Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing of Juice

Forms and Documents

Document Name	Status
0466 Supporting Statement Final 3-17-2017.docx Supporting Statement A	2017-03-17

IC Document Collections

IC ID	Document Title	Status
6161	Sanitation Standard Operating Procedures Monitoring and Correction Records	Modified
194711	Recordkeeping: Verification and Validation of HAACP System and Hazard Analysis	Removed
181365	Hazard Analysis and Critical Control Point Plan	Modified
181364	Application to Imported Products	Modified
181363	Validation of the Hazard Analysis and Critical Control Point Procedures or Hazard Analysis	Modified
181362	Corrective Actions and Vertifications	Modified
181361	Monitoring Critical Control Points	Modified
181360	Hazard Analysis	Modified

ICR Details

OMB Control No: 0910-0466	ICR Reference No: 201702-0910-003
Status: Historical Active	Previous ICR Reference No: 201401-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing of Juice
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: 04/25/2017
	Date Received in OIRA: 03/21/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2020	36 Months From Approved	04/30/2017
Responses	21,980,369	0	21,978,653
Time Burden (Hours)	461,426	0	358,466
Cost Burden (Dollars)	0	0	0

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Abstract: FDA`s regulations in part 120(21 CFR part 120) mandate the application of HACCP procedures to fruit and vegetable juice processing. HACCP is a preventive system of hazard control that can be used by all food processors to ensure the safety of their products to consumers. A HACCP system of preventive controls is the most effective and efficient way to ensure that these food products are safe. FDA's mandate to ensure the safety of the nation`s food supply is derived principally from the Federal Food Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 321, et seq.). Under the Act, FDA has authority to ensure that all foods in interstate commerce, or that have been shipped in interstate commerce, are not misbranded or deceptively packaged; under section 701 (21 U.S.C. 371), the Act authorizes the Agency to issue regulations for its efficient enforcement. The Agency also has authority under section 361 of the Public Health Service Act (42 U.S.C. 264) to issue and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases from one State to another State.

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Authorizing Statute(s): US Code: 42 USC 264 Name of Law: PHS Act
   US Code: 21 USC 321 et seq. Name of Law: FFDCA
  

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:
	81 FR 59636	08/30/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 13811	03/15/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Application to Imported Products
Recordkeeping: Verification and Validation of HAACP System and Hazard Analysis
Hazard Analysis
Corrective Actions and Vertifications
Sanitation Standard Operating Procedures Monitoring and Correction Records
Hazard Analysis and Critical Control Point Plan
Monitoring Critical Control Points
Validation of the Hazard Analysis and Critical Control Point Procedures or Hazard Analysis

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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	21,980,369	21,978,653	0	0	1,716	0
Annual Time Burden (Hours)	461,426	358,466	0	0	102,960	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: This collection of information has increased by 1,560 respondents, 1,716 responses, and 102,960 hours. This adjustment in burden is a result of an error that occurred with the last submission of extension. The recordkeeping burden requirement for writing an HACCP plan under sections 120.8(a), 120.8(b), and 120.12(a)(3), (b) and (c) was inadvertently left off of the burden chart in Item 12 in the supporting statement (but was included in the write up in Item 1). The adjusted total burden requested is now 461,426 recordkeeping hours (358,466 previous recordkeeping hours plus 102,960 new recordkeeping hours). The previously approved ICR submitted to OMB included eight ICs entered in ROCIS. Upon this submission, we added one IC (left out of the previous submission for extension, in error). With this submission we have also consolidated four of the ICs into two ICs. Therefore, for this submission of extension this ICR now has seven ICs. The information collection activities and the burden associated with each IC, however, remain broken down in this supporting statement and in the table in Item 12.

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Annual Cost to Federal Government: $44,150

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]? No

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: 03/21/2017

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