CSMS# 17-000314 - DA Foreign Supplier Verification Programs (FSVP) Initial Compliance Date
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May 30, 2017 represents the first compliance date for the Foreign Supplier Verification Programs (FSVP), which is mandated by the Food Safety Modernization Act (FSMA) passed in 2011. Although most of the compliance responsibility for the FSVP rests with the importers, there will be limited changes to the entry filing process when food codes for FSVP-regulated products are transmitted in the Customs and Border Protection (CBP) Automated Commercial Environment (ACE). Specifically, filers may need to identify and transmit information specific to the FSVP importer. Additional information about determining the identity of the FSVP importer can be found within the following document, Am I Subject to FSVP? (https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472461.pdf
In addition, more information regarding the compliance dates for importers subject to the FSVP rule may be found at the following website: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm.
When a food product under FDA oversight is offered for entry into the United States, the CBP ACE system will prompt the filer to transmit one of the following codes:
1. An entity role code “FSV,” which will send a signal to the ACE system indicating the entry line is subject to the FSVP regulation; or
2. An Affirmation of Compliance code “FSX,” which indicates the food is exempt from the FSVP regulation or that compliance with the FSVP regulation is not yet required; or
3. An Affirmation of Compliance code “RNE,” which indicates the food will be used for research or evaluation, and is therefore exempt from the FSVP regulation in accordance with 21 CFR 1.501(c).
If one of these codes is not transmitted for an imported food product under FDA oversight, the entry line will be rejected. Similar to all rejections in the ACE system, the rejection will generate an error message to the filer. Once an error message is received, the filer can make the appropriate adjustments to the entry submission and retransmit the entry line.
The transmission of entity role code “FSV” will trigger a request for the FSVP importer’s name, email address, and the unique facility identifier (UFI) recognized as acceptable by FDA. At this time, FDA has recognized the DUNS (Dun & Bradstreet Data Universal Numbering System) number as an acceptable UFI for the purpose of compliance with the FSVP regulation. To obtain a DUNS number free of charge, please visit: https://fdadunslookup.com.
For additional information regarding FDA’s identification of the DUNS number as an acceptable UFI, please review the Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm549623.htm.
While FDA expects all FSVP importers to provide their UFI starting on the applicable compliance date, the Agency recognizes that this is a new requirement and there may be factors that prevent importers from doing so. Therefore for a limited time, for FSVP importers temporarily unable to obtain a DUNS number, FDA intends to allow filers to transmit the value “UNK” (to represent “unknown”) in the UFI field for the FSVP importer beginning May 30, 2017. This temporary allowance will allow for articles of food offered for import into the United States to be processed through the ACE system even if an importer has not yet provided a DUNS number. For additional information regarding this temporary allowance, please review the Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation (https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm556661.htm.
For a list of specific data elements required for FSVP, refer to the FDA Supplemental Guide for the ACE/ITDS (currently v2.5, reference page 163: https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16.
For questions related to the submission of FDA data elements for FSVP, please contact FDA’s ACE Support, from 6:00 AM to 10:00 PM, 7 days a week at ACE_Support@fda.hhs.gov, 877-345-1101, or 571-620-7320.
For other questions related to FSVP, such as those related to the rule, programs and/or implementation strategies, please contact FDA’s FSMA Technical Assistance Network (TAN) at the following link: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm
May 30, 2017 represents the first compliance date for the Foreign Supplier Verification Programs (FSVP), which is mandated by the Food Safety Modernization Act (FSMA) passed in 2011. Although most of the compliance responsibility for the FSVP rests with the importers, there will be limited changes to the entry filing process when food codes for FSVP-regulated products are transmitted in the Customs and Border Protection (CBP) Automated Commercial Environment (ACE). Specifically, filers may need to identify and transmit information specific to the FSVP importer. Additional information about determining the identity of the FSVP importer can be found within the following document, Am I Subject to FSVP? (https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472461.pdf
In addition, more information regarding the compliance dates for importers subject to the FSVP rule may be found at the following website: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm.
When a food product under FDA oversight is offered for entry into the United States, the CBP ACE system will prompt the filer to transmit one of the following codes:
1. An entity role code “FSV,” which will send a signal to the ACE system indicating the entry line is subject to the FSVP regulation; or
2. An Affirmation of Compliance code “FSX,” which indicates the food is exempt from the FSVP regulation or that compliance with the FSVP regulation is not yet required; or
3. An Affirmation of Compliance code “RNE,” which indicates the food will be used for research or evaluation, and is therefore exempt from the FSVP regulation in accordance with 21 CFR 1.501(c).
If one of these codes is not transmitted for an imported food product under FDA oversight, the entry line will be rejected. Similar to all rejections in the ACE system, the rejection will generate an error message to the filer. Once an error message is received, the filer can make the appropriate adjustments to the entry submission and retransmit the entry line.
The transmission of entity role code “FSV” will trigger a request for the FSVP importer’s name, email address, and the unique facility identifier (UFI) recognized as acceptable by FDA. At this time, FDA has recognized the DUNS (Dun & Bradstreet Data Universal Numbering System) number as an acceptable UFI for the purpose of compliance with the FSVP regulation. To obtain a DUNS number free of charge, please visit: https://fdadunslookup.com.
For additional information regarding FDA’s identification of the DUNS number as an acceptable UFI, please review the Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm549623.htm.
While FDA expects all FSVP importers to provide their UFI starting on the applicable compliance date, the Agency recognizes that this is a new requirement and there may be factors that prevent importers from doing so. Therefore for a limited time, for FSVP importers temporarily unable to obtain a DUNS number, FDA intends to allow filers to transmit the value “UNK” (to represent “unknown”) in the UFI field for the FSVP importer beginning May 30, 2017. This temporary allowance will allow for articles of food offered for import into the United States to be processed through the ACE system even if an importer has not yet provided a DUNS number. For additional information regarding this temporary allowance, please review the Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation (https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm556661.htm.
For a list of specific data elements required for FSVP, refer to the FDA Supplemental Guide for the ACE/ITDS (currently v2.5, reference page 163: https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16.
For questions related to the submission of FDA data elements for FSVP, please contact FDA’s ACE Support, from 6:00 AM to 10:00 PM, 7 days a week at ACE_Support@fda.hhs.gov, 877-345-1101, or 571-620-7320.
For other questions related to FSVP, such as those related to the rule, programs and/or implementation strategies, please contact FDA’s FSMA Technical Assistance Network (TAN) at the following link: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm
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