Trade Advice Notice

on Terbuthylazine in the Product Terbyne 750 WG Herbicide
APVMA Product Number P56973

 Australian Pesticides and Veterinary Medicines Authority 2012
This work is copyright. Requests and inquiries concerning reproduction and rights can be made to:
The Manager, Public Affairs
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182 
KINGSTON ACT 2604
Australia
Email: communications@apvma.gov.au
ISSN: 1443-1335 
ISBN: 978-0-9873529-0-3
This document is published by the APVMA. In referencing this document the APVMA should be cited as both author and publisher.
This publication is available from the APVMA website: www.apvma.gov.au

Contents
Preface
About this document
Making a submission
Further information
1	Introduction
2	Trade Considerations
2.1	Commodities exported
2.2	Destination and value of exports
2.3	Proposed Australian use-pattern
2.4	Results from residues trials presented to the APVMA
2.5	Codex alimentarius commission and overseas MRLs
2.6	Current and proposed Australian MRLs for terbuthylazine
2.7	Potential risk to trade
3	Conclusions

List of tables
Table 1:	Value of Australian Cereal Exports 2006-07 to 2010-11
Table 2:	Major export markets for Australian sorghum, 2010-2011 financial year
Table 3:	Destination and value of Australian dairy exports
Table 4:	Proposed use pattern
Table 5:	Current relevant entries in the MRL Standard – Table 1, Table 3 and Table 4
Table 6:	 Proposed changes to the MRL Standard – Table1, Table 4

Preface
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the Australian Government regulator with responsibility for assessing and approving agricultural and veterinary chemical products prior to their sale and use in Australia.
The APVMA has a policy of encouraging openness and transparency in its activities and of seeking stakeholder involvement in decision making. Part of that process is the publication of Trade Advice Notices for proposed extensions of use for existing chemicals where there may be trade implications, as defined in Ag MORAG: Manual of Requirements and Guidelines Part 5B.
About this document
This is a Trade Advice Notice. 
It indicates that the Australian Pesticides and Veterinary Medicines Authority (APVMA) is considering an application to vary the use of an existing registered agricultural or veterinary chemical. It provides a summary of the APVMA’s residue and trade assessment.
Comment is sought from industry groups and stakeholders on the information contained within this document.
Making a submission
The APVMA invites any person to submit a relevant written submission as to whether the application to vary the registration of Terbyne 750 WG Herbicide containing the existing active constituent terbuthylazine be granted. Submissions should relate only to matters that the APVMA is required by legislation to take into account in deciding whether to grant the application. In relation to this document, these grounds relate to the trade implications of the extended use of the product. Comments received outside these grounds cannot be considered by the APVMA.
Submissions must be received by the APVMA by close of business on 26th July 2012 and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.
Relevant comments will be taken into account by the APVMA in deciding whether to grant the application and in determining appropriate conditions of registration and product labelling. 
When making a submission please include:
•	Contact name
•	Company or Group name (if relevant)
•	Postal Address
•	Email Address (if available)
•	The date you made the submission.
All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially. 
Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for registration should be addressed in writing to: 
Contact Officer, Pesticides
Pesticides Program 
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604

Phone:	(02) 6210 4748
Fax:	(02) 6210 4776
Email:	pesticides@apvma.gov.au
Further information
Further information can be obtained via the contact details provided above. 
Further information on trade advice notices can be found on the APVMA website: www.apvma.gov.au

1	Introduction
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Sipcam Pacific Australia Pty Ltd to vary the registration of the product, Terbyne 750 WG Herbicide, containing 750 g/kg terbuthylazine, to extend the directions for use to include pre-sowing and pre and post-emergence use in sorghum for the control and suppression of various broadleaf and grass weeds. The proposed extensions of use require the establishment of permanent MRLs for terbuthylazine in sorghum.
The proposed use also involves the addition of 500-750 mL/ha of Acclaim (200g /L fluroxypyr). Acclaim is currently registered for use on sorghum at rates of 500-750 mL/ha from 8 leaf to boot stage and no further consideration of fluroxypyr residues is necessary.
Sorghum is exported along with animals that have been fed feeds containing residues arising from the proposed use. The potential for terbuthylazine residues in sorghum and animal commodities to unduly prejudice trade is discussed below.  

2	Trade Considerations
2.1	Commodities exported
Sorghum is considered to be a major export commodity, as are commodities of animal origin, such as meat, offal and dairy products, which may be derived from livestock feeding on treated animal feeds. Residues in these commodities resulting from the use of Terbyne 750 WG Herbicide have the potential to unduly prejudice trade.
2.2	Destination and value of exports
Sorghum
Export volumes and values for cereals, are tabulated below.
Table 1:	Value of Australian Cereal Exports 2006-07 to 2010-11
Commodity	Export Value ($ million)	
	2006-07	2007-08	2008-09	2009-10	2010-2011	
Wheat (including flour)	2315	3354	5116	3778	5867	
Barley (including malt)	833	1496	1321	1093	1295	
Oats	20	37	64	53	37	
Sorghum	13	76	405	116	146	
Maize	9	11	30	19	15	
Triticale	44	113	93	120	149	
Source: Australian Bureau of Agricultural and Resource Economics (ABARE), Australian commodity statistics, 2011	

Table 2:	Major export markets for Australian sorghum, 2010-2011 financial year
Export commodity	key export market	exports (kilo tonne)	
Sorghum	Japan	409	
	New Zealand	42	
	Papua New Guinea	18	
	Chinese Taipei	16	

Animal Commodities
The significant export markets for Australian meat, kidney and liver are listed in Appendix 3 of Part 5B of Ag MORAG. The destination and value of Australian dairy exports are summarised in Table 1 below.
Table 3:	Destination and value of Australian dairy exports
Destination	VALUE of Australian exports of dairy products, by destination ($ million)	
	2002-03	2003-04	2004-05	2005-06	2006-07	2007-08	2008-09	
Cheese	
Japan	272.0	299.6	378.9	298.5	337.9	426.7	398.9	
Saudi Arabia	98.9	69.0	81.5	103.5	86.7	89.7	30.6	
United States	36.1	33.9	45.4	54.2	52.7	37.2	59.7	
Other	393.3	336.7	370.9	381.0	346.9	414.8	306.9	
Total	800.3	739.2	876.7	837.2	824.2	968.4	796.1	
BUTTER and butter fat	
Egypt	18.9	6.4	10.5	12.5	13.9	5.0	22.0	
Malaysia	12.7	13.5	11.6	15.8	11.0	17.4	14.0	
Singapore	15.5	18.2	16.8	21.1	14.4	26.2	20.2	
Other	176.9	144.8	149.6	175.3	139.3	146.0	175.9	
Total	224.0	182.9	188.5	224.7	178.6	194.6	232.1	
SKIM milk powder	
Malaysia	51.4	52.7	64.2	77.1	72.2	63.4	49.0	
Philippines	71.8	60.1	49.4	72.0	46.1	64.1	99.7	
Singapore	38.4	42.4	57.8	56.1	67.1	61.8	54.0	
Other	246.9	232.3	248.7	323.7	319.6	343.9	350.2	
Total	408.5	387.5	420.1	528.9	505.0	533.2	552.9	

Casein	
Japan	20.6	23.3	23.1	30.4	31.8	38.4	43.6	
United States	81.4	68.8	56.6	27.3	32.4	42.2	29.5	
Other	26.4	30.5	36.5	31.3	49.3	44.2	34.4	
Total	128.4	122.5	116.2	89.0	113.5	124.8	107.5	
WHOLEMILK powder	
Malaysia	22.3	28.9	33.1	23.8	14.5	27.3	14.9	
Singapore	25.2	21.4	30.9	44.6	41.4	88.9	77.0	
Taiwan	44.9	40.0	31.5	22.8	13.5	11.8	9.3	
Other	284.4	231.6	228.9	242.4	205.4	264.1	374.2	
Total	379.8	321.8	324.4	333.6	274.9	392.2	475.3	
OTHER products	
Fresh milk	98.2	104.0	108.8	107.3	96.3	83.6	102.1	
Other fresh products	5.6	9.6	9.1	6.3	11.8	12.0	0.4	
Condensed milk	133.3	121.0	139.8	147.5	156.9	152.4	158.9	
Other powders	274.4	257.3	248.3	241.5	211.0	247.4	249.7	
Total	511.5	492.0	506.0	502.6	476.0	495.5	511.1	
Total dairy products	2,453	2,246	2,432	5,516	2,372	2,709	2,675	
Source: ABARE, Australian commodity statistics 2009, Canberra	

2.3	Proposed Australian use-pattern
The proposed Australian use pattern for Terbyne 750 WG Herbicide (750 g/kg terbuthylazine) in sorghum is summarised below.  
Table 4:	Proposed use pattern 
Terbyne 750 WG Herbicide (750 g/kg terbuthylazine)
RESTRAINTS:
DO NOT apply by air.
DO NOT apply to waterlogged soil.
DO NOT apply if heavy rains or storms that are likely to cause surface runoff are forecast within two days of application.
DO NOT irrigate to the point of runoff for at least 2 days after application.
DO NOT use as a pre-emergence application in sorghum during the wet season in the Northern Irrigation areas of Western Australia.
DO NOT apply more than 1.4 kg/ha per crop.
Crop	Situation	Weeds	Rate (kg/ha)	Critical Comments	
Sorghum	Pre-Sowing AND
Post-Sowing Pre-Emergence	Bladder ketmia, caltrop (yellow vine), dwarf amaranth, milk thistle (sow thistle) and pigweed	1.4	Apply to soil pre-sowing or post-sowing. Refer to the APPLICATION section below. Use only with sorghum treated with Concep* II Sorghum Seed Safener.	
	Post-Emergence	Boggabri weed, noogoora burr, sow thistle (milk thistle), turnip weed, wild gooseberry.	1.4	Always add Hasten at 500 mL/100 L water. Apply up to the 5-7 leaf stage of sorghum. Refer to the Acclaim® label for complete directions and rate selection.	
		All weeds above plus-Annual ground cherry, apple of Peru, Bathurst burr, Bladder ketmia, caltrop (yellow vine), cow vine (peach vine), dwarf amaranth, giant (black) pigweed, pigweed (red), thorn apples (Datura spp)	1.1 PLUS Acclaim (200 g/L fluroxypyr) at 500-750 mL/ha		

WITHHOLDING PERIODS:
Crop	Activity	WHP	
All	Harvest	NOT REQUIRED WHEN USED AS DIRECTED	
Sorghum	Grazing	DO NOT GRAZE OR CUT FOR STOCK FOOD FOR 4 WEEKS AFTER APPLICATION.	

2.4	Results from residues trials presented to the APVMA
Sorghum
The proposed use of Terbyne 750 WG Herbicide involves application of terbuthylazine at up to 1.4 kg ai/ha per crop up until the 5-7 leaf stage of sorghum (GS 15-17). The applicant has proposed that a harvest withholding period is not required when used as directed. A grazing withholding period of 4 weeks has also been proposed.
At each trial site in the Australian trials, an application of Terbyne was made pre-emergent and a second application of Terbyne was made post emergent between the 4-8 leaf growth stage. This was done at two different rates for each trial site and involved either a pre-emergent spray at 1.05 kg ai/ha followed by a post emergent spray at 1.50 kg ai/ha (1.8× the proposed seasonal rate) or a pre-emergent spray at 1.50 kg ai/ha followed by a post emergent spray at 0.83 kg ai/ha (1.7× the proposed seasonal rate). Detectable residues (LOQ = 0.01 mg/kg, LOD = 0.005 mg/kg) of terbuthylazine were not observed in any grain sample (n = 10) at natural harvest, while residues of terbuthylazine in the stubble were <0.01 (×4) and <0.02 (×6) mg/kg. Residues of terbuthylazine in the forage 28 days after treatment were 0.043, 0.054, <0.06, 0.11, 0.26, 0.41, 0.78 and 2.98 mg/kg, on a dry weight basis.
The Spanish trials on sorghum involved a single application of terbuthylazine at a rate of 1.5 kg ai/ha (1.1× the proposed seasonal rate). At harvest, detectable residues (LOQ = 0.02 mg/kg) of terbuthylazine were not observed in any grain sample (n = 2).
Considering 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.
Animal Commodities
Cattle may be exposed to terbuthylazine in the diet from consumption of sorghum forage at up the 100% of the dietary intake. It is estimated that the worst-case dietary exposure to terbuthylazine is 2.98 ppm in the feed.
The estimated worst-case livestock burden is 3 ppm terbuthylazine in the feed. Livestock feeding studies have previously been submitted which showed no detectable residues in the milk of dairy cattle given daily doses of terbuthylazine equivalent to 15 mg/kg in feed. Additionally, residues were only detected in the liver of one animal at the LOQ when beef cattle were given daily doses equivalent to 17.5 mg/kg in the feed. Therefore detectable residues of terbuthylazine are not expected to occur in the milk, meat or offal of mammalian animals.
A feeding or metabolism study for poultry is not available. However, terbuthylazine is not expected to bio-accumulate, and residues in grain are expected to be below the limit of quantitation. Therefore, quantifiable residues of terbuthylazine are unlikely to be found in the eggs, meat or offal of poultry given feed derived from terbuthylazine-treated crops.

2.5	Codex alimentarius commission and overseas MRLs
The Codex Alimentarius Commission (Codex) is responsible for establishing Codex Maximum Residue Limits (CXLs) for pesticides. Codex CXLs are primarily intended to facilitate international trade, and accommodate differences in Good Agricultural Practice (GAP) employed by various countries. Some countries may accept Codex CXLs when importing foods.
Terbuthylazine has not been considered by Codex. The EU has established an MRL of 0.1 mg/kg for terbuthylazine in sorghum. Residues of terbuthylazine are not expected in Australian sorghum following treatment according to the proposed use pattern. Additionally, detectable residues of terbuthylazine are not expected to occur in the tissue or milk of animals that have been fed sorghum forage or fodder treated according to the proposed use.

2.6	Current and proposed Australian MRLs for terbuthylazine
Current relevant MRLs and the residue definition for terbuthylazine are presented below.  A full listing of MRLs can be found at www.apvma.gov.au/residues/standard.php. 
Table 5:	Current relevant entries in the MRL Standard – Table 1, Table 3 and Table 4
MRL Standard: Table 1
COMPOUND	FOOD	MRL (mg/kg)	
Terbuthylazine			
MO	0105	Edible offal (Mammalian)	*0.01	
PE	0112	Eggs	*0.01	
GC	0645	Maize	T*0.02	
MM	0095	Meat [mammalian]	*0.01	
ML	0106	Milks	*0.01	
PO	0111	Poultry, Edible offal of	*0.01	
PM	0110	Poultry meat	*0.01	
GC	0651	Sorghum	T*0.02	

MRL STANDARD: Table 3
COMPOUND	RESIDUE	
terbuthylazine	Terbuthylazine	

MRL Standard: Table 4
COMPOUND	ANimal feed commodity	MRL (mg/kg)	
Terbuthylazine			
AS	0645	Maize fodder	T*0.1	
AF	0645	Maize forage	T*0.1	
AF	0651	Sorghum forage (green)	T*0.1	
AS	0651	Sorghum straw and fodder, dry	T*0.1	

The following changes are proposed to Australian terbuthylazine MRLs:
Table 6:	 Proposed changes to the MRL Standard – Table1, Table 4
MRL Standard: Table 1
COMPOUND	FOOD	MRL (mg/kg)	
Terbuthylazine			
DELETE:			
GC	0651	Sorghum	T*0.02	
ADD:			
GC	0651	Sorghum	*0.01	

MRL Standard: Table 4
COMPOUND	FOOD	MRL (mg/kg)	
Terbuthylazine			
DELETE:			
AF	0651	Sorghum forage (green)	T*0.1	
AS	0651	Sorghum straw and fodder, dry	T*0.1	
ADD:			
AF	0651	Sorghum forage (green) [dry weight]	5	
AS	0651	Sorghum straw and fodder, dry	*0.02	

2.7	
Potential risk to trade
Export of treated produce containing finite (measurable) residues of terbuthylazine may pose a risk to Australian trade in situations where (i) no residue tolerance (import tolerance) is established in the importing country or (ii) where residues in Australian produce are likely to exceed a residue tolerance (import tolerance) established in the importing country.  
Terbuthylazine has not been considered by Codex, while the EU has established an MRL of 0.1 mg/kg for terbuthylazine in sorghum. Residues of terbuthylazine are not expected in Australian sorghum following application according to the proposed use pattern. Additionally, detectable residues of terbuthylazine are not expected to occur in the tissue or milk of animals that have been fed sorghum forage or fodder treated according to the proposed use. The risk to Australian trade from the proposed use of Terbyne 750 WG Herbicide on sorghum is considered to be very low.

3	Conclusions
It is proposed to establish permanent MRLs for terbuthylazine in sorghum. Comment is sought on the potential for terbuthylazine residues to prejudice Australian trade when Terbyne 750 WG Herbicide is used in sorghum for the control and suppression of various broadleaf and grass weeds and when treated feeds are fed to animals.
A more detailed technical assessment report on the evaluation of the trade implications of this chemical can be obtained by contacting the APVMA at (02) 6210 4748. Alternatively, the reports can be viewed at the APVMA Library, which is located at: 
18 Wormald Street
Symonston ACT, 2609
Office hours: 9.00am–5.00pm (EST) Monday to Friday