Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
NEW Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption SS.pdf	Supporting Statement A	Uploaded 2016-05-13	Available
Produce Final RIA.pdf	Supplementary Document	Uploaded 2016-05-06	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
221410	ANNUAL Disclosure		Unchanged
221409	ONE TIME Disclosure		Modified
221408	ANNUAL Recordkeeping; documentation supporting compliance w/§ 112.2		Unchanged
221407	ANNUAL Recordkeeping related to sprouts		Unchanged
221406	ANNUAL Recordkeeping; Testing requirements for sprouts		Unchanged
221405	ANNUAL Recordkeeping; Records relating to agricultural water		Unchanged
221404	ANNUAL Recordkeeping; Testing requirements for agricultural water under §§ 112.44 and 112.45		Unchanged
221403	ANNUAL Recordkeeping; training under § 112.30		Unchanged
221402	ANNUAL Recordkeeping; Exemptions under § 112.7		Unchanged
221401	ONE TIME Recordkeeping; Sprouts - documentation of data and variances		Modified
221400	ONE TIME Recordkeeping; Sprouts - establishment of environmental monitoring and sampling plans		Modified
221399	ONE TIME Recordkeeping; agricultural water - documentation of scientific data		Modified

ICR Details

OMB Control No: 0910-0816	ICR Reference No: 201605-0910-009
Status: Historical Active	Previous ICR Reference No: 201605-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/08/2016
	Date Received in OIRA: 05/16/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved
Responses	964,315	0	0
Time Burden (Hours)	1,513,079	0	0
Cost Burden (Dollars)	27,490	0	0

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Abstract: This information collection implements minimum standards for produce offered for human consumption. The rulemaking sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated because of such hazards.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 105 Name of Law: FSMA; Standards for Produce Safety
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 353 105 Name of Law: Food Safety Modernization Act; Standards for Produce for Human Consumption

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG35	Final or interim final rulemaking	80 FR 74354	11/27/2015

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 45781	01/16/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 74354	11/27/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

table that charts list of burden

IC Title	Form No.	Form Name
ONE TIME Recordkeeping; agricultural water - documentation of scientific data
ONE TIME Recordkeeping; Sprouts - establishment of environmental monitoring and sampling plans
ONE TIME Recordkeeping; Sprouts - documentation of data and variances
ANNUAL Recordkeeping related to sprouts
ANNUAL Recordkeeping; training under § 112.30
ANNUAL Recordkeeping; Records relating to agricultural water
ANNUAL Recordkeeping; Testing requirements for sprouts
ONE TIME Disclosure
ANNUAL Recordkeeping; Exemptions under § 112.7
ANNUAL Recordkeeping; Testing requirements for agricultural water under §§ 112.44 and 112.45
ANNUAL Recordkeeping; documentation supporting compliance w/§ 112.2
ANNUAL Disclosure

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ICR Summary of Burden

table that charts list 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	964,315	0	34,108	930,207	0	0
Annual Time Burden (Hours)	1,513,079	0	20,730	1,492,349	0	0
Annual Cost Burden (Dollars)	27,490	0	0	27,490	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new information collection associated with rulemaking.

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Annual Cost to Federal Government: $0

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: 05/16/2016

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