Procedures for the Safe Processing and Importing of Fish and Fishery Products; 21 CFR Part 123

Forms and Documents

Document Name	Status
SS-0910-0354#2.doc Supporting Statement A	2010-06-24

IC Document Collections

IC ID	Document Title	Status
5969	Recordkeeping: Requirement for Processors to Prepare , Implement & Maintain Records of a Written HACCP Plan If Hazard Analysis Shows Food Safety Hazzads Are Likely to Occur	Modified
193503	Recordkeeping: Verification Procedure Requirements for Importers of Fish and Fishery Products Offered fo Import into the U.S.	New
179133	Recordkeeping: Maintainance of Records by Importers of Seafood Products That Fish & Fishery Products Offered For Import Were Processed in Accordance With the HACCP & Sanitation Provisions	Modified
179132	Recodkeeping: Requirement for Processors to Maintain Sanitation Control Records	Modified
179131	Recordkeeping: Requirement That Processors Maintain Records of The Calibration of "Process-Monitoring" Instruments and The Performing of Any " Periodic End Product and In - Process Testing."	Modified
179130	Recodkeeping: Requirement That Processors Maintain Records of Any Corrective Action When a Deviation From A Critical Limit Occurs	Modified
179129	Recordkeeping: Requirement for Processors to Implement a Recordkeeping System That Documents The Monitoring of The Critical Control Points	Modified
179128	Recordkeeping: Requirement for Importers of Seafood Products to Verify Compliance of Imports and Maintain Records	Modified
179127	Recordkeeping: Verification Requirements for Processors That Their HACCP Plan Is Adequate to Control Food Safety Hazards	Modified
179126	Recordkeeping: Requirement For Processors To Incorporate A Corrective Action Plan Within Their Written HACCP Plan	Modified

ICR Details

OMB Control No: 0910-0354	ICR Reference No: 201006-0910-007
Status: Historical Active	Previous ICR Reference No: 200703-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Procedures for the Safe Processing and Importing of Fish and Fishery Products; 21 CFR Part 123
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/02/2010
	Date Received in OIRA: 06/30/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2013	36 Months From Approved	11/30/2010
Responses	9,860,091	0	3,551,130
Time Burden (Hours)	1,930,264	0	702,350
Cost Burden (Dollars)	0	0	0

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Abstract: 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 is a preventive system of hazard control designed to help ensure the safety of foods. The egulations were issued unde FDAs statutory authority to regulate food safety, including, section 402(a((1) and (a)(4) of the Federal Food & Drug Cosmetic Act ( 21 U.S.C.342(a)(1)and (a)(4). Certain povisions in part 123 require that processors and importers of seafood collect and record information. The HACCP records compiled and maintained by a seafood processor primarily consist of the periodic observations recorded at selected monitoring points during processing and packaging operations, as called for in a processor`s HACCP plan ( e.g., the values for processing times, temperature, acidity, etc., as observed at critical control points).

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Authorizing Statute(s): US Code: 21 USC 342(a)(1) & (a)(2) Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 18211	04/09/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 34746	06/18/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Recordkeeping: Verification Requirements for Processors That Their HACCP Plan Is Adequate to Control Food Safety Hazards
Recordkeeping: Requirement for Importers of Seafood Products to Verify Compliance of Imports and Maintain Records
Recordkeeping: Requirement for Processors to Prepare , Implement & Maintain Records of a Written HACCP Plan If Hazard Analysis Shows Food Safety Hazzads Are Likely to Occur
Recordkeeping: Requirement For Processors To Incorporate A Corrective Action Plan Within Their Written HACCP Plan
Recordkeeping: Requirement for Processors to Implement a Recordkeeping System That Documents The Monitoring of The Critical Control Points
Recodkeeping: Requirement That Processors Maintain Records of Any Corrective Action When a Deviation From A Critical Limit Occurs
Recordkeeping: Requirement That Processors Maintain Records of The Calibration of "Process-Monitoring" Instruments and The Performing of Any " Periodic End Product and In - Process Testing."
Recodkeeping: Requirement for Processors to Maintain Sanitation Control Records
Recordkeeping: Maintainance of Records by Importers of Seafood Products That Fish & Fishery Products Offered For Import Were Processed in Accordance With the HACCP & Sanitation Provisions
Recordkeeping: Verification Procedure Requirements for Importers of Fish and Fishery Products Offered fo Import into the U.S.

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	9,860,091	3,551,130	0	0	6,308,961	0
Annual Time Burden (Hours)	1,930,264	702,350	0	0	1,227,914	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $639,900

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 06/30/2010

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