CHEMICAL / Procymidone
REMAININGSCOPE / Toxicology [3.3], Residues [5.2], OHS [6.3], Finalisation[11.1]
RECONSIDERATIONASSESSMENTPERIOD / 29 months, see Attachment1
TIMEFRAME / START: 1 July2015 / FINISH: 1 November2017
WORK PLANDATE / 1 July 2015, amended 12 May 2016 (revision of expected dates forcomponentreports)
Stage / Details / Timeline
1.Nomination / Nomination decision – Gazetted in January2004.
2.Prioritisation / Concerns about toxicity (risk of reproductive and developmental effects), OHS (exposure andre- entry risks), and residues and trade (residue levels, MRLs and dietaryexposure).
Link to prioritisation decision – Completed in September2004.
3.Scoping andworkplan / Linkto procymidone scoping document –2004. Work plan – Published on 1 July2015.
4.Noticeof reconsideration / s32(1) notices sent to holders of 16 products and 5 actives in November2004. s32(2) notices given to States and Territories in November2004.
Linkto gazette – Published on 7 December 2004 (Submissions and data due 25 February2005). s159 letters for additional toxicology studies sent in2005.
Additional s32 notices sent to holders on 1 July 2015 to include all approved activesandregistered products in thereview.
START DATE (clockstarts) / 01/07/2015
5.Assessment / Component assessment reports to be completed after July 2015
Human health risk assessment (including toxicology andOHS)
Residues and tradeassessment / Publication Dates:
30 0ctober 2016
6.Draftregulatorymeasure / Preliminary review findingsreport.
7.Consultation / 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 / The APVMA will determine whetherto:
  • Vary, suspend or cancel actives, products or labels(s34AB)
  • Affirm actives, products or labels(s34AC)

END DATE (regulatorydecision) / 01/11/2017
Stage / Details / Timeline
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 / 5
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 / 8
2E=thelongestofthefollowingperiods(inmonths)relevanttothescopeofthereconsideration
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 / 0
3C = 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 / 29months