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Avoiding FSVP 483s: Answers To Common Questions

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 food items shipped from Canada exempt from the FSVP?

They are not exempt but may require only a modified FSVP. Canada, Australia, and New Zealand are currently the only three countries with food safety systems recognized under FDA’s Systems Recognition program as “comparable” for certain foods. So, when importing food items from these countries, a “modified” FSVP needs to be created. This means your requirements can be reduced if:

  • The food is within the scope of the Systems Recognition arrangement,
  • Your supplier is under the regulatory oversight of that food safety authority, and
  • The supplier must be in good compliance standing.

If these conditions are met, you are not required to, among other things:

  • Perform a hazard analysis, or
  • Conduct a foreign supplier evaluation for approval and verification.

You must, however:

  • Monitor whether the foreign supplier remains in good compliance standing with the foreign food safety authority,
  • Take prompt corrective action if any information indicates that the hazards associated with the food you import are not being significantly minimized or prevented,
  • Ensure that you as the FSVP importer maintains records relative to all FSVP activities, and
  • Identify yourself as the FSVP importer named on the Customs & Border Protection (CBP) entry filing.

Note: These provisions apply ONLY to food that is not intended for further manufacturing/processing before consumption.

Are food contact packaging materials subject to the FSVP rule?

The FDA announced January 4, 2018, that it does not intend to require importers of food-contact substances to comply with FSVP requirements. FDA cited its premarket review and oversight of food-contact substances, and the regulatory framework for these substances as reasons for exercising enforcement discretion with regards to food-contact substances and the FSVP regulation.

To provide a bit of history: In June 2016, industry representatives met with FDA and informed the agency that the supply chain associated with imported substances used to manufacture food-contact substances is highly complex and very different from traditional food products subject to the FSVP regulation, and that any hazards associated with food-contact substances are already adequately addressed through the food additive petition and food-contact substance notification processes. So, FDA extended the compliance date for verification activities for food-contact substances by two years to May 28, 2019, but then published its intent to not hold food-contact substances to the rule in 2018.

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.

Can the supplier’s hazard analysis be used for the FSVP, or must the importer conduct its own?

You can use the suppliers hazard analysis IF 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 how 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.

How long do importers have to provide documents to an FDA inspector?

Although FDA initially followed a process of “education before regulation,” giving entities a few days to pull together requested documents, the agency is now fully enforcing the rule, although this is typically being done remotely as a pure documentation review.

So, entities subject to the FSVP rule now have only 24 hours to fully submit all FSVP documentation requested by the FDA. This can be in any form, such as an e-mail, direct mail, phone call, or an in-person request. All supporting documentation (such as a GFSI audit, etc.) should be translated into English for FDA readability. If it isn’t, the agency will give you a “reasonable” amount of time to get it translated into English, even if you originally submitted it within 24 hours.

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?

The response to this is very complex. In fact, the FSVP course has an entire chapter dedicated to ways that an entity can verify that a supplier is producing food in a manner that meets US Food Safety Standards. In general, there are several options, but written verification procedures must be established before a food is imported from a foreign supplier.

The basis for determining which verification activities is appropriate is based on the previous evaluations of the foreign supplier performance, and the risk posed by the food. The FSVP rule identifies the following as appropriate verification activities, which must be performed by an FSVP qualified individual:

  • Onsite audits.
  • Sampling and testing of food.
  • Review of the foreign supplier’s relevant food safety records.
  • Other appropriate supplier verification activities.

If there is a reasonable probability that exposure to a hazard in food will result in Serious Adverse Health Consequences Or Death to Humans or Animals (a SAHCODHA hazard), the default verification option is an onsite audit of the foreign supplier before initially importing the food and at least annually thereafter. An alternative, equally effective verification method can be chosen, but the rationale must be justified and documented.

Another option when you run into the hurdle of obtaining copies of audit reports from suppliers is to ask them, “How do I know you are producing safe food? Show me proof that all hazards have been identified (as required by FSMA, not GFSI or HACCP standards) and are being properly controlled.” A “certificate” alone does not necessarily give you adequate assurance that all hazards are being properly addressed. If the supplier continues to fight back, (which is usually a red flag), I suggest using alternate ways to verify their performance as listed above. You are allowed to use more than one verification method.

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?

The answer depends on several scenarios.

  • Scenario 1: If you are processing the ingredient in any manner whatsoever: you simply follow the Human PC, Animal PC or Produce Safety rule (as applicable) using your supply-chain approval process, and potentially supply-chain applied preventive controls. The importer is to follow the process in scenario 3.
  • Scenario 2: If you are receiving an unexposed item, and performing no, or only de minimis, handling of the product, and your importer has agreed to perform the FSVP on your behalf: you should have a written agreement that they are performing the FSVP work.
  • Scenario 3: If the importer is not taking care of the hazards and is depending on you to take care of the hazard(s): An agreement, called the Letter of Assurance, between the importer and the supplier needs to be created where the importer is naming you as the entity who is controlling the hazard(s).

If product is imported and stored by a broker, then sold to a manufacturer in the US, which entity owns FSVP?

This depends on the commodity as there are numerous exemptions, such as all the provisions for grains. Assuming it is not an exempted FDA food, and assuming no processing is being done by the broker or the manufacturer, then in general, there is a choice:

  • The person responsible for customs entry could initiate a discussion among the manufacturers, take on the FSVP importer responsibilities, or designate/retain a commercial firm to carry out the FSVP requirements. In all aspects, there should be open communication, and written agreements, between the manufacturer or distributor and the customs broker or filer so each party knows who is handling the FSVP.

If a US importer is also processing an ingredient, they will then typically follow the supply-chain applied preventive controls under the Human Food PC, Animal Food PC or Produce Safety rule (as applicable). So they would not need an FSVP. FSMA allows companies the choice of following either rule. (See 21 CFR 1.502 (c).)

Is a review log sufficient (e.g., for electronic copies) or is a physical signed document required?

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.

Why would the FDA request a microbiological COA for fresh produce under an FSVP Inspection?

FDA may choose to do so if the produce is not exempted in any way, and the foreign supplier is controlling microbiological hazards via the produce rule requirements to minimize hazards from:

  • Agricultural water (currently under discussion by the FDA)
  • Domesticated and wild animals
  • Biological soil amendment of animal origin
  • Health and hygiene
  • Equipment, tools, buildings, and sanitation
  • Growing, harvesting, packing, and holding activities

If your foreign supplier is required to comply, you must evaluate them and perform verification activities to assure that they are producing food that provides this same level of public health protection. Keep in mind that you also need to consider other FDA food safety requirements that may apply to the foods that you import in determining and performing verification activities.

If you are using the microbiological results of a COA as a means of verification activities, and it is reviewed by the QI, then these COAs become a part of the FSVP, should be called out in your related FSVP written approval process/SOP, and would be subject to FDA FSVP review.

Does FSVP only apply to food being imported into US or does it also apply to suppliers within US?

FSVP would not apply to suppliers within the US, as they are subject to other supply chain controls of FSMA. Additionally, there are several exemptions to FSVP for foreign suppliers, including:

  • Firms subject to juice or seafood HACCP regulations
  • Food for research or evaluation
  • Food for personal consumption
  • Alcoholic beverages and ingredients (when importer uses them to make an alcoholic beverage)
  • Food transshipped through U.S.
  • Food imported for processing and export
  • “U.S. goods returned”
  • Meat, poultry, and egg products subject to USDA regulation at time of importation

Is it acceptable for PCQI to review and approve suppliers under FSVP?

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?

The short answer is yes. You need to have a standard written SOP detailing this as part of the FSVP process. Following are the standard requirements of the FSVP Rule are (with #4 and #5 specifically addressing the question):

  1. Conduct a hazard analysis of the food, including hazard identification and hazard risk evaluation.
  2. Conduct an evaluation of the foreign supplier’s food safety performance and risk posed by the food.
  3. Approve the foreign supplier (based on above evaluations).
  4. Establish written procedures to ensure that food is imported only from approved foreign suppliers (with limited exceptions).
  5. Determine and apply appropriate verification activities and assess results.
  6. Implement corrective action(s), if needed.
  7. Reevaluate foreign supplier (at least every three years or when there is a reason to do so).
  8. Identify the FSVP importer at entry.
  9. Keep required records and documentation.

You do, however, have flexibility in the format you prefer for the documentation.  Typically, a simple SOP will suffice, specifically for items #4 and #5 above.

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?

Correct. If a US importer is also processing the ingredient, they will typically follow the supply-chain applied preventive controls under the Human Food PC, Animal Food PC, 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).)

How do FSMA and FSVP apply to Prop 65 audits for finished product imported from Mexico to US?

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.

Where can we get training for QI?

There are several ways you can become a Qualified Individual (QI) to perform the functions of writing and maintaining an FSVP. The course contains 12.5 hours of content and is typically broken into two days with breaks.

  • Visit the FSPCA Website where several instructors are listed as providing public courses, select a date that best fits your schedule.
  • TAG currently has three virtual web-based training sessions: May 20-21, July 12-13, and September 23-24. The courses are recorded for the FSPCA and the FDA. For more information, visit the TAG Events page.
  • TAG also has an FSVP Lead Instructor who can provide company-specific training virtually or in person at your facility. The in-person sessions are not recorded, and the open, company-focused dialog can be very productive.

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