Generic E. coli, 8058-8060 [05-3030]
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8058
Federal Register / Vol. 70, No. 32 / Thursday, February 17, 2005 / Notices
Please state that your comment refers to
Docket No. 04–136–1.
Reading Room: You may read any
comments that we receive on this
docket in our reading room. The reading
room is located in room 1141 of the
USDA South Building, 14th Street and
Independence Avenue SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 690–2817 before
coming.
Other Information: You may view
APHIS documents published in the
Federal Register and related
information on the Internet at https://
www.aphis.usda.gov/ppd/rad/
webrepor.html.
FOR FURTHER INFORMATION CONTACT: For
information regarding the Cooperative
State-Federal Bovine Tuberculosis
Eradication Program, contact Dr.
Michael Dutcher, National Tuberculosis
Program Coordinator, Eradication and
Surveillance Team, National Center for
Animal Health Programs, VS, APHIS,
4700 River Road Unit 43, Riverdale, MD
20737; (301) 734–5467. For copies of
more detailed information on the
information collection, contact Mrs.
Celeste Sickles, APHIS’’ Information
Collection Coordinator, at (301) 734–
7477.
SUPPLEMENTARY INFORMATION:
Title: Tuberculosis.
OMB Number: 0579–0084.
Type of Request: Extension of
approval of an information collection.
Abstract: The Animal and Plant
Health Inspection Service (APHIS) of
the United States Department of
Agriculture is responsible for, among
other things, preventing the interstate
spread of serious diseases and pests of
livestock, and for eradicating such
diseases from the United States when
feasible.
In connection with this mission,
APHIS participates in the Cooperative
State-Federal Bovine Tuberculosis
Eradication Program, which is a
national program to eliminate bovine
tuberculosis from the United States.
Bovine tuberculosis is a serious disease
of livestock that also affects humans
through contact with infected animals
or their byproducts
The Cooperative State-Federal Bovine
Tuberculosis Eradication Program is
conducted under the various States’
authorities supplemented by Federal
regulations on the interstate movement
of affected animals. A concerted effort
(State and Federal) requires that we
conduct epidemiologic investigations to
locate the disease and provide an
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14:41 Feb 16, 2005
Jkt 205001
effective means of controlling it. Federal
regulations also provide for the payment
of indemnity to owners of animals that
must be destroyed because of
tuberculosis.
This program necessitates the use of
a number of information-gathering
documents, including various forms
needed to properly identify, test, and
transport animals that have been
infected with tuberculosis, or that may
have been exposed to tuberculosis. We
also employ national epidemiology
forms for the purposes of recording,
reporting, and reviewing
epidemiological data. Still other
documents provide us with the
information we need to pay indemnity
to the owners of animals destroyed
because of tuberculosis.
The information provided by these
documents is critical to our ability to
locate herds infected with tuberculosis
and to prevent the interstate spread of
tuberculosis. The collection of this
information is therefore crucial to the
success of the Cooperative State-Federal
Bovine Tuberculosis Eradication
Program.
We are asking the Office of
Management and Budget (OMB) to
approve our use of these information
collection activities for an additional 3
years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
submission of responses.
Estimate of burden: The public
reporting burden for this collection of
information is estimated to average
0.324473748 hours per response.
Respondents: State animal health
protection personnel, accredited
veterinarians, livestock inspectors,
shippers, herd owners, and slaughter
establishment personnel.
Estimated annual number of
respondents: 6,897.
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
Estimated annual number of
responses per respondent: 7.762650427.
Estimated annual number of
responses: 53,539.
Estimated total annual burden on
respondents: 17,372 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
Done in Washington DC, this 11th day of
February 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 05–3056 Filed 2–16–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 02–046N]
Generic E. coli and Salmonella
Baseline Results
Food Safety and Inspection
Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: The Food Safety and
Inspection Service (FSIS) is making
available and publishing the results of
baseline studies that it has conducted
on generic Escherichia coli (E. coli) and
Salmonella. Although these studies
were conducted between 1997 and
2000, FSIS has decided to make the
results available because they may assist
inspected establishments in assessing
their processes. The publication of these
baseline results does not affect the
current generic E. coli criteria and
Salmonella standards listed in the
regulations.
FSIS invites interested
persons to submit comments on these
baseline results. Comments may be
submitted by the following methods:
• Mail, including floppy disks or CD–
ROM’s, and hand-or courier-delivered
items: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety
and Inspection Service, 300 12th Street,
SW., Room 102 Cotton Annex,
Washington, DC 20250.
All submissions received must
include the Agency name and docket
number 02–046N.
All comments submitted in response
to this notice, as well as research and
background information used by FSIS in
developing this document, will be
ADDRESSES:
E:\FR\FM\17FEN1.SGM
17FEN1
Federal Register / Vol. 70, No. 32 / Thursday, February 17, 2005 / Notices
available for public inspection in the
FSIS Docket Room at the address listed
above between 8:30 a.m. and 4:30 p.m.,
Monday through Friday. The comments
also will be posted on the Agency’s Web
site at https://www.fsis.usda.gov/OPPDE/
rdad/FRDockets.htm.
FOR FURTHER INFORMATION CONTACT: For
further information contact Daniel
Engeljohn, Ph.D., Deputy Assistant
Administrator for Office of Policy,
Program and Employee Development,
FSIS, U.S. Department of Agriculture,
Room 3147, South Building, 14th and
Independence SW., Washington, DC
20250–3700; telephone (202) 205–0495,
fax (202) 401–1760.
SUPPLEMENTARY INFORMATION:
Background
On July 25, 1996, FSIS published a
final rule, ‘‘Pathogen Reduction; Hazard
Analysis and Critical Control Point
(HACCP) Systems’’ (61 FR 38806). The
final rule required that all
establishments slaughtering cattle,
swine, chickens, or turkeys test for
generic E. coli at a frequency based on
production volume to verify that the
plants are meeting the established
performance criteria. The final rule also
established pathogen reduction
performance standards for Salmonella
for certain slaughter establishments and
for establishments producing certain
raw ground products.
FSIS developed the criteria and
standards by conducting nationwide
baseline programs or surveys on
different classes of product. While the
final rule provided generic E. coli
criteria and Salmonella standards for
certain classes of product, the Agency
committed to conducting additional
baseline studies to develop additional
criteria and standards in the future. The
term ‘‘baseline studies’’ covers both the
FSIS Nationwide Microbiological
Baseline Data Collection Programs and
its Nationwide Microbiological Surveys
as referenced in the existing regulations.
FSIS regulations require that all
inspected slaughter establishments
conduct generic E. coli testing. FSIS has
established criteria for evaluating cattle
and swine test results only from
samples collected by the excision
sampling method, which in commercial
practice would unfortunately result in
defacement of carcasses and economic
loss. Cattle and swine establishments,
however, can meet their testing
requirements by using the sponge
method of sample collection as part of
a statistical process control system.
Sheep, goat, horse, and mule or other
equine establishments are required to
use the sponge method of sample
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14:41 Feb 16, 2005
Jkt 205001
collection as part of a statistical process
control (SPC) system (64 FR 66553, Nov.
29, 1999). Establishments can sample
young chicken or goose carcasses by the
rinse method of sample collection and
can sample turkey carcasses for generic
E. coli by either the sponge or rinse
method. Because there are no existing
FSIS-established criteria for either goose
or turkey carcasses, establishments must
use statistical process control
techniques to assess their processes.
Statistical process control initially
involves evaluating data to determine
process capability (the typical process
performance level), then checking
subsequent data to see whether they are
consistent with this baseline level to
ensure the process is in control and
variations are within normal and
acceptable limits. The value of
microbiological testing is not negated by
the lack of national m and M criteria
against which to evaluate results. E. coli
testing is intended to provide
verification of process control for fecal
contamination within individual
establishments by use of a
microbiological measure rather than
solely relying upon a visual observation
of carcasses for fecal contamination.
FSIS is responsible for conducting the
Salmonella sampling program for
carcasses and raw product. The National
Advisory Committee on Microbiological
Criteria for Foods (NACMCF) in its
report of August 8, 2002 stated that
Salmonella test results are useful
measures of the level of process controls
(Final—Response to the Questions
Posed by FSIS Regarding Performance
Standards with Particular Reference to
Ground Beef Products). In addition, in
the most recent report on broilers
(adopted February 13, 2004), NACMCF
said the following about E. coli and
broilers: ‘‘Escherichia coli has been
viewed by FSIS as a direct measure of
control of fecal contamination and, by
implication, Salmonella or other enteric
pathogens. However, recent information
indicates that this may not be a valid
assumption for E. coli in broilers. For
example, in broilers, its presence may
also be a result of infectious process and
air sacculitis, in addition to fecal
contamination’’ [Response To The
Questions Posed By FSIS Regarding
Performance Standards With Particular
Reference To Broilers (Young Chickens),
p. 8]. FSIS therefore believes that broiler
operations, in particular, should take
into account increased levels of E. coli
and ensure that fecal contamination and
infectious process and air sacculitis are
not contributors.
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
8059
Additional Baseline Results
FSIS is making available the results of
baseline studies of generic E. coli and
Salmonella that the Agency conducted
over the past seven years but has not
incorporated into regulations. These
baseline studies are the Nationwide
Sponge Microbiological Baseline Data
Collection Programs for Young
Chickens, November 1999–October
2000; Young Turkeys, July 1997–June
1998; Goose, September–November
1997; Cattle, June 1997–May 1998; and
Swine, June 1997–May 1998. FSIS is not
proposing to use these baseline results
as performance standards because of
their age and because it intends to
conduct new baseline studies in coming
years. Nevertheless, FSIS believes that
publishing the results of these baseline
studies, which have been used by the
Agency to evaluate trends, can serve as
a valuable support to an establishment’s
process control efforts. These results can
be used by establishments in assessing
the effectiveness of their processes,
using their own test results. These
baselines are for use as guidance to
establishments and do not replace the
criteria and standards incorporated in
the regulations (Title 9 CFR
310.25(a)(5)(i), 310.25(b)(1),
381.94(a)(5)(i), and 381.94(b)(1)).
Establishments using SPC may find this
guidance to be helpful in gauging their
process control.
The generic E. coli results are for
cattle, swine, and goose carcasses
sampled using the sponge method of
sample collection; for young chicken
carcasses using the rinse method; and
for turkey carcasses using the sponge
and rinse methods of sample collection
(see Table 1).
These results increase the number of
product classes and sampling methods
for which baseline information is now
available. For example, for generic E.
coli, the results that FSIS is making
available provide measures of process
control for cattle and swine production
using the sponge sampling method
rather than the excision sampling
method that was used in setting the PR/
HACCP Rule performance standards.
Baseline E. coli information on turkeys
and geese is being made available by the
Agency for the first time, for both
sponge and rinse sampling methods.
The baseline results include data for
young chickens, using the rinse method,
that are more recent than the data, also
collected by the rinse method, that were
available for the PR/HACCP Rule.
One way that baseline results being
made available in this document can
support or supplement an
establishment’s process control efforts is
E:\FR\FM\17FEN1.SGM
17FEN1
8060
Federal Register / Vol. 70, No. 32 / Thursday, February 17, 2005 / Notices
Standard Deviations above a running
mean average. As a complement to such
SPC criteria, the 80th and 98th
percentile results can be used as an
additional ‘‘early warning’’ for taking
corrective action.
at the time (62 FR 26219, May 13, 1997;
64 FR 66549, Nov. 29, 1999). These E.
coli results can complement SPC by
providing establishments with an
additional measure of process control.
For example, SPC principles require
corrective action when sample results
reach a certain threshold, such as three
through their use in tandem with SPC,
as required by the PR/HACCP Rule, to
help define when a process may be out
of control. SPC for generic E. coli is
required with products that were not
represented in the PR/HACCP Rule by a
performance standard, because no
relevant baseline studies were available
TABLE 1.—GENERIC E. COLI BASELINE RESULTSa
Class of product
Method
80th percentile
98th percentile
Cattle carcasses .....................................................................................
Swine carcasses ....................................................................................
Turkey carcasses ...................................................................................
Turkey carcasses ...................................................................................
Goose carcasses ...................................................................................
Young Chicken carcasses .....................................................................
sponge ..............
sponge ..............
sponge ..............
rinse ..................
sponge ..............
rinse ..................
0.0 CFU/cm2 .................................
0.46 CFU/cm2 ...............................
7.8 CFU/cm2 .................................
89 CFU/ml .....................................
7.0 CFU/cm2 .................................
35 CFU/ml .....................................
3.1 CFU/cm2
400 CFU/cm2
190 CFU/cm2
1,700 CFU/ml
43 CFU/cm2
390 CFU/ml
a The corresponding 80th and 98th percentile values for the previously published baseline studies were defined as the performance criteria m
and M for generic E. coli. The criteria defined a marginal range of values in which no more than 3 out of 13 samples were allowed to fall.
the regulations (9 CFR 310.25(b)(1) and
381.94(b)(1)). As with E. coli, the
Salmonella baseline results provide new
information for young turkeys and
geese, and more recent data for
categories of livestock carcasses that are
already partially covered by PR/HACCP
The Salmonella baseline results are
for cattle, swine, young turkey, and
goose carcasses by sponge sampling,
and for young chickens by whole bird
rinse sampling (see Table 2). These
baseline results do not replace the
Salmonella standards incorporated in
Rule performance standards. Although
FSIS, rather than the industry, takes
Salmonella samples under the
regulations, the Agency believes that
establishments can benefit from
comparing data obtained about their
processes to the national baseline data.
TABLE 2.—SALMONELLA BASELINE RESULTS
Class of product
Method
Young Turkey carcasses ..............................................................................
Goose carcasses ..........................................................................................
Cattle carcasses ...........................................................................................
Swine carcasses ...........................................................................................
Young Chicken carcasses ............................................................................
Baseline prevalence (percent postive
for salmonella)
sponge ..............
sponge ..............
sponge ..............
sponge ..............
rinse ..................
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, in an effort to
ensure that the public and in particular
minorities, women, and persons with
disabilities, are aware of this notice,
FSIS will announce it on-line through
the FSIS web page located at https://
www.fsis.usda.gov/regulations/
2005_Notices_Index/.
FSIS also will make copies of this
Federal Register publication available
through the FSIS Constituent Update,
which is used to provide information
regarding FSIS policies, procedures,
regulations, Federal Register notices,
FSIS public meetings, recalls, and other
types of information that could affect or
would be of interest to our constituents
and stakeholders. The update is
communicated via Listserv, a free e-mail
subscription service consisting of
VerDate jul<14>2003
14:41 Feb 16, 2005
Jkt 205001
industry, trade, and farm groups,
consumer interest groups, allied health
professionals, scientific professionals,
and other individuals who have
requested to be included. The update
also is available on the FSIS web page.
Through Listserv and the web page,
FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an e-mail
subscription service which provides an
automatic and customized notification
when popular pages are updated,
including Federal Register publications
and related documents. This service is
available at https://www.fsis.usda.gov/
news_and_events/email_subscription/
and allows FSIS customers to sign up
for subscription options across eight
categories. Options range from recalls to
export information to regulations,
directives and notices. Customers can
add or delete subscriptions themselves
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
Number of
samples to
test if implemented as a
standard
19.6
13.7
1.2
6.9
8.7
Maximum
number of
positives to
achieve if
used as a
standard
56
54
68
57
55
13
9
1
5
6
and have the option to password protect
their account.
Done at Washington, DC on February 7,
2005.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 05–3030 Filed 2–16–05; 8:45 am]
BILLING CODE 3410–DM–P
DEPARTMENT OF AGRICULTURE
Forest Service
RIN 0596–AB93
Forest Service Outdoor Recreation
Accessibility Guidelines and
Integration of Direction on
Accessibility Into Forest Service
Manual 2330
AGENCY:
E:\FR\FM\17FEN1.SGM
Forest Service, USDA.
17FEN1
]]>Agencies
[Federal Register Volume 70, Number 32 (Thursday, February 17, 2005)]
[Notices]
[Pages 8058-8060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3030]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 02-046N]
Generic E. coli and Salmonella Baseline Results
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is making
available and publishing the results of baseline studies that it has
conducted on generic Escherichia coli (E. coli) and Salmonella.
Although these studies were conducted between 1997 and 2000, FSIS has
decided to make the results available because they may assist inspected
establishments in assessing their processes. The publication of these
baseline results does not affect the current generic E. coli criteria
and Salmonella standards listed in the regulations.
ADDRESSES: FSIS invites interested persons to submit comments on these
baseline results. Comments may be submitted by the following methods:
Mail, including floppy disks or CD-ROM's, and hand-or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW.,
Room 102 Cotton Annex, Washington, DC 20250.
All submissions received must include the Agency name and docket
number 02-046N.
All comments submitted in response to this notice, as well as
research and background information used by FSIS in developing this
document, will be
[[Page 8059]]
available for public inspection in the FSIS Docket Room at the address
listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday.
The comments also will be posted on the Agency's Web site at https://
www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.
FOR FURTHER INFORMATION CONTACT: For further information contact Daniel
Engeljohn, Ph.D., Deputy Assistant Administrator for Office of Policy,
Program and Employee Development, FSIS, U.S. Department of Agriculture,
Room 3147, South Building, 14th and Independence SW., Washington, DC
20250-3700; telephone (202) 205-0495, fax (202) 401-1760.
SUPPLEMENTARY INFORMATION:
Background
On July 25, 1996, FSIS published a final rule, ``Pathogen
Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems''
(61 FR 38806). The final rule required that all establishments
slaughtering cattle, swine, chickens, or turkeys test for generic E.
coli at a frequency based on production volume to verify that the
plants are meeting the established performance criteria. The final rule
also established pathogen reduction performance standards for
Salmonella for certain slaughter establishments and for establishments
producing certain raw ground products.
FSIS developed the criteria and standards by conducting nationwide
baseline programs or surveys on different classes of product. While the
final rule provided generic E. coli criteria and Salmonella standards
for certain classes of product, the Agency committed to conducting
additional baseline studies to develop additional criteria and
standards in the future. The term ``baseline studies'' covers both the
FSIS Nationwide Microbiological Baseline Data Collection Programs and
its Nationwide Microbiological Surveys as referenced in the existing
regulations.
FSIS regulations require that all inspected slaughter
establishments conduct generic E. coli testing. FSIS has established
criteria for evaluating cattle and swine test results only from samples
collected by the excision sampling method, which in commercial practice
would unfortunately result in defacement of carcasses and economic
loss. Cattle and swine establishments, however, can meet their testing
requirements by using the sponge method of sample collection as part of
a statistical process control system. Sheep, goat, horse, and mule or
other equine establishments are required to use the sponge method of
sample collection as part of a statistical process control (SPC) system
(64 FR 66553, Nov. 29, 1999). Establishments can sample young chicken
or goose carcasses by the rinse method of sample collection and can
sample turkey carcasses for generic E. coli by either the sponge or
rinse method. Because there are no existing FSIS-established criteria
for either goose or turkey carcasses, establishments must use
statistical process control techniques to assess their processes.
Statistical process control initially involves evaluating data to
determine process capability (the typical process performance level),
then checking subsequent data to see whether they are consistent with
this baseline level to ensure the process is in control and variations
are within normal and acceptable limits. The value of microbiological
testing is not negated by the lack of national m and M criteria against
which to evaluate results. E. coli testing is intended to provide
verification of process control for fecal contamination within
individual establishments by use of a microbiological measure rather
than solely relying upon a visual observation of carcasses for fecal
contamination.
FSIS is responsible for conducting the Salmonella sampling program
for carcasses and raw product. The National Advisory Committee on
Microbiological Criteria for Foods (NACMCF) in its report of August 8,
2002 stated that Salmonella test results are useful measures of the
level of process controls (Final--Response to the Questions Posed by
FSIS Regarding Performance Standards with Particular Reference to
Ground Beef Products). In addition, in the most recent report on
broilers (adopted February 13, 2004), NACMCF said the following about
E. coli and broilers: ``Escherichia coli has been viewed by FSIS as a
direct measure of control of fecal contamination and, by implication,
Salmonella or other enteric pathogens. However, recent information
indicates that this may not be a valid assumption for E. coli in
broilers. For example, in broilers, its presence may also be a result
of infectious process and air sacculitis, in addition to fecal
contamination'' [Response To The Questions Posed By FSIS Regarding
Performance Standards With Particular Reference To Broilers (Young
Chickens), p. 8]. FSIS therefore believes that broiler operations, in
particular, should take into account increased levels of E. coli and
ensure that fecal contamination and infectious process and air
sacculitis are not contributors.
Additional Baseline Results
FSIS is making available the results of baseline studies of generic
E. coli and Salmonella that the Agency conducted over the past seven
years but has not incorporated into regulations. These baseline studies
are the Nationwide Sponge Microbiological Baseline Data Collection
Programs for Young Chickens, November 1999-October 2000; Young Turkeys,
July 1997-June 1998; Goose, September-November 1997; Cattle, June 1997-
May 1998; and Swine, June 1997-May 1998. FSIS is not proposing to use
these baseline results as performance standards because of their age
and because it intends to conduct new baseline studies in coming years.
Nevertheless, FSIS believes that publishing the results of these
baseline studies, which have been used by the Agency to evaluate
trends, can serve as a valuable support to an establishment's process
control efforts. These results can be used by establishments in
assessing the effectiveness of their processes, using their own test
results. These baselines are for use as guidance to establishments and
do not replace the criteria and standards incorporated in the
regulations (Title 9 CFR 310.25(a)(5)(i), 310.25(b)(1),
381.94(a)(5)(i), and 381.94(b)(1)). Establishments using SPC may find
this guidance to be helpful in gauging their process control.
The generic E. coli results are for cattle, swine, and goose
carcasses sampled using the sponge method of sample collection; for
young chicken carcasses using the rinse method; and for turkey
carcasses using the sponge and rinse methods of sample collection (see
Table 1).
These results increase the number of product classes and sampling
methods for which baseline information is now available. For example,
for generic E. coli, the results that FSIS is making available provide
measures of process control for cattle and swine production using the
sponge sampling method rather than the excision sampling method that
was used in setting the PR/HACCP Rule performance standards. Baseline
E. coli information on turkeys and geese is being made available by the
Agency for the first time, for both sponge and rinse sampling methods.
The baseline results include data for young chickens, using the rinse
method, that are more recent than the data, also collected by the rinse
method, that were available for the PR/HACCP Rule.
One way that baseline results being made available in this document
can support or supplement an establishment's process control efforts is
[[Page 8060]]
through their use in tandem with SPC, as required by the PR/HACCP Rule,
to help define when a process may be out of control. SPC for generic E.
coli is required with products that were not represented in the PR/
HACCP Rule by a performance standard, because no relevant baseline
studies were available at the time (62 FR 26219, May 13, 1997; 64 FR
66549, Nov. 29, 1999). These E. coli results can complement SPC by
providing establishments with an additional measure of process control.
For example, SPC principles require corrective action when sample
results reach a certain threshold, such as three Standard Deviations
above a running mean average. As a complement to such SPC criteria, the
80th and 98th percentile results can be used as an additional ``early
warning'' for taking corrective action.
Table 1.--Generic E. coli Baseline Resultsa
----------------------------------------------------------------------------------------------------------------
Class of product Method 80th percentile 98th percentile
----------------------------------------------------------------------------------------------------------------
Cattle carcasses.................. sponge.................... 0.0 CFU/cm\2\........ 3.1 CFU/cm\2\
Swine carcasses................... sponge.................... 0.46 CFU/cm\2\....... 400 CFU/cm\2\
Turkey carcasses.................. sponge.................... 7.8 CFU/cm\2\........ 190 CFU/cm\2\
Turkey carcasses.................. rinse..................... 89 CFU/ml............ 1,700 CFU/ml
Goose carcasses................... sponge.................... 7.0 CFU/cm\2\........ 43 CFU/cm\2\
Young Chicken carcasses........... rinse..................... 35 CFU/ml............ 390 CFU/ml
----------------------------------------------------------------------------------------------------------------
\a\ The corresponding 80th and 98th percentile values for the previously published baseline studies were defined
as the performance criteria m and M for generic E. coli. The criteria defined a marginal range of values in
which no more than 3 out of 13 samples were allowed to fall.
The Salmonella baseline results are for cattle, swine, young
turkey, and goose carcasses by sponge sampling, and for young chickens
by whole bird rinse sampling (see Table 2). These baseline results do
not replace the Salmonella standards incorporated in the regulations (9
CFR 310.25(b)(1) and 381.94(b)(1)). As with E. coli, the Salmonella
baseline results provide new information for young turkeys and geese,
and more recent data for categories of livestock carcasses that are
already partially covered by PR/HACCP Rule performance standards.
Although FSIS, rather than the industry, takes Salmonella samples under
the regulations, the Agency believes that establishments can benefit
from comparing data obtained about their processes to the national
baseline data.
Table 2.--Salmonella Baseline Results
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Baseline Number of Maximum number
prevalence samples to of positives
Class of product Method (percent test if to achieve if
postive for implemented as used as a
salmonella) a standard standard
----------------------------------------------------------------------------------------------------------------
Young Turkey carcasses............. sponge..................... 19.6 56 13
Goose carcasses.................... sponge..................... 13.7 54 9
Cattle carcasses................... sponge..................... 1.2 68 1
Swine carcasses.................... sponge..................... 6.9 57 5
Young Chicken carcasses............ rinse...................... 8.7 55 6
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Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this notice, FSIS will announce it on-line
through the FSIS web page located at https://www.fsis.usda.gov/
regulations/2005_Notices_Index/.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS web page. Through
Listserv and the web page, FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an e-mail subscription service which
provides an automatic and customized notification when popular pages
are updated, including Federal Register publications and related
documents. This service is available at https://www.fsis.usda.gov/news_
and_events/email_subscription/ and allows FSIS customers to sign up
for subscription options across eight categories. Options range from
recalls to export information to regulations, directives and notices.
Customers can add or delete subscriptions themselves and have the
option to password protect their account.
Done at Washington, DC on February 7, 2005.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 05-3030 Filed 2-16-05; 8:45 am]
BILLING CODE 3410-DM-P
