Vertebrate toxic agent registration and best practice tips

Key points to help users meet compliance requirements

July 2010

Vertebrate toxic agents (VTAs)

Vertebrate toxic agents include:

all products that claim to kill or control a vertebrate

any substance used with the intended purpose of killing or limiting the viability of individual, or populations of, animals

products that have a negative effect on reproduction.

Registration is required

Any VTA product used in New Zealand must be registered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act, which is designed to manage risks to:

agricultural security

animal welfare

public health

trade in primary produce

and to avoid non-compliant residues in food.

(There are some exempt categories (repellents/attractants) but these are still subject to conditions under Schedule 2 of the ACVM Regulations.)

For trials, registration can be research or provisional registration.

You must hold a research/provisional approval before starting trial work.

You must provide ERMA and AEC approvals.

To register a VTA, follow instructions in our Information Requirements and submit applications to the Approvals and ACVM Group of NZFSA. Include:

comprehensive covering letter

real time stability data

justification for all deviations

equivalence data/arguments (cross-referencing)

full data packages for active ingredient.

Remember, applications take time -- early preparation is the key.

Sale and use of VTAs

Kinds of VTAs

There are 3 groups of VTAs:

unrestricted sale/unrestricted use

restricted sale/unrestricted use

restricted sale/restricted use.

The category is determined by NZFSA during the registration process.

Providing information on labels

VTA labels should cover information on:

bait preparation, application directions

restrictions on use, stock withholding period

if a Controlled Substances Licence is required

if the product is to be used only in a suitable bait station.

VTAs must not be used off-label. This is achieved via

label statements, eg ‘By law ...’

compliance with general and product specific conditions (found on our website).

Best practice in the field

Place baits away from stock/wild game, pets.

Use bait stations (if this is a label requirement).

Comply with conditions of registration (licences, notification, signage, storage).

Report adverse events to NZFSA through 0800 NZFSA1.

Use summary

Always read the label directions.

Use VTAs responsibly.

Ensure compliance with other legislation as well (eg, Hazardous Substances and New Organisms Act, Animal Products Act).

Knowingly breaching the conditions of registration is an offence under the ACVM Act.