supporting statement ICRNutrition Facts 02132017

SUPPORTING STATEMENT JUSTIFICATION FOR

REVISION OF NUTRITION FACTS LABELS FOR MEAT AND POULTRY PRODUCTS

AND UPDATING CERTAIN REFERENCE AMOUNTS CUSTOMARILY CONSUMED

1. Circumstances Making Collection of Information Necessary:

This information collection requests a new information collection related to the Revision of the Nutrition Facts Labels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed.

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.), the Poultry Products Inspection Act (PPIA) (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 proposing to amend the nutrition labeling requirements for meat (including fish of the order Siluriformes) and poultry products to better reflect the most recent scientific research and dietary recommendations and to improve the presentation of nutrition information to assist consumers in maintaining healthy dietary practices. FSIS is proposing to update the list of nutrients that are required or permitted to be declared; provide updated Daily Reference Values (DRVs) and Reference Daily Intake (RDI) values that are based on current dietary recommendations from consensus reports; and amend the labeling requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establish nutrient reference values specifically for these population subgroups. FSIS is also proposing to revise the format and appearance of the Nutrition Facts label; amend the definition of a single-serving container; require dual–column labeling for certain containers; and update and modify several reference amounts customarily consumed (RACCs or reference amounts).

2. How, By Whom and Purpose For Which Information is to be Used:

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

FSIS is proposing that manufacturers maintain additional records for Added Sugars, Dietary Fiber, Soluble Fiber, Insoluble Fiber, Dietary Fiber, Vitamin E, and Folate/Folic Acid. FSIS is also proposing to require manufacturers to provide these records to the inspector or any duly authorized representative of the Agency upon request.

3. Use of Improved Information Technology:

Under the E-Gov Act, firms may keep records electronically provided that appropriate controls are implemented to ensure the integrity of the electronic data.

4. Efforts to Identify Duplication:

No other Government agency requires information regarding nutrition facts labels for FSIS products. There is no available information that can be used or modified.

5. Methods to Minimize Burden on Small Business Entities:

FSIS estimates that 3,125 small businesses will be subject to this information collection.

6. Consequences If Information Were Collected Less Frequently:

To conduct the information collections less frequently will reduce the effectiveness of FSIS meat and poultry inspection programs.

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.

Establishments will be required to collect and record data more frequently than quarterly. There are no other circumstances that would cause the guidelines above not to be met by this information collection.

8. Consultation with Persons Outside the Agency:

In accordance with the Paperwork Reduction Act, FSIS embedded a 60-day notice in the proposed rule that published in the Federal Register on January 19, 2017, requesting comments regarding this information collection. FSIS also contacted three persons regarding the information collection: Kathie Schirf, 301-906-8539; Nancy Moyer, 301-805-6725; and Ames Perry, 303-546-3333.

9. Payment or Gifts to Respondents:

Respondents will not receive any gifts or payments.

10. Confidentiality Provided to Respondents:

No additional assurance of confidentiality is provided with this information collection. Any and all information obtained in this collection shall not be disclosed except in accordance with 5 U.S.C.552a.

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 burden estimate for the reporting and recordkeeping requirements associated with this information collection is 240,124 hours. The burden estimates are broken down into four categories described in the pages that follow.

Reporting 19,842

Recordkeeping 19,842

Third Party Disclosure Label Review 100,220

Third Party Disclosure Label Redesign 100,220

Total 240,124 hours

FSIS estimates that a total of 3,307 establishments would report 6 declarations 19,842 times annually for a total of 19,842 hours.

Reporting

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
manufacturers	3,307	6	19,842	60	19,842

FSIS estimates that a total of 3,307 manufacturers would record 6 declarations 19,842 times annually for a total of 19,842 hours.

Recordkeeping

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
manufacturers	3,307	6	19,842	60	19,842

FSIS estimates that a total of 3,307 establishments would review 50,110 labels annually for a total of 100,220 hours.

Annual Third Party Disclosure: Label Review

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
manufacturers	3,307	50,110	50,110	120	100,220

FSIS estimates that a total of 3,307 establishments would redesign 50,110 labels annually for a total of 100,220 hours.

Annual Third Party Disclosure: Label Redesign

Type of Establish- Ment	No. of Respon-dents	No. of Res- ponses per Respondent	Total Responses	Time for Response in Mins.	Total Time in Hours
manufacturers	3,307	50,110	50,110	120	100,220

The cost to the respondents is estimated at $22,566,854 annually. $93.98 is the hourly estimate of wage and benefits for an operations manager according to the Bureau of Labor Statistics, Occupational Employment and Wages from May 2016. Therefore, the Agency estimates that it will cost respondents $93.98 an hour in fulfilling these paperwork and recordkeeping requirements. Respondents will spend an annual total of 240,124 hours and $22,566,854.

13. Capital and Start-up Cost and Subsequent Maintenance

There are no capital and start-up costs and subsequent maintenance burdens.

14. Annual Cost to Federal Government and Respondents:

There is no cost to the Federal Government for these information collection requirements.

15. Reasons for Changes in Burden:

This is a new information collection.

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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