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Author Topic: PFI Wants More Time for Adverse Incident Reporting Starting September 8, 2009  (Read 6254 times)
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menusux
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« on: September 02, 2009, 08:28:41 AM »

http://www.allaboutfeed.net/news/feed-and-pet-food-sector-want-more-time-for-new-rules-3558.html

Allaboutfeed September 2, 2009

Feed and pet food sector want more time for new rules

"Three major national organizations representing the grain, feed and feed ingredient, grain processing and pet food industries have joined in urging the Food and Drug Administration (FDA) in the US to phase in implementation of its new electronic portal, through which facilities will be required to report food- or feed-product safety incidents.
In a 13-page statement submitted recently to FDA, the National Grain and Feed Association (NGFA), National Oilseed Processors Association (NOPA) and Pet Food Institute (PFI) objected to FDA’s announced plan to require firms to begin reporting through the electronic portal – known as the Reportable Food Registry – on Sept. 8.

"That is the same date FDA intends to first make the portal available for use. Instead, the three organizations urged FDA to either further extend by an additional 45 to 60 days the effective date for reporting food- or feed-safety incidents through the electronic portal, or to exercise enforcement discretion for a comparable period to provide an appropriate and necessary phase-in period.


"The three organizations noted that during a phase-in period, FDA could continue its current policy of strongly encouraging facilities to report food/feed safety incidents through existing mechanisms, such as by notifying the appropriate FDA district office."

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm165626.htm

Reportable Food Registry Information

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm165569.htm

The RFR is scheduled for implementation on September 8, 2009, and applies to all FDA-regulated categories of foods, including dietary supplements. Only infant formula is 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 (other than infant formula) 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 draft guidance is in a question and answer format and explains:

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.

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterIVFood/ucm088549.htm
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Sandi K
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« Reply #1 on: September 02, 2009, 09:09:05 AM »

I am so steaming mad over this right now, I have to be careful what I write.   Angry  There was a deadline of July 27th for comments to be submitted.  I tried submitting my comments on that last day and the system wouldnt accept my comments.  I contacted I dont know how many people with FDA about this asking if I could still submit them, I received one call back saying they didnt think so but they would check into it and let me know and I never heard back.  So now I read the actual letter filed by PFI and their co-horts and that letter is dated August 12, 2009 and postmarked August 13, 2009!  I thought the comment period was closed on July 27th, which is what they told me.  You can view their letter in detail at this site, just click on the file:  http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a0d223



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bug
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RIP little angel Katey


« Reply #2 on: September 02, 2009, 09:22:48 AM »

This is only as good as the person reporting it. If you have unscrupulous people at the helm, nothing will be reported.
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My little babies, you'll always be in my heart. Mom will see you later. Look after each other, ok?
menusux
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« Reply #3 on: September 02, 2009, 09:40:18 AM »

http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a0d223&disposition=attachment&contentType=pdf

The link above is a direct one to the pdf letter file, which is too large to be attached here at Itchmo.  When you click the link, you'll be asked what you want to do with this file--open it or save it.  If you open it, you'll be able to view the letter (and can save it after that if you like).

Title
 National Grain and Feed Association (NGFA), National Oilseed Processors Association (NOPA) and Pet Food Institute (PFI) - Comment
 
Date Posted
August 23 2009, at 12:00 AM Eastern Daylight Time


Comment Start Date
June 11 2009, at 12:00 AM Eastern Daylight Time

Document Type
COMMENT

Comments Due
July 27 2009, at 11:59 PM Eastern Daylight Time


Document Sub-Type
C-Comment

Document Date
August 12 2009, at 10:17 PM Eastern Daylight Time
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Sandi K
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« Reply #4 on: September 02, 2009, 09:44:33 AM »

This is only as good as the person reporting it. If you have unscrupulous people at the helm, nothing will be reported.

Did you submit that comment to the guidance?
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Sandi K
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« Reply #5 on: September 02, 2009, 09:49:23 AM »

Yeah Menusux, it clearly showed the envelope with postmark dated 8-13-09 on that joint letter from PFI, NGFA & NOPA....the deadline for submitting comments was supposed to have been 7-27....  Angry
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menusux
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« Reply #6 on: September 02, 2009, 10:11:34 AM »

We have more "after closing" remarks on the subject.  This one is from Darling Industries, the renderers, and has some REALLY interesting comments in it:

http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a03ee0

Title
Darling International Inc. - Comment

Date Posted
August 11 2009, at 12:00 AM Eastern Daylight Time
 
Submitter Category
Animal Feed Industry - C0007

Document Type
COMMENT

Document Sub-Type
EREG-Electronic Regulation from Form

Country
United States

Organization Name
Darling International Inc.

Document Date
July 30 2009, at 12:31 PM Eastern Daylight Time


Remember that as shown on PFI's comments, the closing date for them was July 27, 2009.  We see that clearly on the PFI comment at

http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a0d223

But not here..... Roll Eyes

http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a03ee0&disposition=attachment&contentType=pdf

Again, this link works as the PFI one does.  It will ask if you want to open or save the pdf file when you click it.

Page 2

"Darling encourages the FDA to consider the following points as it finalizes its Draft Guidance:

1. Recognize its own earlier guidance that standards for animal feed and human food differ.

(More attempted justification of this in letter.)

2 .Adulterated food can safely be used in animal feed if the adulterated food has undergone reconditioning that destroys, removes or reduces to an acceptable level the adulterant prior to its use as an animal feed.
 
Darling continues on to wonder about whether landfills won't fill up too quickly if the food that's considered unacceptable for other uses because of adulteration(s) is not recycled into feed or pet food.

Am wondering if Darling's thinking goes further--perhaps cemeteries are filling up too quickly and those either buried or to be buried in them ought to be recycled for some purpose, and am guessing it's a not in one containing any of my friends or loved ones affair. 

If nobody wants to eat what comes through the doors of Darling, why should anyone or anything else?  Angry

More on the way.... 
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menusux
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« Reply #7 on: September 02, 2009, 10:37:36 AM »

http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809fc35c

Title
American Feed Industry Association (AFIA) - Comment

Date Posted
July 28 2009, at 12:00 AM Eastern Daylight Time

Submitter Category
Association - D0003

Comment Start Date
June 11 2009, at 12:00 AM Eastern Daylight Time

Document Type
COMMENT

Comments Due
July 27 2009, at 11:59 PM Eastern Daylight Time

Document Sub-Type
EREG-Electronic Regulation from Form

Country
United States

Organization Name
American Feed Industry Association

Document Date
July 27 2009, at 02:44 PM Eastern Daylight Time

AFIA got theirs in on time but what's keeping them burning the midnight oil over there are questions of a butt-covering nature:

http://www.regulations.gov/search/Regs/contentStreamer?objectId=09000064809fc35c&disposition=attachment&contentType=pdf

Again--this will directly bring up the pdf letter file and you'll be asked if you want to open or save it.

Page 2

"One major deficiency of the draft guide is the lack of specific examples of a "reportable food, and, smiliarly, a list of specific examples that are not "reportable foods" from the feed industry perspective.

"Another major concern of AFIA is FDA's ability to maintain confidentiality of the data that it reviews and collects via the electronic portal.  AFIA is particularly concerned that FDA maintain the confidentiality of a facility's quality control description, including, but not limited to laboratory methods and laboratories utilized, customer and supplier lists and brand named equipment used at the facility.

"If a state official reports a reportable food to the FDA, will the company producing that food have access to that record to determine what is and is not factual and be able to amend that record? 

"Similarly, will FDA communicate with a firm holding the reportable food to ensure that any information the agency releases is accurate and does not compromise the confidential information of the firm regarding its products?"


Some specific questions, along with a suggestion that "raw materials" be defined as just about everything in the book and that said "raw materials" should be classed as "non-reportable" foods.
 
If all of this is so confidential, why not simply keep their products off the shelves, pack in the food business and see if the CIA might take them on as a whole?  Angry
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bug
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RIP little angel Katey


« Reply #8 on: September 02, 2009, 11:54:10 AM »

This is only as good as the person reporting it. If you have unscrupulous people at the helm, nothing will be reported.

Did you submit that comment to the guidance?

I guess I would have, had I known anything about this. This is American regulation and aside from just finding out about it today, I'm not sure they would have accepted my comment (unless you were joking  Undecided).
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My little babies, you'll always be in my heart. Mom will see you later. Look after each other, ok?
menusux
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Posts: 4456



« Reply #9 on: September 02, 2009, 12:07:21 PM »

There's nothing keeping anyone who has something to say, wherever they live, from making a comment. 

http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480a03ee0

Here's the link to submit a comment--they are still accepting them, AFAIK, as I get the ready to go form at that link.  Both Darling and PFI's comments were submitted after the original July 27, 2009 deadline--theirs were accepted and we're now reading them.
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bug
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RIP little angel Katey


« Reply #10 on: September 02, 2009, 12:28:20 PM »

Oh, super. Thanks menusux.
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My little babies, you'll always be in my heart. Mom will see you later. Look after each other, ok?
Sandi K
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« Reply #11 on: September 02, 2009, 04:16:49 PM »

I dont know, if anyone tries and is successful let me know....I tried on the very last day and it didnt work and I was told comments were no longer being accepted.  The difference between the PFI and Darling comments is those were submitted in writing not thru the electronic system.  They then scan those letters to the docket.  So just the fact they were scanned and posted to the docket makes me think their letters were accepted. 



There's nothing keeping anyone who has something to say, wherever they live, from making a comment. 

http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480a03ee0

Here's the link to submit a comment--they are still accepting them, AFAIK, as I get the ready to go form at that link.  Both Darling and PFI's comments were submitted after the original July 27, 2009 deadline--theirs were accepted and we're now reading them.
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menusux
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« Reply #12 on: September 02, 2009, 04:49:29 PM »

Just opened another form of the Darling Comments:

http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a03edf&disposition=attachment&contentType=xml

This one also will ask you if you want to open or save the file when you click the link.

As of: September 02, 2009
Tracking No. 80a03edf
Comments Due: January 01, 0001
Late comments are accepted

This was taken from the Docket Folder

http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2009-D-0260

same as the rest.  Huh
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Sandi K
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« Reply #13 on: September 02, 2009, 07:59:27 PM »

There is another thread here about this Registry that people might not have seen:

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

I dont know whether people from other countries could have submitted comments or not, I think a good thing to always consider is if one wants to submit comments, go ahead and try and if it wont accept comments from someone in another country, it will indicate that in some way Im sure.  It does bring up an interesting fact, Canada gets pet food from the U.S. and vice versa, so does this Registry also apply to pet food manufacturers in Canada?  I would hope so but I dont know.  


This is only as good as the person reporting it. If you have unscrupulous people at the helm, nothing will be reported.

Did you submit that comment to the guidance?

I guess I would have, had I known anything about this. This is American regulation and aside from just finding out about it today, I'm not sure they would have accepted my comment (unless you were joking  Undecided).
« Last Edit: September 02, 2009, 08:01:25 PM by Sandi K » Logged
Sandi K
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« Reply #14 on: September 03, 2009, 07:13:42 AM »

There's nothing keeping anyone who has something to say, wherever they live, from making a comment. 

http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480a03ee0

Here's the link to submit a comment--they are still accepting them, AFAIK, as I get the ready to go form at that link.  Both Darling and PFI's comments were submitted after the original July 27, 2009 deadline--theirs were accepted and we're now reading them.

Just wanted to let you know I was able to submit comments last night through this link provided by Menusux.  But there are a couple of things that make me think it wont be accepted...one was that I received a computer-generated statement back saying it will go thru an approval process first and second, when I first tried to comment back in July, it was through the main docket link and it had a comment button, that same link no longer has a comment button open, Im sure because the comment period is now technically closed.  I actually think its a fluke in their system they dont know about about, that is allowing comments thru the Darling Int'l link....good find Menusux!  Grin
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