Reportable Food (human and animal) Mandatory View

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RFR_proposed_SRP_modifications_12April12[1]

Reportable Food (human and animal) Mandatory View

OMB: 0910-0645

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Proposed Changes to Reportable Food Registry (RFR)

OMB control No. 0910-0645

roposed Field Text

Mandatory or Optional Input

Authority if Mandatory

Justification for Emergency Clearance

Reason this food is reportable (agent)

Mandatory

(e)(4)

Public harm

What did your investigation identify as the root cause of the problem (if you were required to conduct an investigation under section 417(d)(1)(B) of the FD&C Act)?

Mandatory

(e)(5)


(Note also needs a “N/A” option in drop down box for those not required to investigate)

FSMA

How did you determine which products/lots/batches were affected?

Mandatory

(e)(4) and (5)

Public harm

To the best of your knowledge, has all of the reportable food been removed from commerce?

Mandatory

(e)(6)

Public harm

What corrective actions have been taken to prevent future occurrences?

Optional


Public harm

Product Commodity Type

Mandatory

(e)(3)

FSMA

Manufacturing/Production Date(s)

Mandatory

(e)(3) and (4)

Public harm

Use-by dates, if any, or approximate Shelf Life

Mandatory

(e)(7)


(Tying this to use-by dates on package links this to element 7,

which explicitly includes use-by dates)

Public harm

Was product treated to reduce microorganisms

Mandatory (but conditional)

(e)(3) and (4)


(Note- needs to be conditional if mandatory- should only appear if reporter has selected

one of the microbial hazards as the answer to “reason this food is reportable (agent).”

That way this is clearly about the nature of the adulteration as well as the description

of the product.)

FSMA

Microbial Reduction Treatment Details

Mandatory (but conditional)

(e)(3) and (4)


(Conditional for micro hazards only and only after “yes” answer to

was product treated to reduce microorganisms?”)

FSMA

Is a Bacterial Isolate Available for collection?

Mandatory (but conditional)

(e)(4)


(Conditional for micro hazards only.)

Public harm

Animal Species Intended for

Mandatory

(e)(3) and (4)

Public harm

Life Stage of Animal Intended for

Mandatory

(e)(3) and (4)

Public harm

Have you notified all immediate previous sources of this reportable food?

Optional


Public harm

Have you notified all immediate subsequent recipients of this reportable food?

Mandatory

(e)(6)

Public harm


File Typeapplication/msword
File TitleProposed Field Text
AuthorJulie.Lovas
Last Modified ByBean, Domini
File Modified2013-01-30
File Created2013-01-30

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