FDA is Reviewing 3rd Party Lab Analyses of Papayas from Mexico
U.S. Customs and Border Protection has issued CSMS Message #11-000273 announcing the Food and Drug Administration's review of private laboratory analyses for papayas. On August 25, 2011, FDA issued Import Alert #21-17 on the "Countrywide Detention Without Physical Examination of Papaya from Mexico." In this Alert, FDA states that such detention without physical examination (DWPE) of all fresh papayas from Mexico is appropriate based on the presence of salmonella.
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Analysis by 3rd Party Lab is Usually Sufficient to Release Entries of Papayas from Mexico
In order to obtain an FDA release for an entry of papayas from Mexico, the importer has to demonstrate that each entry is free from salmonella. In most instances, a laboratory analysis conducted by a third-party laboratory will be sufficient to justify release of the entry.
But FDA Has Found Issues Regarding 3rd Party Analytics that Could Result in Refused Entry
However, FDA review of third-party analytical packages has revealed numerous issues related to the analyses conducted and the information provided. Such issues could render the analytical package unacceptable, which would result in a refusal of admission for the entry. Rather than taking this step, FDA's laboratory and compliance personnel have been working with the third-party laboratories to reconcile these issues so that the analytical package adequately documents that the product does not contain salmonella.
FDA Working with Labs, Says Importers May Expect Delays in FDA Releases
In addition to working with the third-party laboratories on individual submissions, FDA is also trying to get the third-party laboratories to a point where FDA has sufficient confidence the third-party laboratories can consistently submit acceptable analytical packages. Once a particular third-party laboratory has achieved this, their analytical packages will not require such a stringent review and the entry process may be expedited for some shipments.
This collaboration between FDA laboratory personnel and third-party laboratories takes time and is a reason for perceived delays in the review process. FDA will not issue releases based upon third-party laboratory analyses that are not acceptable. Importers may continue to expect delays in FDA releases of papayas from Mexico until their third-party laboratory can demonstrate an ability to consistently submit acceptable analytical packages.
Importers Encouraged to Verify Private Lab's Quality Controls, Etc.
Unfortunately, FDA does not recommend specific private laboratories. FDA is encouraging importers to verify a private laboratory’s capabilities, quality controls, and successful submission history of Salmonella analysis for papaya with the Agency. FDA is working as expeditiously as possible to get the third-party laboratories to correct their problems so that the third-party laboratories will submit acceptable analytical packages; however, the responsibility ultimately rests with the importer to use sound judgment in the selection of a third-party laboratory and the third-party laboratories to submit acceptable analytical packages.
(See ITT's Online Archives 11101716 for the latest revision of Import Alert #21-17 on October 14, 2011. Note that the original Import Alert was issued on August 25, 2011 and later revised on August 31, October 11, and October 14.)