0751 SS for PCHF 2018 Ext

United States Food and Drug Administration
Current Good Manufacturing Practice, Hazard Analysis,
and Risk-Based Preventive Controls For Human Food
OMB Control No. 0910-0751
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
On January 4, 2011, the Food Safety Modernization Act (FSMA) (Public Law 111–353) was
signed into law. The legislation enables the Food and Drug Administration (FDA, us or we) to
better protect the public health by helping to ensure the safety and security of the food supply.
FSMA amends the Federal Food, Drug, and Cosmetic Act to establish a modernized, preventionbased food safety system. Specifically, section 103 of FSMA amends the Federal Food, Drug,
and Cosmetic Act (FD&C Act, the act) to create new section 418. Section 418(a) requires the
owner, operator, or agent in charge of a facility to evaluate hazards that could affect food
manufactured, processed, packed, or held by the facility; identify and implement preventive
controls; monitor the performance of those controls; and maintain records demonstrating
compliance. Sections 418(b)-(i) contain more specific requirements applicable to facilities,
including corrective actions (§ 418(e)), verification (§ 418(f)), a written plan and documentation
(§ 418(h)), and reanalysis of hazards (§ 418(i)). Finally, section 103(e) of FSMA creates a new
section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit “[t]he operation of a facility
that manufactures, processes, packs, or holds food for sale in the United States if the owner,
operator, or agent in charge of such facility is not in compliance with section 418 [of the FD&C
Act].” FDA has promulgated regulations to implement the provisions of FSMA, which are
codified at 21 CFR part 117.
Accordingly, we are requesting OMB approval of the information collection provisions found in
21 CFR part 117 and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
Respondents to the information collection are owners, operators, or agents-in-charge of food
facilities required to register under section 415 of the FD&C Act. There are approximately
83,819 such facilities. Information collected will assist FDA in determining facility compliance
with current good manufacturing practice requirements and in ensuring that food safety systems
include hazard analysis and risk-based preventive controls. Records will be examined during
food facility inspections and in the event of an outbreak or other food safety incident involving
the food manufactured at the facility. Certain “qualified” facilities are subject to modified
requirements. Qualified facilities must report their status as such a facility and are thus subject
to the reporting requirements identified in the regulations.

3. Use of Improved Information Technology and Burden Reduction
Reporting requirements solicit what we believe is the minimal information necessary. At this
time the information may be submitted to FDA either electronically or by mail, however we
encourage electronic submissions. We have developed Form FDA 3942a (approved under OMB
Control No. 0910-0854) to facilitate the reporting process. We expect the recordkeeping
requirements will utilize an electronic format determined to be most appropriate by respondents.
Under the regulations, records must be available upon FDA request during inspection or to
review a food safety incident.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Facilities may already maintain much of
the information now required. As FDA has been Congressionally mandated to implement FSMA
provisions, we believe that duplication of the information collection from another source is
unlikely. Similar requirements apply to animal foods for which the associated information
collection is covered under OMB Control No. 0910-0789.
5. Impact on Small Businesses or Other Small Entities
FDA has made an effort to minimize any impact the regulations have on small businesses. We
provided for extended and staggered compliance dates for respondents qualifying as small
businesses and believe this will benefit smaller businesses and lower compliance costs.
Additionally, we have developed small entity compliance guides to assist facilities in meeting the
regulatory requirements.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements. If
corrective actions are necessary, further monitoring will be conducted. Data can be collected
hourly, daily, weekly, or yearly as determined by the hazards encountered in a particular
manufacturing process. FDA believes that the information collection schedules represent the
least amount of burden necessary to ensure the effectiveness of the regulations and ensure food
safety.
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
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in the
Federal Register of June 1, 2018 (83 FR 25466). One comment was received stating that our
estimate of burden associated with creating a food safety plan was too low and suggested a much
higher figure. We are appreciative of this comment. However, because the annual burden is

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based on an industry average and included nearly 50,000 estimated respondent; and because we
continue to evaluate this relatively new collection, we have retained our estimate. At the same
time, we continue to invite comment so that we might better refine our estimates for all elements
of the collection.
9. Explanation of Any Payment or Gift to Respondents
There are no payments or gifts to respondents associated with this collection of information.
10. Assurance of Confidentiality Provided to Respondents
There is no assurance of confidentiality associated with this collection of information.
11. Justification for Sensitive Questions
This collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of the information collection below.
Reporting

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Table 1 – Estimated Annual Reporting Burden1

21 CFR Section

No. of
Respondents

No. of
Responses per
Respondent

Total Annual
Responses

117.201(e); qualified
facility

37,134

0.5

18,567

Average
Burden
per
Response
0.5

Total
Hours
9,284

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

Qualified facilities must report their status as such a facility every 2 years; status will
likely be reported electronically through a web portal maintained by FDA. We estimate that
approximately 37,134 qualified facilities will spend 0.5 hours every 2 years reporting to FDA
their status as a qualified facility, for a total annual burden of 9,284 hours (37,134 facilities x 0.5
responses annually x 0.5 hours per response).

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Recordkeeping
Table 2 – Estimated Annual Recordkeeping Burden1
21 CFR Part 1;
Subpart 117
117.126(c) and
117.170(d); food
safety plan and
reanalysis
117.136; assurance
records
117.145(c);
monitoring records
117.150(d);
corrective actions and
corrections records
117.155(b);
verification records
117.160; validation
records
117.475(c)(7)-(c)(9);
supplier records
117.180(d); training
records for preventive
controls qualified
individual
TOTAL
1

No. of
Recordkeepers

No. of
Records Per
Recordkeeper

Total Annual
Records

Avg. Burden
per
Recordkeeping

Total
Hours

46,685

1

46,685

110

5,135,350

16,285

1

16,285

0.25

4,071

8,143

730

5,944,390

0.05

297,220

16,285

2

32,570

1

32,570

8,143

244

1,986,892

0.05

99,345

3,677

6

22,062

0.25

5,515

16,285

10

162,850

4

651,400

46,685

1

46,685

0.25

11,671

6,237,142

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

We estimate approximately 46,685 facilities will need to create a food safety plan, which is a
compilation of many written food safety procedures. We further estimate that creation of the
food safety plan will require 110 hours, averaged among facilities. Multiplying these figures
(46,685 facilities x 110 hours) provides our estimate of 5,135,350 hours.
We estimate the burden associated with assurance records to be approximately 4,071 hours,
allotting 15 minutes per record averaged over an estimated 16,285 establishments.
We believe the burden associated with keeping monitoring records is 297,220 hours. This figure
was reached by estimating that approximately 8,143 facilities will need to keep additional
records of the monitoring that they do of different activities within their food facilities. We then
estimate that this will result in an average of 730 records per recordkeeper; and that it will take 3
minutes (0.05 hours) per record for the activity.
We estimate the recordkeeping burden associated with corrective action records is 32,570 hours.
This estimate was reached by calculating that 2 times per year 16,285 facilities will have
corrective actions to document and that this activity will take one hour per record.
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We estimate that recordkeeping burden associated with verification records is 99,345 hours.
This figure was calculated by estimating that 8,143 will need to keep the requisite verification
records; averaging 244 records per recordkeeper; and then for 3 allotting minutes (0.05 hours)
per record.
We estimate the recordkeeping burden associated with validation records to be 5,515 hours. This
figure was calculated by estimating that 3,677 facilities will keep records of six validation
activities for an average of 22,062 records per recordkeeper, and then factoring 15 minutes (0.25
hours) per record.
We estimate the recordkeeping burden associated with supplier records to be 651,400 hours.
This figure was calculated by estimating that approximately 16,285 establishments will maintain
an average of 10 applicable records and that the total time for this activity will be about 4 hours
per record.
We estimate the recordkeeping burden associated with training for the preventive controls
qualified individual to be 11,671. This figure is based on approximately 46,685 establishments
needing to document the training of their preventive controls qualified individuals,
and by allotting 15 minutes (0.25 hours) for the activity.
Finally, under § 117.206(a)(5) facilities are required to keep records documenting (1) the
monitoring of temperature controls for refrigerated packaged food, (2) the corrective actions
taken when there is a problem with the control of temperature for refrigerated packaged food,
and (3) the verification activities relating to the temperature control of refrigerated packaged
food; however, we believe that the keeping of such records is already common industry practice
and therefore we have not estimated a burden for this activity.
Third-Party Disclosure
Table 3 – Estimated Annual Third-Party Disclosure Burden
21 CFR Section

117.201(e); disclosure
of food manufacturing
facility address
1

No. of
Respondents

No. of Disclosures
per Respondent

Total Annual
Disclosures

Avg. Burden
per Disclosure

Total
Hours

1

37,134

0.25

9,284

37,134

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

Under § 117.201(e) qualified facilities must include the address of the facility where the food
is manufactured in their label. We estimate the hour burden of this disclosure is 15 minutes per
disclosure. This requirement will cause the 37,134 qualified facilities to spend 0.25 hours adding
their address to their new labels for a total hour burden of about 9,284 hours (37,134 facilities x
0.25 hours per response).

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12b. Annualized Cost Burden Estimate
We measure costs based on the best available information from government, industry,
and academic sources.
Type of Respondent
Qualified Individual
Industrial Production
Manager
Food Manufacturing
Production Worker
Total

Annualized Cost Burden Estimate
Total Burden
Hourly Wage Rate
Hours
5,135,350
$56.00

Total Respondent
Costs
$287,579,600

1,101,792

$47.78

$52,643,622

18,568

$19.91

$369,689
$340,592,911

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital costs or operating and maintenance costs associated with this collection of
information.
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.
15. Explanation for Program Changes or Adjustments
Our estimated burden for the information collection remains unchanged. Compliance dates
continue to be realized.
16. Plans for Tabulation and Publication and Project Time Schedule
Information will not be published for statistical use.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval not to display the expiration date of OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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