The harmonization of laws, regulations and standards between and among trading partners is important to food safety and requires intense, complex, time-consuming negotiations by CFSAN officials. Harmonization must simultaneously facilitate international trade and promote mutual understanding, while protecting national interests and establishing a basis to resolve food issues on sound scientific evidence in an objective atmosphere. Failure to reach a consistent, harmonized set of laws, regulations and standards within the free trade agreements and the World Trade Organization Agreements can result in considerable economic repercussions.
Codex Alimentarius Commission
The Codex Alimentarius Commission (CAC), created in 1963, is an intergovernmental body with over 170 members within the framework of the Joint Food Standards Programme established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). The Commission’s purpose is to protect the health of consumers and to ensure fair practices in the food trade. It also promotes coordination of all food standards work undertaken by international governmental and non-governmental organizations.
The Codex Alimentarius, a result of the Commission's work, is a collection of internationally adopted food standards, guidelines, codes of practice and other recommendations and is the major international mechanism for encouraging fair international trade in food while promoting the health and economic interest of consumers.
Systems recognition, previously referred to as comparability, involves reviewing a foreign country’s food safety regulatory system to determine if it provides a similar set of protections to that of FDA. Outcomes of these reviews may be used by FDA to make risk-based decisions regarding foreign inspections, admitting product into the U.S. and follow-up actions when food safety incidents occur.
Once assessments are completed, systems recognition arrangements will lead the way to a new level of regulatory cooperation between FDA and our regulatory partners in other countries, allowing us to avoid duplication of effort while leveraging the high quality work done by regulatory authorities in each country.
FDA, working with New Zealand, pilot tested a systems recognition assessment process using the draft International Comparability Assessment Tool (ICAT). The process includes a comprehensive review of the country’s relevant laws and regulations, inspection programs, response to food-related illness and outbreaks, compliance and enforcement and laboratory support. The report of the New Zealand assessment and the draft ICAT used in the assessment are available and provide context to the arrangement signed by FDA and New Zealand’s Ministry of Primary Industries.
- Draft International Comparability Assessment Tool (ICAT) (PDF: 394KB)
- Report of the Comparability Determination of the Food Safety Component of the New Zealand Minstry for Primary Industries (PDF: 559 KB)
This document is intended to provide information to foreign governments and other stakeholders on FDA’s proposed systems recognition assessment program, including the rationale for creating the program, implications of the program, how systems recognition assessments will be conducted, how information collected will be used, and what impact systems recognition may have on processes for importing foods. FDA intends to collect comments to inform its decision making process as FDA considers moving forward from a pilot phase to implementation. FDA previously used the term “comparability assessment” to describe the process of food safety systems evaluation as outlined in this document. FDA has since adopted the term “systems recognition assessment” as a more descriptive, plain-language term used to describe the same process.
Food and Feed Import Practices of Foreign Governments to Improve Food Safety
Under contract to the U.S. FDA, Eastern Research Group, Inc. (ERG), in collaboration with independent subject matter experts, undertook this study of imported food and feed practices of foreign governments. FDA's objective was to better understand the practices used by other mature food safety systems that have similar public health goals to that of the U.S. and to perform a qualitative analysis of those import practices identified. The contractors reviewed publicly available literature and interviewed country officials involved in the importation of food and feed using a validated semi-structured interview protocol. The study was conducted from January to November 2011.
The countries selected for the study included: Australia, Canada, Chile, Ireland, Israel, Japan, Mexico, New Zealand (NZ), the Netherlands, and South Africa. Interviews were conducted with each country's officials (with the exception of Japan) – either in-person or via digital video conference – and focused on a variety of topics ranging from government authorities and private sector involvement in the safety of imported food and feed to meeting World Trade Organization (WTO) obligations.