FDA's regulations in 21 CFR part 12
mandate the application of hazard analysis and critical control
point (HACCP) principles to the processing of seafood. HACCP
procedures yeild products that are known, with a high degree of
confidence, to be free of the food safety hazards controlled b a
processor's plan. Part 123 mandates recordkeeping related to
seafood processing, sanitation control, and corrective actions, but
the regulation does not require any reporting of this data to FDA
or any other government agency. The HACCP records compiled and
maintained by a seafood processor or importer primarily consist of
the periodic observations recorded at selected monitoring points
during processing and packaging operations. All respondents are
business firms that process or import fish and fishery products for
the U.S. market.
The increase in burden is due
to the increase in the number of processors and importers.
$10,634,250
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
0354 cover memo 3-6-2007.doc
0354 21cfr123.12.pdf
Procedures for the Safe Processing and Importing of Fish and Fishery Products