Download Advice Summary - Australian Pesticides and Veterinary Medicines

ADVICE SUMMARY
APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT
Product name:
DIPTEX 150 WP INSECT GROWTH REGULATOR
Applicant:
AGROCARE PTY. LTD.
Product number:
67871
Application number:
57009
Purpose of Application and Description of Use: Registration of a 150 g/kg cyromazine wettable powder product for control of sciarid and phorid fly
larvae in mushroom compost.
Active Constituent(s):
Cyromazine
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 Standard Conditions for Applications on the APVMA website.
57009
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ADVICE
Australian Government Department Of Health And Ageing, Office Of Chemical Safety (OCS)
The Acceptable Daily Intake (ADI) for cyromazine is 0.02 mg/kg bw/d, established in 1998 based on a No Observable Effect Level (NOEL) of 1.8mg/kg bw/d from a 2-year rat
dietary study. No Acute Reference Dose (ARfD) has been established for cyromazine and no data were submitted to enable an ARfD to be set.
Cyromazine is listed in Appendix B of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), as a substance considered not to require control by
scheduling due to its low toxicity.
The data package provided in the present submission comprised four acute toxicology studies on the proposed product, Diptex 150 WP Insect Growth Regulator (Diptex
150WP). The toxicology studies submitted have been conducted in accordance with contemporary test guidelines, with the exception of an eye irritation study. The data
submitted were considered to be adequate for the assessment of the acute toxicology profile of the proposed product. The data provided in the toxicity studies were relied on
by the OCS in considering whether the proposed use of the product would be an undue health hazard to humans.
Based on the studies submitted, the formulated product was of low acute oral toxicity, was a slight skin irritant, a moderate eye irritant and is not a skin sensitiser. No acute
dermal or inhalational studies were submitted with the product. Based on the acute toxicology profile of the active ingredient and those of the product excipients, it is likely to
be of low acute dermal toxicity, however is likely to be a moderate inhalational toxicant.
The toxicology data provided and considered in this assessment justify the recommendations in the present evaluation. Furthermore, the proposed use of Diptex 150WP will
not be an undue health hazard to humans according to the criteria stipulated in Section 14 of the AgVet Code Act of 1994.
57009
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Data relied on to provide the advice
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Inherited
Party
Application
No.
73815
S
R. Sornat DVM, Inga
Mrzyk MSc
Report of Toxicological studies - part 2 Acute eye
irritation / corrosion study on rabbits
June, 2003
Toxicology
Acute Eye Irritation
Studies, Product
Applicant
73816
S
Dr Bozena Wiadrowska
Acute Oral Toxicity in the Rat for the Product
Agrofarm Cyromazyna 150 WP
10 August, 2000
Toxicology
Acute Oral Studies,
Product
Applicant
73817
S
R. Sornat DVM, Inga
Mrzyk MSc
Report of Toxicological studies - part 1 Acute skin
irritation / corrosion on rabbits
June, 2003
Toxicology
Acute Skin Irritation
Studies, Product
Applicant
73818
S
R. Sornat DVM, Inga
Mrzyk MSc
Agro-Tip 150 WP Report of skin sensitization study
on guinea pigs
June, 2003
Toxicology
Acute Skin Sensitisation
Studies, Product
Applicant
Australian Government Department Of Environment And Heritage (DEH)
Agrocare Pty Ltd is seeking registration and label approval for the use of the product Diptex 150 WP Insect Growth Regulator (Diptex 150WP) for control of sciarid and phorid
fly larvae in the compost used in mushroom production. The product is a wettable powder containing the active constituent cyromazine (150 g/kg). The use in mushroom
production represents the first Australian application of cyromazine in a predominantly non-animal husbandry situation. Cyromazine is currently approved for use in Australia in
animal health protection as a feed-through insect growth regulator to control larvae of nuisance flies in poultry manure.
A summary of ecotoxicity studies in which fish, daphnia and a green algae were exposed to the formulated material was presented in addition to an expert report of an
appraisal of potential risk to bees from use of the product. New environmental fate data were not presented. The environmental risk assessment considered the risks arising
from the proposed registration and also from the use of spent mushroom compost added to soil, this latter being the significant route of potential environmental exposure. A
public domain document relating to removal of restrictions against use of treated mushroom compost as a fertiliser was provided.
DEH concluded that the registration of Diptex 150 WP for control of sciarid and phorid fly larvae in the compost used in mushroom production at 33.3 g/tonne of compost or at
spawning or from 270 to 470 g/100 m2 for after casing rates is unlikely to have a harmful environmental effect as such uses are restricted to localised areas where the compost
is prepared or within buildings when treatment is at a later stage of the mushroom growing process. These use patterns are expected to give little opportunity for off-site
movement and resultant terrestrial or aquatic exposure.
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The principal source of environmental exposure is expected to be via the use of spent mushroom compost as a soil fertiliser/amending agent. It is here that any residual
cyromazine and melamine, a relatively stable chemical formed by cyromazine degradation, will have the opportunity to enter either the soil or, via runoff, the water
compartments.
Exposure of birds to residues of both cyromazine and melamine in spent mushroom compost is expected to be negligible and the risk acceptably low.
With respect to risk to aquatic species, the spent mushroom compost is a solid material either layered onto, or dug into, the soil; consequently spraydrift is not a route of
contamination.
While runoff waters from soils treated with spent mushroom compost could carry cyromazine and melamine off-site resulting in potential exposure to aquatic organisms, the
risks to these organisms are expected to be acceptable and risk to aquatic species as a result of movement of cyromazine or melamine from spent compost into groundwater
was indicated as acceptable.
The risk to honey bees from the proposed use of cyromazine in compost preparation is expected to be negligible as the composting sites are not considered likely to contain
any significant levels of flowering plants. Bees are not, therefore, likely to be attracted to such areas. Similarly, the spent mushroom compost is considered unlikely to be
attractive to bees. Consequently, risk to honey bees and the flying, pollinating insects for which they are surrogates, is expected to be acceptable.
Earthworms will be directly exposed to residues of cyromazine and melamine present in spent mushroom compost that is used on soil. The DEH risk assessment showed that
the acute and long-term applications of spent mushroom compost that might contain residues of these two chemicals are not expected to result in unacceptable risk to
earthworms. Data and information available to the DEH indicated that the proposed use of Agro-Tip 150 WP is unlikely to have adverse effects on soil micro-organisms.
Comparison of expected cyromazine soil levels as a result of use of spent mushroom compost with available phytotoxicity endpoints indicated significant adverse phytotoxicity
effects are not expected to occur as a result of use of Agro-Tip 150 WP in the mushroom compost’s preparation. The presence of melamine in spent mushroom compost is
not expected to result in unacceptable phytotoxicity effects.
DEH recommended that the APVMA be satisfied that the proposed registration of use of Diptex 150 WP Insect Growth Regulator for control of sciarid and phorid fly larvae in
the compost used in mushroom production would not be likely to have an unintended effect that is harmful to animals, plants, or things or to the environment under s 14(1) of
the AgVet Code Act 1994 when the product is used as proposed.
57009
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Data relied on to provide the advice
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Party
86271
S
United State
Environmental Protection
Agency
Removal of Restriction Against Using Treated
Mushroom Compost as Fertilizer. Review of Field
Accumulation in Rotational Crops Study
27 January 2004
Environment Fate
Field Dissipation Soils
Public
86278
S
Anna Raszka PhD, Ewa
Nierzedska MSc,
Przemyslaw Fochtman
PhD
Evaluation of toxicological effects of preparation
Agrofarm Cyromazyna 150 WP on aquatic
organisms
November 2000
Environment
Toxicology
Aquatic Organisms Other
Applicant
86273
S
Institute of Environmental
Protection
Expert opinion on extension of application of AgroTip 150 WP and classification of toxicity for bee
28 April 2008
Environment
Toxicology
Non-target Invertebrates
(terrestrial) Bees
Applicant
Inherited
Application
No.
APVMA Chemistry And Residues Program, Residues Team
Cyromazine is currently approved for use in Australia in animal health protection as a feed-through insect growth regulator to control larvae of nuisance flies in poultry manure.
The Applicant has supplied data concerning the metabolism of cyromazine (JMPR summary report, EFSA conclusion report and two academic papers) and information
regarding analytical methods. The results of a Good Laboratory Practice (GLP) residues study in mushrooms conducted in Poland were also submitted.
A summary of metabolism studies which were conducted on celery, lettuce and tomatoes (representing leafy and fruit crop groups) showed that the common metabolism
pathway for the breakdown of cyromazine was to yield the dealkylated product melamine. Parent cyromazine and melamine represented the major part of the TRR,
accounting for 37.1%–74.0% and 10.9–45.4% respectively.
A summary of five trials conducted on non-radioactive cyromazine showed that residues did not accumulate significantly in mushrooms under normal use conditions when the
crop was grown in amended compost. Cyromazine residues were <0.05 mg/kg in mushrooms in all trials/ flushes with the exception of one trial at a target cyromazine
concentration in the compost of 10 mg ai/kg. Residues of melamine were in the range 1.5–6.6 mg/kg after application to compost at 5 mg ai/kg.
Two papers were submitted which showed the metabolism of radio-labelled cyromazine in greenhouse tomatoes and the fate of cyromazine in plants (bok choy, napa cabbage
and Chinese mustard) under environmental conditions. In both studies the only metabolite of cyromazine to be identified was melamine.
The current residue definition for cyromazine is cyromazine. The available plant metabolism, analytical methods and toxicological advice support the current residue definition
of “cyromazine”.
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A GLP residue study involving residue trials conducted on champignons has been provided in support of the application. The trials were conducted in Poland during 2010. The
highest cyromazine residues observed in champignons were 1.36 mg/kg. In additional summary data from JMPR, in which application was made to casing layer/ compost at
2.0–8.0 kg ai/ha, residues at PHIs ranging from 13–57 days ranged from 0.19–4.2 mg/kg. On the basis of the supplied data a Maximum Residue Limit (MRL) in mushrooms is
proposed at 10 mg/kg.
A Withholding period (WHP) “DO NOT HARVEST FOR 21 DAYS AFTER APPLICATION” is supported when Diptex 150 WP Insect Growth Regulator is used as proposed.
Data relied on to provide the advice
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Inherited
Party
Application
No.
73822
S
D.S. Root, T. Hongtrakul
and W.C. Dauterman
Studies on the Absorption, Residues and Metabolism
of Cyromazine in Tomatoes
22 January 1996
Residues
Crop Residues Human
Consumption
Public
73823
S
Lori O. Lim, Susan J.
Scherer, Kenneth D.
Shuler, and John P.
Toth
Disposition of Cyromazine in Plants under
Environmental Conditions
1990
Residues
Crop Residues Human
Consumption
Public
73821
S
FAO (Food and
Agriculture Organization
of the United Nations)
Cyromazine. In: Pesticide residues in food - 2007.
Report of the Joint Meeting of the FAO Panel of
Experts on Pesticide Residues in Food and the
Environment and the WHO Expert Group on Pesticide
Residues
2007
Residues
Crop Residues Human
Consumption
Public
73812
S
Edyta Mincewicz MSc
Determination of Residues of Cyromazine in
Champignons after Application of Agro-Tip 150 WP
Formulation
May, 2011
Residues
Crop Residues Human
Consumption
Applicant
73814
S
European Food Safety
Authority
Review of the existing maximum residue levels
(MRLs) for cyromazine according to Article 12 of
Regulation (EC) No 396/2005
2011
Residues
Crop Residues Human
Consumption
Public
73819
S
Assoc. Prof.Czeslaw
Slusarski, PhD, Robert
Wrzodak, MSc, Maria
Rogowska, PhD
Sampling Report. Sampling of mushrooms for residue
testing. Report Number: AGMS-A
December 2010
Residues
Crop Residues Human
Consumption
Applicant
73820
S
J. Smith and T. Boone
Determination of Cyromazine and Melamine Residues
in Crops
15 July 1983
Residues
Crop Residues Human
Consumption
Public
57009
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External Efficacy Reviewer
Two studies conducted in mushroom-growing facilities in Europe, with white button mushrooms, Agaricus biosporus were provided. The methods, study designs and
formulations were appropriate. These studies were designed to meet the guidelines of the European & Mediterranean Plant Protection Organisation (EPPO).
The applicant provided detailed reports of the two studies, which were executed in Skierniewice and Warsaw, Poland. Mushrooms were grown in plastic boxes in controlled
growing conditions in mushroom growing rooms. Diptex 150WP was either mixed with the compost (growing medium) or sprayed onto the surface of the growing medium.
The efficacy of Diptex 150WP was assessed by counting the number of Sciaridae & Phoridae flies that emerged from the compost and were captured on sticky plates in the
mushroom growing rooms. There was 80 to 100% control of flies in the boxes treated with Diptex 150WP and this was statistically significant. Diptex 150WP did not have an
adverse effect on the mushroom fruit-bodies (crop).
The data from these reports demonstrate that Diptex 150WP effectively controls Megaselia halterata (Phoridae) and Lycoriella solani (Sciaridae) under commercial growing
conditions during the cultivation of white button mushrooms. The methodology and results of these trials is considered representative of commercial mushroom growing
conditions in Australia and demonstrates that AGRO-TIP 150WP should be effective as claimed on the label, when used according to the proposed label instructions.
The APVMA accepts the advice provided in regard to the efficacy criteria.
Data relied on to provide the advice
Data
No
Data
Source*
Author(s)
Title
Date
Data Type
Data Sub-type
Authorising
Inherited
Party
Application
No.
73810
S
Maria Rogowska PhD,
Assoc Prof Czeslaw
Slusarski PhD, Robert
Wrzodak MSc
Evaluation of the biological efficacy of the plant
protection product Agro-Tip 150 WP, applied to the
casing or compost, in the control of larvae of Sciaridae
Lycoriella ingenua and larvae of Megaselia halterata
occuring in mushroom culture
2010
Efficacy and Safety
Efficacy
Applicant
73809
S
Prof. Jerzy Szwejda, Prof.
Stanislaw Ignatowicz,
Krystian Szudyga PhD
The Assesment of Biological Effectiveness Agro-Tip 150
WP Preparation Against Megaselia Haltertata Meig.
(Diptera Phoridae) and Lycoriella Solani Winn. (Diptera:
Sciaridae) in the Growing of White button mushroom
(Agaricus biosporus)
2010
Efficacy and Safety
Efficacy
Applicant
Other Details About The APVMA’s Decision To Grant The Application
Based on other information available to the APVMA the APVMA was able to be satisfied on all criteria under the AgVet Codes.
* S = Data submitted with the application
I = Data inherited (that is, referenced) from another application
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