0473 2023 Ss (20230531)

May 2023

SUPPORTING STATEMENT

Imports of Live Fish, Fertilized Eggs, and Gametes From

Tilapia Lake Virus (TiLV)-Susceptible Species

OMB Control No. 0579-0473

A. Justification

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict import or export of any animal or related material if necessary to prevent the spread of any livestock or poultry pest or disease. The AHPA is contained in Title X, Subtitle E, Sections 10401-18 of P.L. 107-171, May 13, 2002, the Farm Security and Rural Investment Act of 2002 [7 U.S.C. 8301 et. seq.].

The U.S. aquaculture industry experienced an outbreak of Tilapia Lake Virus (TiLV) in March 2019. The virus can cause high mortality in susceptible fish. Signs of the disease include cloudy or bulging eyes; skin lesions such as darkening, bruising, or ulcers; protruding gills, and abdominal swelling. Fish may move slowly and stop eating. There are currently no treatments or vaccines for the disease.

APHIS determined that the introduction and establishment of TiLV poses a serious threat to U.S. agriculture. An APHIS Preliminary Risk Assessment and Analysis of U.S. Imports and Exports of Live Tilapia, Eggs, and Milt determined the risk posed to relevant industries by the introduction of TiLV via imported tilapia fingerlings (young fish) or the shipping water carrying them as “high.” The assessment also determined a high likelihood that tilapia infected with TiLV will be imported into the United States because the United States currently lacks import regulations certifying tilapia as healthy and disease free; also, there is insufficient global TiLV surveillance and detection. More than 15 countries are considered to be “affected” by TiLV under the assessment, while many more are considered to be “at risk.”

After APHIS determined the United States needed restrictions to prevent the introduction and establishment of TiLV and address the animal health and economic risks associated with imports of live fish, fertilized eggs, and gametes from TiLV-susceptible species, it issued a Federal Order placing certain requirements on importers of these commodities. Importers now must obtain an import permit, submit a health certificate, and undergo an inspection before bringing susceptible commodities into the United States. The APHIS Federal Order import requirements apply uniformly to all live fish, fertilized eggs, and gametes from susceptible species imported into the United States from all countries.

APHIS is asking the Office of Management and Budget (OMB) to approve for 3 years continued use of these information collection activities in connection with its efforts to prevent introduction of TiLV into the United States.

2. Indicate how, by whom, how frequently, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

APHIS uses the following activities to collect information necessary to prevent introduction of TiLV into the United States:

Application for Import or In-Transit Permit (for Live Animals, Animal Semen, Animal

Embryos, Birds, Poultry, and Hatching Eggs) (VS Form 17-129); Federal Order DA-2019‑1; (Business; Foreign Government)

Note: Business and Foreign Government perform this activity and is being corrected in this renewal. The change does not impact the burden.

Businesses or importers seeking to import live fish, fertilized eggs, and gametes from TiLV-susceptible species into the United States must complete an application (VS 17-129) to attain the permit (VS Form 17-135) allowing import of these commodities. The importer must provide his/her name, address, and telephone number as well as the name and address of the shipper in the country of origin. The importer must list the port of embarkation, the country from which the live fish, fertilized eggs, and/or gametes are to be shipped, and the mode of transportation. He/she must also describe the type, number, and identification of the animals to be exported. The importer must further list the origin, intended date and location of arrival, routes of travel, and destination of the animals. APHIS uses the permit applications to track, identify, and monitor animals entering the United States.

Veterinary Health Certificate for the Import of Tilapia into the United States; Federal Order DA-2019‑1; (Business; Foreign Government)

Note: Business and Foreign Government perform this activity and is being corrected in this renewal. The change does not impact the burden.

Businesses or importers seeking to import live fish, fertilized eggs, and gametes from TiLV-susceptible species into the United States must provide an official health certificate issued and endorsed by an official veterinarian of the country of origin’s competent authority. The certificate must accompany the shipment to the port of entry. The health certificate provides the following information:

• The name and address of the consignor.

• The name and address of the consignee.

• The country of origin.

• The port of embarkation.

• The means of transportation.

• The route of travel (country of origin +/- country or countries of transit).

• The designated U.S. port of entry.

• The date of veterinary inspection in the country of origin.

• The total quantity of animals.

• The total number of packages/containers.

• The intended use of the animals (i.e., breeding, culture/grow out, research, human consumption)

The official veterinarian of the exporting country’s competent authority must certify the following statements:

• Either:

• Tilapia from this population to be exported tested negative for TiLV within 30 days prior to export per the World Organization for Animal Health (WOAH)¹ or a laboratory testing method reviewed and approved by APHIS prior to export. Sampling procedures used an assumed pathogen prevalence of 2 percent, with a corresponding confidence level of 95 percent.

• Samples were collected by an official veterinarian or other certifying official representing the competent authority.

Or:

• The facility of origin participates in an ongoing TiLV monitoring program for species susceptible to TiLV, by testing negative twice annually for a minimum of 2 consecutive years, with at least 3 months between tests.

• The facility sampled populations using an assumed pathogen prevalence of 2 percent, with a corresponding confidence level of 95 percent, and found negative for TiLV.

• Samples were collected by an official veterinarian or other certifying official representing the competent authority and tested per WOAH or a laboratory testing method reviewed and approved by APHIS prior to export.

• No OIE-listed disease(s) affecting tilapia was/were reported at the premises of origin within 60 days prior to export.

• The tilapia originated in the exporting country or were legally imported and verified to be of equal health status before entering the population for export.

• The tilapia were inspected by an official veterinarian of the exporting country’s competent authority within 72 hours prior to export and showed no clinical signs of disease.

• All shipping containers are new or have been properly cleaned and disinfected prior to use to ensure removal of organic material and mitigation of diseases of concern the species is susceptible to.

• The shipment will ship directly to the United States with no stops en route other than those provided for on the APHIS import permit.

• After the animal inspection, the health certificate is valid for 72 hours prior to export.

Inspection; Federal Order DA-2019‑1; (Business; State, Local, or Tribal Government)

On arrival at the designated port of entry, the importer, or the importer's agent, must present the original official health certificate and the original APHIS import permit for the live fish, fertilized eggs, and/or gametes to a VS port official. The port official will inspect the shipping containers and the live fish, fertilized eggs, and/or gametes to ensure the accuracy of the information contained in the permit and health certificate. The importer, or the importer’s agent, must notify the VS port official 72 hours in advance of the shipment’s expected arrival to expedite the shipment’s inspection and clearance. The shipment may not be removed until the port official determines that the shipment meets import requirements and releases the shipment.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

Electronic and automated submission methods are minimal, although APHIS accepts electronic permit applications and issues import permits electronically via ePermits. Owners and contractors must provide original signature to the documents. In some situations electronic signatures may be allowed and submitted via email.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purpose described in item 2 above.

The information that APHIS collects in connection with this initiative is not available from any other source. APHIS is the only Federal agency responsible for preventing, detecting, controlling, and eliminating animal diseases from the United States.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

APHIS estimates there are no small entities involved with this information collection. The information collected is the absolute minimum needed to prevent the spread of TiLV.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

Collecting this information less frequently or failing to collect it would make it impossible for APHIS to contain and prevent TiLV outbreaks in the United States.

7. Explain any special circumstances that require the collection to be conducted in a manner inconsistent with the general information collection guidelines in 5 CFR 1320.5, such as:

• 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 3 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.

This information collection is conducted in a manner consistent with the guidelines established in 5 CFR 1320.5.

8. Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting form, and on the data elements to be recorded, disclosed, or reported. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, soliciting comments on the information collection prior to submission to OMB.

APHIS engaged in productive consultations with the following individuals via email or phone in connection with the information collection requirements associated with this renewal. The discussions centered around the necessary information being collected by APHIS to administer the import requirements, how frequently the information is collected; how much data is available; the convenience and clarity of reporting formats and other collection instruments; and the clarity of, and necessity for, any recordkeeping requirements. The respondents expressed no concerns with any of these items and had no further recommendations.

Matt Rice

CIS International Holding Corp.

1405 W. 178^th Street

Gardena, CA 90248

Phone: (310) 515-9469

Email: [email protected]

Lon Michael Baines

Exotic Pet Wholesale

12003 W. Pic Boulevard

Los Angeles, CA 90064

Phone: (310) 801-2235

Email: [email protected]

Mark Goral

Apet, Inc.

195 Prairie Lake Road

East Dundee, IL 60118

Phone: (847) 586-5800

Email: [email protected]

On Friday, December 9, 2022, APHIS published in the Federal Register (87 FR 75586), a 60-day notice seeking public comments on its plans to request a 3-year approval of this collection of information. APHIS did not receive any public comments.

9. Explain any decision to provide any payment or gift to respondents, other than reenumeration of contractors or grantees.

This information collection activity involves no payments or gifts to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

No additional assurance of confidentiality is provided with this information collection.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior or attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

This information collection activity will ask no questions of a personal or sensitive nature.

12. Provide estimates of the hour burden of the collection of information. Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated.

• Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13 of OMB Form 83-I.

See APHIS 71.

• Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories.

APHIS estimates the total annualized cost to these respondents to be $5,126. APHIS arrived at this figure by multiplying the hours of estimated response time (98 hours) by the estimated average hourly wage of the below respondents ($36.10), and then multiplying the result by 1.449 to capture benefit costs.

The average hourly rates used to calculate the estimates include the following:

SOCC Code	Average Salary	Occupation Description
13-1020	$36.13	Buyers and Purchasing Agents
19-1011	$41.28	Animal Scientists
29-1131	$62.07	Veterinarians
45-2011	$23.57	Agricultural Inspectors
45-2093	$17.45	Farmer
	$36.10	Average Hourly Salary

APHIS derived the estimated wage by averaging the following figures from the U.S. Department of Labor; Bureau of Labor Statistics website https://www.bls.gov/oes/current/
oes_stru.htm.

According to DOL BLS news release USDL-23-0488 dated March 17, 2023 (see https://www.bls.gov/news.release/pdf/ecec.pdf), benefits account for 31 percent of employee costs, and wages account for the remaining 69 percent. Mathematically, total costs can be calculated as a function of wages, resulting in a multiplier of 1.449.

13. Provide estimates of the total annual cost burden to respondents or recordkeepers resulting from the collection of information (do not include the cost of any hour burden shown in items 12 and 14). The cost estimates should be split into two components: (a) a total capital and start-up cost component annualized over its expected useful life; and (b) a total operation and maintenance and purchase of services component.

No annual cost burden is associated with capital and startup costs, operation and maintenance expenditures, and purchase of services.

14. Provide estimates of annualized cost to the Federal government. Provide a description of the method used to estimate cost and any other expense that would not have been incurred without this collection of information.

See APHIS Form 79. The annualized cost to the Federal government is estimated at $6,885.

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB Form 83-1.

	Requested	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses	114	0	0	0	0	114
Annual Time Burden (Hr)	98	0	0	2	0	96

This request for renewal is for 114 estimated annual responses and 98 estimated annual burden hours. This renewal corrects the burden distribution for two activities (listed below) by respondent type to include Business and State and the number of estimated responses remains unchanged. There is a 2 hour increase in the total burden hours from the previous renewal request due to a change in the formula calculation.

Activities:

1. Inspection – Importer (Business); Federal Order DA-2019‑1

2. Inspection – Importer (State); Federal Order DA-2019‑1

16. For collections of information whose results are planned to be published, outline plans for tabulation and publication.

APHIS has no plans to publish information it collects in connection with this program.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

Form VS 17-129 is used in multiple information collections with different OMB approval expiration dates. It would not be practical to add an expiration date to this form at this time. APHIS and OIRA are currently developing procedures for creating and maintaining a consolidated intra-Agency common form ICR. Upon the forms’ inclusion in the common form ICR upon its approval, the form will be updated with the appropriate PRA banners, ICR control numbers, and OMB approval expiration dates.

18. Explain each exception to the certification Statement in the "Certification for Paperwork Reduction Act."

APHIS can certify compliance with all provisions under the Act.

B. Collections of Information Employing Statistical Methods

There are no statistical methods associated with the information collection activities used in this program.

1 The World Organization for Animal Health changed its official acronym from OIE to WOAH in June 2022.

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