# Presentation: 525449

## PROCESS FOR EVALUATING THE EQUIVALENCE OF FOREIGN MEAT AND POULTRY FOOD REGULATORY SYSTEMS

- Sally White, JD
- Director
- International Equivalence Staff
- Office of International Affairs
- Food Safety and Inspection Service

## Introduction

- FSIS employs a comprehensive three-part approach for imports that helps to ensure the safety of imported product.

- Equivalence represents one-third of FSIS’ triad of protection.

-    TRIAD APPROACH

## Background

- Imported meat and poultry products must meet _**all**_ safety standards applicable to similar products produced in the United States.

## Background

- In doing so, foreign meat and poultry food regulatory systems may apply *equivalent *sanitary measures to eliminate or abate food safety hazards if those measures provide the *same *“level of public health protection” achieved by U.S. measures.

## Background

- The concept that different sanitary measures can achieve the same level of protection is called _**equivalence**_.

## Background

- International food safety equivalence is a concept introduced by the *Agreement on the Application of Sanitary and Phytosanitary Measures, *or the* “*SPS Agreement.”

## Background

- If an exporting country objectively demonstrates that its sanitary measures achieve the levels of protection set domestically by an importing country, the importing country is obliged to accept the exporting country’s measures as equivalent.

## Concepts of Equivalence

*Equivalence:* Equivalence is the state wherein sanitary measures applied in an exporting country, though different from the measures applied in an importing country, achieve, as demonstrated by the exporting country, the importing country’s appropriate level of sanitary protection.

## Concepts of Equivalence

*Sanitary Measure:* Any measure applied:
- to protect animal life or health from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms;
- to protect human or animal life or health from risks arising from additives, contaminants, and/or toxins.

## Concepts of Equivalence

*Sanitary Measures*
- Sanitary measures _**must**__ _
- be based upon scientific principles and
- be applied by an importing country in a manner that is not arbitrary and would not unjustifiably discriminate between its own industry and that of another country.

## Concepts of Equivalence

*Appropriate Level of Protection (ALOP)*
- Importing countries may set any level of protection they deem appropriate and establish sanitary measures accordingly to eliminate or abate food safety hazards.

**Notes:**
While sanitary measures must be based objectively on scientific or technical knowledge about controlling food safety hazards, an importing country’s level of protection is a societal choice of what is deemed appropriate.

## FSIS Equivalence Determinations

- FSIS works on a government to government basis.

## FSIS Equivalence Determinations

- The requirements for a government inspection system are outlined in the *Code of Federal Regulations*.

## FSIS Equivalence Determinations

- FSIS makes two different types of equivalence determinations:
_**Initial System Equivalence**_: to initially determine whether a foreign food regulatory *system *is equivalent in the case of a country that is not presently eligible to export meat or poultry products to the United States

## FSIS Equivalence Determinations

_**Individual Sanitary Measures**_: to determine whether an *individual sanitary measure *is equivalent in the case of a country that has already established its equivalence and is requesting that FSIS recognize an alternative method of eliminating or abating a particular food safety hazard

## Initial System Equivalence

- Any government can apply for eligibility to export meat or poultry products to the United States.

**Notes:**
Initial equivalence evaluations of foreign meat and poultry food regulatory systems are a prerequisite for trade. 

Normally, the application process begins with a letter to FSIS from a foreign government asking for approval to export its products for sale in the United States.

FSIS responds to these letters with a standard package that contains:
Initial Equivalence Questionnaires 
Copies of pertinent U.S. laws, FSIS regulations, and other documents

## Initial System Equivalence

- FSIS begins the process of determining equivalence by analyzing the applicant’s meat and/or poultry regulatory system with a ***document analysis****.*

**Notes:**

The document analysis is performed to assess whether the country has the laws, regulations, and an infrastructure to support an equivalent system. 

## Initial System Equivalence

- Upon completion of the document analysis step, FSIS decides whether the foreign food regulatory system documentation:
- (1) meets all U.S. import requirements in the same or an equivalent manner, and
- (2) cumulatively provides the *same *level of public health protection attained domestically.

## Initial System Equivalence

- If this step is satisfactorily completed, FSIS plans an on-site audit of the entire foreign meat and/or poultry food regulatory system.

**Notes:**
Initial equivalence audits are conducted by a team of experts.

The audit scope includes:
Interviews at all levels inspection oversight
Laboratories
Selected establishments

The goal of an initial equivalence audit is to verify that the foreign food regulatory system has satisfactorily implemented all the country laws, regulations, and other inspection or certification requirements that FSIS found to be equivalent during the document analysis step. 

In some cases, more than one on-site audit may be required to fully verify system equivalence.

## Initial System Equivalence

- When both the document analysis and on-site audit steps have been satisfactorily completed, FSIS publishes a proposed rule in the *Federal Register *that announces results of the first two steps and proposes to add the country to its list of eligible exporters in the Code of Federal Regulations.

## Initial System Equivalence

- Upon receipt of public comments, FSIS makes a final decision about system equivalence based upon all available information and—if favorable—publishes a final rule in the *Federal Register *announcing country eligibility.

## Initial System Equivalence

- Once a country is determined to be equivalent:
- The foreign government must submit a list of certified establishments
- All imported products are placed on 100% POE re-inspection for one year
- Audit is scheduled prior to the first shipment

## Alternative Sanitary Measures

- Document Analysis
- Measures are verified on-site during the next scheduled audit.

## Future Initiatives

- Objective outcomes
- Hazard levels, e.g., pathogens
- Risk levels, e.g., foodborne illnesses
- 	What hazards or risks are appropriate for evaluating equivalence of a system or measure?

## 

THANK YOU

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