05-3030. Generic E. coli

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 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://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 [phone], fax [phone].

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 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 Results^a

Class of product	Method	80th percentile	98th percentile
Cattle carcasses	sponge	0.0 CFU/cm2	3.1 CFU/cm2
Swine carcasses	sponge	0.46 CFU/cm2	400 CFU/cm2
Turkey carcasses	sponge	7.8 CFU/cm2	190 CFU/cm2
Turkey carcasses	rinse	89 CFU/ml	1,700 CFU/ml
Goose carcasses	sponge	7.0 CFU/cm2	43 CFU/cm2
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

Class of product	Method	Baseline prevalence (percent postive for salmonella)	Number of samples to test if implemented as a standard	Maximum number of positives to achieve if used as a 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://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://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.