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					                                                                 ADVICE SUMMARY
                                     APPLICATION FOR VARIATION OF A REGISTERED CHEMICAL PRODUCT
Product name:               TERBYNE 750 WG HERBICIDE
Applicant:                  SIPCAM PACIFIC AUSTRALIA PTY LTD
Product number:             56973
Application number:         52784


Purpose of Application and Description of Use: Variation of registration and RLP approval to extend the use to include pre-sowing and pre &
                     post-emergence use in sorghum for the control and suppression of various broadleaf and grass weeds


Active Constituent(s): TERBUTHYLAZINE



Regulatory Decision:
To grant the application subject to the following conditions:

Standard Conditions of Label Approval
    1. Label must contain a Date of Manufacture and Batch Number
For full conditions, refer to the Conditions of Product Label Approval on the APVMA website.




52784                                                                     Page 1 of 8                           KP25S_F40 Version: 2 Issued: 10/08/2007
ADVICE

Australian Government Department of Sustainability, Environment, Water, Population and Community
DSEWPaC has previously assessed the application for registration of the product Terbyne 750 WG Herbicide for control of weeds in pulse crops and triazine
tolerant canola using incorporation by sowing, post sowing pre-emergent and early post-emergence applications. The maximum application rate for new use
in sorghum is 1.4 kg formulation/ha, which is the current maximum application rate. The application method for the extension of use is the same as that for
the existing uses.
The proposed extension of use also includes a mandatory tank mix of Terbyne at 1.1 kg/ha (or 825 g terbuthylazine/ha) with a currently registered product
Acclaim Herbicide (Acclaim, 200 g/L fluroxypyr) at 750 mL/ha or 150 g fluroxypyr/ha at post emergent application.

DSEWPaC has also previously assessed the use of Acclaim Herbicide for aerial application of sorghum, winter cereals, winter or summer fallows, sugar cane
(by air) and poppies with a maximum rate of 1.5 L/ha (300 g fluroxypyr/ha).

No new environmental fate and ecotoxicity studies have been supplied with this application. This assessment makes use of data from DSEWPaC’s data
holdings of the previous assessments on the products, relevant literature in the public domain and the efficacy data provided.

Considering the application rates do not exceed the current individual maximum application rates and the toxicity is low to birds, rats, honeybees, earthworms
and soil microorganisms from each of the active constituents, the effects from a combination of the two products are not expected to increase, and therefore,
the risk to these species will not be considered. The combined effects to the most sensitive aquatic species algae and duckweed are expected to be very
similar in magnitude to those effects from current use of terbuthylazine since terbuthylazine’s toxicity to these species swamps that of fluroxypyr, and
therefore, the risk to aquatic species is not expected to change from that previously assessed and is not considered in this risk assessment. Therefore, the
buffer zone of 60 meters calculated previously is retained, and the risk to non-target plants only has been considered in this assessment.

Assessment of the potential risk from additive toxicity of the products -Terbyne and Acclaim indicates an acceptable risk to the non-target terrestrial plants
provided the no-spray zone of 20 m (calculated using Agdrift) is applied.

Based on the assessment, DSEWPaC recommended spray drift restraints and amendments to the protection statement and crop stage for the post-
emergence application. Subject to these label amendments being done, DSEWPaC recommended that the use of Terbyne 750WG Herbicide as proposed
would not be likely to have an unintended effect that is harmful to animals, plants or things, or to the environment under section 14 subsection 1 of the Agvet
Code.




52784                                                                       Page 2 of 8                                           KP25S_F40 Version: 2 Issued: 10/08/2007
Data relied on to provide the advice
Data No    Data        Author(s)                           Title                                   Date          Data Type      Data Sub-type         Authorising Party      Inherited
          Source*                                                                                                                                                          Application No.


56853     S         Anon           Pesticide Fact Sheet Name of Chemical:                30 September 1998   Environment     Other Information       Public
                                   Fluroxypyr                                                                Toxicology
56854     S         Patrick R.     Fluroxypyr Human Health and Ecological Risk           12 June 2009        Environment     Other Information       Public
                    Durkin         Assessment FINAL REPORT                                                   Toxicology
56850     S         Gavin Hall     Assessment of the potential for synergistic effects   1 September 2011    Environment     Other Information       Applicant
                                   from the combination of terbuthylazine and                                Toxicology
                                   fluroxypyr using efficacy data
56839     S         Derek Litzow   Evaluation of terbyne applied post-emergent for the   30 April 2009       Efficacy and    Efficacy                Applicant
                                   control of weeds in sorghum one field trial, Nobby,                       Safety
                                   Queensland, Australia, 2009
56838     S         Derek Litzow   Evaluation of terbyne applied post-emergent for the   4 May 2009          Efficacy and    Efficacy                Applicant
                                   control of weeds in sorghum one field trial,                              Safety
                                   Jondaryan, Queensland, Australia, 2009

56837     S         Andrew         Evaluation of terbyne for post-emergence weed         8 May 2008          Efficacy and    Efficacy                Applicant
                    Somervaille    control in sorghum                                                        Safety
56836     S         Andrew         Evaluation of terbyne for post-emergence weed         8 May 2008          Efficacy and    Efficacy                Applicant
                    Somervaille    control in sorghum                                                        Safety
56834     S         Sam Simons,    Terbyne Efficacy Pre-Emergence in Sorghum #2          February 2011       Efficacy and    Efficacy                Applicant
                    Denis Harvey   Narrabri                                                                  Safety
56833     S         Sam Simons,    Terbyne Efficacy Pre-Emergence in Sorghum             February 2011       Efficacy and    Efficacy                Applicant
                    Denis Harvey   Narrabri                                                                  Safety
56846     S         Sam Simons,    Terbyne Efficacy Post Em in Sorghum #2 Narrabri       February 2011       Efficacy and    Efficacy                Applicant
                    Denis Harvey                                                                             Safety
56845     S         Sam Simons,    Terbyne Efficacy Post Em in Sorghum Narrabri          February 2011       Efficacy and    Efficacy                Applicant
                    Nathan                                                                                   Safety
                    Eulenstein
56844     S         Andrew         Terbyne efficacy post-emergence in sorghum            6 May 2010          Efficacy and    Efficacy                Applicant
                    Somervaille    report of experiment conducted Jandowae East,                             Safety
                                   Qld
56843     S         Andrew         Terbyne efficacy post-emergence in sorghum            6 May 2010          Efficacy and    Efficacy                Applicant
                    Somervaille    report of experiment conducted near Warra, Qld                            Safety
56842     S         Andrew         Evaluation of terbyne for post-emergence weed         26 June 2009        Efficacy and    Efficacy                Applicant
                    Somervaille    control in sorghum                                                        Safety




52784                                                                                    Page 3 of 8                                             KP25S_F40 Version: 2 Issued: 10/08/2007
Data No     Data        Author(s)                            Title                                 Date        Data Type        Data Sub-type        Authorising Party      Inherited
           Source*                                                                                                                                                        Application No.


56828     S          Andrew          Evaluation of terbyne for pre-emergence weed        21 April 2008     Efficacy and     Efficacy                Applicant
                     Somervaille     control in sorghum                                                    Safety
56841     S          Andrew          Evaluation of terbyne for post-emergence weed       22 June 2009      Efficacy and     Efficacy                Applicant
                     Somervaille     control in sorghum                                                    Safety
56830     S          Derek Litzow    Evaluation of terbyne applied pre-emergence for     20 August 2009    Efficacy and     Efficacy                Applicant
                                     the control of weeds in sorghum one trial, Moree,                     Safety
                                     New South Wales, Australia, 2008-09
56831     S          Andrew          Terbyne efficacy pre-emergence in sorghum report    29 April 2010     Efficacy and     Efficacy                Applicant
                     Somervaille     of experiment conducted at Dalby, Qld                                 Safety
56832     S          Andrew          Terbyne efficacy pre-emergence in sorghum report    6 May 2010        Efficacy and     Efficacy                Applicant
                     Somervaille     of experiment conducted at Jandowae East, Qld                         Safety
56840     S          Andrew          Evaluation of terbyne for post-emergence weed       18 June 2009      Efficacy and     Efficacy                Applicant
                     Somervaille     control in sorghum                                                    Safety




APVMA Pesticides Program, Residues Team
Provided data from 5 Australian GLP trials on sorghum, 2 Spanish GLP trials on sorghum and 7 European GLP trials on maize were assessed to support the variation of the
label approval for Terbyne 750 WG Herbicide to extend the pre-sowing and pre and post-emergence use in sorghum for the control and suppression of various broadleaf and
grass weeds.

Considering the assessment of the available data, the proposed use of terbuthylazine on sorghum is supported from a residues perspective, provided that application is made
no later than the 8 leaf growth stage (GS 18). The data support MRLs of *0.01 mg/kg for sorghum grain, *0.02 mg/kg for dry sorghum straw and fodder and 5 mg/kg for
sorghum forage (green) to cover the proposed use of terbuthylazine on sorghum, in conjunction with a harvest withholding period not required when used as directed and a
grazing withholding period of 4 weeks.

No change to the animal commodity MRLs for terbuthylazine is recommended at this stage. The estimated dietary intake of terbuthylazine arising from residues in food is
unlikely to exceed the health standards.
Based on the advice from the residues assessment, the post-emergence use application timing of Terbyne on sorghum has been amended on the label.

APVMA is therefore satisfied that the use of the product in accordance with the required label instructions would not be harmful or an undue hazard to the safety of people
exposed to residues in food as per section 14(3)(e)(i) & (ii) and that the residues aspects of section 14(5) of the Agvet Codes have been met. Further, the use of the product in
accordance with the required instructions would not unduly prejudice trade and commerce between Australia and places outside Australia as per section 14(3)(iv) of the Agvet
Codes, as detectable residues of terbuthylazine are not expected to occur when the product is used as directed.




52784                                                                                    Page 4 of 8                                            KP25S_F40 Version: 2 Issued: 10/08/2007
Data relied on to provide the advice
Data No    Data         Author(s)                               Title                                        Date      Data Type       Data Sub-type             Authorising         Inherited
          Source*                                                                                                                                                   Party          Application No.


12191     I         Chambers, M       Determination of the tissue residues (liver, kidney,        2006               Residues      Animal Commodity          Sipcam Pacific       40585
                                      muscle and fat) following daily ingestion by cattle of                                       Residues Crop             Australia Pty Ltd
                                      terbuthylazine over a 28 day period. Veterinary                                              Transfer
                                      Health Research Pty Ltd Armidale NSW 2350
12192     I         Chambers, M       The determination residues in bovine milk following         2006               Residues      Animal Commodity          Sipcam Pacific       40585
                                      daily ingestion of terbuthylazine by lactating dairy                                         Residues Crop             Australia Pty Ltd
                                      cows over a 28 day period. Veterinary Health                                                 Transfer
                                      Research Pty Ltd Armidale NSW 2350
56829     S         Pietro            Generation of maize grain or green silage maize             31 October 2001    Residues      Crop Residues Human       Applicant
                    Domenichini       samples, suitable for residue analysis following                                             Consumption
                                      applicaiton in post emergence of Terbuthylazine 75%
                                      WG and Terbuthylazine 500 g/L SC (Field trials
                                      carried out in Italy in the year 2001)
56827     S         Giorgio Freschi   Residue analysis of terbuthylazine in maize samples         16 April 2002      Residues      Crop Residues Human       Applicant
                                      (grain)                                                                                      Consumption




56826     S         Giorgio Freschi   Residue analysis of terbuthylazine in maize samples         16 April 2002      Residues      Crop Residues Human       Applicant
                                      (whole plant)                                                                                Consumption
56825     S         Pietro            Generation of maize samples, suitable for residue           30 October 2001    Residues      Crop Residues Human       Applicant
                    Domenichini       analysis of Terbuthylazine following applicaiton in                                          Consumption
                                      post emergence of Terbuthylazine 75% WG and
                                      Terbuthylazine 500 g/L SC
56824     S         Bernardo          Determination of residues of Terbuthylazine after           13 February 2001   Residues      Crop Residues Human       Applicant
                    Pollmann          applicaiton of Terbuthylazine 500 g/L SC and                                                 Consumption
                                      Terbuthylazine 75% WG in maize - 1 site in France
                                      and 3 sites in Germany, 2000
56823     S         Giorgio Freschi   Residue analysis of terbuthylazine in maize samples         21 December 2000   Residues      Crop Residues Human       Applicant
                                      (grain)                                                                                      Consumption
56822     S         Giorgio Freschi   Residue analysis of terbuthylazine in maize samples         21 December 2000   Residues      Crop Residues Human       Applicant
                                      (cobs)                                                                                       Consumption
56821     S         Giorgio Freschi   Residue analysis of terbuthylazine in maize samples         21 December 2000   Residues      Crop Residues Human       Applicant
                                      (plant)                                                                                      Consumption




52784                                                                                          Page 5 of 8                                               KP25S_F40 Version: 2 Issued: 10/08/2007
Data No     Data         Author(s)                             Title                                       Date      Data Type       Data Sub-type             Authorising         Inherited
           Source*                                                                                                                                                Party          Application No.


56820      S         Jose-Ramon        Generation of Sorghum specimens, suitable for            12 July 2002       Residues      Crop Residues Human       Applicant
                     Soler Gil-        residue analysis of Terbuthylazine following                                              Consumption
                     Mascarell         applicaitons of Terbuthylazine 500 g/L SC and
                                       Terbuthylazine 75% WG
56819      S         Giorgio Freschi   Residue analysis of terbuthylazine in sorghum            13 May 2002        Residues      Crop Residues Human       Applicant
                                       samples (grain)                                                                           Consumption
56818      S         Jose-Ramon        Generation of Sorghum specimens, suitable for            24 October 2001    Residues      Crop Residues Human       Applicant
                     Soler Gil-        residue analysis of Terbuthylazine following                                              Consumption
                     Mascarell         applicaitons of Terbuthylazine 500 g/L SC and
                                       Terbuthylazine 75% WG
56817      S         Giorgio Freschi   Residue analysis of terbuthylazine in sorghum            27 February 2001   Residues      Crop Residues Human       Applicant
                                       samples (grain)                                                                           Consumption
56816      S         Richard           Determination of terbuthylazine residues in sorghum      9 November 2010    Residues      Crop Residues Human       Applicant
                     Holzknecht        forage, grain and stubble following applications of                                       Consumption
                                       Terbyne 750 WG Herbicide


State/External Efficacy Reviewer

A total of 19 trials were presented in direct support of the application to vary the registration of Terbyne 750 WG Herbicide for use over sorghum crops for the control and
suppression of a range of weeds. All of the trials were replicated and conducted in commercial cropping situations in different districts across Queensland and New South
Wales.

Each of the studies presented was statistically designed with data statistically analysed. All of the field trials were conducted in typical sorghum cropping regions. This provided
a good geographic range typical of the actual environment in which the product would be used. Dose rates tested align with label recommendations.

The data presented in the 19 trials indicated dose rates of Terbyne of 1.4 kg/ha applied pre-sowing and post-sowing emergence was effective at controlling weeds such as
bladder ketmia, yellow vine, dwarf amaranth, milk thistle and pigweed. In post-emergence application trials, the addition of Hasten as an adjuvant at the same dose rate and
the addition of Acclaim (fluoroxypyr) at 0.50 to 0.675 ml/ha enabled the Terbyne dose to be reduced to 1.1 kg/ha. None of the 19 trials showed phytotoxic effects on a range
of sorghum varieties indicative of acceptable crop safety.

The reviewer therefore concluded that the trial data supplied supports the efficacy of Terbyne in controlling label-listed weeds. Data presented also indicates Terbyne shows
no crop phytotoxicity to sorghum when applied Pre-Sowing, Post-Sowing Pre-Emergence, and Post-Emergence.

Considering the recommendation from the reviewer, the APVMA is satisfied that the use of the product Terbyne 750 WG Herbicide would be effective and safe for the
proposed extension to sorghum when used in accordance with the proposed label instructions.




52784                                                                                        Page 6 of 8                                               KP25S_F40 Version: 2 Issued: 10/08/2007
Data relied on to provide the advice
Data No    Data        Author(s)                             Title                                     Date          Data Type           Data Sub-type          Authorising          Inherited
          Source*                                                                                                                                                  Party           Application No.


56835     S         Andrew         Evaluation of terbyne for post-emergence weed control        30 April 2008   Efficacy and Safety   Efficacy               Applicant
                    Somervaille    in sorghum
56839     S         Derek Litzow   Evaluation of terbyne applied post-emergent for the          30 April 2009   Efficacy and Safety   Efficacy               Applicant
                                   control of weeds in sorghum one field trial, Nobby,
                                   Queensland, Australia, 2009
56838     S         Derek Litzow   Evaluation of terbyne applied post-emergent for the          4 May 2009      Efficacy and Safety   Efficacy               Applicant
                                   control of weeds in sorghum one field trial, Jondaryan,
                                   Queensland, Australia, 2009
56837     S         Andrew         Evaluation of terbyne for post-emergence weed control        8 May 2008      Efficacy and Safety   Efficacy               Applicant
                    Somervaille    in sorghum
56836     S         Andrew         Evaluation of terbyne for post-emergence weed control        8 May 2008      Efficacy and Safety   Efficacy               Applicant
                    Somervaille    in sorghum
56834     S         Sam Simons,    Terbyne Efficacy Pre-Emergence in Sorghum #2                 February 2011   Efficacy and Safety   Efficacy               Applicant
                    Denis Harvey   Narrabri
56833     S         Sam Simons,    Terbyne Efficacy Pre-Emergence in Sorghum Narrabri           February 2011   Efficacy and Safety   Efficacy               Applicant
                    Denis Harvey
56846     S         Sam Simons,    Terbyne Efficacy Post Em in Sorghum #2 Narrabri              February 2011   Efficacy and Safety   Efficacy               Applicant
                    Denis Harvey
56845     S         Sam Simons,    Terbyne Efficacy Post Em in Sorghum Narrabri                 February 2011   Efficacy and Safety   Efficacy               Applicant
                    Nathan
                    Eulenstein


56844     S         Andrew         Terbyne efficacy post-emergence in sorghum report of         6 May 2010      Efficacy and Safety   Efficacy               Applicant
                    Somervaille    experiment conducted Jandowae East, Qld
56843     S         Andrew         Terbyne efficacy post-emergence in sorghum report of         6 May 2010      Efficacy and Safety   Efficacy               Applicant
                    Somervaille    experiment conducted near Warra, Qld
56842     S         Andrew         Evaluation of terbyne for post-emergence weed control        26 June 2009    Efficacy and Safety   Efficacy               Applicant
                    Somervaille    in sorghum
56828     S         Andrew         Evaluation of terbyne for pre-emergence weed control         21 April 2008   Efficacy and Safety   Efficacy               Applicant
                    Somervaille    in sorghum




52784                                                                                        Page 7 of 8                                                 KP25S_F40 Version: 2 Issued: 10/08/2007
Data No    Data        Author(s)                            Title                                    Date           Data Type           Data Sub-type           Authorising          Inherited
          Source*                                                                                                                                                  Party           Application No.


56841     S         Andrew         Evaluation of terbyne for post-emergence weed control      22 June 2009     Efficacy and Safety   Efficacy                Applicant
                    Somervaille    in sorghum
56830     S         Derek Litzow   Evaluation of terbyne applied pre-emergence for the        20 August 2009   Efficacy and Safety   Efficacy                Applicant
                                   control of weeds in sorghum one trial, Moree, New
                                   South Wales, Australia, 2008-09
56831     S         Andrew         Terbyne efficacy pre-emergence in sorghum report of        29 April 2010    Efficacy and Safety   Efficacy                Applicant
                    Somervaille    experiment conducted at Dalby, Qld
56832     S         Andrew         Terbyne efficacy pre-emergence in sorghum report of        6 May 2010       Efficacy and Safety   Efficacy                Applicant
                    Somervaille    experiment conducted at Jandowae East, Qld
56840     S         Andrew         Evaluation of terbyne for post-emergence weed control      18 June 2009     Efficacy and Safety   Efficacy                Applicant
                    Somervaille    in sorghum
56848     S         Linda Bailey   To evaluate the crop safety of Terbyne 750 WG on six       22 March 2010    Efficacy and Safety   Phytotoxicity and       Applicant
                                   sorghum varieties Yelarbon, Queensland, 2009-10                                                   Crop Safety
56847     S         Sam Simons,    Terbyne Sorghum Varietal Tolerance                         February 2011    Efficacy and Safety   Phytotoxicity and       Applicant
                    Nathan                                                                                                           Crop Safety
                    Eulenstein

* S = Data submitted with the application;
I = Data inherited (that is, referenced) from another application




52784                                                                                      Page 8 of 8                                                   KP25S_F40 Version: 2 Issued: 10/08/2007

				
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