0750 Accreditation of 3rd Part Cert Supporting Statement for FR

Accreditation of Third Party Certification Bodies
to Conduct Food Safety Audits and Issue Certifications
OMB Control No. 0910-0750
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 307 of the Food Safety Modernization Act (FSMA), Accreditation of Third-Party
Auditors, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a new
provision, section 808, under the same name (21 U.S.C. 384d). It requires the Food and Drug
Administration (FDA) to establish a system, within two years of enactment, for the recognition
of accreditation bodies that accredit third-party certification bodies(CB) to conduct food safety
audits and to issue certifications for eligible foreign food facilities and their products (21 U.S.C.
384d(b)(1)(A)). While the statute uses the term “auditor” to describe an entity that conducts
audits and issues certifications, we use the term “certification body,” which better comports with
the terminology used by the food industry and the international standards community. The
statute further provides that if FDA has not identified and recognized an accreditation body that
meets the requirements of the section within two years after establishing the system for
recognition, then FDA may begin to directly accredit third-party certification bodies (21 U.S.C.
384d(b)(1)(A)(ii)). FDA direct accreditation of CBs may occur only when both conditions are
met.
FSMA section 307(b)(2) also requires FDA to issue model accreditation standards that thirdparty certification bodies must meet in order to be qualified for accreditation under FDA’s
program (21 U.S.C. 384d(b)(2)). The statute specifies that the model accreditation standards
must include requirements for regulatory audit reports and must look to existing standards for
guidance to avoid unnecessary duplication of efforts and costs (21 U.S.C. 384d(b)(2)). Finally,
the regulations must contain protections against conflicts of interest between accredited third
party auditors/certification bodies (and their audit agents) and the entities they audit or certify,
including requirements on timing and public disclosure of fees and appropriate limits on
financial affiliations (21 U.S.C. 384d(c)(5)(C)(ii) and (iii)). And in addition, the regulations
must require audits to be unannounced (21 U.S.C. 384d(c)(5)(C)(i)).
FSMA section 307 describes two types of certifications that may be issued by accredited thirdparty CBs: facility and food certifications. Facility certifications described in FSMA §§ 302(a)
and 307(c)(2) will be used by FDA to help determine whether a facility is eligible to be a facility
from which food may be offered for import under the voluntary qualified importer program
(VQIP) (21 U.S.C. 384b(d)). FDA is currently developing guidance on VQIP and will solicit
public comment consistent with its good guidance practices regulations found at 21 CFR 10.115.

Food certifications described in FSMA §§ 303(b) and 307(c)(2) will be used by FDA, in
conjunction with any other assurances FDA may require, to help determine whether a food
complies with the applicable requirements of the Act and should be admitted into the United
States (U.S.) (21 U.S.C. 381(q)). FDA may require certification or other assurance of
compliance to admit an imported food into the U.S., where FDA determines that such assurance
is necessary based on the risk of the food.
Before an accredited third-party CB may issue either type of certification, the CB must conduct a
regulatory audit and any other activities necessary to establish compliance with the requirements
of §§ 801(q) or 806, respectively (21 U.S.C. 384d(c)(2)(C)(i)).
2. Purpose and Use of the Information Collection
FDA will use certifications issued by accredited third-party auditors/CBs in deciding whether to
admit certain imported food into the U.S. that FDA has determined poses a food safety risk, and
in deciding whether an importer is eligible to participate in a program for expedited review and
entry of food imports. Except for limited circumstances in which we may directly accredit CBs
to participate in the accredited third-party audits and certification program, we will recognize
accreditation bodies (ABs) to accredit third-party auditors/certification bodies (CBs). We
believe that establishing this program for foreign food safety audits and food and facility
certifications will help us prevent potentially harmful food from reaching U.S. consumers and
thereby improve the safety of the U.S. food supply. Widespread participation and broad
acceptance of audits and certifications under the program will help increase efficiency by
eliminating redundant auditing to assess foreign suppliers’ compliance with the FD&C Act.
3. Use of Improved Information Technology and Burden Reduction
The regulations require ABs and CBs to electronically maintain records and submit reports or
notifications to FDA. We believe that currently all ABs and CBs have appropriate information
technology to comply with these information collection requirements.
4. Efforts to Identify Duplication and Use of Similar Information
The rulemaking underlying this information collection (“Third-Party rule”) updates current
regulations regarding food safety. We are unaware of regulations that would duplicate the
information collection.
5. Impact on Small Businesses or Other Small Entities
In the agency’s Final Regulatory Impact Analysis (FRIA) (found under Docket No. FDA-2011N-0146), we proffer three scenarios discussing the impact of the regulations. While each
scenario contemplates potential costs, we believe the rulemaking imposes minimal burden to
respondents.

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6. Consequences of Collecting the Information Less Frequently
Information collection occurs consistent with statutory requirements.
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
As required by section 3506(c)(2)(B) of the Paperwork Reduction Act of 1995 (PRA), FDA
provided an opportunity for public comment on the information collection requirements of the
proposed rule that published in the Federal Register on July 29, 2013 (78 FR 45781). Comments
received in response to the rulemaking are discussed in the agency’s final rule that published in
the Federal Register on November 27, 2015 (80 FR 74570). As finalized, the estimated
information collection burden has decreased from estimates provided in the agency’s proposed
rule.
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payment or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
The Third-Party rule does not specify confidentiality. However, records that may be reviewed
by FDA are subject to FDA regulations on the release of information found in 21 CFR Part 20.
Confidential commercial information is protected from disclosure under FOIA in accordance
with sections 5 U.S.C. 552(a) and (b) and by 21 CFR 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 contain questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: Respondents to the collection are eligible entities seeking audits,
certification, and/or recertification by accredited certification bodies participating in our
program, and accreditation bodies (ABs) and certification bodies (CBs) seeking to comply with
the recognition requirements of the rule. An eligible entity is a foreign entity in the import
supply chain of food for consumption in the U.S. that chooses to be subject to a food safety audit
conducted by an accredited third-party certification body.

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12 a. Annualized Hour Burden Estimate
In the Federal Register publication of the Third-Party rule (80 FR 74570), we considered
three scenarios for the participation rate of VQIP importers and their associated foreign suppliers
in a 10-year period. Because scenario no. 3 reflects the highest-end estimates we use those
figures for this analysis. Estimates associated with each scenario is discussed and may be found
in the agency’s rulemaking under Docket No. FDA-2011-N-0146 (80 FR at 74639).
Recordkeeping Burden
Under Scenario 3, the total one-time recordkeeping burden by 25 recognized ABs and 208 CBs
accredited under the third-party program is estimated at 58,570 hours. The total annual
recordkeeping burden by 25 recognized ABs and 208 CBs accredited under the third-party
program is estimated at 6,253 hours . For the purpose of this analysis we assume that all ABs
that apply for recognition in the program become recognized and all CBs that apply for
accreditation are accredited.
SCENARIO 3; Estimated One-Time Recordkeeping Burden1
21 CFR Part 1,
Subpart M

No. of
Recordkeepers

§1.615
§1.645
§1.624(d)
§1.657(d)
Contract modification
§1.651
§1.653(b)(2)
1

25
208
25
208
25
208
208

No. of
Total
Avg. Burden per Total
Records per
One-Time
Recordkeeping
Hours
Recordkeeper Records
(in hours)
1
25
2
50
1
208
2
416
1
25
160
4,000
1
208
160 33,280
8.79
220
2
440
48.5
10,088
2 20,176
1
208
1
208

Total One-Time Recordkeeping Burden
58,570
There are no operations and maintenance costs associated with one-time recordkeeping burden.

SCENARIO 3; Estimated Annual (Recurring) Recordkeeping Burden1
21 CFR Part
1; Subpart M

§1.625
§1.624(c)
§1.657(d)
§1.652
§1.653(b)(2)
§1.656(c)
1

No. of
Recordkeepers

25
25
208
208
208
208

No. of Records
per
Recordkeeper
426
1
1
48.5
48.5

Total Annual
Records

10,650
25
208
10,088
10,088
52

Avg. Burden
Total Hours
per
Recordkeeping
(in hours)
0.25
2,663
8
200
8
1,664
0.83
837
0.83
837
1
52

Total Annual Recordkeeping Burden
There are no operations and maintenance costs associated with annual recordkeeping burden.

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6,253

Reporting Burden
Under Scenario 3, the total one-time reporting burden by 25 recognized ABs and 208 CBs
accredited under the third-party program is estimated at 2,080 hours. The total annual reporting
burden by 25 recognized Abs and 208 CBs accredited under the program is estimated at 7,919.
SCENARIO 3; Estimated One-Time Reporting Burden1
21 CFR Part 1;
Subpart M

No. of
Respondents

No. of Responses per
Respondent

§1.630
25
§1.670(a-b)
1
Total One-time Reporting Burden
1

Total one-time
Responses

Avg. Burden Total
per Response Hours
(in hours)
25
80
2,000
1
80
80
2,080

1
1

There are no operating or maintenance costs associated with one-time reporting.

SCENARIO 3; Estimated Annual (Recurring) Reporting Burden1
21 CFR Part 1;
Subpart M

No. of
Respondents

No. of Responses per
Respondent

§1.634
25
§1.673
1
§1.623(a)
25
§1.623(b)
25
§1.653(b)(1)
208
§1.656(a)2
207
§1.656(a)3
207
§1.656(a)4
1
5
§1.656(b)
207
§1.656(b)6
1
§1.656(c)
208
§1.656(e)7
208
§1.656(e)8
207
Total Annual Reporting Burden
1
2.
3.
4.
5.
6.
7.

1
1
8.79
1
48.5
48.5
48.5
55.4
1
1
0.25
0.25
0.25

Total one-time
Responses
25
1
220
25
10,088
10,040
10,040
55
207
1
52
52
52

Avg. Burden Total
per Response Hours
(in hours)
8
200
10
10
0.25
55
0.25
6
0.25
2,522
0.25
2,510
0.25
2,510
0.25
14
0.25
52
0.25
1
0.25
13
0.25
13
0.25
13
7,919

There are no operating or maintenance costs associated with annual reporting.
Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.
Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to the FDA.
Annual reporting of regulatory audit reports by directly accredited CBs to the FDA.
Annual reporting of self-assessment by accredited CBs to their recognized ABs.
Annual reporting of self-assessment by directly-accredited CBs to the FDA.
Annual reporting of serious risk to public health by CBs accredited under the third-party program to eligible
entities.
Annual reporting of serious risk to public health by accredited CBs to their recognized ABs.

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12b. Annualized Cost Burden Estimate
We estimate the annualized cost burden as follows:
SCENARIO 3: Annualized Cost
Eligible Entity

Audited by
Certification Bodies
accredited under other
programs
No. of section 801(q) entities
10
TP Compliance Cost
$227
Section 801(q) Compliance Cost
$2,270
No. of section 806 entities
801
TP Compliance Cost
$227
Section 806 Compliance Cost
$181,827
TOTAL TP Compliance Cost Scenario 3

Audited by
TOTAL Cost
Certification Bodies of
not accredited under Compliance
any program
65
75
$2,102 ---------------$136,630
$138,900
5,359
6,160
$2,102 ---------------$11,264,618
$11,446,445
$11,585,345

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital costs associated with this information collection.
14. Annualized Cost to the Federal Government
In the economic analysis of the Third Party proposed rule, we estimated the annualized cost to
FDA to administer the program (see Preliminary Regulatory Impact Analysis (PRIA) under
Docket No. FDA-2011-N-0146). The administration of the Third Party proposed program
includes review of initial and renewal applications for recognition and accreditation, monitoring
ABs and CBs under the proposed program, and collection and dissemination of information.
Under FSVP co-proposal Option 1, annualized cost to the FDA to administer the Third Party
program is estimated at approximately $17.6 million (see Appendix B of the FSVP Third Party
combined economic analysis; Table B10a). Under FSVP co-proposal Option 2, annualized cost
to the FDA is estimated at approximately $17.0 million (see Appendix B; Table B10b). For
purposes of the final rule we have retained this estimate.
15. Explanation for Program Changes or Adjustments
This is a new information collection request.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA will make available on its website a publicly available registry of recognized accreditation
bodies and of accredited auditors/certification bodies, including the name of and contact
information for such bodies. Such registry may provide information on auditors/certification
bodies accredited by recognized accreditation bodies through links to the websites of such
accreditation bodies.
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17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval not to display the expiration date for OMB approval of the
information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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