[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Pages 28057-28059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0721]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Accreditation of 
Third-Party Certification Bodies To Conduct Food Safety Audits and 
Issue Certifications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
17, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0331. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,

[[Page 28058]]

Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Accreditation of Third-Party Certification Bodies To Conduct Food 
Safety Audits and To Issue Certifications--21 CFR Part 1; Subpart M

OMB Control Number 0910-0750--Extension

    FDA provides for accreditation of third-party certification bodies 
(CBs) to conduct food safety audits of eligible foreign food 
facilities, and issue food and facility certifications, pursuant to the 
FDA Food Safety Modernization Act. In accordance with 21 CFR part 
1.600, subpart M, FDA uses certifications issued by accredited third-
party CBs in deciding whether to admit certain imported food into the 
United States 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 CBs. Use 
of accredited third-party CBs and food and facility certifications 
helps us prevent potentially harmful food from reaching U.S. consumers 
and thereby improve the safety of the U.S. food supply. This collection 
of information increases efficiency by reducing the number of redundant 
audits to assess compliance with applicable food safety requirements of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA 
regulations.
    We estimate that there are about 200,000 foreign food and feed 
exporters that offer their food and feed for import into the United 
States. These foreign food and feed exporters include approximately 
130,000 food and feed production facilities and approximately 71,000 
farms. A proportion of these foreign food and feed exporters may offer 
food subject to mandatory certification requirements under section 
801(q) of the FD&C Act (21 U.S.C. 381(q)(3)). In that case, the 
eligible entities must either comply with this collection of 
information to obtain certification from a CB accredited under the 
third-party program to continue exporting their food products into the 
United States, obtain certification from a foreign government 
designated by FDA, or lose their access to U.S. markets. We assume that 
in any given year, 75 foreign food and feed exporters will be subject 
to section 801(q) of the FD&C Act.
    We estimate that 25 ABs will accredit CBs that will conduct food 
safety audits of foreign eligible entities that offer food or feed for 
import to the United States. We also estimate that approximately 207 
CBs accredited by the 25 AB applicants will comply with the collection 
of information to participate in the program. In addition, we expect 
that one CB will apply and participate in the third-party program via 
direct accreditation by FDA under this collection of information.
    In the Federal Register of February 20, 2019 (84 FR 5084), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Several comments were submitted, however 
only those responsive to the information collection topics solicited 
are addressed here.
    (Comment 1) One comment suggested that the Agency should conduct 
all food safety audits instead of allowing third-party entities to 
conduct them, which would allow for greater accountability.
    (Response) With current resources, we do not have the ability to 
conduct food safety audits for the thousands of foreign suppliers that 
could potentially be interested in using this program to establish 
eligibility for Voluntary Qualified Importer Program under section 806 
of the FD&C Act (21 U.S.C. 384b) or meet the certification requirements 
under section 801(q) of the FD&C Act. With accredited third-party CBs 
and ABs, we can leverage their food safety activities to benefit our 
system of public food safety assurances. The regulation for 
accreditation of third-party CBs includes requirements for the 
accredited CBs to demonstrate their competence and capability to 
determine an eligible entity's compliance with the applicable food 
safety requirements of the FD&C Act and FDA regulations. In leveraging 
private food safety activities, we can prevent potentially harmful food 
from reaching U.S. consumers and thereby improve the safety of the U.S. 
food supply.
    (Comment 2) One comment suggested that there would be less burden 
for the public to deal directly with FDA instead of a third party.
    (Response) The Third-Party Program reduces burden for the public. 
Widespread participation and broad acceptance of audits and 
certifications under the program helps increase efficiency by 
eliminating redundant auditing to assess foreign suppliers' compliance 
with the FD&C Act and FDA regulations.
    (Comment 3) One comment offered that the Third-Party Program is a 
resourceful and competitive way to perform food safety audits and issue 
certifications.
    (Response) We agree with this comment. The use of accredited third-
party CBs and food and facility certifications helps us prevent 
potentially harmful food from reaching U.S. consumers and thereby 
improve the safety of the U.S. food supply. This collection of 
information increases efficiency by reducing the number of redundant 
audits to assess compliance with applicable food safety requirements of 
the FD&C Act and FDA regulations.
    FDA estimates the burden of the collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                               Number of
         21 CFR part 1; subpart M              Number of      records per    Total annual         Average burden per recordkeeping          Total hours
                                             recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   1.615 \2\..........................               7               1               7  2...........................................              14
Sec.   1.645 \2\..........................              68               1              68  2...........................................             136
Sec.   1.624(d) \2\.......................               7               1               7  160.........................................           1,120
Sec.   1.657(d) \2\.......................              68               1              68  160.........................................          10,880
Contract modification \2\.................               7               9              63  2...........................................             126
Sec.   1.651 \2\..........................              68            48.5           3,298  2...........................................           6,596
Sec.   1.653(b)(2) \2\....................              68               1              68  1...........................................              68
Sec.   1.625..............................              25             426          10,650  0.25 (15 minutes)...........................           2,663

[[Page 28059]]

 
Sec.   1.624(c)...........................              25               1              25  8...........................................             200
Sec.   1.657(d)...........................             208               1             208  8...........................................           1,664
Sec.   1.652..............................             208            48.5          10,088  0.083 (5 minutes)...........................             837
Sec.   1.653(b)(2)........................             208            48.5          10,088  0.083 (5 minutes)...........................             837
Sec.   1.656(c)...........................             208            0.25              52  1...........................................              52
                                                                                                                                         ---------------
    Total Annual Recordkeeping Burden.....  ..............  ..............  ..............  ............................................          25,193
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\1\ There are no capital costs or operating and maintenance costs associated with annual recordkeeping burden.
\2\ Initial burden for an AB seeking recognition or a CB seeking accreditation.


                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                               Number of
         21 CFR part 1; subpart M              Number of     responses per   Total annual      Average burden per response (in hours)       Total hours
                                              respondents     respondent       responses
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Sec.   1.630 \2\..........................               7               1               7  80..........................................             560
Sec.   1.670 \2\..........................               1               1               1  80..........................................              80
Sec.   1.634..............................              25               1              25  8...........................................             200
Sec.   1.672..............................               1               1               1  10..........................................              10
Sec.   1.623(a)...........................              25               9             225  0.25 (15 minutes)...........................              56
Sec.   1.623(b)...........................              25               1              25  0.25 (15 minutes)...........................               6
Sec.   1.653(b)(1)........................             208            48.5          10,088  0.25 (15 minutes)...........................           2,522
Sec.   1.656(a) \3\.......................             207            48.5          10,040  0.25 (15 minutes)...........................           2,510
Sec.   1.656(a) \4\.......................             207            48.5          10,040  0.25 (15 minutes)...........................           2,510
Sec.   1.656(a) \5\.......................               1            55.4              55  0.25 (15 minutes)...........................              14
Sec.   1.656(b) \6\.......................             207               1             207  0.25 (15 minutes)...........................              52
Sec.   1.656(b) \7\.......................               1               1               1  0.25 (15 minutes)...........................               1
Sec.   1.656(c)...........................             208            0.25              52  0.25 (15 minutes)...........................              13
Sec.   1.656(e) \8\.......................             208            0.25              52  0.25 (15 minutes)...........................              13
Sec.   1.656(e) \9\.......................             207            0.25              52  0.25 (15 minutes)...........................              13
                                                                                                                                         ---------------
    Total Annual Reporting Burden.........  ..............  ..............  ..............  ............................................           8,560
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\1\ There are no capital costs or operating and maintenance costs associated with annual reporting.
\2\ Initial burden for an AB seeking recognition or a CB seeking accreditation.
\3\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.
\4\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to FDA.
\5\ Annual reporting of regulatory audit reports by directly accredited CBs to FDA.
\6\ Annual reporting of self-assessment by accredited CBs to their recognized ABs.
\7\ Annual reporting of self-assessment by directly-accredited CBs to FDA.
\8\ Annual reporting of serious risk to public health by CBs accredited under the third-party program to eligible entities.
\9\ Annual reporting of serious risk to public health by accredited CBs to their recognized ABs.

    The total annual recordkeeping burden by 25 recognized ABs and 208 
CBs accredited under the third-party program is estimated at 25,193 
hours (see table 1). We assume that all ABs that apply for recognition 
in the program become recognized and all CBs that apply for 
accreditation are accredited. The total annual reporting burden by 25 
recognized ABs and 208 CBs accredited under the program is estimated at 
8,560 hours (see table 2). These estimates reflect a correction to the 
estimates published in the last 60-day notice, which did not include 
estimates for the initial burden needed to apply for entry into the 
program.
    We have adjusted our burden estimate since the last OMB approval to 
reflect the decrease of burden associated with one-time recordkeeping 
and reporting activities and have revised our estimate to reflect the 
initial burden for new ABs seeking recognition and new CBs seeking 
accreditation. The adjustment resulted in decreases of 7,421 responses 
and 41,069 total burden hours.

    Dated: June 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12703 Filed 6-14-19; 8:45 am]
 BILLING CODE 4164-01-P