E7-10469. Availability of Electronic Web-Based FSIS Form 10,240-1, Production Information on Post-Lethality Exposed Ready-To-Eat Products, With Revisions and Detailed Instructions

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice of availability and opportunity for comments.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is announcing the availability of an electronic Web-based version of FSIS Form 10,240-1, Production Information on Post-Lethality Exposed Ready-to-Eat Products. This form is available for the first time for online submission.

FSIS Form 10,240-1 will be used to collect information about the ready-to-eat (RTE) products produced by establishments.

ADDRESSES:

FSIS invites interested persons to send comments on this notice. Comments may be sent 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.
• Electronic mail: [e-mail].
• 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.regulation.gov and in the “Search for Open Regulations” box, select “Food Safety and Inspection Service” from the agency drop-down menu, then click on “Submit.” In the Docket ID column, select FDMS Docket Number 2006-0038 to send or view public comments and to view supporting and related materials available electronically.

All submissions received by mail or electronic mail must include the Agency name and docket number 2006-0038. All comments sent in response to this document, 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. Comments will also be posted on the Agency's Web site at http://www.fsis.usda.gov/​regulations_​&​_​policies/​regulations_​directives_​&​_​notices/​index.asp.

FOR FURTHER INFORMATION CONTACT:

Tom Doyle, U.S. Department of Agriculture, FSIS, Technical Service Center, Program Analysis Staff, FSIS, 1-800-233-3935.

SUPPLEMENTARY INFORMATION:

Background

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 through transportation, storage, and other handling.

On June 6, 2003, FSIS published an interim final rule (68 FR 34207) to require that official establishments that produce RTE meat and poultry products that are exposed to the environment after a lethality treatment has been administered act to 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 products 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, facilitates collection of information about the RTE products produced by establishments. This information is 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 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.

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 * * * .” FSIS Form 10,240-1 was developed for this purpose and is now available in the new, Web-based submittable format. It can be found on the FSIS Web site at http://www.fsis.usda.gov/​Forms/​PDF/​Form_​10240-1.pdf. Any establishment required to complete this form will be able to complete and submit the form entirely online, which will ensure more timely submission and more accurate information. In addition to reformatting the form to facilitate its being fillable and submittable online, FSIS has revised the content of the form in certain minor respects:

• Item 1g, Plant Size Category was added.
• Item 2, Annual Production Volume, Other Than Deli Products, has two new product designations. These new columns are Frozen Products and Pate' Products.
• Item 3, Alternative 3, Question B was deleted.

Establishments are required to file Form 10,240-1 whenever a significant change in the alternative category or volume of production occurs.

The address for any written communication concerning FSIS Form 10,240-1 has changed. Send all written correspondence to: U.S. Department of Agriculture, FSIS, Technical Service Center, Program Analysis Staff, Suite 300 Landmark Center, 1299 Farnam Street, Omaha, NE 68102. Fax number [phone]. Phone: [phone].

Awareness Meeting With Establishment Management

FSIS Inspectors-In-Charge (IICs) at establishments that produce products that are regulated under 9 CFR part 430 have been instructed to provide information on the electronic FSIS Form 10,240-1 to establishment management. The IICs are to provide the following information:

1. The form is located on the FSIS Web site at: http://www.fsis.usda.gov/​Forms/​PDF/​Form_​10240-1.pdf.

2. Adobe Reader 7.0 or greater should be installed in order to submit the form electronically. Download the software free of charge from the Adobe Web site at: http://www.adobe.com/​products/​acrobat/​readstep2.html. (If this free download is accessed, any supplemental items that are not wanted should be unchecked.)

3. If establishment management chooses to submit a paper form by mail, it may obtain a copy of the blank form by printing a blank form from the online version or by contacting the Technical Service Center (TSC) at: USDA/FSIS/OPPED/TSC/PAS, Suite 300 Landmark Center, 1299 Farnam Street, Omaha, NE 68102. Fax: [phone]. Phone: [phone].

4. Establishment management should submit the completed paper form to the address in 3. above.

5. If the establishment is no longer required to file FSIS Form 10,240-1 (e.g., the establishment no longer produces the RTE product for which it had filed the form previously), establishment management should either:

a. Send an e-mail with the message “No Longer Required to File” to the e-mail address [e-mail], or

b. Write across the front of a blank form “No Longer Required to File” and mail to the TSC at the address provided under 3. above.

6. Pursuant to the regulation, the Administrator is requiring each establishment to file, either electronically, by fax, or via mail the new FSIS Form 10,240-1 within 30 days of the date of the meeting.

7. Under the regulation, each establishment is required to continue to submit updates to the form when changes to its production volume or selected alternative occur.

Instructions for completing form 10,240-1 are attached to the form. The additional instructions to assist in completing the form are in Attachment 1 to FSIS Notice 21-07, dated March 8, 2007. The IIC is to provide establishment management with a copy of Attachment 1 to FSIS Notice 21-07.

In a memorandum of meeting, the IIC is to document who was present at the meeting, the date and time of the meeting, what was discussed at the meeting, and any documents that were shared with management. The IIC is to maintain a copy of the memorandum in the official government file and provide a copy to establishment management.

Inspection program personnel are to hold a meeting with establishment management approximately 30 days after the meeting at which the IIC notifies the establishment about completing and submitting the form. At this second meeting, inspection program personnel are to ask the establishment management whether it has completed the revised FSIS Form 10,240-1 and submitted it to FSIS and are to remind establishment management of the need to do so if it has not.

The District Analyst in each District Office will be reviewing the database containing the submitted 10,240-1 forms to verify receipt of forms from establishments that are required to submit them. The TSC will assist districts without a District Analyst.

Any persons with comments on FSIS' decision to make FSIS Form 10,240-1 available and fillable electronically should submit them to the Docket Clerk, whose address is set out at the beginning of this document.

Paperwork Reduction Act

The Office of Management and Budget has approved the information collection and recordkeeping requirements under approval number 0583-0132. This notice contains no other paperwork requirements.

E-Government Act Compliance

FSIS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

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/​2007_​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 constituents and stakeholders. The update is communicated via Listserv, a free electronic mail subscription service for industry, trade and farm groups, consumer interest groups, allied health professionals, and other individuals who have asked to be included. The update is 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/​. 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 May 23, 2007.

David P. Goldman,

Acting Administrator.