FDA Signs Agreement Recognizing Comparabiility of New Zealand Food Safety System
The Food and Drug Administration and New Zealand signed an agreement recognizing that the U.S. and New Zealand food safety systems are comparable. The arrangement is the first time FDA has recognized another country’s food safety system as comparable. “Systems recognition,” as the FDA now terms it, 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, FDA said.
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FDA, working with New Zealand, pilot tested a systems recognition process using the draft International Comparability Assessment Tool (ICAT), it said. 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, FDA said. FDA is currently conducting a pilot systems recognition process with Canada, it said.
A September report from the Government Accountability Office said FDA has not explained how it plans to integrate comparability assessments with the new authorities provided in the Food Safety Modernization Act, such as third-party certification or international capacity building. According to FDA officials, the agency expects to develop a plan for the use of comparability assessments once it concludes its pilot project with Canada in 2013, the report said.
Agreement Allows Better Targeting; Both Countries Retain Right to Inspection
“For years, we have conducted reviews of various food safety policies and programs in place in other countries to provide assurances of the safety of individual products,” said Deborah Autor, deputy commissioner for global regulatory policy, and Michael Taylor, deputy commissioner for foods, in a blog post on the FDA website. “The systems recognition process that we completed with New Zealand goes beyond our previous commodity-specific evaluation strategy, covering the overall food safety system that is in place, and how it is implemented, and extending to all FDA-regulated food products,” they said.
Both countries retain the right to conduct inspections of each other’s products as appropriate, Autor and Taylor said. “But assured about each other’s competency and commitment, both are more likely to focus their resources on higher risks,” they said. “Importantly, if a problem does occur, each country intends to work cooperatively on follow up.”
The blog post announcing the agreement is here.
The text of the memorandum will be here.
The transcript of a March 2011 hearing on mutual recognition is here.
(See ITT’s Online Archives 12103122 for summary of GAO report on third-party verification, including the use of mutual recognition.)
Email ITTNews@warren-news.com for a copy of the constituent update announcing the agreement.