Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020

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2020/130

Coat of Arms of New Zealand

Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020

Patsy Reddy, Governor-General

Order in Council

At Wellington this 22nd day of June 2020

Present:
Her Excellency the Governor-General in Council

These regulations are made under section 75 of the Agricultural Compounds and Veterinary Medicines Act 1997

(a)

on the advice and with the consent of the Executive Council; and

(b)

on the recommendation of the Minister for Food Safety made in accordance with section 78 of that Act.

Regulations

1 Title

These regulations are the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Amendment Regulations 2020.

2 Commencement

These regulations come into force on 23 July 2020.

3 Principal regulations
4 Regulation 3 amended (Interpretation)

(1)

In regulation 3, revoke the definitions of fertiliser additive, non-medicated, and nutrient.

(2)

In regulation 3, insert in their appropriate alphabetical order:

animal nutrient means a nourishing substance, including, but not limited to,—

(a)

a constituent substance of feed that is necessary for, or contributes to, the natural and normal physiological function and metabolic homeostasis of an animal; and

(b)

proteins, carbohydrates, fats, oils, minerals, vitamins, water, and their naturally occurring components

antibiotic means a naturally occurring, semi-synthetic, or synthetic antimicrobial substance that kills or inhibits the growth of bacteria to prevent or treat bacterial infections in or on an animal or a plant

plant biostimulant

(a)

means a substance or biological compound or plant material, or a mix of substances or biological compounds or plant material, whose function when applied to plants, the rhizosphere, or soil is to stimulate natural processes to enhance or benefit plant nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality traits; but

(b)

does not include substances that are plant growth regulators that modify the physiological functions of plants

plant nutrient means an essential element necessary for plant growth, including, but not limited to,—

(a)

a macronutrient (nitrogen, phosphorus, potassium, calcium, sulphur, or magnesium); and

(b)

a micronutrient (boron, chlorine, manganese, iron, zinc, copper, molybdenum, or nickel)

semiochemical preparation means a preparation containing a volatile substance that conveys a signal to an animal to modify the behaviour of the recipient animal

soil conditioner means a substance or biological compound or plant material, or a mix of substances or biological compounds or plant material, that is added to soil to improve its physical or chemical qualities including, but not limited to, structure, porosity, water retention, pH, and cation-exchange capacity

unrefined extract means plant material that has not been subjected to purification processes that result in the isolation of, or alteration of the proportions of, specific chemical constituents of the plant

(3)

In regulation 3, in the definitions of intra-ruminal device, nutritional benefit, nutritional preparation, and therapeutic substance, replace “nutrients” with “animal nutrients” in each place.

(4)

In regulation 3, replace the definition of fertiliser with:

fertiliser

(a)

means a substance or biological compound or plant material, or a mix of substances or biological compounds or plant material, that is described as, or held out to be suitable for, sustaining or increasing the growth, productivity, or quality of plants through the delivery to plants or soil of plant nutrients; and

(b)

includes any—

(i)

non-nutrient attributes of the materials used in fertiliser; and

(ii)

animal nutrients used in fertiliser; but

(c)

does not include a substance or biological compound or plant material, or a mix of substances or biological compounds or plant material, that is intended for use as a plant growth regulator that modifies the physiological functions of plants

5 Regulation 10 amended (Compounded veterinary preparation to be prepared in accordance with documented system)

(1)

In regulation 10, insert before paragraph (a):

(aaa)

a statement of the purpose of the preparation; and

(2)

In regulation 10, insert as subclause (2):

(2)

The compounding veterinarian must ensure that the documented system—

(a)

complies with the conditions of exemption applicable to a compounded veterinary preparation under these regulations; and

(b)

is sufficient to provide a compounded veterinary preparation that is fit for its intended purpose.

6 Regulation 12 amended (Information requirements)

After regulation 12(1), insert:

(1A)

This regulation does not apply to a veterinarian who prepares a compounded veterinary preparation and administers the preparation to an animal.

7 Regulation 14 amended (Recording of documented system and of actions taken in accordance with documented system)

In regulation 14(3)(a), replace “regulation 10(a)” with “regulation 10(1)(aaa)”.

8 Schedule 2 replaced

Replace Schedule 2 with the Schedule 2 set out in the Schedule of these regulations.

9 Schedule 3 revoked

Revoke Schedule 3.

Schedule Schedule 2 replaced

r 8

Schedule  2 Agricultural compounds exempt from registration under sections 21 and 27 of Act

r 5

Column 1Column 2
Agricultural compoundConditions
Part A. Exemptions relating to agricultural compounds that could be used in relation to either animals or plants
1

In vitro diagnostics used to confirm the presence or absence of disease or as an aid in the diagnosis of disease or abnormal conditions

2

Substance or compound—

(a)

prepared by a person (person A) for use on animals or plants owned by person A, or in any land, place, or water owned or occupied by person A (and not for sale); or

(b)

used by person A, or a person employed or engaged by person A, or another person expressly authorised by person A, as described in paragraph (a)

If the substance or compound is used by a person employed or engaged by person A or another person expressly authorised by person A, the use must be in accordance with written instructions from person A about—

(a)

how the substance or compound is to be stored, prepared for use, administered, applied, and (if applicable) disposed of; and

(b)

how the safety and welfare of any person or animal who may come into contact with the active ingredient is to be protected and how any pain or distress of an animal is to be mitigated; and

(c)

how third parties are to be contacted or advised of the use of the substance or compound and warned of any hazards relating to its use

The following substances or compounds may be prepared or used as described in column 1 only in compliance with an approved operating plan:

(a)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981):

(b)

antibiotic substances:

(c)

animal hormones:

(d)

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

(e)

vertebrate toxic agents

3

Agricultural compounds used for—

(a)

any investigative, analytical, experimental, or diagnostic work or toxicity or potency testing work that involves any agricultural compounds; or

(b)

any work that is carried out for the purpose of testing the safety or efficacy of any agricultural compound; or

(c)

any training or teaching of persons, of a kind specified in the approved operating plan, involving agricultural compounds, within the scope of the active ingredients specified in the plan

An operating plan covering the type or class of agricultural compounds the person or organisation wishes to use for research, testing, or training, and the nature of the activities contemplated, must have been approved and must be complied with

The person or organisation subject to the operating plan must, on an ongoing basis, notify the Director-General if an active ingredient is to be used that was not notified to the Director-General as being used or contemplated for use at the time the operating plan was approved, even where the active ingredient to be used is within the scope of agricultural compounds approved for use under that operating plan

4

Vertebrate and invertebrate attractants and repellents that are not applied directly to animals or plants

5

Invertebrate mating disrupters that are not applied directly to animals or plants

6

Agricultural compounds used to control the characteristics of water where—

(a)

the water is used on or in relation to animals or plants; and

(b)

the characteristic must be controlled to maintain the animals or plants in a healthy state or to facilitate the management of the animals or plants

7

Sterilisers, sanitisers, and disinfectants (excluding fumigants) used to maintain hygienic conditions for the purposes of hygiene in places where animals and plants are housed or cultivated

Animals and plants must not be exposed to the substance or compound
8

Agricultural compounds with a solely mechanical mode of action applied to the environment in which animals or plants are kept, to control invertebrate pests of animals or plants

Must not contain any biologically active ingredients
Part B. Exemptions relating to agricultural compounds that could be used in relation to animals
9

Preparations scheduled as medicines under the Medicines Act 1981, and used as veterinary medicines

Must not be used on animals except under the direct care, or with the authorisation, of a veterinarian

The conditions in regulations 9 to 13 do not apply

Must not be advertised for sale for use on animals

The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

10

Compounded veterinary preparations

Must not be used on animals except under the direct care of the compounding veterinarian

Preparations may be used only on animals specified by the compounding veterinarian or animals of a type specified by the compounding veterinarian

Must not be advertised for sale for use on animals

The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

11

Homeopathic oral and topical preparations for use on animals—

(a)

prepared by a process of solution, extraction, or titration of an active ingredient followed by strictly regimented serial dilution to the point that the active ingredient is no longer practically detectable; and

(b)

that are not claimed to prevent, control, or cure a specific disease characterised by pain or distress in animals

If used as a veterinary medicine, the label information must—

(a)

identify the compound as a homeopathic preparation; and

(b)

include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

12

Topical veterinary preparations (non-absorbable) for—

(a)

treatment or prevention of minor wounds or dermatological abnormalities; and

(b)

cleaning teeth, skin, hair, fur, or hooves; and

(c)

maintaining skin, hair, fur, or hoof health/condition; and

(d)

disguising odours

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981):

(f)

substances that are prohibited by countries importing New Zealand primary produce

The compound must not be used on the udders and teats of animals whose milk is being collected for human consumption

For the preparation described in paragraph 12(a), the label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

13

Oral and topical preparations for animals—

(a)

prepared from either any part of a plant or an unrefined extract from a plant; and

(b)

that are not claimed to prevent, control, or cure a specific disease characterised by pain or distress in animals; and

(c)

that are not claimed to have pharmacological or anabolic effects, or to modify the physiological function of an animal

If used as a veterinary medicine, the label information must,—

(a)

if applicable, identify the compound as a herbal preparation; and

(b)

include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

Must not be used on the udders and teats of animals whose milk is being collected for human consumption

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981):

(f)

substances that are prohibited by countries importing New Zealand primary produce

14

Markers, paints, and dyes used as pigments or colourants for topical application to identify animals temporarily

15

Antidiarrhoeal preparations that—

(a)

are used solely as gastrointestinal adsorbent or protectant agents; and

(b)

are not claimed to bind any specific micro-organism or toxin; and

(c)

have only a local, surface-acting effect on the gastrointestinal tract

The label information must include statements that—

(a)

the preparation is suitable for use without veterinary advice only in the treatment of minor cases of diarrhoea; and

(b)

the preparation will not treat dehydration; and

(c)

if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981):

(f)

substances that are prohibited by countries importing New Zealand primary produce

16

Laxatives and lubricants used on animals that have only a local, surface-acting effect on the gastrointestinal tract, vulva, and vagina

The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981):

(f)

substances that are prohibited by countries importing New Zealand primary produce

17

Moist or dry poultice preparations used on animals that—

(a)

are used to treat or prevent inflammation, swelling, or pain solely by heating or cooling, or drawing fluid from, the affected area; and

(b)

are intended for use on intact skin or minor wounds

The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

Must not contain the following ingredients:

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981):

(f)

substances that are prohibited by countries importing New Zealand primary produce

18

Cauterising preparations used or applied superficially

The label information must include a statement that, if the preparation fails to stop bleeding, the user should seek veterinary advice

19

Oral urinary tract modifiers (acidifiers and alkalisers) that are used solely for modification of urinary pH

Must be packaged for sale in dosage-size packages (not in bulk or concentrated form) appropriate for the animals for which the agricultural compound is recommended

The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

20

Respiratory tract modifiers (expectorants and cough suppressants) for use on animals that—

(a)

have only a locally acting, superficial effect on the respiratory tract; and

(b)

are given orally, applied topically to the nose, or inhaled; and

(c)

are used solely in animals to promote mucolysis, for cough suppression (by alleviating only irritation), and to relieve compromised airways and upper respiratory tract congestion

Must be packaged for sale in dosage-size packages (not in bulk or concentrated form) appropriate for the animals for which the agricultural compound is recommended

The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

21

Agricultural compounds used to extend animal semen or to be used as media for animal sperm, cells, ova, and embryos

22

Any agricultural compound (excluding agricultural compounds administered in an intra-ruminal device) ingested by an animal as feed, or a nutritional preparation intended for oral administration to an animal to achieve a nutritional benefit (an oral nutritional compound)

The directions for use on the label must specify the species, type, and class of animal for which use is intended

An agricultural compound that is a therapeutic or pharmacological substance or preparation may only be incorporated into oral nutritional compounds if the agricultural compound is registered as a veterinary medicine under the Act and—

(a)

incorporation of the registered veterinary medicine is consistent with the indications, use patterns, and target species approved for the registered product; and

(b)

the registered veterinary medicine remains adequately distributed throughout the oral nutritional compound for the entirety of the claimed shelf life of the feed; and

(c)

the efficacy of the registered veterinary medicine is maintained for the entirety of the claimed shelf life of the feed

Oral nutritional compounds that are feed commodities are not subject to the conditions in regulations 9 and 12

For the purpose of this special condition, feed commodities means plants (or any part or parts of those plants) that are raised and used as feed or for feed production for animals

If an oral nutritional compound is incorporated with an agricultural compound the label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

23

Oral gastrointestinal-acting microflora-enhancing compounds

The directions for use on the label must specify the species, type, and class of animal for which use is intended

No therapeutic or pharmacological claims that the compound prevents, treats, or cures any disease characterised by pain or distress in animals may be made

24

Semiochemical preparations that modify an animal’s behaviour by sending communication signals through chemicals and are not claimed to prevent, control, or cure a particular disease characterised by pain or distress in animals

Must not contain the following ingredients—

(a)

antibiotic substances:

(b)

hormones:

(c)

pharmacological substances:

(d)

solvents or penetrating agents:

(e)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981)

Label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

25

Biologically active agricultural compounds applied to the contained environment in which non-food producing animals are kept to control invertebrate pests of animals

Must not be used when any animal is present

The label information must state the safe re-entry period for non-food-producing animals and that food-producing animals must not be exposed to the product

26

Topically absorbable animal nutrients

Directions for use on the label must specify the species, type, and class of animal for which use is intended

27

Products with a solely mechanical mode of action applied topically, that are not claimed to prevent, control, or cure a particular disease characterised by pain or distress in animals

Must not contain any biologically active ingredients

Must not be absorbable

The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

Must not be an irritant

Part C. Exemptions relating to agricultural compounds that could be used to manage plants or plant production
28

Products applied to, or within, empty structures to remove pests before—

(a)

introducing produce; or

(b)

growing plants

Must not be used when plants or produce are present

The label information must state the re-entry period before plants or produce are re-introduced (to avoid non-compliant residues)

29

Products with a solely mechanical mode of action to control invertebrate pests on plants or plant produce

Must not contain any biologically active ingredients

30

Spray markers that are coloured indicators to show where liquid agricultural chemicals have been applied to help prevent overlaps

31

Agricultural chemical synergists and other adjuvants, including wetting and sticking agents, pH buffers, drift retardants, and water conditioners

32

Repellents applied directly to plants and used solely to repel vertebrates or invertebrates

33

Attractants applied directly to plants and used solely to attract vertebrates or invertebrates

34

Mating disrupters applied directly to plants and used solely to interfere with the reproduction of invertebrates

35

Agricultural chemical compounds used to protect plants from climatological conditions

Must not contain any biologically active ingredients

36

Agricultural chemicals used solely—

(a)

in home gardens or amenity horticulture on plants that are not intended to produce food for consumption by humans or animals; or

(b)

in commercial plant production on plants that are not intended to produce food for consumption by humans or animals; or

(c)

for the post-harvest treatment of cut flowers and bulbs

The label information must clearly state that the product must not be—

(a)

used on plants that are intended to produce food for consumption by humans or animals; and

(b)

applied to areas that may be grazed by food-producing animals

37

Homeopathic agricultural chemicals used commercially

38

Agricultural compounds used in the production of plant tissue cultures

39

Agricultural compounds (not containing biologically active ingredients) used to protect plant grafts or plant wounds

40

Agricultural compounds (not containing biologically active ingredients) used to provide a physical barrier to infestation or infection of plants

41

Agricultural compounds used in the post-harvest treatment of wood-producing crops

42

Fertilisers

The label information must specify nutrient content value, as applicable

The product must comply with any applicable notice issued under the Act

43

Plant biostimulants

The label information must specify mode of action, as applicable

The product must comply with any applicable notice issued under the Act

44

Soil conditioners

The label information must specify mode of action, as applicable

The product must comply with any applicable notice issued under the Act

Michael Webster,
Clerk of the Executive Council.

Explanatory note

This note is not part of the regulations, but is intended to indicate their general effect.

These regulations, which come into force on 23 July 2020, amend the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 (the principal regulations). The amendments—

  • exempt specified new agricultural compound and veterinary medicine (AVCM) products from registration under the Agricultural Compounds and Veterinary Medicines Act 1997:

  • update the risk status of certain existing ACVM products:

  • improve the clarity of descriptions and conditions for certain ACVM products:

  • make other technical improvements to the principal regulations.

Schedule 2 of the principal regulations is replaced. New Schedule 2 includes 6 new ACVM product groups, and has been restructured to rationalise some exemption groups, and to standardise conditions across groups sharing common factors. New Schedule 2 also updates the risk status of certain ACVM products.

Schedule 3 of the principal regulations is revoked.

Regulation 10 of the principal regulations is amended to strengthen the requirement for a fit for purpose documentation system. An amendment is made to regulation 12 of the principal regulations to clarify that labelling requirements do not apply if a veterinarian compounds a veterinary product and administers the compound to an animal.

Issued under the authority of the Legislation Act 2012.

Date of notification in Gazette: 25 June 2020.

These regulations are administered by the Ministry for Primary Industries.