Agricultural and Veterinary Chemicals Code Regulations (Amendment) (Cth)

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Statutory Rules 1996

No. 162 1

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Agricultural and Veterinary Chemicals Code Regulations 2(Amendment)

I, The Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Agricultural and Veterinary Chemicals Code Act 1994.

Dated 17 July 1996.

WILLIAM DEANE

Governor-General

By His Excellency’s Command,

JOHN ANDERSON

Minister for Primary Industries and Energy

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1. Amendment

1.1 The Agricultural and Veterinary Chemicals Code Regulations are amended as set out in these Regulations.

[NOTE: These Regulations commence on gazettal: see Acts Interpretation Act 1901, s. 48.]

2. Regulation 59 (Manufacture of chemical products—exempt products)

2.1 Subregulation 59 (1):

Add at the end:

“; (e)
any skin cleanser or shampoo;
(f)
any coat conditioner intended for external use only;
(g)
any equine hoof protectant;
(h)
any sheep branding substance;
(i)
a substance of any of the following kinds that is intended to be added to stockfood:
(i)
organic acids;
(ii)
antioxidants;
(iii)
pellet-binding products;
(iv)
mould inhibitors;
(v)
preservatives;
(vi)
feed handling improvers;
(vii)
colouring agents;
(viii)
anticaking agents;
(ix)
deodorising agents;
(x)
flavours;
(xi)
flavour enhancers;
(xii)
sweeteners;
(xiii)
aromatic substances;
(xiv)
appetising substances.”.

3. New regulations 59A, 59B, 59C and 59D

3.1 Insert after regulation 59:

Manufacture of chemical products—exempt persons—single step

“59A. For the purposes of paragraph 121 (4) (a) of the Code, a person who performs only a single step in the manufacture of a product is an exempt person in relation to the manufacture if:

(a)
the step consists only of:
(i)
packaging or labelling, or both packaging and labelling, the product; or
(ii)
analysing or testing the product; and
(b)
either:
(i)
the licence that authorises the manufacture of the product (being a licence held by another person) permits the first-mentioned person to perform the step for the product; or
(ii)
the step consists only of applying a label that contains only a name and address, or the registration number of the product, or both, to a package, or packages, of the product.

Manufacture of chemical products—exempt persons—chemical product that ceases to be exempt

“59B. For the purposes of paragraph 121 (4) (a) of the Code, if a product ceases to be an exempt product under this Part, each person that:

(a)
performs a step in the manufacture of that product; and
(b)
is not the holder of a licence authorising the performance of that step in relation to the product; and
(c)
applied, before the product ceased to be an exempt product, for a licence authorising the performance of that step in relation to the product;

is an exempt person in relation to that product during the period beginning when the product ceases to be exempt and ending when the NRA gives notice of its decision on the application.

Manufacture of chemical products—exempt persons—legal personal representative, etc., of licence holder

“59C.(1) The legal personal representative of a licence holder who dies is an exempt person in relation to the manufacture of a product the production of which is authorised by the licence, subject to the following conditions:

(a)
that he or she gives the NRA notice, in writing, of the grant of probate or administration not later than 3 months after it occurs;
(b)
that he or she complies with the terms of the licence as if he or she were the holder of the licence;
(c)
that he or she complies with the Code and these Regulations as if he or she were the holder of the licence.

“(2) The trustee in bankruptcy of a licence holder is an exempt person in relation to the manufacture of a product the production of which is authorised by the licence, subject to the following conditions:

(a)
that he or she gives the NRA notice, in writing, of the bankruptcy not later than 3 months after it occurs;
(b)
that he or she complies with the terms of the licence as if he or she were the holder of the licence;
(c)
that he or she complies with the Code and these Regulations as if he or she were the holder of the licence.

“(3) An exemption under this regulation has no effect if the licence issued to the deceased person or the bankrupt (as the case may be) is not in force.

“(4) If the NRA reasonably requires further information, or documents, relating to a grant of probate or letters of administration, or a trusteeship, as the case requires, an exemption under this regulation has no effect until that information or those documents are received by the NRA.

Manufacture of chemical products—exempt persons—person that acquires business including transfer of licence

“59D. (1) A person who is the transferee of a business:

(a)
involving the manufacture of chemical products; and
(b)
in relation to which a licence has been issued;

is an exempt person in relation to the manufacture of a product the production of which is authorised by the licence, subject to the following conditions:

(c)
that the person notifies the NRA, in writing, of the transfer not later than 6 weeks after it is agreed;
(d)
that the person complies with the terms of the licence as if he or she were the holder of the licence;
(e)
that the person applies for a licence in relation to the business, in accordance with section 122 of the Code, within 3 months after acquiring the business.

“(2) An exemption under subregulation (1):

(a)
ceases to have effect if the person’s application under paragraph (1) (e) is refused by the NRA; and
(b)
has no effect if the licence referred to in paragraph (1) (b) is not in force.”.

4. Regulation 61 (Licence conditions—general)

4.1 Add at the end:

“(7) If a licence allows a person other than the licence holder (in this subregulation called ‘the contractor’) to perform a step of a kind set out in paragraph 59A (a) in the manufacture of a chemical product, the licence holder:

(a)
must supervise the performance of that step; and
(b)
must ensure that the respective responsibilities of the contractor and the licence holder in relation to the step are recorded in writing; and
(c)
must ensure that the contractor maintains any records that, under the licence condition imposed by subregulation (3), the licence holder would be required to maintain if the licence holder performed the step; and
(d)
must ensure that:
(i)
the premises at which the contractor performs the step; and
(ii)
the records referred to in paragraphs (b) and (c);
are made accessible to a person appointed by the NRA to inspect the operations of the licence holder.

“(8) A holder of a licence must keep a record of complaints and product failures, as specified by Australian/New Zealand Standard AS/NZ/ISO 9002: 1994, Quality systems—Model for quality assurance in production, installation and servicing, as in effect at the commencement of this subregulation.

“(9) If the holder of a licence:

(a)
changes his, her or its name; or
(b)
being a corporation that has amalgamated with another corporation, carries on business under a name that is different from the name of the holder stated on the licence;

the holder must give notice in writing to the NRA of the new name, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.

“(10) If a body corporate that is the holder of a licence becomes an externally-administered body corporate, within the meaning of the Corporations Law, the person responsible for its administration must notify the NRA, in writing, that the body corporate has become an externally-administered body corporate within 3 months after that occurrence.”.

5. New regulation 72A

5.1 After regulation 72, insert:

Fee for issue of licence

“72A. (1) For the purposes of section 164 of the Code, the fee payable for the issue of a licence by the NRA is $6,000, payable by equal annual instalments as set out in this regulation.

“(2) Subject to subregulations (5) and (6), the amount of the annual instalment of the fee payable for the issue of a licence is:

(a)
if only 1 product is produced under the authority of the licence at the premises specified in the licence:
(i)
if that product is a Category 1 product—$1,500; or
(ii)
if that product is a Category 2 or 3 product—$1,000; or
(iii)
if that product is a Category 4 product—$500; or
(b)
if more than 1 product is produced under the licence at the premises specified in the licence, and both or all of those products are of the same category—the amount specified in paragraph (a) in relation to a single product of that category; or
(c)
if more than 1 product is produced under the licence at the premises, and not all of those products are of the same category—the highest amount specified in paragraph (a) in relation to any of those products; or
(d)
if the licence authorises only the performing of a single step in manufacture (including packaging, labelling, analysis or testing) at the premises, and the step is performed by a person other than a person to whom regulation 59A applies or to whom paragraph (e) refers—$500; or
(e)
if the licence authorises only the testing, analysis or sterilisation of a veterinary chemical product, and the holder of the licence is accredited by the National Association of Testing Authorities, Australia for the purposes of the testing, analysis or sterilisation of veterinary chemicals—$300; or
(f)
if the holder of the licence also holds a licence issued under the Therapeutic Goods Act 1989 authorising the production of therapeutic goods, within the meaning of that Act, at those premises—$300; or
(g)
if the holder of the licence is authorised, by an authority specified in subregulation (4), to manufacture, at those premises, chemicals for therapeutic use in relation to human beings, or chemicals for agricultural or veterinary use—$300.

“(3) In subregulation (2):

‘Category 1 product’ means a veterinary chemical product that is:

(a)
registered as being, represented to be, or required to be sterile; or
(b)
an immunobiological product;

‘Category 2 product’ means a veterinary chemical product that is not a Category 1, 3 or 4 product;

‘Category 3 product’ means a veterinary chemical product that is an ectoparasiticide;

‘Category 4 product’ means a veterinary chemical product that is:

(a)
a premix; or
(b)
a stockfood supplement.

[NOTE: Not all stockfood supplements or premixes are veterinary chemical products for the purposes of the Act. See the definition of ‘veterinary chemical product’ in section 5 of the Code, and regulation 8.]

“(4) For the purposes of paragraph (2) (g), each of the following bodies is a specified authority:

(a)
the Medicines Control Agency of the Department of Health of the United Kingdom;
(b)
the Veterinary Medicine Directorate of the United Kingdom;
(c)
the Animal and Plant Health Inspection Service of the Department of Agriculture of the United States of America;
(d)
the Centre for Veterinary Medicine of the Food and Drug Administration of the United States of America.

“(5) If a licence is granted subject to a condition to the effect that:

(a)
the licensee must undergo an audit of its manufacturing processes; and
(b)
the audit must demonstrate that the conduct of those manufacturing processes is satisfactory;

until the condition is satisfied, the amount of the annual instalment of the fee for the issue of the licence is $600.

“(6) Despite subregulations (2) and (5), if:

(a)
the total notional wholesale value (within the meaning of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994) of all the veterinary chemical products (other than veterinary chemical products that are exempt products for the purposes of section 121 of the Code) manufactured in a calendar year at the premises specified in a licence is less than $50,000; and
(b)
the holder of the licence provides evidence of that fact to the satisfaction of the NRA;

the amount of the instalment of the fee for the issue of the licence due in the following calendar year is one-half of the amount worked out in accordance with subregulations (2) and (5).

“(7) For the purposes of paragraph (6) (a), the notional wholesale value of a batch of a veterinary chemical product is the notional wholesale value at the time of completion of manufacture of the batch.

“(8) An instalment of the fee for issue of a licence is due for payment on the day the licence is granted, and a further instalment is due for payment on each anniversary of that day.

“(9) If an instalment of the fee for issue of a licence is not paid before the end of 28 days after the day it is due for payment, all other unpaid instalments for the issue of the licence become due for payment.

“(10) Despite subregulation (1), if a licence is cancelled, the NRA must waive any part of the prescribed fee that has not become due for payment at the time of cancellation.”.

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 24 July 1996.
2. Statutory Rules 1995 No. 27 as amended by 1995 Nos. 54, 137 and 187; 1996 Nos. 83 and 111.

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Agricultural and Veterinary Chemicals Code Regulations (Amendment) (Cth)

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