ICRProductName11

SUPPORTING STATEMENT JUSTIFICATION FOR LABELING REQUIREMENTS

FOR MEAT AND POULTRY PRODUCTS CONTAINING ADDED SOLUTIONS

1. Circumstances Making Collection Of Information Necessary:

This information collection requests a new information collection of burden hours for product labeling requirements for meat and poultry products containing added solutions.

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.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, 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 is proposing to amend its regulations to establish a common or usual name for raw meat and poultry products that do not meet standard of identity regulations and to which solutions have been added. Products with added solutions are sometimes referred to as “enhanced products.” The Agency is proposing that the common or usual name for such products include an accurate description of the raw meat or poultry component, the percentage of added solution incorporated into the raw meat or poultry product, and the individual ingredients or multi-ingredient components in the solution listed in the descending order of predominance by weight. FSIS is also proposing that the print for all words in the common or usual name appear in a single font size, color, and style of print and that the name appear on a single-color contrasting background. In addition, the Agency is proposing to remove the regulatory standard of identity for “ready-to-cook poultry products to which solutions are added.”

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

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

FSIS is proposing common or usual name labeling requirements for raw meat and poultry products that do not meet standard of identity regulations and to which solutions have been added.  The proposed amendments will require establishments that manufacture products containing added solutions to modify or redesign the product label.  The proposed amendments will be effective on the next compliance date provided by the Uniform Compliance Date for Food Labeling Regulations.

FSIS has concluded that without specific, clear, and conspicuous information about the percentage of added solution incorporated into meat orpoultry product, the labeling of these raw meat or poultry products that do not meet a standard of identity is likely to be misleading to consumers. Hence, the new labels will inform consumers that the product contains added solutions.

There are a total of 61,000 burden hours for the information collection requests relating to labeling requirements for meat and poultry product containing added solutions.

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 for large ones. FSIS estimates that 5,719 small establishments and retail firms would be affected by this rule.

6. Consequences If Information Were Collected Less Frequently:

To conduct the information collections less frequently would reduce the effectiveness of the meat and poultry 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.

Respondents must maintain a copy of the label records as long as they use the label; there are no other special circumstances that require the collection of information to be inconsistent with the above guidelines.

8. Consultation With Persons Outside The Agency:

FSIS is embedding a 60 day notice in the proposed rule to be published in the Federal Register.

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 61,000 burden hours.

FSIS estimates that 6,100 establishments and retailers will 8 times a year take an average of 75 minutes to develop, submit, and file labels for products with added solutions for a total of 48,800 responses and 61,000 hours.

DEVELOP NEW LABELS FOR PRODUCTS CONTAINING ADDED SOLUTIONS

(9 CFR 317.2 & 381.117(h))

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
Ests./ firms	6,100	8	48,800	75	61,000

The cost to the respondents is estimated at $2,257,000 annually. The Agency estimates that it will cost respondents $37 an hour in fulfilling these paperwork requirements. Respondents will spend an annual total of 61,000 hours and $2,257,000.

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 $888,000 annually. The Agency estimates a cost of $37 per hour for the time of its personnel.

15. Reasons For Changes In Burden:

This is a new information collection of 61,000 hours.

16. Tabulation, Analyses And Publication Plans:

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

17. OMB Approval Number Display:

FSIS will display the OMB approval number on any instructions it publishes relating to recordkeeping activities.

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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