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

Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption
OMB Control No. 0910-NEW
RIN: 0910-AG35
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
To minimize the risk of serious adverse health consequences or death from consumption of
contaminated produce, the Food and Drug Administration (FDA or we) has established sciencebased minimum standards for the safe growing, harvesting, packing, and holding of produce,
meaning fruits and vegetables grown for human consumption. This rulemaking is part of our
implementation of the FDA Food Safety and Modernization Act. The standards do not apply to
produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce
that is not a raw agricultural commodity. In addition, produce that receives commercial
processing that adequately reduces the presence of microorganisms of public health significance
is eligible for exemption from the requirements of this regulations. 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. We expect the
rule to reduce foodborne illness associated with the consumption of contaminated produce.
2. Purpose and Use of the Information Collection
The regulations promulgated by FDA establish procedures, processes, and practices including
setting forth monitoring and sampling plans, documenting data and training, and ensuring
disclosure that produce for human consumption meets these requirements. The regulations also
provide for certain exemptions and variances to qualified respondents. The agency will use the
information collection to verify that the standards established by the rulemaking are followed
such that produce entering the marketplace is reasonable assured to be safe.
3. Use of Improved Information Technology and Burden Reduction
We believe the information collection associated with the rulemaking imposes minimum burden.
While the regulations do not so require, we believe respondents will rely on information
technology to store, retrieve, and otherwise comply with data collection requirements.
4. Efforts to Identify Duplication and Use of Similar Information
The rulemaking underlying this information collection establishes regulations regarding safety
standards for produce for human consumption. We are unaware of regulations that duplicate the
information collection.

5. Impact on Small Businesses or Other Small Entities
The statutory requirements promulgated by the rulemaking apply to both domestic and imported
produce. At the same time, the rule does not apply to specified produce rarely consumed raw,
nor to produce used for personal or on-farm consumption. Also, the rule provides for
exemptions for produce that receives commercial processing thus adequately reducing the
presence of microorganisms of public health significance. These exemptions must be disclosed.
Finally, the rule provides for modified requirements for farms meeting specific criteria.
6. Consequences of Collecting the Information Less Frequently
Information collection occurs consistent with statutory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
As required by section 3506(c)(2)(B) of the Paperwork Reduction Act of 1995 (PRA), FDA
provided an opportunity for public comment on the information collection requirements of the
proposed rule that published in the Federal Register on January 16, 2013 (78 FR 45781) and
again in its supplemental proposed rule on September 29, 2014 (79 FR 58433). Comments
received in response to the rulemaking are discussed in the agency’s final rule that published in
the Federal Register on November 27, 2015 (80 FR 74354). All comments may be found in the
agency Docket (FDA-2011-N-0921).
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payment or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
The rulemaking does not specify confidentiality. Records that may be reviewed by FDA are
subject to FDA regulations on the release of information found in 21 CFR Part 20. Confidential
commercial information is protected from disclosure under FOIA in accordance with sections 5
U.S.C. 552(a) and (b) and by 21 CFR part 20. To the extent that § 20.64 applies, we will honor
the confidentiality of any data in investigation records compiled for law enforcement purposes.
11. Justification for Sensitive Questions
This information collection does not contain questions of a sensitive nature.

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12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: Respondents to the collection include farms that grow produce,
meaning fruits and vegetables such as berries, tree nuts, herbs, and sprouts. We estimate there
are 37,404 such farms and approximately 285 sprouting operations covered by the rulemaking.
12 a. Annualized Hour Burden Estimate
Recordkeeping Burden
The regulations established at 21 CFR Part 112 provide for specific records under subparts A
(General Provisions); B (General Requirements); C (Personnel Qualifications and Training); D
(Health and Hygiene); E (Agricultural Water); F (Biological Soil Amendments of Animal Origin
and Human Waste); K (Growing, Harvesting, Packing and Holding Activities); L (Equipment,
Tools, Buildings, and Sanitation); M (Sprouts); N (Analytical Methods); O (Records); and P
(variances) where a summary of estimates for both one-time and annual recordkeeping burden is
shown below.
Estimated One-Time Recordkeeping Burden
Activity in 21 CFR Part 112

Agricultural water;
documentation of scientific
data
Sprouts; establishment of
environmental monitoring and
sampling plans
Sprouts; documentation of data
and variances
TOTAL
1.

No. of
Recordkeepers

No. of
Records per
Recordkeeper1

Total
OneTime
Records

Avg. Burden
per
Recordkeeping
(in hours)1

Total
Hours

26,649

1.137

30,310

0.50

15,158

354

1

354

10.658

3,773

185
27,188

1.951

361
31,025

4.299

1,552
20,483

Numbers rounded to nearest 1/1000

Estimated Annual (Recurring) Recordkeeping Burden
Activity in 21 CFR Part
112
Exemptions under §112.7
Training under §112.30
Testing requirements for
agricultural water under
§§112.44 and 112.45
Records related to
agricultural water

No. of
Recordkeepers

No. of Records Total
Avg. Burden per Total
per
Annual
Recordkeeping
Hours
Recordkeeper1 Records
(in hours)1
3,285
1
3,285
0.500
1,643
24,420
1
24,420
7.250 177,045
48,361
2.989
144,599
0.825 119,314

160,605

2.242

3

360,030

2.161

777,913

Activity in 21 CFR Part
112

No. of
Recordkeepers

No. of Records Total
Avg. Burden per Total
per
Annual
Recordkeeping
Hours
Recordkeeper1 Records
(in hours)1
256
245.660
62,889
0.403
25,331

Testing requirements for
sprouts under §§112.144,
112.145, and 112.147
Records related to sprouts
Documentation
supporting compliance
w/§112.2
TOTAL

1,023
4,568

62.061
1

63,488
4,568

242,518

663,279

0.174
0.079

11,033
365

1,112,644

1. Numbers rounded to nearest 1/1000

Third Party Disclosure
The regulations established at 21 CFR Part 112 provide for specific disclosures under subpart A
(general provisions), subpart D (health and hygiene), and subpart M (sprouts). Individual
provisions are discussed more fully in the preamble to the final rule (80 FR at 74538) where a
summary of estimates for both one-time and annual disclosure burden is shown below.
Estimated One-Time Disclosure Burden1
21 CFR Part 112

No. of
Respondents

Disclosure under
§112.6(b)
1

No. of
Disclosures per
Respondent

3,083

Total one-time
Disclosure

Avg. Burden Total
per
Hours
Disclosure
(in hours)
3,083
0.08
247

1

There are no operating or maintenance costs associated with one-time reporting.

Estimated Annual (Recurring) Disclosure Burden1
21 CFR Part 112

Disclosures under §§112.2,
112.6, 112.31, 112.33, and
112.142
1

No. of
Respondents

No. of
Disclosure per
Respondent

77,165

3.459

Total
Disclosures

Avg. Burden Total
per
Hours
Disclosure
(in hours)
266,928
1.422 379,705

There are no operating or maintenance costs associated with annual disclosure

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12b. Annualized Cost Burden Estimate
We estimate the annualized cost burden to farms covered by the rulemaking as follows:
Recording activity
Qualified exempt farms labeling and
documentation
Agricultural water
(§ 112.50)
Biological soil amendments of animal origin
(§ 112.60)
Equipment, tools, buildings, and sanitation
(§ 112.140)
Sprouting operations
(§ 112.150)
Training
(§ 112.30)
Documentation relating to commercial
processing
Total cost (annual in thousands)

Very Small

Small

Large
$0

Total

$5,239

$469

$5,709

$4,510

$829

$1,043

$6,382

$184

$32

$40

$256

$4,829 $2,620

$5,492

$12,941

$108

$109

$484

$702

$1,069

$186

$227

$1,482

$13

$3

$3

$18

$15,95

$4,249

$7,290

$27,490

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
Recordkeeping costs associated with the rulemaking are estimated to be $27.5 million. These
costs are detailed in the agency’s Final Regulatory Impact Analysis (FRIA), Section II.F.9 (at p.
97), and found in the agency’s Docket.
14. Annualized Cost to the Federal Government
These activities will be covered by existing resource allocations. Therefore, we are estimating
zero cost to the Federal government as a result of this rulemaking.
15. Explanation for Program Changes or Adjustments
This is a new information collection request.
16. Plans for Tabulation and Publication and Project Time Schedule
No tabulation of data resulting from this information collection is planned or anticipated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval not to display the expiration date for OMB approval of the
information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
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