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ACVM Publications Update and Order Form

CONSULTATION ENDED

• Classification of Substances as Generally Recognised as Safe (GRAS)
• Registration Standard for Low Risk Products

The consultation period for these two documents has ended. At this stage, limited interest has been shown in forming an industry-led working group to establish and maintain a GRAS list. Therefore, adoption of this proposal has been delayed.

This decision impacts on the Registration Standard for Low Risk Products, which made use of the proposed GRAS list concept. This standard will be implemented from 15 December 1999, without the use of the GRAS list. This will necessitate some changes in the standard that will impact on the range of products that could have been considered low risk. The ACVM Group will begin construction of an internal GRAS list using information provided in applications submitted for consideration as low risk products.

If sufficient interest is shown in establishing an industry-led working group to establish and maintain a GRAS list, this concept will be reconsidered. Expressions of interest should be made to:

Moira Jones
ACVM Group
Post Office Box 2526
Wellington, New Zealand
Phone: 04 460 8750
Fax: 04 460 8771
Email: jonesm@maf.govt.nz

The Registration Standard for Low Risk Products will be available from Manor House Press from 1 December 1999.

OUTSTANDING EFFICACY DISCUSSION DOCUMENTS

• Registration Standard and Guideline for Efficacy of Intramammary Antimicrobials
• Registration Standard and Guideline for Efficacy of Parenteral and Oral Antimicrobials

We are awaiting the decision of the Animal Remedies Board on recommendations made by the Antibiotic Resistance Steering Group before finalising these documents.

• Registration Standard and Guideline for Efficacy of Anthelmintics for Cattle, Sheep, Goats and Deer

Finalisation of this document has been delayed while the implications of anthelmintic resistance are considered.

• Registration Standard and Guideline for Efficacy of Antibloat Products
• Registration Standard and Guideline for Efficacy of Emetics

Submissions on these documents have been addressed, and the standards are now on the website and available from Manor House Press (see updated order form enclosed)

• Registration Standard and Guideline for Efficacy of Prophylactic Zinc Products for Facial Eczema
• Registration Standard and Guideline for Efficacy of Parenteral Calcium and Magnesium Products
• Registration Standard and Guideline for Efficacy of Teat Sanitisers
• Registration Standard and Guideline for Efficacy of Oral Rehydration Therapy

Advice is still being taken on some aspects of these documents. They will be released as soon as these issues are resolved. Our website will be updated with the standards when they are finalised and the Manor House order form will be updated in the next issue of AgVetLink.

• Standard for Distributors of Hormonal Growth Promotants

This standard has been finalised and is published on our website and is available from Manor House Press (order form enclosed). Please note that, because this standard is simply a publication of a current requirement, it is implemented immediately.

UPCOMING EFFICACY DISCUSSION DOCUMENTS

The following efficacy discussion documents will be posted to interested parties on 6 October 1999.

• Registration Standard and Guideline for Efficacy of Vertebrate Pesticides
• Registration Standard and Guideline for Efficacy of Parenteral and Bolus Copper, Cobalt, Selenium and Iron Products
• Registration Standard and Guideline for Efficacy of Antihistamines
• Registration Standard and Guideline for Efficacy of Antispasmodics

If you do not receive the ones relevant to your area of interest and would like copies, please check the website (http://www.maf.govt.nz/acvm) under ‘Discussion Documents’ or contact Moira Jones as above.

Because the subjects of these documents are fairly disparate, the ACVM Group does not envisage holding seminars as we have in the past. If there is sufficient interest, a morning seminar will be held on:

Thursday, 28 October 1999
Cameron Room, MAF
101-103 The Terrace, Wellington
9.00am - 12.30pm.

If you are interested in attending this seminar, please contact Moira Jones as above before 18 October 1999. If any group wishes to organise seminars (for a reasonable number of people) in addition to this seminar, the ACVM Group would be happy to make presentations and discuss concerns on any of these standards and guidelines.

• Pesticides and Bee Toxicity Warnings

This document was not included in the updated Labelling Guide for Pesticides in New Zealand. It is available under ‘Labelling Guides’ in the ‘Publications’ section of the website.

SUBMISSIONS

Submissions that have been collated and addressed for any of our previously released discussion documents can be found on our website under the archived version of the discussion documents to which they relate. Archived documents can be found on the website under ‘Publications’.

ACVM WEBSITE UPDATE

Several new standards, discussion documents, policies and submission summaries are now available on our website as mentioned in the ‘Publications’ update and elsewhere in this issue. In addition, downloadable versions of the following forms are available.

• Adverse Event Report
• Application Form to Licence an Animal Remedy or Variation to an Existing Licensed Animal Remedy
• Application Form for Registration of a Pesticide or Variation to an Existing Registered Pesticide
• Application for Provisional Registration of an Animal Remedy or Variation of an Existing Provisional Registration
• Application for Provisional Registration of a Pesticide or Variation of an Existing Provisional Registration
• Application for Approval to Manufacture Animal Remedies and/or Pesticides

These can be found under ‘Forms’ in the ‘Publications’ section of the website.

Erratum Please note the following error in the ‘Application Form to License an Animal Remedy or Variation to an Existing Licensed Animal Remedy’ that was sent out as a supplement to the Licensing Requirements for Animal Remedies in New Zealand package. Section 16 ‘Formulation Details’ asks for concentration of all ingredients in chemical based formulations to be expressed in g/litre for liquids and g/kg for solids. This sentence should read: Chemical based formulations are to be expressed in %w/v for liquids and %w/w for solids. This error has been corrected in the application form on the website and in subsequent printing. However, packages sent out in our original mailout require correction.

If you have any queries about publications contact:

Erin Daldry
Technical Advisor
ACVM Group
Post Office Box 2526
Wellington
Phone: 04 460 8758
Email: daldrye@maf.govt.nz.