# Presentation: 525448

***Audits*** – *VERIFYING EQUIVALENCE*

**Presented by :**
**Donald Smart **
**Office of International Affairs**
**Food Safety and Inspection Service**

## INTRODUCTION

- 	Meat, Poultry and egg products imported into the United States must achieve the same Appropriate Level of Protection (ALOP) as products produced in the United States.

## INTRODUCTION

**FSIS regulations provide the authority and basis for conducting audits of foreign inspection systems.**
**Requirements center around five risk areas of a foreign country’s inspection system controls:**
**Animal Disease Controls**
**Sanitation Controls**
**Slaughter/Processing Controls**
**Residue Controls**
**Government Oversight/Enforcement**

## SYSTEMS AUDIT

- FSIS achieves this regulatory responsibility by conducting a _systems audit_ to evaluate an exporting country’s inspection system controls.
- FSIS works directly with each foreign country’s inspection management officials in our “government to government” approach.

- Systems audits represent one-third of FSIS’ triad of protection.

-    TRIAD APPROACH

## AUDITS  

*Systems Audits* help verify that a country is maintaining equivalence and achieving the ALOP of the United States.

## AUDITS  

*          **CURRENT PROCESS*

## AUDITS - Current

**Audits are conducted on an annual basis.****  **
**A****udits have two principle sub-elements:**
**I****n-country evaluation**
**Out-of-country evaluation**** **

## AUDITS - Current

- 	_**In-Country Evaluation**_** **
**Standardized approach of verifying a country’s competent authority’s implementation and oversight of its food safety system****.**
**Includes a review of establishments certified to export to the U.S., government offices providing enforcement activities, and laboratories performing analytical testing.**

## AUDITS - Current

- 	_**In-Country Evaluation**_** **
**Assignment of countries is rotated among auditors.**
**More than one auditor can, and is, used for countries with a larger population of establishments certified to export to the U.S.**

## AUDITS - Current

_**Out-of-Country Evaluation**_
**	****Before conducting an in-country evaluation, the auditor reviews and analyzes the following information:**
**Prior audit results for the past three years.**
**Types and amount of products exported to the U.S.**
**Port-of-entry reinspection results. **
**Consumer Complaints.**

## AUDITS - Current

**(continued)**
**Third country audit results (e.g., EU).**
**APHIS restrictions.**
**Equivalence determinations since last audit. **
**Other information relevant to the country.**

## AUDITS - Current

**The information that the auditor has collected is used as a basis to determine the **_**scope**_** of the audit.**
**Combination of statistical chart, history, and other available information to determine the number of establishments.**
**Evaluation of available data to determine number of laboratories and degree of government oversight/enforcement.**

## AUDITS 

***FUTURE PROCESS***

## AUDITS - Future

**Exporting countries do not need to be audited in the same manner or frequency to verify continuing equivalence.****  ****This is based on:**
**Countries are not the same with respect to the degree of inspection system controls;**
**FSIS’ level of confidence in a country’s ability to maintain an equivalent system can vary from one country to another.**

## AUDITS - Future

**	****FSIS is examining different ways to verify that a country is maintaining an equivalent system:**
**Audits could be carried out either during a visit to the exporting country or a desk audit, or a combination of both.**
**Both desk audits and in-country audits would emphasize system controls.**

## AUDITS - Future

**Some countries have the ability to provide FSIS with information/data regarding their inspection activities and other system-control measures on a continuous basis (365-day audit aspect)**
**FSIS believes it can use this information to supplement evaluation of the activities & effectiveness of foreign inspection programs.**

## AUDITS - Future

**A standardized approach that must be objective-based.**
**FSIS would verify accuracy of the information provided during the on-site audit activity.**

## AUDITS - Future

**The scope and timing of an on-site verification audit for any country will consider:**
**Volume of product shipped to the U.S.**
**Types of product shipped and the associated risk.**
**All available historical information.**
**Analysis of information provided by country.**

## AUDITS - Future

**Some factors that FSIS is considering:**
**What types of information should FSIS ask a country to provide on an ongoing basis?**

## AUDITS - Future

**Some factors that FSIS is considering:**
**Should the length of time between **
**   ****on-site audits vary according to compliance history?**

## AUDITS - Future

**Some factors that FSIS is considering:**
**Should the scope of on-site audits vary according to compliance history?**

## THANK YOU