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Affinity force herbicide
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Document Sample
ADVICE SUMMARY
APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT
Product name: AFFINITY FORCE HERBICIDE
Applicant: FMC AUSTRALASIA PTY LTD
Product number: 62003
Application number: 42079
Purpose of Application and Description of Use: Registration of a 240 g/L Carfentrazone-ethyl oil in water product for the control of certain annual
broadleaf weeds in winter cereals and pyrethrum as per Directions For Use Table.
Active Constituent(s): CARFENTRAZONE-ETHYL
Regulatory Decision:
To grant the application subject to the following conditions:
Standard Conditions of Registration/Approval
1. Containers must meet AgVet Code Regulation 18
2. Agricultural products must meet Active Constituents Quality Assurance Requirements
3. Label must contain a Date of Manufacture and Batch Number
For full conditions, refer to http://www.apvma.gov.au/advice_summaries/adv_summaries.shtml.
Australian Government Department Of Health And Ageing, Office Of Chemical Safety
The product Affinity Force Herbicide will be mixed with water and other knockdown herbicides for ground application. When used in winter cereals
(wheat, barley, oats and triticale), Affinity Force Herbicide should always be tank mixed with formulations of MCPA amine. When used in pyrethrum crops
the product will be used alone or in tank mixes with other herbicides registered for use in pyrethrum.
42079 Page 1 of 5 KP25S_F39 Version: 2 Issued: 14/08/2007
Carfentrazone-ethyl is exempt from poisons scheduling and has an ADI of 0.03 mg/kg bw/d based on a NOEL of 3 mg/kg bw/d derived from a rat
carcinogenicity study and a safety factor of 100.
No toxicological studies on the product were included in the submission, however the product was bridged to a previously evaluated product with the same
concentration of active. The bridging product has a higher concentration of irritating excipients than Affinity Force Herbicide and was considered an
acceptable comparison. The potential toxicological effects of the product were estimated from the known toxicological profiles of carfentrazone-ethyl, that
of the bridging product and the excipients.
Based on the toxicity estimation, the product is likely to have low acute oral, dermal and inhalation toxicity. It is expected to be a slight skin and moderate
eye irritant. Personal Protective Equipment (PPE) were recommended based on an assessment of the potential risks associated with acute exposure and
repeat-dose exposure that relied upon the Pesticide Handler Exposure Database (PHED) Surrogate Exposure Guide.
The information on the product provided and considered in this assessment justify the safety directions established in the present evaluation. Furthermore,
the proposed use of Affinity Force Herbicide will not be an undue health hazard to humans according to the criteria stipulated in Section 14 (5)(e) of the
Ag/Vet Code Act of 1994.
Data relied on to provide the advice
Inherited
Data Data Author(s) Title Date Data Type Data Sub-type Authorising Application
No Source* Party No.
State/External Efficacy Reviewer
The proposed product Affinity Force Herbicide (Affinity Force) contains the same active, claims for use and label instructions as the registered reference
product Affinity 400 DF Herbicide (Affinity DF).
Data were provided to establish that products (Affinity Force and Affinity DF) are bioequivalent.
Five efficacy and crop safety field trials were conducted on four different wheat cultivars during 2002 and 2003. They compared the efficacy and crop safety
of Affinity Force and Affinity DF for control of the target weeds bifora, bedstraw, field peas, lentils, faba beans and wild radish when applied at label rates.
Crop safety was further assessed in a cereal cultivar tolerance trial during 2003 in which six wheat, four barley and three triticale cultivars were tested
against Affinity Force and Affinity DF.
Efficacy results against the target weeds ranged from 80-100% control (dry conditions affected some trials) and were equivalent for both Affinity Force and
Affinity DF. Crop safety results showed some minor transient leaf spotting in these wheat trials but yield was improved or unaffected compared to the
untreated controls.
The crop tolerance trial results in wheat and barley showed no yield effects at both the 1x and 2x rates for both Affinity products. Results in triticale were
inconsistent and may be explained as a site effect as no phytotoxicity was evident but some significant yield reduction occurred with both Affinity products.
On balance it is considered that crop safety for both Affinity products is equivalent and is expected to be acceptable for Affinity Force on winter cereals and
pyrethrum as claimed on the label.
42079 Page 2 of 5 KP25S_F39 Version: 2 Issued: 14/08/2007
All the trials used suitable methodology and were conducted in situations equivalent to commercial practice throughout the cereal growing regions of SA,
WA and NSW. All trials used Randomised Complete Block design, with the exception of the crop tolerance trial which used Factorial Split Plot Design,
with three replicates and untreated controls. The formulations tested and rates used were relevant and appropriate to Affinity Force and Affinity DF. The
weed densities (low to high) and growth stages (cotyledon to 8 leaf) in the trials were sufficient to significantly challenge the herbicide and were equivalent
to label claims. The crop stages at treatment application in the trials varied from three leaf to early tillering and are consistent with label claims.
The data presented demonstrate that the efficacy and crop safety of Affinity Force and Affinity DF are equivalent when used under the proposed label
instructions and support the registration of Affinity Force Herbicide.
Data relied on to provide the advice
Inherited
Data Data Author(s) Title Date Data Type Data Sub-type Authorising Application
No Source* Party No.
141 I Anon Site 3 - Werrin Farms 1 2002 Efficacy and Safety Efficacy Botanical 36154
Resources
Australia Pty
Ltd
14132 S Steve Pettenon/ Chad Affinity Formulation Comparison. Watheroo, March Efficacy and Safety Efficacy Applicant
Sayer Western Australia, 2002 2003
142 I Anon Site 3 - Bonney 2003 Efficacy and Safety Efficacy Botanical 36154
Resources
Australia Pty
Ltd
14131 S Chad Sayer Affinity - WG verses EW. Grass Valley, March Efficacy and Safety Efficacy Applicant
Western Australia, 2003 2004
1577 I Anon. Trial 6 - Early Post-emergence Sassafras 2001 Efficacy and Safety Efficacy Botanical 36154
Resources
Australia Pty
Ltd
14130 S Richard Porter Affinity 400 DF: Control of Pulse Crop Beans, Decemb Efficacy and Safety Efficacy Applicant
Peas, Lentils, and Bedstraw in Frame Wheat er 2002
Maitland, South Australia, 2002
14128 S Richard Porter Affinity 400D: Formulation Comparison Port Decemb Efficacy and Safety Efficacy Applicant
Clinton,South Australia, 2002 er 2002
1576 I Anon. Site 10 - Johnson 2003 Efficacy and Safety Efficacy Botanical 36154
Resources
Australia Pty
Ltd
42079 Page 3 of 5 KP25S_F39 Version: 2 Issued: 14/08/2007
138 I Anon Affinity WG: versus EW, control of stinging Aug Efficacy and Safety Efficacy Nufarm 36154
nettles Urtica urens in wheat 2002 Australia Ltd
1572 I Anon. Site 4 - Loane 2003 Efficacy and Safety Efficacy Botanical 36154
Resources
Australia Pty
Ltd
1578 I Anon. Site 2 - Kindred 2002 Efficacy and Safety Efficacy Botanical 36154
Resources
Australia Pty
Ltd
1573 I Anon. Site 5 - Brett Connors 2003 Efficacy and Safety Efficacy Botanical 36154
Resources
Australia Pty
Ltd
139 I MacLennan, A Affinity EW v's WG Sept Efficacy and Safety Efficacy Nufarm 36154
2003 Australia Ltd
14129 S Richard Porter Affinity 400 DF VS EW and WG Formulations Decemb Efficacy and Safety Efficacy Applicant
for the control of Bifora in Durum Wheat at er 2002
Ninnes, South Australia, 2002
137 I Porter, R Evaluation of Affinity plus MCPA amine for 5 Feb Efficacy and Safety Efficacy Nufarm 36154
control of volunteer pulse species and wild 2004 Australia Ltd
radish in barley when used alone and in
combination with various partner herbicides.
1574 I Anon. Site 8 - Laurie Connors 2003 Efficacy and Safety Efficacy Botanical 36154
Resources
Australia Pty
Ltd
1575 I Anon. Site 1 - Wright 2003 Efficacy and Safety Efficacy Botanical 36154
Resources
Australia Pty
Ltd
143 I Hills, J and Goss, S Weed management in pyrethrum 2002-2003. 2002/20 Efficacy and Safety Phytotoxicity and HRDC 36154
The effect of time of herbicide application on 03 Crop Safety
crop safety
14133 S David Lockley, Nufarm Australia Ltd 2003 Results Cultivar X March Efficacy and Safety Phytotoxicity and Applicant
Deirdre Lemerle & Herbicide Screening. 2004 Crop Safety
Bill Littlewood
140 I Anon. Site 5 - Werrin Farms 2 2002 Efficacy and Safety Phytotoxicity and Botanical 36154
Crop Safety Resources
42079 Page 4 of 5 KP25S_F39 Version: 2 Issued: 14/08/2007
Australia Pty
Ltd
Other Details About The APVMA’s Decision To Grant The Application
[Details]
* S = Data submitted with the application
I = Data inherited (that is, referenced) from another application
42079 Page 5 of 5 KP25S_F39 Version: 2 Issued: 14/08/2007
