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Author Topic: FDAAA & AFSS - DOCKET  (Read 162 times)
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Offy
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« on: June 16, 2008, 12:57:45 PM »

The recent docket filings from the industry are interesting:

American Feed (Sellers) - that was more interesting than I had anticipated.
Canadian folks siding up with PFI.


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480517e94&disposition=attachment&contentType=pdf

http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2007-N-0442


And this:
Comment Tracking Number   806255c1 
First Name   
Last Name   
Submitter Category   Private Industry - C0003 
Country   United States 
State or Province   
Organization Name   Micro-Tracers,Inc. 
Third Party   
General Comment 
Comment  In regulating formula feeds, the FDA should require mixer performance validation
data as well as cross-contamination validation data, especially for feedmills mixing
drugs in feeds.

The cost of generating such data, at least once each year and preferably more
often, is trivial. The benefits to the public potentially great. I know of many
customers in Asia who validate mixing once each month and one major feed
manufacturer in Mexico who validates mixing once each week.

The FDA Proposed in 1991 that registered feed manufacturers provide mixer
performance validation data but the American Feed Industry Association filed a
Petition for Stay of Action arguing the legal burden of proof was on the government
to prove commercial feed manufacturers were operating dangerously with drugs,
not on the industry to prove they were operating safely. The FDA withdrew the
Compliance Policy Guide requiremnt and now we are 17 years later and nothing
has happened.

The European Union requires such data. The Province of Quebec has since 1987
required such data. Canada now requires such data and I believe Japan is has for
yars required a chemical assay of every lot of medicated feed (a max. of 120
tonnes making a lot).

It is now right the FDA should require such data.

Actually, the FDA should also require that all feedmills mixing medicated feeds be
registered with it. This requirement was eliminated in 1986. All other advanced
countries require registartion. Why not the USA/

Thank you for connsidering my views.

With best wishes.

David A. Eisenberg
President
Micro-Tracers,Inc.
1370 Van Dyke Avenue
San Francisco, Ca. 94124 
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kb
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« Reply #1 on: June 16, 2008, 04:54:20 PM »

Hmm, interesting comment.  Looks like the company does testing for mixing quality and mixer cleanout.  What an idea!  Wink
http://www.microtracers.com/
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Klondike
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« Reply #2 on: June 16, 2008, 06:17:31 PM »

I wondered if medicated feed, either as a mix-up or cross-contamination was the source of the acetaminophen found in tests.  Very interesting and enlightening comment there, Offy.  Dr. Sandman has a term, "corporate dinosaurs", which IMO applies very nicely to the PFI and animal feed industry in America.

When those genetic scientists start hatching their dinosaur eggs, they might be surprised at what pops out of one:




What are they suggesting here in this industry comment?  Dumbing down the labels so we can't tell if menadione is the form of vitamin K they use?

American Feed Industry Association - Comment
"AFIA is aware that consumers have expressed some concern with the use of named minerals and vitamins and some “by-product” nomenclature. AFIA suggests that the agency could consider allowing the use of common vitamin names (e.g. Vitamin K, Vitamin B2) or other such simple vitamin names in lieu of chemical vitamin names. However, FDA should work in close coordination with the Association of American Feed Control Officials (AAFCO), since any such
changes without corresponding changes to state pet food regulations would cause serious disruption in the marketplace."
« Last Edit: June 16, 2008, 06:21:57 PM by Klondike » Logged

"Our country is now geared to an arms economy bred in an artificially induced psychosis of war hysteria and an incessant propaganda of fear."
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Offy
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« Reply #3 on: June 17, 2008, 12:16:37 PM »

It seemed there are some really mixed messages in that docket entry.

Quote
"AFIA is concerned about the impact on the animal food industry of the Food and Drug Administration Amendments Act (FDAA) of 2007. In AFIA’s discussions with the principal sponsor of the Senate bill that became incorporated into FDAAA as Section 1002, it is clear that pet food was the sole focus and intent of Section 1002 of the act and extension of this section to all animal food would ignore this clear congressional intent."


""The pet food labeling system currently in use in the U.S.A. has evolved over several decades and is required under state pet food regulations. Federal changes to pet food label requirements would cause serious disruption with the state requirements, as FDA was not provided any federal preemption authority in FDAAA."


"AAFCO spent several years discussing and drafting feeding directions requirements for both pet food and non-pet animal food. The consensus reached and adopted by 18 states has been well-received and should not be changed."

 (snork!! 18 states do not a majority make.. oh right, when they finished there weren't that many states in the USA  Grin)

Quote
AFIA believes the development of such a mandatory regulatory program (i.e. AFSS) is premature. The agency should seriously consider a cGMP-(current good manufacturing practices) type approach to pet food regulation until the agency and state investigators become familiar with both the pet food industry and cGMP regulations developed for that specific industry. Development of this type of national regulatory program would allow time for both the industry and regulators to adjust to a “next-step” approach beyond cGMPs. In fact, most firms have in place similar programs, and although, many have risk-based approaches, development of a regulatory program utilizing AFSS as a basis would be a major rule for the industry and the cost/benefit ratio would be extremely high for an industry with rare safety issues. Moreover, such standards would hamper technical innovation by likely applying a “one size fits all” standard program to the highly innovative and competitive pet food industry.

In response to FDA’s request for information on what to include in an approach to regulations,
AFIA believes the most comprehensive list of criteria to include comes from those in the medicated feed cGMP regulations (Title 21, C.F.R., Part 225). These have served the agency and affected industry well for over 35 years and resulted in very few contamination events.

AFIA urges the agency to seriously consider the utilization of these categories in development of
cGMP regulations for pet food manufacturers. "

Maybe they've halfway realized that the FDAAA will be impacting them in ways they didn't consider when this was slammed into one package.  But, isn't AAFCO the one writing the FDA to begin with that got it all wrapped into this pile of inept reviews that cannot accomplish anything for centuries?
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Katie
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« Reply #4 on: June 18, 2008, 02:29:02 PM »

These have served the agency and affected industry well for over 35 years and resulted in very few contamination events.

I love this line! how would they know about contamination; if they don't check for it. And very few contamination events...doesn't matter how many numbers were affected I guess if it's just one event.

Katie
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