Chemical Review Workplan - Methiocarb

CHEMICAL / Methiocarb
REMAININGSCOPE / Environment (7.3), Residues (5.4), OHS(6.3)
RECONSIDERATIONASSESSMENTPERIOD / 24 months, see Attachment1
TIMEFRAME / START: 1 July2015 / FINISH: 1 July2017
WORK PLANDATE / 1 July 2015, amended 13 May 2016 (revision of expected dates forcomponentreports, PRD/PRF and publicconsultation)

Publication Dates:StageDetailsTimeline

1.Nomination

Invitation to nominate agricultural and veterinary chemicals for review – Gazetted on1November1994.

2.PrioritisationMethiocarb was addedto the prioritycandidatereviewlistin 1995 – Gazetted on 2 May1995.

3.Scoping andworkplan

Scope – chemistry, toxicology, OHS, environment, residues and trade – Gazetted on2December1997.

Work plan – Published on 1 July2015.

4.Noticeof reconsideration

Notice of reconsideration – Gazetted on 2 December1997.

Additional s32 notices sent to holders on 1 July 2015 to include all approved activesandregistered products in thereview.

START DATE (clockstarts)1/07/2015

5.Assessment

Component assessment reports published prior to 1 July2015

Link to toxicology assessment – Published in2005.

Link to updated toxicology assessment – Published in2013. Link to OHS assessment – Published in2005.

Link to environment assessment – Published in2005.Link to residues assessment – Published in2005.

Component assessment reports to becompleted after July 2015

Supplementary OHSassessment

Supplementary environmentassessment

Supplementary residuesassessment

Publication Dates:

6.Draftregulatorymeasure

Draft regulatory measures proposed

Link to preliminary review findings and call for residues data to be generated – Publishedin April 2005. There were no draft regulatory measures at thattime.

Draft regulatory measures to becompleted

Preliminary review findingsreport

StageDetailsTimeline

7.Consultation / Details of consultation undertaken todate
There was a 6-month public consultation period following the 1997 notice ofreconsideration.
A 3-month public consultation period also occurred following publication of thepreliminaryreview findings in2005.
Consultation to beundertaken
A 3-month public consultation period is planned. Any further dataorinformation submitted during consultation will be taken intoconsideration before making the final regulatorydecision.
8.Regulatorydecision / Regulatory decisions to bemade
The APVMA will determine whetherto:

Vary, suspend or cancel actives, products or labels(s34AB)
Affirm actives, products or labels(s34AC)

END DATE (regulatorydecision) / 1/07/2017
9.Implementation / The APVMA will publish details of any applicable phase out periods if any approvals ofactives,registration of products or label approvals arecancelled.
The maximum phase out period specified in the legislation is12-months. Anticipated date(s) will be included in thefuture.

Attachment1

AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS 1995 –S78BPERIOD WITHIN WHICH APVMA IS TO CONCLUDERECONSIDERATIONS
A + B + 2E + 3C + J + D +X
A = the longest of the following periods (in months) relevant to the scope of thereconsideration
Item / Module level ortype / Period forcompletion / Scope
3.1 / Toxicology – Level1 / 13
3.2 / Toxicology – Level2 / 9
3.3 / Toxicology – Level3 / 5
4.1 / Toxicology (requiring poison scheduleclassification) / 13
7.1 / Environment – Level1 / 13
7.2 / Environment – Level2 / 7
7.3 / Environment – Level3 / 4 / 
TOTAL TIME FORA / 4
B = the longest of the following periods (in months) relevant to the scope of thereconsideration
Item / Module level ortype / Period forcompletion / Scope
2.1 / Chemistry – Level1 / 13
2.2 / Chemistry – Level2 / 9
2.3 / Chemistry – Level3 / 6
5.1 / Residues – Level1 / 13
5.2 / Residues – Level2 / 8
5.4 / Residues – Level4 / 4 / 
6.1 / Occupational Health and Safety – Level1 / 13
6.2 / Occupational Health and Safety – Level2 / 7
6.3 / Occupational Health and Safety – Level3 / 4 / 
9 / Non-foodtrade / 6
10.1 / Special data – Level1 / 13
10.2 / Special data – Level2 / 7
10.3 / Special data – Level3 / 7
TOTAL TIME FORB / 4
E = the longest of the following periods (in months) relevant to the scope of thereconsideration
Item / Module level ortype / Period forcompletion / Scope
8.1 / Efficacy and safety – Level1 / 6
8.2 / Efficacy and safety – Level2 / 4
8.3 / Efficacy and safety – Level3 / 3
TOTAL TIME FORE / NA
C = the longest of the following periods (in months) relevant to the scope of thereconsideration
Item / Module level ortype / Period forcompletion / Scope
11.1 / Finalisation – type1 / 3 / 
11.2 / Finalisation – type2 / 2
11.3 / Finalisation – type3 / 2
TOTAL TIME FORC / 3 x 3 = 9
J = whichever isrelevant
Consultation with jurisdictionalcoordinator / 3 / 
In any othercase / 0
TOTAL TIME FORJ / 3
D / TOTAL TIME FORD / 4 / 
X = whichever isrelevant
Appointment of an arbitrator unders.64 / 3
In any othercase / 0 / 
TOTAL TIME FORX / 0
TOTALTIMEFRAME / 24months