Notice of Request for Extension of a Currently Approved Information Collection

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

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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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