- Print Friendly - Help

News and Views for December 2008

ACVM Act implementation proposals modified

Our first public discussion document on regulatory change discussed proposals on manufacturing, labelling, own use, advertising and off-label use. Based on the submissions received and legal advice, some of the proposals are either not being progressed at this time or the approach has been modified.

No regulations for manufacturing, labelling and advertising

We are no longer proposing to make regulations for manufacturing, labelling and advertising requirements for registered trade name products. It has been concluded that decisions need to be on a case by case basis and the regulation making powers under the Act may be insufficient for these areas. Therefore, they will be dealt with as conditions of registration.

Regulations for products exempt from registration will be developed

Regulations for products exempt from registration can be progressed. The specifics for these, along with normal additions, deletions or amendments to the schedules in the ACVM Regulations on exemptions, will be in a public discussion document that is likely to be released in the New Year.

Special circumstances policy modified and off-label use proposal removed

The policy on special circumstances has been modified and the off-label use proposal has been removed because it may not be sustainable under the Act.

Work underway on document conversion

The information requirements documents are being updated. A number of standards and guidelines are being converted into information requirements (eg chemistry, efficacy, residues). This project affects dozens of documents and is proceeding slowly as time permits.

We will soon begin converting relevant codes of practice to ‘approved operating plans’. Owners of these codes will be contacted.

The first public discussion document is on our website.

‘Registration by reference’ for some vet meds in 2009

We plan to implement ACVM registration by reference to Australian Pesticides and Veterinary Medicines Authority (APVMA) registration for certain veterinary products in the New Year. The proposal was discussed at this year’s ACVM workshop and is now in the final stages of development with APVMA.

Products for non food-producing animals will be ‘eligible’

We consider that the APVMA registration of products for non food-producing animals is sufficient to support our risk management decisions in regard to ACVM registration of products. APVMA assessments are comprehensive and equivalent to those carried out by NZFSA. We consider that these can be used in lieu of data assessments by NZFSA, reducing the need for applicants to supply additional assessments.

APVMA assessments used as a basis for applying conditions of registration

This is not a mutual recognition initiative. APVMA assessments will be used by NZFSA as the baseline for its consideration of applications for registration. Conditions of registration and labelling requirements will still be imposed by NZFSA as required under the ACVM Act and as appropriate for New Zealand circumstances.

See ACVM Registration by Reference to APVMA Registration, which should be on the website by the time you are reading this, for further details.

Who can do data assessment for applications?

Chemistry and manufacturing: Companies can do their own data assessment for registration applications as long as the data assessor is not the person who generated the data and he/she has the appropriate qualifications and/or experience.

All other data packages: Ideally, an independent data assessor should do these. However, if there are no independent experts and data assessment has to be done by someone within the company, the data assessor:

• cannot be the person who generated the data

• must explain the position and any conflict of interest

• should detail the relevant qualifications/experience.

Last round of MRLs gazetted

The last round of maximum residue limits (MRLs) was gazetted on 5 November 2008. It amended the entries for Clomazone, Cyprodinil, Emamectin benzoate, Fenbendazole, Mandipropamid, Pyraclostrobin, Boscalid, Monepantel, 1-Naphthylacetic acid and Oxfendazole.

The public discussion document is close to being finalised and the proposed amendments are:

New MRLs

• 0.1mg/kg for boscalid in kiwifruit

• 0.05mg/kg for boscalid in stonefruit

• 3mg/kg for carbaryl in cabbages and tomatoes as a replacement for 3mg/kg for carbaryl in vegetables

• 0.01mg/kg for cyprodinil in bulb onions

• 0.5mg/kg for fenitrothion in cereals as a replacement for 10mg/kg for fenitrothion in cereals

• 0.01mg/kg for fludioxonil in bulb onions

• 0.5mg/kg for methomyl in berries and other small fruits, and fruiting vegetables(except cucurbits) as a replacement for 0.3mg/kg in berries and other small fruits, and fruiting vegetables(except cucurbits)

• 0.01mg/kg for propiconazole in olives

• 0.02mg/kg for pyraclostrobin in kiwifruit and stonefruit

• 0.1mg/kg for pyriproxyfen in cucumbers

• 1mg/kg for pyriproxyfen in tomatoes

• 2mg/kg for spinosad in sheep fat as a replacement for 0.2mg/kg in sheep fat

• 0.5mg/kg for spinosad in sheep kidneys and liver as a replacement for 0.05mg/kg in sheep kidneys and liver.

New MRL exemptions

• Benzalkonium chloride when used as a fungicide on kiwifruit and olives

• Boric acid when used as a fungicide for wound treatment

• Iron-EDTA complex when used as a molluscicide

• Iron phosphate when used as a molluscicide

• Salicylic acid when used on fruit.

MRL deletions

• MRLs for Bitertanol, Famphur and Parathion-methyl.

Timetable for public discussion document uncertain

The previous Government required Cabinet sign-off of public discussion documents. Because we do not know if this arrangement will continue with the new Government, we think it is likely that the public discussion document will be released in the New Year, rather than before Christmas.

Antibiotic sales down 11.9% on 2005/06

Total sales of prescription veterinary medicines containing antibiotics in the 2006/07 year have decreased to levels similar to the 2002/03 year, and are down 11.9% on 2005/06 sales.

See NZFSA’s latest report on antibiotic sales for details.

Reports from international meetings

The following summaries of recent international meetings provide you with ACVM highlights.

New Zealand chairing OECD Working Group on Pesticides

4-5 November 2008, Paris

At its 23^rd meeting, the OECD Working Group on Pesticides elected the head of the New Zealand delegation, John Reeve (NZFSA Principal Adviser Toxicology, pictured above), as its Chair for the next three years. John has attended the meetings of this group since 1996, and has established New Zealand as one of its most respected members. He had been vice-Chair for the last three years and his progression to Chair came as no surprise.

This group has a reputation for a very high work output. Its meetings are always conducted with good humour, and it has not been fraught with politics. Compromise has always been easily obtained, and these ethics are not expected to change under its new Chair.

Goal is to harmonise data requirements for pesticide registration

The group’s major goal is to harmonise data requirements for pesticide registration throughout the OECD and countries adhering to its Mutual Acceptance of Data principles. Its major vision is to have a single data package reviewed once in the OECD. Countries would be able to use the single monograph from this review to carry out their own risk management and register the pesticide in their own regulatory systems. This would include the setting of MRLs, subject to their own country-specific Good Agricultural Practice.

Progress in the toxicology and residues data packages

The toxicology data package has been largely harmonised for a few years now, and it is expected that the residues packages will be harmonised within the next year. New Zealand has been a strong part of this development with Dave Lunn (see article below) as an integral member of these working groups.

Extensive work sharing programme reduces registration time

The group has an increasingly extensive OECD work sharing programme. There have been several instances of up to three countries getting together to split and assess the registration packages for various pesticides and then produce a single monograph for use in registration activities. Now the first more truly global work share on a Du Pont insecticide has reached its conclusion. Nine countries were involved in this project , and the outcome was the registration of products containing this active ingredient in all but Europe (and the only hold up there is the requirement for EFSA to peer review all monographs before they can be used in Europe for registration purposes) within one year from submission of the data. This includes the USA where registration can take up to five years if MRLs are required, as they were in this case.

About 12 more potential work shares are being negotiated. This process has been shown to be very efficient, fast, highly robust and acceptable to all participants. It is possible that the vision of the Working Group on Pesticides may be achieved earlier than its projected goal of 2014.

OECD Residue Chemistry Expert Group Meeting

30-31 October 2008, Paris

Dave Lunn, Senior Programme Manager (Residues - Plants), Export Standards Group, attended this meeting.

Over the last 5-6 years, OECD has been developing a series of guidelines on the design, conduct and reporting of studies needed to support registration of pesticides (see article above). The OECD Residue Chemistry Expert Group is now in the last phase of this work -- the preparation of guidelines on the design, conduct and reporting of crop residue trials (CRT Guidelines) and planning the content of the supporting guidance document.

At the meeting, the Expert Group agreed to:

• reduce the content of the CRT Guidelines by concentrating on issues more related to the design, conduct and reporting of field residue trials and to move some of the information on data assessment and extrapolation into an overview document (as an interim measure) and then into the proposed CRT guidance document

• update the existing guidance document on the ‘Definition of the Residue’ to clarify the concept of ‘marker compounds’ to resolve some recently identified issues and to include additional examples of residue definitions adopted by JMPR

• update the guidance material on livestock feeding studies to explain the new US approach of estimating a more realistic livestock diet based on roughage/carbohydrate/protein ratios and to revise the procedure for estimating suitable dose rates for use in livestock feeding studies

• submit final drafts of the three documents to the Working Group on Pesticides (WGP) and the Working Group of National Coordinators of the Test Guidelines Program (WNT) for adoption by April 2009 and to progress the CRT guidance document further at the next meeting of the Expert Group in late 2009.

During the visit, a side trip was made to Brussels to familiarise New Zealand Embassy officials with recent EU activities on pesticide registration and MRL setting, and to strengthen contacts with European Commission officials dealing with pesticides.

IR-4 National Research Planning Meeting

28-29 October, Princeton, New Jersey

Warren Hughes (Programme Manager Approvals and ACVM Standards) attended the IR-4 National Research Planning Meeting (NRPM).

Program to increase pesticide options for specialty crop growers

The IR-4 Project is a cooperative program of the US Department of Agriculture and the SAES (State Agricultural Experiment Station). Its principle goal is to develop data to support and to expedite regulatory clearances of newer, reduced risk pest control products for specialty crop growers.

The Project provides the field trial and laboratory residue data necessary for Environmental Protection Agency (EPA) clearance of minor crop tolerances, and approval of new uses for pesticide labels. In this way the IR-4 Project is filling the gaps in pest management tools for specialty crop growers.

New Zealand growers have limited options for pest control

New Zealand is a small market for agricultural chemicals. This means the range of agricultural chemicals available to growers can be limited compared with other countries. Growers have either fewer or no choices of alternatives. They also face an increased possibility of pesticide resistance.

Another issue is that newer and softer chemistry (particularly those that fit well within Integrated Pest Management [IPM] systems) may be slower to arrive in New Zealand because of the small market size. Both the industry sector and regulators are working on ways to facilitate approvals of new chemistry and new uses for existing chemistry.

Cost is a barrier to generating data

NZFSA allows off-label use for most agricultural chemical products registered under the ACVM Act, provided residues in the crop comply with the NZ MRL Standard. In addition, it allows third parties to make variation applications to registered agricultural chemical products for additional claims. However, one of the significant barriers is the cost of generating the data to support new uses. Reducing costs in this area can make the difference between whether the new use is supported or not by the registrant or third party. Opportunities to minimise the cost, such as partnerships with the IR-4, should be explored.

The main points from the discussion were:

• IR-4 is willing to provide trial data to New Zealand provided the registration being supported by that data has been completed in the US. There is an expectation that New Zealand would also fund trial work in New Zealand to feed into the IR-4 as quid pro quo arrangement for them supplying trial data to New Zealand.

• IR-4 would consider funding trial work to be undertaken in New Zealand for crops that allow two seasons’ worth of trial work to be undertaken in the one year (eg apples). The field and laboratory work would have to be GLP. Currently, only one or two organisations can undertake the field GLP requirements.

• IR-4 invited New Zealand to attend the meeting on setting the work programme and priorities, although there was no definitive statement on whether New Zealand could participate in the meeting as more than an observer. This is likely to hinge on what New Zealand can offer in trial work funded by New Zealand.

• We raised the possibility of having a memorandum of understanding (MOU) with IR-4 to formalise the working relationship. This would assist in ensuring both parties are committed to the working relationship, formalising expectations and matters such as confidentiality of information.

• Both parties agreed that we need to maintain our dialogue and look to opportunities such as side meetings at international forums such as OECD. It was also suggested that the IR-4 should be invited to New Zealand to establish what it can offer in the way of resources.

You’re very welcome, but… (ground rules for meetings)

If you want a meeting with us, there are some basic ground rules that need to be observed. We need:

• two weeks’ notice, with the request going through your key account contact or Maree Zinzley

• your detailed agenda so we can arrange for relevant staff and files to be available.

If the meeting is to discuss products/registration, you will be charged on an hourly basis (one hour is generally MAX for these meetings).

Farewell to Angela

Advisor Angela Waddell is leaving on 24 December. She plans to travel in South America after spending some time learning Spanish. We will miss her and wish her all the best!

Holiday closing

The Approvals and ACVM office will be closed (ie nobody will be here) from noon on 24 December 2008 to 8am 12 January 2009. For border emergencies, contact Trish Whitaker (029 894 2562). For any other emergency, contact Maree Zinzley (029 894 2564).

We wish you all a safe and happy holiday season!

Sign up to be notified when the next issue of News and Views is out.
Send us your suggestions.

This page was last updated on 18 December 2008.