[Federal Register Volume 75, Number 184 (Thursday, September 23, 2010)]
[Notices]
[Pages 57962-57963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23824]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0357]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Hazard Analysis and
Critical Control Point Procedures for the Safe and Sanitary Processing
and Importing of Juice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 October
25, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0466.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-796-3793.
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.
Hazard Analysis and Critical Control Point (HACCP) Procedures for the
Safe and Sanitary Processing and Importing of Juice--(OMB Control
Number 0910-0466)--Extension
FDA's regulations in part 120 (21 CFR part 120) mandate the
application of HACCP procedures to fruit and vegetable juice
processing. HACCP is a preventative system of hazard control that can
be used by all food processors to ensure the safety of their products
to consumers. A HACCP system of preventive controls is the most
effective and efficient way to ensure that these food products are
safe. FDA's mandate to ensure the safety of the Nation's food supply is
derived principally from the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 321, et seq.). Under the FD&C Act, FDA has
authority to ensure that all foods in interstate commerce, or that have
been shipped in interstate commerce, are not contaminated or otherwise
adulterated, are produced and held under sanitary conditions, and are
not misbranded or deceptively packaged; under section 701 (21 U.S.C.
371), the FD&C Act authorizes the Agency to issue regulations for its
efficient enforcement. The Agency also has authority under section 361
of the Public Health Service Act (42 U.S.C. 264) to issue and enforce
regulations to prevent the introduction, transmission, or spread of
[[Page 57963]]
communicable diseases from one State to another State. Information
development and recordkeeping are essential parts of any HACCP system.
The information collection requirements are narrowly tailored to focus
on the development of appropriate controls and document those aspects
of processing that are critical to food safety. Through these
regulations, FDA is implementing its authority under section 402(a)(4)
of the FD&C Act (21 U.S.C. 342(a)(4)).
In the Federal Register of July 14, 2010 (75 FR 40839), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No of Annual Frequency per Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours Per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and (b) 1,875 365 684,375 0.1 68,437.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.7; 120.10(a); and 120.12(a)(2), (b), and (c) 2,300 1.1 2,530 20 50,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.8(b)(7) and 120.12(a)(4)(i) and (b) 1,450 14,600 21,170,000 0.01 211,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.10(c) and 120.12(a)(4)(ii) and (b) 1,840 12 22,080 0.1 2,208
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.11(a)(1)(iv) and (a)(2) and 120.12(a)(5) 1,840 52 95,680 0.1 9,568
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.11(b) and 120.12(a)(5) and (b) 1,840 1 1,840 4 7,360
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.11(c) and 120.12(a)(5) and (b) 1,840 1 1,840 4 7,360
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.14(a)(2), (c), and (d) 308 1 308 4 1,232
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 358,466
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 of this document provides a breakdown of the total
estimated annual recordkeeping burden. FDA bases this hour burden
estimate on its experience with the application of HACCP principles in
food processing.
The burden estimates in table 1 of this document are based on an
estimate of the total number of juice manufacturing plants (i.e.,
2,300) affected by the regulations. Included in this total are 850
plants currently identified in FDA's official establishment inventory
plus 1,220 very small apple juice manufacturers and 230 very small
orange juice manufacturers. The total burden hours are derived by
estimating the number of plants affected by each portion of the final
rule and multiplying the corresponding number by the number of records
required annually and the hours needed to complete the record. These
numbers were obtained from the Agency's final regulatory impact
analysis prepared for these regulations.
Moreover, these estimates assume that every processor will prepare
sanitary standard operating procedures and a HACCP plan and maintain
the associated monitoring records and that every importer will require
product safety specifications. In fact, there are likely to be some
small number of juice processors that, based upon their hazard
analysis, determine that they are not required to have a HACCP plan
under the regulations.
Dated: September 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23824 Filed 9-22-10; 8:45 am]
BILLING CODE 4160-01-S