Timeframes for chemical reviews

Prior to July 2014, chemical reconsiderations were not time limited—the timeframe of individual reviews was determined by the scope and specific details of the review. For this reason, the time that it has taken to complete individual reviews has been highly variable, ranging from less than six months for the most straightforward label review to over 10 years for some of the more technically complex and large reviews. The average time taken to complete a review has been just over three years.

Some reviews do take a considerable period of time to complete. While an individual chemical review will have a unique set of circumstances that can affect its timeframe, there are some generalisations that can be made as to why some chemical reviews can take a considerable period of time to complete:

  • there are very large amounts of complex technical data that need to be scientifically evaluated, which is often undertaken by independent experts external to the APVMA
  • under the current legislative arrangements, approval holders and product registrants can provide additional information or data at any stage. Each time this data is provided, component risk assessment reports may need to be revised and republished for further consultation
  • for some reviews, there may be many hundreds of products and product labels that need to be assessed
  • the outcome of a chemical review may be the removal of certain uses from product labels, or in some cases, the complete removal of a chemical from the market. Such regulatory action can have a significant impact on growers and communities, particularly where there are no viable alternatives. On this basis, the consultation and implementation of a review can be complex.

From 1 July 2014, chemical reviews will be completed within a prescribed timeframe. The Agvet Code Regulations specify a formula that can be used to determine the period within which the APVMA must conclude the reconsideration. The maximum period prescribed in the Regulations for the most complex review will be 57 months. The benefit of now having a prescribed timeframe is the improvement of transparency around the chemical review process and the facilitation of certainty around the timing of review decisions. A significant change that will assist with completing reviews will be limits on when data can be provided for assessment.

The table below provides details around how the timeframe for individual reviews will be calculated. In addition to the formula specified in this table, the timeframe for reconsideration will depend on whether the APVMA requires the holder to provide information, reports, results or samples, and what time period the holder is given to address the requirements. In determining the response period, the APVMA will consider such things as the complexity of the reconsideration and whether trials or laboratory experiments are required. The maximum period that may be given is half the period in which the APVMA is required to complete a reconsideration. The APVMA may allow a further period only where an extraordinary event or circumstance beyond the control of the holder prevents them from fulfilling their obligations.

Table 1 - Period within which the APVMA is to conclude a reconsideration

Period within which the APVMA is to conclude a reconsideration =

A + B + 2E + 3C + J + D + X

A = the longest of the following periods (in months) relevant to the scope of the reconsideration

Item

Module level or type

Period for completion

Scope

3.1

Toxicology—level 1

13

 

3.2

Toxicology—level 2

9

 

3.3

Toxicology—level 3

5

 

4.1

Toxicology (requiring poison schedule classification)

13

l

7.1

Environment—level 1

13

l

7.2

Environment—level 2

7

 

7.3

Environment—level 3

4

 

 

Maximum total time for A

13

 

B = the longest of the following periods (in months) relevant to the scope of the reconsideration

Item

Module level or type

Period for completion

Scope

2.1

Chemistry—level 1

13

l

2.2

Chemistry—level 2

9

 

2.3

Chemistry—level 3

6

 

5.1

Residues—level 1

13

l

5.2

Residues—level 2

8

 

5.4

Residues—level 4

4

 

6.1

Occupational health and safety—level 1

13

l

6.2

Occupational health and safety—level 2

7

 

6.3

Occupational health and safety—level 3

4

 

9

Non-food trade

6

l

10.1

Special data—level 1

13

 

10.2

Special data—level 2

7

 

10.3

Special data—level 3

7

 

 

Maximum total time for B

13

 

E = the longest of the following periods (in months) relevant to the scope of the reconsideration

Item

Module level or type

Period for completion

Scope

8.1

Efficacy and safety—level 1

6

l

8.2

Efficacy and safety—level 2

4

 

8.3

Efficacy and safety—level 3

3

 

 

Maximum total time for 2E

2 x 6 = 12

 

C = the longest of the following periods (in months) relevant to the scope of the reconsideration

Item

Module level or type

Period for completion

Scope

11.1

Finalisation—type 1

3

l

11.2

Finalisation—type 2

2

 

11.3

Finalisation—type 3

2

 

 

Maximum total time for 3C

3 x 3 = 9

 

J = whichever is relevant

 

Consultation with jurisdictional coordinator

3

l

 

Any other case

0

 

 

Maximum total time for J

3

 

D

Total time for D

4

l

X = whichever is relevant

 

Appointment of an arbitrator under s. 64

3

 

 

Any other case

0

l

 

Maximum total time for X

3

 

Total maximum timeframe

57 months

 

 

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