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Author Topic: (New) FDA Reportable Food Registry  (Read 3136 times)
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5CatMom
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Posts: 454


« on: September 08, 2009, 07:05:08 AM »

FDA rolls out something new for the food industry.

Question is, who's exempted?  For example, do RENDERING COMPANIES have to report problems with their products?

http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm

Is this "change we can believe in?" or just more samo, samo - business as usual?   

5CM
« Last Edit: September 08, 2009, 07:37:08 AM by 5CatMom » Logged

What is man without the beasts? If the beasts were gone, men would die from a great loneliness of spirit. For whatever happens to the beasts, soon happens to man. All things are connected - - - Chief Seattle

We are the caretakers of our creatures . . . the peacekeepers of our planet
3catkidneyfailure
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« Reply #1 on: September 08, 2009, 08:06:33 AM »

Don't have your answer yet, 5CatMom:

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm180761.htm

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. ...

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3catkidneyfailure
Guest
« Reply #2 on: September 08, 2009, 08:15:54 AM »

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
                o corrected such adulteration; or
                o 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. (Cool 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.

***This is all from a non-enforceable FDA Guidance to Industry
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Sandi K
Hero Member
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Posts: 7365


« Reply #3 on: September 08, 2009, 08:19:44 AM »

This was also being discussed in these other 2 threads.  The recent letters submitted in the docket by Pet Food Industry and Feed Association and others were past the comment deadline and their letters had requested delay of implementation of the Registry for at least 60 days saying they needed more time to study it and get set up to use it, yada, yada, yada....apparently FDA disagreed with them because they have implemented it regardless of what PFI requested.  Its encouraging to see that......

http://itchmoforums.com/news-recall-related/pfi-wants-more-time-for-adverse-incident-reporting-starting-september-8-2009-t9103.0.html;msg135273#msg135273

http://itchmoforums.com/making-a-difference/fda-seeks-comment-on-the-reportable-food-registry-draft-guidance-t8571.0.html;msg131137#new

Of course, the more I think about this, it could be they didnt want to delay implentation of the whole thing just for PFI and other pet food related industries so went ahead and implemented but perhaps might have given them special permission behind the scenes to not use for it a certain period of time?  Just a thought..nothing would surprise me.... Undecided
« Last Edit: September 08, 2009, 08:53:27 AM by Sandi K » Logged
3catkidneyfailure
Guest
« Reply #4 on: September 08, 2009, 08:39:28 AM »

Thanks, Sandi. Maybe a threads merge in order, maybe?

Crap!!!

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm180761.htm

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.

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3catkidneyfailure
Guest
« Reply #5 on: September 08, 2009, 08:40:51 AM »

Further crap:

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074694.htm

Diversion of Adulterated Food to Acceptable Animal Feed Use (CPG 7126.20) Page 376 http://bit.ly/7GU81 "handled on an ad hoc basis"


Looks like to me: Industrial chemicals, filth, bacteria, drug residues not OK for humans headed into pet food garbage products -
http://bit.ly/7GU81
« Last Edit: September 08, 2009, 09:32:11 AM by 3catkidneyfailure » Logged
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