[Federal Register: September 22, 2004 (Volume 69, Number 183)]
[Page 56742-56743]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety and Inspection Service

[Docket No. 04-014N]

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

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and request for comments.


SUMMARY: 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 

FOR FURTHER INFORMATION CONTACT: 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 http://www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.



    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

[[Page 56743]]

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

    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.

    Done at Washington, DC, on September 17, 2004.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 04-21293 Filed 9-21-04; 8:45 am]