[Federal Register Volume 70, Number 245 (Thursday, December 22, 2005)]
[Notices]
[Pages 76056-76058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7644]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0274]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES:  Fax written comments on the collection of information by 
January 23, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Voluntary Hazard Analysis and Critical Control Point (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.
    The likely respondents to this collection of information are 
operators and regulators of retail and foodservice establishments.
    In the Federal Register of July 21, 2005 (70 FR 42072), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of the collection of information as 
follows:

[[Page 76057]]



                        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     of Recordkeeping       Records          Recordkeeper       Total Hours
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Food Safety                50,000\2\                  1             50,000               60            3,000,000
 Management
 System
--------------------------------------
------------------=======================================
------------------=======================================
------------------=======================================
------------------====================
------------------====================
--------------------------------------
Total First Year Burden\4\:                                                                           26,100,000
------------------                    --------------------------------------------------------
----------------------------------------------------------------------------------------------
Risk Control Plan             50,000                  1             50,000                2              100,000
------------------=======================================
------------------=======================================
------------------====================
--------------------------------------
Annual Burden\5\                                                                                       4,600,000
------------------                    --------------------------------------------------------
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\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

[[Page 76058]]

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
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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
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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.

    Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7644 Filed 12-21-05; 8:45 am]
BILLING CODE 4160-01-S