WHY WERE THESE GUYS ALLOWED TO COMMENT AFTER CLOSURE OF COMMENT PERIOD?
And consumers just getting notice today!!!!!!!!!
AFIA pdf content:
http://www.regulations.gov/search/Regs/home.html#documentDetail?D=FDA-2008-N-0546-0018.1February 19, 2010
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
RE: Comments submitted in reference to Docket No. FDA-2008-N-0546
Now celebrating its Centennial year, the American Feed Industry Association (AFIA),
based in Arlington, Va., is the world's largest organization devoted exclusively to
representing the business, legislative and regulatory interests of the U.S. animal feed
industry and its suppliers. AFIA also is the recognized leader on international industry
developments. Members include more than 500 domestic and international companies
and state, regional and national associations. Member-companies are livestock feed and
pet food manufacturers, integrators, pharmaceutical companies, ingredient suppliers,
equipment manufacturers and companies which supply other products, services and
supplies to feed manufacturers .
We are writing in response to the Agency's Comment Request; Pet Food Early Warning
Recall Rational Questionnaire as Part of the MedWatchPl. Portal and Rational
Questionnaire Initiative, Docket No. FDA-2008-N-0546. Many AFIA members
manufacture pet food and supply ingredients to pet food manufacturers, therefore, this
collection of data could have an effect on these firms.
The information collected through the MedWatchPl. Portal is key to the successful
determination of whether a product has a potential adverse issue. Therefore, AFIA
believes it is crucial all of the information be provided by the submitter and the data
collected on a potential concern be shared with the company who produced or marketed
the product.
AFIA is concerned the name of this report is not reflective of all products consumed by a
pet in the household. That is, "pet food" is only a portion of the products that might be
consumed by an animal . Most consumers think of "pet food" as a dry, extruded kibble F DN - .2 0 aB-N-aSy&I"' 2 101 Wilson Boulevard, Suite 916, Arlington VA 22201 USA
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only. Therefore, the name of the document and the questions should reflect pet foods,
treats, pig ears, supplements, and other items consumed by pets.
Additionally, it should be clear the MedWatchri. Portal submission is to report suspected
or potential product issues or suspected adverse events. "Adverse events" should be
clearly defined for consumers in the form. In short, it should be clear to the submitter the
issue is not necessarily a direct result of the food consumed. Consumers frequently
forget the fact that while "pet food, treats, pig ears, supplements, etc." have been
consumed, the dog or cat also may have consumed other foods or even rodents, rabbits,
birds etc. Therefore, it should be required of the submitter to identify if consumption of
other foods or animals occurred .
The "reporter" is not a preferred term in this instance. A more appropriate term would be
"submitter." In any event, the submitter should be clearly identified so the claim can be
evaluated and all facts can be ascertained. Therefore, contact information should not be
optional, but instead mandatory.
In regards to the form, the following ideas should be captured:
Regarding "what type of report are you submitting" the terms, "adverse event,
product problem, or both." are unclear. Submitters may be reporting anything
from a lethargic animal to vomiting to the death of a pet. The list should be
expanded to include a number of different scenarios as opposed to simply an
"adverse event or "product problem, or both."
To better clarify "indicate any other parties that you notified about this issue," the
drop down list should say "veterinarian, manufacturer, state or store where
purchased."
The "Affected Animal Information" should be listed after the "Product
Information."
Additional space and/or instructions to fill out another form should be provided so
the submitter can address multiple pet households. "Animal name/identifier"
does not appear to have the option to list multiple pets.
Under "species" and "breed" it is assumed there will be a drop down list
providing options for the submitter.
"Date of death" should be followed by "(if applicable)."
In order to add clarity for the consumer, the "RJPC from label" should contain a
picture so consumers can understand the required information.
It is unclear what package types are going to be listed . Many consumers are
unaware of differences between pouches and canned products and may simply
refer to them as "wet." Therefore, there should be a comprehensive drop down
menu representing all package types and "other."
"Package size" should indicate whether the product was purchased collectively in
a case or multi-pack.
To help distinguish between a possible manufacturing issue and a possible
individual bag problem it is important to understand if the package was damaged.
Therefore, additional questions should be added: Was the package damaged?
Were there abnormalities in the appearance and/or smell of the food? Was this
the first feeding from the bag?
The phrase "if the product was reconstituted, what is the percentage of the product
that is water" will be lost in consumer translation and should therefore be in
simple terms such as "did you add water to the product before feeding, and if so,
how much?"
"Describe how the product was used or administered" should be "describe how
the product was fed."
Under "firm/organization name" it needs to be apparent this is the firm or
organization "from the label: "
"Product lots" information needs to be moved to just below the product name.
The "lot number" and "expiration/use-by date" are critical pieces of information
that should be mandatory. Additionally, a picture needs to illustrate the type of
information needed and where it might be found on the label.
In regards to "was a veterinarian consulted," descriptions regarding the animal's
medical status should be determined with "is the animal up to date on veterinary
visits and vaccinations?"
Finally, it is unclear what will prompt action by the FDA or what that action will be.
AFIA encourages the Agency to be open in lines of communication with the respective
company and share details of the potential concern so companies can use due diligence in
the evaluation of consumer concerns. In conclusion, AFIA is committed to working with
the Agency in finalizing the questionnaire and hopes to see the results of this commenting
period in another notice for comment.
Respectfully submitted,
~c
Jac~rod H. Kersey a
Director, Ingredients and State Legislative AM