What is Equivalence?

Equivalence is the process of determining whether a country’s food safety inspection system achieves the Food Safety and Inspection Service's (FSIS) appropriate level of public health protection as applied domestically in the United States (US).  Additionally, the foreign food safety inspection system is to provide standards equivalent to the FSIS to ensure other non-food safety requirements (such as humane handling, accurate labeling, and assurance that meat, poultry, or egg products are not economically adulterated) are met.  This means that the country is not required to develop and implement the same procedures that the US does, but rather the country must objectively demonstrate how its procedures meets the US level of protection. Countries wishing to become eligible to export meat, poultry, or egg products to the US must demonstrate that they have a regulatory food safety inspection system that is equivalent to that of the US.

Equivalence Background

Determining equivalence of a country’s food safety inspection system is important because it protects public health and facilitates trade. An equivalence determination of an exporting country’s regulatory food safety inspection system for meat, poultry, or egg products is a prerequisite for trade for the United States Department of Agriculture's  (USDA) FSIS.  USDA-FSIS is the US central competent authority (CCA) responsible for regulating and inspecting meat, poultry, and egg products. FSIS implements an equivalence process to make an equivalence determination to ensure that US treaty obligations under the World Trade Organization’s (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) are met. The SPS Agreement sets out the basic international rules for food safety, animal, and plant health standards. FSIS ensures during the equivalence process that the following SPS Agreement standards are met through the implementation of the following principles: science, risk assessments, transparency, harmonization, and equivalence.

To ensure that meat, poultry, or egg products (including imported products) do not pose any public health risks to US consumers, FSIS implements the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), Egg Products Inspection Act (EPIA), Humane Methods of Slaughter Act (HMSA), and regulations under Title 9 Code of Federal Regulations (CFR) Parts 300-590. FSIS ensures that a country’s food safety inspection system addresses FSIS’s food safety regulatory-based objectives. Food safety regulatory-based objectives are food safety goals for preventing the occurrence of an identified food safety hazard. 

The criteria by which FSIS assesses the equivalence of a country’s food safety inspection system can be found under Title 9 CFR §327.2 (for meat products), §557.2 (for fish of the order Siluriformes products), §381.196 (for poultry products), and §590.910 (for egg products).  

Countries wishing to request an initial equivalence determination in order to export fish of the order Siluriformes to the US can find information in the initial equivalence process section, and information about exporting Siluriformes fish under Additional Resources. 

Types of Equivalence Determinations

There are four (4) types of equivalence determinations: (1) Initial Equivalence, (2) Ongoing Equivalence Verification, (3) Reinstatement of Equivalence, and (4) Individual Sanitary Measure.
 

The Equivalence Process

The following sections on initial equivalence, ongoing equivalence verification, reinstatement of equivalence and individual sanitary measure breaks down FSIS’s equivalence process steps to make an equivalence determination.

Initial Equivalence

The following six (6) process steps briefly outline how an initial equivalence determination is made for a country wishing to export meat, poultry, or egg products to the US for the first time.

1. Country Submits Written Requests to FSIS
2. Document Submission Through Self-Reporting Tool (SRT)
3. Document Review
4. On-site Verification Audit
5. Public Notification Proposed Rule in Federal Register
6. Final Determination of Equivalence Final Rule in Federal Register

The SRT is a questionnaire that provides an organized means for the country’s government to demonstrate that its inspection system achieves an equivalent level of protection as applied domestically in the US.

The SRT is arranged into six (6) components:

1. Government Oversight (e.g., Organization and  Administration)
2. Government Statutory Authority and Food Safety and Other Consumer Protection Regulations (e.g., Inspection System Operation, Product Standards and Labeling, and Humane Handling)
3. Government Sanitation
4. Government Hazard Analysis and Critical Control Point (HACCP) System
5. Government Chemical Residues Testing Programs
6. Government Microbiological Testing Programs

For more information on the SRT and initial equivalence process, please refer to Additional Resources.

Ongoing Equivalence Verification

FSIS will continuously evaluate and verify the equivalence of an exporting country’s food safety inspection system through a three (3) part process: (1) document reviews, (2) on-site audits, and (3) point-of-entry reinspection of meat, poultry, and egg products.

Part 1- Document Reviews

Countries are to submit the following for review at least annually by May 18^th:

1. Either (1) updated SRT responses, or (2) communicate to FSIS that the Central Competent Authority (CCA) has verified its SRT responses, as recorded in FSIS’s Public Health Information System (PHIS) (i.e., by reviewing the SRT electronically in PHIS) or by mailed hard copy of the version of SRT responses FSIS has entered for the CCA, are accurate and complete.
2. An up-to-date list of all certified establishments eligible to export meat, poultry, or egg products the US.
3. An updated government residue control program, including the previous year’s residue test results and reactions to residue findings.
4. Updated government microbiological sampling and testing programs, including the previous year’s test results and reactions to (A) indicator organism results for intestinal or fecal contamination; (B) Salmonella and Campylobacter results for raw meat and poultry products; (C) Listeria monocytogenes, Salmonella, or other pathogens of public health concern in ready-to-eat (RTE) meat and poultry products and all lots of pasteurized egg products; and (D) shiga toxin-producing Escherichia coli (STEC) in raw beef products.

Part 2 - On-Site Audits

FSIS will periodically conduct an on-site audit of every eligible country’s food safety inspection system to verify whether the country continues to maintain an equivalent inspection system.
 

Part 3-Point of Entry Reinspection

All imported shipments of meat, poultry, and egg products that enter the US are presented to FSIS for reinspection. FSIS checks every imported shipment for eligibility, certification, transportation damage, and labeling. The purpose of point-of-entry reinspection is to monitor the effectiveness of an eligible exporting country’s food safety inspection system, not to assess the performance of an individual certified establishment.

For more information about ongoing equivalence verification, please refer to Additional Resources.

Reinstatement of Equivalence

The following five (5) process steps briefly outline how a reinstatement of equivalence determination is made when a country wants to start exporting meat, poultry, or egg products again to the US.

1. Country Submits Written Requests to FSIS
2. Document Submission through SRT
3. Document Review
4. On-Site Verification Audit (may or may not be needed)
5. FSIS Notifies Country of Equivalence Determination Through a Formal Letter (no rulemaking is necessary)

Note: Rulemaking steps are not applicable for countries seeking to reinstate equivalence, because their food safety inspection systems have already been determined to be equivalent.

For more information on reinstatement of equivalence, please refer to Additional Resources.
 

Individual Sanitary Measure

Eligible countries currently exporting meat, poultry, or egg products to the US request an individual sanitary measure when they want to change a procedure in their food safety inspection system. There are two (2) reasons an eligible country requests an individual sanitary measure equivalence determination.

1. The country wants to make a change to a procedure in its food safety inspection system that FSIS previously determined was equivalent.
2. FSIS has updated its US domestic food safety procedures or requirements and identified that the procedures or requirements affect previous equivalence determinations for specific eligible countries.

The following four (4) process steps briefly outline how an individual sanitary measure equivalence determination is made:

1. Country Submits Written Request to FSIS
2. Document Submission Through SRT
3. Document Review
4. FSIS Notifies Country of Its Individual Sanitary Measure Equivalence Determination Through a Formal Written Letter.

For more information on individual sanitary measures, please refer to Additional Resources.

The attached document contains a list of countries with significant, non-routine finalized individual sanitary measures.

Equivalence Processes

Resources that explain the process to determine initial, reinstatement, and ongoing equivalence, and to assess individual sanitary measures.

• Guideline for Countries on the Food Safety and Inspection Service’s Equivalence Process 
• The FSIS Equivalence Process 
  FSIS PowerPoint presentation that provides an overview on what equivalence is, the types of FSIS equivalence determinations, and an overview of the equivalence process.

Additional Resources

Resources that provide countries with information to obtain level 2 eAuthentication credentials for access to FSIS’s Public Health Information System (PHIS), and submitting a Self-Reporting Tool (SRT).

• 2019 Self-Reporting Tool (v.2019-001)
  Contains questions regarding regulatory-focused food safety objectives that reflect the equivalence criteria used by FSIS to determine whether a country’s documented food safety inspection system is equivalent to the U.S. system.
• Steps to Obtain Level 2 eAuthentication Credential and PHIS Access
  Provides step-by-step instructions on how the designated Central Competent Authority (CCA) official can obtain level 2 eAuthentication credentials and request access to FSIS’s PHIS.
• How to Complete and Submit the SRT Using the PHIS 
  This FSIS PowerPoint presentation provides click-by-click instructions to obtain level 2 eAuthentication credentials for access to PHIS, as well as how to submit a SRT in PHIS.
• FSIS Guidance for a Suggested Reporting Table for the Certified Establishment List 
• FSIS Guidance for Suggested Reporting Tables of the Government Residue Control Program 
• FSIS Guidance on Suggested Reporting Tables of the Government Microbiological Sampling and Testing Program
• Summary of FSIS Government Residue Control Program Frequencies
  Provides a summary of the sampling frequency of FSIS government chemical residue testing, including links to the U.S. National Residue Program (NRP).
• Summary of FSIS Government Microbiological Sampling Programs Frequencies 
  Provides a summary of the sampling frequency of FSIS government microbiological testing, including a link to the current FSIS Annual Sampling Plan.
• FSIS Responses to the SRT (v2019-001)
  Provides a model with FSIS’s responses to the SRT that illustrates the level of detail FSIS needs in foreign country SRT responses to determine whether a country’s food safety inspection system achieves an equivalent level of sanitary protection.
• Food Safety Equivalence and Inspection Seminar
  FSIS hosted webinar held September 13, 2016 in Washington DC on the Self-Reporting Tool (SRT) / Overview and the Public Health Information System.
• Importing Products
  FSIS is responsible for assuring that US imported meat, poultry and processed egg products are safe, wholesome, unadulterated, and properly labeled and packaged.
• Guidebooks and Methods
  These guidebooks contain current protocols for analytical tests required by FSIS regulatory activities on meat, poultry and processed egg products. They include Microbiology Laboratory Guidebook, Chemistry Laboratory Guidebook, and Pathology Laboratory Guidebook.

All communications concerning equivalence should be directed to the Office of International Coordination (OIC). Communication must come from the country’s government’s Central Competent Authority (CCA). Please address correspondence to:

United States Department of Agriculture
Food Safety and Inspection Service
Office of International Coordination
1400 Independence Avenue, SW
Room 3143, South Building
Washington, DC 20250
Phone: (202) 708-9543 
Fax: (202) 690-3856
E-mail: InternationalCoordination@usda.gov