EXPLANATORY STATEMENT
Agricultural and Veterinary Chemicals Code
Amendment Instrument No. 3 (Multiple Applications) 2008
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is a statutory authority of the Commonwealth operating on a fully cost-recovery basis. The APVMA is responsible for ensuring that agricultural and veterinary chemicals entering into the Australian market pose no hazard to humans, target animals and plants and the environment, are effective for their approved use and pose no threat to Australian trade.
Subsection 32(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 provides that the Chief Executive Officer of the APVMA is to manage the affairs of the APVMA and in doing so, may exercise any of the powers and perform any of the functions of the APVMA.
Subsection 164(1A) of the Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code Act) provides that the APVMA may make a legislative instrument setting out criteria for working out which fee applies under the regulations in a particular case.
Subsection 165(1A) of the Agvet Code provides that the APVMA may also make a legislative instrument setting out criteria for working out which period stated in, or determined in accordance with, the regulations made for the purposes of subsection 165(1) applies in a particular case. This period is the period within which the APVMA must determine an application which has been made to it.
Amendments to the Agvet Code and the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Agvet Code Regulations) in 2005 provided for new cost recovery arrangements for the APVMA, including a revised fee structure for applications made to the APVMA. The periods within which the APVMA must determine particular applications were also revised. This revised fee and timeframes structure for applications commenced on 1 July 2005 and is set out in an amended Part 2 of Schedule 6 of the Agvet Code Regulations.
The revised Part 2 of Schedule 6 provides for 25 separate categories of applications. For six of these categories, the fee prescribed is the “modular assessment fee” to be determined in accordance with regulation 71 and Schedule 7 of the Agvet Code Regulations.
Categories 11 to 14 of Part 2 of Schedule 6 of the Agvet Code Regulations are all various forms of applications to vary a registration or label approval. Category 12 is for an application to vary the particulars or conditions of registration or label approval if the variation is to allow a minor change and no data of a technical nature is required. The fee for a Category 12 application is $560. Category 14 is a general “catch-all” category for applications to vary a registration or label approval – that is, for categories 11 to 14. In particular, Category 14 is for an application to vary the particulars or conditions of registration or listed registration or label approval if the application is not of a kind described in any of items 11 to 13. The fee for a Category 14 application is the modular assessment fee.
Schedule 7 provides for twelve broad modules to be applied to any application to be assessed by the modular assessment fee. The modules cover the initial examination of an application by the APVMA (Screening), the assessment of its Chemistry, Toxicology, Poison Scheduling, Residues, Occupational Health and Safety (OH&S), Environment, Efficacy and Safety, Trade and other certain administrative matters. The total modular assessment fee to be paid for the application is the total of all the particular levels for all twelve modules which are relevant (for certain applications some of the modules will not apply). This will then determine a fee for the application that is directly related to the actual amount of assessment by the APVMA that is necessary to determine it.
Pursuant to sections 164(1A) of the Agvet Code, the APVMA enacted the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005 (the Principal Instrument). The Principal Instrument details which modular levels, as set out in Schedule 7 of the Agvet Regulations, are to apply to a particular application. Sections 17 of the Principal Instrument provides that if, as a result of the Principal Instrument, a module, level or type of assessment is appropriate for a particular application then the fee payable in respect of that module, level or type of assessment is the fee set out in column 4 of Schedule 7 of the Agvet Code Regulations for that module, level or type of assessment.
Section 18 provides if, as a result of the Principal Instrument, a module, level or type of assessment is appropriate for a particular application then the period within which the APVMA must complete that particular module, level or type of assessment is the period set out in column 3 of Schedule 7 to the Agvet Code Regulations for that module, level or type of assessment.
The purpose of the Agricultural and Veterinary Chemicals Code Amendment Instrument No. 3 (Multiple Applications) 2008 (the Amendment Instrument) is to add to sections 17 and 18 to provide a new modular fee and timeframe for multiple applications. Multiple applications are applications to vary the particulars or conditions of registration or label approval involving a minor label change and the same applicant seeks the same variation in respect of two or more chemical products.
The new modular fee for multiple applications provides for a form of “bundling” of the multiples so that, in essence the module 1 screening fee (currently $460) applies only once irrespective of how many separate products are included in the multiple application and the module 11.4 finalisation fee (currently $145) applies for each product up to five but then applies only once for each subsequent “bundle” of up to five products.
If any technical assessment of a multiple application is also required the fee would also include whatever technical assessment is required multiplied by the rate or actual number of times that technical assessment has to be carried out.
The new timeframe or period within which the APVMA must complete any multiple application is three months.
The APVMA has discussed the proposals with the agvet chemicals industry and it strongly supports them. While there will be a fee reduction for individual applicants, the overall revenue loss to the APVMA is not expected to be significant.
These amendments are to be made in conjunction with the Agricultural and Veterinary Chemicals Code Amendment Instrument No. 2 (Multiple Applications) 2008 which, by amending the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005, provides that any multiple application must be included in Category 14 for which the modular assessment fee applies.
The Agricultural and Veterinary Chemicals Code Amendment Instrument No. 3 (Multiple Applications) 2008 is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
NOTES ON ITEMS
Item 1 Name of Instrument
1. This item states that the full name of the Amendment Instrument is the Agricultural and Veterinary Chemicals Code Amendment Instrument No. 3 (Multiple Applications) 2008.
Item 2 Commencement
2. This item provides that the Amendment Instrument will commence on the day after it is registered on the Federal Register of Legislative Instruments (FRLI).
Item 3 Amendment of the Agricultural and Veterinary Chemicals Code
Instrument No. 2 (Modular Assessment Fees) 2005
3. This item provides that Schedule 1 amends the Principal Instrument.
Schedule 1 Amendments
Item 1 Subsection 4(2)
4. This item adds a new definition of “multiple application”. The definition provides that “multiple application” means an application to vary the particulars or conditions of registration or label approval where the variation is to allow a minor label change (whether or not data of a technical nature is required) and the same type of variation is requested by the same applicant in respect of more than one chemical product.
Item 2 Sections 17 and 18
5. This items repeals the sections and substitutes new sections.
6. Subsection 17(1) resubstitutes the existing section 17 but, for greater clarity, adds the words “ of assessment” after “type” in line 3 and the words “of the Agvet Code Regulations for that module, level or type of assessment” at the end.
7. Subsection 17(2) confirms that multiple applications are included in Category 14 and sets out how the fee for multiple applications, where no data of a technical nature is required, is to be calculated. For multiple applications involving variations of up to five products the method of calculating the fee is the module 1 screening fee (currently $460) plus the number of products times the module 11.4 finalisation fee (currently $145). The table in paragraph 17(2)(a) shows that this method results in a fee of $750 for a multiple application involving two products; $895 for a multiple application with three products; $1,040 for a multiple with four products; and $1,185 with five products.
8. Paragraph 17(2)(b) sets out the method of calculating the fee for multiple applications involving variations of more than five products. In these cases the fee is the module 1 screening fee (currently $460) plus M minus one plus five times the module 11.4 finalisation fee (currently $145), where M is the number of products in the multiple application (N) divided by 5, but if the result is not a whole number the next highest whole number. This method effectively ‘bundles’ multiple applications into five products and after charging the module 11.4 finalisation fee (currently $145) for each of the first five product then only charges that fee once for each additional ‘bundle’ of up to five products.
9. A table is attached to this Explanatory Statement setting out the current total fees for multiple applications of up to 100 products using the method of calculation set out in the Amendment Instrument.
10. The fee derived by this method for multiple applications is significantly less than would otherwise be the case for several single applications (the appropriate category for a single application would be category 12 with a fee of $560). Thus, a multiple application containing 10 products would have cost $5,600 but by bundling in the way set out in the Amendment Instrument will cost only $1,330.
11. Subsection 17(3) provides for the method of calculating the fee for multiple applications where data of a technical nature is required. Essentially the method of calculating the fee for such multiple applications is the same as for multiple applications where no data of a technical nature is required (the fee for which is set out in subsection 17(2), as explained in paragraph 8 above) except that the calculated fee additionally includes any technical assessment required by the APVMA (other than the screening or finalisation modules) multiplied by the effective rate of that technical assessment – that is, the actual number of each of the technical assessments required for all of the products in the multiple application.
12. Subsection 18(1) resubstitutes the existing section 18 but, for greater clarity, adds the words “ of assessment” after “type” in line 3 and the words “of the Agvet Code Regulations for that module, level or type of assessment” at the end.
13. Subsection 18(2) provides that the timeframe by which the APVMA must complete a multiple application is three months.
Attachment
The fee for multiple applications containing up to 100 products
Number of products in multiple application (N) | M | The method of calculating the fee
| Fee for the application |
2 | – | $460 + 2($145) | $750 |
3 | – | $460 + 3($145) | $895 |
4 | – | $460 + 4($145) | $1,040 |
5 | – | $460 + 5($145) | $1,185 |
6 to 10 | 2 | $460 + ([2–1] + 5)$145 = $460 + 6$145 | $1,330 |
11 to 15 | 3 | $460 + ([3–1] + 5)$145 = $460 + 7$145 | $1,475 |
16 to 20 | 4 | $460 + ([4–1] + 5)$145 = $460 + 8$145 | $1,620 |
21 to 25 | 5 | $460 + ([5–1] + 5)$145 = $460 + 9$145 | $1,765 |
26 to 30 | 6 | $460 + ([6–1] + 5)$145 = $460 + 10$145 | $1,910 |
31 to 35 | 7 | $460 + ([7–1] + 5)$145 = $460 + 11$145 | $2,055 |
36 to 40 | 8 | $460 + ([8–1] + 5)$145 = $460 + 12$145 | $2,200 |
41 to 45 | 9 | $460 + ([9–1] + 5)$145 = $460 + 13$145 | $2,345 |
46 to 50 | 10 | $460 + ([10–1] + 5)$145 = $460 + 14$145 | $2,490 |
51 to 55 | 11 | $460 + ([11–1] + 5)$145 = $460 + 15$145 | $2,635 |
56 to 60 | 12 | $460 + ([12–1] + 5)$145 = $460 + 16$145 | $2,780 |
61 to 65 | 13 | $460 + ([13–1] + 5)$145 = $460 + 17$145 | $2,925 |
66 to 70 | 14 | $460 + ([14–1] + 5)$145 = $460 + 18$145 | $3,070 |
71 to 75 | 15 | $460 + ([15–1] + 5)$145 = $460 + 19$145 | $3,215 |
76 to 80 | 16 | $460 + ([16–1] + 5)$145 = $460 + 20$145 | $3,360 |
81 to 85 | 17 | $460 + ([17–1] + 5)$145 = $460 + 21$145 | $3,505 |
86 to 90 | 18 | $460 + ([18–1] + 5)$145 = $460 + 22$145 | $3,650 |
91 to 95 | 19 | $460 + ([19–1] + 5)$145 = $460 + 23$145 | $3,795 |
96 to 100 | 20 | $460 + ([20–1] + 5)$145 = $460 + 24$145 | $3,940 |
where
N is the number of products in the multiple application;
M is N divided by 5, but if the result is not a whole number the next highest whole number;
$460 is the current module 1 screening fee; and
$145 is the current module 11.4 finalisation fee.
For more than five products, the method of calculating the fee for a multiple application is the module 1 screening fee + ([M–1]+5) times the module 11.4 finalisation fee – that is, currently, $460 + ([M–1]+5)$145.