[Federal Register Volume 71, Number 219 (Tuesday, November 14, 2006)]
[Notices]
[Pages 66336-66340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0419]


Draft Voluntary National Retail Food Regulatory Program 
Standards; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Voluntary National Retail 
Food

[[Page 66337]]

Regulatory Program Standards'' (the Program Standards). The Program 
Standards are intended to help state, local, and tribal regulators 
design and manage a retail food regulatory program that is focused on 
the reduction of foodborne illness risk factors.

DATES: Submit written or electronic comments concerning the draft 
Program Standards document and its recommendations for collection of 
information by January 16, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
Program Standards document to Glenda R. Lewis, Center for Food Safety 
and Applied Nutrition (HFS-626), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2150. Send one 
self-addressed adhesive label to assist that office in processing your 
request. Submit written comments concerning the draft Program Standards 
document and its recommendations for collection of information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments on the draft Program Standards document and its 
recommendations for collection of information to http://www.fda.gov/dockets/ecomments. All comments should be identified with the docket 
number found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
manuals and received comments.

FOR FURTHER INFORMATION CONTACT: Glenda R. Lewis, Center for Food 
Safety and Applied Nutrition (HFS-626), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2150.

SUPPLEMENTARY INFORMATION:

I. Background

    While the responsibility for regulating retail and foodservice 
establishments lies primarily with state, local, and tribal 
jurisdictions, FDA provides assistance to these jurisdictions through 
multiple means including, but not limited to, training and technical 
assistance. Authority for providing such assistance is derived from 
section 311 of the Public Health Service Act (42 U.S.C. 243). In 
addition, FDA's mission under section 903(b)(2)(A) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(A)) includes 
ensuring that foods are safe, wholesome, and sanitary, and section 
903(b)(4) of the act directs FDA to cooperate with food retailers, 
among others, in carrying out this part of its mission.
    The Centers for Disease Control and Prevention has identified the 
major contributing factors associated with foodborne illness outbreaks. 
Five of these contributing factors directly relate to retail and 
foodservice establishments and are called ``foodborne illness risk 
factors'' by FDA. In an effort to assist state, local, and tribal 
regulators and the retail and food service entities they regulate, FDA 
developed draft Program Standards.
    The Program Standards were developed to address the need for 
national uniformity among retail food regulatory programs, to promote 
uniform application of the FDA Food Code, and to reduce the occurrence 
of foodborne illness risk factors. The Program Standards were developed 
with extensive input from state, tribal, and local regulatory 
authorities. They capture the best management practices currently in 
use by those authorities and are intended to help those authorities 
design and manage a retail food regulatory program that is focused on 
the reduction of foodborne illness risk factors.
    The incorporation of a risk-based methodology into regulatory 
inspection programs is an important element in reaching the goals 
established by the President's Council on Food Safety in the document 
entitled ``Food Safety Strategic Plan'' released in January 2001 
(available at http://www.foodsafety.gov/~fsg/cstrpl-4.html) as well as 
FDA's food safety program goals.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Voluntary National Retail Food Regulatory Program Standards
    In the Federal Register of May 9, 2001 (66 FR 23715), a 60-day 
notice was published soliciting comments on FDA's collection of 
information from local, state and tribal authorities concerning their 
use of or planned use of FDA's Program Standards. No comments were 
received in response to that notice. The agency has decided to reissue 
this 60-day notice for further comment because the Program Standards 
have been revised since the previous notice. The January 2005 revision 
of the Program Standards is available in draft for comment on FDA's Web 
site at http://www.cfsan.fda.gov/~dms/ret3toc.html.
    The Program Standards define nine essential elements of an 
effective regulatory program for retail food establishments, establish 
basic quality control criteria for each element, and provide a means of 
recognition for those state, local, and tribal regulatory programs that 
meet the Program Standards. The program elements addressed by the 
Program Standards are as follows: (1) Regulatory foundation, (2) 
trained regulatory staff, (3) inspection program based on HACCP 
principles, (4) uniform inspection program, (5) foodborne illness and 
food security preparedness and response, (6) compliance and 
enforcement, (7) industry and community relations, (8) program support 
and resources, and (9) program assessment. Each standard includes a 
list of records needed to document compliance with the standard 
(referred to in the Program Standards document as ``quality records'') 
and has one or more corresponding appendices that contain forms and 
worksheets to facilitate the collection of information needed to assess 
a retail program under that standard. The respondents are State, local 
and tribal government agencies. Regulatory agencies may use existing, 
available records or may choose to develop and use alternate forms and 
worksheets that capture the same information.
    In the course of their normal activities, state, local, and tribal

[[Page 66338]]

regulatory agencies already collect and keep on file many of the 
records needed as quality records to document compliance with the end 
of each Program Standard by jurisdictions that enroll. Although the 
detail and format in which this information is collected and recorded 
may vary by jurisdiction, records that are kept as a usual and 
customary part of normal agency activities include inspection records, 
written quality assurance procedures and records of quality assurance 
checks, staff training certificates and other training records, a log 
or database of food-related illness or injury complaints, records of 
investigations resulting from such complaints, an inventory of 
inspection equipment, records of outside audits, and records of 
outreach efforts (e.g., meeting agendas and minutes, documentation of 
food safety education activities). No new recordkeeping burden is 
associated with these existing records, which are already a part of 
usual and customary program recordkeeping activities by state, local, 
and tribal regulatory agencies, and which can serve as quality records 
under the Program Standards.
    State, local, and tribal regulatory agencies that enroll in the 
Program Standards and seek listing in the FDA National Registry are 
required to report to FDA on the completion of the following three 
management tasks outlined in the Program Standards: (1) Conducting a 
program self assessment; (2) conducting a baseline survey of the 
regulated industry; and (3) obtaining an independent outside audit 
(verification audit). All three tasks must be completed within a 3-year 
time span. The results are reported to FDA on Form FDA 3519, ``FDA 
National Registry Report,'' and Form FDA 3520, ``Permission to Publish 
in National Registry.'' These forms are located in Appendix I of the 
Program Standards. If a regulatory agency follows all the recordkeeping 
recommendations in the individual standards and their appendices, it 
will have all the information needed to complete the forms. The time 
required to complete the forms is minimal.

Recordkeeping

    FDA's recordkeeping burden estimate includes time required for a 
state, local, or tribal agency to review the instructions in the 
Program Standards, compile information from existing sources, and 
create any records recommended in the Program Standards that are not 
already kept in the normal course of the agency's usual and customary 
activities. Worksheets (Appendices) are provided to assist in this 
compilation. In estimating the time needed for the program self-
assessment (Program Standards 1-8, shown in chart 1 of this document), 
FDA considered responses from four state and three local jurisdictions 
that participated in an FDA Program Standards Pilot study. Chart 2 of 
this document shows the estimated recordkeeping burden for the 
completion of the baseline data collection and chart 3 of this document 
shows the estimated recordkeeping burden for the verification audit. 
The overall program improvement cycle is a 3-year period for completion 
of all three management tasks.

                   CHART 1.--YEAR ONE--SELF ASSESSMENT
------------------------------------------------------------------------
                                                  Hours per Recordkeeper
   Standard         Recordkeeping Activity              (Year One)
------------------------------------------------------------------------
No. 1          Self Assessment: (Appendix A\1\)                       16
 Regulatory     Completion of worksheet
 Foundation     recording results of
                evaluations and comparison on
                worksheets
------------------------------------------------------------------------
No. 2 Trained  Self Assessment: (Appendix B\1\)                       19
 Regulatory     Completion of summary worksheet
 Staff          of each employee training
                records\2\
------------------------------------------------------------------------
No. 3 HACCP    Self Assessment: (Appendix C\1\)                        4
 Principles     Completion of worksheet
                documentation
------------------------------------------------------------------------
No. 4 Uniform  Self Assessment: (Appendix D\1\)                       19
 Inspection     Completion of worksheet
 Program        documentation of jurisdiction's
                quality assurance procedures\2\
------------------------------------------------------------------------
No. 5          Self Assessment: (Appendix E\1\)                        5
 Foodborne      Completion of worksheet
 Illness and    documentation
 Food
 Security
 Preparedness
 and Response
------------------------------------------------------------------------
No. 6          Self Assessment: (Appendix F\1\)                       19
 Compliance     Selection and review of 20 to
 Enforcement    70 establishment files @ 25
                minutes per file. Estimate is
                based on a mean number of 45.
                Completion of worksheet
------------------------------------------------------------------------
No. 7          Self Assessment: (Appendix G\1\)                        2
 Industry and   Completion of worksheet
 Community
 Relations
------------------------------------------------------------------------
No. 8 Program  Self Assessment: (Appendix H\1\)                        8
 Support and    Selection and review of
 Resources      establishment files
------------------------------------------------------------------------
Subtotal       ................................                       92
------------------------------------------------------------------------
\1\Or comparable documentation.
\2\Estimates will vary depending on the number of regulated food
  establishments and the number of inspectors employed by the
  jurisdiction.


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              CHART 2.--YEAR TWO--BASELINE DATA COLLECTION
------------------------------------------------------------------------
                                                  Hours Per Recordkeeper
   Standard         Recordkeeping Activity              (Year Two)
------------------------------------------------------------------------
No. 9 Program  Baseline Data Collection                              333
 Assessment     (Appendices I and J). Selection
                and inspection of randomly
                selected statistical sample of
                9 to 87 establishments from
                each of 9 facility types\1\
------------------------------------------------------------------------
\1\Calculation based on mean sample size of 39 and average FDA
  inspection time for each establishment type. Estimates will vary
  depending on the number of regulated food establishments within a
  jurisdiction and the number of inspectors employed by the
  jurisdiction.


                CHART 3.--YEAR THREE--VERIFICATION AUDIT
------------------------------------------------------------------------
                                                  Hours per Recordkeeper
   Standard         Recordkeeping Activity             (Year Three)
------------------------------------------------------------------------
9              Verification Audit (Appendices I                       46
                and J)\1\
------------------------------------------------------------------------
\1\We estimate that no more than 50 percent of time spent to complete
  self assessment of all nine Standards is spent completing verification
  audit worksheets. Time will be considerably less if less than nine
  standards require verification audits.

    FDA estimated the annual hours per recordkeeper (i.e., per enrolled 
jurisdiction) in table 1 of this document by adding the recordkeeping 
estimates for the management tasks of self assessment, baseline data 
collection, and verification audit (charts 1, 2, and 3 of this 
document) that enrolled jurisdictions must perform during a 3-year 
cycle, then dividing the total by three to obtain an annual average.
    The estimates in tables 1 and 2 of this document are based on the 
estimated participation of 500 regulatory jurisdictions in the Program 
Standards. There are approximately 3,000 jurisdictions in the United 
States and its territories that have retail food regulatory programs. 
Enrollment in the Program Standards is voluntary, and therefore FDA 
does not expect all jurisdictions to participate in the near future. In 
its 2002 operational plan, the FDA National Retail Food Team 
established a goal of enrolling 15 percent of eligible agencies, or 450 
programs, in the Program Standards by the year 2010. For purposes of 
this burden estimate, it is reasonable to take into account the 
possibility that this goal could be exceeded by approximately 10 
percent, for a total of approximately 500 participating agencies.
    Thus, FDA estimates the burden for this collection of information 
as follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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      FDA             No. of         Annual Frequency       Total Annual          Hours per
 Worksheets\2\    Recordkeepers      per Recordkeeping        Records           Recordkeeper        Total Hours
----------------------------------------------------------------------------------------------------------------
Appendices A                  500                     1                500                   157          78,500
 through J
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Total Burden    .................  ....................  .................  ....................          78,500
 Hours
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Or comparable documentation.

Reporting

    Based on the number and nature of the items that need to be 
completed, FDA estimates a total of 12 minutes annually for each 
enrolled jurisdiction to complete both FDA Form 3519, ``FDA National 
Registry Report,'' and Form 3520, ``Permission to Publish in National 
Registry.'' Form 3519 requires the name and address of the 
jurisdiction; completion dates for the self assessment, baseline survey 
(original and update), and verification audit; names of the person(s) 
who completed the self-assessment, verification audit, baseline survey, 
baseline survey update, and action plan; signature of the program 
manager; and date the form was completed. Form 3520 requires the name 
of the jurisdiction, completion date of the self assessment, date of 
the verification audit report, name of the auditor, signature and title 
of the official completing the form, and date the form was completed. 
As explained previously in this document, FDA estimates that 500 
regulatory jurisdictions will enroll in the Program Standards. The 
reporting burden in table 2 of this document includes only the time 
necessary to fill out and send the forms, as compiling the underlying 
information (including self-assessment reports, baseline surveys, 
outside audits, and supporting documentation) is accounted for under 
the recordkeeping estimates in table 1 of this document.
    Thus, FDA estimates the burden for this collection of information 
as follows:

                                 Table 2.--Estimated Annual Reporting Burden\1\
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                      No. of         Annual Frequency       Total Annual        Hours per
   FDA Forms       Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
3519                          500                     1                500              6 min           50 hours
----------------------------------------------------------------------------------------------------------------
3520                          500                     1                500              6 min           50 hours
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[[Page 66340]]

 
Total Burden    .................  ....................  .................  .................          100 hours
 Hours
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft Program 
Standards document and its recommendations for collection of 
information. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. The draft Program 
Standards document and received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft Program 
Standards document at http://www.cfsan.fda.gov/~dms/ret3toc.html.

    Dated: October 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19195 Filed 11-13-06; 8:45 am]
BILLING CODE 4160-01-S