or location where the regulatory audit
                                           was conducted''.
Sec.   1.652(b)(6)(i) and (ii)..........  Inserted ``to humans or animals'' after     Improve clarity.
                                           ``serious adverse health consequences or
                                           death''.
Sec.   1.652(b)(8)......................  Rephrased from ``is used in the facility''  Improve clarity.
                                           to ``is performed in or used by the
                                           facility''.
Sec.   1.653 heading....................  Changed heading from ``What must            Improve clarity.
                                           accredited auditor/certification body do
                                           when issuing food or facility
                                           certifications?'' to ``What must an
                                           accredited third-party certification body
                                           do when issuing food or facility
                                           certifications?''
Sec.   1.653(a)(1)......................  Changed ``(or an audit agent'' to ``(or,    Improve clarity.
                                           where applicable, an audit agent''.
                                          Changed ``to establish compliance'' to
                                           ``to determine compliance.''.
Sec.   1.653(a)(2)......................  Changed ``an observation'' to ``a           Improve clarity.
                                           deficiency''.
Sec.   1.654 heading....................  Rephrased language in heading from          Improve clarity.
                                           ``eligible entity with a food or facility
                                           certification'' to ``eligible entity that
                                           it has issued a food or facility
                                           certification''.
Sec.   1.654............................  Added ``with such requirements'' after      Improve clarity.
                                           ``compliance''.
                                          Changed ``if it determines the eligible
                                           entity is no longer'' to ``if it
                                           withdraws or suspends a food or facility
                                           certification because it determines that
                                           the entity is no longer.''.
Sec.   1.655(a).........................  Changed ``must annually, and as required    Improve clarity.
                                           under Sec.   1.631(f)(1)(i) or upon FDA
                                           request made for cause, conduct a self-
                                           assessment that includes evaluation of:''
Sec.  Sec.   1.655(a)(1), 1.655(a)(2),    Added ``involved in auditing and            Improve clarity.
 1.655(a)(3), 1.655(d)(2), 1.657(a),       certification activities,'' after ``other
 1.657(a)(1), 1.657(c).                    agents''.
Sec.  Sec.   1.655(a)(1), 1.655(a)(2)...  Removed ``under this subpart''............  Improve clarity.
Sec.   1.655(a)(5)......................  Inserted ``of'' between ``determination''   Editorial change.
                                           and ``whether''.
Sec.   1.655(c)(1)......................  Replaced ``area(s) needing improvement''    Improve clarity.
                                           with, ``deficiencies in complying with
                                           the requirements of this subpart''.

Sec.   1.655(c)(2)......................  Rephrased from ``effective corrective       Improve clarity.
                                           action(s) to address those area(s)'' to
                                           ``corrective action(s) that effectively
                                           address the identified deficiencies''.
Sec.   1.656(b).........................  Modified submission timeframe from 2        Conforming change.
                                           months to 60 days.
Sec.   1.656(c).........................  Rephrased ``when any of its audit agents    Improve clarity.
                                           or the accredited auditor/third-party
                                           certification body itself, discovers any
                                           condition found during a regulatory or
                                           consultative audit of an eligible entity,
                                           which''.
Sec.   1.657(a)(3) redesignated as Sec.   Added ``accredited third-party              Improve clarity.
  1.657(a)(4).                             certification body's'' after
                                           ``[p]rohibiting an''.
                                          Changed ``other agent of the accredited
                                           auditor/certification body from accepting
                                           any money, gift, gratuity, or item of
                                           value'' to ``other agent involving in
                                           auditing and certification activities
                                           from accepting any money, gift, gratuity,
                                           or other item of value.''.
Sec.   1.657(a)(4) redesignated as Sec.   Changed reference from ``(a)(3)'' to        Editorial change.
  1.657(a)(5).                             ``(a)(4)''.
Sec.   1.657(a)(4)(i) redesignated as     Changed from ``accreditation'' to,          Correction.
 Sec.   1.657(a)(5)(i).                    ``auditing and certification''.
Sec.   1.657(c).........................  Added ``accredited third-party              Improve clarity.
                                           certification body's'' before
                                           ``officers''.
                                          Changed ``other agents of an accredited
                                           auditor/certification body'' to ``other
                                           agents involving in auditing and
                                           certification activities.''.
Sec.   1.658 heading....................  Changed heading to ``What records           Improve clarity.
                                           requirements must an accredited auditor/
                                           certification body that has been
                                           accredited meet?''
Sec.   1.658(a).........................  Rephrased from ``certification body must    Improve clarity.
                                           maintain electronically for 4 years
                                           records'' to ``certification body that
                                           has been accredited must maintain
                                           electronically for 4 years records
                                           created during its period of
                                           accreditation''.
Sec.   1.658(a)(1)......................  Removed ``laboratory testing records and    Conforming change.
                                           results (as applicable).
Sec.  Sec.   1.658(a)(1), 1.658(a)(3)...  Rephrased from ``and corrective actions''   Improve clarity.
                                           to ``verification of any corrective
                                           action(s) taken''.
Sec.   1.658(a)(4)......................  Replaced ``under Sec.   1.650(a)(5) or by   Conforming change.
                                           the accredited auditor/certification body
                                           to FDA under Sec.   1.656(e)'' with ``in
                                           accordance with Sec.   1.650(a)(5)''.
Sec.   1.658(a)(5)-(a)(9) redesignated    Removed paragraph (a)(5)..................  Conforming change.
 as Sec.   1.658(a)(5)-(a)(8).
Sec.   1.658(a)(8) redesignated as Sec.   Rephrased from, ``taken as a result'' to    Improve clarity.
  1.658(a)(7).                             ``taken to address any deficiencies
                                           identified during a self-assessment''.
Sec.   1.658(a)(9) redesignated as Sec.   Changed ``the auditing or certification     Improve clarity.
  1.658(a)(8).                             program'' to ``its auditing or
                                           certification program''.
Sec.   1.658(b).........................  Changed from ``FDA in accordance with the   Correction.
                                           requirements of subpart J of this
                                           chapter'' to ``FDA in accordance with
                                           section 414 of the FD&C Act''.
Sec.   1.660 heading....................  Changed heading to ``Where do I apply for   Improve clarity.
                                           accreditation or renewal of accreditation
                                           by a recognized accreditation body and
                                           what happens once the recognized
                                           accreditation body decides on my
                                           application?''
Sec.   1.661............................  Added ``by a recognized accreditation       Improve clarity.
                                           body'' at end of header.
Sec.   1.662(a).........................  Rephrased ``comply with the requirements    Improve clarity.
                                           of Sec.  Sec.   1.640 to 1.658 and
                                           whether there are deficiencies in the
                                           performance of the accredited auditor/
                                           certification body that, if not
                                           corrected, would warrant withdrawal of
                                           its accreditation under this subpart.''
Sec.   1.662(b)(4)......................  Rephrased from ``regarding the accredited   Improve clarity.
                                           auditor's/certification body's authority,
                                           qualifications (including the expertise
                                           and training of its audit agents),
                                           conflict of interest program, internal
                                           quality assurance program, and monitoring
                                           by its accreditation body (or, in the
                                           case of direct accreditation, FDA);''
Sec.   1.663(d).........................  Rephrased from ``submission was             Improve clarity.
                                           completed'' to ``completed submission is
                                           received''.
Sec.   1.663(e).........................  Removed ``in writing'' and ``Such           Conforming change.
                                           notification may be made
                                           electronically.''
Sec.   1.663(f).........................  Replaced ``conditions'' with                Improve clarity.
                                           ``limitations''.
Sec.   1.663(f).........................  Replaced ``notification'' with ``issuance   Improve clarity.
                                           of the waiver'' and ``issuance of a
                                           denial of a waiver request'' as
                                           appropriate.
                                          Replaced ``conditions'' with
                                           ``limitations.''.
Sec.   1.664(a)(1)......................  Added ``or chemical or physical hazard''..  Correction.
Sec.   1.664(a)(2)......................  Changed ``meets the requirements'' to       Improve clarity.
                                           ``complies with the applicable
                                           requirements''.
Sec.   1.664(b)(2)......................  Replaced ``steps'' with ``relevant audit    Improve clarity.
                                           records''.
                                          Replaced ``to justify the food or facility
                                           certification'' with ``in support of its
                                           decision to certify''.
Sec.   1.664(c)(2)......................  Deleted ``food or facility''..............  For flexibility.

Sec.   1.664(e)(1)......................  Added ``of its accreditation through        Improve clarity.
                                           issuance of a withdrawal that will
                                           state''.
Sec.   1.664(e)(1)......................  Deleted, ``electronically, in English''...  Conforming change.
Sec.   1.664(e)(2)......................  Added ``issuance of the'' between ``date    Improve clarity.
                                           of'' and withdrawal''.
Sec.   1.664(g)(1)......................  Replaced ``bodies'' with ``body it          Improve clarity.
                                           accredited''.
                                          Added ``by FDA.''.........................
                                          Changed ``2 months'' to ``60 days.''......
                                          Removed ``electronically and in English.''
Sec.   1.664(g)(2)......................  Replaced ``such'' with ``an''.............  Editorial change.
Sec.   1.664(h).........................  Replaced ``and the status of recognition    Improve clarity.
                                           and food and facility certifications'' in
                                           the heading with ``accreditation''.
Sec.   1.664(h).........................  Replaced ``under this subpart'' with ``and  Improve clarity.
                                           provide a description of the basis for
                                           withdrawal''.
Sec.   1.665 heading....................  Changed heading from ``How do I             Improve clarity.
                                           voluntarily relinquish accreditation? to
                                           ``what if I want to voluntarily
                                           relinquish accreditation or do not want
                                           to renew?''
Sec.   1.665(a).........................  Changed ``2 months'' to ``60 days''.......  Improve clarity.
Sec.   1.665(b).........................  Added ``The accreditation body must         Clarification.
                                           establish and maintain records of such
                                           notification under Sec.   1.625(a).''
Sec.   1.666(a)(1)......................  Replaced ``requirements for                 Improve clarity.
                                           accreditation'' with ``applicable
                                           requirements of this subpart''.
Sec.   1.666(a)(2)(i)...................  Replaced ``a'' with ``another'' and         Editorial changes.
                                           ``not'' with ``no''.
Sec.   1.670(a)(3)......................  Added ``(a)(1) of this section, as          Correction.
                                           described in paragraph (a)(2)''.
Sec.   1.670(b)(1)......................  Revised to specify provision ``(a)(1)''...  Improve clarity.
Sec.   1.670(b)(2)......................  Added subsection title ``Submission''.....  Improve clarity.
Sec.   1.670(b)(3)......................  Added subsection title ``Signature''......  Improve clarity.
Sec.   1.671 heading....................  Changed title from ``How will FDA review    Improve clarity.
                                           applications for direct accreditation and
                                           for renewal of direct accreditation?'' to
                                           ``How will FDA review my application for
                                           direct accreditation or for renewal of
                                           direct accreditation and what happens
                                           once FDA decides on my application?''
Sec.   1.671(b).........................  Reorganized the provision: Moved original   Improve clarity.
                                           (f) under (b).
Sec.   1.671(c) previously (c) and (d)..  Redesignated as (c) to state that FDA will  Improve clarity.
                                           notify an applicant that its direct
                                           accreditation or renewal application has
                                           been approved through issuance of direct
                                           accreditation that will list any
                                           limitations associated with the
                                           accreditation.
Sec.   1.671(e).........................  Redesignated (e) to (d)...................  Improve clarity.
                                          Replaced ``denies'' with ``issues a
                                           denial''.
                                          Added ``for direct accreditation or for
                                           renewal of direct accreditation.''.
                                          Replaced ``notification'' with ``issuance
                                           of the denial of direct accreditation.''.
                                          Deleted ``address and''...................
Sec.   1.681............................  Combined (a) and (b)......................  Improve clarity.
                                          Replaced ``seek'' with ``apply for''......
Sec.   1.691(a) and (b).................  Replaced ``decision'' with ``the issuance   Improve clarity.
                                           of such denial''.
Sec.   1.691(c).........................  Replaced ``it describes'' with ``described  Editorial change.
                                           in the notice''.
Sec.   1.691(d).........................  Deleted ``in writing''....................  Improve clarity.
                                          Rephrased ``of its decision to grant the
                                           application or waiver request upon
                                           reconsideration, or its decision to deny
                                           the application or waiver request upon
                                           reconsideration.''.
Sec.   1.692(a).........................  Replaced ``FDA issued'' to ``of issuance    Editorial change.
                                           of''.
Sec.   1.692(d).........................  Deleted ``electronically''................  Improve clarity.
                                          Added phrases ``through issuance of an
                                           application or waiver request upon
                                           reconsideration'' and ``application or
                                           waiver request upon reconsideration
                                           through issuance of a denial of.''.
Sec.   1.692(e).........................  Replaced ``Affirmation'' with ``Issuance''  Improve clarity.
Sec.   1.693............................  Replaced ``FDA issued'' and ``written       For consistency and to
                                           notice'' with ``issuance of''.              improve clarity.
Sec.   1.693(a).........................  Rephrased ``the accreditation body or an    Improve clarity.
                                           individual authorized to act on its
                                           behalf'' to ``an individual authorized to
                                           act on the accreditation body's behalf''.
Sec.   1.693(b).........................  Rephrased ``the auditor/certification body  Improve clarity.
                                           or an individual authorized to act on its
                                           behalf'' to ``an individual authorized to
                                           act on the third-party certification
                                           body's behalf''.
----------------------------------------------------------------------------------------------------------------

XV. Executive Order 13175

    In accordance with Executive Order 13175, FDA has consulted with
tribal government officials. A Tribal Summary Impact Statement has been
prepared that includes a summary of Tribal officials' concerns and how
FDA has addressed them (Ref. 26). Persons with access to the Internet
may obtain the Tribal Summary Impact Statement at http://www.regulations.gov. Copies of the Tribal Summary Impact Statement also
may be obtained by contacting the person listed under FOR FURTHER
INFORMATION CONTACT.

XVI. Analysis of Economic Impact

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is a significant
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the Third-Party program will be used
primarily on voluntary basis where private enterprises determine that
the benefits of participating in our program outweighs their associated
user fee and compliance costs, the Agency certifies that the final rule
will not have a significant economic impact on a substantial number of
small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount. Annualized cost of the Third-Party final rule is
estimated at approximately $2.8 to $11.6 million, depending on the
scenario.

XVII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by OMB under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520). The title, description, and respondent description
of the information collection provisions are shown in the following
paragraphs with an estimate of the annual reporting and recordkeeping
burdens. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    Title: Accreditation of Third-Party Certification Bodies to Conduct
Food Safety Audits and Issue Certifications (Third-Party final rule)
    Description: FDA is amending its regulations to provide for
accreditation of third-party certification bodies (CBs) to conduct food
safety audits of eligible foreign food entities, including foreign food
facilities, and to issue food and facility certifications, pursuant to
the FDA Food Safety Modernization Act. Use of accredited third-party
CBs 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. We also expect that these
regulations will increase efficiency by reducing the number of
redundant audits to assess compliance with applicable food safety
requirements of the FD&C Act and FDA regulations.
    Description of respondents: The coverage of the Third-Party final
rule includes eligible entities seeking audits, certification, and/or
recertification by accredited CBs participating in our program,
accreditation bodies (ABs) seeking to comply with the recognition
requirements of the Third-Party final rule, and CBs seeking to comply
with the accreditation requirements of the Third-Party final rule
(including those accredited by recognized ABs and those directly-
accredited by FDA). An eligible entity is a foreign entity in the
import supply chain of food for consumption in the United States that
chooses to be subject to a food safety audit conducted by an accredited
third-party certification body.
    Based on FDA Operational and Administration System for Import
Support database information, we estimate that there are 200,692
foreign food and feed exporters that offer their food and feed for
import into the United States. These foreign food and feed exporters
include 129,757 food and feed production facilities and 70,935 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. In that case, the eligible entities must either comply
with the Third-Party final rule in order to obtain certification from a
CB accredited under the third-party program to continue exporting their
food products into the United States, or a foreign government
designated by FDA, or lose their access to U.S. markets. In the
economic analysis of the Third-Party final rule, 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.
    In addition to the entities subject to Sec.  801(q), some food
exporters will seek certificates to participate in VQIP under section
806 of the FD&C Act. We consider three different scenarios for the
participation rate of VQIP importers and their associated foreign
suppliers in a 10-year period: (1) Constant number of VQIP importers in
every year, (2) increasing participation over time, peaking at 20
percent of all importers of perishable products by the fifth year, with
stagnant growth in subsequent years, (3) increasing participation over
time, peaking at 40 percent of all importers of perishable products by
the 10th year of the program.
    The VQIP draft guidance document caps the acceptance of
applications by importers for VQIP at 200 for the initial year of the
program. Under Scenario 1, we consider 200 importers participating in
each of first 10 years of VQIP (see table 6). Average number of foreign
suppliers per importers is approximately 5.58; therefore, under
Scenario 1, we expect that 200 importers and approximately 1,116
foreign suppliers (200 importers x 5.58 foreign supplier per importer)
will be participating in VQIP every year for a 10-year period (see
tables 6 and 7).
    According to FDA's Office of Regulatory Affairs Reporting Analysis
and Decision Support System database, the number of importers of
perishable products is approximately 2,759. These importers would have
an incentive to participate in VQIP in order to expedite entry of their
perishable food products into the United States. Under Scenario 2, we
consider 200 importers participating in the initial year of VQIP and
increasing steadily until the fifth year of the program until 552
importers (20 percent x 2,759 importers of perishable products) are
participating in the program. For years 6 through 10, we consider 3
percent increase in

participation of new importers in VQIP (see table 6). Multiplying the
number of importers by the number of foreign suppliers per importers
(5.58), we expect that the number of foreign supplies participating in
VQIP, under Scenario 2, would increase from 1,116 to 3,527 in a 10-year
period (see table 7).
    Under Scenario 3, we consider the number of importers will increase
from 200 in the initial year of VQIP to 1,104 importers (40 percent x
2,759 importers of perishable products) in the 10th year of the
program. Tables 6 and 7 include the number of importers and their
associated foreign suppliers for scenario 3. Table 9 includes total
number of eligible entities in the Third-Party final rule based on the
three considered scenarios in the 10th year of the program.
    The economic analysis of the Third-Party final rule estimates
compliance costs under the assumption that expected efficiency gains,
and foreign food suppliers' incentive to maintain continued importation
of their food to the United States would lead all foreign suppliers
subject to section 801(q) of the FD&C Act, and foreign suppliers who
choose to use third-party food safety audits to satisfy requirements of
FDA's VQIP, to become eligible entities and seek food safety audits
under the Third-Party final rule.
    Considering the demand for food safety audits under the Third-Party
program by foreign suppliers subject to section 801(q) of the FD&C Act
and those wanting to participate in VQIP, we expect that some of the
ABs and CBs operating globally will also have an incentive to
participate and comply with the Third-Party final rule. Under the three
different scenarios discussed above, we have estimated that 11 to 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 91 to 207 CBs will be
accredited by the potential 11 to 25 AB applicants; these CBs will
comply with the Third-Party final rule in order 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 the
Third-Party final rule (see table 9).

                                  Table 6--Potential Number of Importers Participating in VQIP in Its Initial 10 Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Year
                           Scenario                            -----------------------------------------------------------------------------------------
                                                                   1        2        3        4        5        6        7        8        9        10
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.............................................................      200      200      200      200      200      200      200      200      200      200
2.............................................................      200      288      376      464      552      562      579      596      614      632
3.............................................................      200      300      400      500      600      700      800      900    1,000    1,104
--------------------------------------------------------------------------------------------------------------------------------------------------------

               Table 7--Potential Number of Foreign Suppliers (Section 806 of the FD&C Act) Participating in VQIP in Its Initial 10 Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Year
                           Scenario                            -----------------------------------------------------------------------------------------
                                                                   1        2        3        4        5        6        7        8        9        10
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.............................................................    1,116    1,116    1,116    1,116    1,116    1,116    1,116    1,116    1,116    1,116
2.............................................................    1,116    1,607    2,098    2,589    3,080    3,136    3,231    3,326    3,426    3,527
3.............................................................    1,116    1,674    2,232    2,790    3,348    3,906    4,464    5,022    5,580    6,160
--------------------------------------------------------------------------------------------------------------------------------------------------------

                          Table 8--Number of Respondents in the Third-Party Final Rule
----------------------------------------------------------------------------------------------------------------
                        Eligible entities                           Scenario 1      Scenario 2      Scenario 3
----------------------------------------------------------------------------------------------------------------
Section 801(q) of FD&C Act......................................              75              75              75
Section 806 of FD&C Act.........................................           1,116           3,527           6,160
                                                                 -----------------------------------------------
    Total eligible entities.....................................           1,191           3,602           6,235
----------------------------------------------------------------------------------------------------------------

                          Table 9--Number of Respondents to the Third-Party Final Rule
----------------------------------------------------------------------------------------------------------------
                                                                                Number of ABs/CBs
                        Status of ABs/CBs                        -----------------------------------------------
                                                                    Scenario 1      Scenario 2      Scenario 3
----------------------------------------------------------------------------------------------------------------
ABs seeking recognition.........................................              11              17              25
CBs seeking accreditation by recognized ABs.....................              91             140             207
CBs seeking accreditation by FDA................................               1               1               1
                                                                 -----------------------------------------------
    Total CBs accredited........................................              92             141             208
----------------------------------------------------------------------------------------------------------------

    Information Collection Burden Estimate: We estimate the burden for
this information collection as follows:
Recordkeeping Burden
    In summary, under Scenario 1, total one-time recordkeeping burden
by 11 recognized ABs and 92 CBs accredited under the third-party
program is estimated at 25,792 hours (see table 10). Total annual
recordkeeping burden by 11 recognized ABs and 92 CBs accredited under
the third-party

program is estimated at 2,673 hours (see table 13).
    Under Scenario 2, total one-time recordkeeping burden by 17
recognized ABs and 141 CBs accredited under the third-party program is
estimated at 41,640 hours (see table 11). Total annual recordkeeping
burden by 17 recognized ABs and 141 CBs accredited under the third-
party program s is estimated at 4,553 hours (see table 14).
    Under Scenario 3, total one-time recordkeeping burden by 25
recognized ABs and 208 CBs accredited under the third-party program is
estimated at 58,570 hours (see table 12). Total annual recordkeeping
burden by 25 recognized ABs and 208 CBs accredited under the third-
party program is estimated at 6,253 hours (see table 15).
    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.

                          Table 10--Scenario 1, Estimated One-Time Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.615....................              11            1                 11               2              22
Sec.   1.645....................              92            1                 92               2             184
Sec.   1.624(d).................              11            1                 11             160           1,760
Sec.   1.657(d).................              92            1                 92             160          14,720
Contract modification...........              11            8.27              91               2             182
Sec.   1.651....................              92           48              4,416               2           8,832
Sec.   1.653(b)(2)..............              92            1                 92               1              92
                                 -------------------------------------------------------------------------------
    Total One-Time Recordkeeping  ..............  ..............  ..............  ..............          25,792
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with one-time recordkeeping burden.

                          Table 11--Scenario 2, Estimated One-Time Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.615....................              17            1                 17               2              34
Sec.   1.645....................             141            1                141               2             282
Sec.   1.624(d).................              17            1                 17             160           2,720
Sec.   1.657(d).................             141            1                141             160          22,560
Contract modification...........              17            8.23             140               2             280
Sec.   1.651....................             141           55.4            7,811               2          15,623
Sec.   1.653(b)(2)..............             141            1                141               1             141
                                 -------------------------------------------------------------------------------
    Total One-Time Recordkeeping  ..............  ..............  ..............  ..............          41,640
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with one-time recordkeeping burden.

                          Table 12--Scenario 3, Estimated One-Time Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.615....................              25            1                 25               2              50
Sec.   1.645....................             208            1                208               2             416
Sec.   1.624(d).................              25            1                 25             160           4,000
Sec.   1.657(d).................             208            1                208             160          33,280
Contract modification...........              25            8.79             220               2             440
Sec.   1.651....................             208           48.5           10,088               2          20,176
Sec.   1.653(b)(2)..............             208            1                208               1             208
                                 -------------------------------------------------------------------------------
    Total One-Time Recordkeeping  ..............  ..............  ..............  ..............          58,570
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with one-time recordkeeping burden.

                           Table 13--Scenario 1, Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.625....................              11          397              4,367           0.025           1,092
                                                                                (15 minutes)
Sec.   1.624(c).................              11            1                 11               8              88

Sec.   1.657(d).................              92            1                 92               8             736
Sec.   1.652....................              92           48              4,416           0.083             367
                                                                                (5 minutes)
Sec.   1.653(b)(2)..............              92           48              4,416           0.083             367
                                                                                (5 minutes)
Sec.   1.656(c).................              92            0.25              23               1              23
                                 -------------------------------------------------------------------------------
    Total Annual Recordkeeping    ..............  ..............  ..............  ..............           2,673
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with one-time recordkeeping burden.

                           Table 14--Scenario 2, Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.625....................              17          456              7,752            0.25           1,938
                                                                                (15 minutes)
Sec.   1.624(c).................              17            1                 17               8             136
Sec.   1.657(d).................             141            1                141               8           1,128
Sec.   1.652....................             141           55.4            7,811           0.083             648
                                                                                (5 minutes)
Sec.   1.653(b)(2)..............             141           55.4            7,811           0.083             648
                                                                                (5 minutes)
Sec.   1.656(c).................             141            0.25              35               1              35
                                 -------------------------------------------------------------------------------
    Total Annual Recordkeeping    ..............  ..............  ..............  ..............           4,533
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with one-time recordkeeping burden.

                           Table 15--Scenario 3, Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.625....................              25          426             10,650            0.25           2,663
                                                                                (15 minutes)
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             837
                                                                                (5 minutes)
Sec.   1.653(b)(2)..............             208           48.5           10,088           0.083             837
                                                                                (5 minutes)
Sec.   1.656(c).................             208            0                 52               1              52
                                 -------------------------------------------------------------------------------
    Total Annual Recordkeeping    ..............  ..............  ..............  ..............           6,253
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with one-time recordkeeping burden.

    Sections 1.615 and 1.645 of the Third-Party final rule require that
at the time an AB submits an application for recognition (under Sec.
1.630 of the Third-Party final rule) or a CB submits an application for
direct accreditation (under Sec.  1.660, or where applicable under
Sec.  1.670), the AB or CB must demonstrate that it has implemented
written procedures to adequately establish, control, and maintain
records for the period of time necessary to meet its contractual and
legal obligations pertaining to the third-party program. Currently, ABs
maintain recordkeeping protocols relating to their operations; however,
we expect that ABs will review their recordkeeping protocols and, if
necessary, modify them to meet the requirements of Sec.  1.615 of the
Third-Party final rule before submitting applications for recognition.
We believe that the records requirements for ABs in Sec.  1.615 and CBs
in Sec.  1.645 would constitute a new one-time burden for the 11 to 25
ABs in each of the three considered scenario, and 92 to 208 CBs
respectively. We expect that it would take no more than 2 hours for an
AB or a CB to modify its recordkeeping protocol to comply with the
written recordkeeping requirements described in Sec. Sec.  1.615 and
1.645 of the Third-Party final rule (see tables 10 to 12). Therefore,
under Scenario 1, we estimate that it would take 22 hours (2 hours/AB x
11 ABs) for ABs to comply with Sec.  1.615 (34 hours under Scenario 2,
and 50 hours under Scenario 3) (see tables 10 to 12). We estimate 184
hours (2 hours/CB x 92 CBs) for CBs to comply with Sec.  1.645 of the
Third-Party final rule

(282 hours under Scenario 2, and 416 hours under Scenario 3) (see
tables 10 to 12).
    Section 1.625 of the Third-Party final rule requires that an AB
that has been recognized maintain records documenting requests by CBs
for accreditation from the AB (per Sec.  1.660), challenges to adverse
accreditation decisions (Sec.  1.620(c)), monitoring activities of its
accredited CBs (Sec.  1.621), self-assessments and corrective actions
(Sec.  1.622), copies of regulatory audit reports submitted by its
accredited CBs (Sec.  1.656), and copies of records of reports or
notifications made to us, as required by Sec.  1.623. A recognized AB's
requirements for reporting and notifications per Sec.  1.623 of the
Third-Party final rule include submission of results of its annual
performance assessment of each of its accredited CBs (Sec.  1.623(a))
and the results of its self-assessment (Sec.  1.623(b)) (see tables 20
to 22). A recognized AB also must notify us immediately upon granting,
withdrawing, suspending, reducing the scope of accreditation of a CB or
upon its determination that a CB it accredited issued a food or
facility certification in violation of subpart M, pursuant to Sec.
1.623(c) of the Third-Party final rule. Additionally, a recognized AB
must notify us within 30 days after making significant changes to its
operations that would affect the manner in which it complies with the
Third-Party final rule (Sec.  1.623(d)).
    Under current practice, ABs maintain records documenting requests
by CBs for accreditation, monitoring activities of CBs they have
accredited, and self-assessments and corrective actions. The records
currently maintained by ABs are similar to those that would be required
of a recognized AB under Sec.  1.623 of the Third-Party final rule.
However, CBs do not currently send copies of audit reports of their
clients (food facilities) to their ABs. Therefore, an AB's maintenance
of records pertaining to regulatory audit reports submitted by CBs they
have accredited is considered as a new recordkeeping burden for
recognized ABs. We expect that it would take no more than 15 minutes
(0.25 hour) for a recognized AB to file a regulatory audit report
submitted by its accredited CBs. Under Scenario 1, we estimate the
burden for 11 recognized ABs to maintain regulatory audit reports that
were submitted to them by their accredited CBs. We estimate that
following the implementation of the Third-Party final rule, under
Scenario 1, each recognized AB will accredit approximately 8.27 CBs
under the program (average of 10-year period) (8.23 CBs/AB under
Scenario 2; 8.79 CBs/AB under Scenario 3). In addition, under Scenario
1, we estimate that each CB accredited under the third-party program,
on average, will conduct regulatory audits on approximately 48 eligible
entities a year (average of 10-year period) (55.4 foreign suppliers per
CB under Scenario 2; 48.5 foreign suppliers per CB under Scenario 3).
Under Scenario 1, we expect that each recognized AB will receive, on
average, 397 regulatory audit reports (48 regulatory audit reports/CB x
8.27 CBs/AB) from its CBs annually resulting in a total of 4,367
records per year (397 audit reports/AB x 11 ABs). Under Scenario 2, we
expect that each recognized AB will receive, on average, 456 regulatory
audit reports (55.4 regulatory audit reports/CB x 8.23 CBs/AB) from its
CBs annually resulting in a total of 7,752 records per year (456 audit
reports/AB x 17 ABs). Under Scenario 3, we expect that each recognized
AB will receive, on average, 426 regulatory audit reports (48.5
regulatory audit reports/CB x 8.79 CBs/AB) from its CBs annually
resulting in a total of 10,650 records per year (426 audit reports/AB x
25 ABs). Total annual burden of recordkeeping requirement for
recognized AB under Sec.  1.625 of the Third-Party final rule is
estimated at 1,092 hours (4,367 records x 0.25 hours/record) under
Scenario 1 (1,938 hours under Scenario 2; 2,663 hours under Scenario 3)
(see tables 13 to 15).
    Section 1.624(d) of the Third-Party final rule requires each
recognized AB maintain on its Web site an up-to-date list of CBs it has
accredited under the Third-Party final rule and for each CB identify
the duration and scope of accreditation and date(s) on which the CB
paid the AB any fee or reimbursement associated with such
accreditation. Recognized ABs must also include information about
changes in accreditation status of third-party certification bodies.
Our review of AB Web sites found that none of the ABs reviewed publish
all the information that is required by Sec.  1.620(d) of the Third-
Party final rule on their Web sites. We estimate that each AB, on
average, would initially spend approximately 160 hours to update its
Web page to conform with this section of the Third-Party final rule.
Under Scenario 1, the one-time burden of conforming to Sec.  1.624(d)
of the Third-Party final rule by 11 recognized ABs is estimated at
approximately 1,760 hours (11 ABs x 160 hours/AB) (see table 10). Under
Scenario 2, the one-time burden of conforming to Sec.  1.624(d) of the
Third-Party final rule by 17 recognized ABs is estimated at
approximately 2,720 hours (17 ABs x 160 hours/AB) (see table 11). Under
Scenario 3, the one-time burden of conforming to Sec.  1.624(d) of the
Third-Party final rule by 25 recognized ABs is estimated at
approximately 4,000 hours (25 ABs x 160 hours/AB) (see table 12). In
addition, we estimate that each recognized AB would spend 8 hours
annually, following the initial year, to update information as required
by Sec.  1.624(d) of the Third-Party final rule. Under Scenario 1, the
annual hourly burden for 11 recognized ABs to update their Web pages to
conform to disclosure of information requirement per Sec.  1.624(d) of
the Third-Party final rule is estimated at 88 hours (8 hours/AB x 11
ABs) (136 hours under Scenario 2; 200 hours under Scenario 3) (see
tables 13 to 15).
    Similarly, Sec.  1.657(d) of the Third-Party final rule requires a
CB accredited in compliance with the Third-Party final rule to maintain
on its Web site an up-to-date list of eligible entities which it has
issued certifications under this subpart. For each such eligible entity
the Web site also must identify the duration and scope of the
certification and date(s) on which the eligible entity paid the CB
accredited under the third-party program any fee or reimbursement
associated with such audit or certification. In the Third-Party final
Regulatory Impact Analysis, we estimate that following the
implementation of the Third-Party final rule and VQIP draft guidance,
there will be approximately 91 CBs accredited by recognized ABs and 1
directly-accredited CB under Scenario 1 (140 CBs and one directly-
accredited CB under Scenario 2; 207 CBs and 1 directly-accredited CB
under Scenario 3). Under Scenario 1, the one-time recordkeeping burden
of 92 CBs accredited under the third-party program to comply with Sec.
1.657(d) of the Third-Party final rule is estimated at 14,720 hours
(160 hours/CB x 92 CBs) (22,560 hours under Scenario 2; 33,280 hours
under Scenario 3) (see tables 10 to 12). In addition, we estimate that
each CB would spend 8 hours annually, following the initial year, to
update information as required by Sec.  1.657(d) of the Third-Party
final rule. Under Scenario 1, annual hourly burden for 92 CBs
accredited under the third-party program to update their Web pages to
conform to disclosure of information requirement per Sec.  1.657(d) of
the Third-Party final rule is estimated at 736 hours (8 hours/CB x 92
CBs) (1,128 hours under Scenario 2; 1,664 hours under Scenario 3) (see
tables 13 to 15).
    There are certain provisions within the Third-Party final rule that
may require ABs to modify their contracts

with their CBs in order to comply with the Third-Party final rule.
Therefore, it is expected that recognized ABs will modify their
contracts with their accredited CBs to be able to conduct activities
such as conducting unannounced audits of their accredited CBs'
facilities. Minor modifications or addenda to contracts with standard
language provided by provisions in the Third-Party final rule would
consist of no more than 1 hour by an AB executive and 1 hour by a legal
counsel representing the AB. As we discussed, following the
implementation of the Third-Party final rule, we expect that each
recognized AB will accredit approximately 8.27 CBs (8.23 CBs/AB under
Scenario 2; 8.79 CBs/AB under Scenario 3). Therefore, under Scenario 1,
a total of 91 contracts (8.27 contracts/AB x 11 ABs) (140 contracts
under Scenario 2; 220 contracts under Scenario 3) are expected to be
modified to reflect changes in contractual obligations between each
recognized AB and its accredited CBs under the Third-Party final rule
(see tables 10 to 12). The one-time burden of initial modification of
91 contracts between 11 recognized ABs and their respective accredited
CBs is approximately 182 hours (91 contracts x 2 hours/contract) (280
hours under Scenario 2; 440 hours under Scenario 3) (see tables 10 to
12).
    Similarly, CBs accredited by recognized ABs would need to modify or
create new contracts with their client eligible entities in order to
gain access to any records and any area of the facility, its
process(es), and food of the eligible entity relevant to the scope and
purpose of audit being performed by the CB (Sec.  1.651). Considering
that each of the expected 92 CBs accredited under the third-party
program, under Scenario 1, will each have approximately 48 client
eligible entities, we expect that approximately 4,416 contracts (48
contracts/CB x 92 CBs) between CBs accredited under the third-party
program and eligible entities will be modified (7,811 contracts
scenario 2; 10,088 contracts under Scenario 3) (see tables 10 to 12).
Under Scenario 1, the one-time burden of initial modification of 4,416
contracts between 92 CBs accredited under the third-party program and
their respective client eligible entities is approximately 8,832 hours
(4,416 contracts x 2 hours/contract) (15,623 hours under Scenario 2;
20,176 hours under Scenario 3) (see tables 10 to 12).
    Section 1.652 of the Third-Party final rule requires that CBs
accredited under the third-party program include certain information in
reports of food safety audits. We believe that some information such as
the FDA food facility registration number (where applicable) of the
facility subject to the audit are currently not included in food safety
audits conducted by CBs accredited under other programs. Although this
information may not be required as part of the Third-Party program, we
have conservatively included the burden of providing such information
in this analysis. We expect that it would take about 5 minutes (0.083
hour), on average, by a CB accredited under the third-party program to
include additional information, as required in Sec.  1.652, in reports
of food safety audits. Therefore, at a minimum, under Scenario 1, each
CB accredited under the third-party program must modify a regulatory
audit report for each of its 48 eligible entities (55.4 eligible
entities per CB in Scenario 2; 48.5 eligible entities per CB in
Scenario 3) every year. Under Scenario 1, total annual records of 92
CBs accredited under the third-party program modifying regulatory audit
reports of their client eligible entities is estimated at 4,416 records
(92 CBs x 48 eligible entities/CB x 1 record/eligible entity) (7,811
records under Scenario 2; 10,088 records under Scenario 3). Annual
recordkeeping burden of CBs accredited under the third-party program,
per Sec.  1.652 of the Third-Party final rule, is estimated at 367
hours (4,416 records x 0.083 hour/record) for Scenario 1 (648 hours for
Scenario 2; 837 hours for Scenario 3) (see tables 13 to 15).
    Accredited third-party CBs will incur additional recordkeeping
costs associated with modifying existing certification templates to
meet the requirements of Sec.  1.653(b)(2). For example, we are
requiring accredited CBs to provide a certification number that follows
an FDA numeric designation. We have included the burden of providing
such information in this analysis because we know that CBs currently do
not use an FDA designation in numbering their certificates. To the
extent that any of the elements in Sec.  1.653(b)(2) are already
included in current certificates issued by some CBs, such as the
date(s) and scope of the audit, the recordkeeping burden may be
overestimated. We expect that it will take no more than 1 hour, on
average, to change the design of certifications issued by CBs
accredited under the third-party program. Under Scenario 1, we estimate
a one-time recordkeeping burden of modifying the design of the
certifications of 92 CBs accredited under the third-party program at 92
hours (92 CBs x 1 hour/CB) (141 hours under Scenario 2; 208 hours under
Scenario 3) (see tables 16 to 18).
    We expect that the burden to fill additional information on a
certification that is issued is 5 minutes (0.083 hour). Therefore,
under Scenario 1, the annual burden of Sec.  1.653(b)(2) is estimated
at 367 hours (92 CBs x 1 certificate/entity x 48 entities/CB x 0.083
hour/certificate) (see table 19). Under Scenario 2, the annual burden
of Sec.  1.653(b)(2) is estimated at 648 hours (141 CBs x 1
certificate/entity x 55.4 entities/CB x 0.083 hour/certificate) (see
table 20). Finally, under Scenario 3, the annual burden of Sec.
1.653(b)(2) is estimated at 837 hours (208 CBs x 1 certificate/entity x
48.5 entities/CB x 0.083 hour/certificate) (see table 21).
    Section 1.656(c) of the Third-Party final rule requires that CBs
accredited under the third-party program report to us any condition,
found during a regulatory or consultative audit of an eligible entity,
which could cause or contribute to a serious risk to the public health.
We believe that these occurrences are rare and may occur once every 4
years, or 0.25 times per year. Reporting serious hazard conditions
would consist of the onsite audit agent of a CB accredited under the
third-party program to document the event as a record and to
immediately submit the record to us. Therefore, under Scenario 1, the
annual number of records prepared by 92 CBs accredited under the third-
party program is estimated at 23 (0.25 records/CB x 92 CBs) (35 records
under Scenario 2; 52 records under Scenario 3). It is expected that a
CB accredited under the third-party program would take no more than 1
hour to prepare such record (notification). Under Scenario 1, annual
burden of preparation of records per Sec.  1.656(c) of the Third-Party
final rule by 92 CBs accredited under the third-party program is
estimated at 23 hours (23 records x 1 hour/record; see table 13) (35
hours for Scenario 2, and 52 hours for Scenario 3; see tables 14 to
15).
    We also acknowledge that an accreditation body seeking to challenge
a denial of its application for recognition, renewal of recognition, or
reinstatement of recognition will incur costs in compiling information
to support its request for reconsideration under Sec.  1.691 or its
request for internal Agency review under Sec.  1.692. A third-party
certification body seeking to challenge a denial of its application for
direct accreditation, renewal of direct accreditation, or
reaccreditation as a directly accredited third-party certification body
will incur costs in compiling information to support its

request for reconsideration under Sec.  1.691 or its request for
internal Agency review under Sec.  1.692, as will any accredited third-
party certification body seeking to challenge a denial of its request
for a waiver of the conflict of interest requirement of Sec.  1.650(b)
or a waiver extension. We anticipate that most accreditation bodies and
third-party certification bodies who seek to participate in our program
will carefully consider the program requirements before applying to, or
joining, the program or before submitting a waiver request. We
anticipate the submission of challenges under Sec.  1.691 or Sec.
1.692 to be an infrequent event, and one that most program participants
will not encounter. Therefore, we are not calculating costs associated
with the compiling of information to support a request for
reconsideration under Sec.  1.691 or a request for internal agency
review under Sec.  1.692 by an accreditation body seeking to challenge
a denial of its application for recognition, renewal of recognition, or
reinstatement of recognition; by an third-party certification body
seeking to challenge a denial of its application for direct
accreditation, renewal of direct accreditation, or reaccreditation as a
directly accredited third-party certification body; or by an accredited
third-party certification body seeking to challenge a denial of its
request for a waiver of the conflict of interest requirement of Sec.
1.650(b) or a waiver extension.
Reporting Burden
    In summary, under Scenario 1, total one-time reporting burden by 11
recognized ABs and 92 CBs accredited under the third-party program is
estimated at 960 hours (see table 16). Under Scenario 2, total one-time
reporting burden by 17 recognized ABs and 141 CBs accredited under the
third-party program is estimated at 1,440 hours (see table 17). Under
Scenario 3, total one-time reporting burden by 25 recognized ABs and
208 CBs accredited under the third-party program is estimated at 2,080
hours (see table 18). Total annual reporting burden, under Scenarios 1
to 3 is estimated between 3,466 and 7,919 hours (see tables 19 to 21).

                            Table 16--Scenario 1, Estimated One-Time Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.630....................              11               1              11              80             880
Sec.   1.670(a-b)...............               1               1               1              80              80
                                 -------------------------------------------------------------------------------
    Total One-Time Reporting      ..............  ..............  ..............  ..............             960
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with one-time reporting burden.

                            Table 17--Scenario 2, Estimated One-Time Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.630....................              17               1              17              80           1,360
Sec.   1.670(a-b)...............               1               1               1              80              80
                                 -------------------------------------------------------------------------------
    Total One-Time Reporting      ..............  ..............  ..............  ..............           1,440
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with one-time reporting burden.

                            Table 18--Scenario 3, Estimated One-Time Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.630....................              25               1              25              80           2,000
Sec.   1.670(a-b)...............               1               1               1              80              80
                                 -------------------------------------------------------------------------------
    Total One-Time Reporting      ..............  ..............  ..............  ..............           2,080
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with one-time reporting burden.

                             Table 19--Scenario 1, Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.634....................              11            1                 11               8              88
Sec.   1.673....................               1            1                  1              10              10
Sec.   1.623(a).................              11            8.27              91            0.25              23
                                                                                (15 minutes)
Sec.   1.623(b).................              11            1                 11            0.25               3
                                                                                (15 minutes)

Sec.   1.653(b)(1)..............              92           48              4,416            0.25           1,104
                                                                                (15 minutes)
Sec.   1.656(a) \1\.............              91           48              4,368            0.25           1,092
                                                                                (15 minutes)
Sec.   1.656(a) \2\.............              91           48              4,368            0.25           1,092
                                                                                (15 minutes)
Sec.   1.656(a) \3\.............               1           48                 48            0.25              12
                                                                                (15 minutes)
Sec.   1.656(b) \4\.............              91            1                 91            0.25              23
                                                                                (15 minutes)
Sec.   1.656(b) \5\.............               1            1                  1            0.25               1
                                                                                (15 minutes)
Sec.   1.656(c).................              92            0.25              23            0.25               6
                                                                                (15 minutes)
Sec.   1.656(e) \6\.............              92            0.25              23            0.25               6
                                                                                (15 minutes)
Sec.   1.656(e) \7\.............              91            0.25              23            0.25               6
                                                                                (15 minutes)
                                 -------------------------------------------------------------------------------
    Total Annual Reporting        ..............  ..............  ..............  ..............           3,446
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with annual reporting burden.
\1\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.
\2\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to the FDA.
\3\ Annual reporting of regulatory audit reports by directly accredited CBs to the FDA.
\4\ Annual reporting of self-assessment by accredited CBs to their recognized ABs.
\5\ Annual reporting of self-assessment by directly-accredited CBs to the FDA.
\6\ Annual reporting of serious risk to public health by CBs accredited under the third-party program to
  eligible entities.
\7\ Annual reporting of serious risk to public health by accredited CBs to their recognized ABs.

                             Table 20--Scenario 2, Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of    Total one-time    burden per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.634....................              17            1                 17               8             136
Sec.   1.673....................               1            1                  1              10              10
Sec.   1.623(a).................              17            8.23             140            0.25              35
                                                                                (15 minutes)
Sec.   1.623(b).................              17            1                 17            0.25               4
                                                                                (15 minutes)
Sec.   1.653(b)(1)..............             141           55.4            7,811            0.25           1,953
                                                                                (15 minutes)
Sec.   1.656(a) \1\.............             140           55.4            7,756            0.25           1,939
                                                                                (15 minutes)
Sec.   1.656(a) \2\.............             140           55.4            7,756            0.25           1,939
                                                                                (15 minutes)
Sec.   1.656(a) \3\.............               1           55.4               55            0.25              14
                                                                                (15 minutes)
Sec.   1.656(b) \4\.............             140            1                140            0.25              35
                                                                                (15 minutes)
Sec.   1.656(b) \5\.............               1            1                  1            0.25               1
                                                                                (15 minutes)
Sec.   1.656(c).................             141            0.25              35            0.25               9
                                                                                (15 minutes)
Sec.   1.656(e) \6\.............             141            0.25              35            0.25               9
                                                                                (15 minutes)
Sec.   1.656(e) \7\.............             140            0.25              35            0.25               9
                                                                                (15 minutes)
                                 -------------------------------------------------------------------------------
    Total Annual Reporting        ..............  ..............  ..............  ..............           6,093
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with annual reporting burden.
\1\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.
\2\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to the FDA.
\3\ Annual reporting of regulatory audit reports by directly-accredited CBs to the FDA.
\4\ Annual reporting of self-assessment by CBs to their recognized ABs.
\5\ Annual reporting of self-assessment by directly-accredited CBs to the FDA.
\6\ Annual reporting of serious risk to public health by CBs accredited under the third-party program to
  eligible entities.
\7\ Annual reporting of serious risk to public health by CBs to their recognized ABs.

                             Table 21--Scenario 3, Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                     Number of       Number of    Total one-time        per
    21 CFR Part 1, subpart M       recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.634....................              25            1                 25               8             200
Sec.   1.673....................               1            1                  1              10              10
Sec.   1.623(a).................              25            8.79             220            0.25              55
                                                                                (15 minutes)
Sec.   1.623(b).................              25            1                 25            0.25               6
                                                                                (15 minutes)
Sec.   1.653(b)(1)..............             208           48.5           10,088            0.25           2,522
                                                                                (15 minutes)
Sec.   1.656(a) \1\.............             207           48.5           10,040            0.25           2,510
                                                                                (15 minutes)
Sec.   1.656(a) \2\.............             207           48.5           10,040            0.25           2,510
                                                                                (15 minutes)
Sec.   1.656(a) \3\.............               1           55.4               55            0.25              14
                                                                                (15 minutes)
Sec.   1.656(b) \4\.............             207            1                207            0.25              52
                                                                                (15 minutes)
Sec.   1.656(b) \5\.............               1            1                  1            0.25               1
                                                                                (15 minutes)
Sec.   1.656(c).................             208            0.25              52            0.25              13
                                                                                (15 minutes)
Sec.   1.656(e) \6\.............             208            0.25              52            0.25              13
                                                                                (15 minutes)
Sec.   1.656(e) \7\.............             207            0.25              52            0.25              13
                                                                                (15 minutes)
                                 -------------------------------------------------------------------------------
    Total Annual Reporting        ..............  ..............  ..............  ..............           7,919
     Burden.....................
----------------------------------------------------------------------------------------------------------------
Note: There are no operations and maintenance costs associated with annual reporting burden.
\1\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.
\2\ Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to the FDA.
\3\ Annual reporting of regulatory audit reports by directly-accredited CBs to the FDA.
\4\ Annual reporting of self-assessment by CBs to their recognized ABs.
\5\ Annual reporting of self-assessment by directly-accredited CBs to the FDA.
\6\ Annual reporting of serious risk to public health by CBs accredited under the third-party program to
  eligible entities.
\7\ Annual reporting of serious risk to public health by CBs to their recognized ABs.

    Section 1.630 of the Third-Party final rule allows for any AB to
apply for recognition. Under Scenario 1, we estimate that approximately
11 ABs would apply for recognition. We estimate that it will take 80
person-hours to compile all the relevant information and complete the
application for recognition. The initial application for recognition is
a one-time burden for each AB that applies. Under Scenario 1, the one-
time initial application burden for 11 ABs is estimated at 880 hours
(11 applications x 80 hours/application) (see table 16). The one-time
initial application burden for 17 ABs, under Scenario 2 (25 ABs under
Scenario 3), is estimated at 1,360 hours (2,000 hours under Scenario 3)
(see tables 17 and 18). The duration of recognition for a recognized AB
will not exceed 5 years per Sec.  1.632 of the Third-Party final rule.
Therefore, it is expected that each of the recognized ABs would apply
to renew its recognition every 5 years per Sec.  1.634 of the Third-
Party final rule. We expect that applications for renewal of
recognition will take significantly less time to prepare. We use 50
percent of the amount of effort to prepare and submit an application
for renewal of recognition. Therefore, it is expected that, on average,
each recognized AB will spend 40 hours every 5 years (after the initial
application) to complete and submit an application for renewal of its
recognition, or approximately 8 hours per year (40 hours / 5 years) for
each AB. Therefore, the annual burden of completing the renewal of
recognition application by 11 ABs, under Scenario 1, is 88 hours (11
applications x 8 hours/application) per year (136 hours per year for 17
ABs under Scenario 2; 200 per hour for each of 25 ABs under Scenario 3)
(see tables 19 to 21).
    Similarly, Sec.  1.670(a) and (b) of the Third-Party final rule
allows for CBs to apply to us for direct accreditation, when the
criteria for direct accreditation are met. We estimate that
approximately one CB would apply for direct accreditation. It is
expected that the application for direct accreditation would require
the same amount of effort as does an AB's application for recognition.
Hence, we estimate that the initial application for direct
accreditation would take 80-person hours. The one-time initial
application burden for 1 CB, for each scenario, is estimated at 80
hours (1 application x 80 hours/application) (see tables 16 to 18). The
duration of accreditation for a directly-accredited CB will not exceed
4 years, per Sec.  1.671 of the Third-Party final rule. Therefore, it
is expected that each of the expected directly-accredited CBs would
apply to renew its accreditation every 4 years, per Sec.  1.673 of the
Third-Party final rule. We expect that directly accredited CBs use 50
percent amount of effort, or 40 person-hours, for their initial
application for direct accreditation, yielding an average of 10 hours
per year. Therefore, the annual burden of completing the application
for renewal by 1 directly-accredited CB is 10 hours (1 application x 10
hours/application) per year (see tables 19 to 21).
    For the purposes of the Third-Party final economic and PRA
analyses, we have estimated costs assuming that, during the application
process, affected entities will do their paperwork properly and
completely the first time. If we assumed a less consistent outcome, one
that would result in

recognition denials, the initial burden might increase.
    Section 1.623(a) of the Third-Party final rule requires that
recognized ABs annually conduct comprehensive assessments of the
performance of CBs they have accredited and submit the results of the
assessments to us within 45 days of their completion. We expect that it
would take no more than 15 minutes (0.25 hour) for a recognized AB to
electronically submit the assessment of each its accredited CBs.
Following the implementation of the Third-Party final rule and VQIP
draft guidance, we expect, on average, each recognized AB would
accredit approximately 8.27 CBs (8.23 CBs under Scenario 2; 8.79 under
Scenario 3). Therefore, under Scenario 1, each recognized AB would
submit, on average, approximately 91 copies of assessments of
performance of their accredited CBs (8.27 assessments/AB x 11 ABs) (140
assessments under Scenario 2; 220 under Scenario 3). Under Scenario 1,
annual reporting of 91 assessments by 11 recognized ABs is estimated at
23 hours (91 submission of assessments x 0.25 hour/submission) (35
hours under Scenario 2; 55 hours under Scenario 3) (see tables 19 to
21).
    Section 1.623(b) of the Third-Party final rule requires that
recognized ABs annually conduct a self-assessment and submit the
assessments within 45 days of their completion. We expect that it would
take no more than 15 minutes for an AB to electronically submit a copy
of its self-assessment. Under Scenario 1, annual reporting of 11 self-
assessments by 11 recognized ABs is estimated at 3 hours (11 submission
of self-assessments x 0.25 hour/submission) (4 hours under Scenario 2;
6 hours under Scenario 3) (see tables 10 to 21).
    Section 1.656(a) of the Third-Party final rule requires that a CB
accredited under the third-party program must submit the regulatory
audit reports it conducts to us and to the AB that granted its
accreditation (where applicable) within 45 days after completing such
audit. In the Third-Party final economic analysis, we estimate that
following the implementation of the Third-Party final rule, there will
be 11 recognized ABs that accredit 91 CBs (17 recognized ABs and 140
accredited CBs under Scenario 2; 25 recognized ABs and 207 accredited
CBs under Scenario 3), and we will directly accredit one CB. In
addition, we estimated that each CB accredited under the third-party
program, on average, conducts food safety audits and certifies 48
eligible entities under Scenario 1 (55.4 eligible entities/CB under
Scenario 2; 48.5 eligible entities/CB under Scenario 3). Therefore,
under Scenario 1, CBs accredited by recognized ABs will annually submit
4,368 regulatory audit reports (91 CBs x 48 reports/CB) to their
accrediting ABs and 4,368 reports to us (see table 19). Similarly,
under Scenarios 2 and 3, CBs accredited by recognized ABs will annually
submit 7,756 and 10,040 regulatory audit reports to their accrediting
ABs and the FDA, respectively (see tables 20 and 21). Under Scenario 1,
the directly-accredited CB will annually submit 48 regulatory audit
reports (1 CB x 48 reports/CB) (see table 19). The number of eligible
entities per directly-accredited CB increases to 55.4 in Scenario 2. We
assume that the number of eligible entities per directly-accredited CBs
remains the same for Scenario 3. We expect that it would take no more
than 15 minutes (0.25 hour) for a CB accredited under the third-party
program to electronically submit a copy of the regulatory report it
conducts to us and to its AB (where applicable).
    Under Scenario 1, annual reporting burden for CBs accredited by
recognized ABs is estimated at 1,092 hours (4,368 reports x 0.25 hours/
report) for submitting copies of regulatory audit reports they have
conducted to their accrediting ABs and 1,092 hours for submitting the
same records to us (see table 19). Under Scenario 2, annual reporting
burden for CBs accredited by recognized ABs is estimated at 1,939 hours
(7,756 reports x 0.25 hours/report) for submitting copies of regulatory
audit reports they have conducted to their accrediting ABs and 1,939
hours for submitting the same records to us (see table 20). Similarly,
under Scenario 3, annual reporting burden for CBs accredited by
recognized ABs is estimated at 2,510 hours (10,040 reports x 0.25
hours/report) for submitting copies of regulatory audit reports they
have conducted to their accrediting ABs and 2,510 hours for submitting
the same records to us (see table 21). Under Scenario 1, annual burden
for submission of regulatory audit reports by directly-accredited CBs
is estimated at 12 hours (48 reports x 0.25 hours/report) (14 hours for
Scenarios 2 and 3) (see tables 19 to 21).
    Section 1.656(b) of the Third-Party final rule requires CBs
accredited under the third-party program to submit reports of their
annual self-assessments electronically to their ABs, or in the case of
direct accreditation to us, within 45 days of the anniversary date of
their accreditation under subpart M. We expect that it would take no
more than 15 minutes (0.25 hour) for a CB accredited under the third-
party program to electronically send a copy of its annual self-
assessment to its AB or us (as applicable). Under Scenario 1, the
annual burden for CBs accredited by recognized ABs is estimated at 23
hours (91 self-assessments x 0.25 hour/self-assessment; see table 19)
(35 hours under Scenario 2 and 52 hours under Scenario 3; see tables 20
and 21). Annual burden for submission of self-assessments by one
directly-accredited CB is estimated at 0.25 hour (1 self-assessment x
0.25 hour/self-assessment; see tables 19 to 21) (rounded to 1 hour).
    As we discussed, Sec.  1.656(c) of the Third-Party final rule
requires that a CB accredited under the third-party program report to
us any condition, found during a regulatory or consultative audit of an
eligible entity, which could cause or contribute to a serious risk to
the public health. In the Recordkeeping Burden section above, we
estimated that such events are expected to occur once every 4 years, or
0.25 per year. We expect that it would take no more than 15 minutes
(0.25 hour) for a CB accredited under the third-party program to
electronically send a copy of its notification to us. Therefore, under
Scenario 1, the total number of notifications sent to us on an annual
basis per Sec.  1.656(c) of the Third-Party final rule is estimated at
23 (92 CBs x 0.25 records/CB) (35 notifications under Scenario 2; 52
notifications under Scenario 3). Under Scenario 1, annual burden for
submitting a notification under Sec.  1.656(c) of the Third-Party final
rule to us by CBs accredited under the third-party program is estimated
at 6 hours (23 records x 0.25 hour/record) (9 hours under Scenario 2;
13 hours under Scenario 3) (see tables 19 to 21).
    Following reporting under Sec.  1.656(c), a CB accredited under the
third-party program is required under Sec.  1.656(e) of the Third-Party
final rule to immediately notify the eligible entity and its
accrediting AB of any conditions identified during the audit which
triggered the reporting requirement per Sec.  1.656(c) of the Third-
Party final rule. Under Scenario 1, total number of notification sent
to eligible entities by 141 CBs accredited under the third-party
program is estimated at 23 (92 CBs x 0.25 records/CB) (35 notifications
under Scenario 2; 52 notifications under Scenario 3) while the number
of notifications sent to recognized ABs by their accredited CBs is
estimated at 23 (91 CBs x 0.25 records/CB) (35 under Scenario 2; 52
under Scenario 3). Under Scenario 1, annual burden of submitting a
notification under Sec.  1.656(e) of the Third-Party final rule to
affected eligible entities and ABs by accredited CBs is estimated at 6
hours (9 hours under Scenario 2; 13 hours under Scenario 3) (see tables
19 to 21).

XVIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(j) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

XIX. Federalism

    We have analyzed the final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

XX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. We have
verified the Web site addresses, but we are not responsible for any
subsequent changes to Web sites after this document publishes in the
Federal Register.

1. FDA, ``Transcript: FSMA Proposed Rules on Foreign Supplier
Verification Programs and the Accreditation of Third-Party Auditors/
Certification Bodies, Public Meeting, Day One, September 19, 2013.''
Available in Docket No. FDA-2011-N-0143.
2. FDA, ``Transcript: FSMA Proposed Rules on Foreign Supplier
Verification Programs and the Accreditation of Third-Party Auditors/
Certification Bodies, Public Meeting, Day Two, September 20, 2013.''
Available in Docket No. FDA-2011-N-0143.
3. FDA, ``FDA Office of Foods and Veterinary Medicine Memorandum to
the Division of Dockets Management on FDA Records of Outreach
Sessions,'' November 21, 2013. Available in Docket No. FDA-2011-N-
0920.
4. International Organization for Standardization/International
Electrotechnical Commission, ``ISO/IEC 17000:2004 Conformity
Assessment--Vocabulary and General Principles.'' Copies are
available from the International Organization for Standardization,
1, rue de Varembe, Case postale 56, CH-1211 Geneve 20, Switzerland,
or on the Internet at http://www.iso.org/iso/catalogue_detail.htm?csnumber=29316 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
5. International Organization for Standardization/International
Electrotechnical Commission, ISO/IEC ``17011:2004 Conformity
Assessment--General Requirements for Accreditation Bodies
Accrediting Conformity Assessment Bodies.'' Copies are available
from the International Organization for Standardization, 1, rue de
Varembe, Case postale 56, CH-1211 Geneve 20, Switzerland, or on the
Internet at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=29332 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
6. International Organization for Standardization/International
Electrotechnical Commission, ``ISO/IEC 17021:2011 Conformity
Assessment--Requirements for Bodies Providing Audit and
Certification of Management Systems.'' Copies are available from the
International Organization for Standardization, 1, rue de Varembe,
Case postale 56, CH-1211 Geneve 20, Switzerland, or on the Internet
at http://www.iso.org/iso/home/store/publication_item.htm?pid=PUB100353 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
7. International Organization for Standardization/International
Electrotechnical Commission, ``ISO/IEC 17065:2012 Conformity
Assessment--Requirements for Bodies Certifying Products, Processes
and Services.'' Copies are available from the International
Organization for Standardization, 1, rue de Varembe, Case postale
56, CH-1211 Geneve 20, Switzerland, or on the Internet at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=46568 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
8. International Organization for Standardization, ISO 19011:2011
Guidelines for Auditing Management Systems.'' Copies are available
from the International Organization for Standardization, 1, rue de
Varembe, Case postale 56, CH-1211 Geneve 20, Switzerland, or on the
Internet at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=50675 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
9. International Organization for Standardization/International
Electrotechnical Commission, ``ISO/IEC Guide 65:1996 General
Requirements for Bodies Operating Product Certification Systems.''
Copies are available from the International Organization for
Standardization, 1, rue de Varembe, Case postale 56, CH-1211 Geneve
20, Switzerland, or on the Internet at http://www.iso.org/iso/catalogue_detail.htm?csnumber=26796 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
10. International Organization for Standardization/International
Electrotechnical Commission, ``ISO/IEC 17020:2012 Conformity
Assessment--Requirements for the Operation of Various Types of
Bodies Performing Inspection.'' Copies are available from the
International Organization for Standardization, 1, rue de Varembe,
Case postale 56, CH-1211 Geneve 20, Switzerland, or on the Internet
at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=52994 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
11. Global Food Safety Initiative, ``Enhancing Food Safety Through
Third-Party Certification,'' March 2011.
12. International Organization for Standardization/International
Electrotechnical Commission, ``ISO/IEC 17040:2005 Conformity
Assessment--General Requirements for Peer Assessment of Conformity
Assessment Bodies and Accreditation Bodies.'' Copies are available
from the International Organization for Standardization, 1, rue de
Varembe, Case postale 56, CH-1211 Geneve 20, Switzerland, or on the
Internet at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=31815 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
13. International Accreditation Forum, ``IAF Endorsed Normative
Documents, Issue 4 (IAF PR 4:2007),'' http://www.iaf.nu/upFiles/197878.IAF-PR4-2007_Endorsed_NormDocs_Issue_4_Pub.pdf. Accessed on
October 26, 2015.
14. Codex Alimentarius Commission, ``Principles for Food Import and
Export Inspection and Certification (CAC/GL 20-1995).'' http://www.codexalimentarius.org/input/download/standards/37/CXG_020e.pdf.
Accessed on October 26, 2015.
15. Armour, S., Lippert, J., and Smith, M., ``Food Sickens Millions
as Company-Paid Checks Find It Safe,'' Bloomberg Business, October
11, 2012. http://www.bloomberg.com/news/articles/2012-10-11/food-sickens-millions-as-industry-paid-inspectors-find-it-safe. Accessed
on October 26, 2015.
16. Zheng, Y., Muth, M.M., Kosa, K., ``Economic Analysis of Third-
Party Food

Safety Certification of Imported Food,'' RTI International, June
2012.
17. American National Standards Institute, ``About ANSI,'' http://www.ansi.org/about_ansi/overview/overview.aspx?menuid=1. Accessed on
May 6, 2015.
18. United Kingdom Accreditation Service, ``About UKAS,'' http://www.ukas.com/about/. Accessed on October 26, 2015.
19. Danish Accreditation Fund, ``DANAK Home'' http://english.danak.dk/. Accessed on May 4, 2015.
20. International Organization for Standards, ``ISO/TS 22003:2007
Food Safety Management Systems--Requirements for Bodies Providing
Audit and Certification of Food Safety Management Systems.'' Copies
are available from the International Organization for
Standardization, 1, rue de Varembe, Case postale 56, CH-1211 Geneve
20, Switzerland, or on the Internet at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=39834 or may be
examined at the Division of Dockets Management (see ADDRESSES) (Ref.
Docket No. FDA-2011-N-0146 and/or RIN 0910-AG66).
21. International Organization for Standardization/International
Electrotechnical Commission, ``ISO 22000:2005 Food Safety Management
Systems--Requirements for Any Organization in the Food Chain.''
Copies are available from the International Organization for
Standardization, 1, rue de Varembe, Case postale 56, CH-1211 Geneve
20, Switzerland, or on the Internet at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=35466 or may be
examined at the Division of Dockets Management (see ADDRESSES) (Ref.
Docket No. FDA-2011-N-0146 and/or RIN 0910-AG66).
22. British Retail Consortium, ``Global Standard for Food Safety,
Issue 6,'' 2012. Copies are available from the British Retail
Consortium, Second Floor, 21 Dartmouth Street, London SW1H 9BP, or
may be examined at the Division of Dockets Management (see
ADDRESSES) (Ref. Docket No. FDA-2011-N-0146 and/or RIN 0910-AG66).
23. Safe Quality Food Institute, ``SQF Code, Edition 7.2: A HACCP-
Based Supplier Assurance Code for the Food Industry,'' July 2014.
https://www.sqfi.com/wp-content/uploads/SQF-Code_Ed-7.2-July.pdf.
Accessed on October 27, 2015.
24. International Organization for Standardization, ``ISO/TS
22003:2013 Food Safety Management Systems--Requirements for Bodies
Providing Audit and Certification of Food Safety Management
Systems.'' Copies are available from the International Organization
for Standardization, 1, rue de Varembe, Case postale 56, CH-1211
Geneve 20, Switzerland, or on the Internet at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=60605 or
may be examined at the Division of Dockets Management (see
ADDRESSES) (Ref. Docket No. FDA-2011-N-0146 and/or RIN 0910-AG66).
25. FDA, ``Tribal Summary Impact Statement: Final Rule on
Accreditation of Third-Party Certification Bodies to Conduct Food
Safety Audits and to Issue,'' Docket No. FDA-2011-N-0146.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 11

    Administrative practice and procedure, Computer technology,
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1, 11, and 16 are amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as
follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371,
374, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C.
216, 241, 243, 262, 264, 271.

0
2. Add subpart M, consisting of Sec. Sec.  1.600 through 1.695, to read
as follows:
Subpart M--Accreditation of Third-Party Certification Bodies To Conduct
Food Safety Audits and To Issue Certifications
Sec.
1.600 What definitions apply to this subpart?
1.601 Who is subject to this subpart?

Recognition of Accreditation Bodies Under This Subpart

1.610 Who is eligible to seek recognition?
1.611 What legal authority must an accreditation body have to
qualify for recognition?
1.612 What competency and capacity must an accreditation body have
to qualify for recognition?
1.613 What protections against conflicts of interest must an
accreditation body have to qualify for recognition?
1.614 What quality assurance procedures must an accreditation body
have to qualify for recognition?
1.615 What records procedures must an accreditation body have to
qualify for recognition?

Requirements for Accreditation Bodies That Have Been Recognized Under
This Subpart

1.620 How must a recognized accreditation body evaluate third-party
certification bodies seeking accreditation?
1.621 How must a recognized accreditation body monitor the
performance of third-party certification bodies it accredited?
1.622 How must a recognized accreditation body monitor its own
performance?
1.623 What reports and notifications must a recognized accreditation
body submit to FDA?
1.624 How must a recognized accreditation body protect against
conflicts of interest?
1.625 What records requirements must an accreditation body that has
been recognized meet?

Procedures for Recognition of Accreditation Bodies Under This Subpart

1.630 How do I apply to FDA for recognition or renewal of
recognition?
1.631 How will FDA review my application for recognition or renewal
of recognition and what happens once FDA decides on my application?
1.632 What is the duration of recognition?
1.633 How will FDA monitor recognized accreditation bodies?
1.634 When will FDA revoke recognition?
1.635 What if I want to voluntarily relinquish recognition or do not
want to renew recognition?
1.636 How do I request reinstatement of recognition?

Accreditation of Third-Party Certification Bodies Under This Subpart

1.640 Who is eligible to seek accreditation?
1.641 What legal authority must a third-party certification body
have to qualify for accreditation?
1.642 What competency and capacity must a third-party certification
body have to qualify for accreditation?
1.643 What protections against conflicts of interest must a third-
party certification body have to qualify for accreditation?
1.644 What quality assurance procedures must a third-party
certification body have to qualify for accreditation?
1.645 What records procedures must a third-party certification body
have to qualify for accreditation?

Requirements for Third-Party Certification Bodies That Have Been
Accredited Under This Subpart

1.650 How must an accredited third-party certification body ensure
its audit agents are competent and objective?
1.651 How must an accredited third-party certification body conduct
a food safety audit of an eligible entity?
1.652 What must an accredited third-party certification body include
in food safety audit reports?
1.653 What must an accredited third-party certification body do when
issuing food or facility certifications?
1.654 When must an accredited third-party certification body monitor
an eligible entity that it has issued a food or facility
certification?
1.655 How must an accredited third-party certification body monitor
its own performance?
1.656 What reports and notifications must an accredited third-party
certification body submit?

1.657 How must an accredited third-party certification body protect
against conflicts of interest?
1.658 What records requirements must a third-party certification
body that has been accredited meet?

Procedures for Accreditation of Third-Party Certification Bodies Under
This Subpart

1.660 Where do I apply for accreditation or renewal of accreditation
by a recognized accreditation body and what happens once the
recognized accreditation body decides on my application?
1.661 What is the duration of accreditation by a recognized
accreditation body?
1.662 How will FDA monitor accredited third-party certification
bodies?
1.663 How do I request an FDA waiver or waiver extension for the 13-
month limit for audit agents conducting regulatory audits?
1.664 When would FDA withdraw accreditation?
1.665 What if I want to voluntarily relinquish accreditation or do
not want to renew accreditation?
1.666 How do I request reaccreditation?

Additional Procedures for Direct Accreditation of Third-Party
Certification Bodies Under This Subpart

1.670 How do I apply to FDA for direct accreditation or renewal of
direct accreditation?
1.671 How will FDA review my application for direct accreditation or
renewal of direct accreditation and what happens once FDA decides on
my application?
1.672 What is the duration of direct accreditation?

Requirements for Eligible Entities Under This Subpart

1.680 How and when will FDA monitor eligible entities?
1.681 How frequently must eligible entities be recertified?

General Requirements of This Subpart

1.690 How will FDA make information about recognized accreditation
bodies and accredited third-party certification bodies available to
the public?
1.691 How do I request reconsideration of a denial by FDA of an
application or a waiver request?
1.692 How do I request internal agency review of a denial of an
application or waiver request upon reconsideration?
1.693 How do I request a regulatory hearing on a revocation of
recognition or withdrawal of accreditation?
1.694 Are electronic records created under this subpart subject to
the electronic records requirements of part 11 of this chapter?
1.695 Are the records obtained by FDA under this subpart subject to
public disclosure?

Subpart M--Accreditation of Third-Party Certification Bodies To
Conduct Food Safety Audits and To Issue Certifications

Sec.  1.600  What definitions apply to this subpart?

    (a) The FD&C Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Except as otherwise defined in paragraph (c) of this section,
the definitions of terms in section 201 of the FD&C Act apply when the
terms are used in this subpart.
    (c) In addition, for the purposes of this subpart:
    Accreditation means a determination by a recognized accreditation
body (or, in the case of direct accreditation, by FDA) that a third-
party certification body meets the applicable requirements of this
subpart.
    Accreditation body means an authority that performs accreditation
of third-party certification bodies.
    Accredited third-party certification body means a third-party
certification body that a recognized accreditation body (or, in the
case of direct accreditation, FDA) has determined meets the applicable
requirements of this subpart and is accredited to conduct food safety
audits and to issue food or facility certifications to eligible
entities. An accredited third-party certification body has the same
meaning as accredited third-party auditor as defined in section
808(a)(4) of the FD&C Act.
    Assessment means:
    (i) With respect to an accreditation body, an evaluation by FDA of
the competency and capacity of the accreditation body under the
applicable requirements of this subpart for the defined scope of
recognition. An assessment of the competency and capacity of the
accreditation body involves evaluating the competency and capacity of
the operations of the accreditation body that are relevant to decisions
on recognition and, if recognized, an evaluation of its performance and
the validity of its accreditation decisions under the applicable
requirements of this subpart.
    (ii) With respect to a third-party certification body, an
evaluation by a recognized accreditation body (or, in the case of
direct accreditation, FDA) of the competency and capacity of a third-
party certification body under the applicable requirements of this
subpart for the defined scope of accreditation. An assessment of the
competency and capacity of the third-party certification body involves
evaluating the competency and capacity of the operations of the third-
party certification body that are relevant to decisions on
accreditation and, if accredited, an evaluation of its performance and
the validity of its audit results and certification decisions under the
applicable requirements of this subpart.
    Audit means the systematic and functionally independent examination
of an eligible entity under this subpart by an accredited third-party
certification body or by FDA. An audit conducted under this subpart is
not considered an inspection under section 704 of the FD&C Act.
    Audit agent means an individual who is an employee or other agent
of an accredited third-party certification body who, although not
individually accredited, is qualified to conduct food safety audits on
behalf of an accredited third-party certification body. An audit agent
includes a contractor of the accredited third-party certification body
but excludes subcontractors or other agents under outsourcing
arrangements for conducting food safety audits without direct control
by the accredited third-party certification body.
    Consultative audit means an audit of an eligible entity:
    (i) To determine whether such entity is in compliance with the
applicable food safety requirements of the FD&C Act, FDA regulations,
and industry standards and practices;
    (ii) The results of which are for internal purposes only; and
    (iii) That is conducted in preparation for a regulatory audit; only
the results of a regulatory audit may form the basis for issuance of a
food or facility certification under this subpart.
    Direct accreditation means accreditation of a third-party
certification body by FDA.
    Eligible entity means a foreign entity in the import supply chain
of food for consumption in the United States that chooses to be subject
to a food safety audit under this subpart conducted by an accredited
third-party certification body. Eligible entities include foreign
facilities required to be registered under subpart H of this part.
    Facility means any structure, or structures of an eligible entity
under one ownership at one general physical location, or, in the case
of a mobile facility, traveling to multiple locations, that
manufactures/processes, packs, holds, grows, harvests, or raises
animals for food for consumption in the United States. Transport
vehicles are not facilities if they hold food only in the usual course
of business as carriers. A facility may consist of one or more
contiguous structures, and a single building may house more than one

distinct facility if the facilities are under separate ownership. The
private residence of an individual is not a facility. Non-bottled water
drinking water collection and distribution establishments and their
structures are not facilities. Facilities for the purposes of this
subpart are not limited to facilities required to be registered under
subpart H of this part.
    Facility certification means an attestation, issued for purposes of
section 801(q) or 806 of the FD&C Act by an accredited third-party
certification body, after conducting a regulatory audit and any other
activities necessary to establish whether a facility complies with the
applicable food safety requirements of the FD&C Act and FDA
regulations.
    Food has the meaning given in section 201(f) of the FD&C Act,
except that food does not include pesticides (as defined in 7 U.S.C.
136(u)).
    Food certification means an attestation, issued for purposes of
section 801(q) of the FD&C Act by an accredited third-party
certification body, after conducting a regulatory audit and any other
activities necessary to establish whether a food of an eligible entity
complies with the applicable food safety requirements of the FD&C Act
and FDA regulations.
    Food safety audit means a regulatory audit or a consultative audit
that is conducted to determine compliance with the applicable food
safety requirements of the FD&C Act, FDA regulations, and for
consultative audits, also includes conformance with industry standards
and practices. An eligible entity must declare that an audit is to be
conducted as a regulatory audit or consultative audit at the time of
audit planning and the audit will be conducted on an unannounced basis
under this subpart.
    Foreign cooperative means an autonomous association of persons,
identified as members, who are united through a jointly owned
enterprise to aggregate food from member growers or processors that is
intended for export to the United States.
    Recognized accreditation body means an accreditation body that FDA
has determined meets the applicable requirements of this subpart and is
authorized to accredit third-party certification bodies under this
subpart.
    Regulatory audit means an audit of an eligible entity:
    (i) To determine whether such entity is in compliance with the
applicable food safety requirements of the FD&C Act and FDA
regulations; and
    (ii) The results of which are used in determining eligibility for
certification under section 801(q) or under section 806 of the FD&C
Act.
    Relinquishment means:
    (i) With respect to an accreditation body, a decision to cede
voluntarily its authority to accredit third-party certification bodies
as a recognized accreditation body prior to expiration of its
recognition under this subpart; and
    (ii) With respect to a third-party certification body, a decision
to cede voluntarily its authority to conduct food safety audits and to
issue food and facility certifications to eligible entities as an
accredited third-party certification body prior to expiration of its
accreditation under this subpart.
    Self-assessment means an evaluation conducted by a recognized
accreditation body or by an accredited third-party certification body
of its competency and capacity under the applicable requirements of
this subpart for the defined scope of recognition or accreditation. For
recognized accreditation bodies this involves evaluating the competency
and capacity of the entire operations of the accreditation body and the
validity of its accreditation decisions under the applicable
requirements of this subpart. For accredited third-party certification
bodies this involves evaluating the competency and capacity of the
entire operations of the third-party certification body and the
validity of its audit results under the applicable requirements of this
subpart.
    Third-party certification body has the same meaning as third-party
auditor as that term is defined in section 808(a)(3) of the FD&C Act
and means a foreign government, agency of a foreign government, foreign
cooperative, or any other third party that is eligible to be considered
for accreditation to conduct food safety audits and to certify that
eligible entities meet the applicable food safety requirements of the
FD&C Act and FDA regulations. A third-party certification body may be a
single individual or an organization. Once accredited, a third-party
certification body may use audit agents to conduct food safety audits.

Sec.  1.601  Who is subject to this subpart?

    (a) Accreditation bodies. Any accreditation body seeking
recognition from FDA to accredit third-party certification bodies to
conduct food safety audits and to issue food and facility
certifications under this subpart.
    (b) Third-party certification bodies. Any third-party certification
body seeking accreditation from a recognized accreditation body or
direct accreditation by FDA for:
    (1) Conducting food safety audits; and
    (2) Issuing certifications that may be used in satisfying a
condition of admissibility of an article of food under section 801(q)
of the FD&C Act; or issuing a facility certification for meeting the
eligibility requirements for the Voluntary Qualified Importer Program
under section 806 of the FD&C Act.
    (c) Eligible entities. Any eligible entity seeking a food safety
audit or a food or facility certification from an accredited third-
party certification body under this subpart.
    (d) Limited exemptions from section 801(q) of the FD&C Act--(1)
Alcoholic beverages. (i) Any certification required under section
801(q) of the FD&C Act does not apply with respect to alcoholic
beverages from an eligible entity that is a facility that meets the
following two conditions:
    (A) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986
(26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type
that, if it were a domestic facility, would require obtaining a permit
from, registering with, or obtaining approval of a notice or
application from the Secretary of the Treasury as a condition of doing
business in the United States; and
    (B) Under section 415 of the FD&C Act, the facility is required to
register as a facility because it is engaged in manufacturing/
processing one or more alcoholic beverages.
    (ii) Any certification required under section 801(q) of the FD&C
Act does not apply with respect to food that is not an alcoholic
beverage that is received and distributed by a facility described in
paragraph (d)(1)(i) of this section, provided such food:
    (A) Is received and distributed in prepackaged form that prevents
any direct human contact with such food; and
    (B) Constitutes not more than 5 percent of the overall sales of the
facility, as determined by the Secretary of the Treasury.
    (iii) Any certification required under section 801(q) of the FD&C
Act does not apply with respect to raw materials or other ingredients
that are imported for use in alcoholic beverages provided that:
    (A) The imported raw materials or other ingredients are used in the
manufacturing/processing, packing, or holding of alcoholic beverages;
    (B) Such manufacturing/processing, packing, or holding is performed
by the importer;

    (C) The importer is required to register under section 415 of the
Federal Food, Drug, and Cosmetic Act; and