SUPPLEMENTARY INFORMATION:

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

OMB Control Number: 0579-0429.

Type of Request: Revision to and extension of approval of an information collection.

Abstract: The Animal Health Protection Act (AHPA, 7 U.S.C. 8301 et seq.) 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. To facilitate the export of U.S. animals and animal products, the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture maintains information regarding the import health requirements of other countries for animals and animal products, including aquaculture animals, exported from the United States.

While APHIS does not currently require the approval or certification of laboratories that conduct disease tests for the export of aquaculture animals, some countries that import these animals from the United States require them to be tested for certain diseases and the test results recorded on the export certificates. In addition, the test results must originate from a laboratory approved by the competent authority of the exporting country, which is APHIS in this case. State, university, and private laboratories can voluntarily seek APHIS approval of individual diagnostic methods. Though APHIS does not have regulations for the approval or certification of laboratories that conduct tests for the export of aquaculture animals, APHIS provides this approval as a service to U.S. exporters who export aquaculture animals to countries that require this certification.

APHIS evaluates diagnostic methods for detecting aquatic animal pathogens listed by the World Organization for Animal Health (WOAH) in the WOAH diagnostic manual and other supporting scientific literature. APHIS lists the laboratories approved to conduct diagnostic testing in support of export health certification of aquatic species at https://www.aphis.usda.gov/​sites/​default/​files/​approved-labs-aquaculture.pdf. Once approved, the laboratories are inspected by APHIS every 2 years to maintain their approval.

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.

We are asking OMB to approve our use of these information collection activities, as described, for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate 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; ( printed page 42558)

(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public burden for this collection of information is estimated to average 4.3 hours per response.

Respondents: State, university, and private laboratory personnel.

Estimated annual number of respondents: 9.

Estimated annual number of responses per respondent: 47.

Estimated annual number of responses: 419.

Estimated total annual burden on respondents: 1,806 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.