Questions & Answers for Industry Regarding the HVP Recalled By Basic Food Flavors, Inc
Updated March 19, 2010
PREFACE: Please note that the information provided below is specific to the recall of HVP manufactured by Basic Food Flavors, Inc. and is not intended to address other circumstances.
What has been recalled?
Hydrolyzed vegetable protein (HVP) in paste and powder form produced on of after September 17, 2009, by Basic Food Flavors, Inc., of Las Vegas, Nevada. In addition, some distributors of the HVP and manufacturers of products containing the recalled HVP have also recalled products. For a list of these recalled products go to the Hydrolyzed Vegetable Protein Containing Products Recall List.
Can bulk quantities of the recalled HVP be reconditioned?
Yes. Bulk HVP from Basic Food Flavors in the possession of manufacturers, distributors and food service establishments may be reconditioned using procedures validated to inactivate Salmonella. Firms should submit their reconditioning packages for review to the Center for Food Safety and Applied Nutrition at HVP_Reconditioning@fda.hhs.gov and their Local FDA District Office Recall Coordinator at the same time.
E-mails should include:
a. An explanation of how and where the reconditioning will take place
b. Type of process
c. Processing parameters, including all critical factors that inactivate Salmonella
d. Procedures to prevent recontamination of the reconditioned HVP.
All reconditioning must be conducted under applicable current Good Manufacturing Practices (cGMP).
Manufacturers, distributors and food service establishments with recalled HVP that has not been incorporated into other products should discontinue distribution or use of the HVP unless it has been reconditioned by a process reviewed by the FDA.
I have recalled HVP that I have not yet used. Is it appropriate to manufacture seasoning blends with this recalled HVP if the blends will be used by my customers in products that receive a validated kill step for Salmonella?
No, the recalled HVP that has not been incorporated into another product should not be used until it has been reconditioned by a process reviewed by FDA.
Is it appropriate to continue to use an ingredient or product that has already incorporated the recalled HVP?
It is appropriate to use an ingredient or product you have received that contains the recalled HVP if the ingredient or product will receive a validated kill step for Salmonella (e.g., cooking by the manufacturer, a food service operator, or the consumer). However, if you do not apply the kill step or labeling with the kill step, you should obtain a guarantee from your customers that the kill step will be applied further in the supply chain.
I manufacture seasoning blends that contain HVP. If I have blends that have been made with the recalled HVP, is it appropriate to send these to establishments that are further processing them?
If the seasoning blends containing the recalled HVP have been subjected to a validated kill step for Salmonella or have instructions for use that involve a validated kill step for Salmonella, it is appropriate to continue to ship them. If they have not been subjected to a validated kill step and do not have instructions with a validated kill step, it is appropriate to ship them only if you obtain a written guarantee from your customers that the kill step will be applied further in the supply chain.
Should ready-to-eat products be recalled if they contain the recalled HVP?
FDA recommends that ready-to-eat products be recalled if the products have not been subjected to a validated Salmonella kill step (e.g., a 5-log reduction, or the equivalent).
Conversely, if these products have been subjected to a validated Salmonella kill step, FDA does not believe at this time that a recall of these products is necessary. Products cooked in food service establishments to the minimum temperatures and times specified in the 2009 FDA Model Food Code would be considered to have met this level of kill.
For products that already have incorporated the recalled HVP and that are relying on a validated kill step, should information be sent to FDA to verify the adequacy of the kill step?
No, FDA expects establishments to take responsibility for ensuring that their processes are appropriately validated. If a firm has a concern about unique circumstances regarding specific products it may consult with FDA by contacting the Center for Food Safety and Applied Nutrition at HVP_Reconditioning@fda.hhs.gov and its Local FDA District Office Recall Coordinator at the same time.
Is it necessary to recall low-acid canned/acidified canned foods containing the recalled HVP?
No, FDA does not believe at this time that a recall of these products is necessary. Use of the recalled HVP in a product that will be treated in accordance with a low-acid or acidified canned food process filed with FDA will be considered an appropriate reconditioning process without further FDA review.
Is it necessary to recall ready-to-cook products manufactured with the recalled HVP?
FDA believes cooking instructions validated for killing Salmonella will reduce to negligible levels or eliminate the risk from Salmonella, given the small levels of HVP typically present in these types of food products. Therefore, the agency does not believe at this time that recall of these products is necessary to protect public health. FDA will continue to assess the risk of illness through targeted surveillance, testing and risk modeling with respect to these products and will take further action if warranted.
I have read FDA’s information for industry on the recall of HVP manufactured by Basic Food Flavors, but I have additional questions. Whom should I ask?
For further clarification or other information from FDA regarding the recall, contact your Local FDA District Office Recall Coordinator.
Should manufacturers provide FDA the cooking instructions they include on labels to food service operators so that FDA can verify the adequacy of the instructions for Salmonella kill?
No, FDA expects establishments to take responsibility for ensuring that the cooking instructions provided on their products are validated.
What determines whether a food is ready-to-eat versus ready-to-cook?
Ready-to-eat foods are produced by food manufacturing establishments as well as food service and retail operations. With respect to this situation, a ready-to-eat food is one that will be consumed without additional treatment such as cooking that would kill Salmonella. With respect to this situation, a ready-to-cook food is one that contains cooking instructions for food service or for consumers that are validated to kill Salmonella.
What is meant by a "validated kill step for Salmonella" ?
With respect to this situation, a validated kill step is one that has been shown to adequately reduce Salmonella if it is present in a food containing the affected HVP. FDA has previously explained the meaning of “adequately reduce:”
[We] use the phrase “adequately reduce” to mean capable of reducing the presence of Salmonella to an extent sufficient to prevent illness. The extent of reduction sufficient to prevent illness usually is determined by the estimated extent to which Salmonella spp. may be present in the food combined with a safety factor to account for uncertainty in that estimate. For example, if it is estimated that there would be no more than 1000 (i.e., 3 logs) Salmonella organisms per gram of food, and a safety factor of 100 (i.e., 2 logs) is employed, a process adequate to reduce Salmonella spp. would be a process capable of reducing Salmonella species by 5 logs.
My facility has manufactured, processed, packed, or held food affected by the recall. How do I determine whether I am required to submit a report to FDA through the reportable food electronic portal?
Food, other than dietary supplements or infant formula, is reportable if there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. Section 417(d) of the Federal Food, Drug, and Cosmetic Act (21 USC 350f) requires that a responsible party to submit a report as soon as possible, but in no case later than 24 hours, after determining that an article of food is reportable. A responsible party is the person who submits the registration under section 415(a) of the FD&C Act (21 USC 350d) for a food facility that is required to register, at which such article of food is manufactured, processed, packed, or held. If you are a responsible party with regard to a reportable food, then you must submit a report.
[Added March 19, 2009] I have reportable foods that contain recalled HVP from Basic Food Flavors at more than one of my company’s facilities. Can my company submit one combined reportable food report that includes all of the information that would be submitted in separate reports from each facility?
Yes. FDA has recently developed a guidance document entitled “Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007” that may be useful to firms that have reportable foods containing the recalled HVP at more than one facility. It provides guidance on how to submit a report for a specific reportable food situation that involves more than one of your facilities, such as manufacturing and processing facilities, storage facilities, and/or distribution facilities.
Could I be notified by another firm of the need to file a reportable food report?
Yes, you may receive a notification from another responsible party requiring that you file a report. After a responsible party submits a report to FDA, section 417(d) provides that FDA may consult with that party and require them to notify the immediate previous source and immediate subsequent recipient of the food and inform them of the need to submit a report to the electronic portal.
If my supplier or customer has submitted a report to the reportable food electronic portal about the same product, do I still need to submit a report to the electronic portal?
The reporting requirements in section 417 do not provide an exemption based on reporting by another party so you may be required to submit a report even if other responsible parties in your supply chain have already done so. Below is additional information related to the submission of a report under these circumstances.
- In response to Question 2 at the electronic portal, you should indicate you are making an initial report if this your facility’s first report relating to the recalled HVP, even though other facilities may have already reported about the same product.
- If a facility was notified by a supplier or customer who submitted a reportable food report relating to the recalled HVP, the electronic portal will prompt the facility for the ICSR (individual case safety report) number issued to the report submitted by the supplier or customer. If the ICSR number is unknown, please enter 1012285. This number will enable FDA to link the report to other reports relating to the recalled HVP.
- FDA encourages reporters to reference the “Basic Food Flavors, Inc. HVP recall” in the “Product Problem” section of the report.