| Title: | Addition of Affirmation of Compliance Codes for Prior Notice |
|---|---|
| Date: | 2011-08-12 |
| To: | abi |
| Links: | previous, next |
Subject: Addition of Affirmation of Compliance Codes for Prior Notice
On August 13, 2011, FDA will deploy changes to several of its information technology systems including the Prior Notice System Interface (PNSI) and the Operational and Administrative System for Import Support (OASIS) in order to receive and process the new prior notice information required by section 304 of the FDA Food Safety Modernization Act (FSMA). On May 5, 2011, FDA published an interim final rule “Information Required in Prior Notice of Imported Food” (76 FR 25542). The interim final rule amended the Agency's regulations on prior notice of imported food. The change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.
Submitters using ABI/ACS will be able to report the name of any country to which the article of food has been refused entry via affirmation of compliance (AofC) codes in ACS consumption entry transmissions. AofC codes have been established to allow the reporting of up to five (5) country names on each prior notice. The codes are: RF1, RF2, RF3, RF4, and RF5. The qualifier for these codes should be an ISO country (or area) code.
The new AofC codes cannot be used in ABI WP transmissions at this time. Until such time that ACS or its successor system can accommodate such transactions, submitters needing to report any country to which the article has been refused entry must use PNSI or submit the prior notice as part of an ACS Consumption entry in ABI.
The effective date of the interim final rule was July 3, 2011. However, FDA published Guidance for Industry in June 2011 which stated the changes to the information technology systems would not be completed by the July 3, 2011 effective date. As such, the agency did not intend to enforce the interim final rule's requirement that the prior notice submission include the name of any country to which the article has been refused entry until September 6, 2011. Although submitters will be able to submit this information starting on August 13, 2011, enforcement discretion for this information will still be employed until the September 6, 2011 end date.
If you have any questions, please contact the FDA'S Prior Notice Center at (866) 521-2297.