I, Shaleen Narayan, Manager Approvals Operations, of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, give notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), that a decision has been made to reassess the following trade name product under section 29 of the Act:

Purpose of Reassessment

The purpose of the reassessment is to re-evaluate the approved label information, use patterns, and regulatory controls on the trade name product containing semduramicin named below to ensure these controls will manage risks to public health, trade in primary produce, animal welfare, and agricultural security as required under the Act.

The focus of the reassessment will be to:

• Confirm the residue profile for the active ingredient, and associated maximum residue levels; and
• Ensure the products are not used for growth or yield promotion in ruminants.

The trade name product to be reassessed is Aviax (ACVM Registration Number A011658).

Further information about the trade name product listed above, including details of their approved uses and target species, can be found on the ACVM Register at https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.

Any person may make a written submission to the director-general concerning this application.

Each submission must state the trade name product(s) to which the submission pertains.

Under sections 16 and 17 of the Act, a written submission:

1. must state in full the reasons for making the submission; and
2. may state any decision sought on that application; and
3. must be received by the director-general no later than 30 working days after the date of notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

If you wish to provide a submission, please email your submission to ACVM.consultation@mpi.govt.nz. MPI encourages respondents to forward comments by email.

If you wish to forward a submission by post, the following address is:

1. where submissions on this application are to be sent; and
2. where requests for copies of the public information relating to the application can be sent; and
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Programmes and Appraisals, New Zealand Food Safety, Ministry for Primary Industries, PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Phibro Animal Health Pty Limited, Suite 416, 14 Lexington Drive, Bella Vista, New South Wales 2153, Australia.

Dated at Wellington this 14th day of October 2024.

SHALEEN NARAYAN, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).