[Federal Register Volume 70, Number 139 (Thursday, July 21, 2005)]
[Notices]
[Pages 42072-42075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14321]


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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.

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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 http://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\
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                                                              No. of         Annual Frequency      Total Annual         Hours per
                   Types of Records                       Recordkeepers     per Recordkeeping        Records          Recordkeeper        Total Hours
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Food Safety Management System                                   50,000\2\                    1             50,000                60            3,000,000
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Hazard Analysis                                                 50,000\2\                    1             50,000                20            1,000,000
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Prerequisite Program Records                                   100,000\3\                  365         36,500,000                 0.1          3,650,000
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Monitoring Records                                             100,000\3\                  365         36,500,000                 0.3         10,950,000
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Corrective Action Records                                      100,000\3\                  365         36,500,000                 0.1          3,650,000
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Ongoing Verification Records (includes calibration             100,000\3\                  365         36,500,000                 0.1          3,650,000
 records)
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Validation Records                                              50,000\3\                    1             50,000                 4              200,000
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[[Page 42074]]

 
Total First Year Burden:\4\                                                                                                                   26,100,000
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Annual Burden:\4\                                                                                                                             22,100,000
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Risk Control Plan                                                  50,000                    1             50,000                 2              100,000
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Monitoring Records                                                100,000                   90          9,000,000                 0.3          2,700,000
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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)
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  Annual Burden\5\                                                                                                                             4,600,000
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  Total Annual Burden for Operators (Excluding First Year)                                                                                    26,700,000
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\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\
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                        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
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\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 http://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