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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.
Systems Recognition
Systems recognition, previously referred to as comparability, involves reviewing a foreign
countrys 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 countrys 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
Zealands Ministry of Primary Industries.
Report of the Comparability Determination of the Food Safety Component of the New
Zealand Minstry for Primary Industries (PDF: 559 KB)
http://www.fda.gov/Food/InternationalInteragencyCoordination/InternationalCooperation/defaul
t.htm