[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68130-68132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27721]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1105]
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
associated with FDA's technical assistance reference manuals provided
to State, local, territorial, and tribal jurisdictions, and other
Federal Agencies to interpret and promote the application of Hazard
Analysis and Critical Control Point (HACCP) principles to reduce the
risk of foodborne illness in the operation of retail and food service
establishments.
DATES: Submit either electronic or written comments on the collection
of information by January 14, 2013.
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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, [email protected].
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
[[Page 68131]]
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
HACCP principles are designed to reduce the occurrence of foodborne
illness risk factors through preventive controls. FDA has developed two
technical assistance reference manuals that interpret and promote the
application of HACCP principles to reduce the risk of foodborne illness
in the operation of retail and food service establishments.
The responsibility and authority for regulating retail and food
service establishments lie primarily with State and local governments.
Officials in State, local, territorial, and tribal agencies inspect
these food facilities, license establishments, issue permits, and
enforce their State or local government's laws and regulations. FDA's
Retail Food Protection Program provides assistance to the more than
3,000 State and local government agencies that regulate the retail food
industry nationally. The primary objective of the Retail Food
Protection Program is to prevent foodborne illness at the retail level
of the food industry by directing activities toward promotion of
effective State and local regulatory programs. FDA provides assistance
to State, local, territorial, and tribal regulatory 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 FD&C 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 FD&C Act directs FDA to
cooperate with food retailers, among others, in carrying out this part
of its mission.
The first manual, entitled ``Managing Food Safety: A Manual for the
Voluntary Use of HACCP Principles for Operators of Food Service and
Retail Establishments'' (Operator's Manual) (available at http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/ManagingFoodSafetyHACCPPrinciples/Operators/default.htm), provides
operators of retail and food service establishments a roadmap for
developing a food safety management system based on HACCP principles.
Food safety management systems allow establishment operators to take a
proactive role in ensuring that the food served or sold in their
establishment is safe. Rather than responding to a foodborne illness
when it occurs, they can prevent it by taking active steps to
eliminate, prevent, or reduce to an acceptable level food safety
hazards that may cause someone to become sick or injured.
The second manual, entitled ``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'' (Regulator's Manual) (available at http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/ManagingFoodSafetyHACCPPrinciples/Regulators/default.htm), provides State, local, territorial, and tribal
regulatory authorities with a model for prioritizing inspections using
a risk-based approach. The Regulator's Manual provides a roadmap for
evaluating retail and food service establishments based on the
application of HACCP principles.
FDA developed the manuals as technical assistance reference
resources for regulators and operators to help reduce the risk of
foodborne illness. There is no Federal requirement that retail and food
service establishments implement food safety management systems based
on HACCP principles. State, local, territorial, and tribal regulatory
authorities decide whether to require food safety management systems in
the operation of retail and food service establishments. Regulators and
operators will not submit information to FDA based on these manuals.
Regulators and retail and food service operators use the manuals as
technical assistance reference resources. The Regulator's Manual
contains information, recommendations and model documents for State,
local, territorial, and tribal regulators who wish to develop practices
for risk-based inspections of retail and food service establishments
based on the application of HACCP principles. The Operator's Manual
contains information, recommendations and model documents for operators
of retail and food service establishments who wish to develop and/or
validate the practices used in a food safety management system based on
HACCP principles.
Description of Respondents: The respondents are State, local,
territorial, and tribal regulatory jurisdictions and operators of
retail and food service establishments in the United States.
Respondents are from both the public sector (State, local, territorial,
and tribal governments) and the private sector (for-profit businesses).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Annual Total
Activity Number of frequency per annual Hours per record Total hours
recordkeepers recordkeeping records
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Reference of Technical 25,000 1 25,000 0.2 (12 minutes)....... 5,000
Assistance Manuals by
Operators.
Reference of Technical 1,500 1 1,500 0.25 (15 minutes)...... 375
Assistance Manuals by
Regulators.
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Total.................... .............. .............. ........... ....................... 5,375
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The number of operator recordkeepers estimated in column 2 of Table
1 is based on FDA's goal to have 50,000 (\1/2\ of 1 percent) of the
approximately one million U.S. retail and food service operators
implement the recommendations outlined in the two manuals, as estimated
in 2009 (73 FR 77721, at 77722). FDA's estimate of the total number of
retail and food service establishments is based on numbers obtained
from the two major trade organizations representing these industries,
the Food Marketing Institute and the National Restaurant Association.
Gathering reference material to develop and/or validate food safety
management system practices is a one-time burden. We assume that those
50,000 operators have utilized FDA's technical assistance manuals to
the
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degree that they chose to do so over the past 3 years and over the next
3 years will only need to reference these manuals on an as-needed
basis. FDA estimates that, annually, approximately one half of the
operators, 25,000, will choose to reference FDA's information,
recommendations or model documents.
The number of regulator recordkeepers estimated in column 2 of
Table 1 is based on FDA's estimate that there are approximately 3,000
State, local, territorial, and tribal regulatory jurisdictions.
Gathering and reviewing reference material to develop practices for
risk-based inspections of retail and food service establishments based
on HACCP principles is a one-time burden. We assume that those 3,000
regulatory jurisdictions have utilized FDA's technical assistance
manuals to the degree that they chose to do so over the past 3 years
and over the next 3 years will only need to reference these manuals on
an as-needed basis. FDA estimates that, annually, approximately one
half of the regulatory jurisdictions (1,500) will choose to reference
FDA's information, recommendations or model documents.
The hours per record estimated in column 2 of Table 1 are based on
FDA's experience with similar technical assistance materials offered by
the Agency. FDA estimates that over the next 3 years regulators and
operators will only need to reference these manuals on an as needed
basis. We estimate that it will take an operator with a specific need
for information approximately 12 minutes (0.2 hour) to gather and
record the data from the manuals. We estimate that it will take a
regulator with a specific need for information approximately 15 minutes
(0.25 hour) to gather and record the data from the manuals.
The total recordkeeping burden of the technical assistance manuals
is 5,375 hours, as shown in Table 1.
Dated: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27721 Filed 11-14-12; 8:45 am]
BILLING CODE 4160-01-P