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Gazette APVMA 2, 7 February 2006 page 16
NOTICEAminopyralid
in the product: HOTSHOT HERBICIDE
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Dow AgroSciences Australia limited for registration of a new product containing the active constituent aminopyralid in combination with another currently approved active fluroxypyr. The product, HOTSHOT HERBICIDE, is for the control of climbing buckwheat and other broadleaf weeds in winter cereals, lantana and other woody weeds in pastures and non-pasture situations.
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
Product Name: HOTSHOT HERBICIDE
Applicant Company: Dow AgroSciences Australia Ltd
Active Constituents: aminopyralid, fluroxypyr
Poisons Scheduling: Schedule 6
Statement of claims: For the control of climbing buckwheat and other broadleaf weeds in winter cereals, lantana & pasture
Pack sizes: 5L, 10L, 20L & 110L
Summary of the APVMA’s evaluation of HOTSHOT 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 HOTSHOT HERBICIDE would not be an undue hazard to the safety of people exposed to it during its handling and use.
The Department of Health and Ageing, Office of Chemical Safety (Occupational Health and Safety) [OCS (OHS)] section has conducted a risk assessment on HOTSHOT HERBICIDE and concluded that it can be used safely.
Aminopyralid has low oral and dermal toxicity in rats. It is non-irritating to rabbit skin and non-sensitising to guinea pig skin. Aminopyralid is, however, a severe eye irritant in rabbits. Safety directions designed to manage this risk are included on the proposed product label.
The product will be formulated in New Zealand and will be packaged in fluorinated high-density polyethylene (HDPE) containers.
HOTSHOT HERBICIDE is determined to be a hazardous substance according to the NOHSC Approved Criteria for Classifying Hazardous Substances.
The APVMA has considered the OCS (OHS) assessment and accepts its findings and recommendations.
(ii) The APVMA is satisfied that the proposed use of HOTSHOT 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 are recommended for aminopyralid and fluroxypyr in HOTSHOT HERBICIDE when used on cereals and pastures.
The recommended WHPs are stated on the draft label. Aminopyralid MRLs are recommended for cereal grains (0.1 mg/kg), wheat bran unprocessed (0.3 mg/kg), edible offal (mammalian) [except kidney] (0.02 mg/kg) and kidney (mammalian) (0.3 mg/kg). Detectable residues of aminopyralid are not expected to occur in other animal commodities and MRLs of *0.01 mg/kg are recommended for meat, milk and eggs.
With respect to fluroxypyr, the existing MRL for cereal grains of 0.2 mg/kg is supported. The Edible offal MRL of 2 mg/kg is amended to MRLs for Kidney (mammalian) of 1 mg/kg and Edible offal (mammalian) [except kidney] of 0.1 mg/kg. The mammalian meat MRL of 0.1 mg/kg is amended to Meat (mammalian) [in the fat] of 0.1 mg/kg. Existing animal commodity MRLs for milk (0.1 mg/kg), eggs (*0.01 mg/kg), poultry offal and meat (*0.05 mg/kg) remain unamended.
(iii) The APVMA is satisfied that the proposed use of the active constituent aminopyralid in HOTSHOT HERBICIDE is not likely to be harmful to human beings if used according to the product label directions.
The proposed product has been assessed by the National Drugs and Poisons Scheduling Committee and has been placed in Schedule 6 of the SUSDP. The appropriate Signal Heading is on the label. First Aid and Safety Directions (hazard statements) for aminopyralid and HOTSHOT HERBICIDE have been recommended by the Commonwealth Department of Health and Ageing, OCS (Toxicology) section, and have been included on the draft label.
The APVMA has considered the findings of its advisers on this criterion and accepts their recommendations.
(iv) The APVMA is satisfied that the proposed use of new product HOTSHOT HERBICIDE, containing the new active constituent aminopyralid, would not be 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 (DEH) has assessed the data submitted in support of the registration of HOTSHOT HERBICIDE. Assessment indicates that aminopyralid is likely to be slightly persistent in most soils, degrading mainly through microbial metabolism. Some leaching from surface soils may occur, as aminopyralid is highly mobile in soils. Volatilisation is expected to be negligible. Aminopyralid has low toxicity to most non-target organisms but is highly toxic to some plants.
Modelling undertaken by DEH 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 the Department of the Environment and Heritage and accepts its recommendations on this criterion.
(iv) The APVMA is satisfied that the proposed use of aminopyralid in HOTSHOT HERBICIDE would not adversely affect trade between Australia and places outside Australia.
The proposed Australian cereal grains MRL for aminopyralid is similar to the MRL established in the USA. Aminopyralid is scheduled for review by JMPR in October 2006 and interim MRLs will be in the step process for ratification by the Codex Commission in 2007. Comment is sought on the likelihood that low, albeit detectable residues of aminopyralid will unduly prejudice Australian trade in wheat and other cereal grains.
Residues of fluroxypyr will be similar to the existing MRLs established for fluroxypyr. The proposed MRL amendments are considered to be minor and not expected to alter the current trade situation arising from fluroxypyr residues in cereal grains and animal commodities.
Grazing and stockfeed intervals will apply to forage of cereal grains. The likelihood of residues exceeding the recommended animal commodity MRLs as a result of livestock feeding on forage and/or fodder and straw and/or grain is considered to be small.
The APVMA has considered the need for an export slaughter interval (ESI) for livestock that have been exposed to HOTSHOT HERBICIDE through treated cereals or pastures and has determined that an ESI of 3 days is required.
The risk to Australia’s export trade in animal commodities is considered to be low when used according to the label directions.
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 HOTSHOT HERBICIDE adequately demonstrate that under Australian conditions, this product will be effective for the proposed uses.
Public Release Summary
A Public Release Summary (PRS) of the evaluation is available on the APVMA website, www.apvma.gov.au or by contacting David Hutchison on telephone (02) 6271 6384. Submissions on the APVMA’s proposal to grant the application for registration should be in writing and addressed to:
Ranjit Gajanayake
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 5567
Fax: (02) 6272 3218
email: ranjit.gajanayake@apvma.gov.au