0621 Food regulatory program stds SSA 2020 Ext

UNITED STATES FOOD AND DRUG ADMINISTRATION
Voluntary National Retail Food Regulatory Program Standards
OMB Control No. 0910-0621

SUPPORTING STATEMENT Part A – Justification:

1. Circumstances Making the Collection of Information Necessary
This information collection request supports Food and Drug Administration’s (“FDA” or “we”)
Voluntary National Retail Food Regulatory Standards Program. While the responsibility for
regulating retail and food service establishments lies primarily with State, local, territorial and
tribal jurisdictions, we provide assistance to these jurisdictions through multiple means
including, but not limited to, training and technical assistance. Authority for providing such
assistance is derived from section 311 of the Public Health Service Act (42 U.S.C. 243). In
addition, FDA’s mission under section 1003(b)(2)(A) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 393(b)(2)(A)) includes ensuring that foods are safe, wholesome,
and sanitary, and section 1003(b)(4) of the FD&C Act directs FDA to cooperate with food
retailers, among others, in carrying out this part of its mission.
The Centers for Disease Control and Prevention (CDC) has identified major contributing factors
associated with foodborne illness outbreaks. Five of these contributing factors directly relate to
retail and food service establishments and are called “foodborne illness risk factors” by FDA. In
an effort to assist state, local, territorial, and tribal regulators, as well as the retail and food
service entities they regulate, we have developed a Program Standards document entitled,
“Voluntary National Retail Food Regulatory Program Standards,” (the Program Standards).
The Program Standards were developed to address the need for national uniformity among retail
food regulatory programs, to promote uniform application of the FDA Food Code, and to reduce
the occurrence of foodborne illness risk factors. The Program Standards were developed with
extensive input from Federal, State, and local regulatory authorities, industry, trade and
professional associations, academia, and consumers. They are intended to help authorities
responsible for the regulation of food at the retail level to design and manage a food safety
program focused on the reduction of foodborne illness risk factors, and to capture best
management practices currently in use by regulatory authorities.
To assist respondents with the information collection, we developed Form FDA 3958 entitled,
“Voluntary National Retail Food Regulatory Program Standards FDA National Registry
Report.” Form FDA 3958 collects information about jurisdiction participation in the program
and may be completed electronically at: www.fda.gov/RetailProgramStandards.
We therefore request extension of OMB approval of information collection provisions of the
Program Standards which are available at:
http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/ucm245
409.htm, as well as Form FDA 3958.

2. Purpose and Use of the Information Collection
The Program Standards define nine essential elements of an effective regulatory program for
retail food establishments, establish basic quality control criteria for each element, and provide a
means of recognition for those Federal, State, local, territorial and tribal regulatory programs that
meet the Program Standards. The program elements addressed by the Program Standards are as
follows: (1) Regulatory foundation, (2) trained regulatory staff, (3) inspection program based on
Hazard Analysis and Critical Control Point (HACCP) principles, (4) uniform inspection
program, (5) foodborne illness and food defense preparedness and response, (6) compliance and
enforcement, (7) industry and community relations, (8) program support and resources, and (9)
program assessment. Each standard includes a list of records needed to document conformance
with the standard (referred to in the Program Standards document as “quality records”) and has
one or more corresponding forms and worksheets to facilitate the collection of information
needed to assess the retail food regulatory program against that standard. The respondents are
Federal, State, local, territorial, and tribal government agencies. Regulatory agencies may use
existing, available records or may choose to develop and use alternate forms and worksheets that
capture the same information.
In the course of their normal activities, Federal, State, local, territorial, and tribal regulatory
agencies already collect and keep on file many of the records needed as quality records to
document conformance with each of the Program Standards. Although the detail and format in
which this information is collected and recorded may vary by jurisdiction, records that are kept
as a usual and customary part of normal agency activities include inspection records, written
quality assurance procedures and records of quality assurance checks, staff training certificates
and other training records, a log or database of food-related illness or injury complaints, records
of investigations resulting from such complaints, an inventory of inspection equipment, records
of outside audits, and records of outreach efforts (e.g., meeting agendas and minutes,
documentation of food safety education activities). No new recordkeeping burden is associated
with these existing records, which are already a part of usual and customary program
recordkeeping activities by Federal, State, local, territorial, and tribal regulatory agencies, and
which can serve as quality records under the Program Standards.
Federal, State, local, territorial, and tribal regulatory agencies that enroll in the Program
Standards and seek listing in the FDA National Registry must report to FDA on the completion
of the following three management tasks outlined in the Program Standards: (1) Conducting a
program self-assessment, (2) conducting a risk factor study of the regulated industry, and (3)
obtaining an independent outside audit (verification audit). The results will be reported to FDA
on Form FDA 3958, “Voluntary National Retail Food Regulatory Program Standards FDA
National Registry Report.”
Description of Respondents: The respondents are Federal, State, local, territorial, and tribal
regulatory agencies that enroll in the Program Standards and seek listing in the FDA National
Registry.

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3. Use of Improved Information Technology and Burden Reduction
The respondents submit their information to FDA on Form FDA 3958, “FDA National Registry
Report,” which is available online. The agency estimates that about fifty percent (50%) of the
submissions are submitted electronically.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of any comprehensive inventory of Program Standard enrollment from other
sources. There are no similar data that can be used or modified for use. No public comments
were received that identified any other sources. Thus, we believe there is no duplicative
collection of information.
5. Impact on Small Businesses or Other Small Entities
We estimate that none of the respondents are small businesses. Respondents are Federal, State,
local, territorial, and tribal regulatory agencies. No small businesses are involved in this
information collection.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally, i.e., upon enrollment in the Program Standards and within a
12- to 60-month period thereafter. Although the collection of information related to the Program
Standards is voluntary, if information is not collected, regulators may not be employing all the
tools necessary to achieve more effective control of foodborne illness risk factors. The
information allows FDA to assist regulatory programs to improve the services they provide to
consumers and their regulated industries through the use of the continuous improvement model
specified in the Program Standards.
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 on February 21, 2020 (85 FR 10172). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
We do not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
In preparing this supporting statement, we consulted with our Privacy Office to ensure
appropriate handling of information collected. This information collection does not request any
or trade secret or commercial confidential information. The information to be provided is public
in nature. Thus, FDA provides no assurances of confidentiality.

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Privacy Act
This information collection request (ICR) is collecting personally identifiable information (PII)
or other data of a personal nature. PII is collected in the context of the individuals’ professional
capacity. Information is collected via Form FDA 3958 (Voluntary National Retail Food
Regulatory Program Standards FDA National Registry Report). The PII collected is name,
address, telephone number and email address. Although PII is collected, the information
collection is not subject to the Privacy Act of 1974 and the particular notice and other
requirements of the Act do not apply. Specifically, FDA does not use name or any other
personal identifier to routinely retrieve records from the information collected.
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 Cost
12a. Annualized Hour Burden Estimate
Our recordkeeping estimate includes time required for a Federal, State, local, territorial or
tribal agency to review the instructions in the Program Standards, compile information from
existing sources, and create any records recommended in the Program Standards that are not
already kept in the normal course of the agency’s usual and customary activities. Worksheets
are provided to assist in this compilation. In estimating the time needed for the program selfassessment (Program Standards 1 through 8, shown in Table 1 of this document), we considered
responses from four state and three local jurisdictions that participated in a FDA Program
Standards Pilot study. Table 2 of this document shows the estimated recordkeeping burden for
the completion of the risk factor study data collection and Table 3 of this document shows the
estimated recordkeeping burden for the verification audit.
Table 1.--Self-Assessment

Standard

No. 1: Regulatory Foundation

No. 2: Trained Regulatory Staff

No. 3: HACCP Principles
No. 4: Uniform Inspection Program
No. 5: Foodborne Illness Investigation

Recordkeeping Activity
Self-Assessment: Completion of worksheet recording
results of evaluations and comparison on
worksheets1
Self-Assessment: Completion of CFP Field Training
Manual and Documentation of Successful
Completion--Field Training Process; completion
of summary worksheet of each employee training
records1, 2
Self-Assessment: Completion of worksheet
documentation1
Self-Assessment: Completion of worksheet
documentation of jurisdiction’s quality assurance
procedures 1, 2
Self-Assessment: Completion of worksheet
documentation1

4

Hours per
Record
16

19.3

4
19
5

No. 6: Compliance Enforcement

Self-Assessment: Selection and review of 20 to 70
establishment files @ 25 minutes per file.
Estimate is based on a mean number of 45.
Completion of worksheet1

19

No. 7: Industry & Community Relations

Self-Assessment: Completion of worksheet1

2

No. 8: Program Support and Resources

Self-Assessment: Selection and review of
establishment files 1

8

Total

92.3

1

Or comparable documentation.
Estimates will vary depending on number of regulated food establishments and the number of inspectors
employed by the jurisdiction.
Table 2.--Risk Factor Study Data Collection

2

Standard

Recordkeeping Activity

No. 9: Program Assessment

Hours Per
Record

Risk Factor Study and Intervention Strategy1

333

1

Calculation based on mean sample size of 39 and average FDA inspection time for each establishment type.
Estimates will vary depending on number of regulated food establishments within a jurisdiction and the
number of inspectors employed by the jurisdiction.
Table 3.--Verification Audit
Activity

Recordkeeping Activity

Hours per
Record

Verification Audit1

Administrative Procedures

46.15

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We estimate that no more than 50% of time spent to complete self-assessment of all 9 Standards is spent
completing verification audit worksheets. Time will be considerably less if less than 9 standards require
verification audits.
Table 4.--Estimated Annual Recordkeeping Burden
Activity

No. of
Recordkeepers

No. of Records per
Recordkeeper

Total
Annual
Records

Average Burden
per Recordkeeping

Total Hours

Recordkeeping for
500
1
500
94.29
47,145
FDA Worksheets2
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
2
Or comparable documentation.

We base our estimates of the number of recordkeepers and the hours per record on our
experience with the Program Standards over the past 16 years. Based upon the level of
ongoing support provided by FDA to enrolled jurisdictions and the number of forms submitted
annually, we estimate that no more than 500 jurisdictions actively participate in the Program
Standards during any given year. There are approximately 3,000 jurisdictions in the United
States and its territories that have retail food regulatory programs. Enrollment in the Program
Standards is voluntary and, therefore, we do not expect all jurisdictions to participate.

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We base our estimate of the hours per record on the recordkeeping estimates for the
management tasks of self-assessment, risk factor study, and verification audit (Tables 1, 2, and
3 of this document) that enrolled jurisdictions must perform a total of 471.45 hours (92.3 + 333
+ 46.15 = 471.45). Enrolled jurisdictions must conduct the work described in Tables 1, 2, and
3 over a five-year period. Therefore, we estimate that, annually, 500 recordkeepers spend
94.29 hours (471.45/5 = 94.29) performing the required recordkeeping for a total of 47,145
hours as shown in Table 4 of this document.
Regulatory jurisdictions that participates in the Program Standards submits Form FDA 3958
“Voluntary National Retail Food Regulatory Program Standards FDA National Registry
Report” that has four parts. Part 1 requires the name and address of the jurisdiction; name and
contact information for the contact person for this jurisdiction; the jurisdictions website address
and if the jurisdiction is willing to serve as an auditor for another jurisdiction. Part 2 requires
information about enrollment, whether this jurisdiction is a new enrollee and the date of
enrollment; indication whether this jurisdiction would like to be removed from the jurisdiction
listing; indication of updated findings to the self-assessment or verification audit. Part 3
requires information about self-assessment findings and verification audit findings; dates when
self-assessment was completed; which standards have been met as determined by the selfassessment; which standards have been met as verified by a verification audit including the
completion dates. Part 4 requires permission to publish information on FDA’s Web site by
checking the appropriate box(es) to indicate what information we may publish on the website.
The reporting burden in Table 5 of this document includes the time necessary to fill out and
send the forms, as compiling the underlying information (including self-assessment reports,
Risk Factor Study data collection, outside audits, and supporting documentation) is accounted
for under the recordkeeping estimates in Table 4 of this document.
We estimate the reporting burden for this collection of information as follows:
Activity

Submission of
“Voluntary National
Retail Food Regulatory
Program Standards
FDA National Registry
Report”
Request for
documentation of
successful completion
of staff training

Table 5.--Estimated Annual Reporting Burden1
FDA Form
No. of
No. of
Total Annual
Respondents
Responses per
Responses
Respondent

3958

500

1

500

Conference
for Food
Protection
Training Plan
and Log

500

3

1,500

Average
Burden per
Response

0.1
(6 minutes)

0.1
(6 minutes)

50

150

200

Total
1

Total
Hours

There are no capital costs or operating and maintenance costs associated with this collection of information.

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We base our estimates of the number of respondents and the hours per response on our
experience with the Program Standards over the past 16 years. As explained previously in this
document, we estimate that no more than 500 regulatory jurisdictions will participate in the
Program Standards in any given year. We estimate a total of 6 minutes annually for each
enrolled jurisdiction to complete the form. We base our estimate on the small number of data
elements on the form and the ease of availability of the information. We estimate that, annually,
500 regulatory jurisdictions will submit one Form FDA 3958 for a total of 500 annual responses.
Each submission is estimated to take 0.1 hour per response for a total of 50 hours. We estimate
that, annually, 500 regulatory jurisdictions will submit three requests for documentation of
successful completion of staff training using the CFP Training Plan and Log for a total of 1,500
annual responses. Each submission is estimated to take 0.1 hour per response for a total of 150
hours. Thus, the total reporting burden for this information collection is 200 hours.
12b. Annualized Cost Burden Estimate
The annual hour cost burden to respondents is approximately $1,646,659.10 per year.
We estimate that the average hourly wage for the employees engaging in recordkeeping and
submitting information to FDA would be equivalent to a GS-4/Step-2 level in the locality pay
area of Washington-Baltimore in 2020, approximately $17.39 per hour. Doubling this wage to
account for overhead costs, we estimate the average hourly cost to respondents to be
$34.78/hour. Thus, the overall estimated cost incurred by the respondents is $1,646,659.10.
(47,345 burden hours x $34.78/hr = $1,646,659.10).
Type of Respondent
Clerk/Assistant

Total Burden
Hours
47,345

Hourly Wage Rate
$34.78

Total Respondent
Costs
$1,646,659

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized Cost to the Federal Government
At the agency, professional employees collect, review, and maintain the Program Standards
submissions, which requires about 260 hours annually. We estimate that, on average, the hourly
cost for review and evaluation of the submissions is approximately $49.19 per hour, the GS13/Step-1 rate for the Washington-Baltimore locality pay area for the year 2020. To account for
overhead, this cost is increased by 100 percent, making the total cost $98.38 per hour. Thus, we
estimate the annual cost to the Federal government to be $25,578.80 ($98.38/hour x 260 hours).
15. Explanation for Program Changes or Adjustments
Based on a review of the information collection since our last request for OMB approval, we
have made no adjustments to our burden estimate.

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16. Plans for Tabulation and Publication and Project Time Schedule
We list regulatory agencies that have enrolled in the Voluntary National Retail Food Regulatory
Program Standards on the web and update the list quarterly, including the enrolled jurisdictions’
contact information, enrollment dates, and self-reported and verified status of each of the
program standards.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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