supporting statement A Import Inspection Application and Application for the Return of Exported Products ICR 2022

SUPPORTING STATEMENT JUSTIFICATION FOR

IMPORT INSPECTION APPLICATION AND

APPLICATION FOR THE RETURN OF EXPORTED PRODUCTS TO THE UNITED STATES

1. Circumstances Making Collection of Information Necessary:

This is a request to extend the collection of information for electronic import inspection of meat, poultry, and egg 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.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.). These statutes mandate that FSIS protect the public by verifying that meat, poultry, and egg products are safe, wholesome, and properly labeled and packaged.

The Federal Meat Inspection Act (FMIA) (21 U.S.C. 620) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 466) prohibit the importation of meat and poultry products into the United States if such products are adulterated or misbranded and unless they comply with all the inspection and other requirements of the Acts and regulations as are applied to domestic products. The Egg Products Inspection Act (EPIA) (21 U.S.C. 1046) prohibits the importation of egg products unless they were processed under an approved continuous inspection system of the government of the foreign country of origin and comply with the other pertinent requirements of the Act and regulations as they are applied to domestic products.

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

The following is a discussion of the required information collection activities relating to electronic import inspection of meat, poultry, and egg products.

FSIS requires foreign governments to submit additional information when submitting both the foreign establishment certificate and the foreign inspection certificate to FSIS for foreign establishments to be permitted to import product to the United States.

The information that is required with the Foreign Establishment Certificate includes: the type of operation(s) conducted at the establishment (e.g., slaughter, processing, storage, exporting warehouse); the establishment’s eligibility status (e.g., new or relisted (if previously delisted)); and, slaughter and processing establishment certifications that address the species and type of product(s) produced at the establishment and the process category.

Additional information that is required with the Foreign Inspection Certificate includes: the species used to produce the product and the source country and foreign establishment number; whether the source materials originate from a country other than the exporting country; the product’s description, including the process category, the product category, and the product group; the address of the consignor; the address of the consignee; the name and address of the exporter; the name and address of the importer; and, any additional information the Administrator requests to determine whether the product is eligible to be imported into the U.S.

FSIS also requires official import inspection establishments to develop, implement, and maintain written Sanitation Standard Operating Procedures (SSOPs), as provided in 9 CFR 416.11 through 416.17.

The Import Inspection Application (FSIS Form 9540-1) is available to applicants that do not file this information electronically.

When FSIS inspected and passed product is exported and then returned to this country, the owner, broker, or agent of the product (the applicant) arranges for the product’s entry and notifies FSIS. As part of this process, the applicant completes the FSIS Form 9010-1, Application for the Return of Exported Products to the United States. When FSIS inspection program personnel determine that the product is safe and not adulterated or misbranded, the product may be released into domestic commerce.

There are a total of 49,385 burden hours related to the electronic import requirements.

3. Use Of Improved Information Technology:

Under the EGov Act, the additional certificate information may be submitted electronically. Records may be maintained electronically provided that appropriate controls are implemented to ensure the integrity of the electronic data.

4. Efforts To Identify Duplication:

No FSIS office, USDA agency, or any other Government agency requires information regarding exportation, transportation and importation of meat and poultry products. There is no available 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. The information collections must apply to all businesses exporting product to the United States, transporting unmarked product for further processing, and importing product into the United States. There are 100 small businesses affected by this information collection.

6. Consequences If Information Were Collected Less Frequently:

To conduct the information collections less frequently would inhibit the ability of FSIS to ensure that imported product is safe, wholesome, and not adulterated.

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.

To ensure that import inspection establishments are sanitary, there must be regular recordkeeping activities associated with Sanitation SOPS. All other information collection activities in this submission are consistent 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: Import Inspection Application and Application for the Return of Exported Products to the United States, on September 7, 2022 (87 FR 54670). The Agency received one comment that was not relevant to the collection. FSIS also contacted R&D Coordinator, Cargill Protein, (519-453-4996 ext. 314); Inside Sales Coordinator, Piller’s Fine Foods (877-232-7772); and Manager, Eurofins do Brasil Analises de Alimentos Ltda. (55 19 99987 5192) 1110); to request input on the Agency’s burden estimates for the forms. All three individuals agreed with the Agency’s burden estimates. Therefore, the Agency is making no change to the estimated time for completion.

9. Payment or Gifts to Respondents:

Respondents will not receive any 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 burden estimate for the reporting and recordkeeping requirements associated with this information collection is 49,385 hours.

The Agency estimates that 79 respondents will take 10 minutes, 600 times a year to manually supply the information concerning the Import Inspection Application, for a total of 47,400 responses and 7900 hours. The Agency estimates that 174 respondents will take 10 minutes, 600 times a year, to electronically supply the information on the Import Inspection Application through Custom and Border Protection’s Automated Commercial Environment (ACE), for a total of 104,400 responses and 17,400 hours. The total annual time for supplying the information on the Import Inspection Applications is 25,300 hours. 

           IMPORT INSPECTION APPLICATION: ADDITIONAL INFORMATION (PAPER) FSIS FORM 9540-1

                                                (9 CFR 327.5, 381.198, 590.920)

Type of Respondent	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Importers/Brokers	79	600	47,400	10	7900

           IMPORT INSPECTION APPLICATION: ADDITIONAL INFORMATION  (ELECTRONIC)

                                                (9 CFR 327.5, 381.198, 590.920)

Type of Respondent	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Importers/Brokers	174	600	104,400	10	17,400

The Agency estimates that it takes on the average 3 minutes to supply the additional information concerning the Foreign Establishment Certificate. Approximately 30 establishments a year will respond once a year for a total of 1.5 hours.

           FOREIGN ESTABLISHMENT CERTIFICATE ADDITIONAL INFORMATION

                                                (9 CFR 327.4, 381.197, 590.915)

Type of Respondent	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Foreign Gov’ts	30	1	30	3	1.5

FSIS estimates that it will take 30 foreign governments 3 minutes per certificate about 555 times a year to add additional information to the certificate for a total of 832.5 hours.

FOREIGN INSPECTION CERTIFICATE

                                                (9 CFR 327.4, 381.197 & 590.915)

Type of Respondent	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Minutes	Total Annual Time in Hours
Foreign Governments	30	555	16,650	3	832.5

FSIS estimates that 120 Import Inspection establishments will spend three hours one time developing Sanitation Standard Operating Procedures for a total of 360 hours.

SANITATION SOP PLAN DEVELOPMENT

                                     (9 CFR 304.3(a), 381.22 (a))

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins	Total Annual Time in Hours
Import Inspection	120	1	120	180	360

FSIS estimates that 120 Import Inspection establishments will spend 1 hour 3 times a year evaluating and revising their Sanitation Standard Operating Procedures for a total of 360 responses and 360 hours.

SANITATION SOP PLAN EVALUATION AND REVISION

                                                                  (9 CFR 416.14)

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins	Total Annual Time in Hours
Import Inspection	120	3	360	60	360

FSIS estimates that 120 Import Inspection establishments will spend 30 minutes 260 times per establishment a year for a total of 31,200 responses with recordkeeping associated with their Sanitation Standard Operating Procedures for a total of 15,600 hours.

SANITATION SOP RECORDKEEPING

                                                            (9 CFR 416.16)

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Minutes	Total Annual Time in Hours
Import Inspection	120	260	31,200	30	15,600

FSIS estimates that 120 Import Inspection establishments will spend 5 minutes 260 times per establishment for a total of 31,200 responses a year reviewing records of their Sanitation Standard Operating Procedures for a total of 2,600 hours.

SANITATION SOP RECORD REVIEW

                                                (9 CFR 416.16)

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins	Total Annual Time in Hours
Import Inspection	120	260	31,200	5	2,600

FSIS estimates that 146 respondents will take 20 minutes, 89 times a year, to complete FSIS Form 9010-1 for a total of 12,994 responses and 4,331 hours.

FSIS Form 9010-1 Application for the Return of Exported Products to the United States

                                                (9 CFR 327.17, 381.209, 557.17, 590.965)

Type of Respondent	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins	Total Annual Time in Hours
Applicants	146	89	12,994	20	4,331

The cost to the respondents for electronic importation inspection information collection activities is estimated at $2,289,489 annually. The Agency estimates that it will cost respondents $46.36 an hour, including fringe benefits, in fulfilling these paperwork and recordkeeping requirements. Respondents will spend an annual total of 49,385 hours and $2,289,489. The hourly rate for the respondents was attained from the Department of Labor Bureau of Labor and Statistics wage data, May, 2021.

13. Capital and Start-up Cost and Subsequent Maintenance

There are no related capital and start-up costs associated with these information collection activities.

14. Annual Cost To Federal Government:

The cost to the Federal Government for these information collection requirements is $9,272 annually. FSIS estimates that it will cost the Federal Government $46.36 an hour, including fringe benefits for Agency personnel time.

15. Reasons For Changes In Burden:

There is no change in burden for this 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 number on any instructions it publishes relating to these 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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