[Federal Register: February 17, 2005 (Volume 70, Number 32)]
[Page 8058-8060]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/regulations/2005_Notices_Index/

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.



    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 
    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 
    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
                                                                     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

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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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]