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News and Views for March 2009

Revised application forms available

We took on board the comments you made about the 2008 versions of the Product Data Sheet (PDS) application forms and the new forms are now available. We used the ‘majority rules’ principle, so you may not see every suggestion you made reflected in the new forms. We do hope we have come closer to One Size Fits All than One Size Fits None. Thanks for your input.

You will notice a new section in the forms called ‘New Zealand Contact’. This is for overseas companies and has been added at the request of NZFSA’s legal team who reviewed the forms and wanted the ‘contact’ to be distinguished from the ‘agent’, even if it is the same person.

Workshops on new veterinary medicine classification system

March-April 2009

Workshops on the change from prescription animal remedy (PAR) classification to restricted/unrestricted classification are being held throughout the country. South Island and Auckland workshops will take place from 30 March to 8 April. Check out details on the website.

We will provide a summary of the workshops in the next News and Views. However, we would like to clarify one point now. One misconception that has cropped up at several of the North Island workshops is that NZFSA no longer checks product efficacy for veterinary medicines. This is not true — efficacy is considered in all cases where animal welfare would be compromised if the product did not work as claimed or where its use could result in unacceptable pain or distress to the animal being treated. See the Risk Assessment and Hazard Analysis document for more details.

Adverse Event Reporting Programme update

The Adverse Event Reporting (AER) Programme for Veterinary Medicines is a quality assurance programme developed by NZFSA to ensure that all veterinary medicines in the marketplace are:

• safe

• efficacious

• of acceptable quality, and

• used appropriately (including ensuring that product labels provide sufficient consumer information for correct use).

The programme covers adverse event reports involving:

• animal health and welfare issues

• inefficacy, where applicable, and

• residue issues.

There are two complementary components of the AER Programme.

1. The ‘registrant’ component is mandatory. Registrants of veterinary medicines must report the full details of any adverse events that they become aware of for their products.

2. The ‘voluntary’ component encourages veterinarians and the general public (including animal owners, farmers and other product users) to report any adverse events to both NZFSA and the product registrant whenever possible.

What happens once an adverse event report is received?

If an adverse event is reported directly to the product registrant, they will investigate the matter and provide a report to NZFSA. (Reports made directly to NZFSA are copied to the product registrant for immediate investigation.) NZFSA assesses this information and determines whether any further investigative work is required. In some cases, additional expert opinion may be sought. NZFSA also considers scientific information publicly available either on the Internet or from other international regulatory agencies (such as in Australia, UK, Canada or USA).

A standard method of assessment is used to determine whether the adverse event may have been related to the use of a veterinary medicine (ie the ‘causality assessment’). NZFSA also considers whether the product was used according to the label directions.

The person making the report of an adverse event will be advised of the outcome of the investigations as soon as possible. This will include an explanation of whether the observed adverse effects were related to the use of or exposure to the product. NZFSA will explain what these conclusions are and what corrective action recommendations, if any, will be taken. If a causal link is not established between the adverse event and the use of or exposure to the product, or if there is not enough information to make a definite conclusion, then no action may be taken.

Possible regulatory outcomes

Based on evaluation of the investigation information, the causality assessment and whether there have been any other similar reports for the product, NZFSA then determines if any regulatory action is required. This may take the form of:

• additional label warning statements

• product recalls

• formulation or manufacturing process changes, or

• education of product users through the media or other appropriate forums.

New reporting form and guidelines available

The AER form has been updated and is available on the website. We have also developed guidelines for registrants and guidelines for vets/animal owners to help them complete the form. Several veterinarians and registrants commented on drafts of the new form, and we appreciate their input.

Register of Allowable Nutrients amended

Glucosamine levels in the Register of Allowable Nutrients with Known Therapeutic Uses in Exempt Oral Nutritional Compounds are being changed. Information was supplied to NZFSA to support animal safety and show natural levels of glucosamine reach higher levels in pet food than is currently listed. The level will change from a maximum glucosamine inclusion of 500mg/kg to 1300mg/kg.

We reviewed the pet food products registered and found some no longer require registration as a result of this change. The registrants of these products have been notified.

Levels of other nutrients have not changed. The maximum inclusion levels are based on information available to NZFSA at the time the register was developed. If you have information to support changes of other nutrients on the register, you may wish to send us a submission that provides supporting information for animal safety and natural levels in feed.

For further details, check the register.

Ag chem field trip

February 2009, Hastings

Staff from NZFSA and ERMA NZ attended a two-day ag chem field trip. This was a great opportunity to get into the fields/orchards to see the ag chem products we register and regulate. The group viewed apple, grape and herbicide trials, visited AgriVet services and PGG Wrightson’s Store, and got hands-on with some spray equipment. We also viewed large machinery used in commercial spray operations (photo below). Thanks to Colin Sharpe of Dow AgroSciences for the invitation and the arrangements.

Farewell to Paulina

Paulina Rodriguez, who has been a veterinary appraiser with the Group for two years, left us this month to move to Auckland. Paulina obtained her veterinary degree in Mexico and was able to gain a New Zealand veterinary qualification, even though English is a second language for her. We wish her all the best (photo below).

Organisation for Economic Co-operation and Development (OECD) meetings

Warren Hughes attended a number of OECD meetings in San Francisco in February 2009. The purposes of these meetings range from exploring options to minimise risks to use of pesticides to harmonising information requirements between OECD countries to collaboration by regulators on joint reviews of applications for registration of pesticides by registrants. They also provide a forum to discuss matters of mutual interest and to build better networks between regulators.

Highlights from the meetings

• There was a discussion on the role of the OECD maximum residue limit (MRL) calculator and its advantages/disadvantages. This calculator is to assist regulators in determining the appropriate MRL based on residue data points to ensure users follow good agricultural practice (GAP).

• A field trip on spray drift, particularly by aerial application, showed how technologies can help minimise spray drift.  Some suggestions were:

- using the right type of nozzle (meaning the droplet size produced minimises spray drift)

- using GPS for aerial application to avoid over spraying or spraying outside the target area.

An air blaster spray tank with sonic sensors that turn off the spray between tree gaps, particularly at the end of rows, was demonstrated. This developing technology has the potential to reduce amount of spray used and hence reduce spray drift.

• Croplife International gave a presentation on counterfeiting and what regulators can do to assist.

• Joint reviews are increasing, but this raised the issue that documented procedures for both registrants and regulators are lacking.  Documented procedures will aid registrants in outlining criteria for a pesticide to be eligible for joint reviews along with processing of such applications by the regulators.

Working group progress

• Excellent progress is being made on the various residue chemistry guideline documents.

• The Expert Group on Compliance best practice is developing documents in five areas. The first one is on manufacturing.

• The Minor Use Expert Group is making steady progress on looking at options to reduce costs and time for both regulators and industry to support minor uses/crops for pesticides.

• Work is progressing on facilitating exchange of electronic data between regulators and industry.

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This page was last updated on 27 March 2009