ICRGrBeefRecordkeeping3

SUPPORTING STATEMENT JUSTIFICATION FOR RECORDS TO BE KEPT BY OFFICIAL ESTABLISHMENTS AND RETAIL STORES THAT GRIND RAW BEEF PRODUCTS

1. Circumstances Making Collection Of Information Necessary:

This information collection requests a new information collection of burden hours for records to be kept by official establishments and retail stores grinding or chopping raw beef products.

The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the functions of the Secretary as provided in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.). These statutes mandate that FSIS protect the public by verifying that meat and meat products are safe, wholesome, not adulterated, and properly labeled and packaged.

Under this proposed rule, FSIS is proposing to amend its recordkeeping regulations to clarify that all grinders or choppers of raw beef products, beef manufacturing trimmings, or trimmings fabricated at retail intended for use in raw ground or chopped beef products, including retail facilities, are persons required by FMIA to keep records which will fully and correctly disclose all transactions involved in their business subject to the Act. If not doing so already, these businesses will have to commence maintaining records that disclose the identitiy and supplier of all materials used in the preparation of each lot of raw ground or chopped beef product.

In addition, FSIS is proposing to require that specific information be kept in the required records and to require retail stores to maintain store-designed systems that will allow them to link individual packages of raw ground or chopped beef products prepared and sold by them to the required records.

2. How, By Whom and Purpose Information Is To Be Used:

The following is a discussion of the required information collection and recordkeeping activities.

Recordkeeping

All official establishments and retail stores that grind or chop beef products would be required to keep these records. These records provide critical information about how, when, and where raw ground or chopped beef product was prepared, shipped, received, stored, and handled, and which are essential to illness outbreak investigations, recalls, and other agency public health activities conducted by FSIS.

In addition, FSIS is proposing to require that specific information be kept in the required records and to require retail stores to maintain store-designed systems that will allow them to link individual packages of raw ground or chopped beef products prepared and sold by them to the required records. The required records will have to include the following information:

1. Name, point of contact (name, title, e-mail, and facsimile number) telephone number, and establishment number of the Federal, State, or foreign establishment supplying the raw source material;

2. Supplier lot numbers and production dates for each raw source material used; and,

3. The names of the supplied materials.

There are a total of 554,500 burden hours for the information collection requests relating to establishment responses.

3. Use Of Improved Information Technology:

Establishments and retail stores may make use of electronic recordkeeping.

4. Efforts To Identify Duplication:

FSIS has determined that these information collections will not duplicate any other information collections. The required records and reports are not available from other sources, either within government or from non-government sources. There is no similar information that can be used or modified.

5. Methods To Minimize Burden On Small Business Entities:

Data collected from small businesses are the same as from large ones. FSIS estimates that 51,962 small firms will be effected.

6. Consequences If Information Were Collected Less Frequently:

To conduct the information collections less frequently would reduce the effectiveness of the meat inspection program.

7. Circumstances That Would Cause The Information Collection To Be Conducted In A Manner:

• requiring respondents to report informa­tion to the agency more often than quarterly;

• requiring respondents to prepare a writ­ten response to a collection of infor­ma­tion in fewer than 30 days after receipt of it;

• requiring respondents to submit more than an original and two copies of any docu­ment;

• requiring respondents to retain re­cords, other than health, medical, governm­ent contract, grant-in-aid, or tax records for more than three years;

• in connection with a statisti­cal sur­vey, that is not de­signed to produce valid and reli­able results that can be general­ized to the uni­verse of study;

• requiring the use of a statis­tical data classi­fication that has not been re­vie­wed and approved by OMB;

• that includes a pledge of confiden­tiali­ty that is not supported by au­thority estab­lished in statute or regu­la­tion, that is not sup­ported by dis­closure and data security policies that are consistent with the pledge, or which unneces­sarily impedes shar­ing of data with other agencies for com­patible confiden­tial use; or

• requiring respondents to submit propri­etary trade secret, or other confidential information unless the agency can demon­strate that it has instituted procedures to protect the information's confidentiality to the extent permit­ted by law.

There are no special circumstances that require the collection of information to be inconsistent with the guidelines listed above.

8. Consultation With Persons Outside The Agency:

FSIS is embedding its 60 day notice in the proposed rule that will be published in Federal Register.

The burden hours in the proposed rule only account for the additional recordkeeping burden that will be placed on the establishments, but the information collection package seeks approval for all the recordkeeping which includes the development of production records as well as the overall recordkeeping requirements.

9. Payment Or Gifts To Respondents:

Respondents do not receive gifts or payments.

10. Confidentiality Provided To Respondents:

No assurances other than routine protection provided under the Freedom of Information Act have been provided to respondents.

11. Questions Of A Sensitive Nature:

The applicants are not asked to furnish any information of a sensitive nature.

12. Estimate Of Burden:

The total estimated burden for this information collection is 554,500 burden hours.

FSIS estimates that 76,390 official establishments and retail stores will one time take an average of 60 minutes for large firms and 30 minutes for small firms to develop and assemble ground beef production records for a total of 76,398 responses and 50,410 hours.

DEVELOP PRODUCTION RECORDS

(9 CFR 320.1)

Type of Establish- Ment	No. of Respon-dents	No. of Res- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Large retail facilities	24,395	1	24,395	60	24,395
Small retail facilities	50,755	1	50,755	30	25,377.5
Large ests.	33	1	33	60	33
Small ests.	1,207	1	1,207	30	603.5
Total	76,390	1	76,390		50,410

FSIS estimates that 76,390 official establishments and retail stores will one time take an average of 2 minutes to file records 300 times a year for large firms and 150 times a year for small firms for a total of 76,390 responses and 504,090 hours.

RECORDKEEPING—PRODUCTION RECORDS

(9 CFR 320.1)

Type of Establish- Ment	No. of Respon-dents	No. of Res- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Large retail facilities	24,395	300	7,318,500	2	243,950
Small retail facilities	50,755	150	7,613,250	2	253,775
Large ests.	33	300	9,900	2	330
Small ests.	1,207	150	181,050	2	6,035
Total	76,390		15,122,700	2	504,090

The cost to the respondents is estimated at $21,071,000 annually. The Agency estimates that it will cost respondents $38 an hour in fulfilling these paperwork requirements. Respondents will spend an annual total of 554,500 hours and $21,071,000.

13. Capital, Start-up Cost, And Subsequent Maintenance

There are no capital or start-up costs related to this information collection activity.

14. Annual Cost To The Federal Government:

The cost to the Federal Government for this information collection is $30,894 annually. The Agency estimates a cost of $38 per hour for the time of its personnel.

15. Reasons For Changes In Burden:

This is a new information collection of 554,500 hours.

16. Tabulation, Analyses And Publication Plans:

There are no plans to publish the data for statistical use.

17. OMB Approval Number Display:

18. Exceptions To The Certification:

There are no exceptions to the certification. This information collection accords with the certification in item 19 of the OMB 83-I.

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