Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Availability, 7293-7298 [08-548]
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Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0058]
Draft Compliance Policy Guide Sec.
555.320—Listeria monocytogenes;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft Compliance
Policy Guide (CPG) Sec. 555.320 Listeria
monocytogenes (the draft CPG). The
draft CPG provides guidance for FDA
staff on the agency’s enforcement policy
for Listeria monocytogenes in ready-toeat (RTE) foods that support growth of
the organism and RTE foods that do not
support growth of the organism.
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considers your comment on this draft
guidance before it begins work on the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draft guidance by April 7, 2008.
ADDRESSES: Submit written comments
on the draft CPG to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov.
Submit written requests for single
copies of the draft CPG to the Division
of Compliance Policy (HFC–230), Office
of Enforcement, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that
office in processing your request, or fax
your request to 240–632–6861. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft CPG.
FOR FURTHER INFORMATION CONTACT:
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:
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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,
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disease (called invasive listeriosis).
Foods that have been implicated in
outbreaks or sporadic cases of invasive
listeriosis have been foods that are RTE.
The draft CPG is intended to provide
clear policy and regulatory guidance for
FDA staff regarding L. monocytogenes in
certain foods. In particular, the draft
CPG sets forth an enforcement policy
concerning L. monocytogenes in RTE
foods that support the growth of L.
monocytogenes and RTE foods that do
not support the growth of L.
monocytogenes. The draft CPG describes
the characteristics of RTE foods that do
and do not support the growth of L.
monocytogenes and identifies examples
of foods that fall into each category.
For RTE foods that support the growth
of L. monocytogenes, FDA’s current
thinking is that it may regard the food
to be adulterated within the meaning of
section 402(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
342(a)(1)) (the act) when L.
monocytogenes is present in the food,
based on an analytical method that can
detect 1.0 colony forming units (CFUs)
of L. monocytogenes per 25 grams (g) of
food (i.e., 0.04 CFU/g). For RTE foods
that do not support growth of L.
monocytogenes, FDA’s current thinking
is that it may regard the food to be
adulterated within the meaning of
section 402(a)(1) of the act when L.
monocytogenes is present at or above
100 CFUs/g of food.
Further discussion of FDA’s current
thinking on L. monocytogenes in RTE
foods, including the scientific support
informing FDA’s current thinking, can
be found in the Notice of Public Meeting
regarding the draft CPG, published
elsewhere in this issue of the Federal
Register, and in the references cited
therein.
The draft CPG is being issued as a
Level 1 draft guidance consistent with
FDA’s good guidance practices
regulation (21 CFR 10.115). The draft
CPG, when final, will represent the
agency’s current thinking on L.
monocytogenes in 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 alternate
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft CPG. 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
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7293
to be identified with the docket number
found in brackets in the heading of this
document. The draft CPG 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.
III. Electronic Access
Persons with access to the Internet
may obtain the draft CPG from the
Office of Regulatory Affairs home page.
It may be accessed at https://
www.fda.gov/ora under ‘‘Compliance
Reference.’’
Dated: January 23, 2008.
Margaret O’K. Glavin,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. 08–547 Filed 2–6–08; 8:45 am]
BILLING CODE 4160–01–S
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.
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
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Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices
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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
https://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
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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 RFRTE 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.
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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 RFRTE 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 RFRTE foods, FDA is recommending that
the following records be maintained, as
appropriate, to identify trends,
document procedures, and facilitate
corrective actions:
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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 foodcontact and non-food contact surfaces
• Results of tests to detect or
enumerate L. monocytogenes in finished
product
• Corrective actions taken
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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 BURDEN1
Type of Record
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Capital
Costs2
Total Hours
Ingredient and Process Control
List of ingredients reasonably likely to be
contaminated with
L. monocytogenes3
3,755
1
3,755
1
3,755
188
3
564
1
564
2,629
1
2,629
1
*COM041*2,629
Listeristatic control
376
900
338,400
0.1
33,840
Listericidal control
2,629
900
2,366,100
0.1
236,610
Ingredient control
records (includes
COC, COA, and ingredient testing)
1,126
72
81,072
0.1
8,107
Written SSOP3
4,270
1
4,270
Sanitation monitoring
records
4,270
300
1,281,000
Record of verification
of technique used
for listeristatic control measures3
Record of verification
of technique used
for listericidal control
measures3
General Sanitation
8
0.1
34,160
128,100
Environmental Monitoring and Product Sampling
4,270
1
4,270
Food-contact surface
monitoring results
4,270
52
222,040
0.5
111,020
Record of corrective
action taken for
food-contact surface
positive
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Written critical surface
and finished product
monitoring program3
4,270
10
42,700
0.5
21,350
Non-food-contact surface monitoring results
4,270
26
111,020
0.5
55,510
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TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
Type of Record
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Capital
Costs2
Total Hours
Record of corrective
action taken for
non-food-contact
surface positive
4,270
10
42,700
0.5
21,350
Finished product results
4,270
12
51,240
0.5
25,620
Record of corrective
action taken for finished product positive
4,270
0.2
854
0.5
427
0
1
0
0.1
0
4,270
52
222,040
Written analytical
method to detect or
enumerate L.
monocytogenes (besides the bacteriological analytical
manual (BAM) or
the international organization for standardization (ISO))3
Record Maintenance
Record Maintenance
1
222,040
$640,500
Total hours for first year
939,242
Total recurring hours
863,974
1There
are no operating and maintenance costs associated with this collection of information.
capital costs for all record keeping items are combined.
year burden.
2Estimated
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3First
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
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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
1North 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.
2NAICS 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.
3NAICS 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
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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
overestimate. This overestimate is offset to an
unknown degree by the undercounting of
establishments whose primary product is in another
NAICS code.
4Not all seafood processors are covered by this
guidance.
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monitoring and product sampling. All
establishments would need to maintain
those records.
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.
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.
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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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
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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
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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 onetime 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 foodcontact 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 foodcontact 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
VerDate Aug<31>2005
17:02 Feb 06, 2008
Jkt 214001
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 nonfood-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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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 https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0058]
Draft Compliance Policy Guide Sec.
555.320 Listeria monocytogenes; Notice
of Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting to discuss a Draft
Compliance Policy Guide Sec. 555.320
Listeria monocytogenes (the draft CPG)
that provides guidance for FDA staff on
the agency’s enforcement policy for L.
monocytogenes in ready-to-eat (RTE)
foods that support growth of the
organism and RTE foods that do not
support growth of the organism.
DATES: The meeting will be held on
March 28, 2008, from 9 a.m. to 4:30 p.m.
The closing date for requests to make an
oral presentation is March 7, 2008. The
closing date for advance registration, for
notifying the contact person about a
need for special accommodations due to
a disability, and for providing a brief
description of an oral presentation and
E:\FR\FM\07FEN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 26 (Thursday, February 7, 2008)]
[Notices]
[Pages 7293-7298]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-548]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Listericidal control 2,629 900 2,366,100 0.1 .............. 236,610
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food-contact surface monitoring results 4,270 52 222,040 0.5 .............. 111,020
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record of corrective action taken for food- 4,270 10 42,700 0.5 .............. 21,350
contact surface positive
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-food-contact surface monitoring results 4,270 26 111,020 0.5 .............. 55,510
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 7296]]
Record of corrective action taken for non- 4,270 10 42,700 0.5 .............. 21,350
food-contact surface positive
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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
https://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]
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