0773 Sanitary Transport SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Sanitary Transportation of Human and Animal Food
OMB Control No. 0910-0773
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection helps support implementation of the Sanitary Food Transportation
Act of 2005 (2005 SFTA) and the FDA Food Safety Modernization Act of 2011 (FSMA). The
2005 SFTA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), in part, by
creating section 416 of the FD&C Act (21 U.S.C. 350e). Section 416(b) of the FD&C Act
directs us to issue regulations to require shippers, carriers by motor vehicle or rail vehicle,
receivers, and other persons engaged in the transportation of food to use prescribed sanitary
transportation practices to ensure that food is not transported under conditions that may render
the food adulterated.
Specifically, the statute requires the establishment of sanitary practices for the transport of food
along with recordkeeping requirements that document the: (1) sanitation; (2) packaging,
isolation, and other protective measures; (3) limitations on the use of vehicles; and (4)
disclosures to carriers and to manufacturers required by the regulations. Section 416(c) also
provides that the regulations are to include a list of nonfood products that may, if shipped in a
bulk vehicle, render adulterated food that is subsequently transported in the same vehicle and a
list of nonfood products that may, if shipped in a motor vehicle or rail vehicle (other than a tank
vehicle or bulk vehicle), render adulterated food that is simultaneously or subsequently
transported in the same vehicle. Section 111(a) of FSMA, directed us to issue these sanitary
transportation regulations.
In addition, the 2005 SFTA created section 402(i) in the FD&C Act (21 U.S.C. 342(i)) which
provides that food that is transported or offered for transport by a shipper, carrier by motor
vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under
conditions that are not in compliance with the regulations issued under section 416 is
adulterated; and section 301(hh) in the FD&C Act (21 U.S.C. 331(hh)) to prohibit the failure by
a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the
transportation of food to comply with the regulations issued under section 416.
The 2005 SFTA also amended section 703 of the FD&C Act (21 U.S.C. 373) by adding section
703(b), which provides that a shipper, carrier by motor vehicle or rail vehicle, receiver, or other
person subject to section 416 shall, on request of an officer or employee designated by FDA,
permit the officer or employee, at reasonable times, to have access to and to copy all records
that are required to be kept under the regulations issued under section 416. FDA's authority for
SFTA also derives from sections 402(a)(1), (a)(3), (a)(4), and 701(a) of the FD&C Act (21
U.S.C. 371(a)).

Accordingly, we promulgated regulations at § 21 CFR part 1 subpart O (1.900-1.934),
pertaining to the sanitary transportation of human and animal food. As discussed above, the
regulations prescribe recordkeeping to document safety practices, procedures for the
submission of waivers, and required disclosures to other operators engaged in the transport of
food. We therefore request extension of OMB approval for the information collection
provisions covered in the applicable regulations and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The regulations and supporting information collection are intended to ensure that transportation
practices do not create food safety risks. Practices that create such risk include failure to
properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly
protect food during transportation. This builds on current safe food transport practices and is
focused on ensuring that persons engaged in the transportation of food that is at the greatest risk
for contamination during transportation follow appropriate sanitary transportation practices.
Description of Respondents: Respondents to the information collection are domestic and
foreign shippers and carriers of human and animal food (except fully packaged shelf-stable
foods, live food animals and raw agricultural commodities (RACs) when RACs are transported
by farms) except those engaged in food transportation operations that have less than $500,000
in total annual sales. Respondents are from the private sector (for profit businesses).
3. Use of Improved Information Technology and Burden Reduction
The information collection requirements solicit what we believe is the minimal information
necessary to ensure safety of transported food. We believe that 100% of respondents will use
electronic means to fulfill the information collection requirements. Additionally, firms seeking
a waiver under 21 CFR 10.30 may submit them electronically.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. The term “food” is defined consistent
with section 201(f) of the FD&C Act, which includes raw materials and ingredients. This
definition also includes animal food and food subject to the Federal Meat Inspection Act, the
Poultry Products Inspection Act, and the Egg Products Inspection Act administered by the Food
Safety and Inspection Service (FSIS) of the USDA. To prevent duplication of effort, its
compliance policy is to inform FSIS when an apparent violation is encountered involving a
meat or poultry product that has left a USDA inspected establishment. FSIS carries out incommerce surveillance activities to verify that entities whose business activities involve FSISregulated products prepare, store, transport, sell, offer for sale or transportation, import, and
export such products in compliance with FSIS statutory and regulatory requirements. FSIS has
issued guidance for the safe transportation and distribution of meat, poultry and egg products;
however, it does not have requirements that directly address transportation operations for these
foods. This collection of information complements FSIS's efforts to promote the application of
sanitary food transportation practices for FSIS-regulated meat, poultry, and egg products. We

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intend to continue to work together with FSIS to facilitate this shared objective while carrying
out our respective regulatory programs.
5. Impact on Small Businesses or Other Small Entities
We estimate that, among firms analyzed, ninety-eight percent (98%) of shippers/receivers and
ninety-five percent (95%) of carriers are small businesses. We have attempted to assist small
businesses by exempting very small firms with less than $500,000 in total annual sales and by
providing staggered compliance dates for other small businesses. The term “small business”
means a business employing fewer than 500 persons, except that for carriers by motor vehicle
that are not also shippers and/or receivers. The term also refers to a business having less than
$25,500,000 in annual receipts, consistent with the size-based standard established by the U.S.
Small Business Administration for truck transportation firms.
6. Consequences of Collecting the Information Less Frequently
Disclosure and recordkeeping occur on a regular basis while reporting occurs only
occasionally. We believe this collection schedule imposes the minimum burden on respondents
in fulfilling the requirements of the regulations.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in the
Federal Register of February 20, 2019 (84 FR 5087). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No gift or payment is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
This regulation does not specify confidentiality. However, records that may be reviewed
during FDA inspections are subject to FDA regulations on the release of information in 21 CFR
Part 20. Confidential commercial information is protected from disclosure under FOIA in
accordance with section 552(a) and (b) (5 U.S.C. 552(a) and (b)) and by 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.

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Privacy Act of 1974
This ICR does not request any personally identifiable information and does not include a form
that requires a Privacy Act Statement.
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
The information collection includes recordkeeping, reporting, and third-party disclosure
requirements as reflected in the tables below:
Table 1. --Estimated Annual Recordkeeping Burden1
21 CFR section;
activity
1.912; Record
retention
1

No. of
recordkeepers

No. of records
per
recordkeeper

1,502,032

1

Total
annual
records

Avg. burden
per
recordkeeping

1,502,032

0.083
(5 mins.)

Total
hours
124,669

There are no operations and maintenance costs associated with annual recordkeeping burden.

We estimate an annual recordkeeping burden of 124,669 hours. This assumes 1,502,032
workers will spend an average of 5 minutes on activities related to the record retention
requirements under 21 CFR 1.912. We expect these activities will likely include documenting
procedures and training, as well as sanitary transportation operations and specification
requirements.
Table 2. --Estimated Annual Reporting Burden 1
21 CFR section; activity
No. of
No. of
Total
respondents responses per
annual
respondent
responses
1.914; Waiver petitions
2
1
2
1

Avg.
burden per
response
24 hrs.

Total
hours
48

There are no operations and maintenance costs associated with annual reporting burden.

We estimate one waiver petition from each of two firms will be submitted and each respondent
will spend 24 hours to prepare and submit the petition to FDA.

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Table 3. --Estimated Annual Third-Party Disclosure Burden 1
21 CFR section; activity

No. of
respondents

1.908; Sanitary specifications;
operating temperature
conditions
1

Total
annual
disclosures

Number of
disclosures
per
respondent

226

1

226

Total
hours

Avg.
burden
per
disclosure
0.5833
(35 mins.)

131

There are no operations and maintenance costs associated with annual third-party disclosure burden.

We estimate an annual third-party disclosure burden of 132 hours. We assume each of 226
firms will spend an average of 35 minutes, annually, disclosing written records as required
under 21 CFR 1.908.
Total annual burden for this collection is estimated at 124,489 hours (124,669 recordkeeping
hours, 48 reporting hours, and 132 third-party disclosure hours.)
12b. Annualized Cost Burden Estimate
We estimate that the burden of this information collection results in a total of 124,489
hours annually. The salary that a company will pay an employee to respond to the information
collection is considered a cost burden. We estimate that three types of respondent employees
will be responsible for information collection: cargo and freight agents; first-line supervisors of
transportation and material-moving machine and vehicle operators; and, managerial or
professional employees such as plant managers, food safety specialists, and in-house legal
counsel. We base our estimate of the wage rates on the Bureau of Labor Statistics,
Occupational Employment Statistics, May 2017, National Industry-Specific Occupational
Employment and Wage Estimates1.
Table 4–Cost Burden Estimate Annual Costs
Type of Respondent
Total Burden Hours Hourly Wage Total Respondent
Rate
Costs
Cargo and Freight Agent (97.5% total hours)
121,728
$30.51
$3,713,921.28
First-Line Supervisors of Transportation and
Material-Moving Machine and Vehicle
Operators
(2.4% total hours)
Managerial or Professional Employees
(0.1% total hours)
Total

2,996

$39.98

$119,780.08

124

$94.40

$11,705.60

124,848

Therefore, total costs for this collection of information is $3,845,406.96.
1

https://www.bls.gov/oes/2017/may/oessrci.htm.

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$3,845,406.96

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
Our review of retained records will generally occur as part of its routine or for-cause inspection
activities. Because these activities are covered by existing resource allocations we are
estimating zero cost to the Federal government.
15. Explanation for Program Changes or Adjustments
The information collection reflects agency adjustments. Since last OMB review we have
removed one-time burdens we previously attributed to implementation of the new regulations
and realization of compliance dates. Because these milestones have been met, we have
removed initial burden we ascribed to associated with activities. This results in an overall
decrease to the information collection by 1,778,351 responses (from 3,280,611 to 1,502,260),
by 250,416 burden hours (from 375,265 to 124,849), and by $83,708 in cost adjustments.
16. Plans for Tabulation and Publication and Project Time Schedule
Information is not to be published for statistical use.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Approval for not displaying the expiration date of OMB approval is not being sought.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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