1018-0078 Ssa 05162023

Supporting Statement A for

Paperwork Reduction Act Submission

Injurious Wildlife; Importation Certification for

Live Fish and Fish Eggs, 50 CFR 16.13

OMB Control Number 1018-0078

Terms of Clearance. None.

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection.

The U.S. Fish and Wildlife Service (Service, we) is responsible for enforcing the Lacey Act (Act, 18 U.S.C. 42) that prohibits the importation of any animal deemed to be and prescribed by regulation to be injurious to human beings; the interests of agriculture, horticulture, forestry; or wildlife or the wildlife resources of the United States.

The Act and regulations at 50 CFR 16 allow the importation of animals classified as injurious if the importer meets specific criteria. We use the information to determine if the importers meet these criteria. Specifically, this collection allows us to approve the importation of live salmonids or their reproductive products into the United States.

2. Indicate how, by whom, 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. Be specific. If this collection is a form or a questionnaire, every question needs to be justified.

The importation of salmonids or their reproductive products is a three-step process. The first step is a request by the importer to bring the animals into the country. The request must provide information on the source and destination of the animals or reproductive products, as well as the quantity, species, and life stage of the desired import.

The second step requires that a certified Title 50 Inspector submit a health certification. We must inspect imported animals or reproductive products for specific pathogenic organisms. This certification must contain specific information about the animals or reproductive products to be imported and the finding of the disease assays performed. In addition, the certification must provide the site of border crossing, dates of importation, and/or other information aimed at accurately identifying the proposed imported animals and reproductive products. This allows the Service to track the animals and ensure the safety of both the commercial and natural aquatic resources of the United States. The Director of the Service designates “Certifying Title 50 Inspectors” (50 CFR 16.13(b)(1)). To ensure the qualifications of Title 50 Inspectors, the Service requires an application from the inspectors regarding their professional credentials and facilities used to perform Title 50 inspection work.

The final step in the process is to consult with the State natural resource agency of the State of import and ensure that the agency agrees with issuance of a permit. If the State does not raise any objections, we issue an authorization for importation. We use the following forms to collect the necessary information:

FWS Form 3-2273 (Title 50 Certifying Official Form). New applicants and those seeking recertification as a Title 50 Certifying Official provide information so that we can assess their qualifications. Those designated as Title 50 Certifying Officials must use this form to recertify their credentials every 5 years. Information includes, but is not limited to, the following:

• Name, position title, current place of employment (with address) and work phone number, fax number, and e-mail address.

• Professional degrees.

• Primary duties.

• Areas of expertise and related certifications.

• Facilities available for diagnostic tests and available equipment.

FWS Form 3-2274 (U.S. Title 50 Health Certification Form). The Certifying Official uses this form to affirm the health status of the fish or their reproductive products to be imported. The Title 50 Certifying Official must complete and submit this form with every import. We do not share the information derived with organizations outside the Service. Information includes, but is not limited to, the following:

• Certifying official’s name and date of most recent certification.

• Number, life stage, and species of animals or eggs.

• Site and date of sample collection.

• Name and address of laboratory conducting the assays.

• Shipment origination site for all animals or eggs.

• Dates of the shipment.

• Means of shipment and anticipated border crossing.

FWS Form 3-2275 (Title 50 Importation Request Form). The Service uses the information on this form to ensure the safety of the shipment and to track and control importations. The importer must complete and submit this form with every import. We do not share the information derived with organizations outside the Service. Information includes, but is not limited to, the following:

• Name and address of company/agency and facility receiving animals or eggs.

• Number, life stage, and species of animals or eggs.

• Origin of animals or eggs.

• Name and address of exporter.

With this submission, we updated FWS Forms 3-2273 and 3-2275 to clarify the information collected. We did not make any updates to Form 3-2274. We also plan to begin publishing, with OMB approval, the results of this information collection for Form 3-2273 on a publicly accessible, Service-managed webpage to inform importers of Certified Signing Officials by country of origin.

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 and specifically how this collection meets GPEA requirements.

Respondents may submit FWS Form 3-2275 by e-mail, and we estimate that approximately 80 percent of the responses will be by electronic means. FWS Forms 3-2273 and 3-2274 require an original signature; however, the respondent may sign, scan, save as a PDF document, and submit the form electronically. All of the forms are available online in a fillable and printable format at https://www.fws.gov/service/steps-importing-salmonids-united-states-america

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

The Service does not collect duplicate information and we are not aware of any other Federal agency that collects information of this type.

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

The impact on small entities will be minimal; generally 30 minutes to 1 hour to complete the forms. We collect only the minimum information necessary for us to carry out our responsibilities under the Lacey Act.

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.

If we collect this information less frequently or cease collecting this information, it will delay or cease the importation of fish and their reproductive products into the United States. If importation continued without us collecting this information, we would be unable to assess the health of, monitor, or track imported fish or their reproductive products. This would jeopardize the health of our Nation’s commercial aquaculture industry and natural fishery resources serving states, Tribes and Federal hatcheries. Ceasing the importation of fish and their reproductive products would negatively affect U.S. fisheries and may create tensions with our international trading partners.

7. Explain any special circumstances that would cause an 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 secrets, 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.

Not applicable. We do not collection any information in a manner inconsistent with OMB guidelines.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and in response to the PRA statement associated with the collection over the past three years, and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

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 format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every three years — even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

On February 14, 2023, we published in the Federal Register (88 FR 9532) a notice of our intent to request that OMB approve this information collection. In that notice, we solicited comments for 60 days, ending on April 17, 2023. In an effort to increase public awareness of, and participation in, our public commenting processes associated with information collection requests, the Service also published the Federal Register notice on Regulations.gov (Docket No. FWS-HQ-FAC-2023-0002) to provide the public with an additional method to submit comments (in addition to the typical [email protected] email and U.S. mail submission methods). We received no comments in response to that notice.

To validate time burden estimates, we consulted with the nine (9) individuals identified in Table 8.1 familiar with this collection of information. We asked for their response to the quoted statements below. This was done in addition to the Federal Register Notice.

Organization Title

AquaBounty Farms Indiana Director of Canadian Operations

Dug Brook Salmon Hatchery Fish Health Manager

Icelandic Food and Veterinary Authority Veterinary Officer for Fish Diseases

Aquatic Diagnostic Services Title 50 Certified Signing Official

Superior Fresh Assistant Aquaculture Systems Manager

The Conservation Fund Freshwater Institute Director of Research

Kennebec River Biosciences Title 50 Certified Signing Official

Research and Productivity Council Title 50 Certified Signing Official

Atlantic Sapphire, LLC Harvest Manager

“Whether or not the collection of information is necessary, including whether or not the information will have practical utility; whether there are any questions they felt were unnecessary”

All respondents indicated that all of the information requested on each form was necessary.

Comments: Input was provided on the format on Form 3-2273. The commenter asked whether or not official transcripts and/or certification of competence by governments, universities, or employers are asked for, and if not, they should be to confirm competence of applicant.

Agency Response to Comment 1: The provisions of 50 CFR 15.13 do not specifically ask for official transcripts and/or certification of competence, only that the applicant show competency to carry out the provisions of the regulation and be experienced in aquatic animal health.

Comment 2: Input was provided on the Format on Form 3-2275. The commenter asked if the Service has the ability to determine if the fish or eggs arrive at the facility within the U.S., if not this would be useful to avoid possible delivery to an unknown/unauthorized facility. This could be easily done using a shipment tracking number which the facility would provide to Service to affirm the delivery was completed. Also, it may be useful to have the Service confirm that the State Agency involved with importation and disease assessment has also been completed.

Agency Response to Comment 2: The Service does track imports through U.S. Fish and Wildlife Service Declaration for Importation or Exportation for Fish or Wildlife (FWS Form 3-177).

“What is your estimate of the amount of time it takes to complete each form in order to verify the accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used”

All respondents indicated that amount of time it takes to complete each form was appropriate.

Comments: No relevant comments. Everyone who responded indicated that the estimated burden for this collection was generally accurate.

Agency Response/Action Taken: No action necessary

“Do you have any suggestions for us on ways to enhance the quality, utility, and clarity of the information to be collected”

Comment 1: Input was provided on the format on Form 3-2273. The commenter suggested better or more thorough vetting of applicant competence and qualifications.

Agency Response to Comment 1: The Service makes great efforts to vet all applicants objectively and effectively.

Comment 2: Input was provided on the Format on Form 3-2274. The commenter suggested it may be useful to have a copy of the official diagnostic lab results provided, either separately to the Service, but not necessarily attached to the Certificate. This could be easily accomplished by uniquely number each certificate and then uploading diagnostic reports for each certification to a password protected Service server. In this regard every Title 50 official would have a unique password to upload files.

Agency Response to Comment 2: The Service is does allow for electronic submission and does track individual shipments through an internal database.

“Any ideas you might suggest which would minimize the burden of the collection of information on respondents, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of response”

Comment 1: Input was provided on the format on Form 3-2273. The commenter suggested the Service accept all submissions electronically completed initially, and then hard copies or scans of hard copies of necessary qualifications documents should be submitted.

Agency Response to Comment 1: The Service presently accepts submissions electronically.

Comment 2: Input was provided on the format on Form 3-2274. The commenter suggested that all submission should be electronically completed initially, and they hard copies or scans of hard copies of necessary qualifications documents should be submitted via an upload to a password protected Service server.

Agency Response to Comment 2: The Service is does allow for electronic submission and does track individual shipments through an internal database.

Comment 3: Input was provided on the format on Form 3-2275. The commenter suggested that all submission should be electronically completed initially, and they hard copies or scans of hard copies of necessary qualifications documents should be submitted via an upload to a password protected Service server.

Agency Response to Comment 3: The Service is does allow for electronic submission and does track individual shipments through an internal database.

“Any additional comments/feedback you would like to provide us.”

Comment 1: Input was provided on Form 3-2274 An additional comment was provided, that asked whether the USFWS does onsite visits to confirm diagnostic facilities are up to date and capable of providing quality assurance results. The commenter also suggested any lab completing Title-50 work be at ISO1725 or have a validated quality assurance program in place.

Agency Response to Comment 1: The provisions of 50 CFR 15.13 do not specifically call for onsite visits to confirm diagnostic facilities are up to date and capable of providing quality assurance results.

Comment 2: Input was provided on Form 3-2274. The commenter asked if the Service does onsite visits to confirm diagnostic facilities are up to date and capable of providing quality assurance results. It was suggested that any lab completing Title-50 work be at ISO17025 or have a validated quality assurance program in place.

Agency Response to Comment 2: The provisions of 50 CFR 15.13 do not specifically ask for onsite visits to confirm diagnostic facilities are up to date and capable of providing quality assurance results.

Comment 3: Input was provided on Form 3-2274. The commenter asked if the USFWS does onsite visits to confirm diagnostic facilities are up to date and capable of providing quality assurance results. It was suggested that any lab completing Title-50 work be at ISO17025 or have a validated quality assurance program in place.

Agency Response to Comment 3: The provisions of 50 CFR 15.13 do not specifically ask for onsite visits to confirm diagnostic facilities are up to date and capable of providing quality assurance results.

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

We do not provide payment 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.

We do not provide any assurance of confidentiality. Information from this system of records may be disclosed in accordance Freedom of Information Act (5 U.S.C. 552); the Privacy Act of 1974 (5 U.S.C. § 552a) and the routine uses listed in System of Records Notice INTERIOR/FWS–21, Permits System, September 4, 2003, 68 FR 52610; modification published March 16, 2023, 88 FR 16277.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and 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.

We do not ask questions of a sensitive nature.

12. Provide estimates of the hour burden of the collection of information.

We estimate that we will receive 116 responses totaling 54 burden hours. We estimate the annual dollar value of the burden hours is $4,200 (rounded).

We used Table 29-1131 Veterinarians of the Bureau of Labor Statistics (BLS) Occupational Employment and Wages, May 2022, to determine the average hourly wages.

• Private Sector – Table 29-1131 states a mean hourly rate of $62.65 for “Other Professional, Scientific, and Technical Services.” In accordance with Bureau of Labor Statistics (BLS) News Release USDL-23-0488, March 17, 2023, Employer Costs for Employee Compensation—December 2022, we multiplied this rate by 1.41 for private sector workers to calculate benefits, resulting in a fully burdened rate of $88.34.

• State/Tribal Government – Table 29-1131 states a mean hourly rate of $43.07 for government workers. In accordance with the BLS News Release USDL-19-2195, we multiplied this rate by 1.61 for government workers to calculate benefits, resulting in a fully burdened rate of $69.34.

Average Average Average Average Estimated

Number of Number of Number of Completion Annual $ Value of

Annual Responses Annual Time per Burden Hourly Annual

Requirement Respondents Each Responses Response (Hr) Hours* Rate Burden Hours

FWS Form 3-2273 (Title 50 Certifying Official Form)

Private Sector 9 1 9 1 9 $ 88.34 $ 795.06

Government 7 1 7 1 7 69.34 485.38

FWS Form 3-2274 (U.S. Title 50 Health Certification Form)

Private Sector 10 2 20 .5 10 88.34 883.40

Government 15 2 30 .5 15 69.34 1,040.10

FWS Form 3-2275 (Title 50 Importation Request Form)

Private Sector 10 2 20 .25 5 88.34 441.70

Government 15 2 30 .25 8 69.34 554.72

TOTALS: 66 116 54 $ 4,200.36

* Rounded

13. Provide an estimate of the total annual non-hour cost burden to respondents or record keepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected in item 12.)

* The cost estimate 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. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information (including filing fees paid for form processing). Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

* If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collection services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.

* Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

There is no non-hour dollar cost burden to respondents.

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information.

The annual cost to the Federal Government for this information collection is approximately $6,712 (rounded) ($115.73/hour X 58 hours). These costs are primarily for staff time (GS-14/5) to review and process the forms. Review and processing time varies from 15 minutes to 1 hour depending on the activity, with an average of 30 minutes per response. Therefore, we estimate 58 hours annually for this collection. The Office of Personnel Management Salary Table 2023-DCB lists the hourly wage for a GS-14/step 5 as $71.88. In accordance with BLS News Release USDL-23-0488, we multiplied this rate by 1.61 to calculate benefits, resulting in an hourly rate of $115.73.

15. Explain the reasons for any program changes or adjustments in hour or cost burden.

We are not reporting any program changes or adjustments in hour or cost burden.

16. For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

We will publish the results for Form 3-2273 contained in this information collection on a publicly accessible, Service-managed webpage to inform importers of Certified Signing Officials by country of origin.

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.

We will display the OMB control number and expiration date.

18. Explain each exception to the topics of the certification statement identified in "Certification for Paperwork Reduction Act Submissions."

There are no exceptions to the certification statement.

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