0751 SS for PC for human food final rule

Current Good Manufacturing Practice, Hazard Analysis,
and Risk-Based Preventive Controls For Human Food
0910-0751
RIN 0910-AG36
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
On January 4, 2011, the FDA Food Safety Modernization Act (FSMA) (Public Law 111–353)
was signed into law. The legislation enables FDA 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, prevention-based 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].” Accordingly, FDA has promulgated
regulations to implement the provisions of FSMA, and on September 17, 2015, the agency issued
a final rule. This information collection request supports the reporting, recordkeeping, and thirdparty disclosure requirements associated with the final rule and codified in 21 CFR part 117.
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 under the rule 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.
In addition, certain “qualified” facilities may be subject to modified requirements under the rule.
Qualified facilities must report their status as such a facility and are thus subject to the reporting
requirements identified in the regulations.

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3. Use of Improved Information Technology and Burden Reduction
Reporting requirements under the rule solicit what the agency believes 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 are currently
developing both paper and electronic forms to facilitate the reporting process and expect to make
drafts available for comment in the near future.
We expect most respondents will fulfill the recordkeeping requirements under the rule
electronically where facilities may format their records in a manner they determine most
appropriate. 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
Facilities may already maintain much of the information now required under the rule. As FDA
has been Congressionally mandated to implement this rulemaking under FSMA, we believe that
duplication of the information collection from another source is unlikely.
5. Impact on Small Businesses or Other Small Entities
FDA has made an effort to minimize the impact of the rule on small businesses. While the
effective date of the rule is one year from the date of publication in the Federal Register, small
business will have a two year effective date, and very small businesses will have a three year
effective date. The agency believes the staggered effective dates will benefit smaller businesses
and lower compliance costs. Additionally, the agency is developing and will issue small entity
compliance guides to assist facilities in meeting the rule’s requirements.
6. Consequences of Collecting the Information Less Frequently
Information collection under the rule is determined by the applicable regulatory requirements
including the food safety plan of the respondents’ facilities. 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 reflected in the rule 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
FDA published a proposed rule in the Federal Register of January 16, 2013 (78 FR 3646);
supplemental rulemaking in the Federal Register of September 29, 2014 (79 FR 58524); and a

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final rule on September 17, 2015 (80 FR 55907). Comments received in response to the
rulemaking are filed under Docket No. FDA-2011-N-0920 and are addressed in the final rule (80
FR at 56133).
This rulemaking is the result of significant stakeholder engagement, beginning before the
initial proposed rule. In response to extensive stakeholder input on the proposed rule, key
provisions were revised in the supplemental notice of proposed rulemaking. After the
supplemental notice of proposed rulemaking, more outreach was conducted to the stakeholder
community to ensure that the risk-based, preventive requirements in this final rule are practical
and protective of the public health.
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
12 a. Annualized Hour Burden Estimate
FDA estimates the burden associated with this final rule below. Our estimates are based
on our experience with similar information collections and in consideration of feedback during
rulemaking. More detailed information regarding our calculations may be found within the
agency’s Final Regulatory Impact Analysis (FRIA), Reference No. 38, under Docket No. FDA2011-N-0920.
Reporting
Table 1 – Estimated Annual Reporting Burden1

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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

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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).
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
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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.

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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.
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
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0.25 hours per response).
12b. Annualized Cost Burden Estimate
 We measure costs based on the best available information from government, industry, and
academic sources. All wage rates used are identified and discussed more fully in the agency’s
FRIA, Reference 38 of the final rule and filed under Docket No. FDA-2011-N-0920.
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 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
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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