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Notice of Availability and Opportunity for Comments (Establishment Guidance for the Selection of a Commercial or Private Microbiological Testing Laboratory)

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Notice of availability and opportunity for comments.


The Food Safety and Inspection Service (FSIS) is announcing the availability of policy guidance for federally inspected establishments in the selection of commercial and private microbiological testing laboratories. FSIS has posted this policy guidance on its Web page

FSIS encourages establishments that prepare meat, poultry, or processed egg products to follow the criteria in the guidelines in selecting commercial or private microbiological testing laboratories and in determining their capability to provide accurate and reliable results. Regulated establishments are required to enter into commerce food products that are safe and not adulterated or misbranded. Establishments that select laboratories that do not apply appropriate testing methods or maintain effective Quality Control or Quality Assurance (QC/QA) practices may not receive reliable or useful test results from the laboratory and run the risk of producing food that is unsafe.


Written comments may be submitted until May 7, 2012.


FSIS invites interested persons to submit comments regarding any aspect of this document, including but not limited to: Content, readability, applicability, and accessibility, and will revise the guidance document as warranted. Comments may be submitted by either 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 Follow the on-line instructions at that site for submitting comments.

Mail, including floppy disks or CD-ROMs, and hand- or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture (USDA), FSIS, OPPD, RIMD, Docket Unit, Patriots Plaza 3, 1400 Independence Avenue SW., Mail Stop 3782, 8-163A, Washington, DC 20250-3700.

Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2011-0033. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to

Docket: For access to background documents or comments received, go to the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday.


Evelyne Mbandi, Deputy Director, Risk, Innovations, and Management Division, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 355 E. Street SW., Mail Stop 3782, Washington, DC 20250-3700; email:; phone: (301) 504-0897.



FSIS is issuing a guidance document to provide criteria to establishments producing meat, poultry, and processed egg products for selecting a commercial or private laboratory to analyze establishments' samples. Regulated establishments are ultimately responsible for the laboratory's testing methodologies and practices performed on their behalf.

An FSIS-regulated establishment may perform microbiological testing for various reasons, including, but not limited to the following: Fulfilling regulatory requirements, supporting on-going verification of the establishment's HACCP plan, supporting decisions made in the establishment's hazard analysis, evaluating the effectiveness of the establishment's sanitation program, or complying with purchase specifications or requirements.

FSIS encourages establishments to use this guidance for selecting commercial or private laboratories and for ensuring that microbiological testing performed on their behalf meets their food safety needs. FSIS also welcomes comment on this compliance guideline, which will be revised as needed.

USDA Nondiscrimination Statement

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA's Target Center at 202-720-2600 (voice and TTY).

To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). USDA is an equal opportunity provider and employer.

Additional Public Notification

FSIS will announce this notice online through the FSIS Web page located at

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, FSIS 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. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at 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 accounts.

Done at Washington, DC, on: March 5, 2012.

Alfred V. Almanza,


[FR Doc. 2012-5664 Filed 3-7-12; 8:45 am]