[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77721-77723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30278]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0641]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Voluntary Hazard Analysis and Critical Control Point 
Manuals for Operators and Regulators of Retail and Food Service 
Establishments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of the agency's Voluntary Hazard Analysis and Critical 
Control Point Manuals for Operators and Regulators of Retail and Food 
Service Establishments.

DATES:  Submit written or electronic comments on the collection of 
information by February 17, 2009.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under 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, including 
each proposed extension of an existing 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 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.

Voluntary Hazard Analysis and Critical Control Point Manuals for 
Operators and Regulators of Retail and Food Service Establishments (OMB 
Control Number 0910-0578)--Extension

    The 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 Hazard 
Analysis and Critical Control Point (HACCP) principles. Operators may 
decide to incorporate some or all of the principles presented in the 
manual into their existing food safety management systems. The 
recordkeeping practices discussed in the 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 manual includes optional worksheets to assist 
operators in developing and validating a voluntary food safety 
management system.
    The 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 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: (1) 
Validation (assessing whether the establishment's voluntary food safety 
management system is adequate to control food safety hazards) and (2) 
verification (assessing whether the establishment is following its 
voluntary food safety management system). The manual includes a sample 
entitled ``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: (1) Food safety management 
systems (plans that delineate the formal procedures to follow to 
control all food safety hazards in an operation); (2) risk control 
plans (HACCP-based, goal-oriented plans for achieving active managerial 
control over specific out-of-control foodborne illness risk factors); 
(3) hazard analysis (written assessment of the significant food safety 
hazards associated with foods prepared in the establishment); (4) 
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); (5) monitoring (records showing the 
observations or measurements that are made to help determine if 
critical limits are being met and maintained); (6) corrective action 
(records indicating the activities that are completed whenever a 
critical limit is not met); (7) 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 (8)

[[Page 77722]]

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     of Recordkeeping       Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
Prerequisite             \2\ 100,000                365         36,500,000                0.1          3,650,000
 Program Records
----------------------------------------------------------------------------------------------------------------
Monitoring               \2\ 100,000                365         36,500,000                0.3         10,950,000
 Records
----------------------------------------------------------------------------------------------------------------
Corrective Action        \2\ 100,000                365         36,500,000                0.1          3,650,000
 Records
----------------------------------------------------------------------------------------------------------------
Ongoing                  \2\ 100,000                365         36,500,000                0.1          3,650,000
 Verification
 Records
 (includes
 calibration
 records)
----------------------------------------------------------------------------------------------------------------
Validation                \2\ 50,000                  1             50,000                4              200,000
 Records
----------------------------------------------------------------------------------------------------------------
Annual Burden \3\:                                                                                    22,100,000
----------------------------------------------------------------------------------------------------------------
Risk Control Plan             50,000                  1             50,000                2              100,000
----------------------------------------------------------------------------------------------------------------
Monitoring                   100,000                 90          9,000,000                0.3          2,700,000
 Records
----------------------------------------------------------------------------------------------------------------
Corrective Action            100,000                 90          9,000,000                0.1            900,000
 Records
----------------------------------------------------------------------------------------------------------------
Ongoing                      100,000                 90          9,000,000                0.1            900,000
 Verification
 Records
 (includes
 calibration
 records)
----------------------------------------------------------------------------------------------------------------
Annual Burden \4\                                                                                      4,600,000
----------------------------------------------------------------------------------------------------------------
Total Annual Burden for Operators                                                                     26,700,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Annual burden.
\3\ Burden for developing and implementing a food safety management system based on the Operator's Manual.
\4\ 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 (0.05 percent) of the approximately one million U.S. retail and 
foodservice operators implement the recommendations outlined in the 2 
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.
    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 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

[[Page 77723]]

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.

                        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     of Recordkeeping     Records     Recordkeeper   Total Hours
----------------------------------------------------------------------------------------------------------------
Voluntary Food Safety                       50,000                  1        50,000              16      800,000
 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30278 Filed 12-18-08; 8:45 am]
BILLING CODE 4160-01-S