Navigating the New Reportable Food RegistryPresented by Faegre & Benson LLP

Welcome

2

Kim WalkerPARTNER

Faegre & Benson LLP

Welcome

3

Larry OberkfellCHIEF OPERATING OFFICER

International FoodserviceManufacturers Association

Food and Drug Administration AmendmentsAct of 2007

• Required creation and use of Reportable Food Registry:http://rfr.fda.gov/

• Purpose: to track patterns of adulteration to help FDA betteruse its limited inspection resources

• Registry requirements and electronic portal went into effectSeptember 8, 2009

• FDA has issued non-binding guidance document— available onFDA Web site

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Am I a covered “ facility” ?

• Yes, if registered with FDA per 21 U.S.C. § 350d• Any factory, warehouse or other establishment that

manufactures, processes, packs or holds food whetherdomestic or foreign

• But not: farm, restaurant, other retail food establishment(or other misc. categories)

521 U.S.C. § 350d

Am I the responsible party?

• Yes, if you submitted the reporting facility’s registration under§ 350d

• Owner/operator/agent in charge of facility may authorize anindividual to report on their behalf

621 U.S.C. § 350f(a)(1)

What constitutes a reportable food?

• Any article of food (other than infant formula) for which there isa reasonable probability that the use of, or exposure to, sucharticle of food will cause serious adverse health consequencesor death to humans or animals

• Includes any food, drink or gum for humans, including itsingredients

• Includes pet food and animal feed• Excludes foods under exclusive jurisdiction of USDA pursuant

to Meat Inspection, Poultry Products Inspection, and EggProducts Inspection Acts

721 U.S.C. § 350f(a)(2)

What is a “ reasonable probability” ?

• No further definition in statute• FDA guidance document appears to take a “better safe than

sorry” approach• Where one test indicates presence of pathogen and a second

test does not, FDA urges you to submit report, unless clear thatfirst test was inaccurate

• Standard is identical to that of Class I Food Recall

821 U.S.C. § 350f(a)(2)

What is a “ reasonable probability” ?

• Examples of previous Class I Food Recalls:– Peanut butter contaminated with Salmonella– Under-processed canned chili that contained Clostridium botulinum toxin– Smoked salmon contaminated with Listeria monocytogenes (Lm)– Ice cream that did not declare peanut-derived ingredients but contained

peanut butter as an ingredient– Baby food that posed a choking hazard– Horse feed contaminated with elevated levels of monensin– Pet food contaminated with elevated levels of melamine and cyanuric acid– Sheep feed containing elevated levels of copper– Swine feed containing elevated levels of selenium

921 U.S.C. § 350f(a)(2)

When do I have to report?

• As soon as practicable, but in no case later than 24 hours aftermaking determination that article of food is “reportable”

• FDA recognizes not all facts will be known within 24 hours —can amend report later

• Report will be accepted even if one or more data element ismissing, but FDA will expect amended report to fill in blanks orcorrect errors

• Confirmatory test result will trigger 24-hour reporting period;presumptive test result may trigger, depending on reliabilityof test

1021 U.S.C. § 350f(d)(1)

What do I have to report?

• In initial report:1. Facility registration number2. Date when food determined to be reportable3. Description of food article, including quantity/amount4. Extent and nature of adulteration5. Results of any investigation, if possible, into whether adulteration

originated with your facility6. Disposition of food article, if known7. Product information from package (product codes, use-by dates,

and name of manufacturer, packer or distributor)• FDA electronic form addresses likely questions

1121 U.S.C. § 350f(d)(1) and (e)

Electronic portalhttp://rfr.fda.gov/

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What else do I have to do?

• Investigate the source of the adulteration if it may haveoriginated in your facility

• Investigate as soon as practicable— must be within 24 hoursafter learning of problem

• If required by FDA representative:– Amend report to include additional info– Notify immediate previous source and subsequent recipient of

food article

1321 U.S.C. § 350f(d)(1) and (6)

What must I include in the notification?

• FDA may require you to notify immediate previous sourceand/or subsequent recipient

• Content of notification will be defined by FDA representative,but may include:

1. Some or all of the data you reported to FDA2. Actions that recipient must take after receiving notification3. Any other info FDA requires

• If there are multiple immediate previous sources/subsequentrecipients, FDA may require you to notify all of them

• Can notify by email, fax or first class letter. Can even notify byphone, but with a confirmation email, fax or letter

1421 U.S.C. § 350f(d)(6)(B)

What if I receive a reportable food notificationfrom someone else?

• If you have already investigated and submitted a report:• File amended report, including:

– Contact info for immediate previous source(s) and subsequentrecipient(s);

– Unique ICSR number provided by party that notified you

1521 U.S.C. § 350f(d)(8)

What if I receive a reportable food notificationfrom someone else?

• If you have not already investigated and submitted a report,FDA may require you to:

– Submit your own report, including all 11 data elements;– Investigate cause of adulteration, if your facility is possible cause of

adulteration; and/or– Notify immediate previous source and subsequent recipient of

food article• The notification you receive will inform you which steps you

must take

1621 U.S.C. § 350f(d)(7)

Do I have to report all adulterated food articles?

• No. You do not need to report if all of the following are true:1. Adulteration originated with you; and2. You detected adulteration before food article was transferred to

anyone else; and3. You either corrected the adulteration or destroyed the article of food

• Not “transferred” if transfer was intra-company (amongwarehouses, processing plants, distribution centers, etc.)

• Food has been “transferred” if it is sent to any third party, evenif you retain legal custody and possession of food article

1721 U.S.C. § 350f(d)(2)

Other fed, state or local public health officials

• Any federal, state or local public health official may also reportan adulterated food article

• FDA may share your reported info with Dept. of Ag andstate/local officials

• Calling district office and/or state/local public health officialsdoes not fulfill your reporting duties, although the FDAencourages you to do so

• FDA may issue alert or notification to public based on yoursubmitted report

1821 U.S.C. § 350f(d)(3) & (f)

Records

• Must keep records of reports received and submitted, as wellas notifications for 2 years

• Must permit inspection of records by FDA upon request

1921 U.S.C. § 350f(g)

Liability based upon reports

• Reports are considered “safety reports” under 21 U.S.C § 379v• You may include a statement disclaiming or denying admission

that reportable food article:1. Is adulterated; and/or2. Caused or contributed to death, serious injury or serious illness

• This statement will appear on all reports released forpublic disclosure

• Even without this statement, statute provides that submissionof a report/notification cannot be considered an admission thatfood is adulterated or caused or contributed to death, seriousinjury or serious illness

2021 U.S.C. § 350f(i)-(j)

Availability of reports and purging/closingreports

• Reports not publicly available on website or portal• Reports will be available via FOIA requests, with certain

confidential or trade secret information redacted• FDA has ability to close reports, where it determines the food

article was not reportable• FDA is looking into issue of purging reports after closure or

where fraudulent, meritless, etc.

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Future legislation

• Food Safety Enhancement Act of 2009 includes amendmentsto Reportable Food Registry system

• “Covered facility” definition would be expanded to includerestaurants, retail food establishments, and importers as wellas some farms

• Would require results of submission of several types ofanalytical testing results along with initial report

• FDA would have expanded ability to share reported informationwith other federal agencies, state and local governments,foreign governments and agencies, and other internationalpseudo-government agencies

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Conclusion

• Submit additional comments on guidance document andelectronic portal at http://www.regulations.gov/, keyword:“Reportable Food Registry”

• FDA will exercise discretion in enforcing Registry provisionsuntil Dec. 8, 2009, so long as responsible party has madereasonable effort to comply with act requirements andotherwise acted to protect public health

• FDA RFR Center: RFRSupport@fda.hhs.gov (questions onpolicies, procedures and interpretations)

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Future Topics

Proposed Future Topics – Please indicate your interestAny others that you would like to see presented?

– Immigration enforcement issues under the Obama administration– Overview of food safety legislation currently pending in Congress– Antitrust and competition issues in the food arena– Patent strategies for the food industry– Preparing a company for sale– Mergers & Acquisitions 101– Conducting effective due diligence– Joint venture transactions

25

Future Topics

• Overview of food safety legislation currently pending inCongress

• Enforcement issues under the Obama administration as relatesto food (immigration)

• Card check issue• Antitrust and competition issues in the food arena• Risk management issues: contract mitigation, etc.• Other issues

26

Future Topics

• Next Web Event:– Cap and Trade – Carbon Offsets – how this can affect your company

• Watch for a link to a taped Web presentation week of September 28

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Thank You For Attending

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Navigating the New Reportable Food RegistryPresented by Faegre & Benson LLP

fb.us.4373638

Learn of Potential Problem With Article of Food

By internal means or from third party By official notification from another firm

Covered facility?Test: Required to register under 21 USC § 350d? Already reported?

Yes No Yes No

ExemptReportable food?Test: Reasonable probability of causing death

or serious injury to humans or animals?File amended

report with ID #

FDA may require you to:

• Submit reportor serious injury to humans or animals? report, with ID # from notification

Submit report• Investigate cause• Notify others

Yes No

1. Adulteration originated with you?2. Detected before food left possession?3. Corrected, adulterated, or destroyed?

Exempt

Y t llN

Within 24 hours1. Investigate source if possible adulteration

originated with you

Yes to all

Exempt

No

g y2. File report on Reportable Food Registry* FDA may also require you to notify others

in the supply chain

Learn of new factsLearn of new facts

Amend report

Receive Reportable Food Registry

notification from another firm

fb.us.4389248

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Home>Food>Guidance, Compliance & Regulatory Information>Guidance Documents

● Guidance, Compliance & Regulatory Information

● Guidance Documents

● Food Safety

- Resources for You● Reportable

Food Registry

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- Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007Contains Nonbinding Recommendations

June 2009; Revised September 2009

Additional copies from: Office of Food Defense, Communication and Emergency Response, HFS-005 Center for Food Safety and Applied Nutrition

Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740 (Tel) 301-436-1500 http://www.fda.gov/FoodGuidances

You may submit written or electronic comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

U.S. Department of Health and Human Services Food and Drug Administration

Center for Food Safety and Applied Nutrition September 2009

OMB Control No. 0910-0643 Expiration Date: 02/28/2010 *See additional PRA statements in Section IV of this guidance

Contains Nonbinding Recommendations

Table of Contents1. Introduction

2. Background

3. Questions and Answers

1. Reportable Food Electronic Portal

2. Effective Date and Enforcement

3. Responsible Party

4. Reportable Food

5. Submitting a Reportable Food Report

6. Data for Initial Report

7. Submitting an Amended Reportable Food Report

8. Supply Chain Information

9. Notifications

10. Additional Contacts

11. Recordkeeping and Documentation

12. Animal Feed or Food Diversion

13. Federal, State, and Local Public Health Officials

4. Paperwork Reduction Act of 1995

5. Appendix: Instructions for Completing the Reportable Food Registry Report

Contains Nonbinding Recommendations

Guidance for Industry1 Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. If you wish to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. Introduction

This document provides guidance intended to assist those parties responsible for complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085). As required by section 1005(f) of this law, we are issuing guidance to industry about submitting reports of instances of reportable food through the electronic portal and providing notifications to other persons in the supply chain of such articles of food.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Background

On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). This law amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by creating a new section 417, Reportable Food Registry. Section 417 requires the Secretary of Health and Human Services (the Secretary) to establish within the Food and Drug Administration (FDA) a Reportable Food Registry. The congressionally-identified purpose of the Reportable Food Registry is to provide a "reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health" (Pub. L. 110-085, section 1005(a)(4)). The Secretary has delegated to the Commissioner of the Food and Drug Administration the responsibility for administering the FD&C Act, including section 417. To further the development of the Reportable Food Registry, section 417 of the FD&C Act requires FDA to establish an electronic portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. After receipt of reports through the electronic portal, FDA is required to review and assess the information submitted for purposes of identifying reportable food, submitting entries to the Reportable Food Registry, issuing an alert or notification as FDA deems necessary, and exercising other existing food safety authorities under this Act to protect the public health.

This guidance document contains questions and answers relating to the requirements under section 417 of the FD&C

Act, including (1) how, when, and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

III. Questions and Answers

A. Reportable Food Electronic Portal

1. How will FDA implement the FDAAA requirement to establish an electronic portal?

The Reportable Food electronic portal will be implemented as a part of FDA's new electronic system for collecting, submitting and processing adverse event reports and other safety information for all FDA-regulated products: the MedWatchPlus Portal.

2. When will the Reportable Food electronic portal be available?

The Reportable Food electronic portal will be listed and available on the FDA.GOV website on September 8, 2009.

3. Will the Reportable Food electronic portal as described in this guidance be the final version?

FDA will launch release 1.0 of the Reportable Food electronic portal on September 8, 2009. However, new versions (enhancements and upgrades) may be released subsequent to this launch as FDA continues to consolidate and improve its agency-wide data collection systems. FDA intends that the Reportable Food electronic portal will stay consistent with current FDA Web policy, which currently includes supporting the most widely used versions of Internet Explorer and Firefox browsers.

4. How will I access the Reportable Food electronic portal?

When the Reportable Food electronic portal becomes available, it will be accessible through a link on the FDA.GOV web site home page (http://www.fda.gov) under the heading "Report a Problem." Alternatively, you will be able to access the Reportable Food electronic portal directly by entering the following URL into your browser: http://rfr.fda.gov Upon entering the site, you will be asked some general questions pertaining to the criteria for a Reportable Food Registry report and, based on your answers, you will be directed to the appropriate screens for submitting such reports.

5. What should I do if the Reportable Food electronic portal is not operating?

FDA intends to post an announcement on http://www.fda.gov as to how to submit a Reportable Food Registry report in the event that the Reportable Food electronic portal is not operating. If http://www.fda.gov is not operating, FDA recommends that you contact the FDA District Office serving your area. To find the phone number for the FDA District Office serving your area, you can look in your local telephone directory under U.S. Government, or call 1-888-SAFEFOOD (Monday-Friday, 10:00 AM to 4:00 PM, Eastern Standard Time) or 1-888-INFO-FDA.

6. Will there be additional instructions available on how to use the Reportable Food electronic portal?

Yes. Instructions for completing the Reportable Food electronic portal screens are attached as an Appendix to this guidance. The same information will be found at the link "Instructions" on every Reportable Food electronic portal screen.

7. Will the Reportable Food electronic portal allow electronic documents to be submitted in addition to the reportable food report?

Yes. After the reportable food report is submitted, the reporter will have an opportunity to submit documents as attachments to an email. The reporter can also email documents at other times after the reportable food report is completed by placing the unique identifier number for the associated report (also known as an Individual Case Safety Report number or ICSR number) in the subject line of an email to "FDAReportableFoods@fda.hhs.gov".

8. What file types may be submitted as attachments to the email you may send to FDA after completing

the reportable food registry report?

The following file types are supported:

�❍ .pdf - Portable document format.

�❍ .jpg, .jpeg - Image file format.

�❍ .tiff - Tagged image file format.

�❍ .rtf - Rich tech format.

�❍ .txt - Text format.

�❍ .xls - Spreadsheet file format.

�❍ .doc, docx - Word processing document formats.

�❍ .wpd - Word processing document format.

9. Will the Reportable Food electronic portal allow partial submissions to be saved and will it save them automatically? Will I be able to review a report that I previously submitted?

No, release 1.0 of the Reportable Food electronic portal will not allow partial submissions to be saved, and it will not have an automatic save feature (in case you end your session before submitting your report). Also, you will not be able to use release 1.0 of the Reportable Food electronic portal to retrieve and review previously submitted reports.

Enhanced features, such as the ability to save partial reports, the ability to retrieve previously submitted reports, and the ability to make edits to previously submitted information are planned for future versions of the Reportable Food electronic portal.

10. How will future upgrades or enhancements of the Reportable Food electronic portal be announced?

FDA may announce major upgrades, new versions, or enhancements to the Reportable Food electronic portal in any or all of the following ways, depending on the circumstances: publishing a Federal Register notice, making web announcements on the Reportable Food electronic portal web site, and/or issuing press releases or constituent updates.

11. Will the Reportable Food electronic portal be available in other languages?

No. The Reportable Food Electronic portal will only be available in English.

B. Effective Date and Enforcement

12. When must I comply with the requirements of the Reportable Food Registry (Section 417 of the FD&C Act)?

Under Section 1005(e) of FDAAA, the requirements of section 417(d) of the FD&C Act (21 U.S.C. 350f(d)) became effective on September 27, 2008, one year after FDAAA was signed into law. Under section 107 of FDAAA, all other requirements related to the Registry became effective on October 1, 2007. On May 27, 2008, FDA announced a delay in implementation of the Reportable Food Registry and acknowledged that the prohibited act provisions would not apply until FDA established the electronic portal to implement the registry.

You must comply with the requirements of the Reportable Food Registry (Section 417 of the FD&C Act) on September 8, 2009, and the prohibited act provisions of the FD&C Act related to the Registry will apply on that date. However, FDA intends to consider exercising enforcement discretion for a period of 90 days, until December 8, 2009, in circumstances where FDA determines that a responsible party has made a reasonable effort to comply with the requirements of section 417 of the FD&C Act and has otherwise acted to protect public health.

C. Responsible Party

13. Who is the "responsible party" that must submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal?

The responsible party is the person who submits the registration under section 415(a) of the FD&C Act (21 U.S.C. 350d) for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held. Persons who are required to submit a facility registration under section 415 of the FD&C Act are the owner, operator, or agent in charge of a domestic or foreign facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States. "Person" is defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)) as including individuals, partnerships, corporations and associations.

(Sections 201(e) and 417(a)(1) of the FD&C Act).

14. If the registration information submitted under section 415(a) of the FD&C Act is no longer correct, is a responsible party precluded from submitting a Reportable Food report through the portal?

No. Persons who are required to submit a facility registration under section 415(a) of the FD&C Act are required to update and correct that information in a timely manner (Section 415(a)(2) of the FD&C Act). However, a reportable food report may be submitted, and may be required, even if the responsible party's registration information needs to be updated. FDA also encourages the individual submitting the reportable food report to provide his or her contact information in the reportable food report, especially if the registration information is out of date.

(Section 415(a)(2) of the FD&C Act).

15. Can an owner, operator, or agent in charge of a facility authorize an individual to report an instance of reportable food through the Reportable Food electronic portal on their behalf?

Yes. An owner, operator, or agent in charge of a facility may authorize an individual to report an instance of reportable food on their behalf through the Reportable Food electronic portal. FDA notes that an owner, operator or agent in charge of a facility may authorize an individual to register their facility on their behalf (21 CFR 1.225(c)). An individual who is authorized by the responsible party to submit a reportable food report need not be the same individual who is authorized to register a facility. FDA also encourages the individual submitting the reportable food report to provide his or her contact information in the reportable food report, especially if the registration information does not include the individual reporter's contact information.

16. Can an individual who did not submit the responsible party's initial report submit an amended report on behalf of the responsible party?

Yes. The individual submitting the amended report will need the unique identifier number (ICSR number) provided by FDA for the initial report so that this number may be included in any amended reports. FDA also encourages the individual submitting the amended report to provide his or her contact information, especially if it was not included in the initial report.

D. Reportable Food

17. What is a "reportable food?"

A "reportable food" is an article of food (other than dietary supplements or infant formula) for which 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.

(Sections 201(ff) and 417(a)(2) of the FD&C Act).

18. Are animal feed and pet food included in the definition of reportable food?

Yes. All food and food products, including animal feed and pet food under FDA's jurisdiction, are required to be reported if they meet the definition of a "reportable food."

19. How is "food" defined in the FD&C Act?

The term "food" is defined as (1) articles used for food or drink for man or other animals (other than infant formula), (2) chewing gum, and (3) articles used for components of any such article.

(Section 201(f) of the FD&C Act).

20. Is a food that presents a Class I recall situation a reportable food?

Yes. FDA interprets the definition of reportable food to include those foods that would meet the definition of a Class I recall situation. A Class I recall situation is one in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death (21 CFR 7.3(m)(1)).

(Section 417(a)(2) of the FD&C Act).

21. What are some circumstances under which food might be reportable?

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities, including recalls. The website lists recalls by classification, with Class I recalls at the top of the list. Contained within the information for each product is the reason for the Class I recall. This information may be helpful in providing examples of foods that FDA has considered to present a reasonable probability of serious adverse health consequences or death. While these examples can be helpful in understanding the standard for reportable foods, they should not be used as a substitute for evaluating the facts of your particular situation in order to determine if a food is reportable. These reports can be accessed via the following link:

http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm

Listed below are some examples of previous Class I recall situations:

�❍ Peanut butter contaminated with Salmonella.

�❍ Under-processed canned chili that contained Clostridium botulinum toxin.

�❍ Smoked salmon contaminated with Listeria monocytogenes (Lm).

�❍ Ice cream that did not declare peanut-derived ingredients but contained peanut butter as an ingredient.

�❍ Baby food that posed a choking hazard.

�❍ Horse feed contaminated with elevated levels of monensin.

�❍ Pet food contaminated with elevated levels of melamine and cyanuric acid.

�❍ Sheep feed containing elevated levels of copper.

�❍ Swine feed containing elevated levels of selenium.

22. Are products regulated exclusively by the USDA subject to the reportable food registry requirements?

No. Food that is within the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) is excluded from the requirements of the reportable food registry while that food is under the exclusive jurisdiction of USDA.

23. I received a positive microbiological test result indicating the presence of a pathogen in food. Based on this test result, the food would be "reportable." However, I retested the food for the pathogen and the second test result did not indicate the presence of the pathogen. Should I still consider the food to be reportable?

Yes. There are a number of explanations why a food may test positive for a pathogen in one test and negative in one or more additional tests although the food continues to be contaminated. For example, the distribution of a pathogen in the food may not be homogeneous. Therefore, absent other circumstances clearly demonstrating the inaccuracy of the first test result, the first test result upon which the reportable food determination was made should be considered valid.

E. Submitting a Reportable Food Report

24. When is a responsible party required to report an instance of reportable food to FDA?

A responsible party is required to submit a report to FDA through the Reportable Food electronic portal as soon as practicable, but in no case later than 24 hours after determining that an article of food is a reportable food.

(Section 417(d)(1) of the FD&C Act).

25. Is a responsible party required to investigate and report the cause of the adulteration?

Yes, if the adulteration of the article of food may have originated with the responsible party, the responsible party is required to investigate the cause of the adulteration and report their findings when known.

(Sections 417(d)(1)(B) and 417(e)(5) of the FD&C Act).

26. When is a responsible party not required to submit a reportable food report to FDA for food that would otherwise be reportable?

A responsible party is not required to submit a reportable food report when all of the following criteria are met:

�❍ The adulteration originated with the responsible party; AND

�❍ The responsible party detected the adulteration prior to any transfer to another person of such article of food; AND

�❍ The responsible party

■ corrected such adulteration; or

■ destroyed or caused the destruction of such article of food.

(Section 417(d)(2)(A)-(C) of the FD&C Act).

27. When does a "transfer to another person" occur under section 417(d)(2)(B) of the FD&C Act?

A transfer to another person occurs when the responsible person releases the food to another person. "Person" is defined in section 201(e) of the FD&C Act as including individuals, partnerships, corporations and associations.

FDA does not consider an intra-company transfer in a vertically integrated company to be a "transfer to another person," where the company maintains continuous possession of the article of food. For example, if Company A owns a processing plant, warehouse facility, and distribution facility, the intra-company transfer from the processing plant to the warehouse facility and/or the warehouse facility to the distribution facility would not be considered a transfer to another person.

(Sections 417(d)(2)(B) and 201(e) of the FD&C Act).

28. If a reportable food is shipped to a third-party warehouse, but the responsible party maintains ownership and direct control over distribution, must the responsible party submit the reportable food report?

Yes. Transfer to another person occurs when the responsible person releases the food to another person. "Person" is defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)) as including individuals, partnerships, corporations and associations. In this situation, the warehouse operator is a distinct legal person.

(Sections 417(d)(2)(B) and 201(e) of the FD&C Act).

29. When does the 24-hour reporting requirement start? For example, if I conduct a test, that if positive, would trigger the reporting requirement, does the 24-hour clock start when I receive a presumptive positive result, or when I confirm that positive result?

A responsible party must submit a report to the Reportable Food electronic portal as soon as practicable, but in no case

later than 24 hours after determining that an article of food is a reportable food. Some test methods do not yield presumptive positive results with sufficient reliability to create a reasonable probability that the use of, or exposure to, the related article of food will cause serious adverse health consequences or death to humans or animals; however, in some cases a presumptive positive result could indicate such a reasonable probability. In contrast, for a confirmed positive, a test method would be expected to be sufficiently reliable to trigger the reporting requirement. Therefore, you must evaluate your particular circumstances to determine your reporting obligation. FDA recommends that persons in the supply chain use a validated test method whenever possible; follow up any presumptive positive result with additional testing to obtain a final result; and take appropriate action to protect public health when confirmation of a presumptive positive test result is pending.

30. If I received a product from my supplier that I found to be a reportable food and I contain the problem and do not ship any of the reportable food, am I required to submit a report?

Yes. A responsible party that receives a reportable food is required to submit a report even if the responsible party has not shipped the food. The exception in Section 417(d)(2)(A)-(C) does not apply (see Question 26).

31. Will a reportable food report be issued a number by FDA?

Yes. FDA will issue a unique number for that instance of reportable food to the person who submits the report.

(Section 417(d)(4) of the FD&C Act).

F. Data for Initial Report

32. What are the data elements that a responsible party must include in an initial report to FDA?

The following data elements must be included in an initial report:

1. (1) The registration numbers of the responsible party under section 415(a)(3) of the FD&C Act;

2. (2) The date on which the article of food was determined to be a reportable food;

3. (3) A description of the article of food including the quantity or amount;

4. (4) The extent and nature of the adulteration;

5. (5) The results of any investigation of the cause of the adulteration if it may have originated with the responsible party, when known;

6. (6) The disposition of the article of food, when known; and

7. (7) The product information typically found on packaging including product codes, use-by dates, and the names of manufacturers, packers, or distributors sufficient to identify the article of food.

In addition, upon submission of a report, a unique number (ICSR number) as discussed in response to Question 31 above will be issued through the Reportable Food electronic portal to the person submitting the report. This unique number will be used by responsible parties for submitting amended reports and providing notifications.

(Sections 417(d)(1)(A), 417(d)(4), and 417(e) of the FD&C Act).

33. Will an initial report that does not include all of the data elements described in (1)-(7) in Question 32 above be accepted by the Reportable Food electronic portal?

Yes. The reportable food registry provisions recognize that the responsible party may not have sufficient information to include all seven data elements in its report within 24 hours of becoming aware of a reportable food (i.e., elements (5) and (6) above must be reported "when known"). FDA has designed the Reportable Food electronic portal to accept initial reports with a subset of the required data elements. If a required data element has not been provided or is incorrect, FDA recommends that the responsible party submit an amended report to FDA including the new or corrected information immediately.

(Sections 417(d)(1)(A) and 417(e) of the FD&C Act).

34. Will the required data elements be clearly indicated in the Reportable Food electronic portal?

Yes. Required data elements for initial submissions will be clearly indicated by the Reportable Food electronic portal.

G. Submitting an Amended Reportable Food Report

35. What may FDA require a responsible party to do following FDA's receipt of a report?

After consultation with the responsible party, FDA may require the responsible party to perform, as soon as practicable, but in no case later than the time specified by FDA, one or more of the following actions:

�❍ Amend the report the responsible party submitted to FDA to include the contact information for the immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food directly linked in the supply chain and notified by the responsible party;

�❍ Provide notification to the immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food that includes the following data elements:

1. (1) the date on which the article of food was determined to be a reportable food;

2. (2) a description of the article of food including the quantity or amount;

3. (3) the extent and nature of the adulteration;

4. (4) the results of any investigation of the cause of the adulteration if it may have originated with the responsible party, if known;

5. (5) the disposition of the article of food, when known;

6. (6) the product information typically found on packaging including product codes, use-by dates, and the names of manufacturers, packers, or distributors sufficient to identify the article of food;

7. (7) contact information for the responsible party;

8. (8) the contact information for parties directly linked in the supply chain and notified by the responsible party;

9. (9) the unique report number issued through the Reportable Food electronic portal to the person submitting the report;

10. (10) the actions that the recipient of the notification shall perform (i.e., submit a report to FDA, investigate the cause of the adulteration, and/or provide a notification to the recipient's immediate previous source(s) and/or immediate subsequent recipient(s)), as may be specified by FDA; and

11. (11) any other information FDA may require.

(Sections 417(d)(6) and 417(e) of the FD&C Act).

36. Will a new unique number be assigned to amended reports?

Yes. In version 1.0 of the Reportable Food electronic portal, every submission (initial or amended report) receives a new unique number. FDA recognizes that the responsible party may need to amend the report as additional information or documents become available. When amending a report that was previously submitted, you must include the unique number (ICSR number) that was provided by FDA when the initial report was submitted and received so that FDA can link the amended report to the initial report.

(Section 417(d)(4) of the FD&C Act).

37. How do I amend a report after I have submitted it?

In version 1.0 of the Reportable Food electronic portal, you should complete all fields that were required for the initial

report, and must include the unique number (ICSR number) that was received from the initial report. The particular information that is required depends on the circumstances.

(Sections 417(d)(4), 417(d)(6)(A), and 417(d)(8) of the FD&C Act).

38. What is the time frame for filing amended reports?

After consultation with the responsible party, FDA may require the responsible party to amend the report. FDA will specify the time frame for completing the amended report during or after the consultation. In addition, if at any time a responsible party determines that a required data element has not been provided or is incorrect, FDA recommends that the responsible party submit an amended report to FDA including the new or corrected information immediately.

(Sections 417(d)(1)(A), 417(d)(6), 417(d)(7), and 417(e) of the FD&C Act).

H. Supply Chain Information

39. Will the Reportable Food electronic portal allow the submission of contact information for immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food directly linked in the supply chain and notified by the responsible party as an attachment to a report, or will responsible parties need to directly enter each party's contact information into the portal?

The portal will ask (if applicable) for information for at least one immediate previous source or immediate subsequent recipient. We encourage reporters to enter all distribution information into the portal. However, if you have a large volume of distribution information, you may provide it to FDA in an email attachment using one of the file types listed in Question 8.

40. Are restaurants, delicatessens, supermarkets, and retail outlets considered immediate subsequent recipients within the meaning of section 417 of the FD&C Act?

Yes, if a restaurant, delicatessen, supermarket, or retail outlet is the entity that acquired the reportable food directly from the responsible party, FDA considers that entity to be an immediate subsequent recipient within the meaning of section 417 of the FD&C Act.

(Sections 417(d)(6)(B)(i)-(ii), 417(d)(7)(C)(i)-(ii), and 417(e)(9) of the FD&C Act).

I. Notifications

41. If a responsible party (Party A) notifies the immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food (Party B), as required by FDA, should Party B submit a report to FDA and provide a notification to Party B's own immediate previous source(s) and/or immediate subsequent recipient(s)?

Yes, if Party B meets the definition of a responsible party, Party B should submit a report to FDA as soon as practicable, and within 24 hours after receiving the notification regarding the reportable food. FDA may require Party B to submit a report to FDA as soon as practicable, but in no case later than a time specified by FDA, and/or to provide a notification to Party B's own immediate previous source(s) and/or immediate subsequent recipient(s) of the reportable food. See the response to Question 45 for more information.

(Sections 417(d)(1) and 417(d)(7) of the FD&C Act).

42. If a responsible party (Party A) submits a report to FDA as required by section 417(d)(1) of the FD&C Act and receives a notification from another responsible party (Party B) concerning the same article of food that was the subject of Party A's report to FDA, does Party A have to submit an additional report to FDA or provide additional notifications to the immediate previous source(s) and/or immediate subsequent recipient of the article of food?

No. Party A does not have to submit an additional report to FDA or provide additional notifications to the immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food. However, Party A is required to amend its report to FDA to include Party B's contact information and the unique number issued to Party B's report so that FDA can link the two reports in the Reportable Food Registry.

(Section 417(d)(8) of the FD&C Act).

43. If I receive allegations of product problems from sources such as consumer complaints and restaurant complaints, but not from a facility registered under section 415(a) of the FD&C Act, am I required to submit a report to the Reportable Food electronic portal?

If you determine that a food is a reportable food, you must submit a reportable food report as soon as practicable, but in no case later than 24 hours after determining that the article of food is a reportable food. Note that FDA considers that you have received a notification within the meaning of section 417(d)(7) of the FD&C Act if a responsible party who is registered under section 415(a) and has previously filed a reportable food report contacts you and provides you with an FDA-issued ICSR number for linkage to previous report(s).

(Sections 417(d)(1) and 417(d)(7) of the FD&C Act).

44. When FDA requires a responsible party to provide notifications, if there are multiple immediate previous sources or multiple immediate subsequent recipients of the reportable food, will the responsible party be required to provide notifications to all such parties?

Yes. When FDA requires a responsible party to provide notifications to its immediate previous sources and/or immediate subsequent recipients of a reportable food, such notifications will be required for all of the responsible party's immediate previous sources and/or immediate subsequent recipients of the reportable food.

(Sections 417(d)(6)(B)(i)-(ii) and 417(d)(7)(C)(i)-(ii) of the FD&C Act).

45. What activities may FDA require a responsible party that is the immediate previous source or immediate subsequent recipient of an article of food to perform after receiving a notification?

FDA may require such a responsible party to perform, as soon as practicable, but in no case later than a time specified by FDA, one or more of the following actions:

�❍ Submit a report to FDA through the Reportable Food electronic portal that includes the data elements listed in the answer to question 35 above and any other information FDA deems necessary.

�❍ Investigate the cause of the adulteration, if the adulteration of the article of food may have originated with the responsible party.

�❍ Provide a notification to the immediate previous source(s) and/or immediate subsequent recipient(s) that includes the data elements listed in the answer to question 35 above.

(Section 417(d)(7)(A)-(C) of the FD&C Act).

46. How do responsible parties provide a notification to the immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food?

Notification to the immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food may be accomplished by electronic communication methods such as e-mail, fax or text messaging or by telegrams, mailgrams, or first class letters. Notification may also be accomplished by telephone calls or other personal contacts but FDA recommends that such notifications also be confirmed in writing and/or documented in an appropriate manner.

47. After consultation with the responsible party, what are some specific examples of information regarding the reportable food that FDA may require to be included in a notification to the immediate previous source(s) and/or immediate subsequent recipient(s)?

�❍ Product name, brand name, product description, UPC codes, lot number

�❍ Use-by or expiration date or other date-related information;

�❍ Product label for ease in identifying the product at retail/user level;

�❍ Nature of the problem and the potential health hazard;

�❍ The business's contact details;

�❍ Quantity by lot, dates and amounts shipped or received;

�❍ Instructions on what to do with the product;

�❍ A description of the disposition of the product;

�❍ The unique report number (ICSR number) provided by FDA.

(Sections 417(d)(6)(B) and 417(d)(7)(C) of the FD&C Act).

48. Assume that I received notification from another responsible party (Party A), and then submitted a report to FDA through the Reportable Food electronic portal and received my own ICSR number. When I provide notifications to my own suppliers and distributors, either voluntarily or after being directed to by FDA, which ICSR number would I include in my notifications - the ICSR number that I received as part of the notification from Party A, or the ICSR number that I received when I submitted my own reportable food report to FDA after I was notified by Party A?

Under the circumstances described in your question, you should include in your notifications to your suppliers and distributors the ICSR number that was provided to you in the notification from Party A. This ICSR number will allow FDA to link reportable food reports that are related to the initial report and the reportable food.

J. Additional Contacts

49. Should responsible parties call the FDA district office and notify state and local public health or regulatory officials if they determine that an article of food is a reportable food?

Yes. FDA encourages responsible parties to contact their FDA district office and state or local public health or regulatory officials as soon as possible if they determine that an article of food is a reportable food. Calling the FDA district office and state or local health officials does not relieve the responsible party of the responsibility to submit an electronic report as soon as practicable but in no case later than 24 hours after determining that an article of food is a reportable food as specified under Section 417(d)(1) of the FD&C Act.

50. Does calling the FDA district office and/or local or state public health officials about a reportable food relieve the responsible party of the responsibility to submit a report?

No. Responsible parties are required to submit a report through the Reportable Food electronic portal to FDA as soon as practicable but in no case later than 24 hours of determining that an article of food is a reportable food (Section 417(d)(1)(A) of the FD&C Act). Calling an FDA district office and/or a local or state public health official does not relieve the responsible party of this responsibility.

51. If I have submitted my report within 24 hours, worked with the FDA district office on follow-up questions, or have provided documentation or additional information to the FDA district office, could I be required to submit an amended report?

Yes. After FDA consults with the responsible party, FDA may require the responsible party to amend its report to include the contact information for parties directly linked to the responsible party in the supply chain and notified of the reportable food by the responsible party.

(Section 417(d)(6)(A) of the FD&C Act).

K. Recordkeeping and Documentation

52. What are the recordkeeping requirements for responsible parties?

The responsible party shall maintain records related to each report received, notification made, and report submitted to the FDA under section 417 of the FD&C Act for 2 years.

(Section 417(g) of the FD&C Act).

53. Can FDA examine or inspect my records related to reports received, notifications made, and/or reports submitted to FDA under section 417 of the FD&C Act?

Yes. FDA may request records related to each report received, notification made, and report submitted to the FDA under section 417 of the FD&C Act, and a responsible party shall permit inspection of such records as provided for in section 414 of the FD&C Act.

(Sections 414 and 417(g) of the FD&C Act).

54. Is a report to FDA or notification of instances of reportable food an admission that the food involved is adulterated or caused or contributed to a death, serious injury, or serious illness?

No. A report or notification of a reportable food shall not be considered an admission that the food involved is adulterated or caused or contributed to a death, serious injury, or serious illness. Any report or notification of an instance of reportable food is considered a safety report under section 756 of the FD&C Act (21 U.S.C. 379v), Safety Report Disclaimers, and may be accompanied by a statement, which shall be part of any report that is released for public disclosure, that denies that the report or notification constitutes an admission that the product involved caused or contributed to a death, serious injury, or serious illness.

(Sections 417(i) and 417(j) of the FD&C Act).

55. Will the information collected in a reportable food report be available for public disclosure?

Under section 417(h) of the FD&C Act, a record in the Reportable Food Registry is subject to a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552), except that FDA registration numbers and information derived from such registrations are protected from disclosure to the extent that they would disclose the identity or location of a specific registered person, as provided by section 415(a)(4) of the FD&C Act. In addition, certain information, including but not limited to trade secrets and confidential commercial or financial information, are protected from disclosure under FOIA under section 552(b) (5 U.S.C. 552(b)), and by part 20 of FDA's regulations (21 CFR part 20).

(Sections 415(a)(4) and 417(h) of the FD&C Act).

L. Animal Feed or Food Diversion

56. I am interested in diverting my reportable food to use in animal feed. What has been FDA's position with respect to the use of adulterated food in animal feed?

In the past, FDA has authorized the salvage of human or animal food considered to be adulterated for its intended use by diverting that food to an acceptable animal feed use. See response to Questions 57 and 58 for details about such authorization.

57. Where should requests for human or animal food diversion to animal feed be submitted?

Requests for food diversion should be submitted in writing to the FDA District Office that is responsible for the geographic area in which the food is located. A directory of FDA District Offices can be found at http://www.fda.gov/ICECI/Inspections/IOM/ucm124008.htm.

58. Where can the procedures for submitting requests to FDA for authorization for human or animal food diversion to animal feed be located?

Procedures for requesting diversion are outlined in the Agency's Compliance Policy Guide 7126.20, Diversion of Adulterated Food to Acceptable Animal Feed Use, and can be found on FDA's website at http://www.fda.gov/

ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074694.htm.

M. Federal, State, and Local Public Health Officials

59. Who else may submit instances of reportable food to FDA?

Federal, state and local public health officials may submit instances of reportable food to FDA through the Reportable Food electronic portal.

(Section 417(b)(1)(A) of the FD&C Act).

60. If a federal, state or local public health official identifies a reportable food as part of inspection or regulatory activities, can the public health official inform the facility that they may be required to submit a report?

Yes. The public health official may inform the facility that they may be required to submit a report.

IV. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

The time required to complete this information collection is estimated to average 36 minutes per reportable food report, 36 minutes per each notification to the immediate previous recipient and immediate subsequent recipient, and 15 minutes of recordkeeping per record per year, including the time to review instructions, search existing data sources, gather the data needed, and complete and review the information collection. Send comments regarding this burden estimate or suggestions for reducing this burden to:

Office of Food Defense, Communication and Emergency Response, HFS - 005, Center for Food Safety and Applied Nutrition Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740.

This guidance also refers to previously approved collections of information found in FDA regulations. The collection of information in § 7.46 of FDA's regulations (21 CFR 7.46) has been approved under OMB Control No. 0910-0249.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for this information collection are 0910-0643 (expires 02/28/2010) and 0910-0645 (expires 09/30/2012).

V. Appendix: Instructions for Completing the Reportable Food Registry Report

See attached instructions.

1. This guidance has been prepared by the Office of Food Defense, Communication and Emergency Response in the Center for Food Safety and Applied Nutrition, in cooperation with the Center for Veterinary Medicine, the Office of Regulatory Affairs, the Office of Information Management and the Office of Emergency Operations at the U.S. Food and

Drug Administration.

This document supercedes the previous version, issued June 2009.

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Home>Food>Guidance, Compliance & Regulatory Information>Guidance Documents

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Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Adminstration Amendments Act of 2007 - AppendixContains Nonbinding Recommendations

September 2009

V. Appendix: Instructions for Completing the Reportable Food Registry ReportReturn to Main Guidance Document or to the Reportable Food Registry home page

OVERVIEWThis document is intended to provide step-by-step instructions to responsible parties and public health officials on how to submit reports regarding instances of reportable food to FDA via the Reportable Food electronic portal in order to

comply with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-085, section 1005).

The Reportable Food electronic portal collects information in six sections, as described below:

1. Introduction - questions regarding the type of report you are submitting.

2. Responsible Party Information - questions regarding the identity of the Responsible Party and the identity of the individual submitting the report.

3. Location of Reportable Food - questions regarding the facility where the reportable food problem was first identified, as well as contact information for individuals and entities that can provide additional information about the reportable food.

4. Problem Origination Site - questions about the location that is the suspected or known source of the problem. The Problem Origination Site may or may not be a facility owned by your firm. You will see this section if you indicate that you know where the problem originated. If you indicate that you know where the problem originated and that the Problem Origination Site is the same as the Location of Reportable Food, this information will be pre-populated for you.

5. Product Problem - questions about the reportable food and its supply chain, where applicable:

�❍ Description of the Problem - questions about the discovery of the reportable food problem and description of the problem.

�❍ Received Product Information - if you indicate that you received reportable food, you will see questions about reportable food you received and its supplier(s).

�❍ Distributed Product Information - if you indicate that you distributed reportable food, you will see questions about outbound shipments of reportable food you distributed and its recipient(s).

�❍ Product Information - if you indicate that you are not ready or required to report supply chain information, you will see questions about reportable food you manufactured, processed, packed, or held.

6. Submit Report and Confirmation - this section provides an opportunity to review your report before submission, instructions for attaching supplemental information to accompany your report, and assigns an FDA-issued unique identifier number (also known as an Individual Case Safety Report number (ICSR), or ICSR number) with which to identify your report.

FDA wants to be sure we have all the necessary information to follow up on the reportable food instance you are reporting. Although optional information is not required for report submission, we encourage you to provide as much information as you can to assist in our investigation of the problem.

You can move back and forth between sections of the electronic portal, however, you must complete all required fields on each page to proceed. The ‘Return to Previous Page' button allows you to navigate backwards without having to fill in the required fields. There is no save function in this application and the system will time-out if it sits idle for more than 30 (thirty) minutes.

All required questions in all sections must be answered prior to submitting the report.

SECTION 1: Introduction(Note: Asterisk, *, beside a question or sub-question indicates a required field)

The questions in the Introduction section enable us to generate the correct set of questions for your reporting situation.

1.1 Are you required by law to submit a report about a reportable food? *

If you are a Responsible Party (a person who submits a facility registration under section 415(a) of the Federal Food,

Drug, and Cosmetic Act [21 U.S.C. 350d] who is required by law to submit a report regarding an instance of reportable food to FDA through the electronic portal), select "Yes." If you are a Federal, State, or local public health official submitting a voluntary report, select "No." If you do not fall into one of these two categories, you should not submit a reportable food report through the electronic portal. Instead, please contact the FDA District Office consumer complaint coordinator serving your geographic area to report a problem.

Note that if you are a Federal, State, or local public health official, on the following screens you will see a report that differs in some ways from the mandatory report. For example, you will not see some questions and/or sections of the report described here, and some questions will appear but will be worded differently. Federal, State, and local public health officials may choose not to complete any question, even those questions marked with an asterisk. For example, for an asterisked question requesting a text response, you could answer "NA," "Information not available," or a similar response. If you are unable to proceed through the report because you cannot answer a required question, please contact your local FDA District Office for assistance.

1.2 Type of Submission *

Indicate whether this is your initial report or an amended report. If you indicate that this is an amended report, questions 2a, 2b, and 2c on your screen also apply to you.

1. 1.2.1 ICSR number from initial report *

Enter the ICSR number that was provided to you when you submitted your initial report.

2. 1.2.2 Is this amended report in response to an FDA request for additional information?

Indicate Yes, No, or I don't know.

3. 1.2.3 Reason for amended report:

Select all the reasons why you are submitting an amended report. You may select more than one option. You should select "additional information" if you are submitting new information not included in your initial report; "correction" if you are submitting information that is different from what was included in your initial report; "nullification" if you are indicating that your initial report was submitted in error; and/or "product evaluation" if you are submitting additional information based on research or analysis to confirm or identify a product problem.

Click the "Continue" button to begin your report. As you proceed through the report, you can click the "Continue" button to proceed to the next page or "Return to the Previous Page" if you want to go back. When you click the "Continue" button any required information that is missing will be flagged.

SECTION 2: Responsible Party Information2.1 Responsible Party's Organization Name

1. 2.1.1 Responsible Party's Organization Name*

This is the organizational name of the responsible party. For Federal, State, and local public health officials, this question appears as Reporter's Organization Name and should be completed with the name of your own organization.

2. 2.1.2 Registration/Identifier Type and ID

The required registration/identifier type is your Food Facility Registration Number (FFRN). More information on how to register for this number is available at: http://www.fda.gov/Food/

GuidanceComplianceRegulatoryInformation/ RegistrationofFoodFacilities/OnlineRegistration/default.htm.

�❍ Food Facility Registration Number*

If you have additional identifier numbers of the types listed below, please provide the corresponding ID number in the space provided. These additional numbers are not required.

�❍ Federal Establishment Inventory Number (FEI)

�❍ Data Universal Numbering System (DUNS) Number

�❍ Food Canning Establishment Number

3. 2.1.3 Type of Organization

Select the various establishment types which apply to your organization. Please visit http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm for definitions of establishment types.

4. 2.1.4 Country Location of Responsible Party*

Select the Responsible Party's country from the drop down list of countries. For Federal, State, and local public health officials, this question appears as Reporter's Country and should be completed with your own country.

2.2 Responsible Party Information1. 2.2.1 Street Address

Enter the number and street name of the Responsible Party's physical address, and other information as necessary. Do not enter Post Office Box address information in this field. For Federal, State, and local public health officials, this question refers to the reporter's street address and should be completed with your own address.

2. 2.2.2 City/Town *

Enter the city/town of the Responsible Party's physical address. For Federal, State, and local public health officials, this question refers to the reporter's city/town and should be completed with your own city/town.

3. 2.2.3 State (State/Province if not in the United States)*

Select the Responsible Party's state from the drop down list. If you are not located in the United States, this question will appear as State/Province. For Federal, State, and local public health officials, this question refers to the reporter's state and should be completed with your own state.

4. 2.2.4 ZIP Code (Postal Code if not in the United States)*

Enter the ZIP Code of the Responsible Party's physical address. If you are not located in the United States, your question will appear as Postal Code. If your country does not use postal codes, enter "NA" in this field. For Federal, State, and local public health officials, this question refers to the reporter's ZIP code and should be completed with your own ZIP code.

5. 2.2.5 First Name of the Individual Submitting this Report

Enter your first name.

6. 2.2.6 Last Name of the Individual Submitting this Report

Enter your last name.

7. 2.2.7 Email Address

Enter your email address, or if different, the email address of the Responsible Party's primary contact person, and re-enter the same email address to confirm that it is correct. Federal, State, or local public health officials should enter their own email address. FDA will use the email address entered in response to this question to send you an electronic copy of your reportable food report and to contact you, if necessary.

8. 2.2.8 Primary Phone

Enter your primary telephone number, or if different, the primary telephone number (and extension, if applicable) for the Responsible Party's primary contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact you. Federal, State, and local public health officials should enter their own primary telephone number.

9. 2.2.9 Other Phone

Enter a secondary telephone number and extension for you, or if different, the Responsible Party's primary contact person, if applicable. Federal, State, and local public health officials should enter their own secondary telephone number.

10. 2.2.10 Fax

Enter a fax number for you, or if different, the Responsible Party's primary contact person. Federal, State, and local public health officials should enter their own fax number.

11. 2.2.11 Is this location the same as the Location of Reportable Food? * (The Location of Reportable Food is the location of the reportable food within the responsible party's organization or company.)

Select Yes, No, or Unknown. The Location of Reportable Food may or may not be same as the location of the Responsible Party, but it is a location within the Responsible Party's organization/company. For example, for a large food company, corporate headquarters may be the Responsible Party, but the Location of Reportable Food may be a different facility that manufactured, processed, packed, or held the food. If the Responsible Party still has the reportable food, the Location of Reportable Food is the physical location of the reportable food at this time. If the Responsible Party has distributed all of the Reportable Food, the Location of Reportable Food is the physical location of the reportable food when it was within the control of the Responsible Party.

12. 2.2.12 Is the contact person for the Location of Reportable Food the same as the Responsible Party contact person?

Select Yes or No.

SECTION 3: Location of Reportable FoodThe Location of Reportable Food is the location of the reportable food within the responsible party's organization or company.

3.1 Location of Reportable Food (first screen)1. 3.1.1 Location of Reportable Food Site Name: *

This is the organizational name of the food or feed facility for which the Responsible Party is submitting a report. The Location of Reportable Food may or may not be same as the location of the Responsible Party, but it is a location within the Responsible Party's organization/company. For example, for a large food company, corporate headquarters may be the Responsible Party, but the Location of Reportable Food may be a different facility that manufactured, processed, packed, or held the food. If the Responsible Party still has the reportable food, the Location of Reportable Food is the physical location of the reportable food at this time. If the Responsible Party has distributed all of the Reportable Food, the Location of Reportable Food is the physical location of the reportable food when it was within the control of the Responsible Party.

For Federal, State, and local public health officials, the Location of Reportable Food is the entity that is the current manufacturer, processor, packer or holder of the food to the best of your knowledge.

2. 3.1.2 Registration/Identifier Type and ID

The required registration/identifier type is the Location of Reportable Food's Food Facility Registration Number (FFRN). More information on how to register for this number is available at: http://www.fda.gov/

Food/GuidanceComplianceRegulatoryInformation/ RegistrationofFoodFacilities/OnlineRegistration/default.htm.

�❍ Food Facility Registration Number*

If the Location of Reportable Food has additional identifier numbers of the types listed below, please provide the corresponding ID number in the space provided. These additional numbers are not required.

�❍ Federal Establishment Inventory Number (FEI)

�❍ Data Universal Numbering System (DUNS) Number

�❍ Food Canning Establishment Number

3. 3.1.3 Type of Organization

Select the various establishment types which apply to the Location of Reportable Food. Please visit http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm for definitions of establishment types.

4. 3.1.4 Location of Reportable Food Country*

Select the country of the Location of Reportable Food from the drop down list of countries.

3.2 Location of Reportable Food (second screen)1. 3.2.1 Street Address

Enter the number and street name of the Location of Reportable Food's physical address, and other information as necessary. Do not enter Post Office Box address information in this field.

2. 3.2.2 City/Town *

Enter the city/town of the physical address of the Location of Reportable Food.

3. 3.2.3 State (State/Province if not in the United States) *

Select the state of the Location of Reportable Food from the drop down list. If the Location of Reportable Food is not in the United States, this question will appear as State/Province.

4. 3.2.4 ZIP Code (Postal Code if not in the United States)*

Enter the ZIP Code of the physical address of the Location of Reportable Food. If the Location of Reportable Food is not in the United States, this question will appear as Postal Code.

5. 3.2.5 Title of the Site Contact Person (Title of the Site US Agent if not in the United States)

Enter the organizational title of the Location of Reportable Food's primary contact person. If the Location of Reportable food is not located in the United States, this question will appear as Title of the Site US Agent.

6. 3.2.6 First Name of the Site Contact Person (First Name of US Agent if not in the United States)

Enter the first name of the Location of Reportable Food's primary contact person. If the Location of Reportable Food is not located in the United States, this question will appear as First Name of US Agent.

7. 3.2.7 Last Name of the Site Contact Person (Last Name of US Agent if not in the United States)

Enter the last name of the Location of Reportable Food's primary contact person. If the Location of Reportable Food is not located in the United States, this question will appear as Last Name of US Agent.

8. 3.2.8 Email Address

Enter the email address of the Location of Reportable Food's primary contact person, and re-enter the same email address to confirm that it is correct.

9. 3.2.9 Primary Phone

Enter the primary telephone number (and extension, if applicable) for the Location of Reportable Food's primary contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact the Location of Reportable Food.

10. 3.2.10 Other Phone

Enter a secondary telephone number for the Location of Reportable Food's primary contact person, if applicable.

11. 3.2.11 Fax

Enter a fax number for the Location of Reportable Food's primary contact person.

12. 3.2.12 Do you know where the problem originated? *

This question asks whether you know or suspect where the reportable food problem initially started. This site may be within your organization or outside your organization. Select Yes, No, or Unknown.

3.2.12.1 If yes, did the problem originate at the Location of Reportable Food? *

If you selected Yes in response to the previous question (12), select Yes or No in response to this question (12a).

SECTION 4: Problem Origination SiteThe Problem Origination Site is the site at which the reportable food problem originated. You will see this section if you indicated that you know where the problem originated. If you indicated that you know where the problem originated and that this location is the same as the Location of Reportable Food, the fields will be pre-populated with information that you previously entered regarding the Location of Reportable Food.

Please provide any additional information you might have about the Problem Origination Site to help the FDA respond to this reportable food report.

4.1 Problem Origination Site (first screen)1. 4.1.1 Problem Origination Site Name

Enter the organizational name of the site at which the problem originated or is suspected to have originated.

2. 4.1.2 Type of Organization

Select the various establishment types which apply to the Problem Origination Site. Please visit http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm for codified definitions of establishment types.

3. 4.1.3 Problem Origination Site Country

Select the Problem Origination Site's country from the drop down list of countries.

4.2 Problem Origination Site (second screen)1. 4.2.1 Street Address

Enter the number and street name of the Problem Origination Site's physical address, and additional information as necessary. Do not enter Post Office Box address information in this field.

2. 4.2.2 City/Town

Enter the city/town of the physical address of the Problem Origination Site.

3. 4.2.3 State

Select the state of the Problem Origination Site from the drop down list. If the Problem Origination Site is not in the United States, this question will appear as State/Province.

4. 4.2.4 ZIP Code

Enter the ZIP Code of the physical address of the Problem Origination Site. If the Problem Origination Site is not in the United States, this question will appear as Postal Code.

5. 4.2.5 Title of the Site Contact Person

Enter the organizational title of the primary contact person of the Problem Origination Site. If the Problem Origination Site is not in the United States, this question will appear as Title of the Site U.S. Agent.

6. 4.2.6 First Name of Site Contact Person

Enter the first name of the primary contact person of the Problem Origination Site. If the Problem Origination Site is not in the United States, this question will appear as First Name of Site U.S. Agent.

7. 4.2.7 Last Name of Site Contact Person

Enter the last name of the primary contact person of the Problem Origination Site. If the Problem Origination Site is not in the United States, this question will appear as Last Name of Site U.S. Agent.

8. 4.2.8 Email Address

Enter the email address of the Problem Origination Site's primary contact person, and re-enter the same email address to confirm that it is correct.

9. 4.2.9 Primary Phone

Enter the primary telephone number (and extension, if applicable) for the Problem Origination Site's primary contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact the Problem Origination Site.

10. 4.2.10 Other Phone

Enter a secondary telephone number for the Problem Origination Site's primary contact person, if applicable.

11. 4.2.11 Fax

Enter a fax number for the Problem Origination Site's primary contact person.

SECTION 5: Product ProblemIn this section, you will provide a description of the product problem, including how it happened and when you learned of the problem. You will be asked to provide information about the origination and distribution of the reportable food. You will also be asked to provide additional details to enable FDA to fully understand the problem and investigate the report.

If you do not have all the details at this time, you may submit an amended report as soon as you have more information using the FDA-supplied ICSR number you will receive after submitting this report.

5.1 Product Problem (first screen)1. 5.1.1 Does your organization have an internal identifier corresponding to this reportable food report?

Please enter your organization's assigned number or code used to identify this report internally, if applicable.

2. 5.1.2 Date the article of food was determined to be a reportable food. *

Enter the date you determined that the food was a reportable food. The date format is MM/DD/YYYY. For Federal, State, and local public health officials, enter the date you suspected the food to be a reportable food.

3. 5.1.3 How the Location of Reportable Food first learned about the problem. *

Please select one of the two options that determine how the Location of Reportable Food first learned about the product problem. You should select "Notification by another firm in the supply chain" if a responsible party who is registered under section 415(a) of the Federal Food, Drug, and Cosmetic Act and has previously filed a reportable food report contacted you and provided you with an FDA-issued ICSR number for linkage to a previous report(s). You should

select "Self discovery or other" if you learned about the problem in any other way.

1. 5.1.3.1 If you select "Notified by another firm in the supply chain," you will be prompted to provide answers to the questions below.Who notified you?

Please enter the name of the other firm in the supply chain that notified you about the reportable food.

2. 5.1.3.2 Date notified.

Please enter the date (in MM/DD/YYYY format) on which the other firm notified you about the reportable food.

3. 5.1.3.3 What is the FDA-issued ICSR number for this product problem provided by the site that notified you? *

Enter the FDA-issued ICSR number that you received from the firm that notified you about the reportable food.

5.2 Product Problem Narrative (second screen)

On this screen, you should describe the sequence of events that have occurred in connection with this instance of reportable food, including, as applicable: a detailed description of the discovery, investigation (if any), and disposition of the reportable food. This description should answer the questions "who, what, where, when, and how," regarding the instance of reportable food, and should include anything else FDA should know that was not asked for elsewhere. Four open text boxes have been provided. You must enter information in at least one of the four text boxes. If you do not have information to enter in the other boxes, please enter "NA".

1. 5.2.1 Describe the problem *

Enter a clear description of the problem that includes the "who, what, where, when, and how" of what happened. If known, include what the problem is, how it happened, any contributing factors, and how long the problem has been occurring. If known, specify if the problem involves biological, physical, radiological or chemical adulteration.

2. 5.2.2 Describe any investigations in progress and any available investigation results *

Enter information about the ongoing investigation and any results or conclusions at this point.

3. 5.2.3 Describe the current status *

Provide a description of the current status of the instance of reportable food, including what is being done to contain or dispose of any affected products.

4. 5.2.4 Other relevant details *

Provide any other relevant details you believe will assist the FDA in responding to this instance of reportable food.

5. 5.2.5 Do you believe the problem was intentionally caused? *

Select Yes, No, or Unknown.

6. 5.2.6 Has a human adverse event(s) been reported? *

Select Yes, No, or Unknown.

If yes, please provide a narrative including, if known, the number of affected individuals, symptoms, lab results, and date/time of onset relative to product consumption. To protect patient privacy, do not provide personally-identifiable information; instead, the responsible party should assign a code (e.g., the patient's initials) to each adverse event. The assigned code will permit the responsible party to cross-reference identifying information and contact information for the patient in the event that the responsible party needs to follow up.

7. 5.2.7 Has an animal adverse event(s) been reported? *

Select Yes, No, or Unknown.

If yes, please provide a narrative including, if known, the number of affected animals, symptoms, lab results, and date/time of onset relative to product consumption.

5.3 Product Problem - Supply Chain Information1. 5.3.1 Select one site in the supply chain for the reportable food. What is your relationship to the site? *

Your answer to this question describes the relationship between your facility and the other firm/site. You can either choose to describe your relationship with firms in the supply chain by indicating that you receive or distribute products to those firm(s) or you can indicate that you are not ready or required to report supply chain information. Select one of the following:

�❍ You received reportable food from the other firm/site. If you select this option, you should specify the supplier firm and the product in the next two questions. Then you will see additional questions regarding the received product and your supplier(s).

�❍ You distributed reportable food to the other firm/site. If you select this option, you should specify the recipient firm and the product in the next two questions. Then you will see additional questions regarding the distributed product and your recipient(s).

�❍ You are not ready to report supply chain information or are not required to report this information. If you select this option, you must still identify the product, but you will not need to report supplier or recipient information in order to complete your report.

2. 5.3.2 Organization Name

Please enter the organizational name of the firm/site from which you received products or to which you distributed products.

3. 5.3.3 Product Name *

Enter the name of the reportable food. Include the brand and the product name, as printed on the product label or the product itself.

If you indicated that you received products from a site, you will see the following screens and questions in section 5:

5.4 Received Product Information

1. 5.4.1 Name of Received Product *

Enter the name of the reportable food. Include the brand and the product name, as printed on the product label or the product itself. This portal only collects data for one site/product at a time. If there is more than one site from which you have received reportable food, you will be given the opportunity to add information after completing this entry.

2. 5.4.2 Received From

Enter the name of the organization that supplied the product to you.

3. 5.4.3 Did the company entered in question 2 (4.4.1.2) notify you of this product problem?

Please select either Yes or No. If yes, provide the date you were notified of the reportable food by the other company. The date format is MM/DD/YYYY.

4. 5.4.4 Universal Product Code (UPC)

Enter the actual UPC code on the package here.

5. 5.4.5 Product Group *

Select the product group from the drop down list.

6. 5.4.6 Intended Product Use *

Select the intended product use from the drop down list.

7. 5.4.7 Was product imported?

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted to select the Country of Origin and the Port of Entry from their respective drop down lists.

8. 5.4.8 Was the product recalled? *

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted for the FDA Recall Number, if known.

9. 5.4.9 Package Category

Select the food package category: Bulk, Retail, or Institutional.

10. 5.4.10 Container Type

Please select the container type from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.

11. 5.4.11 Container Size

Please enter the container size and select the unit of measure from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.

12. 5.4.12 Number of Lots or Batches of Reportable Food Received

Enter the total number of lots or batches of the reportable food that you received from the organization that distributed the product to you.

5.5 Supplier Information (Continued) (first screen)1. 5.5.1 Supplier Type of Site

Select the various establishment types which apply to your supplier's site. Please visit http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm for definitions of establishment types.

2. 5.5.2 Supplier's Country

Select the supplier's country from the drop down list of countries. The United States is the default country.

5.6 Supplier Information (Continued) (second screen)1. 5.6.1 Supplier's Street Address

Enter the number and street name of the supplier's physical address, and other information as necessary. Do not enter Post Office Box address information in this field.

2. 5.6.2 Supplier's City/Town

Enter the city/town of the supplier's physical address.

3. 5.6.3 Supplier's State

Select the supplier's state from the drop down list. If the supplier is not in the United States, this question will appear as Supplier's State/Province.

4. 5.6.4 Supplier's ZIP Code

Enter the ZIP Code of the supplier's physical address. If the supplier is not in the United States, this question will appear as Supplier's Postal Code.

5. 5.6.5 Contact Person Title

Enter the organizational title of the supplier's primary contact person.

6. 5.6.6 Contact First Name

Enter the first name of the supplier's primary contact person.

7. 5.6.7 Contact Last Name

Enter the last name of the supplier's primary contact person.

8. 5.6.8 Email Address

Enter the email address of the supplier's primary contact person.

9. 5.6.9 Primary Phone

Enter the primary telephone number (and extension, if applicable) for the supplier's contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact the supplier.

10. 5.6.10 Other Phone

Enter a secondary telephone number and extension for the supplier's primary contact person, if applicable.

11. 5.6.11 Fax

Enter fax number for the supplier's primary contact person.

5.7 Received Product Information (Continued)

Additional Information About Reportable Foods Received

This screen uses your answer to the question "Number of Lots or Batches of Reportable Food Received" to generate question sets by lot or batch. Please complete the questions regarding each individual lot or batch.

1. 5.7.1 Lot Number or ID

Enter the lot number or ID of the batch.

2. 5.7.2 Expiration/Use-by Date

Enter the expiration or use-by month, day, and year that is on the reportable food container. The date format is MM/DD/YYYY.

3. 5.7.3 Number of Containers Received

Enter the number of containers received from the supplier.

4. 5.7.4 Total Amount Received

Enter the total amount of the reportable food received from the supplier and select the unit of measure associated with the product.

5. 5.7.5 First Receipt Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you first received the reportable food from the supplier.

6. 5.7.6 Last Receipt Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you last received the reportable food from the supplier.

7. 5.7.7 Did you dispose of any of the received product? *

Select either Yes, No, or Unknown. If you select "Yes", you will be prompted for the additional information below.

1. 5.7.7.1 Disposal Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you disposed of the reportable food.

2. 5.7.7.2 Number of Containers Disposed

Enter the number of containers disposed of.

3. 5.7.7.3 Total Amount Disposed

Enter the total amount of the reportable food that was disposed of on the Disposal Date and select the unit of measure associated with the product.

4. 5.7.7.4 Method of Disposal

Select the method of disposal. Check all that apply.

5.8 Supplier & Distribution Summary

A summary of all the supplier and/or recipient sites and products that you have entered will be displayed in this section. If you would like to add additional sites or products, click the appropriate add button and enter the additional information. If you have entered all the supplier and recipient sites and products associated with this product problem (or if you have entered all of the sites you plan to enter manually and you are planning to send the rest of your sites to FDA using an email attachment), click the "Continue" button.

If you indicated that you distributed products to a site, you will see the following screens and questions in Section 5:

5.9 Distributed Product Information1. 5.9.1 Name of Distributed Product *

Enter the name of the reportable food. Include the brand and the product name, as printed on the product label or the product itself. This portal only collects data for one site/product at a time. If there is more than one site to which you have distributed reportable food, you will be given the opportunity to add information after completing this entry.

2. 5.9.2 Universal Product Code (UPC)

Enter the actual UPC code on the package here.

3. 5.9.3 Product Group *

Select the product group from the drop down list.

4. 5.9.4 Intended Product Use *

Select the intended product use from the drop down list.

5. 5.9.5 Was the product imported?

Please select either YES, NO, or Unknown. If you select "Yes", you will be prompted to select the Country of Origin and the Port of Entry from their respective drop down lists.

6. 5.9.6 Was the product recalled? *

Please select either YES, NO, or Unknown. If you select "Yes", you will be prompted for the FDA recall number. Please enter the FDA recall number, if known.

7. 5.9.7 Package Category

Select the food package category: Bulk, Retail, or Institutional.

8. 5.9.8 Container Type

Please select the container type from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.

9. 5.9.9 Container Size

Please enter the container size and select the unit of measure from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.

10. 5.9.10 Number of Lots or Batches of Reportable Food Distributed

Enter the total number of lots or batches of the reportable food that you distributed and select the unit of measure from the drop down list of values.

11. 5.9.11 Number of Sites Distributed To

Enter the total number of sites to which you distributed the reportable food.

5.10 Distributed Product Information (Continued)

Additional Information About Reportable Foods Distributed

This screen uses your answer to the question "Number of Lots or Batches of Reportable Food Distributed" to generate question sets by lot or batch. Please complete the questions regarding each individual lot or batch.

1. 5.10.1 Lot Number or ID

Enter the lot number or ID of the batch.

2. 5.10.2 Expiration/Use-by Date

Enter the expiration or use-by month, day, and year that is on the reportable food container. The date format is MM/DD/YYYY.

3. 5.10.3 Number of Containers Distributed

Enter the number of containers distributed by your site.

4. 5.10.4 Total Amount Distributed

Enter the total amount of the reportable food that was distributed by you and select the unit of measure associated with the product.

5. 5.10.5 Did you dispose of any of the Product? *

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted for additional information below.

1. 5.10.5.1 Disposal Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you disposed of the reportable food.

2. 5.10.5.2 Number of Containers Disposed

Enter the number of containers disposed of.

3. 5.10.5.3 Total Amount Disposed

Enter the total amount of the reportable food that was disposed of by you and select the unit of measure associated with the product.

4. 5.10.5.4 Method of Disposal

Select the method of disposal. Check all that apply.

5.11 Distribution Information

This screen uses your answer to the question "Number of Sites Distributed To" to generate question sets by recipient. Please complete the questions regarding each recipient.

1. 5.11.1 Organization Type

Select the various establishment types which apply to your recipient. Please visit http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm for definitions of establishment types.

2. 5.11.2 Name of Recipient Site

Enter the name of the recipient to which you distributed the reportable food.

1. 5.11.2.1 Have you notified this site of the product problem?

Please select either Yes or No. If yes, provide the date you notified this recipient of the reportable food.

3. 5.11.3 Container Quantity Distributed

Enter the number of containers of the reportable food you distributed to this recipient.

4. 5.11.4 Total Amount Distributed

Enter the total amount of the reportable food that was distributed to this recipient and select the unit of measure associated with the product.

5. 5.11.5 First Distributed Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you first distributed the reportable food to this recipient.

6. 5.11.6 Last Distributed Date

Enter the month, day, and year, in the MM/DD/YYYY format, that you last distributed the reportable food to this recipient.

7. 5.11.7 Country

Select the recipient's country from the drop down list of countries. The United States is the default country.

8. 5.11.8 Street Address

Enter the number and street name of the recipient's physical address, and other information as necessary. Do not enter Post Office Box address information in this field.

9. 5.11.9 City/Town

Enter the city/town of the recipient's physical address.

10. 5.11.10 State/Province

Select the state or province of the recipient from the drop down list.

11. 5.11.11 ZIP or Postal Code

Enter the ZIP Code or Postal Code of the recipient's physical address.

12. 5.11.12 Contact Person Title

Enter the organizational title of the recipient's primary contact person.

13. 5.11.13 Contact First Name

Enter the first name of the recipient's primary contact person.

14. 5.11.14 Contact Last Name

Enter the last name of the recipient's primary contact person.

15. 5.11.15 Email Address

Enter the email address of the recipient's primary contact person.

16. 5.11.16 Primary Phone

Enter the primary telephone number for the recipient's primary contact person. This number is likely to be used by FDA from approximately 8:00 a.m. - 5:00 p.m. Monday-Friday, Eastern Standard Time if FDA needs to contact the recipient.

17. 5.11.17 Other Phone

Enter the secondary telephone number for the recipient's primary contact person, if applicable.

18. 5.11.18 Fax

Enter a fax number for the recipient's primary contact person.

5.12 Supplier & Distribution Summary

A summary of all the supplier and/or recipient sites and products that you have entered will be displayed in this section. If you would like to add additional sites or products, click the appropriate add button and enter the additional information. If you have entered all the supplier and recipient sites and products associated with this product problem (or if you have entered all of the sites you plan to enter manually and you are planning to send the rest of your sites to FDA using an email attachment), click the "Continue" button.

If you indicated that you were not ready or required to report supply chain information, you will see the following screens and questions in section 5. Federal, State, and local public health officials will see some but not all of the following questions in section 5.

5.13 Product Information1. 5.13.1 Name of Product *

Enter the name of the reportable food. Include the brand and the product name, as printed on the product label or the product itself. This portal only collects data for one product at a time. If there is more than product associated with the reportable food, you will be given the opportunity to add information after completing this entry.

2. 5.13.2 Product Manufacturer

Enter the name of the organization that manufactures the product.

3. 5.13.3 Did the company entered in the previous question notify you of this product problem?

Please select either Yes or No. If yes, provide the date you were notified of the reportable food by the company. The date format is MM/DD/YYYY.

4. 5.13.4 Universal Product Code (UPC)

Enter the actual UPC code on the package here.

5. 5.13.5 Product Group *

Select the product group from the drop down list.

6. 5.13.6 Intended Product Use *

Select the intended product use from the drop down list.

7. 5.13.7 Was product imported?

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted to select the Country of Origin and the Port of Entry from their respective drop down lists.

8. 5.13.8 Was the product recalled? *

Please select either Yes, No, or Unknown. If you select "Yes", you will be prompted for the FDA recall number, if known.

9. 5.13.9 Package Category

Select the food package category: Bulk, Retail, or Institutional.

10. 5.13.10 Container Type

Please select the container type from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.

11. 5.13.11 Container Size

Please enter the container size and select the unit of measure from the drop down list of values. Choose the option that describes the smallest container available for retail sale or further distribution.

12. 5.13.12 Total Containers Manufactured, Processed, Packed, or Held

Enter the number of containers of the reportable food that you manufactured, processed, packed, or held. Federal, State, and local public health officials should answer regarding the total number of containers of the reportable food manufactured, processed, packed or held by the Location of Reportable Food, if known.

13. 5.13.13 Total Amount Manufactured, Processed, Packed, or Held

Enter the total amount of the reportable food that you manufactured, processed, packed, or held and select the unit of measure from the drop down list of values. Federal, State, and local public health officials should answer regarding the total amount of reportable food manufactured, processed, packed or held by the Location of Reportable Food, if known.

14. 5.13.14 Number of Lots or Batches of Product Manufactured, Processed, Packed, or Held

Enter the total number of lots or batches of the reportable food that you manufactured, processed, packed, or held. Federal, State, and local public health officials should answer regarding the total number of lots or batches of reportable food manufactured, processed, packed or held by the Location of Reportable Food, if known.

5.14 Product Summary

A summary of all the products for which you entered information but indicated that you were not ready or required to report supply chain information will be displayed in this section. If you would like to add additional products, click the "Add another Product" button and enter the product information associated with this reportable food. If you have entered all the products associated with the reportable food, click the "Continue" button.

SECTION 6: Submit Report and ConfirmationPlease review your information to ensure it is correct and complete. We appreciate any optional information you can provide at this time even though it is not required for initial report submission. Click the link "Click to review your report" to review your report. Upon submission of your report, you will immediately receive a confirmation page with an FDA-assigned Individual Case Safety Report (ICSR) number. It is important that you use this ICSR number if you submit amended reports and/or consult with the FDA regarding this instance of reportable food. Depending on the circumstances, you may also need to use this ICSR number if you notify immediate previous sources or immediate subsequent recipients of the reportable food. If you have additional documents to submit, the confirmation page also provides an FDA email address, FDAReportableFoods@fda.hhs.gov, or a button ("Send Supplemental Report Information to FDA") that you can click to email the related files to the FDA. If you send any additional documents to FDA by email, please include your ICSR number in the subject line of the email.

Contact Us● Reportable Food

Registry RFR Center for questions about policies, procedures and interpretationsRFRSupport@fda.hhs.gov RFR Help Desk for technical and computer-related questions about about the RFR electronic portalRFRTechSupport@fda.hhs.gov

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Navigating FDA’s Reportable Food RegistryLive Web Event, September 17, 2009

Summary of Questions & Answers

Q. I’m a regulatory compliance officer for a company withmany processing plants and warehouses. Will I need to fillout all this information each time I need to report a foodarticle?

A. Currently, yes. The FDA has indicated, however, that it willbe working on updates to the portal so you will be able tocreate a user account for easy reporting.

Q. For any particular product, I may have hundreds of potentialupstream suppliers and downstream customers. Will I haveto manually input contact information for each one of thosein the electronic portal if the FDA requests that information?

A. Thankfully, no. You will only need to manually enter thecontact info for one upstream and downstream firm and youwill be able to submit the rest in an electronic format, such asan Excel or PDF file.

Q. Will the disclaimer that says submission of the report is notan admission of causation appear on the reportsautomatically?

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A. According to an FDA representative, this statement ordisclaimer appears on the final submission page whensubmitting a report through the electronic portal. However, itis not clear whether merely submitting the report will causethat statement to appear on the report if it is ever disclosed tothe public. Until the FDA has clarified this issue, it is best totype this statement into one of the text boxes on the finalsubmission page when making a report or to enclose thestatement in a separate email to the FDA immediately aftersubmitting the report.

Q. I understand I don’t have to report a food problem if I catchthe food before it leaves my facility and I destroy it or fix it.What if I catch it while it is in one of my warehouses or whenit is in transit to somewhere else, but before it arrives?

A. There is some ambiguity in the statute as to what it means totransfer the food to “anyone else.” The Guidance documentclarifies that an intra-company transfer between or amongcompany facilities does not constitute “transfer to anyoneelse.” However, it also indicated that where a companytransfers food articles into a third party warehouse, evenwhere the company retains ownership and direct control overdisposition of the food articles, it has transferred to the foodarticle to another person for the purposes of this exception.

Therefore, if you have caught the food article while it is inone of your facilities or in transit between your company’sfacilities, you don’t need to report it. If, on the other hand, ithas left one of your facilities and is either in transit to or hasarrived at a facility owned by a third party or consumer, youmust report it.

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Q. What if after I have transferred one of my food products to athird party, say to a warehouse, I find out that somethinghappened at the warehouse that may have contaminated thefood. For example, I know that my product is stored in thewarehouse basement, and I learn that the warehouse had afire in the basement and some of my product was damaged asa result, through water damage or something similar. Do Ineed to make a report?

A. If you become aware of a potentially adulterated product,your responsibility to report does not disappear because theproduct is no longer in your facility

- If we assume that you are a covered facility and that youare the responsible party, the next step is to determine, isthis a reportable food item?

- Again, the determining factor in this instance: is there areasonable probability that the use of, or exposure to,such article of food will cause serious adverse healthconsequences or death to humans or animals. In thisinstance, it is going to depend on the circumstancessurrounding the potential damage to your product. Whatinformation are you aware of that indicates what kind ofdamage was done to your product? Was there a test? Isit reliable information or not? Go through same processto determine you otherwise would undertake if you haddiscovered a potentially adulterated product in your ownfacility.

- Because of the 24 hour time period, it might be prudentto err on the side of caution by submitting a report andlater seeking to close or purge the report if you determinethat no report was necessary - either due to lack of

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damage or one of the other exceptions

- The flow chart provided as part of the “related materials”may be helpful to you in analyzing this type of situation

Q. What does this “Reasonable probability” phrase mean? Howwill I know whether I need to submit a report?

A. Unfortunately, neither the statute, nor the FDA’s guidancedocument provide any better explanation of what thisstandard means, other than that Class I Food Recalls wouldmeet this standard. You will need to make an individualcase-by-case assessment every time you have a potentiallyreportable food article. At least in the beginning, you maywant to take a “better safe than sorry” route and report anyborderline cases. You can then request the FDA close anycases which it later determines do not rise to the level of areportable food article.

Q. You said the standard for a reportable food is the same as fora Class 1 Food recall. Do you have any examples of whatthat might be?

A. Examples of previous Class 1 Food recalls include:- Confirmed presence of Clostridium botulinum toxin- Undeclared allergens (where the allergen could cause

serious allergic reactions)- High levels of histamines- Listeria monocytogenes or Salmonella in ready-to-eat

products- Other examples of Class 1 Food recalls are available

through the FDA’s weekly Enforcement Reports on theFDA website.

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Q. When does the 24 hour investigation and reporting deadlinebegin? When I learn there is a potential problem, through apreliminary or presumptive test? When I confirm thatproblem?

A. FDA Guidance documents indicate that while a positiveconfirmatory test will always trigger the reporting andinvestigation deadline, not all positive presumptive orpreliminary tests will do so. You will need to look at theparticular type of presumptive or preliminary test and make adetermination as to whether the positive result wassufficiently reliable to constitute a reasonable probability.For instance, a presumptive test that is 90% accurate wouldprobably constitute a reasonable probability, but otherpresumptive tests that are far less reliable may not.

In any case, you may wish to take a “better say than sorry”approach to submitting reports based upon presumptive tests.This is because FDA representatives have the ability to closea particular case submission if it ultimately turns out to not bea reportable food issue. With that in mind (and consideringthat failure to adequately report is a felony), it may beprudent to consider the 24 hour time period as starting whenthe responsible person receives a preliminary or presumptiveresult. The responsible person can then amend the report orask for its closure later if a confirmatory result comes backnegative.

Q. Will consumers be able to make their own reports throughthe electronic portal?

A. No. Only registered facilities and public health officials maysubmit reports through the portal. However, consumers maymake complaints to public health officials who may submitreports based upon those complaints. Additionally,

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registered facilities must investigate and report potentiallyreportable food articles where they learn of the adulterationthrough consumer or end user complaints, if they determinethere is a reasonable probability that the food article willcause serious adverse health consequences or death inhumans or animals.

Q. Would a commissary be covered under the definition ofregistered food facility?

A. A commissary should be considered the equivalent of arestaurant or retail food establishment and therefore wouldnot be a covered facility. However, if the commissary waspart a vertically-integrated food company that includedcovered facilities, and the responsible person learns of apotentially reportable food article that could have becomeadulterated somewhere higher up the supply chain (i.e. otherthan at the commissary), then the responsible person for thecompany or facility must investigate and determine if thepotentially adulterated food rises to the level of a reportablefood article. For instance, if the adulteration could haveoriginated in a processing plant owned by the same companyas the commissary, you would need to investigate and submita report if the food is otherwise reportable.

Q. What are the potential penalties if a responsible party/personfails to submit a report as required?

A. Failure to adequately submit a report as required or to falsifyany such report is a prohibited act under 28 U.S.C. § 331.Penalties, defined under 28 U.S.C. §§ 332 and 333 includeinjunctions, imprisonment of not more than a year and fine ofnot more than $1,000 or both for the first offense. Thepenalties for second or subsequent offenses or where false or

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misleading information was submitted are substantiallyhigher.

Q. If I discover a problem with my product before it has left myfacility, but it will take me more than 24 hours to determine ifI was the source or if one of my upstream suppliers was thesource, do I need to submit a report

A. Yes. Unless you determine within 24 hours of finding areportable food article that you are the source of theadulteration and therefore have the ability to destroy orrecondition the food article, you must submit a report. Youmay wish to note in your initial report that you are unsure ofwhether you are an upstream supplier is the source of theadulteration. If you later find out that you were the source ofthe adulteration and can thereafter destroy or recondition thefood article, you can do so and ask the FDA to close thereport.

Important note: Further details are necessary for a completeunderstanding of the subjects covered in this summary. For that reason,the specific advice of legal counsel is recommended before acting on anylegal matter discussed on these pages.

For more information contact Kristin Eads, keads@faegre.com orJennifer Zwagerman, jwilliamszwagerman@faegre.com.