[Federal Register: December 22, 2005 (Volume 70, Number 245)]
[Notices]
[Page 76056-76058]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de05-61]
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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
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Total First Year Burden\4\: 26,100,000
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Risk Control Plan 50,000 1 50,000 2 100,000
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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)
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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