Document ID: FDA-2008-D-0096-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Availability
Posted Date: 2008-02-07T05:00Z

[Federal Register: February 7, 2008 (Volume 73, Number 26)]
[Notices]               
[Page 7293-7298]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07fe08-74]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0494]

 
Draft Guidance for Industry: Control of Listeria monocytogenes in 
Refrigerated or Frozen Ready-To-Eat Foods; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Guidance for Industry: 
Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-
Eat Foods'' (the draft Listeria guidance). This draft guidance, when 
finalized, will complement FDA's current good manufacturing practices 
(CGMP) regulations by providing specific guidance on the control of L. 
monocytogenes in the processing of refrigerated or frozen ready-to-eat 
foods (RF-RTE foods). The draft Listeria guidance and the CGMP 
regulations are intended to assist processors in controlling L. 
monocytogenes in the food processing environment during the manufacture 
of RF-RTE foods.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft

[[Page 7294]]

guidance before it begins work on the final version of the guidance, 
submit written or electronic comments on the draft guidance by April 7, 
2008. Submit written or electronic comments concerning the collection 
of information provisions by April 7, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: Control of Listeria 
monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods'' to the 
Office of Food Safety, Center for Food Safety and Applied Nutrition 
(HFS-325), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request, or fax your request to 
301-436-2601. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.
    Submit written comments on the draft guidance and the proposed 
collection of information provisions to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov
.

FOR FURTHER INFORMATION CONTACT: With regard to the information 
collection provisions: Jonna Capezzuto, Office of the Chief Information 
Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.
    With regard to the draft guidance document: Mary Losikoff, Center 
for Food Safety and Applied Nutrition (HFS-325), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1412.

SUPPLEMENTARY INFORMATION:

I. Background

    L. monocytogenes is a pathogenic bacterium that is widespread in 
the environment and thus may be introduced into a food processing 
facility. L. monocytogenes can contaminate foods and cause a mild 
illness (called listerial gastroenteritis) or a severe, sometimes life-
threatening, disease (called invasive listeriosis). With rare 
exceptions, foods that have been implicated in outbreaks or sporadic 
cases of invasive listeriosis have been refrigerated foods that can 
support the growth of L. monocytogenes and that are RTE. RF-RTE foods 
can be contaminated if ingredients in the foods are contaminated with 
L. monocytogenes and not treated to destroy viable cells of this 
pathogen, or if L. monocytogenes is present on surfaces (e.g., in the 
food processing environment) that can contaminate food or food-contact 
surfaces.
    With this notice, FDA is announcing the availability of the draft 
Listeria guidance. This draft guidance is being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The draft 
guidance, when finalized, will represent FDA's current thinking on the 
control of L. monocytogenes in the processing of RF-RTE foods. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C 3501-
3520). Under the PRA, Federal agencies must obtain approval from the 
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 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.
    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 collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Control of Listeria monocytogenes in Refrigerated or Frozen 
Ready-To-Eat Foods.
    Description: The Federal Food, Drug, and Cosmetic Act prohibits the 
distribution of adulterated food in interstate commerce (21 U.S.C. 331 
and 342). L. monocytogenes is a pathogenic bacterium that is widespread 
in the environment and thus may be introduced into a food processing 
facility. L. monocytogenes can contaminate foods and cause a mild 
illness (called listerial gastroenteritis) or a severe, sometimes life-
threatening, disease (called invasive listeriosis). Foods that have 
been implicated in outbreaks of invasive listeriosis have been 
refrigerated foods that can support the growth of L. monocytogenes and 
that are RTE. RF-RTE foods can be contaminated if ingredients in the 
foods are contaminated with L. monocytogenes and not treated to destroy 
viable cells of this pathogen, or if L. monocytogenes is present on 
surfaces (e.g., in the food processing environment) that can 
contaminate food or food-contact surfaces. The draft Listeria guidance, 
when finalized, will complement FDA's CGMP regulations in 21 CFR part 
110 by providing specific guidance on the control of L. monocytogenes 
in the processing of RF-RTE foods. The draft Listeria guidance and the 
CGMP regulations are intended to assist processors in controlling L. 
monocytogenes in the food processing environment during the manufacture 
of RF-RTE foods. FDA encourages processors of RF-RTE foods to adopt the 
general recommendations in the draft Listeria guidance and to tailor 
practices to their individual operations.
    FDA's draft Listeria guidance represents the agency's 
recommendations to industry based on the current state of science. 
Following the recommendations set forth in the draft Listeria guidance 
is the choice of each individual operation, plant, or processor. FDA 
estimates the burden of this draft guidance on industry by assuming 
that those in the industry who process RF-RTE foods and who do not 
currently follow the recommendations put forth in the guidance will 
find it of value to do so. Therefore, the estimates of the burden 
associated with the issuance of this guidance represent the upper bound 
estimate of burden: the burden if every operation, plant, or processor 
that does not follow the recommendations of the guidance should choose 
to do so.
    In order to minimize L. monocytogenes contamination in RF-RTE 
foods, FDA is recommending that the following records be maintained, as 
appropriate, to identify trends, document procedures, and facilitate 
corrective actions:

[[Page 7295]]

Ingredient and Process Control
     List of ingredients reasonably likely to be contaminated 
with L. monocytogenes
     Listeristatic or listericidal control measures
     Ingredient control records, i.e. certificate of 
conformance (COC), certificate of analysis (COA)
     Ingredient testing records
General Sanitation
     Written sanitation standard operating procedures (SSOP)
     Sanitation monitoring records
Monitoring of Critical Surfaces and Sampling of Finished Product
     Written plan for monitoring L. monocytogenes on food-
contact and non-food-contact surfaces
     Procedures to detect and enumerate L. monocytogenes, 
unless the procedure used is the procedure that FDA identifies in the 
guidance
     Results of tests to detect or enumerate L. monocytogenes 
on food-contact and non-food contact surfaces
     Results of tests to detect or enumerate L. monocytogenes 
in finished product
     Corrective actions taken
    Description of Respondents: The likely respondents to this request 
to keep the records described previously are U.S. processors of RF-RTE 
foods.
    FDA estimates the burden of this collection of information as 
follows:
    The estimated recurring annual burden for this information 
collection is 863,974 hours. Thus, the first year estimated burden for 
this information collection is 939,242 hours (863,974 hours + 75,268 
first-year-only hours). A detailed breakdown of the estimated burden is 
shown in table 1 of this document.

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   No. of         Annual Frequency      Total Annual       Hours per      Total Capital
               Type of Record                  Recordkeepers      per Recordkeeping       Records           Record          Costs\2\       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ingredient and Process Control
--------------------------------------------------------------------------------------------------------------------------------------------------------
List of ingredients reasonably likely to be              3,755                     1            3,755               1    ..............            3,755
 contaminated with L. monocytogenes\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record of verification of technique used                   188                     3              564               1    ..............              564
 for listeristatic control measures\3\
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Record of verification of technique used                 2,629                     1            2,629               1    ..............    *COM041*2,629
 for listericidal control measures\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Listeristatic control                                      376                   900          338,400               0.1  ..............           33,840
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Listericidal control                                     2,629                   900        2,366,100               0.1  ..............          236,610
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Ingredient control records (includes COC,                1,126                    72           81,072               0.1  ..............            8,107
 COA, and ingredient testing)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Sanitation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written SSOP\3\                                          4,270                     1            4,270               8    ..............           34,160
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sanitation monitoring records                            4,270                   300        1,281,000               0.1  ..............          128,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Environmental Monitoring and Product Sampling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written critical surface and finished                    4,270                     1            4,270               8    ..............           34,160
 product monitoring program\3\
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Food-contact surface monitoring results                  4,270                    52          222,040               0.5  ..............          111,020
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Record of corrective action taken for food-              4,270                    10           42,700               0.5  ..............           21,350
 contact surface positive
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Non-food-contact surface monitoring results              4,270                    26          111,020               0.5  ..............           55,510
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[[Page 7296]]

Record of corrective action taken for non-               4,270                    10           42,700               0.5  ..............           21,350
 food-contact surface positive
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Finished product results                                 4,270                    12           51,240               0.5  ..............           25,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record of corrective action taken for                    4,270                   0.2              854               0.5  ..............              427
 finished product positive
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written analytical method to detect or                       0                     1                0               0.1  ..............                0
 enumerate L. monocytogenes (besides the
 bacteriological analytical manual (BAM) or
 the international organization for
 standardization (ISO))\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record Maintenance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record Maintenance                                       4,270                    52          222,040               1    ..............          222,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             .................  ....................  ...............  ................        $640,500  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total hours for first year                                                                                                                       939,242
----------------------------------------------------------------------------------------------------------------------------------------
Total recurring hours                                                                                                                            863,974
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\1\There are no operating and maintenance costs associated with this collection of information.
\2\Estimated capital costs for all record keeping items are combined.
\3\First year burden.

    Data for the number of establishments potentially affected by this 
guidance were obtained from U.S. Census Bureau's 2003 ``County Business 
Patterns.'' Including grocery stores, delicatessens, and retail 
establishments that might perform some sort of RF-RTE food processing 
would bring the number of affected establishments to over 100,000. 
However, FDA anticipates this guidance would be used mainly by firms 
that are primarily RF-RTE food processors and manufacturers. Overall, 
there are 4,270 RF-RTE food processors and manufacturers that might be 
affected by this guidance. Liquid milk producers account for 515 of the 
establishments, and are already regulated by each state individually 
through the adoption of the Pasteurized Milk Ordinance (PMO). FDA 
assumes that milk producers would refer to the PMO for guidance in 
production and therefore would only be collecting or maintaining new 
information for general sanitation and on environmental monitoring and 
product sampling. There are currently 34 butter manufacturers, 408 ice 
cream manufacturers, 514 cheese manufacturers, and 501 ice 
manufacturers in the United States. There are 643 producers of 
perishable foods (including sandwiches, salads, and fresh-cut 
vegetables).\1\ There are 782 canned fruit and vegetable processors 
(including orange juice).\2\ There are 259 frozen pastry 
manufacturers.\3\ Furthermore, there are 614 RF-RTE seafood 
establishments.\4\ Some aspects of this record collection, such as 
sanitation monitoring records, are covered by FDA's regulations 
concerning hazard analysis and critical control point (HACCP) systems 
(21 CFR parts 120 and 123), though not specifically for L. 
monocytogenes. Therefore, some of the records may already be collected 
by some establishments. For the purposes of this analysis, FDA assumes 
that none of the affected establishments are currently collecting the 
information specific to L. monocytogenes. There are approximately 3,755 
establishments (4,270 establishments - 515 milk producers) that would 
be collecting new information on ingredient and process control. All 
4,270 establishments would be collecting new information for general 
sanitation and on environmental

[[Page 7297]]

monitoring and product sampling. All establishments would need to 
maintain those records.
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    \1\North American Industry Classification System (NAICS) code 
311991 also includes items such as fresh pasta and prepared meals. 
Producers of some of these items will not follow the guidance, 
either because their item is not an RF-RTE food or they are under 
the jurisdiction of the U.S. Department of Agriculture (USDA). In 
this regard, using the total from NAICS 311991 is an overestimate of 
the total burden. However, this is offset by the establishments in 
``County Business Patterns'' that are counted only under their 
primary NAICS code. Establishments whose primary line of business is 
not in NAICS 311991 are not counted in this category.
    \2\NAICS 311421 includes many items that are not refrigerated. 
Therefore, this number is an overestimate of the burden of the 
guidance. However, that may be offset to some extent by failure to 
count establishments whose primary line of business is in another 
NAICS code.
    \3\NAICS code 311813 contains some items, such as some frozen 
pies, that are not considered RF-RTE foods. Therefore, using the 
total number of establishments within NAICS 311813 is an 
overestimate. This overestimate is offset to an unknown degree by 
the undercounting of establishments whose primary product is in 
another NAICS code.
    \4\Not all seafood processors are covered by this guidance.
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    The draft guidance recommends that establishments keep a list of 
ingredients likely to be contaminated with L. monocytogenes. It is not 
likely that many establishments will have such a list, so this will be 
a one-time burden for 3,755 establishments. FDA estimates the list will 
take about 1 hour to compile, for a total one-time burden of about 
3,755 hours.
    Plants employing either a listericidal or listeristatic step would 
be recommended to maintain documentation of scientific studies that 
demonstrate that the control measure consistently destroys viable cells 
or is effective in preventing the growth of L. monocytogenes. FDA 
believes that about 80 percent of the establishments will either employ 
a listericidal or listeristatic step (approximately 70 percent will 
have a listericidal step and 10 percent will have listeristatic steps).
    Based on these assumptions, there will be roughly 2,629 
establishments (0.70 x 3,755) that would be recommended to keep a new 
record showing the efficacy of their listericidal step. Although the 
time taken to commit the verification to record will vary, FDA 
estimates that, on average, it will take about 1 hour for the 
documentation.\5\ The total one-time burden is estimated to be about 
2,629 hours.
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    \5\ Many firms may choose a well-established listericidal 
measure, identified in the draft guidance (such as irradiation or 
thermal processing). The efficacy of these measures will take less 
time to record than less well-known means of listericidal control.
---------------------------------------------------------------------------

    Under the draft guidance, listeristatic control measures fall into 
two categories: Those that are generally recognized as effective in 
preventing the growth of L. monocytogenes (such as maintaining a pH of 
4.4 or below, or maintaining a water activity of 0.92 or below) and 
those that a firm would develop on its own (such as formulating a food 
to contain one or more inhibitory substances that, alone or in 
combination, prevent the growth of L. monocytogenes). We estimate that 
about 50 percent of firms that establish and use listeristatic control 
measures (0.50 x 376, or 188 establishments) would develop their own 
listeristatic control measures, and would do so for three different 
food products on average. We also estimate that it would take 
approximately 1 hour to establish a record documenting the scientific 
studies that establish that the control measure consistently prevents 
the growth of L. monocytogenes, for a total one-time burden of about 
564 hours.
    As stated, the draft guidance recommends that processors of RF-RTE 
foods select one or more identified measures to control ingredients. 
The recommended measures to control ingredients that may be adopted by 
firms expected to collect new records include: Eliminating L. 
monocytogenes by using a listericidal control measure at some point 
between the arrival of the ingredient and the shipping of the final 
product, receiving ingredients under a COA or COC, or testing the 
ingredients for the presence of L. monocytogenes.
    For firms that choose to eliminate L. monocytogenes by using a 
listericidal control measure at some point between the arrival of the 
ingredient and the shipping of the final product, the draft guidance 
recommends that records of listericidal control measures be kept on a 
daily basis, per product, per lot, either per ingredient lot or per 
final product lot. FDA estimates that most firms choosing to employ a 
listericidal control measure would do so on the final product and that 
although the number of lots may vary from firm to firm, the time taken 
to record the entire process for each product would not. Therefore, the 
records can be treated as a daily collection for each unique product. 
We estimate that records of each listericidal control measure could be 
produced in approximately 6 minutes for an average of three products 
per plant. FDA does not have information to predict how many 
establishments would employ a listericidal control step. For this 
analysis, FDA estimates that about 70 percent of the affected 
establishments (2,629 establishments) would do so. These records would 
produce a total annual burden of about 236,610 hours ((2,629 plants) x 
(3 products) x (300 days of production) x (0.1 hours)).
    Under the recommendations in the draft guidance, firms may instead 
choose to test ingredients for L. monocytogenes on a per ingredient 
basis, or to receive ingredients under a COC or a COA. Firms that 
choose to test would test each lot after it arrives at the facility. 
Firms employing a listericidal step would not need to perform this type 
of ingredient control, so FDA estimates that this may be a new burden 
for 1,126 establishments. FDA assumes that processors of RF-RTE foods 
typically receive ingredients twice a month and the number of 
ingredients varies from firm to firm. Although some products could 
contain more than 20 ingredients, we assume that only an average of 3 
ingredients would need to be tested for the presence of L. 
monocytogenes in a single product. Therefore, the frequency of the 
collection is 72 times per year. FDA estimates that the record of the 
test results could be produced in about 6 minutes. Firms that choose to 
receive ingredients under a COC or a COA would produce a record of the 
COC or COA on a per ingredient, per delivery basis, resulting in an 
average of 72 collections per year. FDA believes that these records 
would take less than 6 minutes each to produce. Ingredient testing 
records or collecting a COC or COA would produce a total annual 
paperwork burden of about 8,107 hours ((1,126 plants) x (72 collections 
per year) x (6 minutes per record)).
    Firms may choose to add a listeristatic step in addition to the 
COC, COA, or ingredient testing. FDA recommends in the draft guidance 
that records of listeristatic control measures be kept on a daily basis 
per lot, either per ingredient lot or per final product lot. FDA 
assumes that, similar to listericidal control records, listeristatic 
control records can be treated as a daily collection for each product, 
taking approximately 6 minutes. FDA does not have information to 
predict how many establishments would employ a listeristatic step. For 
this analysis, FDA estimates that about 10 percent of the affected 
establishments (376 establishments) would collect the information for 
an average of 3 products. These records would produce a total annual 
burden of about 33,840 hours ((376 plants) x (3 products) x (300 days 
of production) x (0.1 hours)).
    In the draft guidance, FDA is recommending that firms have written 
SSOPs. FDA assumes this is a new collection for 4,270 establishments. 
Developing written SSOPs would be a one-time cost and we assume that 
this would take approximately 8 hours. This results in a first year 
burden of 34,160 hours (4,270 plants x 8 hours). The guidance also 
recommends that firms have written sanitation monitoring records. As 
stated previously, establishments subject to FDA's HACCP regulations 
are already required to have sanitation monitoring records, in order in 
order to comply with those regulations. However, because these records 
may not be specific to L. monocytogenes, FDA assumes this is a new 
collection for 4,270 establishments. We assume that sanitation 
monitoring records would be kept every day and could be produced in 
about 6 minutes per day. Therefore about 128,100 hours would be spent 
annually on sanitation records ((4,270 plants) x (300 days of 
production) x (0.1 hours)).
    FDA assumes that although some firms may have an environmental 
monitoring program for critical surfaces in place (including surfaces 
that contact

[[Page 7298]]

food as well as surfaces that do not contact food), very few would have 
a program in place as thorough as the one described in the draft 
guidance. Therefore, FDA estimates that 4,270 establishments may choose 
to adopt the recommendations to develop a written environmental 
monitoring program, keep environmental testing results, and record 
finished product testing results. Developing a written environmental 
monitoring program would be a one-time cost and we assume that it would 
take approximately 8 hours. This results in a first year burden of 
about 34,160 hours (4,270 plants x 8 hours). For critical food-contact 
surfaces, the draft guidance recommends that tests be conducted on a 
weekly basis. We assume that it would take up to half an hour to 
produce a record of the results of the test, depending on the number of 
sites tested and subject to variability between firms, resulting in an 
annual burden of about 111,020 hours ((4,270 plants) x (52 records per 
year) x (0.5 hours)). For critical non-food-contact surfaces, the draft 
guidance recommends that tests be conducted every 2 weeks. As with 
testing for food-contact surfaces, we assume that the records would 
take up to half an hour to produce, resulting in an annual burden of 
about 55,510 hours ((4,270 plants) x (26 records per year) x (0.5 
hours)). The draft guidance recommends ``periodic'' testing of finished 
product, such as weekly, monthly, or quarterly. For purposes of this 
analysis, FDA assumes most firms would conduct monthly testing of 
finished product. As with testing of critical surfaces, we assume the 
records would take approximately one half hour to produce, for an 
annual burden of about 25,620 hours ((4,270 plants) x (12 records per 
year) x (0.5 hours)).
    In the draft guidance, FDA is recommending that firms that detect 
Listeria species on critical surfaces or in the finished product take 
corrective action and keep a record of what was done. The time to 
record the corrective actions would vary, but on average FDA estimates 
the record would require one half hour to produce. FDA cannot 
accurately predict how often firms would detect Listeria species in the 
environment. For the purposes of this analysis, and assuming that firms 
follow the rest of the guidance, FDA conservatively assumes that firms 
would detect Listeria species on food-contact surfaces about 20 percent 
of the time that tests are run, producing a total of 10 new records per 
establishment annually. Because non-food-contact surfaces cover 
inherently more space than food-contact surfaces and may be cleaned 
less stringently, FDA estimates that firms would detect Listeria 
species twice as often per test as they do when running tests on food-
contact surfaces. Because these tests are run only half as often as 
food-contact surface tests (every 2 weeks rather than every week), this 
record would also be produced an average of 10 times annually per 
establishment. We assume that Listeria species would not often be 
detected in the final product, based on the projections of the 
``Quantitative Assessment of Relative Risk to Public Health From 
Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-
Eat Foods,'' (the Risk Assessment), written jointly by USDA and FDA. 
The Risk Assessment projected that 2 percent of RF-RTE food is 
contaminated with L. monocytogenes. FDA uses this number to estimate 
that records for corrective action due to finished product testing 
would produce, on average, 0.2 new records per establishment annually. 
The total annual burden produced by corrective action records would be 
about 43,127 hours ([(4,270 plants) x (10 records per year for 
corrective actions taken after food-contact surface positive) x (0.5 
hours per record)] + [(4,270 plants) x (10 records per year) x (0.5 
hours per record for corrective actions taken after non-food-contact 
surface positive )] + ((4,270 plants) x (0.2 records per year for 
corrective actions after finished product positive) x (0.5 hours per 
record)]).
    If a firm does not use one of the methods described in FDA's BAM or 
by ISO, FDA is recommending that the firm have a written record of its 
method to enumerate or detect L. monocytogenes. FDA assumes most firms 
would use one of the methods described in the BAM or by ISO. Therefore, 
there would be no new collection of information.
    FDA estimates that record maintenance would require roughly 1 hour 
per week for each firm, for a total of about 222,040 annual hours 
((4,270 plants) x (52 weeks maintenance) x (1 hour per week)).
    FDA estimates that each of the 4,270 establishments expected to 
keep new records would purchase a storage unit for the records. A 
standard file cabinet large enough for such records as described in the 
guidance costs about $150. Therefore, there would be total first year 
capital costs of about $640,500 (4,270 plants x $150).

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft 
guidance and the collection of information provisions. Submit a single 
copy of electronic comments or two paper copies of any mailed comments, 
except that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The draft guidance and received comments may be seen in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through the FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
from the Center for Food Safety and Applied Nutrition home page at 
http://www.cfsan.fda.gov/guidance.html.

    Dated: January 16, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 08-548 Filed 2-6-08; 8:45 am]

BILLING CODE 4160-01-S