0752 FSVP Supporting Statement for FR 27 Nov 2015

Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals
RIN 0910-AG64
OMB Control No. 0910-0752
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
FDA is required to issue rulemaking under section 301 of the FDA Food Safety
Modernization Act (FSMA) (Public Law 111-353), signed into law on January 4, 2011.
Section 301 of FSMA adds section 805 to the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 384a) to require persons who import food into the United States to perform
risk-based foreign supplier verification activities for the purpose of verifying the following:
(1) The 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).
Section 805(c) of the FD&C Act directs FDA to issue regulations on the content of its
foreign supplier verification programs (FSVPs). Section 805(c)(2)(A) states that these
regulations shall require that the FSVP of each importer be adequate to provide assurances
that each of the importer’s foreign suppliers produces food in compliance with processes and
procedures, including 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. Section 805(c)(2)(B) states
that these regulations shall include such other requirements as 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.
In addition to the authority specified in section 301 of FSMA (adding section 805 of the
FD&C Act) to issue these proposed regulations, section 701(a) of the FD&C Act (21 U.S.C.
371(a)) gives us the authority to promulgate regulations for the efficient enforcement of the
FD&C Act. Also, some aspects of the proposed FSVP regulations are being issued under
section 421(b) of the FD&C Act (21 U.S.C. 350j(b)).
This information collection request supports new regulatory requirements under 21 CFR Part
1 as promulgated under FDA’s final rule for “Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals.”

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2. Purpose and Use of the Information Collection
We are requiring that respondents establish and maintain records on their FSVPs and on the
performance of certain activities under those FSVPs, including the identification of hazards
that are reasonably likely to occur with a food and verification that these hazards are being
adequately controlled by the foreign supplier or other appropriate entity. These
recordkeeping requirements will help ensure that importers are meeting responsibilities under
the FSVP regulations and will better enable us to monitor importers’ compliance with the
regulations.
Certain reporting to Customs and Border Protection (CBP) (for subsequent transfer to FDA)
relating to FSVP requirements and exemptions is also required under the rule. 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.
The rulemaking also requires that the name and Dun and Bradstreet Universal Numbering
System (DUNS) number of the importer be provided for each line entry of food product
offered for importation into the United States. This information is needed to effectively
monitor importers’ compliance with the FSVP regulations. Knowing the identity of the
importer for a particular food being imported helps us implement section 421(b) of the
FD&C Act. In this way FDA can allocate resources for examining imported products based
on certain risk factors, including the rigor and effectiveness of the importer’s FSVP.
Moreover, obtaining the identity of the importer at entry enables us to “publish and maintain
on [our] Internet Website . . . a current list that includes the name and location of, and other
important information deemed necessary by [FDA] about, importers participating under this
section.” (Section 805(g) of the Act.)
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 under
the rule.
4. Efforts to Identify Duplication and Use of Similar Information
The FSVP rule implements food protection provisions not implemented elsewhere and
therefore we believe the information collection provisions are not duplicative. While we
considered requiring food importers to register and developing a database of importers, not

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all importers are required to register under the regulations and thus our current food facility
registration system would not be sufficient for FSVP purposes. At the same time, by
collecting this information with each entry as required under the rule, we learn the firm’s last
importation date and receive updated information with each importation (as opposed to
periodic updating through the registration process). In turn, this enables us to better assess
and allocate our limited inspectional resources.
5. Impact on Small Businesses or Other Small Entities
Most respondents subject to the rule are small businesses. However, the rule establishes
requirements specifically for “very small importers” and “very small foreign suppliers” that
differ from the “standard” FSVP requirements. We believe that this approach minimizes
burden on small entities while at the same time provides reasonable assurance of protecting
the public health by ensuring a safe food supply. As agency guidance is developed to
support the FSVP regulations, we intend to include recommendations to assist small entities
in establishing FSVPs and complying with the FSVP regulations.
6. Consequences of Collecting the Information Less Frequently
Written FSVP procedures and records of implementation of those procedures are necessary
to ensure their proper administration under the regulations, as well as assist with monitoring
compliance. 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.
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.

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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
FDA published a proposed rule regarding FSVP in the Federal Register of July 29, 2013 (78
FR 45730), and published a supplemental notice of proposed rulemaking regarding FSVP in
the Federal Register of September 29, 2014 (79 FR 58574). Some comments addressed
recordkeeping generally and are addressed in the final rule which published November 27,
2015 (80 FR at 74225, at page 74303). Other comments received in response to the
rulemaking did not respond to the four information collection topics solicited but are also
addressed in the final rule (at page 74321). All comments are filed under Docket No. FDA2011-N-0143.
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
This regulation 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
12 a. 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.
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), filed under Docket No. FDA-2011-N0143.

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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)

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.)

Total
1

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
Written procedures for conducting
verification activities; 1.506(b),
1.511(c)(3)
11,701
1
11,701
2
23,402

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IC Activity; 21 CFR Section

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

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

SUBTOTAL for FSVP RECORDKEEPING ITEMIZED ABOVE:

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

Total
Annual
Records

11,700
1,917,174

11,701

2.88

33,664

2.25

75,744

50,450

1

50,450

1

50,450

50,450

2.8

141,084

2.25

317,439
2,370,579

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12b. Annualized Cost Burden Estimate
FDA estimates 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) 113051 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

FDA’s review of the retained records will generally occur as part of its routine or for-cause
establishment inspection activities. FDA estimates that its review of the retained records
would take five hours per inspection. FDA estimates the hourly cost for review and evaluation
to be $16.33 to $55.46 per hour, the GS-5/Step 1 rate to the GS 13/Step 10 rate for the
Washington-Baltimore locality pay area for the year 2012. To account for overhead, this cost
is increased by 50 percent, making the total cost $24.50 to $83.19 per hour. The midpoint of
this range is $53.85 per hour. Thus, FDA estimates the cost to the Federal Government for the
review of records to be $269.25 per review ($53.85/hour x 5 hours). FDA estimates that it will
review records for an average of 500 inspections per year. Thus, FDA estimates that the total
annual cost to the Federal Government for reviewing records during inspections would be
$134,625 ($269.25 x 500 inspections).
15.

Explanation for Program Changes or Adjustments

This is a new information collection.

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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.