[Federal Register Volume 63, Number 33 (Thursday, February 19, 1998)]
[Notices]
[Pages 8423-8424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4158]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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 delegations of authority, filing of petitions and applications and agency 
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  Federal Register / Vol. 63, No. 33 / Thursday, February 19, 1998 / 
Notices  

[[Page 8423]]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service
[Docket No. 98-001N]


Notice of Request for Extension of a Currently Approved 
Information Collection

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and the 
Office of Management and Budget regulations, this notice announces the 
Food Safety and Inspection Service's (FSIS) intention to request an 
extension of a currently approved information collection package 
regarding the regulatory requirements of FSIS's ``Pathogen Reduction; 
Hazard Analysis and Critical Control Point (HACCP) Systems,'' final 
rule.

DATES: Comments on this notice must be received on or before April 20, 
1998.

ADDITIONAL INFORMATION OR COMMENTS: Contact Lee Puricelli, Paperwork 
Specialist; (202) 720-0346.

SUPPLEMENTARY INFORMATION:
    Title: Pathogen Reduction; Hazard Analysis and Critical Control 
Point (HACCP) Systems.
    OMB Number: 0583-0103.
    Expiration Date of Approval: April 30, 1997.
    Type of Request: Extension of a currently approved information 
collection.
    Abstract: FSIS has been delegated the authority to exercise the 
functions of the Secretary as provided in the Federal Meat Inspection 
Act (21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (21 
U.S.C. 451 et seq.). These statutes mandate that FSIS protect the 
public by ensuring that meat and poultry products are safe, wholesome, 
unadulterated, and properly labeled and packaged.
    FSIS is requesting an extension of the information collection 
package addressing meat and poultry paperwork and recordkeeping 
requirements related to FSIS's final rule ``Pathogen Reduction; Hazard 
Analysis and Critical Control Point (HACCP) Systems'' (61 FR 38806, 
July 25, 1996). In the final rule, FSIS established requirements 
applicable to meat and poultry establishments designed to reduce the 
occurrence and numbers of pathogenic microorganisms on meat and poultry 
products, reduce the incidence of foodborne illness associated with the 
consumption of those products and provide a new framework for 
modernization of the current system of meat and poultry inspection.
    The regulations require that each establishment develop and 
implement written sanitation standard operating procedures (Sanitation 
SOP's); require regular microbial testing by slaughter establishments 
to verify the adequacy of the establishments' process controls for the 
prevention and removal of fecal contamination and associated bacteria; 
and require that all meat and poultry establishments develop and 
implement a system of preventive controls, known as HACCP, designed to 
improve the safety of their products.

Standard Operating Procedures (SOP) for Sanitation

    Establishments must develop and maintain an SOP for sanitation that 
will be used by inspection personnel in performing monitoring 
verification tasks. The establishment must detail in a written plan how 
they will meet the basic sanitation requirements. The SOP's specify the 
cleaning and sanitizing procedures for all equipment and facilities 
involved in the production of every product.
    FSIS does not review or approve the plans. However, plans must be 
on file and available to FSIS program employees upon request. Based on 
current regulatory standards, inspectors review the plans and if an 
establishment's sanitation activities are determined to be 
insufficient, then inspectors may suggest modifications.
    Each official establishment maintains daily records sufficient to 
document the implementation and monitoring of the Sanitation SOP's. In 
most cases, inspectors review the records once a day.

Microbiological Testing

    As part of E. coli verification testing, each slaughter 
establishment must develop written procedures outlining specimen 
collection and handling. The slaughter establishments are responsible 
for entering the results into a statistical process control chart. The 
data and chart must be available for review by the Inspector-in-Charge, 
upon request.

HACCP

    Establishments must develop written HACCP plans that include: 
Identification of the processing steps which present hazards; 
identification and description of the critical control point (CCP) for 
each identified hazard; specification of the critical limit which may 
not be exceeded at the CCP, and if appropriate a target limit; 
description of the monitoring procedure or device to be used; 
description of the corrective action to be taken if the limit is 
exceeded; description of the records which will be generated and 
maintained regarding this CCP; and description of the establishment 
verification activities and the frequency at which they are to be 
conducted. Critical limits which are currently a part of FSIS 
regulations or other requirements must be addressed.
    FSIS does not review or approve the plans. However, plans must be 
on file and available to FSIS program employees upon request. 
Inspectors will review the plans and if an establishment's HACCP 
operations are determined to be insufficient by inspectors, then they 
may suggest modifications.
    Establishments keep records for monitoring activities during 
slaughter and processing, corrective actions, verification check 
results, and related activities that contain the identity of the 
product, the product code or slaughter production lot, and the date the 
record was made. The information is recorded at the time that it is 
observed, and the record is signed by the operator or observer.
    Lastly, HACCP records generated by the processor are retained on 
site for at least one year for slaughter and refrigerated products and 
two years for shelf-stable products. Off-site storage of records is 
permitted after six months, if such records can be retrieved and 
provided, on-site, within 24 hours of an FSIS employee's request. 
Records must be available to FSIS program employees

[[Page 8424]]

upon request for verification of the HACCP system. However, it is the 
Agency's intent to generate its own records of its verification tasks 
and results rather than duplicate the records of the establishment.
    The paperwork requirements of these regulations, records and plans, 
represent an alternative to the previous process of inspection. The 
industry's documentation of its processes, first in a plan and 
thereafter in a continuous record of process performance, is a more 
effective food safety approach than the less systematic generation of 
information by plant employees and inspectors. It gives inspectors a 
much broader picture of production than they can generate on their own 
and gives them time to perform higher priority tasks. At the same time, 
it gives the managers a better view of their own process and more 
opportunity to adjust it to prevent safety defects. As a result, 
managers and inspectors will use their time more effectively. Moreover, 
any increased paperwork burden will be offset by a reduction in the 
number of face-to-face contacts between management and the inspectors.
    Estimate of Burden: The public reporting burden for this collection 
of information is estimated to average .1126685 hours per response.
    Respondents: Meat and poultry establishments.
    Estimated Number of Respondents: 7,374.
    Estimated Number of Responses per Respondent: 9513.7803.
    Estimated Total Annual Burden on Respondents: 7,904,222 hours.
    (Due to rounding, the total annual burden hours may not equal the 
product of the annual number of responses multiplied by the average 
reporting burden per response.)
    Copies of this information collection assessment and comments can 
be obtained from Lee Puricelli, Paperwork Specialist, Food Safety and 
Inspection Service, USDA, 300 12th Street SW, Room 109, Washington, DC 
20250-3700, (202) 720-0346.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of FSIS's 
functions, including whether the information will have practical 
utility; (b) the accuracy of FSIS' estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on those who 
are to respond, including through use of appropriate automated, 
electronic, mechanical, or other technological collection techniques, 
or other forms of information technology.
    All responses to this notice will be summarized and included in the 
request for OMB approval. All comments will also become a matter of 
public record.

    Dated: February 12, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 98-4158 Filed 2-18-98; 8:45 am]
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