§350k Laboratory accreditation for analyses of foods

Summary

The Secretary must set up a national program for food testing and a public list of approved accreditation groups and the labs they approve. This must happen within 2 years after January 4, 2011. The list must show names, contact details, and other information the Secretary finds useful. Approved accreditation groups and approved labs must tell the Secretary about any changes that could affect their approval. The program will recognize accreditation groups that meet the Secretary’s rules. That can include private labs and labs run by federal, state, or local governments, and can include labs outside the United States if they meet the same standards. The Secretary must create model standards for lab work. Those standards must cover using correct sampling and testing methods (including rapid tests), keeping internal quality systems, handling complaints quickly, making sure staff are trained and experienced, and any other needed criteria. The Secretary will review approved accreditation groups at least every 5 years and can remove approval if they do not follow the rules. Within 30 months after January 4, 2011, food testing tied to safety problems, required tests, import admission, or Import Alerts must be done by federal labs or non-federal labs that are accredited and on the public list. Test results must be sent straight to the Food and Drug Administration, unless the Secretary exempts them by rule. The Secretary can temporarily waive the accreditation rule for new validated test methods if no lab is yet accredited and the test is needed to stop an emergency or outbreak. If an accredited state or local lab’s tests lead to a state recall, the Secretary will review the results to decide on a national recall or other actions. The Secretary may limit public access to the list for national security reasons, working with the Secretary of Homeland Security.