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AgVetLink February 2005

ACVM Regulations Amendment 2005

The ACVM Regulations 2001 provide exemptions from the requirement to be registered for certain groups of agricultural compounds. The groups are defined by the intended purpose; that is, if a trade name product is sold for a use that is specified in one of the first three Schedules of the Regulations, then the product may be imported, manufactured, sold or used without registration as long as the product complies with the conditions prescribed in the Regulations and Schedules.

Amendments to the ACVM Regulations are being drafted by the Parliamentary Counsel Office. They should be promulgated around April 2005. The amendments make some changes in existing exemptions and add new exemptions.

Risk analysis

It should be noted that, in deciding if a group of agricultural compound products could be exempted from registration and how the exemptions should be worded, the ACVM Group carries out a general risk analysis for the whole group. If the risks posed by all the products in the group can be managed by prescribing conditions common to the whole group, then registration is not considered necessary. However, the group must be defined carefully and the conditions must be simple and not ambiguous. Otherwise, products posing unique risks that should be assessed individually may inadvertently be included in an exempt group. With that in mind, the following are the specific provisions in the Amendment.

Application of more than one exemption

The Regulations are being amended to make it clear that more than one exemption and the associated conditions may apply to multi-purpose products. For example, an animal feed that is exempt from registration as an oral nutritional compound may also make claims as a urinary tract modifier, which is also exempt from registration. The animal feed would be exempt from registration in regard to both the nutritional claims and the urinary tract modification claims. However, the feed would be subject to all the prescribed conditions for both oral nutritional compounds and urinary tract modifiers.

Amendments to Schedule 1

Listings in Schedule 1 are exempt from registration with no conditions other than to comply with an approved code of practice if one exists. If there is no approved code of practice, then there are no conditions that must be met.

The first entry in Schedule 1 regarding agricultural compounds prepared for own use (i.e. not sold or supplied to someone else) will be qualified to exclude the following kinds of active ingredients:

• antibiotics

• hormones

• substances that are prescription medicines or restricted medicines as defined in the Medicines Act 1981

• substances that are prohibited by countries importing New Zealand primary produce

• vertebrate toxic agents.

New entries in Schedule 1 are:

• homeopathic plant compounds that are offered for sale (as opposed to ones prepared for a person’s own use, which are already exempt from registration)

• compounds used in the production of tissue cultures

• compounds used to protect plant grafts by mechanical means (i.e. do not contain biologically active ingredients.

The unqualified plant material entry in Schedule 1 will be revoked. This means that plant material sold or supplied to someone as an agricultural compound must be registered unless the particular use corresponds with an agricultural compound that is exempt from registration in its own right. As examples, herbal preparations (i.e. made from plant material) for managing plants must be registered, but oral and topical herbal preparations that are veterinary medicines are exempt from registration in Schedule 2.

Plant material (feed commodities such as standing grass, hay, silage, grain, horticultural produce etc.) used as animal feed must comply with the standards in Schedule 4 (see below).

Removal of obligation to report agricultural compounds in Schedule 3

Regulation 7 will be revoked. This Regulation imposed an obligation on persons importing or manufacturing agricultural compounds listed in Schedule 3 to report (initially and annually) that importation or manufacture. Because knowledge of the importation or manufacture reaches the ACVM Group by other means, the obligation to report is unnecessary.

With revocation of Regulation 7, the obligations imposed on agricultural compounds listed in Schedule 3 are the same as those in Schedule 2. Consequently, the entries in Schedule 3 will be placed in Schedule 2.

Amendments to Schedule 2

In addition to relocating all the entries in Schedule 3 into Schedule 2, the entries for the following products will be adjusted.

The entry for topical skin preparations will be adjusted to read “used solely to treat minor injuries or to prevent dermatological abnormalities”. This will allow specific treatment products used to treat minor cuts and abrasions to be exempt from registration. (General first aid products are already exempt from registration.)

However, there will be a new Schedule listing active ingredients or groups of active ingredients that would prompt registration if they were included in a formulation. At this stage, the only active ingredients that will be included in the new Schedule will be antibiotics. This is because topical preparations containing antibiotics require special consideration that can be achieved only via the registration process.

The entry for cauterising preparations will be qualified to limit the use to superficial application to make it clear that it does not include preparations designed to control blood loss in serious wounds or major surgery.

All the entries for agricultural compounds used to manage plants that refer to Part B of Schedule 7 will be amended to delete that reference and impose an alternative condition that they “must not be used on food crops unless they do not produce residues in primary produce that fail to comply with applicable food residue standards set in or under any enactment”. This amendment will make Part B of Schedule 7 superfluous and it will be revoked.

The ACVM Group will maintain an administrative list of substances that are generally recognised as safe (GRAS) when included in agricultural compounds used to manage plants, but there will be no need to have the substances prescribed in the Regulations because residues (the only relevant ACVM risk to be managed) can be managed via the new condition.

Amendment to Schedule 4

The standards for oral nutritional compounds in Schedule 4 will be amended to add a criterion of ‘fit for purpose’ that is related to possible physical harm that could be caused by foreign objects such as broken glass.

To make sure that feed commodities that are sold as animal feeds are not subject to unnecessary labelling requirements, Schedule 4 will make reference to feed commodities and state that they are not subject to the labelling requirements in clause 1 of the Schedule.

Amendment to Schedule 7

As stated above, Part B of Schedule 7 will be revoked because it is now superfluous with the new reference to food residue standards.

A similar action is not appropriate for Part A of Schedule 7 because the inclusion into oral nutritional compounds of the substances listed in Part A has animal welfare implications as well as residue implications. Therefore, the amendment will also include a list of substances that have been assessed as generally recognised as safe (GRAS) for inclusion into oral nutritional compounds.

In the interim, until the amended Regulations are promulgated, the ACVM Group will give advice on products in anticipation of the changes. This should avoid the need for unnecessary short-term registration decisions.