[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Draft Guidance for Industry: Control of Listeria monocytogenes in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availability of the draft guidance entitled ``Guidance for Industry: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 This draft guidance, when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submit written or electronic comments on the draft guidance by April 7,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ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: Control of Listeria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access to the draft guidance.
Submit written comments on the draft guidance and the proposed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
<bullet> List of ingredients reasonably likely to be contaminated
with L. monocytogenes
<bullet> Listeristatic or listericidal control measures
<bullet> Ingredient control records, i.e. certificate of
conformance (COC), certificate of analysis (COA)
<bullet> Ingredient testing records
General Sanitation
<bullet> Written sanitation standard operating procedures (SSOP)
<bullet> Sanitation monitoring records
Monitoring of Critical Surfaces and Sampling of Finished Product
<bullet> Written plan for monitoring L. monocytogenes on food-
contact and non-food-contact surfaces
<bullet> Procedures to detect and enumerate L. monocytogenes,
unless the procedure used is the procedure that FDA identifies in the
guidance
<bullet> Results of tests to detect or enumerate L. monocytogenes
on food-contact and non-food contact surfaces
<bullet> Results of tests to detect or enumerate L. monocytogenes
in finished product
<bullet> 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\
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No. of Annual Frequency Total Annual Hours per Total Capital
Type of Record Recordkeepers per Recordkeeping Records Record Costs\2\ Total Hours
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Ingredient and Process Control
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List of ingredients reasonably likely to be 3,755 1 3,755 1 .............. 3,755
contaminated with L. monocytogenes\3\
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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\
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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)
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General Sanitation
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Written SSOP\3\ 4,270 1 4,270 8 .............. 34,160
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Sanitation monitoring records 4,270 300 1,281,000 0.1 .............. 128,100
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Environmental Monitoring and Product Sampling
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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
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Record of corrective action taken for 4,270 0.2 854 0.5 .............. 427
finished product positive
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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\
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Record Maintenance
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Record Maintenance 4,270 52 222,040 1 .............. 222,040
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................. .................... ............... ................ $640,500 ...............
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Total hours for first year 939,242
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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.
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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