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USDA Submission for OMB Review: Aquatic Animal Test Lab Approval

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Detected March 17th, 2026
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Summary

The Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) has submitted an information collection for OMB review concerning the approval of laboratories for conducting aquatic animal tests for export health certificates. Comments are requested on the necessity, utility, and burden of this collection.

What changed

The U.S. Department of Agriculture (USDA), through its Animal and Plant Health Inspection Service (APHIS), has submitted an information collection requirement (OMB Control number 0579-0429) to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. This submission pertains to the "Approval of Laboratories for Conducting Aquatic Animal Tests for Export Health Certificates." While APHIS regulations do not currently mandate approval for these laboratories, certain importing countries require testing results from an APHIS-approved entity. The proposed collection aims to establish a voluntary approval process for laboratories to meet these international export requirements, thereby supporting U.S. exporters of aquaculture animals.

Regulated entities, specifically laboratories that wish to test aquatic animals for export to countries requiring such certification, should be aware of this submission. The public is invited to submit comments on the proposed information collection by March 25, 2026, via www.reginfo.gov/public/do/PRAMain. The collection involves notification of intent, application submission, protocol statements, recordkeeping of diagnostic reports and quality assurance plans, and notification of protocol changes. The agency is seeking input on the practical utility, accuracy of burden estimates, and methods to minimize the collection burden.

What to do next

  1. Submit comments on the proposed information collection by March 25, 2026, via www.reginfo.gov/public/do/PRAMain.
  2. Review the information collection requirements for laboratory approval for aquatic animal export testing.
  3. Assess the necessity and utility of the proposed information collection for laboratories seeking export approval.

Source document (simplified)

Content

The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance
under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding; whether the collection of
information is necessary for the proper performance of the functions of the agency, including whether the information will
have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions
used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden
of the collection of information on those who are to respond, including through the use of appropriate automated, electronic,
mechanical, or other technological

  collection techniques or other forms of information technology.

Comments regarding this information collection received by March 25, 2026 will be considered. Written comments and recommendations
for the proposed information collection should be submitted within 30 days of the publication of this notice on the following
website www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using
the search function. An agency may not conduct or sponsor a collection of information unless the collection of information
displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection
of information that such persons are not required to respond to the collection of information unless it displays a currently
valid OMB control number.

Animal and Plant Health Inspection Service

Title: Approval of Laboratories for Conducting Aquatic Animal Tests for Export Health: Certificates

OMB Control number: 0579-0429.

Summary of Collection: The Animal Health Protection Act (APHA) of 2002 is the primary Federal law governing the protection of animal health. The
AHPA 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. Disease prevention is the most effective method for maintaining
a healthy animal population and enhancing the ability of U.S. producers to compete in the global market of animal and animal
product trade. Animal and Plant Health Inspection Service (APHIS) regulations do not require approval or certification for
laboratories conducting disease tests for the export of aquaculture animals. However, as a condition of entry, some countries
require testing results from a laboratory approved by the competent authority, in this case APHIS. States, universities, and
private laboratories can voluntarily seek approval to test for specific diseases. APHIS provides laboratory approval as a
service to U.S. exporters who ship aquaculture animals to countries requiring this certification. The AHPA is contained in
Title X, Subtitle E, Sections 10401-18 of Public Law 107-171, May 13, 2002, the Farm Security and Rural Investment Act of
2002.

Need and Use of the Information: The approval of laboratories to conduct tests for the export of aquaculture animals requires the use of certain information
collection activities including notification of intent to request approval, application for APHIS approval, protocol statement,
submission and recordkeeping of sample copies of diagnostic reports, quality assurance/control plans and their recordkeeping,
notification of proposed changes to assay protocols, recordkeeping of supporting assay documentation, and request for removal
of approved status. If APHIS did not collect this information, U.S. producers would be prevented from exporting aquaculture
animals and products to countries that specifically require APHIS approved laboratories to certify they have performed aquatic
animal pathogen detection procedures.

Description of Respondents: Business or other for-profits; State, Local or Tribal.

Number of Respondents: 9.

Frequency of Responses: Recordkeeping; Reporting: On occasion.

Total Burden Hours: 1,806.

Levi S. Harrell, Departmental Information Collection Clearance Officer. [FR Doc. 2026-03553 Filed 2-20-26; 8:45 am] BILLING CODE 3410-34-P

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Classification

Agency
ERS
Compliance deadline
March 25th, 2026 (8 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Consultation
Change scope
Substantive

Who this affects

Applies to
Manufacturers Government agencies
Geographic scope
National (US)

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Food Safety International Trade

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