoc advisory

b odies, hiring of consultants, inspection or verification visits and any other input necessary

for re solving the matter. 2. Feasibility

anal ys is: Notification of the party concerned with respect to the need to carry out an Import Risk Anal ys is 1 (IRA). Where the information required to conduct the above

- mentioned analysis is not available, the request submitted shall be returned to the party

c oncerned, together with notification of the situation and a list of the information required to carry out the IRA. 3. The Animal Quarantine Directorate may make small changes or considerations [sic ] to already existing import requirements without having to conduct a new IRA. This pro c ess is called a routine IRA. The corresponding report shall be issued within NI NETY

- SIX (96) working hours fol lowing receipt of the request. This result may

1 Risk evaluation shall be understood to mean the procedures for identification and assessment of the events necessary to produce an adverse sanitary situation.26

include a final ruling of Acceptance or Rejection. The operating area shall proceed to notify the inter ested party

of the results by

reliable means. 4. Applications for imports of animals or derived product s that involve significant vari ations to already

e stablished import health policies shall require a non - routine IRA pro c ess. This ty

pe of IRA could involve a lengthy period of time and a co mplex process. 5. The report corresponding to the need to carry o ut a non - routine IRA shall be issued within FIVE (5) to FIFTEEN (15) working days following receipt of the import request. 6. Import Risk Anal ys is: this shall be initiated when the Animal Quarantine Directorate re ceives all the required information from the responsible official body o f the exporting country
. When establishing zoosanitary requirements, measures that guarantee minimum risk and produce the minimum impact on marketing shall be considered. Once the IRA has been completed, it shall be approved and the interested parties so informed through the Animal Quarantine Directorate. A minimum period of THREE (3) months shall apply for e s tablishing the requirements. 7. Once the preestablished steps have been complied with, if procedures that ensure an adequate level of zoosanitary p rotection are determined, the Animal Quarantine Dire c torate shall draft the technical report with the quarantine requirements to be stipulated in the proposed zoosanitary requirement. 8. Wherever deemed appropriate or necess ary, the Quarantines, Borders and Certifications Coordination Office may o rder that a quantitative Risk Analysis be conducted.27 PART 2 ESTABLISHMENT OF PHYTOSANITARY REQUIREMENTS. Products of plant origin that present possible phy tosanitary risk based on their level of pro c essing and proposed use are subject to phy tosanitary import regulations, in keeping with the terms of Regional Phy tosanitary P rotection Standard 3.15 [ Harmonization of Phy to sanitary Measures by

Path Way (C O SAVE/1999)]. TWO (2) scenarios are possible in this case: 1. Phy tosanitary r equirements are in place for the product requested, products of equiv alent or greater risk and/or specific prohibitions are in effect. 2. Phy tosanitary requirements have not yet been established, which means th at a Risk Analysis is necessary . The Plant Quarantine Directorate must therefore prepare a work sche d

ule that specifies the need for resources for the above

- mentioned anal ys is and an estimate of the probable time required to rule on the matter. The schedule must include the following details: p ersonnel resources, particularly if the need arises for consultation of permanent or ad hoc advisory b odies, hiring of consultants, need for inspection or verific ation visits and any o ther input necessary for resolv ing the matter. 2.1. Pest Risk Analysis (PRA). Phy tosanitary requirements shall be established as a result of the PRA based on the International Standards for Phy tosanitary M ea s ures (I SPM) No 2
“ Guidelines for pest risk anal ys is ” and IS PM No 11 “ Pest ris k anal ys is for quarantine pests ” (FAO /1996). The analysis shall consider the species and plant part (fruit, seed, plant, etc.), pests existing in the place of origin, biology , economic importance, internatio n ally

recognized quarantine treatments, use or d estination of the good in our country

and any other factor of phytosanitary or legislative importance. When establishing phy

tosanitary requirements, measures that en sure minimum risk and produce the minimum impact on marketing shall be considered. The Plant Quarantine Directorate shall state the need for a PRA for products and places of origin in which that anal ys is has not been performed at the time of submission of the Import Phy tosanitary Authorization (AFID I). TWO (2) scenarios are possible: a) The Plant Quarantine Directorate has the information necessary to establish the phy tosanitary requirements in a minimum period of THREE (3) months as of submission of the AFIDI request; b) the Plant Quarantine Directorate does not have the information necessary to car ry out the PRA, in which case the application submitted shall be returned to the interested party , together with a list of the in formation required to carry out this anal ys is.28 The PRA shall be carried out when the Plant Quarantine Directorate receives th e requested information from the national phy tosanitary p rotection body

o f the exporting country , and it shall have a minimum period of THREE (3) months to establish import phy tosanitary requirements. Where the products analyzed are of high risk to agricultural production, the Quarantines, Borders and Certifications Coordination Office may o rder that a quantitative Risk Anal ys is be conducted. Where, as a result of the PRA, it has been determined that the phy tosanitary c o n di tions of the country

of origin con stitute a risk for the entry of quarantine pests and/or the established risk management option(s) cannot be implemented, the Plant Quarantine Directorate shall not issue the AFIDI. 2. 2. Pest risk management options a) Recognition of “pest free areas”. The ARGENTINE REPUBLIC shall recognize “pest free areas” in third countries as established in the International Standards for Phy tosanitary Mea s ures (I SPM) No. 4 “ Requirements for the establishment of pest free areas ” (FAO/1996) or the approved Regional Phy tos anitary P rotection Sub standards of COSAVE. b) Recognition of “ system approach for pest risk management”

. The ARGENTINE REPUBLIC shall recognize this risk management option in third countries, as established in Regional Phy tosanitary Protection Stan dard 3.13 “ Guidelines for a system approach for pest risk management” COSAVE/1999. c) Recognition of “pest free places of produc tion and/or pest free production sites ”. The ARGENTINE REPUBLIC shall recognize “pest free places of produc tion and/or pest free production si tes ” in third countries, as established in International Standards for Phy tosanitary M easures (ISPM) No. 10 “ Requirements for the establishment of pest free places of produc tion and pest free production sites ” (FAO/1999). d) Recognition of “Phy tosanitary C ertification Systems” and “Equivalence Measures”. The ARGENTINE REPUBLI C shall recognize Phy tosanitary Certification Systems in third countries as established in IS PM No. 7 Export certific ation system” (FAO/1999) and equivalence measures according to Re gional Phy tosanitary P rotection Standard 3.7. “ Procedures for the approval of qu arantine treatments ” (COSAVE/ 2000) and Annexes IVo f SENASA Res o lution No. 601 dated 28 December 2001 which sets out minimum condi tions for the authorization of quarantine treatment application centres.29

Review of the Pest Risk Analysis In the event of changes to phy tosanitary c onditions in the place of origin, the discovery o f irregularities in the phy

tosanitary certification, interception of quarantine pests in ship ments from a sp ecific place of origin, deemed expiry o f phy tosanitary requirements, or ex istence of a bilateral agreement, and lack of compliance with the “ Principles of plant quarantine as rel ated to international trade ” (FAO/1995), the Quarantines, Borders and Certific ations Coo rdination Office shall establish the need for a new Pest Risk Analysis or review of the prev i ous PRA.30

Annex 3 STANDARD PROCEDURE FOR IMPORTS OF PRODUCTS, B YPRODUCTS AND/OR DERIVATIVES OF ANIMALO RI GI N AND/OR GOODS AND/OR IN PUTS WHOSE COMPONENTS CONSIST OF OR INCLUDE IN GREDIENTS OF ANIMALORIGIN 1. The approval of all import procedures shall be dependent upon THREE (3) prior condi tions being met: firstly, issuance of a favourable report by the Animal Quarantine Dire c torate that dete r

mines country

risk, product risk and destination risk in accordance with current standards, previously d etermining, based on that and other technical comp o nents, the requirements for that import; second, authorization of the slaughterhouses, manufa c turing plants and/or w arehouse of origin and/or shipment, if applicable, in acco rdance with the terms of this resolution; and, finally , registration of the product where a

pplicable. There is no deadline for meeting these THREE (3) conditions. Once these conditions have been met , the formalities will take no longer than FORTY

- FIVE (45) calendar days, barring delays attributable to the applicant. 2. In order to be authorized to enter the country , products, by products and/or derivatives of animal origin and/or goods and/or inputs who se components consist of or contain ingre dients of animal origin must have been produced in plants authorized by the competent veterin ary

and/or official sanitary

administration of the country o f origin whose processes are supervised by the latter. In case s unlike that described above that could be considered equivalent, the veterinary and/or official sanitary

administration of the exporting country

m ay b ring the case to the attention of the N A TIONAL AGRI

FOOD HEALTH AND QUALITY SERVICE [NATIONAL AGRI

- FOOD HEALTH AND QUA L ITY SERVICE] with the corresponding background information. This N ational Service shall proceed to study that case and, if applicable, to authorize the proposed pro cedure. 3. All requests for imports of products, by products and/or derivatives of animal origin and/or goods and/or inputs whose components consist of or contain ingredients of animal origin shall be sent in file form to the Mesa de Entradas y Salidas [Entry and Exit Desk] of this body

and forwarded to the Product Importation Coordin ation Office, an op erating area of the International Traffic Directorate, both of which report to the Quarantines, Borders and Certifications Coordination Office of the NATIONAL AGRI

FOOD HEALTH AND QUALITY SERVI CE. Form I ( Request for importation of produ cts, b

y products and/or derivatives of animal origin and/or goods and/or inputs whose comp o nents consist of or contain ingredients of animal origin ), which forms part of this resolution and has the status of a sworn statement , shall be used for that purpose , attaching the documentation requested in the aforementioned form in compiling the file, and indicating, among other information: country o f origin, animal species, ty pe of good, specific ation of the manufacturing establishment, official authorization number for that establis hment issued by the competent body

r ecognized by

this National Service, and its ge o graphical location. The request in que s tion to be submitted to the Entry , Exit, Archives and Public In formation Desk of this National Service shall be accompanied b y the documentation listed in the following point.31

4. When requesting approval, registration or an import permit, as applicable, for a product, by product and/or derivative of animal origin and/or goods and/or inputs whose comp o nents consist of or contain ingredients of animal origin to be imported, the importer must submit the following documentation together with Form I: a) A cop y of the product’s descriptive monograph including the following: identification of the manufac turer, official number of the establishment, animal species, brand and name of the product and name under regulatory l egislation, manufacturing technique including operational flowchart, list of ingredients including additives and manufac turing aids, quantifying the declaration where their use is restricted under current le g islation, decreasing percentage composition, shelf life and/or expiry

date, conserv ation and transport conditions, heat penetration studies in sterilized or therm oprocessed products and any o ther treatment and/or process to which the product is submitted, u s ing as a guide those described in Form II that forms part of this resolution. Submission of this documentation shall not be required for products whose operational manufacturing procedure does not extend to the processes of slaughtering, butchering, fileting, cold application and/or collection. In such cases, a descriptive declaration must be submitted stating the maintenance temperature, maturation if a

pplicable and/or shelf life of the product. b) Descriptive mono graph for the packing system, listing materials to be used as well as a description of the packaging, sealing s ys tem and weight of each unit of sale. c) Packing certificate where required under current regulations. d) TWO (2) copies of the original labels of the product to be imported when the file is opened for technical study and approval. To these should be attached TWO (2) copies of the draft complementary l abel which should provide full details on the importer, country o f origin and/or ship ment, name of the production establishment, official number of the manufacturing e s tablishment, declaration of ingredients, range of maintenance temperatures, minimum shelf life and all obligatory information that does not appear or does not appear in Spanish on the original printed label. The draft complementary

l abel shall be an exact cop y of that to be applied in the place of origin to the main label by b ox and/or by

unit when the product is destined for direct sale to the public or to the primary and/or secondary

p ackage when the product is to be used for processing. The original copies of the monograph for the product and for the packing system, de scriptive de c laration and certification of fitness of the packaging must be presented as a sworn statement signed by the resp onsible professional of the exporting company and en dorsed by the Official Sanitary

S ervice of the exporting country
. The Official Inspection Service of the country of origin of the product must confirm or identify

the following points, among others, as authorized by e quivalent systems specificall y recognized by the NA TI ONAL AGRI

- FOOD HEALTH AND QUALITY SERVICE: species or animal species of the raw materials used to manufacture the product, heat penetration studies in sterilized or heat processed products (time and temperature), maturation times, salting or other conservation process, fitness for human consumption and unrestricted marketing in the country of ori gin.32 Copies or photocopies submitted must in all cases be authenticated by the National Public Not ary . When the original documents are not submitted in Spanish, they must in all cases be translated b y a nationally certified translator. 5. Products, by

products and/or derivatives of animal origin and/or goods and/or inputs whose components consist of or c ontain ingredients of animal origin to be imported shall, ac cording to their intended use, be subjected to the following procedures for registration, if applicable, prior to their final import authorization granted by the operating area of the Quarantines, Borders and Certifications Coordination Office, as indicated: a) Products intended for human consumption or processing for subsequent human co n sumption, or for human pharmacological or organotherapeutic use, wine

- making and edible gelatins, edible fats and o ils and all those with this purpose, in addition to finished animal feed, biological products, manures and/or fertilizers with animal comp o nents, must be registered with the Dirección de Agroquímicos, Productos Farm a cológicos y Veterinarios [Agrochemicals and Pharmacological and Veterinary

Pro d ucts Directo rate]. b) Animal raw materials used in the preparation of animal feed or others for animal co n sumption with animal components shall be registered with the Dirección de Fiscaliza tion de Pro ductos de Origen Animal [Directorate for the Supervision of Products of Animal Origin]. c) Products intended solely f or industry

and not in any

w ay intended for human or animal consumption in any of their forms need not be registered. 6. Where there are amendments to the authorization in the original file, the interested party must request their incorporation into same, attaching the corresponding documentation endorsed by

the Official Sanitary

S ervice of the exporting country
. That amendment must be approved in advance b y the comp etent areas, and a new “Import Authoriz ation” to that effect shall be issued within the TEN (10) days follwoign the aforementioned a pprovals. 7. As of submission of the documentation to the Entry , Exit, Archives and Public In form ation Desk of this National Service and provided that the THREE (3) conditions set out in Point 1 have been met, the above

- mentioned body must issue a ruling in that regard within a period not to exceed TWENTY

- FIVE (45) calendar days. Where the THREE (3) conditions have been met an d SENASA does not issue a ruling within the stipulated period, barring delays not attributable to the Service, the person re sponsible for the import may s ubmit a note to the competent area of the Quarantines, Borders and Certific ations Coordination Office requesting “PROMPT CLEARANCE” of the file in que s tion. If, FIVE (5) working days after such submission, the aforementioned Service has not issued a ruling, the applicant may import the product into the national ter

ritory using the file number granted to him/her upon submission of the documentation re quested by this body

to proceed with feasibility analysis of the import authorization, attaching to the Notice of Arrival the aforementioned request for Prompt Clearance.33

8. The Import authorization for products, by products and/or derivatives of animal origin and/or goods and/or inputs whose components consist of or contain ingredients of animal origin, intended for human consumption, animal feed, indu s trial use or other purpose, shall be issued by the Coordinación de Importación de Productos [Product Importation Coordination Office], an operating area of the International Traffic Office, both of which report to the Quarantines, Borders and Certifications Coordination Office. That authoriz ation shall be valid for a period of ONE (1) ye ar. Once that period has transpired, the a

uthorization shall cease to be valid, except where health or other reasons have required its cancellation, suspension or modification prior to that time. The Quarantines, Borders and Certific ations Coordination Office issuing such authorizations has NI

NETY

- SIX (96) working hours after receiving the necessary information, and provided there are no impediments whatsoever, to issue that authorization. The sanitary , zoosanitary , quality and/or other conditions, as applicable, indicated on that import authorization, shall be identical to those that must appear on the certification of origin and/or shipment, as appl i cable, that acco mpanies the goods destined for the ARGENTINE REPUBLIC. 9. Renewals or extensions of the Import Authorization shall be issued by the competent area of the Quarantines, Borders and Certifications Coordination Office upon request to that effect by

the inte rested party, between THIRTY (30) and SEVEN (7) days prior to their expiry , with a note from the importer and cop y of the expiring “Import Authorization” that is to be renewed, according to the terms of this resolution. When such a re quest is submitted, SENASA shall make the new authorization available to the importer, provided there are no sanitary , technical, legal or other impediments, prior to the expiry

d ate. Where the ONE (1) ye ar term of the “Import Authorization” has expired and its renewal has not been requested in due time in accordance with the terms hereof, its renewal shall be subject to the time required for the technical reports by the competent areas of the Ser vice. SENASA shall officially n otify the competent sanitary

a uthorities of the country o f origin of the conditions that must be met through the corresponding model certificate, which shall be made available to users who so request. That model International Sanitary C ertificate shall be subject, together with import a uthorizations, to cancellation, suspension or amendment where necessary in the case of changes to country

/product/destination risk, expired authorization of manufacturing plants or the need to update quality o r identity

r equirements where nece s sary . A reference generic model appears as Form III, which forms an integral part of this resolution. 10. Products which, due to their characteristics, cannot be accompanied in their place of ori gin by o ne certificate per shipment and which are intended for industrial use rather than consumption

—culture media, reactants or others

-- must be accompanied by officiall y en dorsed generic approval certificates, approved monographs or documentation that SENASA, via the Quarantines, Borders and Certifications Coordination Office, deems appropriate for that purpose, to ensure their traceability

. Import authoriz ations granted in such cases shall have a term of SIX (6) months provided their characteri s tics do not change. T hese authorizations may be renewed upon request in writing fo l lowing the same administrative procedure. They s hall34

become void if, within their period of validity , there are changes to their characteristics or original conditions. The interested party bears full responsibility f or providing notification of such changes for review of the feas ibility o f issuing authoriz ation adapted to those changes. 11. SENASA shal l cancel or suspend import authorizations issued and take the sani tary and/or administrative measures it deems necessary under the following circumstances: a) Changes to the animal health status of the country of origin of the good could pose a risk to the animal health status of the ARGENTINE REPUBLIC; b) Authorization of the manufacturing establishment is revoked or suspended; c) The importer is struck from or suspended from the corresponding register; d) An injunction is ordered to that effect; e) At the discretion of the NATIONAL AGRI

- FOOD HEALTH AND QUALITY SE RVI CE, for reasons of public interest or risk that renders such action necessary

. 12. The a pproval and subsequent authorization of goods, carried out in accordance with the pre ceding points, shall be valid for so long as the health conditions of the cou ntry of origin are not altered, and provided that no other health

-related reason makes such a move necessary . All im

porters wishing to import a good already approved and registered with the body b y a third party must submit documentation to the Entry , Exit, Archives and Public Inform ation Desk that shall be forwarded to the Product Importation Coordination O f fice, an operating area of the International Traffic Directorate, both of which report to the Quarantines, Borders and Certifications Coordination Office. They s hall fill out an application for an import permit in accordance with Form IV , which forms part of this resolution and consists of a sworn statement , referring to the procedures already a pproved and authoriz ed. The relevant authoriz a tion shall be granted within a period of no more than TWENTY

- FIVE (25) calendar days. If there is a difference between the packaging monograph and the net weight of the product, the form appearing as FORM I must be filled out, and the deadline stipulated for that pu r pose shall apply

. 13. Prior to the arrival of each shipment, the importer must submit in dupl i cate to the Product Importation Coordination Office the Notice of arrival corresponding to the importation of products, by produc ts and/or derivatives of animal origin and/or goods and/or inputs whose components consist of or contain ingredients of animal origin in accordance with Form V, which forms an integral part of this resolution and has the status of a sworn statement , where that shipment is intended for human consumption in any o f its forms or animal consumption as indicated in Point 5, or with Form VI, which forms an integral part of this resolution and has the status of a sworn statement , where the products are for industri al use and not for consumption as indicated in the same point. That Notice of Arrival must be presented at least THREE (3) working days in advance of the entry

o f the good by

s ea, air, river or overland. The Office must authorize or reject that notice. It shall be returned to the applicant signed and validated, barring any impediments, within FORTY

- EI GHT (48) hours of receipt. The Notice of Arrival shall be valid for FIFTEEN (15) calendar days counted from the date of its authorization. It may b e e xtended o ne time only f or a similar period, where circum stances so warrant, with a request in writing from the importer with the original notice or copy o f same35

attached. 14. The following must be attached to the aforementioned Notice of Arrival: a) Copy of the “Import Authorization” for the product to be imported. b) Copy o f the “final labels” approved for products for human or animal consumption or labels presented for goods for industrial use (those for industrial use that are neither approved nor registered) and proof of registration and approval of label and mon o graph where applicable that identify the good and that have been approved by the comp etent area. c) At the request of the competent areas, ONE (1) copy o f the certificate of quality , anal ys is and fitness for human c onsumption, wholesomeness and/or health, as appl i cable, covering the goods, translated by a n ationally

c ertified translator where not wri tten in Spanish. d) Copy o f the certificate covering the goods for shipments by s ea and in cases in which certification is required and in which, due to the certification procedure in the country o f origin, it is not possible to obtain the above

- mentioned documentation prior to arrival of the good (e.g., air or land shipments), the importer must sub mit a copy to the Product Importation Coordination Office within TWENTY

- FOUR (24) hours fol lwoign the entry of same. 15. A Notice of arrival corresponding to the importation of products, by products and/or derivatives of animal origin and/or goods and/or inputs whose components consist of or contain ingredients of animal origin, which, like Forms V and VI , constitutes an inte gral part of this resolution, must be requested for each shipment of goods corresponding to ONE (1) truck, car, container or ship’s cargo. 16. Its hall be the responsib ility o f the importer or his or her representative to notify the SENASA In spection Service of the plant of destination and the entry land post at which the good is to arrive. That notification must be carried out by r eliable means no less than ONE (1) working day prior to arrival in the country of the goods. 17. Where the maximum validity p eriod of the Notice of Arrival (including the extension) of THIRTY (30) days has expired and the importation for which it was requested has not been carried out, the importer must return that notice to the office of the Service that i s sued it or to the land post at which it was to be presented (which shall return it to its o f fice of origin) within no more than SEVEN (7) working days counted from the day fo l lowing expiry , so that it can be removed from the list, accompanied by a n ote to that e f fect. Where non

- compliance with the foregoing is encountered, and until such time as the situation is co r

rected, the operating area shall issue no further Notices of Arrival to the company involved. 18. The original Notice of Arrival delivered to the interested party with the attached documentation as described in Point 14 of this Annex must form an integral part of the documentation presented to the land post, photocopies of which shall subs equently acco mpany the good to the establishment of destination declared on same. 19. Changes to the establishment of destination shall only b e granted prior to entry o f the36

goods with a written request from the importer attaching the original or a copy o f th e n o tice, to the Product Importation Coordination Office, an operating area of the Intern ational Traffic Office, both of which report to the Quarantines, Borders and Certifications Coo rdination Office. 20. The Notice of Arrival, whether or not it contains new information upon arrival, shall co n sist of the information requested in Point 6 of same and must be signed by the responsible party

o f the SENASA Inspection Service at the receiving plant and filed at the In spection Service as documentation for the import , in keeping with directives issued to that e f

fect by the competent areas. The relevant area shall be advised of the new information to gether with the applicable documentation and the certificate, if applicable. 21. Goods considered to be samples and describe d as such on the accompanying commercial and/or health documentation and which, due to their subsequent use (tasting, special events, technical quality anal ys is, packing, etc.), do not require prior registration, must be authorized through submission of th e Notice of arrival corresponding to the import ation of samples of products, by products and/or deriv atives of animal origin and/or goods and/or inputs whose components consist of or contain ingre dients of animal origin, which, as Form VII, is an integral p art of this resolution and subject to a sworn statement
. The goods must be accompanied by ONE (1) International Sanitary

C ertificate i s sued by

the competent authority recognized by SENASA attesting to compliance with the sani tary /zoosanitary

and or quality requirements stipulated to that effect by the above

- mentioned body , in keeping with the origin and product in question. The certi f icate must be drafted in Spanish or translated by a n ationall y certified translator. Where applicable, this National Service shall determine its subsequent destination once the basis for its importation has concluded. It is not necessary

to be registered as an importer, nor is registration and approval of a good classified as a “sample” required. The interested party must also fill out Form VIII. The processing and validity o f the notice of arrival for a sample shall be the same as those for Forms V and VI. Goods considered to be samples are ex empt from the requirement for use in plants authorized by

S ENASA, except where reason s of a sanitary or zoosanitary

nature, risk factor or other warrant official restriction of their destination to an authorized establishment, and it is the authority of this body

to so stipulate where it deems ne c essary . 22. With respect to cases covered by the preceding point, the goods in question shall in all cases be goods whose importation into the country does not involve a potential sanitary or zoosanitary

risk, which shall be determined prior to granting the entry authorization by the competent areas o f SENASA, which shall assess the zoosanitary risk involved in importing the products and issue a technical report to that effect. Under no circumstances shall the entry o f handcrafted goods, goods produced in establishments not subject to o f

ficial control or products that are not correctly identified be autho rized. The time required for the above

- mentioned "risk anal ys is" shall be similar to that required for any commercial importation. 23. Products, by

products and/or derivatives of animal origin and/or goods and/or inputs37

whose components consist of or contain ingredients of animal origin whose importation is sought for human consumption must be subject, in their country o f origin, to a Food Hygiene and Residue Control Plan equivalent to the Food Hygiene and Residue Control Plan of the ARGENTINE REPUBLIC. Acceptance of the country o f origin as an exporter of the above

- mentioned products to the ARGENTINE REPUBLIC shall be subject to approval by S ENASA of the guarantees o f

fered by that plan with respect to monito ring of the possible presence of residues of co ntaminating substances and veterinary m edicines, as well as the detection of path o genic microorganisms. In addition, and for purposes of maintaining the above

- mentioned status, the anal ytical results for the p revious ye ar obtained under the framework of that plan must be officiall y remitted during the first quarter of the ye ar. 24. All products, by

products and/or derivatives of animal origin and/or goods and/or inputs whose components consist of or contain ingredients of animal origin must enter the country a ccompanied by

ONE (1) copy

of the original International Sanitary C ertificate attes ting to compliance with SENASA requirements in matters of animal and public health and, if applicable, quality or o ther requirements, issued by the official competent autho rity of the country

o f origin recognized by

this National Service, and written in or tran s lated into Spanish by an ationall y certified translator. Onl y the options set out for compl i ance with Point 10 of this Annex shall be included as exceptions. 25. At border inspection points, personnel of the NATIONALA GRI

- FOOD HEALTH AND QUALITY SERVICE shall in all cases carry out physical, thermal (if applicable), documentary

and identity

c ontrol of goods and consistency b etween authorization and certif i cation. Lo cked vehicles, trucks, rail cars, containers, must enter the country p re sealed and will be subject to verification, upon their arrival, of the correspondence and integrity of the original bands that must appear on the certificates. This correspondence and integrity will likewise be accepted if the packages of origin ar rive sealed with numbered security b ands or other equivalent method accepted by SENASA. The certificate shall also identify the means of transport: f o r trucks, the ownership number is required; for containers, the acronymand number identification; for rail cars, identification of the car with acronym and/or number; for ships, name; and for airplanes, ai rline and flight number. Provided there are no imp ediments, the SENASA document used to authorize transport through the national territory f or entry into a nationally a uthorized establishment shall be issued, with the excep tions set out in this standard. To that document shall be attached copies of the No tice of Arrival, copies of the “Import Authorization” and of the “Final Label”, and the original(s) of the corresponding certif

i cate(s), with the original Notice of Arrival and copy of the attached documentation remaining in the possession of the land post together with a copy o f the certificates. In cases in which the goods must be transhipped at the point of entry into the country for their transfer to the establishment of destination, that transhipment must be carried out under supervision by SENASA pers onnel, and the transport must be autho rized by the competent area of this body subject to hygiene conditions suited to that purpose.38

26. The importation of products, by products and/or derivatives of animal origin and/or goods and/or inputs whose components co nsist of or contain ingredients of animal origin for which SENASA is responsible, and which are not intended for human and/or animal co n sump tion but rather exclusively f or industrial use, is subject to the same procedures as those for products intended for the food industry, with the exception of regi stration of the product, and their destination may be other than plants authorized by this National Ser

vice or p lants that do not have official authorization. In t he latter case, it shall be the responsibi lity of the plant of destination to keep all documentation relating to the impor tation on file for submi s sion to the authorities of the NATIONAL AGRI

- FOOD HEALTH AND QUALITY SER VICE upon request. This method shall apply p rovided there are no reasons of a sanit ary, t echnical or documentary

n ature that would, in the opinion of the personnel assigned to the entry post, cause the good to be prohibited, in which case the correspon ding routine procedures shall be carried out with an authorized establishment as the de stination. 27. Where the official on duty at the border notes that the goods do not meet the requirements set out by

S ENASA for import authorization, he/she shall draw up the corresponding document and refuse to authorize the import. Notwithstanding the foreg oing, where there is non - compliance with the terms of this res o lution and non - compliance with the requirements is noted, provided that public or animal health is not compromised, the Quarantines, Borders and Certifications Coordin ation Office may consider exceptions upon specific request of the i mporter. To that end, a note must be submitted to the aforementioned office where an exception is authorized, and the corresponding document must be drawn up. Entry o f the good may b e authorized as “prohibited with out rights of use”, granting a period not longer than FIFTEEN (15) day s to the importing company to correct the situation, during which p e riod the interested party shall take responsibility f or maintaining the good under the a

ppropriate conditions and covering the expenses incurred in that regard. SENASA, through the Quarantines, Borders, and Certifications Coordination Office, may m ake a final decision as to entry , change of fitness, rejection, reexportation or destruc tion of the goods. If the period set out in this point has expired and no solution has been found to the prob lem that gave rise to the prohibition, the NATIONALA GRI

- FOOD HEALTH AND QUALITY SERVICE shall decide upon the procedure to be followed, of which the importer shall be notified together with the time frame for the measure. If, once that period has expired, no action has been taken and there are no reasons of force majeure to justify

an extension, the importer shall be deemed to have aban doned the goods, in which case an order shall be given to destroy them. All forms of expenses in curred as a result of that destruction shall be for the account of the responsible firm. 28. The following, among others, shall be considered grounds for rejection: a) Lack of an International Sanitary C ertificate of origin issued by an official authority recognized b y SENASA covering the goods to be imported. b) Certification in which the sanitary requirements are not documented and in which such status suggests a potential risk to the human or animal popul ation of the country
.39

c) Lack of correspondence between what is declared on the certificate of origin and what is authorized and approved, and information with respect to identity , including thermal condition. d) Alteration of the organoleptic characteristics of the products to be imported. e) Undocumented violation of bands declared on the documentation of origin. f) Lack of identification of the band(s) in the certificate, lack of identification of the means of tran sport in those documents. g) Labels that do not correspond to those declared to SENASA and those regi s tered with and authorized by

that body

. h) Certificates not written in Spanish or lacking the corresponding translation by a certi fied translator. i) Sanitary

and zoosanitary

c ertificates covering goods that lack the official identific ation corresponding to the issuing country
. Certificates without official letterhead or proper identif i cation shall not be accepted. j) Goods with unauthorized origins. k) Failure to indicate the name of the importer in the certificate accompanying the go od. 29. The pro cedure described below shall be followed to obtain information on compliance of entry o f the goods into the establishment autho rized by S ENASA, as authorized in the Notice of Arrival Form V: a) This procedure shall apply to all operations involving the importation of pro d ucts, by products and derivatives of animal origin destined for plants supervised by SENASA. b) All land posts covered by S ENASA involved in the inspection of pro d ucts identified in Point 1 shall periodicall y inform the Quarantines, Bo rders and Certifications Coo rdination Office of such entries. c) The aforementioned Coordination Office shall provide the National Agrifood Inspe c tion Directorate with a list of plants that saw movement during the period of the report. d) The Quarantines, Border s and Certifications Coordination Office shall periodically i s sue a report for each plant, including the following information: official number of the plant, transit permit, Notice of Arrival number, date of entry into the country , animal species, description of the product, kilograms imported, land post handling the entry , country

of origin, producer and importer. e) These reports shall be sent periodicall y by the Quarantines, Borders and Certi fications Coordination Office to the supervisors of the various pl ants, who shall distribute them to the SENASA personnel present at same. f) The personnel of this National Service in each plant shall ensure that the products of which they

are informed coincide qualitatively and quantitatively

with those that have entered the plant. g) According to the results of this verification, the SENASA personnel in the plant shall in all cases produce a report entitled "New information” or “No new information” signifying, respectivel y, that there is or is not total correspondence between the pro d

ucts entering the plant and information obtained from the Quarantines, Borders and Certifications C o ordination Office. h) The National Agrifood Inspection Directorate shall take the necessary steps to40 obtain the results of this verification in each p lant, whether or not there was new inform ation, and shall advise the Quarantines, Borders and Certifications Coo rdination Office of the results within a period of no more than FIFTEEN (15) days fo l lowing the issue of the reports issued b y that coordination office. i) Where there is new information, it shall so inform the Quarantines, Borders and Certi fications Coordination Office in order that the latter might proceed to verify the accuracy of the data supplied and, if applicable, take the corresponding action

. j) Where this new information consists of entries with variations, the Quarantines, Bo rders and Certifications Coordination Office shall proceed to verify the data pro vided by

the land posts, according to the importance of same, correcting the incorrect data in the databases where applicable. k) Where plant personnel provides information on new destinations, the Quarantines, Borders and Certifications Coordination Office shall proceed to record that new in formation in the databases. l) Inc ases in which entries through border points are found not to have arrived at the plants declared by

the importers, the Quarantines, Borders and Certifications Coordination Office shall institute the legal proceedings necessary and advise the National Agrifood Inspection Directorate of this situation. m) Where goods not reported by the Quarantines, Borders and Certifications Coordin ation Office have entered the plant, the latter shall proceed to determine why the plant was not advised thereof. 30. Import authorizations granted prior to the entry into effect of this resolution shall b e come void according to the following schedule.

Date of issue Expiry d ate (expre ssed in days following the entry into effective of this resolution) 1993

- 1996 SIXTY (60) days 1997

- 1999 NI NETY (90) days 20 00

- 2001 ONE HUNDRED AND TWENTY (120) days 2002 Calendar ye ar 31. For the renewal of “import authorizations” issued prior to the entry into effect of this resolution, companies must present a copy o f same no less than TWENTY (20) days prior to expiry, so as to proceed with their renewal, and must turn in the original authorizations when the corresponding renewals are issued. 32. Authorization notes issued as of the entry into effect of this standard shall be drawn up in accordance with the model appearing as For m IX of this resolution. 33. The NATIONAL AGRI

- FOOD HEALTH AND QUALITY SERVICE may request commercial documentation from importers or any other documentation accompanying a shipment, where it is necessary to verify data or the uniformity

thereof.41

34. Skins and t anned leathers and goods or clothing manufactured from same shall be e x empt from this Annex. Skins or tanned leathers (except manufactured goods and goods derived from same or clothing) from species susceptible to transmissible spongiform encephal opathies from countries affected by these diseases, must only b e accompanied by

a f avour able report prior to their importation of the Animal Quarantine Directorate, which shall be obtained from the Product Importation Coordination Office with a note from the intere sted party indicating the intended use and attaching all the accompanying documentation or that which SENASA deems relevant. Once the Animal Quarantine Dire c torate has made a decision, the operating office shall have FORTY

EI GHT (48) hours to notify the us er. Processed seashells and/or sea sponges or products manufactured from them are exempt from this Annex. Any

o ther manufactured good with these characteristics that does not pose a sanitary

or zoosanitary

risk may also be exempted. 35. Cessation of use b y on e importance in favour of another is prohibited. 36. Notices of arrival shall be subject to a charge of TEN PESOS ($ 10.

- ) each, in accordance with Resolution No. 670 dated 11 October 2000 of the former MI NI STRY OF AGRI CULTURE, LIVESTOCK, FISHERIES AND FOOD. 37. All goods with animal components that, following enactment of this standard, fall under the purview of the Quarantines, Borders and Certifications Coordination Office, shall adhere to this procedure, except where higher standards (e.g., SOUTHERN COMMON MARKET OR OTHER) require a specific procedure.42

Annex 4 APPLICATION AND ISSUING PROCEDURE FOR PHYTOSANITARY IMPORT AUTHORIZAT ION (AFID I) Phy tosanitary import authorization (AFIDI) Before any plants, plant parts, products, b yproducts and derivatives, organic growth and/or sustenance media and soil conditioners may be brought into the country for commercial purposes, application must be made to the Plant Quarantine Directorate for phy tosanitary import authorization (AFIDI) . The AFIDI sets out the plant

-health requirements for imports. Products for which an AFIDI is required An AFID I is required for all products whose level of phytosanitary risk places them in categories 2, 3, 4 and 5 of COSAVE Standard 3.15 (“Harmonization of phy tosanitary measures b y way of entry” (v2)

– not required for categories 0 and 1). AFID I application form A separate AFIDIapplication form must be submitted for each product to be imported. For AFIDI purposes a product is defined according to the following parameters: botanical genus and species, plant part (fruit, foliage, bulb, plant, seed, etc.), country o f origin, intended use (consumption, propagation, etc), form (natural, cutting, pellets, etc), packaging (boxes, bags, etc.), means of shipment and point of entry into the cou

ntry
. There are four different AFIDI application forms, depending on intended use: (1) products for consumption, industrial use or processing; (2) propagating material; (3) seeds for laboratory use; and (4) peat. A model of each of these forms can be f ound at the end of this Annex. Copies of these forms may be used. Application forms must be submitted with all requisite information duly entered. When an application is submitted to import seed for laboratory u se, the back of the AFIDI form must be comp leted (information on quantity o f seed, testing to be performed, and laboratory

where work is to be done). In the case of asexual propagating material, ex cept ornamentals, the AFIDI application must be accompanied by

a n application for approval of the qua rantine facility

. Such material must meet the requirements set forth in Resolutions SAGPy A N° 292/92 for General Post

- Entry Quarantine and SENASA N° 69/99 for post

- entry quarantine of grapevines. Where to submit AFIDIapplication43

AFIDIa pplication forms must be submitted in person, by mail or by

f ax to the Plant Quarantine Directorate (DCV) of SENASA, Mondays to Fridays from 09:00 to 13:30. Address: Paseo Colón N° 367, Piso 7°, (1063) Ciudad Autónoma de Buenos Aires Fax: (011) 4342

- 5137. AFIDIissue and delivery

times Where a file has already

b een opened in the AFIDI s ystem for the product/origin, the Plant Quarantine Directorate will issue the AFIDIwithin five business days. Otherwise, a pest risk analysis must be carried out in accordance with Annex II of this resolution. Those who reside, or have a representative, in the city of Buenos Aires may

p ick up an AFIDI original (no copy

) at the Plant Quarantine Directorate at the SENASA head office, Mondays to Fridays from 09:00 to 13:30. Others may f ax or mail their request, indicating the fax number or address to which the AFIDIi s to be sent. When the AFIDIi s sent by f ax, the Plant Quarantine Directorate will simultaneously s end the original to the SENASA local office at the point of entry

. Submission of AFIDI The importer must submit a copy o f the AFID I to the National Plant Protection Organization of the exporting country , so that it can certify c ompliance with the phy tosanitary requirements. Inc ases where it is necessary to carry out laboratory

an alysis, crop inspections, etc, beforehand, the requirements should be reported to the exporting country with sufficient lead time prior to shipment of the products. The original of the AFIDImust be shown at the point of entry o f the goods , along with the phy tosanitary c ertificate from the country o f origin. The inspector at the point of entry will ensure that the AFIDI ’s phy tosanitary requirements appear in the phy tosanitary certificate as “additional declarations .” He will also take samples for laboratory a nal ys is to confirm the absence of quarantine pests. In c ases of high

-value germ plasm imported in small quantities for experimental purposes, the Plant Quarantine Directorate may, at the request of the importer, waive the taking of samples. In t his cas e, the AFIDI application must be accompanied by

a note specify

ing the test to be carried out and a sworn statement by t he importer that the material is to be imported for experimental purposes. Depending on the case, the material will be subject to the post
- entry quarantine process. AFIDIvalidity

period The validity

p eriod is variable, depending on the proposed use of the plant product to be imported. Inthe case of products for consumption, peat and seed for laboratory u se: TWO months; for propagation: NI NE months. Inthe latter case, a specific quantity o f material will be authorized, which may be imported at different times with the same document, until the full amount is reached and until the expiry date.44

Unauthorized use of products In the case of products that enter the country f or consumption, industrial or processing purposes, but whose botanical and physiological characteristics make them usable for propagation (bulbs, seed, tubers, etc.), the AFIDIa pplication form must be accompanied by a sworn statement regarding the use to be made of the product. A model statement appears at the end of this annex. The penalties for unauthorized use of the product are set forth in Decree Law 6704/63 and Decree 2266/91. Fees Resolution SAGPy

A N° 782 (19 99

- 11

- 23) prescribes the fee to be charged for the AFIDI. Conditions of pay

ment:

- Pay ment may be made at any

branch of the Banco de la Nación Argentina or at the SENASA head office, Paseo Colón N° 367, Planta Baja, Ciudad Autónoma de Buenos Aires .

- Pay ment must be made by

means of deposit slip (blank) to account 2864/24

–Plaza de Mayo branch

– SENASA 50/623 RECAUDADORA F.12

- The fee code must be entered on the deposit slip. The codes are as follows:

DIRECTORATE CODE DESCRIPT ION UNIT OF MEASURE

MENT DUTY PER UN IT Plant Quarantine Directorate 123

-A AFIDI for products for co n sumption or industrial use (commercial cargoes, mail, passengers, etc.) ONE per plant species (valid for 60 days) $ 12.

- (for each 60 tons

or fraction thereof). For wood $12.

- (for each 6 0 m3 or fraction thereof) Plant Quarantine Directorate 150 AFIDI for propagating material for commercial, experimental or official

agency use (commercial cargoes, mail, passengers, etc.) ONE for AFIDI General Service* $ 102.

- for AFIDI

General Service on each customs clearance (regardless of number of AFIDIs)

- It is not necessary

to make any

pay ment when requesting the AFIDI.

- AFID Is for products for consumption will be valid for SIXTY days and no quantity will be specified therein.

- The AFID I will cover partial pay ments (inward customs clearance), so that the same AFID I may

b e used for any

number of shipments within the validity period specified in the issued AFIDI.

- The fee must be paid upon arrival of each import shipment, i.e. TWELVE PESOS ($12.

- ) for eac h SIXTY tons or fraction thereof; or, in the case of wood, for each45

SIXTY CUBI C METERS (60 m3) or fraction thereof, according to the number of tons/m 3 imported in each shipment.

- Stub 3 (AFIDI fee payment) must be presented to the SENASA inspector processin g the import shipment. The inspector will put the stub and the original of the AFIDIin the first file opened and will seal and put the file number initiated on an authenticated photocopy

o f the AFIDI, which must be presented at the time of arrival of the next shipment of the same ty

pe of goods, together with the new pay ment stub. The validity period is SIXTY days.

- The AFIDI fee for propagating material is ONE HUNDRED TWO PESOS ($102.

- ) and c o rresponds to general AFID I service for each shipment, regardless of the number of AFID Is issued.

- In the case of propagating material, the amount to be imported must be specified. The AFID I issued may

b e used for partial receipts of the goods, i.e. it may b e used for one or more shipments during the validity period speci fied in the AFIDI issued. The AFID I will be valid for NINE months.

- Stub 3 (pay

ment of AFIDIf

ee of ONE HUNDRED TWO PESOS) must be presented to the SENASA inspector processing the import shipment, which may include one or more species. The inspector will put the stub and the original of the AFIDI in the first file opened and will seal and put the file number initiated on an authenticated photocopy of the AFIDI, which must be presented at the time of the next shipment of the same ty pe of goods, together with the new pay ment stub. The AFID I will be valid for NI NE months.

- Each month the local office must send the Plant Quarantine Directorate photocopies of the pay ment stubs received, in which the corresponding AFIDI numbers are entered, so that the Directorate c an create its own file.

- No processing will be done without proof of pay ment (Stub 3).

- If pay ment is made by

c heque, the cheque must be made payable to account 2864/24

– Plaza de Mayo branch

– SENASA 50/623 RECAUDADORA F.12, or to the BANCO DE LA NACION ARGENTINA, with the following note on the back of the cheque: “For deposit to account 2864/24

–Plaza de Mayo branch

– SENASA 50/623 RECAUDADORA F.12”.