supporting statementICRGrBeefRecordkeeping012019

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 is a request for a renewal of the information collection related to 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.

FSIS requires 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 must maintain records that disclose the identity and supplier of all materials used in the preparation of each lot of raw ground or chopped beef product.

In addition, FSIS requires that specific information be kept in the required records and that retail stores maintain store-designed systems that 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 are 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 requires that specific information be kept in the required records and that retail stores maintain store-designed systems that 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 must 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 3,317,301 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 affected.

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:

In accordance with the Paperwork Reduction Act, FSIS published a 60-day notice, Notice of Request To Renew an Approved Information Collection (Records To Be Kept by Official Establishments and Retail Stores That Grind Raw Beef Products) on October 9, 2018 (83 FR 50633) requesting comments on this information collection renewal. The Agency received one comment that was outside the scope of the request for comments in response to the Federal Register notice. FSIS also contacted Joseph Spadafore (215-918-3900), Janet Lacava (408-855-0980), and Eric Nash (281-361-0342) to request input on the Agency’s burden estimates for recordkeeping. The input and estimates supplied were consistent with the Agency’s calculated estimates, therefore, FSIS made no change to the current burden estimates.

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 3,317,301 burden hours.

FSIS estimates that 65,911 official establishments and retail stores will take an average of 50 minutes to file records 4 times a year for large firms and 4 times a year for small firms for a total of 263,644 responses and 3,317,301 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	Annual Time in Response (Hours)	Total Annual Time in Hours
Large retail facilities and ests.	18,956	4	75,824	50.33	954,055
Small retail facilities and ests.	46,955	4	187,820	50.33	2,363,245
Total	65,911		263,644		3,317,301

The cost to the respondents is estimated at $149,245,372 annually. The Agency estimates that it will cost respondents $44.99 an hour, including fringe benefits, in fulfilling these paperwork requirements. Respondents will spend an annual total of 3,317,301 hours and $149,245.372. The hourly rate for the respondents was attained from the Department of Labor Bureau of Labor and Statistics wage data, May, 2017.

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 these information collection requirements is $218,831.36 annually. The costs arise primarily from the time spent by FSIS staff reviewing protocols and data. The Agency estimates a cost of $44.99 per hour, including fringe benefits, for the FSIS staff.

15. Reasons For Changes In Burden:

There is no change to the burden estimate.

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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