[Federal Register: May 31, 2007 (Volume 72, Number 104)]
[Page 30333-30335]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety and Inspection Service

[Docket No. FSIS-2006-0038]

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 
    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: fsis.regulationscomments@fsis.usda.gov.
     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

[[Page 30334]]

at http://www.fsis.usda.gov/regulations_&_policies/2007_Notices_Index/index.asp

Agriculture, FSIS, Technical Service Center, Program Analysis Staff, 
FSIS, 1-800-233-3935.



    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 
    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 
    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 (402) 344-5006. Phone: 1-800-233-3935.

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 
    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: 402-344-5006. Phone: 1-800-233-
    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 RTEform@fsis.usda.gov, 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 
    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 

[[Page 30335]]

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.
 [FR Doc. E7-10469 Filed 5-30-07; 8:45 am]