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

Forms and Documents

Document Name	Status
0816 83-C FINAL 8-18-2023.docx Justification for No Material/Nonsubstantive Change	2023-08-18
0816 Produce Stds Part 112 SSA 2022 EXT.docx Supporting Statement A	2022-07-21

IC Document Collections

IC ID	Document Title	Status
236397	Recommendations in GFI (Sprouts Guidance) Other-Agency Guidance	Modified
221410	3rd Party-Disclosure	Unchanged
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 produce	Unchanged
221403	ANNUAL Recordkeeping; training under § 112.30	Unchanged
221402	ANNUAL Recordkeeping; Exemptions under § 112.7 Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0816	ICR Reference No: 202308-0910-016
Status: Received in OIRA	Previous ICR Reference No: 202111-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/23/2023

	Requested	Previously Approved
Expiration Date	09/30/2025	09/30/2025
Responses	871,993	871,993
Time Burden (Hours)	1,521,594	1,521,594
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports FDA regulations that implement minimum standards for produce offered for human consumption. The regulations set 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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 68673	12/03/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 43273	07/20/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
3rd Party-Disclosure
ANNUAL Recordkeeping related to sprouts
ANNUAL Recordkeeping; Exemptions under § 112.7
ANNUAL Recordkeeping; Records relating to agricultural water
ANNUAL Recordkeeping; Testing requirements for sprouts
ANNUAL Recordkeeping; Testing requirements produce
ANNUAL Recordkeeping; documentation supporting compliance w/§ 112.2
ANNUAL Recordkeeping; training under § 112.30
Recommendations in GFI (Sprouts Guidance)

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ICR Summary of Burden

	Total Request	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	871,993	871,993	0	0	0	0
Annual Time Burden (Hours)	1,521,594	1,521,594	0	0	0	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: $0

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 08/23/2023

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