0773 Sanitary Transportation FR SS 2016

Sanitary Transportation of Human and Animal Food
OMB Control No. 0910-0773
RIN 0910-AG98
SUPPORTING STATEMENT

A. Justification
1. Circumstances Making the Collection of Information Necessary
The Food and Drug Administration (FDA or we) is establishing requirements for
shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation
of food, including food for animals, to use sanitary transportation practices to ensure the safety
of the food they transport. This action is part of our larger effort to focus on prevention of food
safety problems throughout the food chain and is part of our 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 a new section 416 of the FD&C Act (21 U.S.C. 350e). Section 416(b) of the
FD&C Act directed 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. Section 416(c) of the FD&C Act specifies that we shall prescribe
those practices that we determine are appropriate relating to: (1) Sanitation; (2) packaging,
isolation, and other protective measures; (3) limitations on the use of vehicles; (4) information to
be disclosed to carriers and to manufacturers; and (5) recordkeeping. Section 416(c) of the
FD&C Act also states 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 new 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 new 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

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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 this
rule 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)).
The rule requires shippers, carriers by motor vehicle or rail vehicle, receivers, and other
persons engaged in the transportation of food to use sanitary transportation practices to ensure
that food is not transported under conditions that may render the food adulterated. The goal of
the rule is 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. The rule 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. It otherwise allows the transportation industry to
continue to use best practices concerning cleaning, inspection, maintenance, loading and
unloading of, and operation of vehicles and transportation equipment, that it has developed to
ensure that food is transported under the conditions and controls necessary to prevent
contamination and other safety hazards.
As finalized, persons engaged in the transportation of food are required to implement
measures to prevent contamination or microbial spoilage during transportation, including
training, and to maintain records concerning compliance with the rule. The rule also establishes
procedures for affected persons to request a waiver of any requirement.
2. Purpose and Use of the Information Collection
The potential exists for food to be transported under conditions that expose the food to
the risk of contamination or other safety hazards such as microbial spoilage associated with
improper temperature control. This final rule establishes requirements for sanitary transportation
practices for food to prevent contamination or spoilage and provides for information collection to
support these requirements. FDA will use the information to determine compliance with the
regulatory requirements of the rule thereby protecting the food supply and helping to ensure the
public health.
Description of Respondents: Respondents 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 under the rule solicit what the agency believes is
the minimal information necessary. We believe that all respondents will use electronic means to

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fulfill the information collection requirements. Additionally, firms seeking a waiver under 21
CFR 10.30 may submit electronically.
4. Efforts to Identify Duplication and Use of Similar Information
FDA is the only Federal agency collecting the information. Under the rule, “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. FDA notes that, 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 in-commerce surveillance activities to verify that entities whose business
activities involve FSIS-regulated 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 rulemaking complements FSIS's efforts to
promote the application of sanitary food transportation practices for FSIS-regulated meat,
poultry, and egg products. We intend to work together with FSIS to facilitate this shared
objective while carrying out our respective regulatory programs.
Finally, we note that we have developed this final rule implementing the 2005 SFTA and
FSMA to operate in conjunction with other rules promulgated under FSMA to ensure that the
safety of food during transportation is effectively addressed as part of FDA's comprehensive
effort to strengthen the food safety system.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that, among firms analyzed, ninety-eight percent (98%) of
shippers/receivers and ninety-five percent (95%) of carriers are small businesses. Under the rule,
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 rule defines “small business” to mean a business employing fewer than 500
persons, except that for carriers by motor vehicle that are not also shippers and/ or receivers the
term means a business having less than $25,500,000 in annual receipts, consistent with the sizebased standard established by the U.S. Small Business Administration for truck transportation
firms. FDA believes it is reasonable to allow 1 year after the date of publication of the final rule
for businesses other than small businesses to come into compliance with the new requirements.
FDA also believes it is reasonable to allow 2 years after the date of publication of the final rule
for small businesses to come into compliance with the new requirements.

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6. Consequences of Collecting the Information Less Frequently
Disclosure and recordkeeping occur as the regulations require while reporting occurs
only occasionally. We believe this collection schedule imposes the minimum burden on
respondents in fulfilling the requirements of the rulemaking.
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
The final rule published in the Federal Register on April 6, 2016 (81 FR 20091). In
accordance with 5 CFR 1320.8(d), FDA provided an opportunity for public comment on the
information collection provisions in its proposal, which published in the Federal Register of
February 5, 2014 (79 FR 7005). Comments received in response to the proposed rule were
considered by the agency, are addressed in the final rule, and are included in the rulemaking
docket FDA-2013-N-0013.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payments or gifts 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.
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
12 a. Annualized Hour Burden Estimate
The information collection includes recordkeeping, reporting, and third-party disclosure
requirements as discussed here:

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Recordkeeping
Table 1 – Estimated First Year and Annual Recordkeeping Burden
First Year Only 
Activity; 21 CFR Section

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Avg. Burden
per
Recordkeeping

Total
Hours

1

Written procedures for
integrated operation; 1.908(a)(4)

343

1

343

2

686

2

Written procedures to ensure
sanitary condition of vehicles;
1.908(b)(3)
Written procedures to ensure that
previous cargo does not make
food unsafe; 1.908(b)(4)
Written procedures to ensure that
food is transported under
adequate temperature control;
1.908(b)(5)
Written procedures, cleaning and
sanitation; 1.908(e)(6)(i)
Written procedures bulk
vehicles; 1.908(e)(6)(iii)
Training records; 1910(b)

4,483

1

4,483

0.5

2,242

4,483

1

4,483

0.5

2,242

4,483

1

4,483

0.5

2,242

37,249

1

37,249

2

74,498

6,713

1

6,713

2

13,426

1,668,698

1

1,668,698

.08

133,496

3

4

5
6
7

First Year Only Hourly Recordkeeping Burden

228,832

Recurring Recordkeeping Burden
Proposed 21 CFR
Section/Activity

8

Training Records; 1.910(b)

No. of
Recordkeepers

No. of Records
per
Recordkeeper

1,502,032

Total Annual
Records

1

1,502,032

Avg. Burden
per
Recordkeeping

.08

Annual Hourly Recordkeeping Burden

Total
Hours

120,163
120,163

The estimated hourly recordkeeping burden is 228,832 one-time hours ( 76,277.33
annualized one-time hours), and 120,163 annual hours.
The one-time cost of developing written procedures regarding integrated transportation
operations, as required by § 1.908(a)(4), is estimated at the shipper level. It is estimated that
about 343 recordkeepers will each spend 2 hours (one-time) developing written procedures

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related to integrated transportation operations, as required by § 1.908(a)(4). Therefore, 343 x 2 =
686 (686.13) one-time hours, as presented in line 1.
The one-time cost of developing written procedures to ensure sanitary condition of
vehicles and equipment, as required by § 1.908(b)(3), is estimated at the shipper level. It is
estimated that these written procedures are relatively simple and easy to assemble, and that one
recordkeeper for about 4,483 firms will spend 0.5 hour adjusting current practices with respect to
this requirement. Therefore, 0.5 hours x 4,483 = 2,242 (2,241.69) one-time hours for
§ 1.908(b)(3), as shown in line 2.
The one-time cost of developing written procedures to ensure that previous cargo does
not make food unsafe, as required by § 1.908(b)(4), is estimated at the shipper level. It is
estimated that these written procedures are relatively simple and easy to assemble, and that one
recordkeeper for about 4,483 firms will spend 0.5 hour adjusting current practices with respect to
this requirement. Therefore, 0.5 hours x 4,483 = 2,242 (2,241.69) one-time hours for
§ 1.908(b)(4), as shown in line 3.
The one-time cost of developing written procedures to ensure that food is transported
under adequate temperature control, as required by § 1.908(b)(5), is estimated at the shipper
level. It is estimated that these written procedures are relatively simple and easy to assemble,
and that one recordkeeper for about 4,483 firms will spend 0.5 hour aligning current practices
with this requirement. Therefore, 0.5 hours x 4,483 = 2,242 (2,241.69) one-time hours for
§ 1.908(b)(5), as shown in line 4.
The one-time cost of development of written procedures related to cleaning and
sanitation, as required by § 1.908(e)(6)(i), is estimated at the carrier level. It is estimated that
one recordkeeper for about 37,249 firms will spend 2 hours developing written procedures.
Therefore, 2 hours x 37,249 = 74,498 (74,498.48) one-time hours for § 1.908(e)(6)(i), as shown
in line 5.
The one-time cost of development of written procedures related to bulk vehicles, as
required by § 1.908(e)(6)(iii), is estimated at the bulk carrier level. It is estimated that one
recordkeeper for about 6,713 firms will spend 2 hours developing written procedures. Therefore,
2 hours x 6,713 = 13,426 (13,426.48) one-time hours for § 1.908(e)(6)(iii), as shown in line 6.
The one-time cost of establishing training records, as required by § 1.910(b), is estimated
at the employee level. It is estimated that one recordkeeper will establish a record for about
1,668,698 workers, and this will take 5 minutes (0.08 hours) for each worker. Therefore, 0.08
hour x 1,668,698 = 133,496 (133,495.86) one-time hours for § 1.910(b), as shown in line 7.
The annual cost of training records, as required by final § 1.910(b), is estimated at the
worker level. It is estimated that one recordkeeper for each of about 1,502,032 workers will
spend 5 minutes (0.08 hour) minutes completing records related to annual training (the time
spent training is estimated separately and was not included in the agency’s PRA analysis). We
believe recordkeeping will be very simple and can consist of, for example, printing a certificate
of completion. Therefore, 0.08 hour x 1,502,032 workers = 120,163 (120,162.59) annual hours

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for § 1.910(b), as shown in line 8. Thus, the estimated annual hourly recordkeeping burden is
120,163 hours.
Reporting
Table 2 –First Year and Annual Reporting Burden
Estimated First Year Only Reporting Burden
Activity; 21 CFR
Section

No. of
Respondents

1

Waiver Petitions; §
6
1.914
Estimated Annual Reporting Burden

2

Proposed 21 CFR
Section/Activity

No. of
Respondents

Waiver Petitions §
1.914

2

No. of
Responses per
Respondent

Total
Annual
Responses

Avg. Burden per
Response

Total
Hours

1

6

24

144

No. of
Responses per
Respondent
1

Total
Annual
Responses
2

Avg. Burden per
Response

Total
Hours

24

48

In the first year, we estimate that one recordkeeper from each of a total of 6 firms will
spend 24 hours submitting a waiver petition to FDA. Therefore, 6 waiver petitions x 24 hours =
144 one-time hours, as shown in line 1. Annually, we estimate that one recordkeeper from each
of a total of two firms will spend 24 hours submitting a waiver petition to FDA. Therefore, two
waiver petitions x 24 hours = 48 annual hours, as shown in line 2.
Third party disclosure
Table 3—Third Party Disclosure Burden
Estimated First Year Only Third-Party Disclosure Burden
21 CFR Section
No. of
First Year
Recordkeepers
Frequency of
Recordkeeping
1
Written Sanitary
10,163
1
Specifications
1.908(b)(1)
2
Notification of
5,646
1
operating temperature
1.908(b)(2)
3
Records pertaining to 36,084
1
disclosure of
information 1.912(a)
TOTAL

7

Total
Records

Hours Per
Record

Total Hours

10,163

0.5

5,082
(5,081.57)

5,646

0.5

2,823
(2,823.13)

36,084

0.5

18,042
(18,041.88)
25,947
(25,946.57)

Estimated Annual Third-Party Disclosure Burden
21 CFR Section
No. of
First Year
Recordkeepers
Frequency of
Recordkeeping
4
Sanitary Specifications 226
1
1.908(b)(1)
5
Operating temperature 226
1
conditions 1.908(b)(2)
TOTAL

Total
Records

Hours Per
Record

Total Hours

226

0.08

18 (18.07)

226

0.5

113
(112.93)
131
(130.99)

The one-time cost of developing written sanitary specifications necessary for
transportation, as required by § 1.908(b)(1), is estimated at the shipper level. It is estimated that
one recordkeeper for each of about 10,163 firms will spend 30 minutes developing written
sanitary specifications. Therefore, 0.5 hour x 10,163 firms = 5,082 (5,081.57) one-time hours for
§ 1.908(b)(1), as shown in line 1.
The one-time cost of developing initial notifications of operating temperature, as required
by § 1.908(b)(2), is estimated at the shipper level. It is estimated that one recordkeeper for each
of about 5,646 firms will spend 30 minutes (0.5 hour) developing these notifications. Therefore,
0.5 hour x 5,646 firms = 2,823 (2,823.13) hours, as shown in line 2.
The one-time cost of establishing records pertaining to disclosure of information, as
required by § 1.912(a), is estimated at the firm level. It is estimated that one recordkeeper will
establish a record at a total of about 36,084 firms, and this will take 30 minutes (0.5 hour) for
each record. Therefore, 0.5 hour x 36,084 = 18,042 (18,041.88) one-time hours for § 1.912(a),
as shown in line 3.
The annual cost of disclosing necessary sanitary specifications, as required by
§ 1.908(b)(1), is estimated at the firm level. It is estimated that 1 recordkeeper for each of about
226 firms will spend 5 minutes disclosing sanitary specifications. Therefore, 0.08 hour x 226
shipments = 18 (18.07) annual hours for § 1.908(b)(1), as shown in line 4.
The annual cost of disclosing operating temperature conditions, as required by
§ 1.908(b)(2), is estimated at the shipper level. It is estimated that 1 recordkeeper for each of
about 226 firms will spend 30 minutes (0.5 hour) disclosing necessary temperature conditions.
Therefore, 0.5 hour x 226 firms = 113 (112.93) annual hours for § 1.908(b)(2), as shown in line
5.
b. Annualized Cost Burden Estimate
We estimate that the burden of this information collection results in a total of 125,054.54
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

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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 2012, National Industry-Specific Occupational Employment and
Wage Estimates. Wages are increased by 50 percent to account for overhead.
Table 4–Cost Burden Estimate
First Year Only
Type of Respondent
Total Burden
Hours
Cargo and Freight Agent
533.76
First-Line Supervisors of
4,686.06
Transportation and
Material-Moving Machine
and Vehicle Operators
Managerial or Professional 144
Employees
Total
Annual Costs
Cargo and Freight Agent
First-Line Supervisors of
Transportation and
Material-Moving Machine
and Vehicle Operators
Managerial or Professional
Employees
Total

Hourly Wage
Rate
$30.51
$39.98

Total Respondent Costs

$94.40

$13,593.60

$16,285.02
$187,348.67

$217,227.29 ($72,409.06
annualized)

116,785.64
2,857.09

$30.51
$39.98

$3,563,129.88
$144,226.45

48

$94.40

$4,531.20
$3,711,887.53

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

FDA’s 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.

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15.

Explanation for Program Changes or Adjustments
This is a new information collection.

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 to not display 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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