The general effective date of FSVP is May 30, 2017. At that point, you will be expected to have a FSVP in place and entries will reject if the FSVP identification information is not included. However, there are some exceptions which can push back this effective date based upon;
- The size of the foreign supplier,
- The nature of the importer, and
- Whether the foreign supplier must be in compliance with the final rules for 21 CFR 117 and 21 CFR 507 (collectively, “PC rules”), or 21 CFR 112 (“produce safety rule”)
Your foreign supplier required to comply with the PC rule for human food.
- Your foreign supplier is a small business as defined by 21 CFR 117.3: March 19, 2018
- Your foreign supplier is a qualified facility (including Very Small Businesses as defined by 21 CFR 117.3: March 18, 2019
- Your supplier is subject to the Pasteurized Milk Ordinance: March 18, 2019
Your foreign supplier subject to CGMP requirements in the PC rule for animal food (21 CFR 507 subpart B).
- Your foreign supplier is a small business as defined by 21 CFR 507.3: March 19, 2018
- Your foreign supplier is a qualified facility (including Very Small Businesses as defined by 21 CFR 507.3: March 18, 2019
Your foreign supplier subject the animal food preventative controls requirements (21 CFR 507 subpart C) but not required to comply with the CGMP requirements (21 CFR 507 subpart B).
- Your foreign supplier is a small business as defined by 21 CFR 507: March 18, 2019
- Your foreign supplier is a qualified facility (including Very Small Businesses as defined by 21 CFR 507.3: March 17, 2020
- All others: July 26, 2018
You import sprouts from a foreign supplier who is required to comply with the produce safety rule (21 CFR 112 subpart M).
- Your foreign supplier is a small business as defined by 21 CFR 112.3: July 26, 2018
- Your foreign supplier is a Very Small Businesses as defined by 21 CFR 112.3: July 29, 2019
- All Others: July 26, 2017
You import foods other than sprouts from a foreign supplier who is required to comply with the produce safety rule.
- Your foreign supplier is a small business as defined by 21 CFR 112.3: July 29, 2019
- Your foreign supplier is a Very Small Businesses as defined by 21 CFR 112.3: July 27, 2020
- All Others: July 26, 2018
Sources:
- Federal Register Volume 80, Number 228, Page 74332-74333, Comment/Response 334
- https://www.fda.gov/food/guidanceregulation/fsma/ucm503822.htm