0752 FSVP SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals
OMB Control No. 0910-0752
SUPPORTING STATEMENT Part A: Justification:
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we)
regulations and associated guidance. Section 301 of the Food and Drug Administration Food
Safety Modernization Act (FSMA) (Public Law 111-353) added section 805 to the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) requiring persons who import
food into the United States to perform risk-based foreign supplier verification activities for
the purpose of verifying:
(1) that food is produced in compliance with section 418 (concerning hazard analysis and
risk-based preventive controls) or 419 (concerning standards for the safe production and
harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs))
of the FD&C Act (21 U.S.C. 350g and 350h), as appropriate;
(2) the food is not adulterated under section 402 of the FD&C Act (21 U.S.C. 342); and
(3) the food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C.
343(w)) (concerning food allergen labeling).
Regulations in 21 CFR part 1; subpart L (Foreign Supplier Verification Programs for Food
Importers) set forth requirements intended to implement risk-based preventive controls (PC)
that provide the same level of public health protection as those required under sections 418
and 419 of the FD&C Act, and in compliance with sections 402 and 403(w) of the FD&C
Act. The regulations also establish requirements FDA deems necessary and appropriate to
verify that food imported into the United States is as safe as food produced and sold within
the United States.
Accordingly, we are seeking to extend OMB approval for the information collection
provisions found in 21 CFR part 1; subpart L (1.500-1.514) regarding FDA’s FSVPs for food
importers, and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The information collection requires that respondents establish and maintain records on FSVP
activities, including the hazard controls set forth in the regulations. We believe adherence to
the hazard control requirements will help ensure that importers safeguard food imported into
the United States. The regulations also establish requirements pertaining to reporting to

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Customs and Border Protection (CBP) (for subsequent transfer to FDA). Specifically,
persons who wish to import food for research or evaluation purposes must submit a
declaration that the food will be used for that purpose. Submission of these declarations
enables us to effectively monitor whether the requirements for the FSVP exemption for food
for research or evaluation are being met.
3. Use of Improved Information Technology and Burden Reduction
Although the recordkeeping requirements for FSVPs do not require the use of electronic
recordkeeping, we encourage this approach. We expect that most of the importers will
maintain their records in electronic format. Likewise, the reporting requirements to CBP
specify that the information must be provided electronically. This is necessary to ensure the
efficient collection of information by CBP and the subsequent transfer of the information to
FDA for FSVP monitoring and enforcement purposes. Therefore, we estimate that 100% of
respondents will use electronic means to satisfy the information collection provisions.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
Most respondents are small businesses. To assist respondents with the FSVP requirements
we have developed a small entity compliance guide available at:
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryI
nformation/UCM593089.pdf.
We also provide a Small Business Guide on our website at:
http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm along with draft
guidance regarding FSVP implementation.
6. Consequences of Collecting the Information Less Frequently
The information collection includes recordkeeping undertaken at the discretion of
respondents. Information may be reported or retained on a daily, weekly, monthly, or yearly
basis depending on which types of documents are being transmitted and which regulations
are applicable. Some information from respondents will be needed every time a food is
imported into the United States while other information may not be needed every time. For
example, a DUNS number will be provided to CBP with every entry line; shipments could
occur regularly (e.g., on a weekly basis) between the same importer and foreign supplier, or
they could happen once a year, or sporadically. As another example, audit results of a
supplying facility could be transmitted to the importer once annually for a relationship
between a specific supplier supplying the same product to the same importer over the course
of the year. We believe that the reporting and record collection schedules provided for in the
regulations are minimal and collecting the information less frequently would undermine our
public protection mandate.

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7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The reporting requirements concerning (1) declarations of food for research or evaluation (in
§1.501(c)) and (2) identification of the importer when a food is offered for importation into
the United States (in § 1.509(c)) must be made when filing entry for the food with CBP.
Consequently, this reporting must occur as frequently as the food is offered for importation,
which could be as often as multiple times in a single day. There are no other special
circumstances relating to the information collection request.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In the Federal Register of October 22, 2018 (83 FR 53271) we published a 60 day notice in
soliciting public comment on the proposed collection of information. No comments were
received.
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 information collection does not specify confidentiality. However, records that may be
reviewed during FDA inspections of food importers 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 contain questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Description of Respondents: Generally, respondents include all persons who import food
into the United States. We estimate that there are approximately 56,800 respondents who
meet the definition of importer as set forth in the regulations.

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Table 1.—Estimated Annual Reporting Burden1
21 CFR Section

No. of
Respondents

Exemption for Food for
research
1.501(c)
DUNS number for filing with
CBP
1.509(c), 1.511(c), 1.512(b)(2)
Total
1

No. of
Total
Avg. Burden
Total
Responses per Annual
Per Response
Hours
Respondent
Responses
36,360
40
1,454,400
0.083
120,715
(5 mins.)
56,800

157

8,917,600

0.02
(1.2 mins.)

178,352
299,067

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

Table 2.—Estimated Annual Recordkeeping Burden
IC Activity; 21 CFR Section

No. of
Recordkeepers

Controls for LACF; 1.502(b)

2,443

No. of Records
per
Recordkeeper
4

Total
Annual
Records
9,772

Avg. Burden
per
Recordkeeping
1

Total
Hours
9,772

FSVP RECORDKEEPING including hazard determination, written procedures, reevaluation; audits; and
corrective actions:
Determine and document
hazards; 1.504(a)
11,701
1
11,701
3.5
40,954
Review hazard analysis;
1.504(d)
11,701
7
81,907
0.33
27,029
Evaluation of food and
foreign supplier; 1.505(a)(2),
1.511(c)(1)
11,701
1
11,701
4
46,804
Approval of suppliers;
1.505(b), 1.512(c)(1)(iii)
8,191
1
8,191
12
98,292
Reevaluation of food and
foreign supplier; 1.505(c),
1.512(c)(1)(ii)(A)
11,701
365 4,270,865
0.25 1,067,716
Confirm or change
requirements of foreign
supplier verification activity;
1.505(c), 1.512(c)(1)(ii)(A)
2,340
1
2,340
2
4,680
Review of other entities
assessments; 1.505(d),
1.512(c)(1)(iii)
3,510
1
3,510
1.2
4,212
Written procedures for use of
approved foreign suppliers;
1.506(a)(1), 1.511(c)(2),
1.512(c)(3)(i)
11,701
1
11,701
8
93,608
Review of written
procedures; 1.506(a)(2),
1.511(c)(2)(ii), 1.512(c)(3)(ii)
11,701
1
11,701
1
11,701

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IC Activity; 21 CFR Section

Written procedures for
conducting verification
activities; 1.506(b),
1.511(c)(3)
Determination and
documentation of appropriate
supplier verification
activities; 1.506(d)(1)-(2)
1.511(c)(5)(i)
Review of appropriate
supplier verification activities
determined by another entity;
1.506(d)(3) 1.511(c)(5)(iii)
Conduct/review audits;
1.506(e)(1)(i),
1.511(c)(6)(i)(A)
Conduct periodic
sampling/testing;
1.506(e)(1)(ii),
1.511(c)(6)(i)(B)
Review records;
1.506(e)(1)(iii),
1.511(c)(6)(i)(C)
Document your review of
supplier verification activity
records; 1.506(e)(3),
1.511(c)(6)(iii)
1.507(a)(1)
Written assurances;
1.507(a)(2), 1.507(a)(3), and
1.507(a)(4)
Disclosures that accompany
assurances; 1.507(a)(2),
1.507(a)(3), and 1.507(a)(4)
Document assurances from
customers; 1.507(c)
Document corrective actions;
1.508(a) and 1.512(b)(4)
Investigate and determine
FSVP adequacy; 1.508(b),
1.511(c)(1)

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Avg. Burden
per
Recordkeeping

Total
Hours

11,701

1

11,701

2

23,402

11,701

4

46,804

3.25

152,113

11,701

2

23,402

0.33

7,723

11,701

2

23,402

3

70,206

11,701

2

23,402

1

23,402

11,701

2

23,402

1.6

37,443

11,701
11,701

6
3.17

70,206
37,082

0.25
1.25

17,552
46,353

11,701

8.72

102,038

0.50

51,019

102,038

1

102,038

0.50

51,019

36,522

2.8

102,262

0.25

25,566

2,340

1

2,340

2

4,680

2,340

1

2,340
4,984,036

5

33,664
50,450

2.25
1

SUBTOTAL for FSVP RECORDKEEPING ITEMIZED ABOVE:

Written assurances for food
produced under dietary
supplement CGMPs; 1.511(b)
Document very small

Total
Annual
Records

11,701
50,450

2.88
1

11,700
1,917,174

75,744
50,450

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IC Activity; 21 CFR Section

importer/certain small foreign
supplier status; 1.512(b)(1)
Written assurances associated
with very small
importer/certain small foreign
supplier 1.512(b)(3)
TOTAL

No. of
Recordkeepers

No. of Records
per
Recordkeeper

50,450

2.8

Total
Annual
Records

141,084

Avg. Burden
per
Recordkeeping

2.25

Total
Hours

317,439
2,370,579

12b. Annualized Cost Burden Estimate
We estimate that records will be kept by the employee performing the corresponding
activity. In most cases, this employee will be, or will be similar to, a production manager in the
food manufacturing industry. The mean wage for Standard Occupations Classification (SOC)
11-3051 Production Managers in North American Industry Classification System (NAICS) code
311000 Food Manufacturing in 2010 was $40.96. (Bureau of Labor Statistics, Occupational
Employment Statistics, May 2010, National Industry-Specific Occupational Employment and
Wage Estimates for NAICS 31100 - Food Manufacturing,
http://bls.gov/oes/current/naics3_311000.htm. ) We increased this wage by 50 percent to
$61.44 to account for overhead. The overall estimated cost incurred by the respondents,
therefore is $164,023,050 (2,669,646 burden hours x $61.44/hr).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
Table 3- Estimated Annual Operating and Maintenance Costs
21 CFR Part 1
Operating and Maintenance Costs
Conduct/Review audits; 1.506(g)(1)(i),
$3,085,000
1.506(h), 1.511(c)(5)(i)
Conduct periodic sampling/testing;
$158,240,430
1.506(g)(1)(ii), 1.506(h), 1.511(c)(5)(ii)
Investigate adulteration or misbranding;
$6,661,250
1.507(b), 1.511(c)(1)
Total Annual Costs
$167,986,680
14. Annualized Cost to the Federal Government
We estimate a “per-inspection” cost for the review of records of $269.25 per review
($53.85/hour x 5 hours). We assume an average of 500 inspections per year. Thus, our
estimated annual cost to the Federal Government for reviewing records during inspections
would be $134,625 ($269.25 x 500 inspections).

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15. Explanation for Program Changes or Adjustments
The estimated burden for the information collection remains unchanged. However, we have
removed costs previously attributed to reviewing and implementing newly established
requirements, which we believe to have been realized by respondents.
16. Plans for Tabulation and Publication and Project Time Schedule
We are considering using the information that importers would provide to CBP in accordance
with proposed § 1.509(c) to help us meet the requirement, stated in section 805(g) of the
FD&C Act, to “publish and maintain on [our] Internet Web site . . . a current list that includes
the name and location of, and other important information deemed necessary by [FDA] about,
importers participating under this section [i.e., section 805].” The meaning of the phrase
“importers participating under this section” is ambiguous. Among other things, it could mean
the list must include all importers subject to section 805 or only those subject to section 805
and in compliance with that provision. If so, FDA needs a way to know the identity of these
importers. One way to gather this information would be to obtain from CBP the importer
information provided in accordance with proposed § 1.509(c).
17. Reason(s) Display of OMB Expiration Date Is Inappropriate
Display of the OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.