[Federal Register: November 14, 2006 (Volume 71, Number 219)]
[Notices]
[Page 66336-66340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no06-47]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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.
[[Page 66339]]
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Total Burden ................. .................... ................. .................... 78,500
Hours
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
[[Page 66340]]
Total Burden ................. .................... ................. ................. 100 hours
Hours
----------------------------------------------------------------------------------------------------------------
\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