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• Recent events and What’s coming up
• Process for registration under the ACVM Act 1997
• Codes of practice
• Import clearance
• Applications update
• Claims affecting animal welfare
• Discretionary use of human and veterinary medicines by registered veterinarians
• AVMAC and ILC updates
• Prescribed standards for oral nutrional compounds and fertilisers
• Homeopathic recommendation update and Herbal products
• Pesticide residues in wool
• ACVM Group assessment service and Accredited risk assessors
• Information requirements
• Compliance update
• Operational and staff updates
• Strategic plan review

 

Recent Events

• In September, the ACVM Group ran a series of workshops in Wellington, Auckland and Christchurch covering the ACVM Act framework, the exemptions process and proposals, registration, the data assessment service, accreditation of risk assessors, information requirements, compliance, the MRL process, codes of practice, and fees and charges. (Copies of the overheads from these workshops will soon be available on the web site.) As a result of feedback , we are planning a further series of workshops in February/March 1999. The workshops also raised a number of issues for resolution in the near future – updates on these issues and details of the 1999 workshops will be in future issues of AgVetLink.
• The ACVM web site (www.maf.govt.nz/acvm/) has been updated and now provides an opportunity for feedback on ACVM Act issues and matters related to the current legislation and process. It has all of the back copies of AgVetLink, and downloadable versions of all the ACVM Act documents, as well as the animal remedies and pesticides licencing/registration packages. Remember to save the site in your ‘favourites’ menu for easy access, and try out the ‘URL minder’ function to get automatic advice of any additions to the site or changes to documents of interest.
• The ACVM Group has recently held meetings of the Animal Remedies and Pesticides Subcommittees, the Industry Liaison Group (ILG) and AVMAC (see page 4). Notes from the ILG and AVMAC meetings are available from Sonali de Silva (04 474 4245).
• Copies of the summary of submissions on Recovery of costs under the ACVM Act , Exemption from registration under the ACVM Act and Compliance under the ACVM Act have been sent to all those who contributed. The summaries are available on the web site or by contacting Sonali de Silva.

What's Coming Up

• Process for registration under the ACVM Act 1997 has just been published (see the next page). Contact Debbie Morris (04 4744141) for a copy or check out the web site for a downloadable version.
• Details of proposed fees and charges will soon be published and sent to all AgVetLink recipients. MAF would like comments on the proposals – copies will be available from Debbie Morris.
• In October we plan to add an area to the ACVM web site: Frequently asked questions about the ACVM Act and its implementation.

Codes Of Practice

The ACVM Act gives MAF the power to approve codes of practice. MAF intends to use this power to give statutory recognition to codes designed to manage the risks specified in the Act. However, this statutory recognition will not automatically impose an obligation on people to comply with that particular code. The obligation to comply with an approved code would be imposed (if necessary) via the specified conditions of registration (or exemption from registration).

It is expected that affected industry groups will develop codes of practice to assist their members to meet the conditions specified under the ACVM Act. Codes will remain the property of the industry groups that develop them. They will have the right to review, amend or revoke the code as they see fit. However, any material alteration in the code affecting its appropriateness to manage the ACVM Act risks would require a new approval from MAF before the altered code would be considered an acceptable means of meeting specified conditions.

MAF will not specify a pro forma for a code, nor will it require the code to be entitled a ‘code of practice’. It could be called an industry standard or guideline, but it will be approved by MAF as a code of practice without altering its title. MAF will approve only those parts of a code that relate to managing the ACVM Act risks. The approval will not be used to give statutory recognition to any aspect of industry quality control that is not relevant to the ACVM Act.

MAF must consult with affected parties before approving a code of practice to ensure that no one is unreasonably or inequitably disadvantaged by approval of the code. MAF is also obliged to have copies of approved codes of practice available for public inspection. However, MAF can and will protect the property and will not allow copies to be made of the code without written permission from the owner. When considering MAF approval for their codes, industry groups should ensure that any commercially sensitive information or parts irrelevant to the approval can be easily separated from the material that must be made available for public inspection.

MAF will make compliance to a particular code of practice compulsory via the conditions of registration or exemption only if it is essential to do so. In most cases the conditions will be expressed in such a way as to require compliance to any code of practice approved for that purpose.

The New Zealand Veterinary Association has submitted a code of practice for MAF consideration (see ‘discretionary use’ policy article, page 4). The New Zealand Feed Manufacturers Association is considering submitting a code for MAF approval as is the New Zealand Fertiliser Manufacturers Research Association.

MAF will expect codes of practice to be submitted for approval before it would consider making provision for special use of products outside the conditions of registration of those products. This would include the use of restricted euthanasia, capture or emergency trauma products by horse grooms on international flights, specialist farmer groups, RNZSPCA inspectors, and Department of Conservation staff.

Anyone wishing more information on codes of practice should contact:

        Brian Pidford
        National Manager (ACVM Conformance)
        ACVM Group
        Ministry of Agriculture and Forestry
        Post Office Box 40063
        UPPER HUTT
    

Import Clearance

MAF is proposing a significant change in the way imported agricultural compounds are cleared at the border under the ACVM Act.

Under the existing clearance process MAF Quarantine Service officers determine if an agricultural compound should be cleared for entry into New Zealand. They check the database of licensed/registered products to see if the product in question has already been approved for entry. If a product is not on the database, the Quarantine Service contacts the ACVM Group to obtain an approval to clear the product or for a decision whether or not the product is of regulatory concern.

This system encourages hasty decisions because of the restricted time frame in which people and goods must be cleared at the border. This has in the past resulted in inconsistencies in the rationale for assessing the acceptability of unknown products.

To alleviate the time pressure and the inconsistencies of decisions, MAF will specify more directly the way its Quarantine Service is to deal with all interceptions of unknown agricultural compound products. Under the ACVM Act the person/agent will be advised that if the product is not on the agricultural compound database, it is not approved for entry into New Zealand.

The person will then be advised of these options:

• the person can make a declaration that the product will not be used as an agricultural compound; or
• the product can be re-shipped out of the country; or
• it can be turned over to the Quarantine Service for destruction; or
• the product can be held by the Quarantine Service (at the person’s expense) until the person obtains a class determination for the product from the ACVM Group.

The product will be released to the person/agent if the class determination confirms it is eligible for importation and any holding charges have been paid. If products are not claimed within 28 days after the class determination has been made (or other arrangements have been made with the Quarantine Service) the product will be destroyed.

Anyone wishing to comment on MAF’s clearance proposal should contact:

            Brian Pidford
            National Manager (ACVM Conformance)
            ACVM Group
            Ministry of Agriculture and Forestry
            Post Office Box 40063
            UPPER HUTT
        

Applications Update

Claims affecting animal welfare

The ACVM Act is not intended to control the quality of products for consumer protection reasons. Therefore, MAF is intending to make it clear that, in most cases, it has not assessed and does not endorse claims made about agricultural compound trade name products. The exception to this policy is in regard to claims that have a direct impact on the welfare of animals treated with those products.

The ACVM Act does not specify what consititutes a risk to animal welfare. MAF considers that such risks should be interpreted as treatment resulting in unnecessary pain or distress in the animal(s). This could be caused by adverse reactions or toxic effects caused by the trade name product, but it could also be caused by a failure of the product to work (resulting in the animal(s) suffering unnecessary pain or distress) if the disease or abnormal condition being treated is characterised by obvious pain or distress. Examples for which effectiveness directly impacts on the welfare of the animal(s) treated would include products used to prevent, treat or cure debilitating infectious diseases, internal parasitism, severe colic (including bloat in ruminants) and emergency trauma.

People will purchase and use trade name products for the diseases or abnormal conditions listed above on the grounds that there are claims made by the proprietor that the product can be used to prevent, treat or cure them. MAF considers that, in these cases, the animal(s) will suffer unnecessarily if the product does not work as claimed. The importer or manufacturer of the product must provide sufficient information to support such claims.

Therefore, MAF will regulate the claims made about agricultural compound trade name products only if the claims are to prevent, treat or cure specific diseases or abnormal conditions charcterised by obvious pain or distress.

discretionary use of human and veterinary medicines

by registered veterinarians

MAF has developed a policy on the discretionary use of human and veterinary medicines by registered veterinarians. The policy allows registered veterinarians to use products registered as pharmacy-only, prescription and restricted medicines registered under the Medicines Act 1981 on animals under their direct care as long as they comply with a code of practice approved by MAF.

The policy also allows registered veterinarians, under the same conditions, to use veterinary medicines in a manner not specified in the conditions of registration or exemption for those products. Veterinarians will also be allowed, under the same conditions, to compound their own veterinary medicines. However, they will not be allowed to wholesale or retail such products for use on animals that are not under their direct care. Such products would be subject to the same regulatory control as any other comparable product.

Anyone wishing a copy of the discretionary use policy should contact:

    Sonali de Silva
    MAFReg
    Post Office Box 2526
    WELLINGTON

AVMAC and ILC Update

AVMAC

The last meeting of AVMAC was held on 18 August. The key issues discussed were the details of the ACVM Act fees and charges, the proposed registration process for trade name products, the data assessment service proposal and the initial proposal for information requirements under the ACVM Act. AVMAC confirmed the compliance policy, and the details of the exemptions proposal. The ACVM Group’s Strategic Direction has been reviewed by an AVMAC working group and will be amended to reflect their input. Notes from the meeting are available from Sonali de Silva (phone 04 474 4245).

Industry Liaison Committee

The latest meeting of the ILC took place in Wellington on 9 September. As mentioned in the August edition of AgVetLink, the membership has been increased to include other interested parties. The membership now includes representatives from Federated Farmers, NZ Vegetable and Potato Growers Federation, NZ Fruit Growers Association, Poultry Industry Association (NZ), Egg Producers Federation (NZ) and the NZ Feed Manufacturers Association. Contact Kieran Galvin (04 527 4454) for details.

Prescribed Standards For Oral Nutritional Compounds and Fertilisers

MAF, in consultation with specialists and some members of the affected industries, has prepared draft standards for oral nutritional compounds and for fertilisers. When these drafts are acceptable they will be recommended to Government for making regulations governing the regulatory control of these types of products under the ACVM Act. Once the standards have been prescribed in regulations, MAF will recommend to Government that these types of products be exempted from the requirement to be registered on the condition that they comply with the prescribed standard.

The draft standards place the obligation on importers or manufacturers to ensure that the products meet the specifications in the standard, including ensuring that the materials used in preparing these products are fit for purpose, and adequate information is provided to ensure that the products are used properly.

The drafts propose that compliance to an approved code of practice (see section 2) will be deemed to be taking adequate measures to meet the specifications in the standard.

Anyone who wishes to comment on the draft standards should contact:

    Chris Boland
    Special Adviser (Technical Policy) ACVM Group
    Ministry of Agriculture and Forestry
    Post Office Box 40063
    Upper Hutt

Homeopathic and Herbal Update

Homeopathic recommendation update

MAF received a number of responses on its proposal to exempt homeopathic preparations from the requirement to be registered (AgVetLink, 1 August 1998). All the respondents were in support of the proposal and some made suggestions to improve the practicality and risk management effect of the proposal.

The suggestions were:

• all homeopathic preparations prepared for use on animals owned by the person who made the preparation should be exempted with no conditions;
• there should be an additional requirement that labels on exempted homeopathic preparations must include a statement that MAF has not assessed and does not endorse any claims made about the product; and
• registration must be required for homeopathic preparations claiming that the product can be used to prevent, treat or cure a specific disease condition that is characterised by obvious pain or distress.

MAF considers that all three suggestions would improve its proposal and they will be incorporated into its recommendation to Government.

Herbal Products

The ACVM Group are considering whether agricultural compounds and veterinary medicines containing active ingredients of herbal origin can be exempted from registration under the ACVM Act 1997. We are aware of the perception that such products may be of low risk, but are also aware that some plant products contain active principals that have high biological activity and thus may, in fact, present a high risk. We will keep readers informed as this issue is progressed. Any comments or queries should be addressed to:

    Chris Boland
    Special Adviser (Technical Policy) ACVM Group
    Ministry of Agriculture and Forestry
    Post Office Box 40063
    Upper Hutt

Pesticide Residues in Wool

The use of ectoparaciticides on sheep leads to residues in the wool fleece, which in turn pose a risk to the environment near wool scouring plants.

A 60 day withholding period was imposed for these products to reduce wool residues.

As better residue data becomes available, withholding periods are being revised by WoolPro (ex Wools of New Zealand) to ensure that fibre residues remain acceptable to New Zealand’s trading partners.

ACVM group assessment service

Under the ACVM Act it will be the responsibility of the applicant to provide an application for registration that is based on a thorough assessment of the risks as specified in the ACVM Act. The applicant will also be required to provide with their application an independent risk assessment report from a MAF accredited risk assessor. Details of which types of application will require an independent risk assessment report are noted in the Process for registration under the ACVM Act 1997 consultation document. Further details will follow in the information requirements document.

Due to the specified time lines for processing applications for registration under the ACVM Act as well as industry requirements, MAF considers that the process of carrying out risk identification and assessment is not within its regulatory role.

MAF is consulting with a number of individuals who have expressed an interest in becoming an independent accredited risk assessor. Whilst there is considerable interest from interested individuals, we consider it unlikely that there will be sufficient accredited assessors necessary to provide a service to support applicants’ needs when the Act is implemented on 1 April 1999.

Therefore, in order to cope with the transitional period and until such time as there are sufficient independent accredited risk assessors, the ACVM Group will offer a discretionary risk assessment service. The service will be for a defined period of time after which the ACVM Group will withdraw the service. The service will have clearly defined boundaries between staff providing the risk assessment service and the risk evaluation role (regulatory function). Details of how the service will operate and the costs associated with providing this service will be available shortly.

Accredited Risk Assessors

A document proposing standards for applicants seeking approval as MAF accredited risk assessors under the ACVM Act is nearing completion; it is intended to release the paper for public comment by the end of October. The standards will be in the areas of general requirements, attributes and knowledge/experience. Also included in the paper will be a description of the proposed process that will be implemented to enable the accreditation of an applicant by the Chief Agricultural Compounds Officer.

In the meantime, a list of people who have expressed an interest in being accredited as independent risk assessors has been started and further expressions of interest would be welcomed. Contact Brian Pidford, National Manager (ACVM Conformance), on phone 04 527 4462 or 025 230 1511, or email (pidfordb@maf.govt.nz).

Information requirements

There has been a considerable amount of work covering the information requirements package for the ACVM Act. Work has progressed well on the draft standards and guidelines for each of the main data packages (residues, labelling, manufacturing, chemistry etc). Other parts of the information requirements package will consist of application forms, fees and charges information, and general guidelines on the registration process.

One of the key tools for applicants being developed is the information requirements ‘matrix’. This is designed to show applicants which of the data packages are required for a particular group of agricultural compounds, depending on the risks posed by the group in question. As the segments (such as the draft standards for the data packages) of the information requirements package become available they will be circulated to interested and affected parties, posted on the ACVM web site and advised in AgVetLink. Contact Debbie Morris (04 474 4141) for further information.

Compliance Update

The policy paper Compliance under the Agricultural Compounds and Veterinary Medicines Act 1997 has been prepared and was endorsed by the Agricultural Compounds and Veterinary Medicines Consultative Committee (AVMAC) at its meeting in August 1998 prior to adoption by the Chief Agricultural Compounds Officer.

The paper describes the purpose and scope of compliance under the ACVM Act, accreditation activities, types and extent of compliance monitoring proposed and enforcement activities that will be undertaken following implementation of the Act. Contact Asha Gandhi (04 527 4455) for copies.

Operational Update

ISAC Development

ISAC is the acronym for the ACVM Group’s new database "Information System for Agricultural Compounds" and is being developed to help us meet our statutory obligations under the ACVM Act. ISAC is due for phase one implementation during October 1998 and will replace our existing database, ‘PARIS’. PARIS was built in 1989 (DOS based) and is not year 2000 compliant, nor will it support our future business needs from either a legislative or customer service perspective.

The benefits that ISAC will bring to the ACVM Group will be more flexible reporting and quality work flow management, both of which are critical to support the future needs of the ACVM Group business. We will bring you further details of ISAC’s development in the next issue of AgVetLink.

Customer Charter

In the August edition of AgVetLink we introduced the ACVM Group customer charter. We summarised the purpose of the charter and how it will be developed. We are now finalising the details of the charter and are defining key performance indicators (KPIs) for the services we provide. Further information on the KPIs will be published in the next issue of AgVetLink.

We consider that consultation with industry is an extremely important step in the development of the charter and have welcomed input and feedback on the details proposed in the charter. If you wish to make comments on the charter, or find our more about it, please contact:

    Kieran Galvin
    National Operations Manager (Registration)
    ACVM Group
    Ministry of Agriculture and Forestry
    Post Office Box 40063
    Upper Hutt
    Phone: 04 527 4455

Conferences

The ACVM Group’s John Reeve recently attended the 8th International Congress of Toxicology in Paris, and the 9th International Congress of Pesticide Chemistry in London.

The opening theme of both congresses was that regulatory time and resources being put into pesticide regulation far exceed the hazards posed when compared with the levels of known natural mammalian carcinogens in plant foods, and the real effects of microbial contamination of foods (which include severe illness and death).

An author of the US Food Quality Protection Act commented that the legislation preceded the ability of science to deliver what it was requiring – it was hoped that the legislation would force science to ‘catch up’. It was clear that as science does catch up, the validity of the assumptions made in that Act are being increasingly questioned. In particular, the requirements for an extra ten-fold safety factor when deciding on the acceptability of pesticide residues in children’s food, and the validity of adding exposures from all routes when estimating total human intakes of pesticides are being questioned by world experts.

Staff Update

Nick Whelan has returned to the ACVM Group after a period of study leave. During Nick’s absence Barry Marshall has been Acting Registrar, Animal Remedies. Barry has agreed to continue in the Registrar role in order for Nick to focus on completion of the technical standards and conditions necessary to implement the ACVM Act. Nick will be full time in this role. Barry Marshall has therefore been appointed Registrar, Animal Remedies, and will hold this role through to the completion of work under the Animal Remedies Act.

Contact details

Cell phone details to add to your list of contacts for the ACVM Group (a complete list is available on the ACVM web site):

• Kieran Galvin 025 230 1512
• Brian Pidford 025 230 1511

Strategic Plan Review

The ACVM Group’s Strategic Direction (1997-2000) was published in December 1997. Details of the strategic direction are currently undergoing the first annual review. AVMAC has reviewed the document and proposed a number of modifications and additions, including the following revised Vision Statement and Strategic Goals:

Vision Statement

To be effective and efficient regulators of agricultural compounds and veterinary medicines, in order to protect New Zealand’s trade in primary products, animal welfare, agricultural security, and food safety, as measured by:

• national and international acceptance of regulatory decisions, and
• independent stakeholder satisfaction surveys.

Strategic Goals

Goal 1: Move to the new legislative and operational environment, building on current strengths, and developing methods to deal with new philosophical, technical, process, interface, consultation and people challenges.

Goal 2: Move the MAFReg (ACVM Group) operational focus from assessment of raw data, to audit of industry submissions, experts and processes.

Goal 3: Develop and maintain a product registration system for the ACVM Act that complies with the ISO 9002 standard, and delivers a cost effective process for approval of applications that meets the approved standards and legislative timelines.

Goal 4: Develop and operate robust funding mechanisms, financial and information management systems.

Goal 5: ACVM Group staff feel valued by MAF and stakeholders, and are satisfied with their contribution.

Comments on the 1998 revised version of the ACVM Group’s Strategic Direction should be made by 20 October to:

    Sonali de Silva
    MAF Regulatory Authority
    Post Office Box 2526
    WELLINGTON
    Phone:      04 474 4245
    Email:  desilvas@maf.govt.nz

No 7
ISSN: 1174-3735