[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11783-11786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0265] (formerly Docket 2007N-0026)


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Canning 
Establishment Registration, Process Filing, and Recordkeeping for 
Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically 
Sealed Containers

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 (the PRA).

[[Page 11784]]


DATES: Fax written comments on the collection of information by April 
4, 2011.

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 e-mailed to <a href="/cdn-cgi/l/email-protection#a6c9cfd4c7f9d5d3c4cbcfd5d5cfc9c8e6c9cbc488c3c9d688c1c9d0"><span class="__cf_email__" data-cfemail="d1beb8a3b08ea2a4b3bcb8a2a2b8bebf91bebcb3ffb4bea1ffb6bea7">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0037. 
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, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, 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.

Food Canning Establishment Registration, Process Filing, and 
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid 
Foods in Hermetically Sealed Containers--(OMB Control Number 0910-
0037)--Revision

    Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA 
is authorized to prevent the interstate distribution of food products 
that may be injurious to health or that are otherwise adulterated, as 
defined in section 402 of the FD&C Act (21 U.S.C. 342). Under the 
authority granted to FDA by section 404 of the FD&C Act (21 U.S.C. 
344), FDA regulations require registration of food processing 
establishments, filing of process or other data, and maintenance of 
processing and production records for acidified foods and thermally 
processed low-acid foods in hermetically sealed containers. These 
requirements are intended to ensure safe manufacturing, processing, and 
packing procedures and to permit FDA to verify that these procedures 
are being followed. Improperly processed low-acid foods present life-
threatening hazards if contaminated with foodborne microorganisms, 
especially Clostridium botulinum. The spores of C. botulinum must be 
destroyed or inhibited to avoid production of the deadly toxin that 
causes botulism. This is accomplished with good manufacturing 
procedures, which must include the use of adequate heat processes or 
other means of preservation.
    To protect the public health, FDA regulations require that each 
firm that manufactures, processes, or packs acidified foods or 
thermally processed low-acid foods in hermetically sealed containers 
for introduction into interstate commerce register the establishment 
with FDA using Form FDA 2541 (Sec. Sec.  108.25(c)(1) and 108.35(c)(1) 
(21 CFR 108.25(c)(1) and 108.35(c)(1))). In addition to registering the 
plant, each firm is required to provide data on the processes used to 
produce these foods, using Form FDA 2541a for all methods except 
aseptic processing, or Form FDA 2541c for aseptic processing of low-
acid foods in hermetically sealed containers (Sec. Sec.  108.25(c)(2) 
and 108.35(c)(2)). Plant registration and process filing may be 
accomplished simultaneously. Process data must be filed prior to 
packing any new product (Sec. Sec.  108.25(c)(2) and 108.35(c)(2)). For 
processors of thermally processed low-acid foods in hermetically sealed 
containers, operating processes and procedures must be posted near the 
processing equipment or made available to the operator (Sec.  113.87(a) 
(21 CFR 113.87(a))).
    Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and 
114) require firms to maintain records showing adherence to the 
substantive requirements of the regulations. These records must be made 
available to FDA on request. Firms are also required to document 
corrective actions when process controls and procedures do not fall 
within specified limits (Sec. Sec.  113.89, 114.89, and 114.100(c)); to 
report any instance of potential health-endangering spoilage, process 
deviation, or contamination with microorganisms where any lot of the 
food has entered distribution in commerce (Sec.  108.25(d) and Sec.  
108.35(d) and (e)); and to develop and keep on file plans for recalling 
products that may endanger the public health (Sec. Sec.  108.25(e) and 
108.35(f)). To permit lots to be traced after distribution, acidified 
foods and thermally processed low-acid foods in hermetically sealed 
containers must be marked with an identifying code (Sec. Sec.  
113.60(c) (thermally processed foods) and 114.80(b) (acidified foods)).
    These collection of information provisions are currently approved 
under OMB control number 0910-0037 (expires August 31, 2011). In the 
Federal Register of March 14, 2007 (72 FR 11990), FDA published a 
proposed rule entitled ``Temperature-Indicating Devices; Thermally 
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers'' 
(the proposed rule). This document proposed to revise FDA's regulations 
for thermally processed low-acid foods in part 113 to, among other 
things, provide for the use of temperature-indicating devices other 
than mercury-in-glass thermometers during processing, require that 
temperature-indicating devices be tested for accuracy against a 
calibrated reference device, and to establish recordkeeping 
requirements for temperature-indicating devices and reference devices 
maintained by the processor. In compliance with the PRA (44 U.S.C. 
3506(c)(2)(B)), the Agency requested public comment on the information 
collection provisions of the proposed rule (72 FR 11990 at 12004).
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule entitled ``Temperature-Indicating Devices; Thermally 
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers'' 
(the final rule). The final rule revises the information collection 
currently approved under OMB control number 0910-0037 by adding 
recordkeeping requirements in new Sec.  113.100(c) and (d). The 
information to be recorded under these regulations is related to 
accuracy tests of temperature-indicating devices and reference devices 
maintained by processors of low-acid canned foods. These tests must be 
performed to ensure the accuracy of the devices during the processing 
of these foods. If these devices are not accurate, the processor cannot 
ensure that the low-acid canned foods it produces are safe to eat, and 
consumers may be harmed. The recordkeeping requirements of the final 
rule are necessary to document that appropriate accuracy tests have 
been performed with the appropriate frequencies for each temperature-
indicating device and each reference device maintained by the 
processor. Records of accuracy tests for these devices also help 
processors determine how frequently the devices should be tested for 
accuracy. Much of the information is currently generated for accuracy 
tests performed under current regulations. However, the information may 
not be recorded as required under the final rule.
    Current low-acid canned food regulations recommend, but do not 
require, that processors keep records of accuracy tests for mercury-in-
glass thermometers, including test date, standard used, method used, 
and person performing the test. The final rule requires processors to 
keep records documenting the accuracy of temperature-indicating devices 
(including but not limited to mercury-in-glass thermometers) and of 
reference devices that are maintained by the processor. These records 
include the

[[Page 11785]]

identifier of the device being tested, such as its tag or seal; the 
name of the manufacturer of the device; the identity of the reference 
device, equipment, and procedures used for the accuracy test and to 
adjust the device or, if an outside facility conducts the accuracy 
test, documentation regarding the traceability of the accuracy to a 
National Institute of Standards and Technology or other national 
metrology institute standard; the identity of the person or facility 
that performed the accuracy test and adjusted or calibrated the device; 
the date and results of each accuracy test, including the amount of 
adjustment; and the date on or before which the next accuracy test must 
be performed.
    In addition to requesting public comment on the new recordkeeping 
provisions, the proposed rule also stated that FDA had submitted the 
recordkeeping provisions to OMB for review (72 FR 11990 at 12005). 
However, due to an administrative error, the Agency did not actually do 
so, and, therefore, FDA is submitting them to OMB now. Because OMB 
approval for the collections of information in the regulations the 
final rule amends is set to expire on August 31, 2011, FDA is also 
submitting those collections (as revised by the final rule) for OMB 
review, along with the others currently approved under OMB control 
number 0910-0037.
    Description of Respondents: The respondents to this information 
collection are commercial processors and packers of acidified foods and 
thermally processed low-acid foods in hermetically sealed containers.
    FDA estimates the burden of this information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Annual
              Form No.                          21 CFR section               Number of     frequency per   Total annual      Hours per      Total hours
                                                                            respondents      response        responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 2541 (Registration)........  108.25 and 108.35.................             515            1                515            .17               88
Form FDA 2541a (Process Filing).....  108.25 and 108.35.................           1,489            8.62          12,835            .333           4,274
Form FDA 2541c (Process Filing).....  108.35............................              84            7.77             653            .75              490
                                     -------------------------------------------------------------------------------------------------------------------
    Total...........................  ..................................  ..............  ..............  ..............  ..............           4,852
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimates of the number of respondents and the hours 
per response on its experience with registration and process filing and 
on information from industry. FDA estimates the total burden of 
registration under Sec. Sec.  108.25 and 108.35 to be 88 hours (515 
respondents x 1 annual response x 0.17 hours = 87.55 hours, rounded to 
88 hours). FDA estimates the total burden of process filing on Form FDA 
2541a under Sec. Sec.  108.25 and 108.35 to be 4,274 hours (1,489 
respondents x 8.62 annual responses x 0.333 hours = 4,274.12 hours, 
rounded to 4,274 hours). FDA estimates the total burden of process 
filing on Form FDA 2541c under Sec.  108.35 to be 490 hours (84 
respondents x 7.77 annual responses x 0.75 hours = 489.51 hours, 
rounded to 490 hours). The reporting burden for Sec.  108.25(d) and 
Sec.  108.35(d) and (e) is minimal because notification of spoilage, 
process deviation, or contamination of product in distribution occurs 
less than once per year. Most firms discover these problems before the 
product is distributed and, therefore, are not required to report the 
occurrence. To avoid double-counting, estimates for Sec. Sec.  
108.25(g) and 108.35(h) have not been included because they merely 
cross-reference recordkeeping requirements contained in parts 113 and 
114.
    FDA permits electronic registration and filing on the Internet. The 
electronic submission capability of the Low Acid Canned Food (LACF) 
Program entitled eLACF was the second major registration application to 
be supported by and integrated under the FDA Unified Registration and 
Listing System (FURLs). Food canning establishments can request an 
electronic account by sending an e-mail to <a href="/cdn-cgi/l/email-protection#660a07050026000207480e0e1548010910"><span class="__cf_email__" data-cfemail="a3cfc2c0c5e3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></a>.

                                Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
       21 CFR part/section           Number of     frequency of    Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
21 CFR Parts 113 and 114........           9,500               1           9,500             250       2,375,000
Burden added by new Sec.                   4,225              15          63,375          0.0097             615
 113.100(c) and (d).............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       2,375,615
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA received six letters, each containing one or more comments on 
the proposed rule. Although the Agency did not identify any comments 
referring specifically to the PRA, several comments discussed the 
proposed recordkeeping provisions. FDA has summarized and responded to 
these comments in section II of the final rule (Comments 1, 4, 11 
through 13, and 18). None of the comments on the proposed rule 
suggested that we modify our burden estimates for the new information 
collection provisions. Thus, we have not changed our estimates of the 
annual frequency per recordkeeping or the hours per record. We have, 
however, increased the estimated number of recordkeepers to reflect 
growth in the low-acid canned food processing industry since the 2007 
proposed rule.
    Currently, there are 9,491 active firms in the LACF database, which 
encompasses processors of low-acid

[[Page 11786]]

canned food, processors of acidified food, and processors of both types 
of food. Thus, we estimate the number of processors keeping records 
under parts 113 and 114 to be 9,500, as shown in table 2, row 1 of this 
document. In the final rule, we estimated that there are approximately 
8,450 foreign and domestic low-acid canned food processing 
establishments. This estimate, which does not encompass establishments 
that process only acidified foods (because such processors are not 
affected by the final rule), was based on data in the LACF database as 
of September 2009. As discussed in the explanation of the recordkeeping 
estimate for the final rule in the following paragraphs, our estimate 
assumes that half of the LACF industry currently does not record all of 
the device accuracy testing information that the final rule requires. 
Thus, as shown in table 2, row 2 of this document, we estimate that 
4,225 low-acid canned food manufacturers that are not currently keeping 
the records that are required under the final rule will begin to keep 
such records to comply with the final rule when it becomes effective.
    FDA bases its estimates of the number of recordkeepers and the 
hours per record on its experience and on information from industry. 
FDA estimates that it takes 250 hours per respondent to comply with the 
recordkeeping requirements in parts 113 and 114. In table 2, row 1 of 
this document, FDA estimates the total burden of recordkeeping under 
parts 113 and 114 before the effective date of the final rule to be 
2,375,000 hours (9,500 respondents x 250 hours = 2,375,000 hours). 
Table 2, row 2 reports the average annual recordkeeping burden of the 
final rule. The burden of the recordkeeping requirement of the final 
rule consists of the set-up time required to design and establish a 
form for recording the required information, and the additional hours 
of labor needed to record the information. The set-up time required for 
designing a new recordkeeping form is assumed to be minimal because we 
estimate that only a few data elements required in the final rule are 
currently unreported by some processors and that only small 
modifications to a processor's recordkeeping form would be required to 
accommodate the additional data elements.
    We estimate that the amount of time needed to comply with the 
recordkeeping requirements of the final rule will be small because 
current industry practice is to keep track of most, if not all, of this 
information. Because current incentives to track accuracy of mercury-
in-glass thermometers may vary across the industry, however, some 
information that is currently generated during accuracy tests may not 
be recorded as required under the final rule. Thus, we assume there 
will be a burden incurred from the final rule to record information 
that is currently generated, but not recorded.
    We assume that half of the industry currently does not record all 
of the device accuracy testing information that the final rule 
requires. We further assume that current practice by these firms is to 
leave unrecorded 1 to 4 separate pieces of information required under 
the final rule, and that each piece of information takes between 10 and 
15 seconds to record. Consequently, we estimate that half of all low-
acid canned food manufacturers will spend between 10 seconds and 1 
minute (i.e., 1 x 10 seconds and 4 x 15 seconds) per device to record 
information required in the final rule.
    Based on a survey conducted by FDA between 1992 and 1993 of 
mercury-in-glass thermometer calibration in the low-acid canned food 
industry, we estimate that low-acid food firms use an average of 10 
temperature-indicating devices, including reference devices. We 
estimate that 4,225 low-acid canned food manufacturers (half of the 
industry) currently do not fully record the accuracy test results 
required by the final rule. Because the regulations specify that each 
device must be tested upon installation and at least once per year 
thereafter, or more frequently if necessary to ensure accuracy, we 
estimate that each device requires 1 to 2 tests per year (midpoint of 
1.5 tests per year). We therefore estimate the annual frequency per 
recordkeeping to be 15 (i.e., 10 devices x 1.5 tests per year). We 
estimate the burden for recording the additional information to be 
between 10 and 60 seconds per device (midpoint of 35 seconds or 0.0097 
hours per device). Therefore, the estimated total annual burden in 
hours for the recordkeeping requirements of the final rule is 
approximately 615 hours (63,375 x 0.0097 = 614.7 hours, rounded to 615 
hours). Thus, the final rule increases the total burden of this 
information collection by approximately 0.3 percent, from 2,375,000 
hours to 2,375,615 hours.

    Dated: February 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-4474 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P


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