Summary of RequirementsThe first obvious question with any new regulation is, who has to comply? The FDA has provided this table as a helpful tool to determine if compliance is required. Simply stated, the FSVP importer, whom the FDA will hold responsible for compliance, is the U.S. owner or consignee of products for import. The entity whose DUNS number is entered into the Customs & Border Patrol system is the one who will be held accountable.Because of the large risk associated with compliance, we highly recommend that any food importers attend a voluntary FSVP course to help ensure they understand the requirements. According to FDA inspectors, nearly half of all importers audited this year had significant gaps in compliance with the regulation. There are many elements to the regulation that are difficult to implement without the proper food safety knowledge and understanding, so it is much better to be prepared than to find yourself in a stressful audit later. In order to ensure your compliance with the rule, schedule a third-party gap analysis with Safe Food Certifications at firstname.lastname@example.org.Rule’s Intent: to ensure that imported foods are produced as safely as products made in the U.S., and are in accordance with FSMA regulations.To meet that intent, importers are held responsible for verification of their foreign suppliers’ programs. In most cases your suppliers will need to comply with the Preventive Controls rule or the Produce Safety rule.The following are some key activities required by the rule, each of which must be done by a “qualified individual”:
- Identify and evaluate potential foodborne hazards, based on current scientific understanding
- Conduct an assessment of suppliers
- Identify appropriate verification steps to ensure suppliers’ compliance
- Conduct these verification activities, or ensure they are conducted and review their results
- Apply corrective actions as needed
- Develop and maintain documented procedures for the above
- Maintain required records
The Qualified Individual (“QI”)A key concept within the FSMA rules by FDA is the “Qualified Individual”, referred to by some as the “QI.” The idea is that anyone with a key responsibility that may impact food safety of products, should be specifically qualified for that role through a combination of job experience, knowledge, and training. In essence it comes down to employee competence, similar to any GFSI audit or ISO-based audit. It makes sense if you consider it; anyone who is involved in approving or verifying suppliers, assessing hazards, or maintaining documentation, should be qualified to do so. It’s also worth noting that you can use contractors or third party service providers to conduct some of the functions required by the regulation. If you require such assistance feel free to contact us for help.You can find a helpful guide here that will allow you to identify and keep records of who is responsible in your organization for each key function required by the FSVP rule.
FSV Rule Versus Preventive ControlsFor companies who not only import, but also process, there is an important consideration regarding the FSVP rule. Companies who have programs in place to comply with the Preventive Controls rule, are considered in compliance with the FSVP rule, if they fully comply with the PC rule supply chain requirements. The requirements are basically equivalent, although not the same word for word. The only exception is that import documentation requirements still must be complied with, including obtaining a DUNS number and other relevant requirements.
Key Take-Aways from the TrainingWe wanted to share a few notable items from the training we attended:
- It’s important to identify which U.S. regulations your imported items fall under. Items like dietary supplements, alcoholic beverages, and red meats will still be regulated according to applicable regulatory structures already established.
- If FDA makes a request for records, they must be submitted within 24 hours of the request. This is where cloud-based systems come in handy.
- The training should be expected to last 1 ½ to 2 days.
- Complete attendance of all sections is mandatory of the attendee to be granted a certificate.
- Many importers will have to seek outside help to comply with all the aspects of this regulation.
- The importer of record is not necessarily the FSVP party who will be regulated by FDA.
- Supplier verification records that are not in English must be translated before being submitted to FDA. If the importer does not employ someone who is able to read and translate them, they must be translated anyway – these documents have to be reviewed before items can be received and sold.
Steps to Take Now
- First, make sure you understand the requirements of the regulation. If this involves training, be sure to get it.
- Identify key roles required by the regulation, and who your organization will rely on to complete those roles. This document should help with that.
- Ensure that you have a good system for tracking documents and records. We strongly recommend a cloud-based system, whether something like Dropbox, Google Documents, or a paid provider. You need to have records readily available.
- Consider attending Safe Food California this coming April to get important updates on various aspects of your program.