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Food Focus June 2009

ACVM under the spotlight

Agricultural chemicals and veterinary medicines imported or manufactured for sale and use in New Zealand are subject to the provisions of the Agricultural Compounds and Veterinary Medicines (ACVM) Act, administered by NZFSA. With more than 2000 products currently registered for sale and use in New Zealand, NZFSA’s ACVM operations programme manager Maree Zinzley takes her role very seriously. We invited Maree to talk about the role her team plays in ensuring NZFSA’s commitments under the ACVM Act are met.

Put very simply, NZFSA’s primary responsibility is to ensure that any product intended for use on animals, plants or primary produce in New Zealand is safe, and does what the product applicant says it is going to do. I guess you could liken our role to that of the Ministry of Health’s, in the sense that they ensure human medicines pose no risk to patients or users. NZFSA ensures agricultural chemicals, such as fertilisers and pesticides, and veterinary medicines pose no risks to public health, trade in primary produce, animal welfare and agricultural security. NZFSA also ensures that the use of these products does not exceed limits set for domestic food residues.

Under the provisions of the Act, NZFSA assesses the risks associated with agricultural chemicals or veterinary medicines to determine their safety and suitability for plants and animals. Before any agricultural chemical or veterinary medicine can be imported, manufactured, sold or administered in New Zealand, NZFSA approval must be sought.

Products undergo robust assessment

NZFSA’s approvals process is very robust because we need to be convinced of the safety and efficacy of the product when it is used as it is supposed to be. The process of registering an agricultural chemical or veterinary medicine for the ‘first timer’ is quite complex. People who are new to the process are encouraged to talk to one of the consultants listed on our website before submitting their application.

Applicants are required to submit a draft product label, a product data sheet (essentially an application form) which includes key information about the product such as if it’s a powder or a liquid, state the intended target animal or plant, and how it will be administered. They must also provide supporting chemical and manufacturing data and proof that the manufacturer has an approved good manufacturing programme (GMP) in place. Every application is assigned a unique ACVM identifying number – if the application is successful, this is the number consumers see printed on the label of a registered trade name product.

Once we are satisfied that the documentation is complete, the file is then handed over to our technical team for review. This team comprises people who appraise the veterinary, agricultural chemical, chemistry, and maximum residue level aspects of each product. There are also a number of specialist experts available.

The criteria used to assess the safety and suitability of an agricultural chemical differs to that of a veterinary medicine. All products must comply with the levels set under the Food Act for residues allowed in domestic foods, and there must be sufficient consumer information available about the product on the label. We also look at the effect the product will have on plants, produce and animals. In the case of veterinary medicines, the appraiser would also consider whether the product is likely to cause any unnecessary pain or distress to the animal. We all know that some medicines cause side effects. We need to be sure that the side effects are not going to compromise the health and wellbeing of the animal during the treatment process. In some instances, appraisers will recommend that an application is approved subject to specific conditions being imposed, such as the product can only be administered by a registered veterinarian.

Before any recommendation can be made to approve an agricultural chemical or veterinary medicine, appraisers must be firmly convinced that the data provided has met the requirements, and that any risks associated with the product can be managed.

Straightforward applications for the registration of brand new chemicals that have been submitted with a complete dossier of information are likely to be approved within six to twelve months. However, for more complex products or where there is insufficient supporting data, or approval is needed from the Environmental Risk Management Authority (ERMA), or the Ministry of Health (MOH), this can take longer.

NZFSA operates a ‘smart-track’ system for simpler applications, for example where a registrant is updating an application due to a change in manufacturer. Registrants of agricultural compounds and veterinary medicines are required to renew their product registrations every three years.

Border control

Agricultural chemicals and veterinary medicines cannot be imported into New Zealand unless they are registered with the ACVM group. MAF Biosecurity New Zealand (MAF BNZ) operates a ‘class determination process’ on behalf of NZFSA at the border. Products purchased overseas that can’t be clearly identified are held in quarantine until MAF BNZ receives notification from NZFSA that the products can be cleared.

Products exempt from registration

Not all products available in the New Zealand market require registration, such as some domestic pet shampoos. As long as the product isn’t making claims to treat or cure a specific condition or disease, and the ingredients are recognised as being safe – they must be listed on NZFSA’s ‘substances generally recognised as safe’ (GRAS) list – the product may be exempt from registration. This is a difficult area to police, especially with the influx of homeopathic products on the market that often claim to treat animal ailments. People need to be aware that they use these types of products largely at their own risk if they don’t have an ACVM registration number printed on the label.

Non-compliance

NZFSA takes non-compliance with the Act very seriously. The best way to tell if an agricultural chemical or veterinary medicine is registered is to look for the unique ACVM identifier number printed on the label. NZFSA also publishes a list of registered trade name products on its website.

People who suspect a product of making false claims, or suspect products of being imported, manufactured, sold or administered illegally are encouraged to report it to NZFSA.

For more information about the ACVM group or to view an up-to-date list of registered agricultural compounds or veterinary medicines visit NZFSA’s website

What are agricultural compounds?

Agricultural compounds are agricultural chemicals and veterinary medicines used in the production of primary produce (farmed plants or animals). They are also used by home gardeners, and for the health of domestic animals such as cats and dogs.

Types of agricultural compounds:

• veterinary medicines, including those used on domestic pets

• agricultural chemicals, including herbicides, fungicides, insecticides, plant growth regulators, surfactants, and adjuvants

• vertebrate toxic agents that are used to kill animals such as possums and rodents

• fertilisers and soil conditioners

• animal feeds, including some domestic pet foods.