October 21, 2013

White House FSMA/Foreign Supplier Verification Program Rules Redline

From: Politico

The FDA Friday quietly posted the White House’s redline version of the proposed Foreign Supplier Verification Program and third party auditor accreditation rules to the regulatory docket, offering the first look at what exactly what the Office of Management and Budget changed during the two years it was reviewing these provisions.

Like many FSMA-watchers, MA is poring over these documents. At first blush, the most significant change seems to be in the FSVP rule: The White House axed FDA’s suggestion that perhaps onsite audits should be required when importers are relying on suppliers overseas to control certain hazards. Instead, OMB inserted two options: the first would establish mandatory onsite auditing requirements for serious hazards to be controlled by a foreign supplier, while giving more flexibility for less-serious hazards. The second choice would not require onsite auditing, instead allowing importers to choose how to verify their suppliers — whether it be using onsite audits, testing or monitoring food safety records.

“Option 2 would give importers somewhat greater flexibility in selecting effective verification activities without adversely affecting food safety,” reads the text inserted by OMB, which adds that the agency would like comments on which option is preferable and why.

The FSVP rule redline version is available here: http://politico.pro/1da8ay7. For the third-party auditor rule redline, go here: http://politico.pro/1bOhELT



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