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PROCESS FOR EVALUATING THE EQUIVALENCE OF FOREIGN MEAT AND POULTRY FOOD REGULATORY SYSTEMS International Policy Division Food Safety and Inspection Service U.S. Department of Agriculture Washington, DC. Introduction.
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PROCESS FOR EVALUATING THEEQUIVALENCE OF FOREIGNMEAT AND POULTRYFOOD REGULATORY SYSTEMSInternational Policy DivisionFood Safety and Inspection ServiceU.S. Department of AgricultureWashington, DC
Introduction • This presentation explains the evaluation process FSIS applies to make equivalence judgements • Meat and poultry exported to the U.S. must meet all FSIS requirements 1
Introduction • Process implements regulations that require the evaluation of foreign inspection systems • Agency regulations set forth specific evaluation criteria for making equivalence judgements 2
Introduction • Under international law exporting countries may employ measures that differ from those used by importing countries • Exporting countries can employ either the same or equivalent sanitary measures to obtain the same level of protection established by the importing country 3
Background • Food safety equivalence judgements are based on the provisions of the SPS Agreement • U.S. bound as a signatory 4
Background • Article 4.1 of the SPS Agreement: • Members shall accept the sanitary…measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary…protection 5
Background • Exporting country has the burden to demonstrate equivalence • Importing country has the right to decide if a foreign inspection system is: • Equivalent • Inadequate to achieve its appropriate level of protection • Unable to adequately demonstrate equivalence 6
Background U.S. Laws and Regulation • FSIS regulations amended to reflect “equivalent to” as the standard for eligibility • Criteria for evaluating foreign systems are set forth in the regulations • Each criterion constitutes a sanitary measure as defined in the SPS Agreement 7
Concepts of Equivalence Sanitary Measures • Sanitary measures must be based on scientific principles and applied in a non-arbitrary non-discriminatory manner • Sanitary measures must be based on an assessment of the risk from a food safety hazard 8
Concepts of Equivalence Appropriate Level of Protection • Importing country may set any level of protection it deems appropriate 9
FSIS Equivalence Process Introduction Series of cooperative steps between importing and exporting countries regarding equivalence determinations: • Importing country provides notice of a particular sanitary measure • Exporting country requests an explanation of the appropriate level of protection 10
FSIS Equivalence Process Introduction • Importing country provides an explanation by stating the FSO • Exporting country develops a case for equivalence • Importing country evaluates and: • finds that the difference sanitary measure is equivalent • requests more information • rejects the equivalence of the different sanitary measure 11
FSIS Equivalence Process Initial System Eligibility • Foreign inspection systems must be equivalent before they can export • The initial evaluation includes a document review and on-site review • After a country is determined to be equivalent it certifies establishments that meet U.S. requirements 12
FSIS Equivalence Process Three-part Process 1. Document Analysis • Fundamental laws, regulations, policies • Food production requirements • Regulatory oversight, verification and enforcement requirements 14
FSIS Equivalence Process Three-part Process 2. System Audits • Annual • Evaluate foreign inspection system • Determine that sanitary measures provide the same level of protection • Focus on process control and government oversight • Audit plan developed 15
FSIS Equivalence Process 2. System Audits • Auditor examines records, foreign oversight of establishments, laboratories • Post audit evaluation: advise country of equivalence issue, track issues • Prepare audit report 16
FSIS Equivalence Process Three-part Process 3.Port-of-entry Reinspection • Reinspection of random samples • Automated centralized computer database • Performance based • Compliance histories continuously updated • All shipments checked for damage,labeling, certification and general condition 17