AUSTRALIan pesticides and veterinary medicines authority

Trade Advice Notice

on Milbemectin in the Product Milbeknock Miticide
APVMA Product Number 61269

 Commonwealth of Australia 2010
This work is copyright. Apart from any use permitted under the Copyright Act 1968, no part may be reproduced without permission from the Australian Pesticides & Veterinary Medicines Authority. 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

This document is published by the APVMA. In referencing this document the APVMA should be cited as both author and publisher.

Website: This publication is available from the APVMA website: http://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	Overseas registration and approved label instructions
2.6	Codex alimentarius commission and overseas MRLs
2.7	Current and proposed Australian MRLs for milbemectin
2.8	Potential risk to trade
3	Conclusions

List of tables

Table 1: Australian Stone Fruit Exports in 2007/08 (Australian Bureau of Statistics)
Table 2: Proposed use pattern for MILBEKNOCK MITICIDE (9.3 g/L milbemectin)
Table 3: Overseas tolerances for milbemectin in relevant commodities
Table 4: Current relevant entries in the MRL Standard – Table 1, Table 3 and Table 4
Table 5: Proposed changes to the MRL Standard

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 grant the registration of MILBEKNOCK MITICIDE containing the existing active constituent milbemectin 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 4 January 2010 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: 
Kim Garsia
Evaluator, Pesticides
Pesticides Program 
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Symonston ACT 2609

Phone:	(02) 6210 4858
Fax:	(02) 6210 4776
Email:	kim.garcia@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: http://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 extend the use of the product, MILBEKNOCK MITICIDE, containing 
9.3 g/L milbemectin, to stone fruit for the control of two-spotted mite (Tetranychus urticae).
The potential for milbemectin residues in stone fruit to unduly prejudice trade is discussed below. 

2	Trade Considerations
2.1	Commodities exported
Stone fruit are considered to be a major export commodity.
2.2	Destination and value of exports
The total combined exports of Australian apricots, cherries, peaches and plums were approximately $30.62 million in the 2007-2008 financial year. The 10 largest export markets for various Australian stone fruit commodities by value are shown in the following table.
Table 1: Australian Stone Fruit Exports in 2007/08 (Australian Bureau of Statistics)
Apricots	Cherries	Peaches	Plums	
Destination	$ mill.	Destination	$ mill.	Destination	$ mill.	Destination	$ mill.	
Netherlands	0.31	Taiwan      	4.41	UAE     	0.86	Hong Kong                	4.30	
UAE	0.17	Hong Kong        	3.23	Singapore                	0.82	UK           	2.12	
Hong Kong	0.14	Singapore               	1.71	Hong Kong                	0.29	Singapore                	1.65	
France	0.11	Thailand                	1.64	Saudi Arabia             	0.27	Malaysia                 	0.69	
Belgium	0.06	Netherlands             	1.13	Malaysia                 	0.16	UAE     	0.45	
Singapore	0.03	UAE	0.56	France                   	0.16	Thailand                 	0.25	
Saudi Arabia	0.03	USA	0.43	Kuwait                   	0.14	Kuwait                   	0.25	
Canada	0.03	Malaysia                	0.42	UK           	0.13	India                    	0.19	
Russia	0.03	Japan                   	0.22	Jordan                   	0.09	Vietnam                  	0.17	
Qatar	0.02	Russia                  	0.21	Qatar                    	0.08	New Caledonia            	0.15	
Total Exports	1.05	-	15.24	-	3.46	-	10.87	

2.3	
Proposed Australian use-pattern
The proposed Australian use pattern for MILBEKNOCK MITICIDE (9.3 g/L milbemectin) is summarised below.  
Table 2: Proposed use pattern for MILBEKNOCK MITICIDE (9.3 g/L milbemectin)
Crop	Pest	Rate	Critical Comments	
Stone Fruit	Two-Spotted Mite (Tetranychus urticae)	Dilute Spraying
100-150 mL/100L plus Agral* 600 at 25 mL/100 L

(0.9-1.4 g ai/100 L)

Concentrate Spraying
Refer to the Mixing/Application section	Spray to wet foliage to near the point of run-off. Thorough coverage and penetration into the plant canopy is essential. Use the higher rate on larger mature trees with dense foliage or when a longer period of residual control is required. The lower rate should be used on smaller trees where good coverage is more easily achieved and when predators are present and Integrated Mite Control (IMC) is being practiced. Total volume of application should be 1000-200 L/ha. For best results, apply the product using dilute spraying equipment. MILBEKNOCK will control moderate to high mite populations, but in the absence of predatory mites, re-treatment with another miticide may be necessary. If re-treatment is required, use an approved miticide from a different chemical group.

Restraints:	
DO NOT apply if rainfall or irrigation is expected before the MILBEKNOCK spray has time to dry on the leaves.
DO NOT use by aerial application.
Withholding periods:
Stone Fruit: 	DO NOT harvest for 14 DAYS after application. 
Stone fruit: 	DO NOT allow livestock to graze treated area.
Export Trade Advice:
Treated crop commodities destined for export may require extra time being allowed between application and harvest, as some export markets have either no Maximum Residue Limit (MRL) or different MRL to those of Australia. Details of overseas standards and export interval can be obtained by contacting Sipcam before using this product.
Spray drift
DO NOT apply when wind speed is less than 3 or more than 20 kilometres per hour at the application site.
DO NOT apply if there are livestock, pasture or any land that is producing feed for livestock downwind from the application area and within the mandatory no-spray zone shown in the table below.
FOR GROUND APPLICATION: AIRBLAST APPLICATION	

Wind Speed Range at Time of Application	
Downwind Mandatory No-Spray Zone	

from 3 to 20 kilometres per hour	
80 m	

2.4	Results from residues trials presented to the APVMA
The applicant has proposed that a maximum concentration of 9.3 g ai/100L be allowed on stone fruit. In support of this application, the Applicant has submitted Australian residue data from 3 peach, 2 nectarine and 2 cherry trials. Overseas residue data for stone fruit was submitted from 10 US trials and 1 New Zealand trial.
At the proposed withholding period of 14 days, residues in peaches taken from the Australian trials were at the LOQ for total milbemectin of <0.02 mg/kg (n=3), in nectarines were <0.02 and 0.02 mg/kg and in cherries were also <0.02 and 0.02 mg/kg. Residues in peaches taken from the US trials, 14 days after the last application were 0.02 (n=2), and <0.04 mg/kg, in cherries were <0.02 and 0.02 mg/kg, and in plums were <0.02 (n=4) and 0.03 mg/kg. Residues in peaches taken from the NZ trial, 14 days after the last application were <0.004 mg/kg. Residues in prunes taken and processed 14 days after the last application were 0.03 mg/kg.
Residue data support the establishment of a MRL of 0.1 mg/kg for stone fruit, accompanied by a WHP of 14 days. A grazing restriction of ‘DO NOT allow livestock to graze treated area’ should also be included on the label’.
Spray drift modelling, using APVMA spray drift standard application scenarios, shows that with respect to no-spray zones for a ‘sparse orchard’ airblast application a downwind buffer of 68 m is required and for a ‘dense orchard’ a buffer of 78 m is required to ensure residues are below 0.001 mg/kg for animal commodities.

Animal Commodities
Stone fruit are not considered to be stockfeed. Vegetable by-products and waste fruit are assumed to be fed at proportions not exceeding 5% of the animal diet on a dry matter basis. The maximum dietary intake for beef cattle based on the highest residue of 0.03 mg/kg observed in plums with a dry matter content of 12% is calculated below:
Cattle- 500 kg bw, 20 kg DM/day
Commodity	% in diet	Feed intake	Residue, mg/kg	% DM
	Livestock dietary exposure	
					mg/animal	ppm 	mg/kg bw	
Plums	5	20	0.03	12	0.25	0.01	0.0005	
The Applicant had proposed a grazing withholding period to reflect the harvest withholding period; however, as no residue data for pasture or animal feed commodities or an animal transfer study have been provided a ‘DO NOT allow livestock to graze treated area’ statement should be included on the label. 
Based on a lactating goat metabolism study, residues resulting from feeding at 0.01 ppm are expected to be two orders of magnitude below analytical method LOQs for this class of compounds. However, as animal transfer studies are currently not available, animal commodity MRLs will not be established at this time.
2.5	Overseas registration and approved label instructions
The applicant indicated that milbemectin products are registered for use on unspecified commodities in the USA, EU, Japan, Taiwan, Korea, India, Thailand, Kenya, South Africa, Colombia, Ecuador, Peru, Chile, Brazil, Syria, Egypt, UAE, Israel, Mexico, New Zealand, Jordan, Turkey, Qatar, Morocco and Cyprus.
2.6	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.  Milbemectin has been considered by Codex.  Animal commodity MRLs are not currently established and are not required at this time.  The following relevant Codex CXLs and overseas residue MRLs/ tolerances have been established for milbemectin in plant commodities:

Table 3: Overseas tolerances for milbemectin in relevant commodities

Country	Plant 
Commodity	Tolerance 
( mg/kg)	Residue Definition	
Australia#	Stone fruit	0.1	Sum of milbemycin MA3 and milbemycin MA4 and their photoisomers, milbemycin (Z) 8,9-MA3 and (Z) 8,9Z-MA4	
Canada	Stone fruit	None Est.	-	
CODEX	Stone fruit	None Est.	-	
EU	Stone fruit	*0.05	Monitoring: Milbemectin (sum of MA4 +8,9Z-MA4, expressed as milbemectin)
Risk Assessment: (MA3 + 8,9Z-MA3) + (MA4 + 8,9Z-MA4), expressed as milbemectin or Monitoring RD × Conversion Factor (1.5), accounting for MA3: MA4 ratio of 3:7.	
Japan	Peach, Nectarine	0.2	Sum of residues of milbemectin A3 and milbemectin A4	
	Apricot, Japanese plum (inc. prune), Mume plum, cherry	0.5		
Korea	Stone fruit	None Est.	-	
Malaysia	Stone fruit	0.01+	-	
New Zealand	Stone fruit	*0.02	Sum of milbemycin A3, milbemycin A4, (Z)-8,9 milbemycin A3, (Z)-8,9 milbemycin A4, expressed as Milbemectin	
Taiwan	Stone fruit	None Est.	-	
US	Stone fruit	None Est.	-	
2.7	Current and proposed Australian MRLs for milbemectin
Current relevant MRLs and the residue definition for milbemectin are presented below.  A full listing of MRLs can be found at http://www.apvma.gov.au/residues/standard.php. 
Table 4: Current relevant entries in the MRL Standard – Table 1, Table 3 and Table 4
MRL Standard: Table 1
COMPOUND	FOOD	MRL (mg/kg)	
Milbemectin			
FB	0275	Strawberry	0.2	

MRL Standard: Table 3
COMPOUND	RESIDUE	
Milbemectin	Sum of milbemycin MA3 and milbemycin MA4 and their photoisomers, milbemycin (Z) 8,9-MA3 and (Z) 8,9Z-MA4	
The following changes are proposed to Australian milbemectin MRLs:
Table 5: Proposed changes to the MRL Standard
MRL Standard: Table 1
COMPOUND	FOOD	MRL (mg/kg)	
Milbemectin			
ADD:			
FS	0012	Stone fruits 	0.1	

2.8	Potential risk to trade
Export of treated produce containing finite (measurable) residues of milbemectin 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.  
The proposed MRL of 0.1 mg/kg is higher than the tolerances currently establish in the EU and NZ for stone fruit of *0.05 and *0.02 mg/kg, respectively; however is lower than those established in Japan for various stone fruit commodities (0.2 and 0.5 mg/kg). The key export markets of UAE, Hong Kong, Singapore, Taiwan and Thailand do not currently have established export tolerances.
In order to mitigate the risk to trade with countries where a lower MRL has been established, or to countries where a MRL has not yet been established, the applicant has proposed the following trade advice statement for inclusion on the product label:
‘Treated crop commodities destined for export many require extra time being allowed between application and harvest, as some export markets have either no Maximum Residue Limit (MRL) or different MRL to those of Australia. Details of overseas standards and export interval can be obtained by contacting Sipcam before using this product.’
Comment is sought on the likelihood of the changes in use for MILBEKNOCK MITICIDE to cause undue prejudice to Australian trade in stone fruit commodities.  

3	Conclusions

It is proposed to establish MRLs for Apricots, Citrus fruits, Kiwifruits, Peaches, Pome fruit and Stone fruit [except apricots and peaches]. Comment is sought on the potential for milbemectin in MILBEKNOCK MITICIDE to prejudice Australian trade when it is used on stone fruit for the control of two spotted mite.

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: 9.00 - 5.00 (EST) Monday to Friday