Draft Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments; Availability, 42072-42075 [05-14321]
Download as PDF
<![CDATA[
42072
Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Notices
Dated: July 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14330 Filed 7–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0274]
Draft Voluntary Hazard Analysis and
Critical Control Point Manuals for
Operators and Regulators of Retail and
Food Service Establishments;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of two draft manuals
entitled ‘‘Managing Food Safety: A
Manual for the Voluntary Use of HACCP
Principles for Operators of Food Service
and Retail Establishments’’ (the
‘‘Operator’s Manual’’) and ‘‘Managing
Food Safety: A Regulator’s Manual for
Applying HACCP Principles to RiskBased Retail and Food Service
Inspections and Evaluating Voluntary
Food Safety Management Systems’’ (the
‘‘Regulator’s Manual’’). The Operator’s
Manual presents FDA’s best advice to
retail and foodservice operators for
voluntarily implementing food safety
management systems based on hazard
analysis and critical control point
(HACCP) principles to reduce the
occurrence of foodborne illness risk
factors. The Regulator’s Manual is
intended to assist State, local, and tribal
regulatory authorities in identifying and
assessing control of foodborne illness
risk factors during routine inspections
of retail and foodservice establishments
by providing a risk-based inspection
methodology.
Submit written or electronic
comments concerning the draft manuals
and their recommendations for
collection of information by September
19, 2005.
ADDRESSES: Submit written comments
concerning the draft manuals and their
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
manuals and their recommendations for
collection of information to https://
www.fda.gov/dockets/ecomments.
DATES:
VerDate jul<14>2003
19:42 Jul 20, 2005
Jkt 205001
Submit written requests for single
copies of the draft manuals to Margaret
Boone, Center for Food Safety and
Applied Nutrition (HFS–625), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–1559. Send one self-adhesive
address label to assist that office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft manuals
and received comments.
FOR FURTHER INFORMATION CONTACT:
Alan Tart, Office of Regulatory Affairs,
Southeast Regional Office, State
Cooperative Programs (HFR–SE670),
Food and Drug Administration, 60 8th
St., NE., Atlanta, GA 30309, 404–253–
1267.
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. Food safety
management systems based on HACCP
principles are designed to reduce the
occurrence of these risk factors through
preventive controls. For industry, the
rationale for developing and
implementing a food safety management
system based on HACCP principles is to
ensure that final products are not
contaminated with agents that could
cause foodborne illness or injury. In an
effort to assist State, local, and tribal
regulators and the retail and foodservice
entities they regulate, FDA has
developed two draft manuals for the
voluntary use of HACCP principles in
retail and foodservice establishments.
The Operator’s Manual provides
operators of retail and foodservice
establishments with a step-by-step
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
scheme for designing and voluntarily
implementing food safety management
systems based on HACCP principles. By
voluntarily implementing food safety
management systems, active managerial
control of foodborne illness risk factors
can be achieved. Any operator of a retail
or foodservice establishment is
encouraged to voluntarily utilize the
methods and procedures presented in
the draft manual.
The Regulator’s Manual provides
State, local, and tribal regulatory
authorities with a step-by-step scheme
for conducting risk-based inspections
based on HACCP principles. In
addition, the draft manual details
intervention strategies that can be
developed with retail and foodservice
operators to reduce the occurrence of
foodborne illness risk factors. It also
provides a methodology for evaluating
voluntarily-implemented food safety
management systems, if invited to do so,
by retail or foodservice operators.
Comments received from the
Conference for Food Protection (CFP)
have been incorporated into the draft
manuals. The CFP is composed of
regulators, industry, academia,
professional organizations, and
consumers. Its purpose is to identify
problems, formulate recommendations,
and develop and implement practices
that relate to food safety. In 2004, CFP
endorsed both draft manuals with a
recommendation that both industry and
regulatory entities consider
implementing the principles of the
documents into their respective food
safety programs.
The utilization of voluntary food
safety management systems by industry,
as well as the incorporation of a riskbased methodology into regulatory
inspection programs, are important
elements in reaching the goals
established by the President’s Council
on Food Safety and also FDA 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
E:\FR\FM\21JYN1.SGM
21JYN1
42073
Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Notices
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 these topics: (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 HACCP Manuals for
Operators and Regulators of Retail and
Food Service Establishments
The draft Operator’s Manual contains
information and recommendations for
operators of retail and foodservice
establishments who wish to develop
and implement a voluntary food safety
management system based on HACCP
principles. Operators may decide to
incorporate some or all of the principles
presented in the draft manual into their
existing food safety management
systems. The recordkeeping practices
discussed in the draft manual are
voluntary and may include
documenting certain activities, such as
monitoring and verification, which the
operator may or may not deem
necessary to ensure food safety. The
draft manual includes optional
worksheets to assist operators in
developing and validating a voluntary
food safety management system.
The draft Regulator’s Manual contains
recommendations for State, local, and
tribal regulators on conducting riskbased inspections of retail and
foodservice establishments, including
recommendations about recordkeeping
practices that can assist operators in
preventing foodborne illness. These
recommendations may lead to voluntary
actions by operators based on
consultation with regulators. For
example, an operator may develop a risk
control plan as an intervention strategy
for controlling specific out-of-control
foodborne illness risk factors identified
during an inspection. Further, the draft
manual contains recommendations to
assist regulators when evaluating
voluntary food safety management
systems in retail and foodservice
establishments. Such evaluations
typically consist of the following two
components: Validation (assessing
whether the establishment’s voluntary
food safety management system is
adequate to control food safety hazards)
and verification (assessing whether the
establishment is following its voluntary
food safety management system). The
draft manual includes a sample
‘‘Verification Inspection Checklist’’ to
assist regulators when conducting
verification inspections of
establishments with voluntary food
safety management systems.
Types of operator records discussed
in the manuals and listed in the
following burden estimates include:
Food safety management systems (plans
that delineate the formal procedures to
follow to control all food safety hazards
in an operation); risk control plans
(HACCP-based, goal-oriented plans for
achieving active managerial control over
specific out-of-control foodborne illness
risk factors); hazard analysis (written
assessment of the significant food safety
hazards associated with foods prepared
in the establishment); prerequisite
programs (written policies or
procedures, including but not limited
to, standard operating procedures,
training protocols, and buyer
specifications that address maintenance
of basic operational and sanitation
conditions); monitoring (records
showing the observations or
measurements that are made to help
determine if critical limits are being met
and maintained); corrective action
(records indicating the activities that are
completed whenever a critical limit is
not met); ongoing verification (records
showing the procedures that are
followed to ensure that monitoring and
other functions of the food safety
management system are being
implemented properly; and validation
(records indicating that scientific and
technical information is collected and
evaluated to determine if the food safety
management system, when properly
implemented, effectively controls the
hazards).
All recommendations in both manuals
are voluntary. For simplicity and to
avoid duplicate estimates for operator
recordkeeping practices that are
discussed in both manuals, the burden
for all collection of information
recommendations for retail and
foodservice operators are estimated
together in table 1 of this document,
regardless of the manual in which they
appear. Collection of information
recommendations for regulators in the
Regulator’s Manual are listed separately
in table 2 of this document.
Description of Respondents: The
likely respondents to this collection of
information are operators and regulators
of retail and foodservice establishments.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR OPERATORS1
No. of
Recordkeepers
Types of Records
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
Food Safety Management System
50,0002
1
50,000
60
3,000,000
Hazard Analysis
50,0002
1
50,000
20
1,000,000
Prerequisite Program Records
100,0003
365
36,500,000
0.1
3,650,000
Monitoring Records
100,0003
365
36,500,000
0.3
10,950,000
Corrective Action Records
100,0003
365
36,500,000
0.1
3,650,000
Ongoing Verification Records (includes calibration records)
100,0003
365
36,500,000
0.1
3,650,000
50,0003
1
50,000
Validation Records
VerDate jul<14>2003
19:42 Jul 20, 2005
Jkt 205001
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
E:\FR\FM\21JYN1.SGM
4
21JYN1
200,000
42074
Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR OPERATORS1—Continued
No. of
Recordkeepers
Types of Records
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
Total First Year Burden:4
26,100,000
Burden:4
22,100,000
Annual
Risk Control Plan
50,000
1
50,000
2
Monitoring Records
100,000
90
9,000,000
0.3
2,700,000
Corrective Action Records
100,000
90
9,000,000
0.1
900,000
Ongoing Verification Records (includes calibration records)
100,000
90
9,000,000
0.1
900,000
Annual Burden5
4,600,000
Total Annual Burden for Operators (Excluding First Year)
1
2
3
4
5
100,000
26,700,000
There are no capital costs or operating and maintenance costs associated with this collection of information.
First year burden only.
Annual burden.
Burden for developing and implementing a food safety management system based on the Operator’s Manual.
Annual burden for developing and implementing a risk control plan based on the Regulator’s Manual.
The burden for these activities may
vary among retail and foodservice
operators depending on the type and
number of products involved, the
complexity of an establishment’s
operation, the nature of the equipment
or instruments required to monitor
critical control points, and the extent to
which an operator uses the Operator’s
Manual and/or the Regulator’s Manual.
The estimate does not include
collections of information that are a
usual and customary part of an
operator’s normal activities.
FDA has established as a goal to have
50,000 (1/2 of 1 percent) of the
approximately one million U.S. retail
and foodservice operators implement
the recommendations outlined in the
two manuals. This target figure is used
in calculating the burden in tables 1 and
2 of this document because the agency
lacks data on how to base an estimate
of how many retail and foodservice
establishments are likely to use one or
more of the manuals to voluntarily
implement a comprehensive food safety
management system based on HACCP
principles or a risk control plan for outof-control processes identified during an
inspection. FDA’s estimate of the total
number of retail and foodservice
VerDate jul<14>2003
19:42 Jul 20, 2005
Jkt 205001
establishments is based on numbers
obtained from the two major trade
organizations representing these
industries, the Food Marketing Institute
and the National Restaurant
Association, respectively. FDA seeks
comments on this estimate.
The hour burden estimates in table 1
of this document for operators who
follow the HACCP-based
recommendations in the Operator’s
Manual are based on the estimated
average annual information collection
burden for mandatory HACCP rules,
including seafood HACCP (60 FR 65096
at 65178, December 18, 1995) and juice
HACCP (66 FR 6138 at 6202, January 19,
2001). FDA estimates that during the
first year, 20 labor hours are needed to
conduct the hazard analysis and 60
labor hours are needed to develop a
food safety management system (HACCP
plan). Once the system is in place, the
annual frequency of records is based on
365 operating days per year. Assuming
there is one recordkeeper per shift of
operation, the agency estimates that two
recordkeepers per day would be needed
to conduct monitoring, corrective
action, recordkeeping, and verification
outlined in the system. The agency
further estimates that validation will be
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
conducted once per year, based on
menu or food list changes, changes in
distributors, or changes in food
preparation processes used. The
validation will require a total of 4 labor
hours.
The second set of estimates in table 1
of this document shows the annual
burden for developing and
implementing a risk control plan to
control specific out-of-control foodborne
illness risk factors identified during an
inspection by a State, local, or tribal
regulatory authority. If an operator
decides to use a risk control plan as
recommended in the Regulator’s
Manual, one person from the
establishment is needed to work with
the regulator to develop the written
plan. FDA estimates that two
recordkeepers per day (one
recordkeeper for each shift) would be
needed to conduct monitoring,
corrective action, recordkeeping, and
verification outlined in the risk control
plan. The estimated duration of
implementation for a risk control plan is
90 days, which is the minimum
recommended time to achieve long-term
behavior change.
E:\FR\FM\21JYN1.SGM
21JYN1
42075
Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR REGULATORS1
No. of
Recordkeepers
Types of Records
Voluntary Food Safety Management
System Evaluation (includes validation, verification, and completion of verification inspection
checklist)
Annual Frequency
per Recordkeeping
50,000
Total Annual
Records
1
Hours per
Recordkeeper
50,000
Total Hours
16
800,000
Total Annual Burden for Regulators
1There
800,000
are no capital costs or operating and maintenance costs associated with this collection of information.
It is difficult to predict the number of
State, local, and tribal regulatory
jurisdictions that will use the
Regulator’s Manual. But FDA
anticipates that retail and foodservice
establishments which voluntarily
develop and implement a food safety
management system based on the
Operator’s Manual will request their
regulatory authorities to conduct an
evaluation of their system. The
estimates in table 2 of this document for
the annual burden to State, local, and
tribal regulators that follow the
recommendations in the Regulator’s
Manual were calculated based on the
usual time needed for one person to
evaluate a voluntarily-implemented
food safety management system and
record the findings. The number of
times an inspector may be asked by an
operator to evaluate a voluntarilyimplemented system is not expected to
exceed once per year.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft manuals and
their 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 manuals 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
An electronic version of these draft
manuals is available on the Internet at
https://www.fda.gov/.
Dated: July 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14321 Filed 7–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; The Effectiveness
of the NIH Curriculum Supplements
and Workshops Survey
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Director, Office of Science Policy, Office
of Science Education, National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection has not been previously
published in the Federal Register. The
purpose of this notice is to allow 30
days for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB number.
Proposed Collection: Title: The
Effectiveness of the NIH Curriculum
Supplements and Workshops Survey.
Information Collection Request: NEW.
New and Use of Information Collection:
The survey will attempt to assess the
effectiveness of the NIH curriculum
supplements in aiding teachers to teach
science in a more engaging and
interactive way. The supplements help
k–12 educators teach science in more
engaging and effective ways by featuring
the latest NIH research. A typical
supplement contains two weeks of
student activities on the science behind
a health topic, such as cancer, sleep or
obesity. Web-based simulations,
animations and experiments enhance
the ‘‘pencil and paper’’ activities. In
addition to developing and distributing
the supplements, OSE conducts
professional workshops to help teachers
successfully implement these lessons
with their students. Since January 2000,
over 3,000 teachers have attended an
OSE workshop.
Assessing the effectiveness of the NIH
Curriculum Supplements and teacher
workshops is critical to determining if
OSE is successfully fulfilling its
mission. OSE has the database
infrastructure in place to easily collect
customer satisfaction data from
supplement requests and workshops
attendees. At present, we do not have
clearance to contact our customers to
determine how NIH resources are
meeting their educational needs.
BURDEN ESTIMATES
Number of
respondents
Type of respondent: survey title
Teacher:
Teacher:
Teacher:
Teacher:
Teacher:
Teacher:
supplement requestor survey .........................................................
focus group participant ...................................................................
workshop short survey ...................................................................
workshop long survey ....................................................................
Career video requestor ..................................................................
Career poster requestor .................................................................
VerDate jul<14>2003
19:42 Jul 20, 2005
Jkt 205001
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Frequency of
response
9,000
60
1,300
260
500
585
E:\FR\FM\21JYN1.SGM
1
1
1
1
1
1
21JYN1
Ave. time per
response
0.17
2.0
0.17
0.5
0.17
0.17
Hour burden/yr
500
120
220
130
85
100
]]>Agencies
[Federal Register Volume 70, Number 139 (Thursday, July 21, 2005)]
[Notices]
[Pages 42072-42075]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14321]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0274]
Draft Voluntary Hazard Analysis and Critical Control Point
Manuals for Operators and Regulators of Retail and Food Service
Establishments; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of two draft manuals entitled ``Managing Food Safety: A
Manual for the Voluntary Use of HACCP Principles for Operators of Food
Service and Retail Establishments'' (the ``Operator's Manual'') and
``Managing Food Safety: A Regulator's Manual for Applying HACCP
Principles to Risk-Based Retail and Food Service Inspections and
Evaluating Voluntary Food Safety Management Systems'' (the
``Regulator's Manual''). The Operator's Manual presents FDA's best
advice to retail and foodservice operators for voluntarily implementing
food safety management systems based on hazard analysis and critical
control point (HACCP) principles to reduce the occurrence of foodborne
illness risk factors. The Regulator's Manual is intended to assist
State, local, and tribal regulatory authorities in identifying and
assessing control of foodborne illness risk factors during routine
inspections of retail and foodservice establishments by providing a
risk-based inspection methodology.
DATES: Submit written or electronic comments concerning the draft
manuals and their recommendations for collection of information by
September 19, 2005.
ADDRESSES: Submit written comments concerning the draft manuals and
their 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 manuals and their recommendations for collection of
information to https://www.fda.gov/dockets/ecomments. Submit written
requests for single copies of the draft manuals to Margaret Boone,
Center for Food Safety and Applied Nutrition (HFS-625), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1559. Send one self-adhesive address label to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft manuals and received comments.
FOR FURTHER INFORMATION CONTACT: Alan Tart, Office of Regulatory
Affairs, Southeast Regional Office, State Cooperative Programs (HFR-
SE670), Food and Drug Administration, 60 8th St., NE., Atlanta, GA
30309, 404-253-1267.
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. Food safety management systems based on HACCP
principles are designed to reduce the occurrence of these risk factors
through preventive controls. For industry, the rationale for developing
and implementing a food safety management system based on HACCP
principles is to ensure that final products are not contaminated with
agents that could cause foodborne illness or injury. In an effort to
assist State, local, and tribal regulators and the retail and
foodservice entities they regulate, FDA has developed two draft manuals
for the voluntary use of HACCP principles in retail and foodservice
establishments.
The Operator's Manual provides operators of retail and foodservice
establishments with a step-by-step scheme for designing and voluntarily
implementing food safety management systems based on HACCP principles.
By voluntarily implementing food safety management systems, active
managerial control of foodborne illness risk factors can be achieved.
Any operator of a retail or foodservice establishment is encouraged to
voluntarily utilize the methods and procedures presented in the draft
manual.
The Regulator's Manual provides State, local, and tribal regulatory
authorities with a step-by-step scheme for conducting risk-based
inspections based on HACCP principles. In addition, the draft manual
details intervention strategies that can be developed with retail and
foodservice operators to reduce the occurrence of foodborne illness
risk factors. It also provides a methodology for evaluating
voluntarily-implemented food safety management systems, if invited to
do so, by retail or foodservice operators.
Comments received from the Conference for Food Protection (CFP)
have been incorporated into the draft manuals. The CFP is composed of
regulators, industry, academia, professional organizations, and
consumers. Its purpose is to identify problems, formulate
recommendations, and develop and implement practices that relate to
food safety. In 2004, CFP endorsed both draft manuals with a
recommendation that both industry and regulatory entities consider
implementing the principles of the documents into their respective food
safety programs.
The utilization of voluntary food safety management systems by
industry, as well as the incorporation of a risk-based methodology into
regulatory inspection programs, are important elements in reaching the
goals established by the President's Council on Food Safety and also
FDA 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
[[Page 42073]]
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 these topics: (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 HACCP Manuals for Operators and Regulators of Retail
and Food Service Establishments
The draft Operator's Manual contains information and
recommendations for operators of retail and foodservice establishments
who wish to develop and implement a voluntary food safety management
system based on HACCP principles. Operators may decide to incorporate
some or all of the principles presented in the draft manual into their
existing food safety management systems. The recordkeeping practices
discussed in the draft manual are voluntary and may include documenting
certain activities, such as monitoring and verification, which the
operator may or may not deem necessary to ensure food safety. The draft
manual includes optional worksheets to assist operators in developing
and validating a voluntary food safety management system.
The draft Regulator's Manual contains recommendations for State,
local, and tribal regulators on conducting risk-based inspections of
retail and foodservice establishments, including recommendations about
recordkeeping practices that can assist operators in preventing
foodborne illness. These recommendations may lead to voluntary actions
by operators based on consultation with regulators. For example, an
operator may develop a risk control plan as an intervention strategy
for controlling specific out-of-control foodborne illness risk factors
identified during an inspection. Further, the draft manual contains
recommendations to assist regulators when evaluating voluntary food
safety management systems in retail and foodservice establishments.
Such evaluations typically consist of the following two components:
Validation (assessing whether the establishment's voluntary food safety
management system is adequate to control food safety hazards) and
verification (assessing whether the establishment is following its
voluntary food safety management system). The draft manual includes a
sample ``Verification Inspection Checklist'' to assist regulators when
conducting verification inspections of establishments with voluntary
food safety management systems.
Types of operator records discussed in the manuals and listed in
the following burden estimates include: Food safety management systems
(plans that delineate the formal procedures to follow to control all
food safety hazards in an operation); risk control plans (HACCP-based,
goal-oriented plans for achieving active managerial control over
specific out-of-control foodborne illness risk factors); hazard
analysis (written assessment of the significant food safety hazards
associated with foods prepared in the establishment); prerequisite
programs (written policies or procedures, including but not limited to,
standard operating procedures, training protocols, and buyer
specifications that address maintenance of basic operational and
sanitation conditions); monitoring (records showing the observations or
measurements that are made to help determine if critical limits are
being met and maintained); corrective action (records indicating the
activities that are completed whenever a critical limit is not met);
ongoing verification (records showing the procedures that are followed
to ensure that monitoring and other functions of the food safety
management system are being implemented properly; and validation
(records indicating that scientific and technical information is
collected and evaluated to determine if the food safety management
system, when properly implemented, effectively controls the hazards).
All recommendations in both manuals are voluntary. For simplicity
and to avoid duplicate estimates for operator recordkeeping practices
that are discussed in both manuals, the burden for all collection of
information recommendations for retail and foodservice operators are
estimated together in table 1 of this document, regardless of the
manual in which they appear. Collection of information recommendations
for regulators in the Regulator's Manual are listed separately in table
2 of this document.
Description of Respondents: The likely respondents to this
collection of information are operators and regulators of retail and
foodservice establishments.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden for Operators\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Types of Records Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Safety Management System 50,000\2\ 1 50,000 60 3,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hazard Analysis 50,000\2\ 1 50,000 20 1,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prerequisite Program Records 100,000\3\ 365 36,500,000 0.1 3,650,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monitoring Records 100,000\3\ 365 36,500,000 0.3 10,950,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corrective Action Records 100,000\3\ 365 36,500,000 0.1 3,650,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ongoing Verification Records (includes calibration 100,000\3\ 365 36,500,000 0.1 3,650,000
records)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Validation Records 50,000\3\ 1 50,000 4 200,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 42074]]
Total First Year Burden:\4\ 26,100,000
--------------------------------------------------------------------------------------------------------------------------------------
Annual Burden:\4\ 22,100,000
--------------------------------------------------------------------------------------------------------------------------------------
Risk Control Plan 50,000 1 50,000 2 100,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monitoring Records 100,000 90 9,000,000 0.3 2,700,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corrective Action Records 100,000 90 9,000,000 0.1 900,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ongoing Verification Records (includes calibration 100,000 90 9,000,000 0.1 900,000
records)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Burden\5\ 4,600,000
--------------------------------------------------------------------------------------------------------------------------------------
Total Annual Burden for Operators (Excluding First Year) 26,700,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ First year burden only.
\3\ Annual burden.
\4\ Burden for developing and implementing a food safety management system based on the Operator's Manual.
\5\ Annual burden for developing and implementing a risk control plan based on the Regulator's Manual.
The burden for these activities may vary among retail and
foodservice operators depending on the type and number of products
involved, the complexity of an establishment's operation, the nature of
the equipment or instruments required to monitor critical control
points, and the extent to which an operator uses the Operator's Manual
and/or the Regulator's Manual. The estimate does not include
collections of information that are a usual and customary part of an
operator's normal activities.
FDA has established as a goal to have 50,000 (1/2 of 1 percent) of
the approximately one million U.S. retail and foodservice operators
implement the recommendations outlined in the two manuals. This target
figure is used in calculating the burden in tables 1 and 2 of this
document because the agency lacks data on how to base an estimate of
how many retail and foodservice establishments are likely to use one or
more of the manuals to voluntarily implement a comprehensive food
safety management system based on HACCP principles or a risk control
plan for out-of-control processes identified during an inspection.
FDA's estimate of the total number of retail and foodservice
establishments is based on numbers obtained from the two major trade
organizations representing these industries, the Food Marketing
Institute and the National Restaurant Association, respectively. FDA
seeks comments on this estimate.
The hour burden estimates in table 1 of this document for operators
who follow the HACCP-based recommendations in the Operator's Manual are
based on the estimated average annual information collection burden for
mandatory HACCP rules, including seafood HACCP (60 FR 65096 at 65178,
December 18, 1995) and juice HACCP (66 FR 6138 at 6202, January 19,
2001). FDA estimates that during the first year, 20 labor hours are
needed to conduct the hazard analysis and 60 labor hours are needed to
develop a food safety management system (HACCP plan). Once the system
is in place, the annual frequency of records is based on 365 operating
days per year. Assuming there is one recordkeeper per shift of
operation, the agency estimates that two recordkeepers per day would be
needed to conduct monitoring, corrective action, recordkeeping, and
verification outlined in the system. The agency further estimates that
validation will be conducted once per year, based on menu or food list
changes, changes in distributors, or changes in food preparation
processes used. The validation will require a total of 4 labor hours.
The second set of estimates in table 1 of this document shows the
annual burden for developing and implementing a risk control plan to
control specific out-of-control foodborne illness risk factors
identified during an inspection by a State, local, or tribal regulatory
authority. If an operator decides to use a risk control plan as
recommended in the Regulator's Manual, one person from the
establishment is needed to work with the regulator to develop the
written plan. FDA estimates that two recordkeepers per day (one
recordkeeper for each shift) would be needed to conduct monitoring,
corrective action, recordkeeping, and verification outlined in the risk
control plan. The estimated duration of implementation for a risk
control plan is 90 days, which is the minimum recommended time to
achieve long-term behavior change.
[[Page 42075]]
Table 2.--Estimated Annual Recordkeeping Burden for Regulators\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Types of Records Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
Voluntary Food 50,000 1 50,000 16 800,000
Safety
Management
System
Evaluation
(includes
validation,
verification,
and completion
of verification
inspection
checklist)
----------------------------------------------------------------------------------------------------------------
Total Annual Burden for Regulators 800,000
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
It is difficult to predict the number of State, local, and tribal
regulatory jurisdictions that will use the Regulator's Manual. But FDA
anticipates that retail and foodservice establishments which
voluntarily develop and implement a food safety management system based
on the Operator's Manual will request their regulatory authorities to
conduct an evaluation of their system. The estimates in table 2 of this
document for the annual burden to State, local, and tribal regulators
that follow the recommendations in the Regulator's Manual were
calculated based on the usual time needed for one person to evaluate a
voluntarily-implemented food safety management system and record the
findings. The number of times an inspector may be asked by an operator
to evaluate a voluntarily-implemented system is not expected to exceed
once per year.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft manuals and
their 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 manuals 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
An electronic version of these draft manuals is available on the
Internet at https://www.fda.gov/.
Dated: July 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14321 Filed 7-20-05; 8:45 am]
BILLING CODE 4160-01-S
