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Gazette APVMA 4, 4 April 2006 page 11
NOTICEPINOXADEN
in the product: [AXIAL 100EC SELECTIVE HERBICIDE]
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Syngenta Crop Production Pty Ltd for the registration of a new product containing the active constituents Pinoxaden and Cloquintocet-mexyl. The product is AXIAL 100EC SELECTIVE HERBICIDE and is for the control of grass weeds in wheat and barley.
In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for registration should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to matters outlined below that the APVMA is required to take into account in deciding whether to grant the application. Comments must be received by the APVMA within 28 days of the date of this notice.
Particulars of Application
Proposed Product Name: AXIAL 100EC SELECTIVE HERBICIDE
Applicant Company: Syngenta Crop Production Pty. Ltd.
Active Constituents: Pinoxaden, Cloquintocet-mexyl
Poisons Sheduling: Schedule 5
Statement of Claims: For the control of grass weeds in barley and
wheat
Pack sizes: 1 L; 5 L
Withholding Period:
Barley and wheat:
Harvest: Not required when used as directed.
Grazing: Do not graze or cut for stockfood
for 21 days after application.
Summary of the APVMA’s evaluation of AXIAL 100EC SELECTIVE HERBICIDE in accordance with Section 14(3)(e) and (f) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994
The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under section 14(3)(e) of the Agvet Code, it proposes to determine that:
(i) The APVMA is satisfied that the proposed use of AXIAL 100EC SELECTIVE HERBICIDE would not be an undue hazard to the safety of people exposed to it during its handling and use.
The Office of Chemical Safety (OCS) has conducted a risk assessment on AXIAL 100EC SELECTIVE HERBICIDE and concluded that it can be used safely. Pinoxaden has low acute oral, dermal and inhalation toxicity and is not a skin irritant or skin sensitiser. Cloquintocet-mexyl is a 'safener' with low acute oral, dermal and inhalational toxicity in rats. Cloquintocet-mexyl has been previously assessed as part of other product registrations and when included in AXIAL 100EC SELECTIVE HERBICIDE is not expected to present any risks other than those already assessed and found acceptable.
The product, AXIAL 100EC SELECTIVE HERBICIDE, has a similar acute toxicity profile, except that it is a moderate skin and eye irritant. In repeat-dose studies with rats, the primary toxic effect of pinoxaden was renal toxicity with high incidences of chronic progressive nephropathy observed in a chronic study.
The APVMA having considered the findings and recommendations of the OCS evaluation accepts these findings and recommendations.
(ii) The APVMA is satisfied that the proposed use of AXIAL 100EC SELECTIVE HERBICIDE will not be an undue hazard to the safety of people using anything containing its residues. Residue data were assessed by the APVMA and Maximum Residue Limits (MRLs) and associated Withholding Periods (WHPs) are recommended for pinoxaden and cloquintocet-mexyl in Axial 100EC Selective Herbicide when used on wheat and barley.
The recommended WHPs are stated on the draft label. A cloquintocet-mexyl MRL is recommended for barley (*0.1 mg/kg) similar to the MRL established for wheat (*0.1 mg/kg). Existing animal commodity MRLs of *0.1 mg/kg remain appropriate for cloquintocet-mexyl.
Pinoxaden MRLs are recommended for wheat and barley (0.1 mg/kg); and unprocessed wheat bran (0.5 mg/kg). Detectable residues are not expected to occur in animal commodities and MRLs of *0.01 mg/kg are recommended for milk, *0.02 mg/kg for mammalian meat and offal, and *0.04 mg/kg for poultry meat, offal and eggs.
The residue definition for pinoxaden is under consideration for revision where only the relevant metabolites are included in the definition for compliance monitoring, being subject to analytical capability.
(iii) The APVMA is satisfied that the proposed use of AXIAL 100EC SELECTIVE HERBICIDE is not likely to be harmful to human beings if used according to the product label directions.
The active constituents have been evaluated and approved and the product is placed in Schedule 5 of the SUSDP. The appropriate Signal Heading appears on the label. First Aid and Safety Directions for Pinoxaden have been recommended by the Commonwealth Department of Health and Ageing and have been included on the label.
The product will be formulated overseas and imported ready to use in HDPE containers. AXIAL 100EC SELECTIVE HERBICIDE is determined to be a hazardous substance, based on NOHSC hazard classification of active and non-active constituents and product toxicology information provided.
The APVMA accepts the findings and recommendations of its advisers on these criteria.
(iv) The APVMA is satisfied that the proposed use of the new active constituent Pinoxaden in the product AXIAL 100 EC SELECTIVE HERBICIDE for the control of certain weeds in wheat and barley is not likely to have an unintended effect that is harmful to animals, plants or things, or to the environment.
The Department of the Environment and Heritage has assessed data in support of the proposed use and has concluded that the risks to the environment from the proposed use are acceptable.
Cloquintocet-mexyl has been previously assessed as part of other product registrations and when included in AXIAL 100EC SELECTIVE HERBICIDE is not expected to present any risks other than those already assessed and found acceptable. Assessment indicates that Pinoxaden is unlikely to persist in soils as it is rapidly degraded, mainly through microbial metabolism. Some leaching from surface soils may occur as pinoxaden is mobile in soils, but lysimeter studies have indicated that only low concentrations of metabolites can be detected in leachate collected at depths in the order of one metre. Volatilisation is expected to be negligible.
Pinoxaden is slightly toxic or practically nontoxic to most non-target organisms but is highly toxic to some grasses.
Modelling indicates that damage from spray drift is unlikely, particularly as the label instructs users to avoid situations in which non-target plants may be exposed to spray drift.
The APVMA has considered the findings of DEH and accepts these findings.
(v) The APVMA is satisfied that the proposed use of AXIAL 100EC SELECTIVE HERBICIDE would not adversely affect trade between Australia and places outside Australia.
Detectable residues of pinoxaden may occur in treated barley and wheat not exceeding the proposed MRL of 0.1 mg/kg. Equivalent overseas MRLs have been established in USA, Canada, UK/Europe and Japan. However, no Codex MRLs or equivalent standards have been established in other major export markets in Asia (Indonesia, Korea and China) and the Middle East (Iraq, Iran, UAE, Kuwait, Saudi Arabia). Comment is sought on the likelihood that low, albeit detectable residues of pinoxaden will unduly prejudice Australian trade in wheat and other cereal grains.
No detectable residues of Cloquintocet-mexyl are expected to occur in barley and wheat cereal grains, and therefore potential risks to trade will be low.
A grazing withholding period of 21 days after treatment will apply to AXIAL 100EC SELECTIVE HERBICIDE. The feeding of treated produce of forage, straw and grain to animals is unlikely to result in detectable residues in meat and dairy commodities. Thus, the potential risk to Australia’s export trade in animal commodities is considered to be low when used according to the label directions.
The APVMA has considered the need for export slaughter intervals (ESIs) for livestock that have been exposed to AXIAL 100EC SELECTIVE HERBICIDE through treated cereals and has determined that none are required.
In relation to its assessment of efficacy under section 14(3)(f), the APVMA proposes to determine that:
(i) The APVMA is satisfied the data from trials supporting the efficacy of AXIAL 100EC SELECTIVE HERBICIDE adequately demonstrates that under local conditions this product is effective for the proposed uses.
Public Release Summary
A Public Release Summary of the evaluation is available by contacting David Hutchison on telephone (02) 6272 6384. Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to:
Dr G.F.Smart
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 3354
Fax: (02) 6272 3218