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

Forms and Documents

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

IC Document Collections

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

ICR Details

OMB Control No: 0910-0816	ICR Reference No: 201605-0910-002
Status: Historical Inactive	Previous ICR Reference No:
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: Emergency	Approval Requested By: 05/16/2016
OIRA Conclusion Action: Improperly submitted	Conclusion Date: 05/13/2016
	Date Received in OIRA: 05/06/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		6 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

---

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.

Emergency Justfication: Rule became effective January 26, 2016.

---

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

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
ONE TIME Disclosure
ANNUAL Recordkeeping; Exemptions under § 112.7
ANNUAL Recordkeeping; Testing requirements for agricultural water under §§ 112.44 and 112.45
ANNUAL Recordkeeping; training under § 112.30
ANNUAL Recordkeeping; Records relating to agricultural water
ANNUAL Recordkeeping; Testing requirements for sprouts
ANNUAL Recordkeeping; documentation supporting compliance w/§ 112.2
ANNUAL Disclosure
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

---

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 in support of agency rulemaking.

---

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

---

Common Form ICR:  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:

(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: 05/06/2016

---