FDA to Delay FSMA Foreign Supplier Verification, Qualified Importer Program, Etc.
During the September 2011 annual National Customs Brokers and Forwarders Association of America’s Government Affairs Conference, a Food and Drug Administration official gave updates on a number of import provisions in the Food Safety Modernization Act (FSMA), two of which he said would be delayed.
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Foreign Supplier Verification Delayed to Sync with Preventive Controls
The FSMA requires food importers to establish a foreign supplier verification program (FSVP) and conduct “verification activities” to ensure that food they import is safe. The FDA official states that the agency is supposed to issue guidance and regulations on the content of the FSVP program by January 4, 2012.
However, FDA will not make that time frame because it believes that the FSVP is linked to another FSMA requirement, the Preventive Controls rulemaking (on facility hazard analysis and controls), which is required to be completed by July 4, 2012. Therefore, the agency plans to issue the two rules together and is finalizing their proposals for both now.
(See ITT's Online Archives or 05/17/11 news, 11051718, for BP summary of trade comments on the VSFP in which they urge FDA to only require verification for immediate suppliers, etc.)
Voluntary Qualified Importer Program Delayed Until 2013 Certification RegsIssued
The FSMA also allows for the establishment of a Voluntary Qualified Importer Program (VQIP) to provide expedited review and importation to qualified participants that import from certified foreign facilities. The official explained that even though FDA is required to establish the VQIP program by July 4, 2012, it cannot establish this program until the requirements on certification are issued, which are not due until January 4, 2013. Therefore, this program will be delayed as well.
Considering Electronic Data Elements, not a Certificate, for High Risk Food Imports
He explained that under the FSMA, FDA may require some form of “certification” for imported food articles it determine to be of higher-risk or from higher risk countries. The official stated that FDA is making progress on this issue and noted that the agency would like to require electronic submission of certain data elements instead of a certificate.
Blank “Denied Entry” PN Field Is a Claim Food Was not Denied Abroad
The official reminded the trade that since September 6, 2011, persons submitting Prior Notice of imported food or feed have had to report the name of any country to which the article has been refused entry. In response to a question, the official confirmed that leaving that this PN element blank is in effect a claim that the product has not been rejected by another country. Brokers indicated their concern that this has not been adequately explained to the importing community, and the official stated FDA would try to make this clearer.
(See ITT’s Online Archives or 09/01/11 news, 11090106, for BP summary of FDA announcing it would enforce this PN element starting September 6, 2011.)
Already Able to Deny Entry if Foreign Facility Refuses/Delays FDA Inspectors
As provided for in the FSMA, FDA has already implemented its ability to deny entry to imported food/feed from a foreign facility that denied or delayed entry of FDA inspectors.
Not Enough Resources to Meet FSMA Foreign Facility Inspection Mandate
The official reiterated what other agency representatives have stated in the past - that FDA does not have the resources to meet the foreign facility inspection mandates of the FSMA. He predicts that FDA will meet the target of inspecting 600 facilities this year and is likely to meet the target of 1200 inspections next year, but will not meet the targets in later years. This is because the requirement doubles each year until FDA inspects 19,200 foreign facilities in the sixth year after enactment.
He says that the only way to inspect all of these facilities is to work with foreign governments (which is provided for in the FSMA) and with third-parties to leverage resources.
(See ITT's Online Archives or 01/05/11, 06/24/11 and 06/28/11 news, 11010516, 11062404 and 11062803, for BP summaries of FDA stating that the fee resources in the FSMA were insufficient and that Congress would need to ensure additional funding and of House-passed agriculture appropriations bill with low FDA-funding levels which some members of Congress said would undermine FSMA implementation.)
(See ITT’s Online Archives or 09/22/11 news, 11092226, for a separate BP summary of this presentation stating that PREDICT was now deployed in 13 Districts.
See future issues of ITT for additional BP summaries from this presentation.)