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Author Topic: FDA Seeks Comment on the Reportable Food Registry Draft Guidance  (Read 677 times)
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JustMe
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Elvis


« on: June 16, 2009, 03:08:44 PM »

I won't pretend to understand what this means, whether JohnQPublic can comment or not.

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm167267.htm

FDA Seeks Comment on the Reportable Food Registry Draft Guidance
June 16, 2009

The U.S. Food and Drug Administration (FDA) is asking for comment on its Reportable Food Registry (RFR) draft guidance for the food industry. The RFR applies to all FDA-regulated categories of foods, including animal feed. Only infant formula and dietary supplements are exempt from the RFR requirements.

The RFR requires a responsible party to file a report through an FDA internet portal when there is reason to believe that an adulterated food will cause serious adverse health consequences or death to humans or animals. "Responsible party" is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. Federal, state, and local government officials may also use the portal to report information that may come to them about such foods.  The RFR and electronic portal are scheduled for implementation on September 8, 2009.

The congressionally-identified purpose of the RFR is to provide a "reliable mechanism to track patterns of adulteration in food [which] would support efforts by the FDA to target limited inspection resources to protect the public health."

The draft guidance explains the following:

Who must submit RFR reports of adulterated foods to FDA,
How, when and where RFR reports may be submitted,
What information the RFR reports must include, and
What steps must be taken to notify others in the supply chain of the adulterated food. 
Interested persons may submit written comments on or before July 27, 2009, to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  Electronic comments may be submitted to http://www.regulations.gov. Identify all submissions to the docket with the following docket number: FDA-2009-D-0260. Single copies of the draft guidance are available by written request to the Office of Food Defense, Communication and Emergency Response, CFSAN (HFS-005), FDA, 5100 Paint Branch Pkwy., College Park, MD 20740. Please include two self-addressed adhesive labels to assist that office in processing your request.

For questions regarding this draft document, please contact Mr. Kim Young, Center for Veterinary Medicine (CVM), at 240-276-9207.

     
-Additional Information
Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007; Draft Guidance 
Federal Register Notice of Availability; Draft Guidance: Questions and Answers Regarding the Reportable Food Registry 
- Contact Us240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855
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menusux
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« Reply #1 on: June 16, 2009, 03:18:14 PM »

UH-HUH!  Smiley

"Interested persons may submit written comments on or before July 27, 2009, to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  Electronic comments may be submitted to http://www.regulations.gov. Identify all submissions to the docket with the following docket number: FDA-2009-D-0260. Single copies of the draft guidance are available by written request to the Office of Food Defense, Communication and Emergency Response, CFSAN (HFS-005), FDA, 5100 Paint Branch Pkwy., College Park, MD 20740. Please include two self-addressed adhesive labels to assist that office in processing your request."
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Sandi K
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« Reply #2 on: June 16, 2009, 09:04:36 PM »

I think this is part of the FDA Amendment Act that we had all been wanting, the early warning system so to speak.  But this already has problems that concerns me, one being the person that notifies them of a problem would be the pet food company or manufacturer but they also say state health officials but does that mean veterinarians too?  Second, when you read the details, it looks like because they call this a guidance, it is not enforceable by FDA or anything so it begs me to ask, what is the incentive of them even using this?  And then it says this:  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.  I also cant tell when they say state health officials, if that means veterinarians? 

This is the link that gives the details, can you tell me if Im reading this wrong?  http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm165626.htm

We all need to submit our written comments and also cc: to our reps asking how this got so watered down and where are repercussions for these companies not reporting unsafe pet food and whether veterinarians can also use this to report food problems.
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Sandi K
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« Reply #3 on: July 01, 2009, 01:43:58 PM »

I learned a little more about this Reportable Food Registry and it does apply to pet food manufacturers however it appears if you read it, that it leaves things open for them to do things a different way if it meets the requirements set forth by FDA.  Also, its not mandatory best I can tell.  And it says the people who can report to the Food Registry include state, local and fed officials which I dont think includes vets.  I encourage everyone to read this and make comments to FDA about changes you want to see with this such as mandatory registration, allowing vets to be included in the people who can file a report on the registry re: pet food.......the deadline is 7-27-09 and this was one of the things that were supposed to help with so called early warning system that we had all wanted.  Once again, its all so watered down I doubt it will mean anything but we can still voice our concerns to FDA about it not being enough.

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm167267.htm

http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2009-D-0260
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Sandi K
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« Reply #4 on: July 26, 2009, 09:27:01 AM »

It appears the deadline for writing comments in for this is tomorrow so I wanted to bump this up in case anyone still wants to do that. 
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Sandi K
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« Reply #5 on: July 28, 2009, 11:32:59 AM »

Sigh....I tried submitting my comments/questions on the Reportable Food Registry yesterday and it wouldnt take them...kept getting an "error on page" message but it wouldnt say what that error was.  I tried contacting one person from FDA and they said they didnt know, that its not an FDA site, yada, yada, yada. It may not be an FDA site but its a site they use to solicit comments so in my opinion, they should know or should be able to direct you to someone who can help get the comments submitted....real helpful, once again, FDA, thanks a bunch.    Tongue  I did send a message to the "contact us" button they have at that site but so far no response.....I cant figure out why it wouldnt accept my comments....it does ask you to identify what group you represent and I marked individual consumer....maybe they arent accepting comments from consumers on that Registry....I dont know if there is someone else I can contact about it.....sigh...why does it all have to be so d--n complicated.
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Sandi K
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« Reply #6 on: July 28, 2009, 08:27:03 PM »

An update, I got a response back from the "contact us" e:mail I sent.....they said the comment period for the Food Registry is closed... Roll Eyes  OK Im trying to hold back my smartypants comments but its realllllly hard...excuse me or squeeze me or whatever they say, but I know the comment period is closed as of today but it was open yesterday when I was trying to submit my comment...as I said in my message to them.  So now Ive been told to contact another person about it....sigh... Roll Eyes Tongue
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