Trade Advice Notice

on Triclopyr in the product Tops Plant Growth Regulator
APVMA Product Number 66481

© Australian Pesticides and Veterinary Medicines Authority 2013
ISSN: 2200-3894 (electronic)
ISBN: 978-1-922188-31-1 (electronic)
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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 of Oranges and Mandarins
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 triclopyr
2.7	Potential risk to trade
3	Conclusions

List of tables
Table 1 - Major destinations for Australian orange and mandarin exports
Table 2 - Proposed use pattern
Table 3 - Proposed Australian and overseas MRLs/tolerances for triclopyr
Table 4 - Current Food MRLs in the Maximum Residue Limit Standard (Table 1)
Table 5 - Current Animal feed Commodities in the Maximum Residue Limit Standard (Table 4)
Table 6 - Proposed changes for Tops Plant Growth Regulator in the Maximum Residue Limit Standard (Table 1)
Table 7 - Proposed changes for Tops Plant Growth Regulator in the Maximum Residue Limit Standard (Table 4)

Preface
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is an independent statutory authority with responsibility for assessing and approving agricultural and veterinary chemical products prior to their sale and use in Australia.
In undertaking this task, the APVMA works in close cooperation with advisory agencies, including the Department of Health and Aging, Office of Chemical Safety (OCS), Department of Sustainability Environment, Water, Population and Communities (DSEWPaC), and State Departments of Primary Industry.
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 all proposed extensions of use for existing products where there may be trade implications.
The information and technical data required by the APVMA to assess the safety of chemical products and the methods of assessment must be undertaken according to accepted scientific principles. Details are outlined in the APVMA’s publication Ag MORAG: Manual of Requirements and Guidelines. 
About this document
This is a Trade Advice Notice. 
It indicates that the Australian Pesticides and Veterinary Medicines Authority (APVMA) is considering an application for registration of an 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.
Any advice the APVMA receives through this consultation which it relies on to grant this application will be noted in a subsequent Advice Summary. 
Advice Summaries can be found on the APVMA website: www.apvma.gov.au
Making a submission
The APVMA invites any person to submit a relevant written submission as to whether the application to registration of Tops Plant Growth Regulator should 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. These grounds relate to the trade implications of the extended use of the product. Submissions should state the grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA.
Submissions must be received by the APVMA by close of business on 28 May 2013 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: 
Pesticide Contact Officer 
Pesticide 
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Symonston ACT 2609

Phone:	+61 2 6210 4748
Fax:	+61 2 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 Agriphar S.A., to register Tops Plant Growth Regulator for thinning and increasing fruit size in oranges and mandarins.

2	Trade Considerations
2.1	Commodities exported
Oranges and mandarins are exported, and are considered major export commodities (in Appendix 1 of Part 5B of Manual of Requirements and Guidelines for Agricultural Products). A new MRL is proposed for citrus fruit. Registration of the product for reducing fruit drop in lychees is also proposed. Lychees are not considered to be a major export commodity and they will not be discussed further. 
Mammalian animal commodities derived from stock fed dried citrus pulp from treated oranges and mandarins may be exported. No changes are required to existing MRLs for animal commodities, and residues in livestock consuming treated feed (dried citrus pulp) connected with the proposed use pattern are expected to be lower than residues arising from existing use patterns such as grazing of pasture, forestry and other non-cropping areas treated by broadacre application at rates up to 2.88 kg ai/ha for control of woody weeds. Residues in animal commodities will therefore not be considered further. 
2.2	Destination and value of exports of Oranges and Mandarins
Exports of Australian oranges and mandarins are detailed below (Agricultural Commodity Statistics 2012, Australian Bureau of Agriculture and Resource Economics and Sciences, Commonwealth of Australia).
Total exports of navel oranges from Australia in 2011/12 were 99.87 kilotonnes, at a value of $96.2 million, while total exports of Valencia oranges were 16.31 kilotonnes, at a value of $12.1 million. Total mandarin exports in 2011/12 were 32.58 kilotonnes, worth $46.0 million.
Table 1 - Major destinations for Australian orange and mandarin exports
COMMODITY	MAJOR DESTINATIONS	
Oranges	Japan, Hong Kong, Malaysia, Singapore, Indonesia, United Arab Emirates, New Zealand, India, Canada, Papua New Guinea, Thailand, USA	
Mandarins	New Zealand, Indonesia, United Arab Emirates, Taiwan, Thailand, Hong Kong, Singapore, USA, Japan, Russia	
2.3	Proposed Australian use-pattern
Table 2 - Proposed use pattern
Crop	Situation	Rate	Critical Comments	
Oranges and mandarins	Thinning and increasing fruit size	1–2 tablets per 100 L (1–2 g ai/100 L)	Apply once only per season with a suitable sprayer.
Thinning:
Oranges: apply when mean fruitlet diameter is 10–20 mm
Mandarins: apply when mean fruitlet diameter is 8–10 mm
Fruit sizing effect only:
Apply when natural fruit thinning has finished, when average fruit diameters are 26–28 mm (oranges) or 18–20 mm (mandarins). 
Use the higher standard rate if the fruit diameter is at the larger end of the stated range. 	
General instructions
Application: Apply by conventional airblast, oscillating boom or multi fan sprayer with direct blast axial fan, as a high volume spray to drip-off point. 
Drift warning: DO NOT apply under meteorological conditions or from spraying equipment which could be expected to cause spray to drift onto adjacent crops, crop lands, pastures or livestock. 
Withholding periods:
Harvest (oranges and mandarins): 	Not required when used as directed. 
2.4	Results from residues trials presented to the APVMA
Oranges and mandarins:
The combined data set for oranges and mandarins treated at or within ±30% of the proposed GAP is <0.01, <0.025, <0.05 (15), 0.054, 0.055, 0.07 and 0.083 mg/kg (STMR = 0.05 mg/kg). 
An MRL of 0.2 mg/kg is recommended for triclopyr in citrus fruit. A harvest withholding period is not required when the product is used as directed. 
A citrus processing study was not provided with the application. An MRL for dried citrus pulp, which can be used as a stockfeed, was calculated theoretically. 
Fresh citrus pulp after juice manufacture comprises 50–70% of the fresh weight of the fruit. Drying typically reduces the water content of the citrus pulp from 80% to around 11%1. 
The HR value for triclopyr in citrus fruit is 0.083 mg/kg, while the STMR value is 0.05 mg/kg. Assuming all the residue partitions into the citrus pulp rather than the juice, and assuming a worst case from a residue perspective of the pulp comprising 50% of the weight of the fresh fruit gives HR and STMR values for the fresh citrus pulp of 0.166 and 0.10 mg/kg respectively. Based on the water content of 80% for fresh citrus pulp (see above), the HR and STMR values for dried citrus pulp are 0.83 and 0.5 mg/kg respectively. 
An MRL of 2 mg/kg is proposed for triclopyr in dried citrus pulp. 
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.
Triclopyr has not been evaluated by Codex. 
The following relevant residue tolerances for triclopyr in citrus fruit have been established:
Table 3 - Proposed Australian and overseas MRLs/tolerances for triclopyr
Country	Commodity	Tolerance, mg/kg	Reference	
Australia	Citrus fruit	0.2	Proposed by APVMA. 	
Japan	Orange (including navel orange)	0.1	Japan Ministry of Health, Labour and Welfare, www.mhlw.go.jp; Japan Food Chemical Research Foundation	
	Other citrus fruits	0.1		
	Other fruits	0.03		
Korea	Mandarin	0.1	MRLs for Pesticides in Foods, www.kfda.go.kr 	
EU	Mandarins	*0.1	EU Pesticides Database. 	
	Oranges	*0.1		
2.6	Current and proposed Australian MRLs for triclopyr
The Australian residue definition for triclopyr is:
Triclopyr.
Table 4 - Current Food MRLs in the Maximum Residue Limit Standard (Table 1)
Compound	Food	MRL (mg/kg)	
Triclopyr	MO	0812	Cattle, edible offal of	5	
	MM	0812	Cattle meat [in the fat]	0.2	
	FC 	0001	Citrus fruits	T0.1	
	PE	0112	Eggs	*0.05	
	MO	0814	Goat, edible offal of	5	
	MM	0814	Goat meat [in the fat]	0.2	
	ML	0106	Milks [in the fat]	0.1	
	SO	0698	Poppy seed	T*0.01	
	PO	0111	Poultry, edible offal of	*0.05	
	PM	0110	Poultry meat [in the fat]	*0.05	
	MO	0822	Sheep, edible offal of	5	
	MM	0822	Sheep meat [in the fat]	0.2	
	GC	0651	Sorghum	*0.1	
Table 5 - Current Animal feed Commodities in the Maximum Residue Limit Standard (Table 4)
Compound	Animal feed commodity	MRL (mg/kg)	
Triclopyr				
	AS	0651	Sorghum straw and fodder (dry)	*0.1	
Table 6 - Proposed changes for Tops Plant Growth Regulator in the Maximum Residue Limit Standard (Table 1)
Compound	Food	MRL (mg/kg)	
Triclopyr				
DELETE:	FC	0001	Citrus fruit	T0.1	
				
ADD:	FC	0001	Citrus fruit	0.2	
	FI	0343	Litchi	0.1	
Table 7 - Proposed changes for Tops Plant Growth Regulator in the Maximum Residue Limit Standard (Table 4) 
Compound	Animal feed commodity	MRL (mg/kg)	
Triclopyr				
ADD:	AB	0001	Citrus pulp, dry	2	
				
2.7	Potential risk to trade
Export of treated produce containing finite (measurable) residues of triclopyr 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.
Oranges and mandarins
There is a potential risk to Australian trade in oranges and mandarins, as there is a possibility of finding finite residues of triclopyr in treated fruit at low levels. An MRL of 0.2 mg/kg is proposed for triclopyr in citrus fruit. Not all overseas markets have established tolerances for triclopyr in citrus fruit.
Stakeholders are requested to provide comment on the potential risks to trade in oranges and mandarins.

3	Conclusions
Comments are sought on the potential for Tops Plant Growth Regulator to unduly prejudice Australian export trade in oranges and mandarins when it is used for thinning and fruit sizing.