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Availability of FSIS Form 10,240-1-Production Information on Post-Lethality Exposed Ready-to-Eat Products

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Food Safety and Inspection Service, USDA.


Notice of availability and request for comments.


The Food Safety and Inspection Service (FSIS) is announcing the availability of FSIS Form 10,240-1, Production Information on Post-Lethality Exposed Ready-to-Eat Products. This form will be used to collect information about the ready-to-eat products produced by establishments.

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Dr. Arshad Hussain, Director, Data Analysis and Statistical Support Staff, Food Safety and Inspection Service, U.S. Department of Agriculture, (202) 720-3219.


FSIS invites interested persons to submit comments on the information required in this notice and the frequency of its collection. Comments may be submitted by any of 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 04-014N. 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​OPPDE/​rdad/​FRDockets.htm.

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FSIS is committed to developing strategies that address food safety hazards throughout the entire food production chain. Under the Federal Meat Inspection Act and the Poultry Products Inspection Act, FSIS has the authority and responsibility to provide for the safety of meat and poultry products during in-plant production and also through transportation, storage, and other handling.

On June 6, 2003, FSIS published an interim final rule (68 FR 34207) that amended its regulations to require that official establishments that produce certain ready-to-eat (RTE) meat and poultry products prevent product adulteration by the pathogen Listeria monocytogenes (L. monocytogenes). In this interim final rule, FSIS identified three alternative methods for addressing post-lethality contamination of RTE Start Printed Page 56743products by L. monocytogenes and required that establishments adopt and implement one of these alternatives.

The use of FSIS Form 10,240-1, Production Information on Post-Lethality Exposed Ready-to-Eat Products, will facilitate collection of information about the RTE products produced by establishments. This information will be used in developing FSIS' annual sampling frequencies for establishments and RTE products. The annual collection of this information was addressed in the interim final rule (68 FR 34207) in 9 CFR 430.4(d). The Agency will use this information, along with the FSIS verification testing history of the establishment, to design a risk-based verification testing program, as stated in the preamble to the interim final rule and in FSIS Directive 10,240.4, Verification Procedures for the Listeria monocytogenes Regulation and Microbial Sampling of Ready-to-Eat (RTE) Products for the FSIS Verification Testing Program. In addition, FSIS will be issuing an FSIS notice to instruct FSIS inspection program personnel on how to verify that establishments are completing and submitting FSIS Form 10,240-1 to FSIS. At the first weekly meeting held after receipt of the FSIS notice, inspection program personnel are to inform plant management (1) about the availability of the form, (2) that the establishment is to complete and submit the form to meet the regulatory requirement at 9 CFR 430.4(d), and (3) that the establishment's failure to complete the form or to submit it to FSIS within 30 days from the date of the meeting may cause the Agency to seek appropriate enforcement actions against the establishment or responsible officials. The regulations at 9 CFR 430.4(d) state that “* * * an establishment that produces post-lethality exposed RTE product shall provide FSIS * * * with estimates of annual production volume and related information for the types of meat and poultry products processed * * *” under 9 CFR part 430—Requirements for Specific Classes of Product.

In a memorandum of interview, inspection program personnel are to document who was present at the meeting, the date and time of the meeting, what was discussed, and any documents that were shared with management. Inspection program personnel are to maintain a copy of the memorandum in the official government file and provide a copy to the plant management.

After 30 days from the meeting at which inspection program personnel notified the establishment about completing and submitting the form, inspection program personnel are to ask the establishment management whether it has completed FSIS Form 10,240-1 and submitted it to FSIS.

If an establishment has not completed the form, and does not indicate that it plans to do so in a timely manner, inspection program personnel are to notify the appropriate FSIS District Office through supervisory channels. The District Office will take the necessary follow-up actions.

FSIS Form 10,240-1 is available on the FSIS Web site at​Forms/​index.asp and is also available to FSIS employees in the FAIM forms library. The form can either be printed and filled out, signed and mailed to FSIS/USDA or filled out online, printed, signed and mailed to FSIS/USDA. The full address is FSIS/USDA, Data Analysis and Statistical Support Staff, Cotton Annex Building, 300 12th Street, SW., Room 201, Washington, DC 20250, or faxed to (202) 690-0824. (The form can also be requested from the FSIS Data Analysis and Statistical Support Staff at the address above).

Paperwork Reduction Act

The Office of Management and Budget has approved the information collection and recordkeeping requirements under approval number 0583-0132.

As establishments continue to adapt to the regulatory approach embodied in the interim final rule, FSIS will evaluate the need for the specific information required and the frequency of its collection. The Agency will consider, for example, whether establishments with no change in Listeria control methods or products affected could simply verify the fact and report production volume.

Copies of this information collection assessment can be obtained from John O'Connell, Paperwork Reduction Act Coordinator, FSIS, USDA, 112 Annex, 300 12th Street, SW., Washington, DC 20250-3700.

Government Paperwork Elimination Act (GPEA) Compliance

FSIS is committed to compliance with the GPEA, which requires Government agencies, in general, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.

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

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.

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Done at Washington, DC, on September 17, 2004.

Barbara J. Masters,

Acting Administrator.

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[FR Doc. 04-21293 Filed 9-21-04; 8:45 am]