Each month, TAG holds a FSMA Friday webinar the last Friday of the month. In March, TAG Food Safety Associate Lily Yang and Food Safety Director Christopher Snabes presented the webinar, “Don’t Get 483’d for Your FSVP.” Following the presentation, the participants had so many questions for the experts on developing and maintaining their Foreign Supplier Verification Programs (FSVP) that there was not time to address them all. Because of the complexity of the rule, TAG felt it would be of value to address the questions in a public forum in this newsletter, as follows:
Are foreign suppliers required to have an effective pest program in place as is required for US companies?
Yes. All FDA-based food facilities exporting food to the US are expected to produce food safely according to the manner prescribed by FSMA. This includes following cGMPs which require an effective pest control program.
You can use the suppliers hazard analysis it is robust and meets FSMA requirements. In addition to calling out traditional biological, chemical, and physical risks, it must also identify any radiological hazards and food safety (not quality) related economically motivated adulteration (EMA) issues, and most importantly, define the allergens will be controlled. A good hazard analysis will include the QI’s review of the supplier’s hazard analysis, and typically add a QI supplement if the supplier fails to call out a hazard. During the FSVP review, the FDA will cross check the hazard analysis against the known recognized hazards , and anything that is missing will likely lead to a 483.
It is often difficult to get suppliers to share their audit reports; does FDA require these? Or could you suggest any alternatives, such as just the certification?
Can you simply hold a foreign raw material supplier to the standards of the human foods rule – as the two rules seem to have very similar requirements?
If a US importer is also processing an ingredient, they will typically follow the supply-chain applied preventive controls under the Human PC and/or Animal Food PC rule, (or Produce Safety Rule as applicable). So this entity would not need an FSVP. The FSMA rules allows companies a choice of either rule to follow, but does not require, nor suggest, they follow both the FSVP rule and the PC/PS rules. The FSVP rule is designed, and typically used, for those products for which there is no, to only de minimis/minor, handling of an unexposed product that comes into the US and is distributed/sold. (See 21 CFR 1.502 (c).)
My company is not an importer, but our suppliers import raw materials. What are our requirements under FSVP?
If product is imported and stored by a broker, then sold to a manufacturer in the US, which entity owns FSVP?
Based on the FSVP 483s for which TAG has assisted clients in responding to the FDA, it appears the agency prefers to see each document reviewed individually, signed, and dated by the FSVP QI. However, the signatures and dates can be applied electronically.
No, the trainings are not equivalent. Qualified Individual certification is specific to each rule. So while a person may become qualified as both a PCQI and FSVP QI with the requisite training for each, being certified as a PCQI does not automatically qualified a person to be an FSVP QI. While a PCQI may be qualified to conduct the Hazard Analysis portion of the FSVP, they would not be qualified for the remaining portions of the FSVP. TAG strongly suggests a person take training as recognized as adequate by the FDA thru the FSPCA training curriculum.
Say I have conducted all my hazard analysis of a supplier, audited the facility, and ensured they have a food safety plan that meets FSMA. Do I also need a form that states I have approved the company?
Upon receiving ingredients from overseas suppliers, we further processing to make finish products, so that would be covered under our Food Safety Plan, which is not under FSVP – correct?
While the FDA, FSMA, FSVP and Prop 65 all deal with food regulation and safety, Prop 65 is not directly related to any part of FDA’s FSMA or the FSVP program. Prop 65 is a California-specific mandatory disclosure labeling law that is enforced by the state of California and legal actions by private citizens of California. FDA, as well as FSMA and its FSVP program, are based at the federal level, and since they do not enforce or deal with Prop 65, they do not perform audits.