This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

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rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

53406 

Vol. 73, No. 180 

Tuesday, September 16, 2008 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2008–0007] 

Revised FSIS Testing Methodology for 

Escherichia coli (E. coli) O157:H7 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Notice. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is announcing 

that, since January 28, 2008, its 

laboratories have implemented a revised 

laboratory methodology for detecting 

and identifying E. coli O157:H7 in 

regulatory verification samples. This 

new method can be found in the 

Microbiology Laboratory Guidebook 

(MLG), Chapter 5.04. 

DATES: Submit comments by November 

17, 2008. 

ADDRESSES: FSIS invites interested 

persons to submit comments on this 

notice. Comments may be submitted by 

any of the following methods: 

• Federal eRulemaking Portal: This 

Web site provides the ability to type 

short comments directly into the 

comment field on this Web page or 

attach a file for lengthier comments. Go 

to http://www.regulations.gov and, in 

the ‘‘Search Documents’’ box type the 

docket number, FSIS–2008–0007. After 

accessing the docket, click on ‘‘Send a 

Comment or Submission.’’ 

• Mail, including floppy disks or 

CD–ROMs, and hand- or courierdelivered items: Send to Docket Clerk, 

U.S. Department of Agriculture (USDA), 

FSIS, 1400 Independence Avenue, SW., 

Room 2534 South Building, 

Washington, DC 20250. 

All submissions received must 

include the Agency name and docket 

number FSIS–2008–0007. 

All comments submitted in response 

to this notice will be posted to Agency’s 

Web site at http://www.fsis.usda.gov/ 

regulations_&_policies/ 

2008_Notices_Index/index.asp. 

Individuals who do not wish FSIS to 

post their personal contact 

information—mailing address, e-mail 

address, telephone number—on the 

Internet may leave this information off 

of their comments. Comments will also 

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. 

FOR FURTHER INFORMATION CONTACT: For 

further information contact William K. 

Shaw, Jr., Ph.D., Office of Policy and 

Program Development, FSIS, USDA, 

Room 3533, South Building, 14th and 

Independence, SW., Washington, DC 

20250–3700; Telephone (202) 205–0695, 

Fax (202) 720–7027, E-mail: 

william.shaw@fsis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

FSIS’ revised laboratory methodology 

for detecting and identifying E. coli 

O157:H7 in regulatory verification 

samples can be found in the 

Microbiology Laboratory Guidebook 

(MLG), Chapter 5.04 protocol, now 

available on the FSIS Web site at the 

following URL: http:// 

www.fsis.usda.gov/Science/ 

Microbiological_Lab_Guidebook/ 

index.asp. The revised MLG 5.04 

describes the use of an improved 

enrichment broth and confirmatory 

identification procedures for E. coli 

O157:H7. The revisions to the protocol 

include an updated limit of the level at 

which E. coli O157:H7 can be detected 

for various products, and new 

instructions for preparing sub-samples 

of beef manufacturing trimmings and 

other ground beef components, and for 

preparing environmental sponge 

samples for E. coli O157:H7 analysis. 

In recent months, FSIS, in 

collaboration with the USDA 

Agricultural Research Service, has 

conducted an extensive validation of an 

enrichment broth, mTSB+n (also known 

as Modified Tryptone Soya Broth with 

Novobiocin and casamino acids or 

Modified Trypticase Soy with 

Novobiocin and casamino acids) to 

replace the broth that it had been using 

for detection of E. coli O157:H7. This 

broth has been found to support more 

rapid growth of E. coli O157:H7 than the 

mEC+n broth that FSIS laboratories 

have been using in past years. Moreover, 

the mTSB+n broth is cost-effective and 

is used by many laboratories around the 

world for detection of E. coli O157:H7. 

The use of mTSB+n will allow FSIS 

laboratories greater flexibility in the 

conducting of screening test procedures 

because it allows for greater flexibility 

in incubation time than does the broth 

FSIS previously used. Also, for some 

samples, its use will allow screening 

tests to be conducted earlier on the 

second day of analysis because the 

incubation period using this broth can 

be less than the broth FSIS previously 

used. The ability to conduct screening 

test procedures earlier can assist in 

more efficient laboratory staffing. Use of 

the replacement enrichment broth will 

also allow FSIS to obtain results faster 

for some samples. In addition, its use 

will reduce the number of samples that 

need to be discarded when there are 

shipping problems that delay the arrival 

of samples. 

Based on testing with inoculated 

samples, FSIS believes the new 

enrichment procedure is likely to 

provide increased sensitivity for 

detection in some samples. Therefore, 

there may be some increase in the 

number of E. coli O157:H7-positive 

samples found by FSIS laboratories. 

FSIS is also implementing new 

technologies to make its confirmatory 

identification testing procedures more 

robust and comprehensive for 

accurately identifying E. coli O157:H7, 

including variant strains that react in an 

atypical manner. Because serological 

testing procedures may not provide 

reliable identification for some strains of 

E. coli O157:H7, the revised protocol in 

the MLG 5.04 includes the use in FSIS 

laboratories of genetic testing to 

determine ‘‘O157’’ and ‘‘H7’’ identity in 

circumstances where atypical serology 

or other reactions are encountered. FSIS 

will use genetic testing to determine if 

the E. coli isolate is positive for Shiga 

toxin production, positive for the Shiga 

toxin gene, or genetically determined to 

be ‘‘H7’’. 

Since January 28, 2008, FSIS 

laboratories have been using the 

following terminology and criteria in 

the MLG 5.04 in reporting E. coli 

O157:H7 sample results: 

• Potential Positive—a sample that 

causes a positive reaction with the 

screen test. 

• Presumptive Positive—a sample 

that has typical colonies, observed on 


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Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices 53407 

Rainbow Agar, and reacts specifically 

with O157 antiserum. 

• Confirmed Positive—a 

biochemically-identified Escherichia 

coli isolate that is serologically or 

genetically determined to be ‘‘O157’’ 

that meets at least one of the following 

criteria: 

(1) Positive for Shiga toxin (ST) 

production 

(2) Positive for the Shiga toxin gene (stx) 

(3) Genetically determined to be ‘‘H7’’ 

If an FSIS laboratory’s confirmatory 

test results are insufficient to allow 

identification of E. coli O157:H7, then 

the isolate is transferred to the 

Outbreaks Section of the Eastern 

Laboratory Microbiology Branch 

(OSEL), or to an FSIS reference 

laboratory, for further testing prior to 

issuance of a report of the test results. 

State Programs and Foreign 

Government Programs 

States that have their own meat 

inspection programs for meat products 

produced and transported solely within 

the State are required to have mandatory 

ante mortem and post mortem 

inspection, reinspection, and sanitation 

requirements that are at least equal to 

those in the Federal Meat Inspection Act 

(21 U.S.C. 661(a)(1)). Therefore, these 

States’ sampling procedures and testing 

methods for E. coli O157:H7 in raw beef 

products must be at least as sensitive as 

FSIS’ procedures and testing methods 

for E. coli O157:H7. 

Foreign countries that are eligible to 

export meat products to the United 

States must apply inspection, sanitary, 

and other standards that are equivalent 

to those that FSIS applies to those 

products (21 U.S.C. 620). Thus, in 

evaluating a foreign country’s meat 

inspection system to determine the 

country’s eligibility to export products 

to the United States, FSIS considers 

whether the testing methods and 

procedures for E. coli O157:H7 that the 

country applies are equivalent to those 

that FSIS uses. 

Establishment Testing or Testing on 

Behalf of Establishments (Non-FSIS 

Laboratories) 

As discussed above, FSIS will use 

genetic testing to determine ‘‘O157’’ and 

‘‘H7’’ identity in circumstances where 

atypical serology or other reactions are 

encountered. The genetic testing now 

used by FSIS laboratories for 

identification of certain strains of E. coli 

O157:H7 detected in FSIS laboratories 

may pose some difficulties for non-FSIS 

laboratories. Some non-FSIS 

laboratories may not be able to conduct 

genetic analyses because they do not 

have the necessary resources. Moreover, 

the improper application of a less robust 

or inadequately validated genetic test by 

a laboratory might lead to a false 

negative or other misleading results. 

FSIS believes that alternative criteria 

for confirmatory identification of E. coli 

O157:H7 or E. coli O157:H7-like bacteria 

may be appropriate if it is equivalent to 

the criteria used by FSIS. To be regarded 

as equivalent to the FSIS criteria, a test 

would have to detect all hypothetical E. 

coli O157:H7 strains, typical or variant, 

that would be identified using FSIS’ 

confirmatory testing procedures and 

criteria. 

For establishment testing or testing on 

behalf of an establishment, FSIS 

recognizes that other criteria, while not 

used specifically by FSIS for 

identification of E. coli O157:H7, may be 

a significant and expedient indicator of 

the presence of E. coli O157:H7 in 

products. Such tests might be applied as 

rapid screening procedures to expedite 

analyses. If an establishment uses or 

contracts with a laboratory that uses 

such rapid screening procedures, and 

product is found positive by that test, 

FSIS expects the establishment to take 

appropriate corrective action and to 

ensure the proper disposition of 

adulterated products following a 

positive test result (9 CFR 417.3). 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that minorities, women, and 

persons with disabilities are aware of 

this notice, FSIS will announce it online 

through the FSIS Web page located at 

http://www.fsis.usda.gov/regulations/ 

2008_Notices_Index/. FSIS will also 

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, public 

meetings, and other types of information 

that could affect or would be of interest 

to constituents and stakeholders. The 

Update is communicated via Listserv, a 

free electronic mail subscription service 

for industry, trade groups, consumer 

interest groups, health professionals, 

and other individuals who have asked 

to be included. The Update is also 

available on the FSIS Web page. 

Through the Listserv and Web page, 

FSIS is able to provide information to a 

much broader and more diverse 

audience. In addition, FSIS offers an 

e-mail subscription service which 

provides automatic and customized 

access to selected food safety news and 

information. This service is available at 

http://www.fsis.usda.gov/ 

news_and_events/email_subscription/. 

Information is available about a variety 

of topics including recalls, exports, 

regulations, directives, and notices. 

Customers can add or delete 

subscriptions themselves, and they have 

the option to password protect their 

accounts. 

Done at Washington, DC, on September 4, 

2008. 

Alfred V. Almanza, 

Administrator. 

[FR Doc. E8–21575 Filed 9–15–08; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF COMMERCE 

International Trade Administration 

The Manufacturing Council: Meeting 

AGENCY: International Trade 

Administration, U.S. Department of 

Commerce. 

ACTION: Supplemental Notice of a 

Meeting. 

SUMMARY: The Manufacturing Council 

will hold a meeting to deliberate for 

approval a draft letter of 

recommendation on Sustainable 

Manufacturing metrics. 

DATES: September 23, 2008. 

TIME: 4 p.m. (EDT). 

ADDRESSES: Louise Slaughter Building 

Conference Room 2120, Rochester 

Institute of Technology, Center for 

Integrated Manufacturing Studies, 111 

Lomb Memorial Drive, Rochester, NY 

14623. 

FOR FURTHER INFORMATION, CONTACT: The 

Manufacturing Council Executive 

Secretariat, Room 4043, Washington, DC 

20230 (Phone: 202–482–1369), or visit 

the Council’s Web site at http:// 

www.manufacturing.gov/council. 

Dated: September 11, 2008. 

Kate Sigler, 

Executive Secretary, The Manufacturing 

Council. 

[FR Doc. E8–21572 Filed 9–11–08; 4:15 pm] 

BILLING CODE 3510–DR–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

RIN 0648–XK41 

Atlantic Highly Migratory Species; 

Meeting of the Atlantic Highly 

Migratory Species Advisory Panel 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 


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