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News and Views for February 2009

Proposed changes to ACVM Regulations coming soon

NZFSA is working on changes to the ACVM Regulations. These changes consider proposals based on the earlier discussion document (Implementation of the ACVM Act: Regulatory Changes) and stakeholder feedback NZFSA received on it.

Other changes include additions/amendments to the schedules exempting groups of products from registration. A discussion document on the proposed changes should be out in the next couple of months.

How long does the application process take?

How long is a piece of string? It is a bit like that when trying to answer the above question. Every application is different! The table gives you a picture of 2008 application ‘averages’.

Type of application	Number in 2008	Average Net Working Days
A1 New active ingredient	22	37.32
A2 Known active ingredient	38	34.74
B1 Identical to a registered product	7	13.57
B2 Similar to a registered product	119	25.10
B3 Specified requirements product	18	12.83
C1 Formulation change	49	20.84
C2 Manufacturing change	97	15.28
C3 Shelf life change	45	19.53
C4 Target host change	24	28.92
C5 Pest/disease change	23	29.48
C6 Dose/rate change	11	26.82
C7 Administration method change	1	3.00
C8 Withholding period change	14	21.14
C9 Administrative change	674	4.74
C10 Reassessment	1	35.00
Provisional registration	86	14.53

Who can do data assessments?

In the December 2008 News and Views, we explained our policy on data assessors. This generated questions about conflict of interest, so we hope this clarifies the situation.

The rules have not changed. A third party who has acted as consultant should not also be the data assessor.

Chemistry and manufacturing data assessors can be from the applicant's company, provided they declare the potential conflict of interest and have not been involved in any other part of the application process including:

• generating data

• providing advice on the submission

• putting together the data package/label content and/or

• submitting the application (including completion of the product datasheet).

However, we prefer these data assessments to be from an independent third party or NZFSA. Data assessments completed by staff from within the applicant company may be subject to a higher degree of scrutiny.

Other data assessments should be completed by NZFSA or an independent third party (not otherwise involved with the application) contracted by the applicant.

In some cases where there is a very small pool of experts in a given area (eg VTA efficacy or animal welfare assessors) it may be acceptable to use a person who has had some involvement with the application (eg trial work). Generally this should not be someone from the applicant company, and any potential conflict of interest should be declared in the submission. In these circumstances it would also pay to contact us first to confirm use of the proposed assessor is acceptable.

Provide Smart Track supporting information

If you are applying for a formulation change using a C1 Smart Track application, you must provide evidence that the proposed new formulation is covered by an ERMA approval when the application is submitted to us. A Smart Track is intended to be processed both promptly and cheaply, so all the supporting information to allow a decision to be made needs to be supplied with the application.

How about a refund?

We are sometimes asked about annual fee refunds when a registration is cancelled partway through a year. This is rarely an option.

Much of the annual fee goes to compliance activities and this certainly does not stop when a registration ceases. In most instances residue monitoring and other compliance and monitoring activities, including explaining the New Zealand position in the international arena, continue well into the future. In certain cases, cancellations cause extra work in considering the relevance of any existing MRL.

Manufacturers must be approved

In the ‘slice of life’ compliance checks, we have discovered that some agricultural chemical registrants are sourcing actives from manufacturers who are not approved. We remind you that using only approved manufacturers is a condition of registration.

There are two ways of complying with this requirement:

• you can have possible as well as actual manufacturers approved when you register your product, so you are in compliance if you have to change suppliers

• you can request a variation to your registration.

Aminoglycoside reassessment reminder

This is a further reminder that NZFSA will begin a reassessment of certain veterinary medicines containing antimicrobials in the aminoglycoside class on 1 July 2009.

The reassessment is in response to the report of the Antimicrobial Resistance Expert Panel (30 August 2005) and the advice of the Antimicrobial Resistance Steering Group.

Recommendations

The recommendations of the Expert Panel and the Steering Group concluded that for products containing aminoglycoside antibiotics the following should apply:

• Evidence of synergistic effect and enhanced efficacy of mixtures of β lactam and aminoglycoside should be required at the time of their next registration.

• Oral aminoglycosides, alone or in combinations, should not be used to treat non-specific enteric infections in groups of food-producing animals. If used to treat gut infections, their selection should be confirmed by bacteriology and susceptibility testing.

Reassessment

The aim of the reassessment is to:

• ensure there is adequate supporting evidence to justify the continued use in terms of synergistic effect and enhanced efficacy of mixtures of β lactam and aminoglycoside antimicrobial (intramammary and injectable products)

• ensure oral amingoglycosides are not marketed for use to treat non-specific enteric infections in groups of food-producing animals (mainly oral scour treatments).

Products

There are good animal health and welfare reasons to retain injectable and topical aminoglycosides as prescription veterinary medicines. However, injectable and intramammary combinations of aminoglycosides with β lactam antimicrobials are to be included in this reassessment. Topical preparations for use on skin, eyes or ears are not included.

Affected registrants should have been contacted in 2007 and reminded in 2008 regarding the intended reassessment. If you have a product that you feel may be affected and have not been notified, contact us as soon as possible to discuss requirements.

Time frame

As mentioned above, the reassessment will begin on 1 July. This time frame was selected following consultation with registrants to allow sufficient time to bring their products in line with the recommendations prior to the commencement of the reassessment.

Registrants have been reminded previously there will be no time extensions given beyond the formal reassessment period. You have been advised to submit applications well in advance of the proposed reassessment commencement date to allow sufficient time for further information or label changes to be processed. Reassessments will be completed within usual statutory timeframes. Continued sale or marketing of products that do not meet the requirements of the reassessment will not be allowed beyond the end of the reassessment period. If this is likely to cause any concerns, please contact us immediately.

Note to affected registrants

You are again reminded to submit applications well before the review commences to allow plenty of time to bring your products into conformance. Please:

• submit applications as soon as possible

• notify us of your intentions for your affected products before 1 July 2009.

This will assist with planning workloads and resources during the reassessment period.

For further information on the review and reassessment, contact Lucy Johnston, Advisor (ACVM Standards-Animals). Email: lucy.johnston@nzfsa.govt.nz

AVMAC/ILG update

The membership of the Agricultural Compounds and Veterinary Medicines Advisory Council (AVMAC) and the Industry Liaison Group (ILG) has been reviewed against the issues that are expected to come up in the next few years.

A number of these issues (antimicrobial resistance, animal feeds, classification of PAR products, implementation of the ACVM Act, APVMA alignment etc) have the potential to impact on the pork industry, so the Pork Industry Association of New Zealand (PIANZ) will now be represented at the two groups by Francis Clements.

Meeting dates for 2009 are posted on the website.

Antimicrobial Resistance Steering Group meeting

The Antibiotic Resistance Steering Group is likely to meet in March 2009. The Group normally meets at least once a year to consider matters of interest relating to antimicrobial resistance.

Workshop feedback results

In December we posted a survey asking for feedback on the October workshops held in Auckland. Because attendance at the workshops was low, we wanted to find out what timing and content would be better for you. We did not receive any replies. If you have any comments, please contact us (link at end).

Dow AgroSciences field trip

February 2009, Hastings

Dow AgroSciences has invited NZFSA, ERMA and Ministry for the Environment staff to attend a two-day field trip this month. The group will:

• view apple and grape trials

• visit AgriVet services

• visit Skeltons agchem store

• visit a helicopter operation in central Hawkes Bay. 

Upcoming international meetings

The following gives you a ‘heads up’ on meetings of ACVM interest.

Codex Committee on Pesticide Residues

April 2009, Beijing

• NZFSA’s Warren Hughes and Dave Lunn will attend this annual meeting, which sets Codex maximum residue limits (MRLs).

• Of interest this year is a report on the working group on minor uses/crops and whether JMPR (the technical body that evaluates residue and toxicological submissions) should work on such submissions prior to at least one national authority approving a pesticide. This scheme is being considered to facilitate evaluations at the national level and, where possible, to have harmonised MRLs where good agricultural practice (GAP) is similar in all countries.

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

February 2009, San Francisco

• Warren Hughes will attend the Registration Steering Group (RSG) and Risk Reduction Steering Group (RRSG) meetings. There will also be a side meeting to discuss ‘joint reviews’ (regulators from various countries working together to evaluate a submission from a chemical company).

• Of interest at the meeting is the progress of Expert Groups developing standards and guidelines in the areas of residue chemistry, minor use/crops, and compliance. Also the RRSG will consider a project on pesticide counterfeiting and illegal trade.

June 2009, Paris

• The OECD Working Group on Pesticides meeting will be held in late June (both the RSG and RRSG report to this Group).

November 2009, Japan

• The next RSG and RRSG meetings will be held in November.

• In addition, the OECD is streamlining these meetings so the schedule will change in 2010. This will mean one less meeting every second year.

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This page was last updated on 17 February 2009