What Are the FSVP Compliance Dates?
The date by which FSVP importers must comply with the FSVP regulations is the latest of the following dates. FDA will inspect FSVP importers to ensure they are in compliance:
- May 30, 2017
- For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations.
- For an FSVP importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions.
Unless exempt, or subject to modified requirements, an FSVP importer may need to perform the following activities:
- Use a qualified individual (QI) to develop an FSVP and to perform FSVP activities.
- Perform a hazard analysis that includes identifying known or reasonably foreseeable hazards associated for each imported food or type of food and determining whether they require a control. Potential hazards include:
- biological hazards, including parasites and disease-causing bacteria
- chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved additives, food allergens, and (in animal food) nutrient deficiencies or toxicities; and
- physical hazards, such as glass.
- • Evaluate risks posed by the food and the performance of the foreign supplier, considering:
- the hazard analysis for the food
- the entity that will be applying hazard controls, such as the foreign supplier or the foreign supplier’s ingredient supplier
- the foreign supplier’s food safety practices and procedures
- applicable U.S. food safety regulations and information regarding the foreign supplier’s compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter or import alert; and
- the foreign supplier’s food safety performance history, including results from testing, audit results, and the supplier’s record of correcting problems.
- Conduct appropriate supplier verification activities to provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented. These activities may include:
- annual onsite audits (must be performed by a qualified auditors
- sampling and testing of a food
- a review of the supplier’s relevant food safety records; and/or
- other appropriate activities.
- Take corrective actions (if necessary) and investigate the adequacy of the FSVP when appropriate.
- Reevaluate the food and foreign supplier every three years or sooner if the FSVP importer becomes aware of new information about the hazards in the food or the foreign supplier’s performance.
- Identify the FSVP importer when filing for entry with U.S. Customs and Border Protection using the FSVP importer’s name, electronic mailing address, and unique facility identifier recognized as acceptable to FDA. FSVP importers can meet key FSVP obligations by relying on analyses, evaluations, and activities performed by other entities in certain circumstances, as long as the FSVP importer reviews and assesses corresponding documentation.
When a Preventive Controls Qualified Individual (PQCI) develops a supplier’s hazard analysis a QI may use it, but he has to document a subsequent review and assessment of the PCQI prepared hazard analysis.
In addition to the hazard analysis, the QI must also evaluate each foreign supplier’s ability to provide safe food in compliance with U.S. regulation based on hazards associated with the food type being supplied, the supplier’s food safety plan and/or procedures, and the supplier’s past performance. A documented supplier risk assessment shall serve as the basis for determining supplier approval, verification activities and frequency.