RFR proposed SRP modifications_12April12

P 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